Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations

Citation84 FR 40482
CourtCenters For Medicare & Medicaid Services
Publication Date14 Aug 2019
Record Number2019-16041
Federal Register, Volume 84 Issue 157 (Wednesday, August 14, 2019)
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
                [Proposed Rules]
                [Pages 40482-41289]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-16041]
                [[Page 40481]]
                Vol. 84
                Wednesday,
                No. 157
                August 14, 2019
                Part II
                Book 2 of 3 Books
                Pages 40481-41289
                Department of Health and Human Services
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                Centers for Medicare & Medicaid Services
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                42 CFR Parts 403, 410, 415, 416, et al.
                Medicare Program; CY 2020 Revisions to Payment Policies Under the
                Physician Fee Schedule and Other Changes to Part B Payment Policies;
                Medicare Shared Savings Program Requirements; Medicaid Promoting
                Interoperability Program Requirements for Eligible Professionals;
                Establishment of an Ambulance Data Collection System; Updates to the
                Quality Payment Program; Medicare Enrollment of Opioid Treatment
                Programs and Enhancements to Provider Enrollment Regulations Concerning
                Improper Prescribing and Patient Harm; and Amendments to Physician
                Self-Referral Law Advisory Opinion Regulations; Proposed Rules
                Federal Register / Vol. 84 , No. 157 / Wednesday, August 14, 2019 /
                Proposed Rules
                [[Page 40482]]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Medicare & Medicaid Services
                42 CFR Parts 403, 410, 414, 415, 416, 418, 424, 425, 489, and 498
                [CMS-1715-P]
                RIN 0938-AT72
                Medicare Program; CY 2020 Revisions to Payment Policies Under the
                Physician Fee Schedule and Other Changes to Part B Payment Policies;
                Medicare Shared Savings Program Requirements; Medicaid Promoting
                Interoperability Program Requirements for Eligible Professionals;
                Establishment of an Ambulance Data Collection System; Updates to the
                Quality Payment Program; Medicare Enrollment of Opioid Treatment
                Programs and Enhancements to Provider Enrollment Regulations Concerning
                Improper Prescribing and Patient Harm; and Amendments to Physician
                Self-Referral Law Advisory Opinion Regulations
                AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
                ACTION: Proposed rule.
                -----------------------------------------------------------------------
                SUMMARY: This major proposed rule addresses: Changes to the physician
                fee schedule (PFS); other changes to Medicare Part B payment policies
                to ensure that payment systems are updated to reflect changes in
                medical practice, relative value of services, and changes in the
                statute; Medicare Shared Savings Program quality reporting
                requirements; Medicaid Promoting Interoperability Program requirements
                for eligible professionals; the establishment of an ambulance data
                collection system; updates to the Quality Payment Program; Medicare
                enrollment of Opioid Treatment Programs and enhancements to provider
                enrollment regulations concerning improper prescribing and patient
                harm; and amendments to Physician Self-Referral Law advisory opinion
                regulations.
                DATES: Comment date: To be assured consideration, comments must be
                received at one of the addresses provided below, no later than 5 p.m.
                on September 27, 2019.
                ADDRESSES: In commenting, please refer to file code CMS-1715-P. Because
                of staff and resource limitations, we cannot accept comments by
                facsimile (FAX) transmission.
                    Comments, including mass comment submissions, must be submitted in
                one of the following three ways (please choose only one of the ways
                listed):
                    1. Electronically. You may submit electronic comments on this
                regulation to http://www.regulations.gov. Follow the ``Submit a
                comment'' instructions.
                    2. By regular mail. You may mail written comments to the following
                address ONLY: Centers for Medicare & Medicaid Services, Department of
                Health and Human Services, Attention: CMS-1715-P, P.O. Box 8016,
                Baltimore, MD 21244-8016.
                    Please allow sufficient time for mailed comments to be received
                before the close of the comment period.
                    3. By express or overnight mail. You may send written comments to
                the following address ONLY: Centers for Medicare & Medicaid Services,
                Department of Health and Human Services, Attention: CMS-1715-P, Mail
                Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                FURTHER INFORMATION CONTACT:
                    Jamie Hermansen, (410) 786-2064, for any issues not identified
                below.
                    Michael Soracoe, (410) 786-6312, for issues related to practice
                expense, work RVUs, conversion factor, and impacts.
                    Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-
                4735, for issues related to malpractice RVUs and geographic practice
                cost indicies (GPCIs).
                    Larry Chan, (410) 786-6864, for issues related to potentially
                misvalued services under the PFS.
                    Lindsey Baldwin, (410) 786-1694, or Emily Yoder, (410) 786-1804,
                for issues related to telehealth services.
                    Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694,
                for issues related to Medicare coverage of opioid use disorder
                treatment services furnished by opioid treatment programs (OTPs).
                    Lindsey Baldwin, (410) 786-1694, for issues related to bundled
                payments under the PFS for substance use disorders.
                    Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237,
                for issues related to the comment solicitation on opportunities for
                bundled payments under the PFS.
                    Regina Walker-Wren, (410) 786-9160, for issues related to physician
                supervision for physician assistant (PA) services and review and
                verification of medical record documentation.
                    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane
                Grayson, (410) 786-6583, or Christiane LaBonte, (410) 786-7237, for
                issues related to care management services.
                    Kathy Bryant, (410) 786-3448, for issues related to coinsurance for
                colorectal cancer screening tests.
                    Pamela West, (410) 786-2302, for issues related to therapy
                services.
                    Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or
                Christiane LaBonte, (410) 786-7237, for issues related to payment for
                evaluation and management services.
                    Kathy Bryant, (410) 786-3448, for issues related to global surgery
                data collection.
                    Thomas Kessler, (410) 786-1991, for issues related to ambulance
                physician certification statement.
                    Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542,
                for issues related to the ambulance fee schedule-BBA of 2018
                requirements for Medicare ground ambulance services data collection
                system.
                    Linda Gousis, (410) 786-8616, for issues related to intensive
                cardiac rehabilitation.
                    David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-
                3816, for issues related to the Medicaid Promoting Interoperability
                Program.
                    Fiona Larbi, (410) 786-7224, for issues related to the Medicare
                Shared Savings Program (Shared Savings Program) Quality Measures.
                    Katie Mucklow, (410) 786-0537, or Diana Behrendt, (410) 786-6192,
                for issues related to open payments.
                    Cheryl Gilbreath, (410) 786-5919, for issues related to home
                infusion therapy benefit.
                    Joseph Schultz, (410) 786-2656, for issues related to Medicare
                enrollment of opioid treatment programs, and enhancements to provider
                enrollment regulations concerning improper prescribing and patient
                harm.
                    Jacqueline Leach, (410) 786-4282, for issues related to Deferring
                to State Scope of Practice Requirements: Ambulatory Surgical Centers
                (ASC).
                    Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring
                to State Scope of Practice Requirements: Hospice.
                    [email protected], for issues related to Advisory
                Opinions on Application of the Physician Self-referral law.
                    Molly MacHarris, (410) 786-4461, for inquiries related to Merit-
                based Incentive Payment System (MIPS).
                    Megan Hyde, (410) 786-3247, for inquiries related to Alternative
                Payment Models (APMs).
                SUPPLEMENTARY INFORMATION:
                Addenda Available Only Through the Internet on the CMS Website
                    The PFS Addenda along with other supporting documents and tables
                referenced in this proposed rule are available on the CMS website at
                http://www.cms.gov/Medicare/Medicare-Fee-
                [[Page 40483]]
                for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-
                Notices.html. Click on the link on the left side of the screen titled,
                ``PFS Federal Regulations Notices'' for a chronological list of PFS
                Federal Register and other related documents. For the CY 2020 PFS
                proposed rule, refer to item CMS-1715-P. Readers with questions related
                to accessing any of the Addenda or other supporting documents
                referenced in this proposed rule and posted on the CMS website
                identified above should contact Jamie Hermansen at (410) 786-2064.
                CPT (Current Procedural Terminology) Copyright Notice
                    Throughout this proposed rule, we use CPT codes and descriptions to
                refer to a variety of services. We note that CPT codes and descriptions
                are copyright 2019 American Medical Association. All Rights Reserved.
                CPT is a registered trademark of the American Medical Association
                (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
                Federal Acquisition Regulations (DFAR) apply.
                I. Executive Summary
                A. Purpose
                    This major proposed rule proposes to revise payment polices under
                the Medicare PFS and make other policy changes, including proposals to
                implement certain provisions of the Bipartisan Budget Act of 2018 (BBA
                of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-
                Disorder Prevention that Promotes Opioid Recovery and Treatment
                (SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L.
                115-271, October 24, 2018), related to Medicare Part B payment,
                applicable to services furnished in CY 2020 and thereafter. In
                addition, this proposed rule includes proposals related to payment
                policy changes that are addressed in section III. of this proposed
                rule. We are requesting public comments on all of the proposals being
                made in this proposed rule.
                1. Summary of the Major Provisions
                    The statute requires us to establish payments under the PFS based
                on national uniform relative value units (RVUs) that account for the
                relative resources used in furnishing a service. The statute requires
                that RVUs be established for three categories of resources: Work;
                practice expense (PE); and malpractice (MP) expense. In addition, the
                statute requires that we establish by regulation each year's payment
                amounts for all physicians' services paid under the PFS, incorporating
                geographic adjustments to reflect the variations in the costs of
                furnishing services in different geographic areas.
                    In this major proposed rule, we are proposing to establish RVUs for
                CY 2020 for the PFS to ensure that our payment systems are updated to
                reflect changes in medical practice and the relative value of services,
                as well as changes in the statute. This proposed rule also includes
                discussions and proposals regarding several other Medicare Part B
                payment policies, Medicare Shared Savings Program quality reporting
                requirements, Medicaid Promoting Interoperability Program requirements
                for eligible professionals, the establishment of an ambulance data
                collection system, updates to the Quality Payment Program, Medicare
                enrollment of Opioid Treatment Programs and enhancements to provider
                enrollment regulations concerning improper prescribing and patient
                harm; and amendments to Physician Self-Referral Law advisory opinion
                regulations. This proposed rule addresses:
                 Practice Expense RVUs (section II.B.)
                 Malpractice RVUs (section II.C.)
                 Geographic Practice Cost Indices (GPCIs) (section II.D.)
                 Potentially Misvalued Services Under the PFS (section II.E.)
                 Telehealth Services (section II.F.)
                 Medicare Coverage for Opioid Use Disorder Treatment Services
                Furnished by Opioid Treatment Programs (section II.G.)
                 Bundled Payments Under the PFS for Substance Use Disorders
                (section II.H.)
                 Physician Supervision for Physician Assistant (PA) Services
                (section II.I.)
                 Review and Verification of Medical Record Documentation
                (section II.J.)
                 Care Management Services (section II.K.)
                 Coinsurance for Colorectal Cancer Screening Tests (section
                II.L.)
                 Therapy Services (section II.M.)
                 Valuation of Specific Codes (section II.N.)
                 Comment Solicitation on Opportunities for Bundled Payments
                Under the PFS (section II.O.)
                 Payment for Evaluation and Management (E/M) Services (section
                II.P.)
                 Ambulance Coverage Services--Physician Certification Statement
                (section III.A.)
                 Ambulance Fee Schedule--Medicare Ground Ambulance Services
                Data Collection System (section III.B.)
                 Intensive Cardiac Rehabilitation (section III.C.)
                 Medicaid Promoting Interoperability Program Requirements for
                Eligible Professionals (EPs) (section III.D.)
                 Medicare Shared Savings Program Quality Measures (section
                III.E.)
                 Open Payments (section III.F.)
                 Home Infusion Therapy Benefit (section III.G.)
                 Medicare Enrollment of Opioid Treatment Programs and
                Enhancements to Existing General Enrollment Policies Related to
                Improper Prescribing and Patient Harm (section III.H.)
                 Deferring to State Scope of Practice Requirements (section
                III.I.)
                 Advisory Opinions on the Application of the Physician Self-
                Referral Law (section III.J.)
                 Updates to the Quality Payment Program (section III.K.)
                2. Summary of Costs and Benefits
                    We have determined that this major proposed rule is economically
                significant. For a detailed discussion of the economic impacts, see
                section VI. of this proposed rule.
                II. Provisions of the Proposed Rule for the PFS
                A. Background
                    Since January 1, 1992, Medicare has paid for physicians' services
                under section 1848 of the Act, ``Payment for Physicians' Services.''
                The PFS relies on national relative values that are established for
                work, practice expense (PE), and malpractice (MP), which are adjusted
                for geographic cost variations. These values are multiplied by a
                conversion factor (CF) to convert the relative value units (RVUs) into
                payment rates. The concepts and methodology underlying the PFS were
                enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub.
                L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus
                Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November
                5, 1990) (OBRA '90). The final rule published in the November 25, 1991
                Federal Register (56 FR 59502) set forth the first fee schedule used
                for payment for physicians' services.
                    We note that throughout this major proposed rule, unless otherwise
                noted, the term ``practitioner'' is used to describe both physicians
                and nonphysician practitioners (NPPs) who are permitted to bill
                Medicare under the PFS for the services they furnish to Medicare
                beneficiaries.
                1. Development of the RVUs
                a. Work RVUs
                    The work RVUs established for the initial fee schedule, which was
                [[Page 40484]]
                implemented on January 1, 1992, were developed with extensive input
                from the physician community. A research team at the Harvard School of
                Public Health developed the original work RVUs for most codes under a
                cooperative agreement with the Department of Health and Human Services
                (HHS). In constructing the code-specific vignettes used in determining
                the original physician work RVUs, Harvard worked with panels of
                experts, both inside and outside the federal government, and obtained
                input from numerous physician specialty groups.
                    As specified in section 1848(c)(1)(A) of the Act, the work
                component of physicians' services means the portion of the resources
                used in furnishing the service that reflects physician time and
                intensity. We establish work RVUs for new, revised and potentially
                misvalued codes based on our review of information that generally
                includes, but is not limited to, recommendations received from the
                American Medical Association/Specialty Society Relative Value Scale
                Update Committee (RUC), the Health Care Professionals Advisory
                Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
                and other public commenters; medical literature and comparative
                databases; as well as a comparison of the work for other codes within
                the Medicare PFS, and consultation with other physicians and health
                care professionals within CMS and the federal government. We also
                assess the methodology and data used to develop the recommendations
                submitted to us by the RUC and other public commenters, and the
                rationale for their recommendations. In the CY 2011 PFS final rule with
                comment period (75 FR 73328 through 73329), we discussed a variety of
                methodologies and approaches used to develop work RVUs, including
                survey data, building blocks, crosswalk to key reference or similar
                codes, and magnitude estimation. More information on these issues is
                available in that rule.
                b. Practice Expense RVUs
                    Initially, only the work RVUs were resource-based, and the PE and
                MP RVUs were based on average allowable charges. Section 121 of the
                Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
                October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
                required us to develop resource-based PE RVUs for each physicians'
                service beginning in 1998. We were required to consider general
                categories of expenses (such as office rent and wages of personnel, but
                excluding MP expenses) comprising PEs. The PE RVUs continue to
                represent the portion of these resources involved in furnishing PFS
                services.
                    Originally, the resource-based method was to be used beginning in
                1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
                105-33, enacted on August 5, 1997) (BBA of 1997) delayed implementation
                of the resource-based PE RVU system until January 1, 1999. In addition,
                section 4505(b) of the BBA of 1997 provided for a 4-year transition
                period from the charge-based PE RVUs to the resource-based PE RVUs.
                    We established the resource-based PE RVUs for each physicians'
                service in the November 2, 1998 final rule (63 FR 58814), effective for
                services furnished in CY 1999. Based on the requirement to transition
                to a resource-based system for PE over a 4-year period, payment rates
                were not fully based upon resource-based PE RVUs until CY 2002. This
                resource-based system was based on two significant sources of actual PE
                data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's
                Socioeconomic Monitoring System (SMS) data. These data sources are
                described in greater detail in the CY 2012 PFS final rule with comment
                period (76 FR 73033).
                    Separate PE RVUs are established for services furnished in facility
                settings, such as a hospital outpatient department (HOPD) or an
                ambulatory surgical center (ASC), and in nonfacility settings, such as
                a physician's office. The nonfacility RVUs reflect all of the direct
                and indirect PEs involved in furnishing a service described by a
                particular HCPCS code. The difference, if any, in these PE RVUs
                generally results in a higher payment in the nonfacility setting
                because in the facility settings some resource costs are borne by the
                facility. Medicare's payment to the facility (such as the outpatient
                prospective payment system (OPPS) payment to the HOPD) would reflect
                costs typically incurred by the facility. Thus, payment associated with
                those specific facility resource costs is not made under the PFS.
                    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
                106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
                Health and Human Services (the Secretary) to establish a process under
                which we accept and use, to the maximum extent practicable and
                consistent with sound data practices, data collected or developed by
                entities and organizations to supplement the data we normally collect
                in determining the PE component. On May 3, 2000, we published the
                interim final rule (65 FR 25664) that set forth the criteria for the
                submission of these supplemental PE survey data. The criteria were
                modified in response to comments received, and published in the Federal
                Register (65 FR 65376) as part of a November 1, 2000 final rule. The
                PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
                and 68 FR 63196) extended the period during which we would accept these
                supplemental data through March 1, 2005.
                    In the CY 2007 PFS final rule with comment period (71 FR 69624), we
                revised the methodology for calculating direct PE RVUs from the top-
                down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
                year transition to the new PE RVUs. This transition was completed for
                CY 2010. In the CY 2010 PFS final rule with comment period, we updated
                the practice expense per hour (PE/HR) data that are used in the
                calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
                we began a 4-year transition to the new PE RVUs using the updated PE/HR
                data, which was completed for CY 2013.
                c. Malpractice RVUs
                    Section 4505(f) of the BBA of 1997 amended section 1848(c) of the
                Act to require that we implement resource-based MP RVUs for services
                furnished on or after CY 2000. The resource-based MP RVUs were
                implemented in the PFS final rule with comment period published
                November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and
                physician-owned insurers' MP insurance premium data from all the
                states, the District of Columbia, and Puerto Rico. For more information
                on MP RVUs, see section II.C. of this proposed rule, Determination of
                Malpractice Relative Value Units.
                d. Refinements to the RVUs
                    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
                less often than every 5 years. Prior to CY 2013, we conducted periodic
                reviews of work RVUs and PE RVUs independently. We completed 5-year
                reviews of work RVUs that were effective for calendar years 1997, 2002,
                2007, and 2012.
                    Although refinements to the direct PE inputs initially relied
                heavily on input from the RUC Practice Expense Advisory Committee
                (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
                the use of the updated PE/HR data in CY 2010 have resulted in
                significant refinements to the PE RVUs in recent years.
                [[Page 40485]]
                    In the CY 2012 PFS final rule with comment period (76 FR 73057), we
                finalized a proposal to consolidate reviews of work and PE RVUs under
                section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
                codes under section 1848(c)(2)(K) of the Act into one annual process.
                    In addition to the 5-year reviews, beginning for CY 2009, CMS and
                the RUC identified and reviewed a number of potentially misvalued codes
                on an annual basis based on various identification screens. This annual
                review of work and PE RVUs for potentially misvalued codes was
                supplemented by the amendments to section 1848 of the Act, as enacted
                by section 3134 of the Affordable Care Act, that require the agency to
                periodically identify, review and adjust values for potentially
                misvalued codes.
                e. Application of Budget Neutrality to Adjustments of RVUs
                    As described in section VI. of this proposed rule, the Regulatory
                Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of
                the Act, if revisions to the RVUs cause expenditures for the year to
                change by more than $20 million, we make adjustments to ensure that
                expenditures do not increase or decrease by more than $20 million.
                2. Calculation of Payments Based on RVUs
                    To calculate the payment for each service, the components of the
                fee schedule (work, PE, and MP RVUs) are adjusted by geographic
                practice cost indices (GPCIs) to reflect the variations in the costs of
                furnishing the services. The GPCIs reflect the relative costs of work,
                PE, and MP in an area compared to the national average costs for each
                component. Please refer to the CY 2017 PFS final rule with comment
                period for a discussion of the last GPCI update (81 FR 80261 through
                80270).
                    RVUs are converted to dollar amounts through the application of a
                CF, which is calculated based on a statutory formula by CMS's Office of
                the Actuary (OACT). The formula for calculating the Medicare PFS
                payment amount for a given service and fee schedule area can be
                expressed as:
                Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
                MP)] x CF
                3. Separate Fee Schedule Methodology for Anesthesia Services
                    Section 1848(b)(2)(B) of the Act specifies that the fee schedule
                amounts for anesthesia services are to be based on a uniform relative
                value guide, with appropriate adjustment of an anesthesia CF, in a
                manner to ensure that fee schedule amounts for anesthesia services are
                consistent with those for other services of comparable value.
                Therefore, there is a separate fee schedule methodology for anesthesia
                services. Specifically, we establish a separate CF for anesthesia
                services and we utilize the uniform relative value guide, or base
                units, as well as time units, to calculate the fee schedule amounts for
                anesthesia services. Since anesthesia services are not valued using
                RVUs, a separate methodology for locality adjustments is also
                necessary. This involves an adjustment to the national anesthesia CF
                for each payment locality.
                B. Determination of PE RVUs
                1. Overview
                    Practice expense (PE) is the portion of the resources used in
                furnishing a service that reflects the general categories of physician
                and practitioner expenses, such as office rent and personnel wages, but
                excluding MP expenses, as specified in section 1848(c)(1)(B) of the
                Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a
                resource-based system for determining PE RVUs for each physicians'
                service. We develop PE RVUs by considering the direct and indirect
                practice resources involved in furnishing each service. Direct expense
                categories include clinical labor, medical supplies, and medical
                equipment. Indirect expenses include administrative labor, office
                expense, and all other expenses. The sections that follow provide more
                detailed information about the methodology for translating the
                resources involved in furnishing each service into service-specific PE
                RVUs. We refer readers to the CY 2010 PFS final rule with comment
                period (74 FR 61743 through 61748) for a more detailed explanation of
                the PE methodology.
                2. Practice Expense Methodology
                a. Direct Practice Expense
                    We determine the direct PE for a specific service by adding the
                costs of the direct resources (that is, the clinical staff, medical
                supplies, and medical equipment) typically involved with furnishing
                that service. The costs of the resources are calculated using the
                refined direct PE inputs assigned to each CPT code in our PE database,
                which are generally based on our review of recommendations received
                from the RUC and those provided in response to public comment periods.
                For a detailed explanation of the direct PE methodology, including
                examples, we refer readers to the 5-year review of work relative value
                units under the PFS and proposed changes to the practice expense
                methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007
                PFS final rule with comment period (71 FR 69629).
                b. Indirect Practice Expense per Hour Data
                    We use survey data on indirect PEs incurred per hour worked, in
                developing the indirect portion of the PE RVUs. Prior to CY 2010, we
                primarily used the PE/HR by specialty that was obtained from the AMA's
                SMS. The AMA administered a new survey in CY 2007 and CY 2008, the
                Physician Practice Expense Information Survey (PPIS). The PPIS is a
                multispecialty, nationally representative, PE survey of both physicians
                and NPPs paid under the PFS using a survey instrument and methods
                highly consistent with those used for the SMS and the supplemental
                surveys. The PPIS gathered information from 3,656 respondents across 51
                physician specialty and health care professional groups. We believe the
                PPIS is the most comprehensive source of PE survey information
                available. We used the PPIS data to update the PE/HR data for the CY
                2010 PFS for almost all of the Medicare-recognized specialties that
                participated in the survey.
                    When we began using the PPIS data in CY 2010, we did not change the
                PE RVU methodology itself or the manner in which the PE/HR data are
                used in that methodology. We only updated the PE/HR data based on the
                new survey. Furthermore, as we explained in the CY 2010 PFS final rule
                with comment period (74 FR 61751), because of the magnitude of payment
                reductions for some specialties resulting from the use of the PPIS
                data, we transitioned its use over a 4-year period from the previous PE
                RVUs to the PE RVUs developed using the new PPIS data. As provided in
                the CY 2010 PFS final rule with comment period (74 FR 61751), the
                transition to the PPIS data was complete for CY 2013. Therefore, PE
                RVUs from CY 2013 forward are developed based entirely on the PPIS
                data, except as noted in this section.
                    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
                oncology supplemental survey data submitted in 2003 for oncology drug
                administration services. Therefore, the PE/HR for medical oncology,
                hematology, and hematology/oncology reflects the continued use of these
                supplemental survey data.
                    Supplemental survey data on independent labs from the College of
                [[Page 40486]]
                American Pathologists were implemented for payments beginning in CY
                2005. Supplemental survey data from the National Coalition of Quality
                Diagnostic Imaging Services (NCQDIS), representing independent
                diagnostic testing facilities (IDTFs), were blended with supplementary
                survey data from the American College of Radiology (ACR) and
                implemented for payments beginning in CY 2007. Neither IDTFs, nor
                independent labs, participated in the PPIS. Therefore, we continue to
                use the PE/HR that was developed from their supplemental survey data.
                    Consistent with our past practice, the previous indirect PE/HR
                values from the supplemental surveys for these specialties were updated
                to CY 2006 using the Medicare Economic Index (MEI) to put them on a
                comparable basis with the PPIS data.
                    We also do not use the PPIS data for reproductive endocrinology and
                spine surgery since these specialties currently are not separately
                recognized by Medicare, nor do we have a method to blend the PPIS data
                with Medicare-recognized specialty data.
                    Previously, we established PE/HR values for various specialties
                without SMS or supplemental survey data by crosswalking them to other
                similar specialties to estimate a proxy PE/HR. For specialties that
                were part of the PPIS for which we previously used a crosswalked PE/HR,
                we instead used the PPIS-based PE/HR. We use crosswalks for specialties
                that did not participate in the PPIS. These crosswalks have been
                generally established through notice and comment rulemaking and are
                available in the file called ``CY 2020 PFS Proposed Rule PE/HR'' on the
                CMS website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    For CY 2020, we have incorporated the available utilization data
                for two new specialties, each of which became a recognized Medicare
                specialty during 2018. These specialties are Medical Toxicology and
                Hematopoietic Cell Transplantation and Cellular Therapy. We are
                proposing to use proxy PE/HR values for these new specialties, as there
                are no PPIS data for these specialties, by crosswalking the PE/HR as
                follows from specialties that furnish similar services in the Medicare
                claims data:
                     Medical Toxicology from Emergency Medicine; and
                     Hematopoietic Cell Transplantation and Cellular Therapy
                from Hematology/Oncology.
                    These updates are reflected in the ``CY 2020 PFS Proposed Rule PE/
                HR'' file available on the CMS website under the supporting data files
                for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                c. Allocation of PE to Services
                    To establish PE RVUs for specific services, it is necessary to
                establish the direct and indirect PE associated with each service.
                (1) Direct Costs
                    The relative relationship between the direct cost portions of the
                PE RVUs for any two services is determined by the relative relationship
                between the sum of the direct cost resources (that is, the clinical
                staff, medical supplies, and medical equipment) typically involved with
                furnishing each of the services. The costs of these resources are
                calculated from the refined direct PE inputs in our PE database. For
                example, if one service has a direct cost sum of $400 from our PE
                database and another service has a direct cost sum of $200, the direct
                portion of the PE RVUs of the first service would be twice as much as
                the direct portion of the PE RVUs for the second service.
                (2) Indirect Costs
                    We allocate the indirect costs at the code level on the basis of
                the direct costs specifically associated with a code and the greater of
                either the clinical labor costs or the work RVUs. We also incorporate
                the survey data described earlier in the PE/HR discussion. The general
                approach to developing the indirect portion of the PE RVUs is as
                follows:
                     For a given service, we use the direct portion of the PE
                RVUs calculated as previously described and the average percentage that
                direct costs represent of total costs (based on survey data) across the
                specialties that furnish the service to determine an initial indirect
                allocator. That is, the initial indirect allocator is calculated so
                that the direct costs equal the average percentage of direct costs of
                those specialties furnishing the service. For example, if the direct
                portion of the PE RVUs for a given service is 2.00 and direct costs, on
                average, represent 25 percent of total costs for the specialties that
                furnish the service, the initial indirect allocator would be calculated
                so that it equals 75 percent of the total PE RVUs. Thus, in this
                example, the initial indirect allocator would equal 6.00, resulting in
                a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
                percent of 8.00).
                     Next, we add the greater of the work RVUs or clinical
                labor portion of the direct portion of the PE RVUs to this initial
                indirect allocator. In our example, if this service had a work RVU of
                4.00 and the clinical labor portion of the direct PE RVU was 1.50, we
                would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
                clinical labor portion) to the initial indirect allocator of 6.00 to
                get an indirect allocator of 10.00. In the absence of any further use
                of the survey data, the relative relationship between the indirect cost
                portions of the PE RVUs for any two services would be determined by the
                relative relationship between these indirect cost allocators. For
                example, if one service had an indirect cost allocator of 10.00 and
                another service had an indirect cost allocator of 5.00, the indirect
                portion of the PE RVUs of the first service would be twice as great as
                the indirect portion of the PE RVUs for the second service.
                     Next, we incorporate the specialty-specific indirect PE/HR
                data into the calculation. In our example, if, based on the survey
                data, the average indirect cost of the specialties furnishing the first
                service with an allocator of 10.00 was half of the average indirect
                cost of the specialties furnishing the second service with an indirect
                allocator of 5.00, the indirect portion of the PE RVUs of the first
                service would be equal to that of the second service.
                (3) Facility and Nonfacility Costs
                    For procedures that can be furnished in a physician's office, as
                well as in a facility setting, where Medicare makes a separate payment
                to the facility for its costs in furnishing a service, we establish two
                PE RVUs: Facility and nonfacility. The methodology for calculating PE
                RVUs is the same for both the facility and nonfacility RVUs, but is
                applied independently to yield two separate PE RVUs. In calculating the
                PE RVUs for services furnished in a facility, we do not include
                resources that would generally not be provided by physicians when
                furnishing the service. For this reason, the facility PE RVUs are
                generally lower than the nonfacility PE RVUs.
                (4) Services With Technical Components and Professional Components
                    Diagnostic services are generally comprised of two components: A
                professional component (PC); and a technical component (TC). The PC and
                TC may be furnished independently or by different providers, or they
                may be
                [[Page 40487]]
                furnished together as a global service. When services have separately
                billable PC and TC components, the payment for the global service
                equals the sum of the payment for the TC and PC. To achieve this, we
                use a weighted average of the ratio of indirect to direct costs across
                all the specialties that furnish the global service, TCs, and PCs; that
                is, we apply the same weighted average indirect percentage factor to
                allocate indirect expenses to the global service, PCs, and TCs for a
                service. (The direct PE RVUs for the TC and PC sum to the global.)
                (5) PE RVU Methodology
                    For a more detailed description of the PE RVU methodology, we refer
                readers to the CY 2010 PFS final rule with comment period (74 FR 61745
                through 61746). We also direct readers to the file called ``Calculation
                of PE RVUs under Methodology for Selected Codes'' which is available on
                our website under downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
                contains a table that illustrates the calculation of PE RVUs as
                described in this proposed rule for individual codes.
                (a) Setup File
                    First, we create a setup file for the PE methodology. The setup
                file contains the direct cost inputs, the utilization for each
                procedure code at the specialty and facility/nonfacility place of
                service level, and the specialty-specific PE/HR data calculated from
                the surveys.
                (b) Calculate the Direct Cost PE RVUs
                    Sum the costs of each direct input.
                    Step 1: Sum the direct costs of the inputs for each service.
                    Step 2: Calculate the aggregate pool of direct PE costs for the
                current year. We set the aggregate pool of PE costs equal to the
                product of the ratio of the current aggregate PE RVUs to current
                aggregate work RVUs and the projected aggregate work RVUs.
                    Step 3: Calculate the aggregate pool of direct PE costs for use in
                ratesetting. This is the product of the aggregate direct costs for all
                services from Step 1 and the utilization data for that service.
                    Step 4: Using the results of Step 2 and Step 3, use the CF to
                calculate a direct PE scaling adjustment to ensure that the aggregate
                pool of direct PE costs calculated in Step 3 does not vary from the
                aggregate pool of direct PE costs for the current year. Apply the
                scaling adjustment to the direct costs for each service (as calculated
                in Step 1).
                    Step 5: Convert the results of Step 4 to a RVU scale for each
                service. To do this, divide the results of Step 4 by the CF. Note that
                the actual value of the CF used in this calculation does not influence
                the final direct cost PE RVUs as long as the same CF is used in Step 4
                and Step 5. Different CFs would result in different direct PE scaling
                adjustments, but this has no effect on the final direct cost PE RVUs
                since changes in the CFs and changes in the associated direct scaling
                adjustments offset one another.
                (c) Create the Indirect Cost PE RVUs
                    Create indirect allocators.
                    Step 6: Based on the survey data, calculate direct and indirect PE
                percentages for each physician specialty.
                    Step 7: Calculate direct and indirect PE percentages at the service
                level by taking a weighted average of the results of Step 6 for the
                specialties that furnish the service. Note that for services with TCs
                and PCs, the direct and indirect percentages for a given service do not
                vary by the PC, TC, and global service.
                    We generally use an average of the 3 most recent years of available
                Medicare claims data to determine the specialty mix assigned to each
                code. Codes with low Medicare service volume require special attention
                since billing or enrollment irregularities for a given year can result
                in significant changes in specialty mix assignment. We finalized a
                policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use
                the most recent year of claims data to determine which codes are low
                volume for the coming year (those that have fewer than 100 allowed
                services in the Medicare claims data). For codes that fall into this
                category, instead of assigning specialty mix based on the specialties
                of the practitioners reporting the services in the claims data, we
                instead use the expected specialty that we identify on a list developed
                based on medical review and input from expert stakeholders. We display
                this list of expected specialty assignments as part of the annual set
                of data files we make available as part of notice and comment
                rulemaking and consider recommendations from the RUC and other
                stakeholders on changes to this list on an annual basis. Services for
                which the specialty is automatically assigned based on previously
                finalized policies under our established methodology (for example,
                ``always therapy'' services) are unaffected by the list of expected
                specialty assignments. We also finalized in the CY 2018 PFS final rule
                (82 FR 52982 through 59283) a policy to apply these service-level
                overrides for both PE and MP, rather than one or the other category.
                    For CY 2020, we are proposing to clarify the expected specialty
                assignment for a series of cardiothoracic services. Prior to the
                creation of the expected specialty list for low volume services in CY
                2018, we previously finalized through rulemaking a crosswalk to the
                thoracic surgery specialty for a series of cardiothoracic services that
                typically had fewer than 100 services reported each year (see, for
                example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we
                noted that for many of the affected codes, the expected specialty list
                for low volume services incorrectly listed a crosswalk to the cardiac
                surgery specialty instead of the thoracic surgery specialty. We are
                proposing to update the expected specialty list to accurately reflect
                the previously finalized crosswalk to thoracic surgery for these
                services. The affected codes are shown in Table 1.
                             Table 1--Proposed Updates to Expected Specialty
                ------------------------------------------------------------------------
                                         CY 2019 expected       Updated CY 2020 expected
                     CPT code               specialty                  specialty
                ------------------------------------------------------------------------
                33414.............  Cardiac Surgery..........  Thoracic Surgery.
                33468.............  Cardiac Surgery..........  Thoracic Surgery.
                33470.............  Cardiac Surgery..........  Thoracic Surgery.
                33471.............  Cardiac Surgery..........  Thoracic Surgery.
                33476.............  Cardiac Surgery..........  Thoracic Surgery.
                33478.............  Cardiac Surgery..........  Thoracic Surgery.
                33502.............  Cardiac Surgery..........  Thoracic Surgery.
                33503.............  Cardiac Surgery..........  Thoracic Surgery.
                33504.............  Cardiac Surgery..........  Thoracic Surgery.
                33505.............  Cardiac Surgery..........  Thoracic Surgery.
                33506.............  Cardiac Surgery..........  Thoracic Surgery.
                33507.............  Cardiac Surgery..........  Thoracic Surgery.
                33600.............  Cardiac Surgery..........  Thoracic Surgery.
                33602.............  Cardiac Surgery..........  Thoracic Surgery.
                33606.............  Cardiac Surgery..........  Thoracic Surgery.
                33608.............  Cardiac Surgery..........  Thoracic Surgery.
                33610.............  Cardiac Surgery..........  Thoracic Surgery.
                33611.............  Cardiac Surgery..........  Thoracic Surgery.
                33612.............  Cardiac Surgery..........  Thoracic Surgery.
                33615.............  Cardiac Surgery..........  Thoracic Surgery.
                33617.............  Cardiac Surgery..........  Thoracic Surgery.
                33619.............  Cardiac Surgery..........  Thoracic Surgery.
                33620.............  Cardiac Surgery..........  Thoracic Surgery.
                33621.............  Cardiac Surgery..........  Thoracic Surgery.
                33622.............  Cardiac Surgery..........  Thoracic Surgery.
                33645.............  Cardiac Surgery..........  Thoracic Surgery.
                33647.............  Cardiac Surgery..........  Thoracic Surgery.
                33660.............  Cardiac Surgery..........  Thoracic Surgery.
                33665.............  Cardiac Surgery..........  Thoracic Surgery.
                33670.............  Cardiac Surgery..........  Thoracic Surgery.
                33675.............  Cardiac Surgery..........  Thoracic Surgery.
                33676.............  Cardiac Surgery..........  Thoracic Surgery.
                33677.............  Cardiac Surgery..........  Thoracic Surgery.
                33684.............  Cardiac Surgery..........  Thoracic Surgery.
                33688.............  Cardiac Surgery..........  Thoracic Surgery.
                33690.............  Cardiac Surgery..........  Thoracic Surgery.
                33692.............  Cardiac Surgery..........  Thoracic Surgery.
                33694.............  Cardiac Surgery..........  Thoracic Surgery.
                33697.............  Cardiac Surgery..........  Thoracic Surgery.
                33702.............  Cardiac Surgery..........  Thoracic Surgery.
                33710.............  Cardiac Surgery..........  Thoracic Surgery.
                33720.............  Cardiac Surgery..........  Thoracic Surgery.
                33722.............  Cardiac Surgery..........  Thoracic Surgery.
                33724.............  Cardiac Surgery..........  Thoracic Surgery.
                33726.............  Cardiac Surgery..........  Thoracic Surgery.
                33730.............  Cardiac Surgery..........  Thoracic Surgery.
                33732.............  Cardiac Surgery..........  Thoracic Surgery.
                33735.............  Cardiac Surgery..........  Thoracic Surgery.
                33736.............  Cardiac Surgery..........  Thoracic Surgery.
                [[Page 40488]]
                
                33737.............  Cardiac Surgery..........  Thoracic Surgery.
                33750.............  Cardiac Surgery..........  Thoracic Surgery.
                33755.............  Cardiac Surgery..........  Thoracic Surgery.
                33762.............  Cardiac Surgery..........  Thoracic Surgery.
                33764.............  Cardiac Surgery..........  Thoracic Surgery.
                33766.............  Cardiac Surgery..........  Thoracic Surgery.
                33767.............  Cardiac Surgery..........  Thoracic Surgery.
                33768.............  Cardiac Surgery..........  Thoracic Surgery.
                33770.............  Cardiac Surgery..........  Thoracic Surgery.
                33771.............  Cardiac Surgery..........  Thoracic Surgery.
                33774.............  Cardiac Surgery..........  Thoracic Surgery.
                33775.............  Cardiac Surgery..........  Thoracic Surgery.
                33776.............  Cardiac Surgery..........  Thoracic Surgery.
                33777.............  Cardiac Surgery..........  Thoracic Surgery.
                33778.............  Cardiac Surgery..........  Thoracic Surgery.
                33779.............  Cardiac Surgery..........  Thoracic Surgery.
                33780.............  Cardiac Surgery..........  Thoracic Surgery.
                33781.............  Cardiac Surgery..........  Thoracic Surgery.
                33782.............  Cardiac Surgery..........  Thoracic Surgery.
                33783.............  Cardiac Surgery..........  Thoracic Surgery.
                33786.............  Cardiac Surgery..........  Thoracic Surgery.
                33788.............  Cardiac Surgery..........  Thoracic Surgery.
                33800.............  Cardiac Surgery..........  Thoracic Surgery.
                33802.............  Cardiac Surgery..........  Thoracic Surgery.
                33803.............  Cardiac Surgery..........  Thoracic Surgery.
                33813.............  Cardiac Surgery..........  Thoracic Surgery.
                33814.............  Cardiac Surgery..........  Thoracic Surgery.
                33820.............  Cardiac Surgery..........  Thoracic Surgery.
                33822.............  Cardiac Surgery..........  Thoracic Surgery.
                33824.............  Cardiac Surgery..........  Thoracic Surgery.
                33840.............  Cardiac Surgery..........  Thoracic Surgery.
                33845.............  Cardiac Surgery..........  Thoracic Surgery.
                33851.............  Cardiac Surgery..........  Thoracic Surgery.
                33852.............  Cardiac Surgery..........  Thoracic Surgery.
                33853.............  Cardiac Surgery..........  Thoracic Surgery.
                33917.............  Cardiac Surgery..........  Thoracic Surgery.
                33920.............  Cardiac Surgery..........  Thoracic Surgery.
                33922.............  Cardiac Surgery..........  Thoracic Surgery.
                33924.............  Cardiac Surgery..........  Thoracic Surgery.
                33925.............  Cardiac Surgery..........  Thoracic Surgery.
                33926.............  Cardiac Surgery..........  Thoracic Surgery.
                35182.............  Cardiac Surgery..........  Thoracic Surgery.
                ------------------------------------------------------------------------
                    We note that the cardiac surgery and thoracic surgery specialties
                are similar to one another, sharing the same PE/HR data for PE
                valuation and nearly identical MP risk factors for MP valuation. As a
                result, we do not anticipate this proposal having a discernible effect
                on the valuation of the codes listed above. For additional discussion
                on this issue, we refer readers to section II.C of this proposed rule,
                Malpractice. The complete list of expected specialty assignments for
                individual low volume services, including the assignments for the codes
                identified in Table 1, is available on our website under downloads for
                the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    Step 8: Calculate the service level allocators for the indirect PEs
                based on the percentages calculated in Step 7. The indirect PEs are
                allocated based on the three components: The direct PE RVUs; the
                clinical labor PE RVUs; and the work RVUs.
                    For most services the indirect allocator is: indirect PE percentage
                * (direct PE RVUs/direct percentage) + work RVUs.
                    There are two situations where this formula is modified:
                     If the service is a global service (that is, a service
                with global, professional, and technical components), then the indirect
                PE allocator is: indirect percentage (direct PE RVUs/direct percentage)
                + clinical labor PE RVUs + work RVUs.
                     If the clinical labor PE RVUs exceed the work RVUs (and
                the service is not a global service), then the indirect allocator is:
                indirect PE percentage (direct PE RVUs/direct percentage) + clinical
                labor PE RVUs.
                    (Note: For global services, the indirect PE allocator is based on
                both the work RVUs and the clinical labor PE RVUs. We do this to
                recognize that, for the PC service, indirect PEs would be allocated
                using the work RVUs, and for the TC service, indirect PEs would be
                allocated using the direct PE RVUs and the clinical labor PE RVUs. This
                also allows the global component RVUs to equal the sum of the PC and TC
                RVUs.)
                    For presentation purposes, in the examples in the download file
                called ``Calculation of PE RVUs under Methodology for Selected Codes'',
                the formulas were divided into two parts for each service.
                     The first part does not vary by service and is the
                indirect percentage (direct PE RVUs/direct percentage).
                     The second part is either the work RVU, clinical labor PE
                RVU, or both depending on whether the service is a global service and
                whether the clinical PE RVUs exceed the work RVUs (as described earlier
                in this step).
                    Apply a scaling adjustment to the indirect allocators.
                    Step 9: Calculate the current aggregate pool of indirect PE RVUs by
                multiplying the result of step 8 by the average indirect PE percentage
                from the survey data.
                    Step 10: Calculate an aggregate pool of indirect PE RVUs for all
                PFS services by adding the product of the indirect PE allocators for a
                service from Step 8 and the utilization data for that service.
                    Step 11: Using the results of Step 9 and Step 10, calculate an
                indirect PE adjustment so that the aggregate indirect allocation does
                not exceed the available aggregate indirect PE RVUs and apply it to
                indirect allocators calculated in Step 8.
                    Calculate the indirect practice cost index.
                    Step 12: Using the results of Step 11, calculate aggregate pools of
                specialty-specific adjusted indirect PE allocators for all PFS services
                for a specialty by adding the product of the adjusted indirect PE
                allocator for each service and the utilization data for that service.
                    Step 13: Using the specialty-specific indirect PE/HR data,
                calculate specialty-specific aggregate pools of indirect PE for all PFS
                services for that specialty by adding the product of the indirect PE/HR
                for the specialty, the work time for the service, and the specialty's
                utilization for the service across all services furnished by the
                specialty.
                    Step 14: Using the results of Step 12 and Step 13, calculate the
                specialty-specific indirect PE scaling factors.
                    Step 15: Using the results of Step 14, calculate an indirect
                practice cost index at the specialty level by dividing each specialty-
                specific indirect scaling factor by the average indirect scaling factor
                for the entire PFS.
                    Step 16: Calculate the indirect practice cost index at the service
                level to ensure the capture of all indirect costs. Calculate a weighted
                average of the practice cost index values for the specialties that
                furnish the service. (Note: For services with TCs and PCs, we calculate
                the indirect practice cost index across the global service, PCs, and
                TCs. Under this method, the indirect practice cost index for a given
                service (for example, echocardiogram) does not vary by the PC, TC, and
                global service.)
                    Step 17: Apply the service level indirect practice cost index
                calculated in Step 16 to the service level adjusted indirect allocators
                calculated in Step 11 to get the indirect PE RVUs.
                (d) Calculate the Final PE RVUs
                    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
                from Step 17 and apply the final PE budget neutrality (BN) adjustment.
                The final PE BN adjustment is calculated by comparing the sum of steps
                5 and 17 to the proposed aggregate work RVUs scaled by the ratio of
                current aggregate PE and work RVUs. This adjustment ensures that all PE
                RVUs in the PFS account for the fact that certain specialties are
                excluded from the calculation of PE RVUs but included in maintaining
                overall PFS budget neutrality. (See ``Specialties excluded from
                ratesetting calculation'' later in this proposed rule.)
                    Step 19: Apply the phase-in of significant RVU reductions and its
                associated adjustment. Section 1848(c)(7) of the Act specifies that for
                services that are not new or revised codes, if the total RVUs for a
                service for a year would otherwise be decreased by an estimated 20
                percent or more as compared to the total RVUs for the previous year,
                the applicable
                [[Page 40489]]
                adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
                period. In implementing the phase-in, we consider a 19 percent
                reduction as the maximum 1-year reduction for any service not described
                by a new or revised code. This approach limits the year one reduction
                for the service to the maximum allowed amount (that is, 19 percent),
                and then phases in the remainder of the reduction. To comply with
                section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the
                total RVUs for all services that are not new or revised codes decrease
                by no more than 19 percent, and then apply a relativity adjustment to
                ensure that the total pool of aggregate PE RVUs remains relative to the
                pool of work and MP RVUs. For a more detailed description of the
                methodology for the phase-in of significant RVU changes, we refer
                readers to the CY 2016 PFS final rule with comment period (80 FR 70927
                through 70931).
                (e) Setup File Information
                     Specialties excluded from ratesetting calculation: For the
                purposes of calculating the PE and MP RVUs, we exclude certain
                specialties, such as certain NPPs paid at a percentage of the PFS and
                low-volume specialties, from the calculation. These specialties are
                included for the purposes of calculating the BN adjustment. They are
                displayed in Table 2.
                       Table 2--Specialties Excluded From Ratesetting Calculation
                ------------------------------------------------------------------------
                     Specialty code                    Specialty description
                ------------------------------------------------------------------------
                49......................  Ambulatory surgical center.
                50......................  Nurse practitioner.
                51......................  Medical supply company with certified
                                           orthotist.
                52......................  Medical supply company with certified
                                           prosthetist.
                53......................  Medical supply company with certified
                                           prosthetist[dash]orthotist.
                54......................  Medical supply company not included in 51, 52,
                                           or 53.
                55......................  Individual certified orthotist.
                56......................  Individual certified prosthetist.
                57......................  Individual certified
                                           prosthetist[dash]orthotist.
                58......................  Medical supply company with registered
                                           pharmacist.
                59......................  Ambulance service supplier, e.g., private
                                           ambulance companies, funeral homes, etc.
                60......................  Public health or welfare agencies.
                61......................  Voluntary health or charitable agencies.
                73......................  Mass immunization roster biller.
                74......................  Radiation therapy centers.
                87......................  All other suppliers (e.g., drug and department
                                           stores).
                88......................  Unknown supplier/provider specialty.
                89......................  Certified clinical nurse specialist.
                96......................  Optician.
                97......................  Physician assistant.
                A0......................  Hospital.
                A1......................  SNF.
                A2......................  Intermediate care nursing facility.
                A3......................  Nursing facility, other.
                A4......................  HHA.
                A5......................  Pharmacy.
                A6......................  Medical supply company with respiratory
                                           therapist.
                A7......................  Department store.
                A8......................  Grocery store.
                B1......................  Supplier of oxygen and/or oxygen related
                                           equipment (eff. 10/2/2007).
                B2......................  Pedorthic personnel.
                B3......................  Medical supply company with pedorthic
                                           personnel.
                B4......................  Rehabilitation Agency.
                B5......................  Ocularist.
                C1......................  Centralized Flu.
                C2......................  Indirect Payment Procedure.
                C5......................  Dentistry.
                ------------------------------------------------------------------------
                     Crosswalk certain low volume physician specialties:
                Crosswalk the utilization of certain specialties with relatively low
                PFS utilization to the associated specialties.
                     Physical therapy utilization: Crosswalk the utilization
                associated with all physical therapy services to the specialty of
                physical therapy.
                     Identify professional and technical services not
                identified under the usual TC and 26 modifiers: Flag the services that
                are PC and TC services but do not use TC and 26 modifiers (for example,
                electrocardiograms). This flag associates the PC and TC with the
                associated global code for use in creating the indirect PE RVUs. For
                example, the professional service, CPT code 93010 (Electrocardiogram,
                routine ECG with at least 12 leads; interpretation and report only), is
                associated with the global service, CPT code 93000 (Electrocardiogram,
                routine ECG with at least 12 leads; with interpretation and report).
                [[Page 40490]]
                     Payment modifiers: Payment modifiers are accounted for in
                the creation of the file consistent with current payment policy as
                implemented in claims processing. For example, services billed with the
                assistant at surgery modifier are paid 16 percent of the PFS amount for
                that service; therefore, the utilization file is modified to only
                account for 16 percent of any service that contains the assistant at
                surgery modifier. Similarly, for those services to which volume
                adjustments are made to account for the payment modifiers, time
                adjustments are applied as well. For time adjustments to surgical
                services, the intraoperative portion in the work time file is used;
                where it is not present, the intraoperative percentage from the payment
                files used by contractors to process Medicare claims is used instead.
                Where neither is available, we use the payment adjustment ratio to
                adjust the time accordingly. Table 3 details the manner in which the
                modifiers are applied.
                     Table 3--Application of Payment Modifiers to Utilization Files
                ------------------------------------------------------------------------
                                                             Volume
                      Modifier           Description       adjustment    Time adjustment
                ------------------------------------------------------------------------
                80,81,82............  Assistant at      16%............  Intraoperative
                                       Surgery.                           portion.
                AS..................  Assistant at      14% (85% * 16%)  Intraoperative
                                       Surgery--Physic                    portion.
                                       ian Assistant.
                50 or LT and RT.....  Bilateral         150%...........  150% of work
                                       Surgery.                           time.
                51..................  Multiple          50%............  Intraoperative
                                       Procedure.                         portion.
                52..................  Reduced Services  50%............  50%.
                53..................  Discontinued      50%............  50%.
                                       Procedure.
                54..................  Intraoperative    Preoperative +   Preoperative +
                                       Care only.        Intraoperative   Intraoperative
                                                         Percentages on   portion.
                                                         the payment
                                                         files used by
                                                         Medicare
                                                         contractors to
                                                         process
                                                         Medicare
                                                         claims.
                55..................  Postoperative     Postoperative    Postoperative
                                       Care only.        Percentage on    portion.
                                                         the payment
                                                         files used by
                                                         Medicare
                                                         contractors to
                                                         process
                                                         Medicare
                                                         claims.
                62..................  Co-surgeons.....  62.5%..........  50%.
                66..................  Team Surgeons...  33%............  33%.
                ------------------------------------------------------------------------
                    We also make adjustments to volume and time that correspond to
                other payment rules, including special multiple procedure endoscopy
                rules and multiple procedure payment reductions (MPPRs). We note that
                section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
                for multiple imaging procedures and multiple therapy services from the
                BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
                MPPRs are not included in the development of the RVUs.
                    For anesthesia services, we do not apply adjustments to volume
                since we use the average allowed charge when simulating RVUs;
                therefore, the RVUs as calculated already reflect the payments as
                adjusted by modifiers, and no volume adjustments are necessary.
                However, a time adjustment of 33 percent is made only for medical
                direction of two to four cases since that is the only situation where a
                single practitioner is involved with multiple beneficiaries
                concurrently, so that counting each service without regard to the
                overlap with other services would overstate the amount of time spent by
                the practitioner furnishing these services.
                     Work RVUs: The setup file contains the work RVUs from this
                proposed rule.
                (6) Equipment Cost per Minute
                    The equipment cost per minute is calculated as:
                (1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
                interest rate)-life of equipment)))) + maintenance)
                Where:
                minutes per year = maximum minutes per year if usage were continuous
                (that is, usage=1); generally 150,000 minutes.
                usage = variable, see discussion below in this proposed rule.
                price = price of the particular piece of equipment.
                life of equipment = useful life of the particular piece of
                equipment.
                maintenance = factor for maintenance; 0.05.
                interest rate = variable, see discussion below in this proposed
                rule.
                    Usage: We currently use an equipment utilization rate assumption of
                50 percent for most equipment, with the exception of expensive
                diagnostic imaging equipment, for which we use a 90 percent assumption
                as required by section 1848(b)(4)(C) of the Act.
                    Stakeholders have often suggested that particular equipment items
                are used less frequently than 50 percent of the time in the typical
                setting and that CMS should reduce the equipment utilization rate based
                on these recommendations. We appreciate and share stakeholders'
                interest in using the most accurate assumption regarding the equipment
                utilization rate for particular equipment items. However, we believe
                that absent robust, objective, auditable data regarding the use of
                particular items, the 50 percent assumption is the most appropriate
                within the relative value system. We welcome the submission of data
                that would support an alternative rate.
                [[Page 40491]]
                    Maintenance: This factor for maintenance was finalized in the CY
                1998 PFS final rule with comment period (62 FR 33164). As we previously
                stated in the CY 2016 PFS final rule with comment period (80 FR 70897),
                we do not believe the annual maintenance factor for all equipment is
                precisely 5 percent, and we concur that the current rate likely
                understates the true cost of maintaining some equipment. We also
                believe it likely overstates the maintenance costs for other equipment.
                When we solicited comments regarding sources of data containing
                equipment maintenance rates, commenters were unable to identify an
                auditable, robust data source that could be used by CMS on a wide
                scale. We do not believe that voluntary submissions regarding the
                maintenance costs of individual equipment items would be an appropriate
                methodology for determining costs. As a result, in the absence of
                publicly available datasets regarding equipment maintenance costs or
                another systematic data collection methodology for determining a
                different maintenance factor, we do not believe that we have sufficient
                information at present to propose a variable maintenance factor for
                equipment cost per minute pricing. We continue to investigate potential
                avenues for determining equipment maintenance costs across a broad
                range of equipment items.
                    Interest Rate: In the CY 2013 PFS final rule with comment period
                (77 FR 68902), we updated the interest rates used in developing an
                equipment cost per minute calculation (see 77 FR 68902 for a thorough
                discussion of this issue). The interest rate was based on the Small
                Business Administration (SBA) maximum interest rates for different
                categories of loan size (equipment cost) and maturity (useful life). We
                are not proposing any changes to these interest rates for CY 2020. The
                Interest rates are listed in Table 4.
                                   Table 4--SBA Maximum Interest Rates
                ------------------------------------------------------------------------
                                                                               Interest
                               Price                    Useful life years      rate (%)
                ------------------------------------------------------------------------
                $50K..............................  $50K..............................  7+....................         6.00
                ------------------------------------------------------------------------
                3. Changes to Direct PE Inputs for Specific Services
                    This section focuses on specific PE inputs. The direct PE inputs
                are included in the CY 2020 direct PE input public use files, which are
                available on the CMS website under downloads for the CY 2020 PFS
                proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                a. Standardization of Clinical Labor Tasks
                    As we noted in the CY 2015 PFS final rule with comment period (79
                FR 67640-67641), we continue to make improvements to the direct PE
                input database to provide the number of clinical labor minutes assigned
                for each task for every code in the database instead of only including
                the number of clinical labor minutes for the preservice, service, and
                postservice periods for each code. In addition to increasing the
                transparency of the information used to set PE RVUs, this level of
                detail would allow us to compare clinical labor times for activities
                associated with services across the PFS, which we believe is important
                to maintaining the relativity of the direct PE inputs. This information
                would facilitate the identification of the usual numbers of minutes for
                clinical labor tasks and the identification of exceptions to the usual
                values. It would also allow for greater transparency and consistency in
                the assignment of equipment minutes based on clinical labor times.
                Finally, we believe that the detailed information can be useful in
                maintaining standard times for particular clinical labor tasks that can
                be applied consistently to many codes as they are valued over several
                years, similar in principle to the use of physician preservice time
                packages. We believe that setting and maintaining such standards would
                provide greater consistency among codes that share the same clinical
                labor tasks and could improve relativity of values among codes. For
                example, as medical practice and technologies change over time, changes
                in the standards could be updated simultaneously for all codes with the
                applicable clinical labor tasks, instead of waiting for individual
                codes to be reviewed.
                    In the CY 2016 PFS final rule with comment period (80 FR 70901), we
                solicited comments on the appropriate standard minutes for the clinical
                labor tasks associated with services that use digital technology. After
                consideration of comments received, we finalized standard times for
                clinical labor tasks associated with digital imaging at 2 minutes for
                ``Availability of prior images confirmed'', 2 minutes for ``Patient
                clinical information and questionnaire reviewed by technologist, order
                from physician confirmed and exam protocoled by radiologist'', 2
                minutes for ``Review examination with interpreting MD'', and 1 minute
                for ``Exam documents scanned into PACS.'' Exam completed in RIS system
                to generate billing process and to populate images into Radiologist
                work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through
                80186), we finalized a policy to establish a range of appropriate
                standard minutes for the clinical labor activity, ``Technologist QCs
                images in PACS, checking for all images, reformats, and dose page.''
                These standard minutes will be applied to new and revised codes that
                make use of this clinical labor activity when they are reviewed by us
                for valuation. We finalized a policy to establish 2 minutes as the
                standard for the simple case, 3 minutes as the standard for the
                intermediate case, 4 minutes as the standard for the complex case, and
                5 minutes as the standard for the highly complex case. These values
                were based upon a review of the existing minutes assigned for this
                clinical labor activity; we determined that 2 minutes is the duration
                for most services and a small number of codes with more complex forms
                of digital imaging have higher values.
                [[Page 40492]]
                    We also finalized standard times for clinical labor tasks
                associated with pathology services in the CY 2016 PFS final rule with
                comment period (80 FR 70902) at 4 minutes for ``Accession specimen/
                prepare for examination'', 0.5 minutes for ``Assemble and deliver
                slides with paperwork to pathologists'', 0.5 minutes for ``Assemble
                other light microscopy slides, open nerve biopsy slides, and clinical
                history, and present to pathologist to prepare clinical pathologic
                interpretation'', 1 minute for ``Clean room/equipment following
                procedure'', 1 minute for ``Dispose of remaining specimens, spent
                chemicals/other consumables, and hazardous waste'', and 1 minute for
                ``Prepare, pack and transport specimens and records for in-house
                storage and external storage (where applicable).'' We do not believe
                these activities would be dependent on number of blocks or batch size,
                and we believe that these values accurately reflect the typical time it
                takes to perform these clinical labor tasks.
                    In reviewing the RUC-recommended direct PE inputs for CY 2019, we
                noticed that the 3 minutes of clinical labor time traditionally
                assigned to the ``Prepare room, equipment and supplies'' (CA013)
                clinical labor activity were split into 2 minutes for the ``Prepare
                room, equipment and supplies'' activity and 1 minute for the ``Confirm
                order, protocol exam'' (CA014) activity. We proposed to maintain the 3
                minutes of clinical labor time for the ``Prepare room, equipment and
                supplies'' activity and remove the clinical labor time for the
                ``Confirm order, protocol exam'' activity wherever we observed this
                pattern in the RUC-recommended direct PE inputs. Commenters explained
                in response that when the new version of the PE worksheet introduced
                the activity codes for clinical labor, there was a need to translate
                old clinical labor tasks into the new activity codes, and that a prior
                clinical labor task was split into two of the new clinical labor
                activity codes: CA007 (``Review patient clinical extant information and
                questionnaire'') in the preservice period, and CA014 (``Confirm order,
                protocol exam'') in the service period. Commenters stated that the same
                clinical labor from the old PE worksheet was now divided into the CA007
                and CA014 activity codes, with a standard of 1 minute for each
                activity. We agreed with commenters that we would finalize the RUC-
                recommended 2 minutes of clinical labor time for the CA007 activity
                code and 1 minute for the CA014 activity code in situations where this
                was the case. However, when reviewing the clinical labor for the
                reviewed codes affected by this issue, we found that several of the
                codes did not include this old clinical labor task, and we also noted
                that several of the reviewed codes that contained the CA014 clinical
                labor activity code did not contain any clinical labor for the CA007
                activity. In these situations, we continue to believe that in these
                cases the 3 total minutes of clinical staff time would be more
                accurately described by the CA013 ``Prepare room, equipment and
                supplies'' activity code, and we finalized these clinical labor
                refinements. For additional details, we direct readers to the
                discussion in the CY 2019 PFS final rule (83 FR 59463-59464).
                    Historically, the RUC has submitted a ``PE worksheet'' that details
                the recommended direct PE inputs for our use in developing PE RVUs. The
                format of the PE worksheet has varied over time and among the medical
                specialties developing the recommendations. These variations have made
                it difficult for both the RUC's development and our review of code
                values for individual codes. Beginning with its recommendations for CY
                2019, the RUC has mandated the use of a new PE worksheet for purposes
                of their recommendation development process that standardizes the
                clinical labor tasks and assigns them a clinical labor activity code.
                We believe the RUC's use of the new PE worksheet in developing and
                submitting recommendations will help us to simplify and standardize the
                hundreds of different clinical labor tasks currently listed in our
                direct PE database. As we did in previous calendar years, to facilitate
                rulemaking for CY 2020, we are continuing to display two versions of
                the Labor Task Detail public use file: One version with the old listing
                of clinical labor tasks, and one with the same tasks crosswalked to the
                new listing of clinical labor activity codes. These lists are available
                on the CMS website under downloads for the CY 2020 PFS proposed rule at
                http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                b. Equipment Recommendations for Scope Systems
                    During our routine reviews of direct PE input recommendations, we
                have regularly found unexplained inconsistencies involving the use of
                scopes and the video systems associated with them. Some of the scopes
                include video systems bundled into the equipment item, some of them
                include scope accessories as part of their price, and some of them are
                standalone scopes with no other equipment included. It is not always
                clear which equipment items related to scopes fall into which of these
                categories. We have also frequently found anomalies in the equipment
                recommendations, with equipment items that consist of a scope and video
                system bundle recommended, along with a separate scope video system.
                Based on our review, the variations do not appear to be consistent with
                the different code descriptions.
                    To promote appropriate relativity among the services and facilitate
                the transparency of our review process, during the review of the
                recommended direct PE inputs for the CY 2017 PFS proposed rule, we
                developed a structure that separates the scope, the associated video
                system, and any scope accessories that might be typical as distinct
                equipment items for each code. Under this approach, we proposed
                standalone prices for each scope, and separate prices for the video
                systems and accessories that are used with scopes.
                (1) Scope Equipment
                    Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through
                46177), we proposed standardizing refinements to the way scopes have
                [[Page 40493]]
                been defined in the direct PE input database. We believe that there are
                four general types of scopes: Non-video scopes; flexible scopes; semi-
                rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and
                rigid scopes would typically be paired with one of the scope video
                systems, while the non-video scopes would not. The flexible scopes can
                be further divided into diagnostic (or non-channeled) and therapeutic
                (or channeled) scopes. We proposed to identify for each anatomical
                application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
                flexible scope; (4) a non-channeled flexible video scope; and (5) a
                channeled flexible video scope. We proposed to classify the existing
                scopes in our direct PE database under this classification system, to
                improve the transparency of our review process and improve appropriate
                relativity among the services. We planned to propose input prices for
                these equipment items through future rulemaking.
                    We proposed these changes only for the reviewed codes for CY 2017
                that made use of scopes, along with updated prices for the equipment
                items related to scopes utilized by these services. We did not propose
                to apply these policies to codes with inputs reviewed prior to CY 2017.
                We also solicited comment on this separate pricing structure for
                scopes, scope video systems, and scope accessories, which we could
                consider proposing to apply to other codes in future rulemaking. We did
                not finalize price increases for a series of other scopes and scope
                accessories, as the invoices submitted for these components indicated
                that they are different forms of equipment with different product IDs
                and different prices. We did not receive any data to indicate that the
                equipment on the newly submitted invoices was more typical in its use
                than the equipment that we were currently using for pricing.
                    We did not make further changes to existing scope equipment in CY
                2017 to allow the RUC's PE Subcommittee the opportunity to provide
                feedback. However, we believed there was some miscommunication on this
                point, as the RUC's PE Subcommittee workgroup that was created to
                address scope systems stated that no further action was required
                following the finalization of our proposal. Therefore, we made further
                proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962)
                to continue clarifying scope equipment inputs, and sought comments
                regarding the new set of scope proposals. We considered creating a
                single scope equipment code for each of the five categories detailed in
                this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video
                flexible scope; (4) a non-channeled flexible video scope; and (5) a
                channeled flexible video scope. Under the current classification
                system, there are many different scopes in each category depending on
                the medical specialty furnishing the service and the part of the body
                affected. We stated our belief that the variation between these scopes
                was not significant enough to warrant maintaining these distinctions,
                and we believed that creating and pricing a single scope equipment code
                for each category would help provide additional clarity. We sought
                public comment on the merits of this potential scope organization, as
                well as any pricing information regarding these five new scope
                categories.
                    After considering the comments on the CY 2018 PFS proposed rule, we
                did not finalize our proposal to create and price a single scope
                equipment code for each of the five categories previously identified.
                Instead, we supported the recommendation from the commenters to create
                scope equipment codes on a per-specialty basis for six categories of
                scopes as applicable, including the addition of a new sixth category of
                multi-channeled flexible video scopes. Our goal was to create an
                administratively simple scheme that would be easier to maintain and
                help to reduce administrative burden. In 2018, the RUC convened a Scope
                Equipment Reorganization Workgroup to incorporate feedback from expert
                stakeholders with the intention of making recommendations to us on
                scope organization and scope pricing. Since the workgroup was not
                convened in time to submit recommendations for the CY 2019 PFS
                rulemaking cycle, we delayed proposals for any further changes to scope
                equipment until CY 2020 in order to incorporate the feedback from the
                aforementioned workgroup.
                (2) Scope Video System
                    We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through
                46177) to define the scope video system as including: (1) A monitor;
                (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a
                printer. We believe that these equipment components represent the
                typical case for a scope video system. Our model for this system was
                the ``video system, endoscopy (processor, digital capture, monitor,
                printer, cart)'' equipment item (ES031), which we proposed to re-price
                as part of this separate pricing approach. We obtained current pricing
                invoices for the endoscopy video system as part of our investigation of
                these issues involving scopes, which we proposed to use for this re-
                pricing. In response to comments, we finalized the addition of a
                digital capture device to the endoscopy video system (ES031) in the CY
                2017 PFS final rule (81 FR 80188). We finalized our proposal to price
                the system at $33,391, based on component prices of $9,000 for the
                processor, $18,346 for the digital capture device, $2,000 for the
                monitor, $2,295 for the printer, and $1,750 for the cart. In the CY
                2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did
                not finalize, a proposal to add an LED light source into the cost of
                the scope video system (ES031), which would remove the need for a
                separate light source in these procedures. We also described a proposal
                to increase the price of the scope video system by $1,000 to cover the
                expense of miscellaneous small equipment associated with the system
                that falls below the threshold of individual equipment pricing as scope
                accessories (such as cables, microphones, foot pedals, etc.). With the
                addition of the LED light (equipment code EQ382 at a price of $1,915),
                the updated total price of the scope video system would be set at
                $36,306.
                    We did not finalize this updated pricing to the scope video system
                in CY 2018, but we did propose and finalize the updated pricing for CY
                2019 to $36,306 along with changing the name of the ES031 equipment
                item to ``scope video system (monitor, processor, digital capture,
                cart, printer, LED light)'' to reflect the fact that the use of the
                ES031 scope video system is not limited to endoscopy procedures.
                (3) Scope Accessories
                    We understand that there may be other accessories associated with
                the use of scopes. We finalized a proposal in the CY 2017 PFS final
                rule (81 FR 80188) to separately price any scope accessories outside
                the use of the scope video system, and individually evaluate their
                inclusion or exclusion as direct PE inputs for particular codes as
                usual under our current policy based on whether they are typically used
                in furnishing the services described by the particular codes.
                (4) Scope Proposals for CY 2020
                    The Scope Equipment Reorganization Workgroup organized by the RUC
                submitted detailed recommendations to CMS for consideration in the CY
                2020 rule cycle, describing 23 different types of scope equipment, the
                HCPCS codes associated with each scope type, and a series of invoices
                for scope pricing. We
                [[Page 40494]]
                appreciate the information provided by the workgroup and continue to
                welcome additional comments and feedback from stakeholders. Based on
                the recommendations from the workgroup, we are proposing to establish
                23 new scope equipment codes (see Table 5).
                           Table 5--CY 2020 Proposed New Scope Equipment Codes
                ------------------------------------------------------------------------
                                         Proposed scope
                       CMS code            equipment      Proposed price     Number of
                                          description                        invoices
                ------------------------------------------------------------------------
                ES070................  rigid scope,       ..............               0
                                        cystoscopy.
                ES071................  rigid scope,       ..............               0
                                        hysteroscopy.
                ES072................  rigid scope,       ..............               0
                                        otoscopy.
                ES073................  rigid scope,       ..............               0
                                        nasal/sinus
                                        endoscopy.
                ES074................  rigid scope,       ..............               0
                                        proctosigmoidosc
                                        opy.
                ES075................  rigid scope,            $3,966.08               5
                                        laryngoscopy.
                ES076................  rigid scope,            14,500.00               1
                                        colposcopy.
                ES077................  non-channeled      ..............               0
                                        flexible digital
                                        scope,
                                        hysteroscopy.
                ES078................  non-channeled      ..............               0
                                        flexible digital
                                        scope,
                                        nasopharyngoscop
                                        y.
                ES079................  non-channeled      ..............               0
                                        flexible digital
                                        scope,
                                        bronchoscopy.
                ES080................  non-channeled           21,485.51               7
                                        flexible digital
                                        scope,
                                        laryngoscopy.
                ES081................  channeled          ..............               0
                                        flexible digital
                                        scope,
                                        cystoscopy.
                ES082................  channeled          ..............               0
                                        flexible digital
                                        scope,
                                        hysteroscopy.
                ES083................  channeled          ..............               0
                                        flexible digital
                                        scope,
                                        bronchoscopy.
                ES084................  channeled               18,694.39               5
                                        flexible digital
                                        scope,
                                        laryngoscopy.
                ES085................  multi-channeled         17,360.00               1
                                        flexible digital
                                        scope, flexible
                                        sigmoidoscopy.
                ES086................  multi-channeled         38,058.81               6
                                        flexible digital
                                        scope,
                                        colonoscopy.
                ES087................  multi-channeled    ..............               0
                                        flexible digital
                                        scope,
                                        esophagoscopy
                                        gastroscopy
                                        duodenoscopy
                                        (EGD).
                ES088................  multi-channeled         34,585.35               5
                                        flexible digital
                                        scope,
                                        esophagoscopy.
                ES089................  multi-channeled    ..............               0
                                        flexible digital
                                        scope, ileoscopy.
                ES090................  multi-channeled    ..............               0
                                        flexible digital
                                        scope,
                                        pouchoscopy.
                ES091................  ultrasound         ..............               0
                                        digital scope,
                                        endoscopic
                                        ultrasound.
                ES092................  non-video                5,078.04               4
                                        flexible scope,
                                        laryngoscopy.
                ------------------------------------------------------------------------
                    We note that we did not receive invoices for many of the new scope
                equipment items. There also was some inconsistency in the workgroup
                recommendations regarding the non-channeled flexible digital scope,
                laryngoscopy (ES080) equipment item and the non-video flexible scope,
                laryngoscopy (ES092) equipment item. These scopes were listed as a
                single equipment item in some of the workgroup materials and listed as
                separate equipment items in other materials. We are proposing to
                establish them as separate equipment items based on the submitted
                invoices, which demonstrated that these were two different types of
                scopes with distinct price points of approximately $17,000 and $5,000
                respectively.
                    We noted a similar issue with the submitted invoices for the rigid
                scope, laryngoscopy (ES075) equipment item. Among the eight total
                invoices, five of them were clustered around a price point of
                approximately $4,000 while the other three invoices had prices of
                roughly $15,000 apiece. The invoices indicated that these prices came
                from two distinct types of equipment, and as a result we are proposing
                to consider these items separately. We are proposing to use the initial
                five invoices to establish a proposed price of $3,966.08 for the rigid
                scope, laryngoscopy (ES075) equipment item. We note that this is a
                close match for the current price of $3,178.08 used by the endoscope,
                rigid, laryngoscopy (ES010) equipment, which is the closest equivalent
                scope equipment. The other three invoices appear to describe a type of
                stroboscopy system rather than a scope, and they have an average price
                of $14,737. This is a reasonably close match for the price of our
                current stroboscoby system (ES065) equipment, which has a CY 2020 price
                of $17,950.28 as it transitions to a final CY 2022 destination price of
                $16,843.87 (see the 4-year pricing transition of the market-based
                supply and equipment pricing update discussed later in this section for
                more information). We believe that these invoices reinforce the value
                established by the market-based pricing update for the stroboscoby
                system carried out last year, and we are not proposing to update the
                price of the ES065 equipment at this time. However, we are open to
                feedback from stakeholders if they believe it would be more accurate to
                assign a price of $14,737 to the stroboscoby system based on these
                invoice submissions, as opposed to maintaining the current pricing
                transition to a CY 2022 price of $16,843.87.
                    For the eight new scope equipment items where we have submitted
                invoices for pricing, we are proposing to replace the existing scopes
                with the new scope equipment. We received recommendations from the
                RUC's scope workgroup regarding which HCPCS codes make use of the new
                scope equipment items, and we are proposing to make this scope
                replacement for approximately 100 HCPCS codes in total (see Table 6).
                BILLING CODE 4120-01-P
                [[Page 40495]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.000
                [[Page 40496]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.001
                [[Page 40497]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.002
                [[Page 40498]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.003
                BILLING CODE 4120-01-C
                    In all but three cases, we are proposing for the new scope
                equipment item to replace the existing scope with the identical amount
                of equipment time. For CPT codes 92612 (Flexible endoscopic evaluation
                of swallowing by cine or video recording), 92614 (Flexible endoscopic
                evaluation, laryngeal sensory testing by cine or video recording), and
                92616 (Flexible endoscopic evaluation of swallowing and laryngeal
                sensory testing by cine or video recording), the current scopes in use
                are the FEES video system (ES027) and the FEESST video system (ES028).
                Since we are proposing the use of a non-channeled flexible digital
                scope that requires a corresponding scope video system, we are adding
                the ES080 equipment at the same equipment time
                [[Page 40499]]
                to these three procedures rather than replacing the ES027 and ES028
                equipment. In all other cases, we are proposing to replace the current
                scope equipment listed in Table 6 with the new scope equipment, while
                maintaining the same amount of equipment time.
                    We identified inconsistencies with the workgroup recommendations
                for a small number of HCPCS codes. CPT code 45350 (Sigmoidoscopy,
                flexible; with band ligation(s) (e.g., hemorrhoids)) was recommended to
                include a multi-channeled flexible digital scope, flexible
                sigmoidoscopy (ES085), however, we noted that this CPT code does not
                include any scopes among its current direct PE inputs. CPT code 31595
                was recommended to include a non-channeled flexible digital scope,
                laryngoscopy (ES080) but it no longer exists as a CPT code after having
                been deleted for CY 2019. CPT code 43232 (Esophagoscopy, flexible,
                transoral; with transendoscopic ultrasound-guided intramural or
                transmural fine needle aspiration/biopsy(s)) was recommended to include
                a multi-channeled flexible digital scope, esophagoscopy (ES088), but it
                does not include a scope amongst its direct PE inputs any longer
                following clarification from the same workgroup recommendations that
                CPT code 43232 is never performed in the nonfacility setting. In all
                three of these cases, we are not proposing to add one of the new scope
                equipment items to these procedures.
                    We did not receive pricing information along with the workgroup
                recommendations for the other 15 new scope equipment items. For CY
                2020, we are proposing to establish new equipment codes for these
                scopes as detailed in Table 5. However, due to a lack of pricing
                information, we are not proposing to replace existing scope equipment
                with the new equipment items as we did for the other eight new scope
                equipment items for CY 2020. We welcome additional feedback from
                stakeholders regarding the pricing of these scope equipment items,
                especially the submission of detailed invoices with pricing data. We
                are proposing to transition the scopes for which we do have pricing
                information over to the new equipment items for CY 2020, and we look
                forward to engaging with stakeholders to assist in pricing and then
                transitioning the remaining scopes in future rulemaking.
                c. Technical Corrections to Direct PE Input Database and Supporting
                Files
                    Subsequent to the publication of the CY 2019 PFS final rule,
                stakeholders alerted us to several clerical inconsistencies in the
                direct PE database. We are proposing to correct these inconsistencies
                as described below and reflected in the CY 2020 proposed direct PE
                input database displayed on the CMS website under downloads for the CY
                2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    For CY 2020, we are proposing to address the following
                inconsistencies:
                     The RUC's Scope Equipment Reorganization Workgroup
                recommended deletion of the non-facility inputs for CPT codes 43231
                (Esophagoscopy, flexible, transoral; with endoscopic ultrasound
                examination) and 43232 (Esophagoscopy, flexible, transoral; with
                transendoscopic ultrasound-guided intramural or transmural fine needle
                aspiration/biopsy(s)). The gastroenterology specialty societies stated
                that these services are never performed in the non-facility setting.
                After our own review of these services, we agree with the workgroup's
                recommendation, and we are proposing to remove the non-facility direct
                PE inputs for these two CPT codes.
                     In rulemaking for CY 2018, we reviewed a series of CPT
                codes describing nasal sinus endoscopy surgeries. At that time, we
                sought comments on whether the broader family of nasal sinus endoscopy
                surgery services should be subject to the special rules for multiple
                endoscopic procedures instead of the standard multiple procedure
                payment reduction. We received very few comments in response to our
                solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated
                that we would continue to explore this option for future rulemaking. We
                are proposing to apply the special rule for multiple endoscopic
                procedures to this family of codes beginning in CY 2020. This proposal
                would treat this group of CPT codes consistently with other similar
                endoscopic procedures when codes within the CPT code family are billed
                together with another endoscopy service in the same family. Similar to
                other similar endoscopic procedure code families, we are proposing that
                CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral
                (separate procedure)) would be the base procedure for the remainder of
                nasal sinus endoscopies. The codes affected by this proposal are as
                follows (see Table 7).
                 Table 7--Proposed Nasal Sinus Endoscopy Codes Subject to Special Rules
                                   for Multiple Endoscopic Procedures
                ------------------------------------------------------------------------
                               CPT code                         Short descriptor
                ------------------------------------------------------------------------
                31231................................  Nasal endoscopy dx.
                31233................................  Nasal/sinus endoscopy dx.
                31235................................  Nasal/sinus endoscopy dx.
                31237................................  Nasal/sinus endoscopy surg.
                31238................................  Nasal/sinus endoscopy surg.
                31239................................  Nasal/sinus endoscopy surg.
                31240................................  Nasal/sinus endoscopy surg.
                31241................................  Nsl/sins ndsc w/artery lig.
                31253................................  Nsl/sins ndsc total.
                31254................................  Nsl/sins ndsc w/prtl ethmdct.
                31255................................  Nsl/sins ndsc w/tot ethmdct.
                31256................................  Exploration maxillary sinus.
                31257................................  Nsl/sins ndsc tot w/sphendt.
                31259................................  Nsl/sins ndsc sphn tiss rmvl.
                31267................................  Endoscopy maxillary sinus.
                31276................................  Nsl/sins ndsc frnt tiss rmvl.
                31287................................  Nasal/sinus endoscopy surg.
                31288................................  Nasal/sinus endoscopy surg.
                31290................................  Nasal/sinus endoscopy surg.
                31291................................  Nasal/sinus endoscopy surg.
                31292................................  Nasal/sinus endoscopy surg.
                31293................................  Nasal/sinus endoscopy surg.
                31294................................  Nasal/sinus endoscopy surg.
                31295................................  Sinus endo w/balloon dil.
                31296................................  Sinus endo w/balloon dil.
                31297................................  Sinus endo w/balloon dil.
                31298................................  Nsl/sins ndsc w/sins dilat.
                ------------------------------------------------------------------------
                    Special rules for multiple endoscopic procedures would apply if any
                of the procedures listed in Table 7 are billed together for the same
                patient on the same day. We apply the multiple endoscopy payment rules
                to a code family before ranking the family with other procedures
                performed on the same day (for example, if multiple endoscopies in the
                same family are reported on the same day as endoscopies in another
                family, or on the same day as a non-endoscopic procedure). If an
                endoscopic procedure is reported together with its base procedure, we
                do not pay separately for the base procedure. Payment for the base
                procedure is included in the payment for the other endoscopy. For
                additional information about the payment adjustment under the special
                rule for multiple endoscopic services, we refer readers to the CY 1992
                PFS final rule where this policy was established (56 FR 59515) and to
                Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available
                on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf).
                d. Updates to Prices for Existing Direct PE Inputs
                    In the CY 2011 PFS final rule with comment period (75 FR 73205), we
                finalized a process to act on public
                [[Page 40500]]
                requests to update equipment and supply price and equipment useful life
                inputs through annual rulemaking, beginning with the CY 2012 PFS
                proposed rule. For CY 2020, we are proposing the following price
                updates for existing direct PE inputs.
                    We are proposing to update the price of one supply and one
                equipment item in response to the public submission of invoices. As
                these pricing updates were each part of the formal review for a code
                family, we are proposing that the new pricing take effect for CY 2020
                for these items instead of being phased in over 4 years. For the
                details of these proposed price updates, please refer to Table 22,
                Proposed CY 2020 Invoices Received for Existing Direct PE Inputs in
                section II.N., Proposed Valuation of Specific Codes, of this proposed
                rule.
                    We are also proposing to update the name of the EP001 equipment
                item from ``DNA/digital image analyzer (ACIS)'' to ``DNA/Digital Image
                Analyzer'' due to clarification from stakeholders regarding the typical
                use of this equipment.
                (1) Market-Based Supply and Equipment Pricing Update
                    Section 220(a) of the Protecting Access to Medicare Act of 2014
                (PAMA) (Pub. L. 113-93) provides that the Secretary may collect or
                obtain information from any eligible professional or any other source
                on the resources directly or indirectly related to furnishing services
                for which payment is made under the PFS, and that such information may
                be used in the determination of relative values for services under the
                PFS. Such information may include the time involved in furnishing
                services; the amounts, types and prices of PE inputs; overhead and
                accounting information for practices of physicians and other suppliers,
                and any other elements that would improve the valuation of services
                under the PFS.
                    As part of our authority under section 1848(c)(2)(M) of the Act, we
                initiated a market research contract with StrategyGen to conduct an in-
                depth and robust market research study to update the PFS direct PE
                inputs (DPEI) for supply and equipment pricing for CY 2019. These
                supply and equipment prices were last systematically developed in 2004-
                2005. StrategyGen submitted a report with updated pricing
                recommendations for approximately 1300 supplies and 750 equipment items
                currently used as direct PE inputs. This report is available as a
                public use file displayed on the CMS website under downloads for the CY
                2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    The StrategyGen team of researchers, attorneys, physicians, and
                health policy experts conducted a market research study of the supply
                and equipment items currently used in the PFS direct PE input database.
                Resources and methodologies included field surveys, aggregate
                databases, vendor resources, market scans, market analysis, physician
                substantiation, and statistical analysis to estimate and validate
                current prices for medical equipment and medical supplies. StrategyGen
                conducted secondary market research on each of the 2,072 DPEI medical
                equipment and supply items that CMS identified from the current DPEI.
                The primary and secondary resources StrategyGen used to gather price
                data and other information were:
                     Telephone surveys with vendors for top priority items
                (Vendor Survey).
                     Physician panel validation of market research results,
                prioritized by total spending (Physician Panel).
                     The General Services Administration system (GSA).
                     An aggregate health system buyers database with discounted
                prices (Buyers).
                     Publicly available vendor resources, that is, Amazon
                Business, Cardinal Health (Vendors).
                     Federal Register, current DPEI data, historical proposed
                and final rules prior to CY 2018, and other resources; that is, AMA RUC
                reports (References).
                    StrategyGen prioritized the equipment and supply research based on
                current share of PE RVUs attributable by item provided by CMS.
                StrategyGen developed the preliminary Recommended Price (RP)
                methodology based on the following rules in hierarchical order
                considering both data representativeness and reliability.
                    (1) If the market share, as well as the sample size, for the top
                three commercial products were available, the weighted average price
                (weighted by percent market share) was the reported RP. Commercial
                price, as a weighted average of market share, represents a more robust
                estimate for each piece of equipment and a more precise reference for
                the RP.
                    (2) If no data were available for commercial products, the current
                CMS prices were used as the RP.
                    GSA prices were not used to calculate the StrategyGen recommended
                prices, due to our concern that the GSA system curtails the number and
                type of suppliers whose products may be accessed on the GSA Advantage
                website, and that the GSA prices may often be lower than prices that
                are available to non-governmental purchasers. After reviewing the
                StrategyGen report, we proposed to adopt the updated direct PE input
                prices for supplies and equipment as recommended by StrategyGen.
                    StrategyGen found that despite technological advancements, the
                average commercial price for medical equipment and supplies has
                remained relatively consistent with the current CMS price.
                Specifically, preliminary data indicated that there was no
                statistically significant difference between the estimated commercial
                prices and the current CMS prices for both equipment and supplies. This
                cumulative stable pricing for medical equipment and supplies appears
                similar to the pricing impacts of non-medical technology advancements
                where some historically high-priced equipment (that is, desktop PCs)
                has been increasingly substituted with current technology (that is,
                laptops and tablets) at similar or lower price points. However, while
                there were no statistically significant differences in pricing at the
                aggregate level, medical specialties would experience increases or
                decreases in their Medicare payments if CMS were to adopt the pricing
                updates recommended by StrategyGen. At the service level, there may be
                large shifts in PE RVUs for individual codes that happened to contain
                supplies and/or equipment with major changes in pricing, although we
                note that codes with a sizable PE RVU decrease would be limited by the
                requirement to phase in significant reductions in RVUs, as required by
                section 1848(c)(7) of the Act. The phase-in requirement limits the
                maximum RVU reduction for codes that are not new or revised to 19
                percent in any individual calendar year.
                    We believe that it is important to make use of the most current
                information available for supply and equipment pricing instead of
                continuing to rely on pricing information that is more than a decade
                old. Given the potentially significant changes in payment that would
                occur, both for specific services and more broadly at the specialty
                level, in the CY 2019 PFS proposed rule we proposed to phase in our use
                of the new direct PE input pricing over a 4-year period using a 25/75
                percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021),
                and 100/0 percent (CY 2022) split between new and old pricing. This
                approach is consistent with how we have previously incorporated
                significant new data into the calculation of PE RVUs, such as the 4-
                year transition period finalized in CY 2007 PFS final rule with comment
                period when changing to the ``bottom-
                [[Page 40501]]
                up'' PE methodology (71 FR 69641). This transition period will not only
                ease the shift to the updated supply and equipment pricing, but will
                also allow interested parties an opportunity to review and respond to
                the new pricing information associated with their services.
                    We proposed to implement this phase-in over 4 years so that supply
                and equipment values transition smoothly from the prices we currently
                include to the final updated prices in CY 2022. We proposed to
                implement this pricing transition such that one quarter of the
                difference between the current price and the fully phased-in price is
                implemented for CY 2019, one third of the difference between the CY
                2019 price and the final price is implemented for CY 2020, and one half
                of the difference between the CY 2020 price and the final price is
                implemented for CY 2021, with the new direct PE prices fully
                implemented for CY 2022. An example of the transition from the current
                to the fully-implemented new pricing is provided in Table 8.
                            Table 8--Example of Direct PE Pricing Transition
                ------------------------------------------------------------------------
                
                ------------------------------------------------------------------------
                Current Price...............                  $100
                Final Price.................                   200  ....................
                    Year 1 (CY 2019) Price..                   125  \1/4\ difference
                                                                     between $100 and
                                                                     $200.
                    Year 2 (CY 2020) Price..                   150  \1/3\ difference
                                                                     between $125 and
                                                                     $200.
                    Year 3 (CY 2021) Price..                   175  \1/2\ difference
                                                                     between $150 and
                                                                     $200.
                    Final (CY 2022) Price...                   200  ....................
                ------------------------------------------------------------------------
                    For new supply and equipment codes for which we establish prices
                during the transition years (CYs 2019, 2020 and 2021) based on the
                public submission of invoices, we proposed to fully implement those
                prices with no transition since there are no current prices for these
                supply and equipment items. These new supply and equipment codes would
                immediately be priced at their newly established values. We also
                proposed that, for existing supply and equipment codes, when we
                establish prices based on invoices that are submitted as part of a
                revaluation or comprehensive review of a code or code family, they will
                be fully implemented for the year they are adopted without being phased
                in over the 4-year pricing transition. The formal review process for a
                HCPCS code includes a review of pricing of the supplies and equipment
                included in the code. When we find that the price on the submitted
                invoice is typical for the item in question, we believe it would be
                appropriate to finalize the new pricing immediately along with any
                other revisions we adopt for the code valuation.
                    For existing supply and equipment codes that are not part of a
                comprehensive review and valuation of a code family and for which we
                establish prices based on invoices submitted by the public, we proposed
                to implement the established invoice price as the updated price and to
                phase in the new price over the remaining years of the proposed 4-year
                pricing transition. During the proposed transition period, where price
                changes for supplies and equipment are adopted without a formal review
                of the HCPCS codes that include them (as is the case for the many
                updated prices we proposed to phase in over the 4-year transition
                period), we believe it is important to include them in the remaining
                transition toward the updated price. We also proposed to phase in any
                updated pricing we establish during the 4-year transition period for
                very commonly used supplies and equipment that are included in 100 or
                more codes, such as sterile gloves (SB024) or exam tables (EF023), even
                if invoices are provided as part of the formal review of a code family.
                We would implement the new prices for any such supplies and equipment
                over the remaining years of the proposed 4-year transition period. Our
                proposal was intended to minimize any potential disruptive effects
                during the proposed transition period that could be caused by other
                sudden shifts in RVUs due to the high number of services that make use
                of these very common supply and equipment items (meaning that these
                items are included in 100 or more codes).
                    We believed that implementing the proposed updated prices with a 4-
                year phase-in would improve payment accuracy, while maintaining
                stability and allowing stakeholders the opportunity to address
                potential concerns about changes in payment for particular items.
                Updating the pricing of direct PE inputs for supplies and equipment
                over a longer time frame will allow more opportunities for public
                comment and submission of additional, applicable data. We welcomed
                feedback from stakeholders on the proposed updated supply and equipment
                pricing, including the submission of additional invoices for
                consideration.
                    We received many comments regarding the market-based supply and
                equipment pricing proposal following the publication of the CY 2019 PFS
                proposed rule. For a full discussion of these comments, we direct
                readers to the CY 2019 PFS final rule (83 FR 59475-59480). In each
                instance in which a commenter raised questions about the accuracy of a
                supply or equipment code's recommended price, the StrategyGen
                contractor conducted further research on the item and its price with
                special attention to ensuring that the recommended price was based on
                the correct item in question and the clarified unit of measure. Based
                on the commenters' requests, the StrategyGen contractor conducted an
                extensive examination of the pricing of any supply or equipment items
                that any commenter identified as requiring additional review. Invoices
                submitted by multiple commenters were greatly appreciated and ensured
                that medical equipment and supplies were re-examined and clarified.
                Multiple researchers reviewed these specified supply and equipment
                codes for accuracy and proper pricing. In most cases, the contractor
                also reached out to a team of nurses and their physician panel to
                further validate the accuracy of the data and pricing information. In
                some cases, the pricing for individual items needed further
                clarification due to a lack of information or due to significant
                variation in packaged items. After consideration of the comments and
                this additional price research, we updated the recommended prices for
                approximately 70 supply and equipment codes identified by the
                commenters. Table 9 in the CY 2019 PFS final rule lists the supply and
                equipment codes with price changes based on feedback from the
                commenters and the resulting additional research into pricing (83 FR
                59479-59480).
                    After consideration of the public comments, we finalized our
                proposals associated with the market research study to update the PFS
                direct PE inputs for supply and equipment pricing. We continue to
                believe that implementing the proposed updated prices with a 4-year
                phase-in will improve payment
                [[Page 40502]]
                accuracy, while maintaining stability and allowing stakeholders the
                opportunity to address potential concerns about changes in payment for
                particular items. We continue to welcome feedback from stakeholders on
                the proposed updated supply and equipment pricing, including the
                submission of additional invoices for consideration.
                    For CY 2020, we received invoice submissions for approximately 30
                supply and equipment codes from stakeholders as part of the second year
                of the market-based supply and equipment pricing update. These invoices
                were reviewed by the StrategyGen contractor and the submitted invoices
                were used in many cases to supplement the pricing originally proposed
                for the CY 2019 PFS rule cycle. The contractor reviewed the invoices,
                as well as prior data for the relevant supply/equipment codes to make
                sure the item in the invoice was representative of the supply/equipment
                item in question and aligned with past research. Based on this
                research, we are proposing to update the prices of the following supply
                and equipment items:
                BILLING CODE 4120-01-P
                [[Page 40503]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.004
                BILLING CODE 4120-01-C
                    For most supply and equipment items, there was an alignment between
                the research carried out by the StrategyGen contractor and the
                submitted invoice. The updated CY 2020 pricing was calculated using an
                average between the previous market research and the newly submitted
                invoices in these cases. In some cases the submitted invoices were not
                representative of market prices, such as for the centrifuge with rotor
                (EP007) equipment item where the invoice price of $8,563 appeared to be
                an outlier. We did not use the invoices to calculate our pricing
                recommendation in these situations and instead continued to rely on our
                prior pricing data. In other instances, such as for the kit, probe,
                cryoablation, prostate (Galil-Endocare)
                [[Page 40504]]
                (SA099) supply item, our research indicated that the submitted invoice
                price was more representative of the commercial price than our CY 2019
                research and pricing. We are proposing the new invoice prices for these
                supply and equipment items due to our belief in their greater accuracy.
                    For some of the remaining supply and equipment items, such as the
                five-gallon paraffin (EP031) equipment and the Olympus DP21 camera
                (EP089) equipment, we maintained the extant pricing for CY 2019 due to
                a lack of sufficient data to update the pricing. In these situations
                where we did not have an updated price for CY 2019, we believe that the
                newly submitted invoices are more representative of the current
                commercial prices that are being paid on the market. We are again
                proposing the new invoice prices for these supply and equipment items
                due to our belief in their greater accuracy.
                    In addition, we were alerted by stakeholders that the price of the
                EM visit pack (SA047) supply did not match the sum of the component
                prices of the supplies included in the pack. After reviewing the prices
                of the individual component supplies, we agree with the stakeholders
                that there was a discrepancy in the previous pricing of this supply
                pack. We are proposing to update the price of the EM visit pack to
                $5.47 to match the sum of the prices of the component supplies, and
                proposing to continue to transition towards this price over the
                remaining years of the phase-in period.
                    We finalized a policy last year to phase in the new supply and
                equipment pricing over 4 years so that supply and equipment values
                transition smoothly from their current prices to the final updated
                prices in CY 2022. We finalized our proposal to implement this pricing
                transition such that one quarter of the difference between the current
                price and the fully phased in price was implemented for CY 2019, one
                third of the difference between the CY 2019 price and the final price
                is implemented for CY 2020, and one half of the difference between the
                CY 2020 price and the final price is implemented for CY 2021, with the
                new direct PE prices fully implemented for CY 2022. An example of the
                transition from the current to the fully-implemented new pricing is
                provided in Table 8. For CY 2020, one third of the difference between
                the CY 2019 price and the final price will be implemented as per the
                previously finalized policy.
                    The full list of updated supply and equipment pricing as it will be
                implemented over the 4-year transition period will be made available as
                a public use file displayed on the CMS website under downloads for the
                CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                (2) Invoice Submission
                    We routinely accept public submission of invoices as part of our
                process for developing payment rates for new, revised, and potentially
                misvalued codes. Often these invoices are submitted in conjunction with
                the RUC-recommended values for the codes. For CY 2020, we noted that
                some stakeholders have submitted invoices for new, revised, or
                potentially misvalued codes after the February 10th deadline
                established for code valuation recommendations. To be included in a
                given year's proposed rule, we generally need to receive invoices by
                the same February 10th deadline we noted for consideration of RUC
                recommendations. However, we would consider invoices submitted as
                public comments during the comment period following the publication of
                the PFS proposed rule, and would consider any invoices received after
                February 10th or outside of the public comment process as part of our
                established annual process for requests to update supply and equipment
                prices.
                (3) Adjustment to Allocation of Indirect PE for Some Office-Based
                Services
                    In the CY 2018 PFS final rule (82 FR 52999 through 53000), we
                established criteria for identifying the services most affected by the
                indirect PE allocation anomaly that does not allow for a site of
                service differential that accurately reflects the relative indirect
                costs involved in furnishing services in nonfacility settings. We also
                finalized a modification in the PE methodology for allocating indirect
                PE RVUs to better reflect the relative indirect PE resources involved
                in furnishing these services. The methodology, as described, is based
                on the difference between the ratio of indirect PE to work RVUs for
                each of the codes meeting eligibility criteria and the ratio of
                indirect PE to work RVU for the most commonly reported visit code. We
                refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000)
                for a discussion of our process for selecting services subject to the
                revised methodology, as well as a description of the methodology, which
                we began implementing for CY 2018 as the first year of a 4-year
                transition. For CY 2020, we are proposing to continue with the third
                year of the transition of this adjustment to the standard process for
                allocating indirect PE.
                C. Determination of Malpractice Relative Value Units (RVUs)
                1. Overview
                    Section 1848(c) of the Act requires that each service paid under
                the PFS be composed of three components: Work, PE, and malpractice (MP)
                expense. As required by section 1848(c)(2)(C)(iii) of the Act,
                beginning in CY 2000, MP RVUs are resource based. Section
                1848(c)(2)(B)(i) of the Act also requires that we review, and if
                necessary adjust, RVUs no less often than every 5 years. In the CY 2015
                PFS final rule with comment period, we implemented the third review and
                update of MP RVUs. For a comprehensive discussion of the third review
                and update of MP RVUs, see the CY 2015 proposed rule (79 FR 40349
                through 40355) and final rule with comment period (79 FR 67591 through
                67596). In the CY 2018 proposed rule (82 FR 33965 through 33970), we
                proposed to update the specialty-level risk factors used in the
                calculation of MP RVUs, prior to the next required 5 year update (CY
                2020), using the updated MP premium data that were used in the eighth
                Geographic Practice Cost Index (GPCI) update for CY 2017; however the
                proposal was ultimately not finalized for CY 2018.
                    We consider the following factors when we determine MP RVUs for
                individual PFS services: (1) Specialty-level risk factors derived from
                data on specialty-specific MP premiums incurred by practitioners; (2)
                service-level risk factors derived from Medicare claims data of the
                weighted average risk factors of the specialties that furnish each
                service; and (3) an intensity/complexity of service adjustment to the
                service-level risk factor based on either the higher of the work RVU or
                clinical labor portion of the direct PE RVU. Prior to CY 2016, MP RVUs
                were only updated once every 5 years, except in the case of new and
                revised codes.
                    As explained in the CY 2011 PFS final rule with comment period (75
                FR 73208), MP RVUs for new and revised codes effective before the next
                5-year review of MP RVUs were determined either by a direct crosswalk
                from a similar source code or by a modified crosswalk to account for
                differences in work RVUs between the new/revised code and the source
                code. For the modified crosswalk approach, we adjusted (or scaled) the
                MP RVU for the new/revised code to reflect the difference in work RVU
                between the source code and the new/revised work RVU (or, if greater,
                the difference in the
                [[Page 40505]]
                clinical labor portion of the fully implemented PE RVU) for the new
                code. For example, if the proposed work RVU for a revised code was 10
                percent higher than the work RVU for its source code, the MP RVU for
                the revised code would be increased by 10 percent over the source code
                MP RVU. Under this approach, the same risk factor was applied for the
                new/revised code and source code, but the work RVU for the new/revised
                code was used to adjust the MP RVUs for risk.
                    In the CY 2016 PFS final rule with comment period (80 FR 70906
                through 70910), we finalized a policy to begin conducting annual MP RVU
                updates to reflect changes in the mix of practitioners providing
                services (using Medicare claims data), and to adjust MP RVUs for risk
                for intensity and complexity (using the work RVU or clinical labor
                RVU). We also finalized a policy to modify the specialty mix assignment
                methodology (for both MP and PE RVU calculations) to use an average of
                the three most recent years of data instead of a single year of data.
                Under this approach, for new and revised codes, we generally assign a
                specialty-level risk factor to individual codes based on the same
                utilization assumptions we make regarding specialty mix we use for
                calculating PE RVUs and for PFS budget neutrality. We continue to use
                the work RVU or clinical labor RVU to adjust the MP RVU for each code
                for intensity and complexity. In finalizing this policy, we stated that
                the specialty-level risk factors would continue to be updated through
                notice and comment rulemaking every 5 years using updated premium data,
                but would remain unchanged between the 5-year reviews.
                    Section 1848(e)(1)(C) of the Act requires us to review, and if
                necessary, adjust the GPCIs at least every 3 years. For CY 2020, we are
                conducting the statutorily required 3-year review of the GPCIs, which
                coincides with the statutorily required 5-year review of the MP RVUs.
                We note that the MP premium data used to update the MP GPCIs are the
                same data used to determine the specialty-level risk factors, which are
                used in the calculation of MP RVUs. Going forward, we believe it would
                be logical and efficient to align the update of MP premium data used to
                determine the MP RVUs with the update of the MP GPCI. Therefore, we are
                proposing to align the update of MP premium data with the update to the
                MP GPCIs, that is, we are proposing to review, and if necessary update
                the MP RVUs at least every 3 years, similar to our review and update of
                the GPCIs. If we align the two updates, we would conduct the next
                statutorily-mandated review and update of both the GPCI and MP RVU for
                implementation in CY 2023. We are proposing to implement the fourth
                comprehensive review and update of MP RVUs for CY 2020 and are seeking
                comment on these proposals.
                2. Methodology for the Proposed Revision of Resource-Based Malpractice
                RVUs
                a. General Discussion
                    We calculated the proposed MP RVUs using updated malpractice
                premium data obtained from state insurance rate filings. The
                methodology used in calculating the proposed CY 2020 review and update
                of resource-based MP RVUs largely parallels the process used in the CY
                2015 update; however, we are proposing to incorporate several
                methodological refinements, which are described below in this proposed
                rule. The MP RVU calculation requires us to obtain information on
                specialty-specific MP premiums that are linked to specific services,
                and using this information, we derive relative risk factors for the
                various specialties that furnish a particular service. Because MP
                premiums vary by state and specialty, the MP premium information must
                be weighted geographically and by specialty. We calculated the proposed
                MP RVUs using four data sources: Malpractice premium data presumed to
                be in effect as of December 31, 2017; CY 2018 Medicare payment and
                utilization data; higher of the CY 2020 proposed work RVUs or the
                clinical labor portion of the direct PE RVUs; and CY 2019 GPCIs. We
                will use the higher of the CY 2020 final work RVUs or clinical labor
                portion of the direct PE RVUs in our calculation to develop the CY 2020
                final MP RVUs while maintaining overall PFS budget neutrality.
                    Similar to the CY 2015 update, the proposed MP RVUs were calculated
                using specialty-specific malpractice premium data because they
                represent the expense incurred by practitioners to obtain malpractice
                insurance as reported by insurers. For CY 2020, the most current
                malpractice premium data available, with a presumed effective date of
                no later than December 31, 2017, were obtained from insurers with the
                largest market share in each state. We identified insurers with the
                largest market share using the National Association of Insurance
                Commissioners (NAIC) market share report. This annual report provides
                state-level market share for entities that provide premium liability
                insurance (PLI) in a state. Premium data were downloaded from the
                System for Electronic Rates & Forms Filing Access Interface (SERFF)
                (accessed from the NAIC website) for participating states. For non-
                SERFF states, data were downloaded from the state-specific website (if
                available online) or obtained directly from the state's alternate
                access to filings. For SERFF states and non-SERFF states with online
                access to filings, the 2017 market share report was used to select
                companies. For non-SERFF states without online access to filings, the
                2016 market share report was used to identify companies. These were the
                most current data available during the data collection and acquisition
                process.
                    Malpractice insurance premium data were collected from all 50
                States, and the District of Columbia. Efforts were made to collect
                filings from Puerto Rico; however, no recent filings were submitted at
                the time of data collection and therefore filings from the previous
                update were used. Consistent with the CY 2015 update, no filings were
                collected for the other U.S. territories: American Samoa, Guam, Virgin
                Islands, or Northern Mariana Islands. Malpractice premiums were
                collected for coverage limits of $1 million/$3 million, mature, claims-
                made policies (policies covering claims made, rather than those
                covering losses occurring, during the policy term). A $1 million/$3
                million liability limit policy means that the most that would be paid
                on any claim is $1 million and the most that the policy would pay for
                claims over the timeframe of the policy is $3 million. Adjustments were
                made to the premium data to reflect mandatory surcharges for patient
                compensation funds (PCF, funds used to pay for any claim beyond the
                state's statutory amount, thereby limiting an individual physician's
                liability in cases of a large suit) in states where participation in
                such funds is mandatory.
                    Premium data were included for all physician and NPP specialties,
                and all risk classifications available in the collected rate filings.
                Although premium data were collected from all states, the District of
                Columbia, and previous filings for Puerto Rico were utilized, not all
                specialties had distinct premium data in the rate filings from all
                states. In previous updates, specialties for which premium data were
                not available for at least 35 states, and specialties for which there
                were not distinct risk groups (surgical, non-surgical, and surgical
                with obstetrics) among premium data in the rate filings, were
                crosswalked to a similar specialty, either conceptually or based on
                available premium data. This resulted in not using those premium data
                because
                [[Page 40506]]
                the 35 state threshold was not met. In this proposed CY 2020 update, we
                note that the proposed methodological improvement discussed below in
                this proposed rule expands the specialties and amount of filings data
                used to develop the proposed risk factors, which are used to develop
                the proposed MP RVUs.
                b. Proposed Methodological Refinements
                    For the CY 2020 update, we are proposing the following
                methodological improvements to the development of MP premium data:
                    (1) Downloading and using a broader set of filings from the largest
                market share insurers in each state, beyond those listed as
                ``physician'' and ``surgeon'' to obtain a more comprehensive data set.
                    (2) Combining minor surgery and major surgery premiums to create
                the surgery service risk group, which yields a more representative
                surgical risk factor. In the previous update, only premiums for major
                surgery were used in developing the surgical risk factor.
                    (3) Utilizing partial and total imputation to develop a more
                comprehensive data set when CMS specialty names are not distinctly
                identified in the insurer filings, which sometimes use unique specialty
                names.
                    In instances where insurers report data for some (but not all)
                specialties that explicitly corresponded to a CMS specialty, where
                those data were missing, we propose to use partial imputation based on
                available data to establish what the premiums would likely have been
                had that specialty been delineated in the filing. In instances where
                there are no data corresponding to a CMS specialty in the filing, we
                propose to use total imputation to establish premiums.
                    For example, if a specialty of Sleep Medicine is listed on the
                insurer's rate filing, this rate will be matched to the CMS specialty
                Sleep Medicine (C0). However, if the Sleep Medicine specialty is not
                listed on the insurer's rate filing, under our proposed methodology,
                the insurer's rate filing for General Practice would be matched to the
                CMS specialty of Sleep Medicine (C0). In this example, we believe
                General Practice is likely to be consistent with the rate that a Sleep
                Medicine provider would be charged by that insurer. This proposed
                methodological improvement means that instead of discarding specialty-
                specific information from some insurers' filings because other insurers
                lacked that same level of detail, we would instead impute the missing
                rates at the insurer/specialty level in an effort to utilize as much of
                the information from the filings as possible.
                    We are seeking comment on these proposed methodological
                improvements. Additional technical details are available in our interim
                report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
                for the Medicare Physician Fee Schedule,'' on our website. It is
                located under the supporting documents section for the CY 2020 PFS
                proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                c. Steps for Calculating Malpractice RVUs
                    Calculation of the proposed MP RVUs conceptually follows the
                specialty-weighted approach used in the CY 2015 final rule with comment
                period (79 FR 67591), along with the above proposed methodological
                improvements. The specialty-weighted approach bases the MP RVUs for a
                given service on a weighted average of the risk factors of all
                specialties furnishing the service. This approach ensures that all
                specialties furnishing a given service are reflected in the calculation
                of the MP RVUs. The steps for calculating the proposed MP RVUs are
                described below.
                    Step (1): Compute a preliminary national average premium for each
                specialty.
                    Insurance rating area malpractice premiums for each specialty are
                mapped to the county level. The specialty premium for each county is
                then multiplied by its share of the total U.S. population (from the
                U.S. Census Bureau's 2013-2017 American Community Survey (ACS) 5-year
                estimates). This is in contrast to the method used for creating
                national average premiums for each specialty in the 2015 update; in
                that update, specialty premiums were weighted by the total RVU per
                county, rather than by the county share of the total U.S. population.
                We refer readers to the CY 2016 PFS final rule with comment period (80
                FR 70909) for a discussion of why we have adopted a weighting method
                based on share of total U.S. population. This calculation is then
                divided by the average MP GPCI across all counties for each specialty
                to yield a normalized national average premium for each specialty. The
                specialty premiums are normalized for geographic variation so that the
                locality cost differences (as reflected by the 2019 GPCIs) would not be
                counted twice. Without the geographic variation adjustment, the cost
                differences among fee schedule areas would be reflected once under the
                methodology used to calculate the MP RVUs and again when computing the
                service specific payment amount for a given fee schedule area.
                    Step (2): Determine which premium service risk groups to use within
                each specialty.
                    Some specialties had premium rates that differed for surgery,
                surgery with obstetrics, and non-surgery. These premium classes are
                designed to reflect differences in risk of professional liability and
                the cost of malpractice claims if they occur. To account for the
                presence of different classes in the malpractice premium data and the
                task of mapping these premiums to procedures, we calculated distinct
                risk factors for surgical, surgical with obstetrics, and nonsurgical
                procedures where applicable. However, the availability of data by
                surgery and non-surgery varied across specialties. Historically, no
                single approach accurately addressed the variability in premium class
                among specialties, and we previously employed several methods for
                calculating average premiums by specialty. These methods are discussed
                below.
                    Developing Distinct Service Risk Groups: We determined that there
                were sufficient data for surgery and non-surgery premiums, as well as
                sufficient differences in rates between classes for 15 specialties
                (there were 10 such specialties in the CY 2015 update). These
                specialties are listed in Table 10. Additionally, as described in the
                proposed methodological refinements, in some instances, we combined
                minor surgery and major surgery premiums to create a premium to develop
                the surgery service risk group, rather than discard minor surgery
                premium data as was done in the previous update. Therefore, we
                calculated a national average surgical premium and non-surgical premium
                for those specialties. For all other specialties (those that are not
                listed in Table 10) that typically do not distinguish premiums as
                described above, a single risk factor was calculated, and that
                specialty risk factor was applied to all services performed by those
                specialties.
                    This is consistent with prior practice; however, we have refined
                the nomenclature to more precisely describe that some specialties are
                delineated into service risk groups, as is the case for surgical, non-
                surgical, and surgical with obstetrics, and some specialties are not
                further delineated into service risk subgroups and are instead referred
                to as ``All''--meaning that all services performed by that specialty
                receive the same risk factor.
                [[Page 40507]]
                   Table 10--Proposed Specialties Subdivided Into Service Risk Groups
                ------------------------------------------------------------------------
                      Service risk groups                      Specialties
                ------------------------------------------------------------------------
                Surgery/No Surgery.............  Otolaryngology (04), Cardiology (06),
                                                  Dermatology (07), Gastroenterology
                                                  (10), Neurology (13), Ophthalmology
                                                  (18), Urology (34), Geriatric Medicine
                                                  (38), Nephrology (39), Endocrinology
                                                  (46), Podiatry (48), Emergency
                                                  Medicine (93).
                Surgery/No Surgery/OB..........  General Practice (01), Family Practice
                                                  (08), OB/GYN (16).
                ------------------------------------------------------------------------
                    Step (3): Calculate a risk factor for each specialty.
                    The relative differences in national average premiums between
                specialties are expressed in our methodology as a specialty-level risk
                factor. These risk factors are calculated by dividing the national
                average premium for each specialty by the national average premium for
                the specialty with the lowest premiums for which we had sufficient and
                reliable data, which remains allergy and immunology (03). For
                specialties with rate filings that are indicative of sufficient
                surgical and non-surgical premium data, we recognized those service-
                risk groups (that is, surgical, and non-surgical) as risk groups of the
                specialty and we calculated both a surgical and non-surgical risk
                factor. Similarly, for specialties with rate filings that distinguished
                surgical premiums with obstetrics, we recognized that service-risk
                subgroup of the specialty and calculated a separate surgical with
                obstetrics risk factor.
                (a) Technical Component (TC) Only Services
                    We note that for determining the risk factor for suppliers of TC-
                only services in the CY 2015 update, we updated the premium data for
                independent diagnostic testing facilities (IDTFs) that we used in the
                CY 2010 update. Those data were obtained from a survey conducted by the
                Radiology Business Management Association (RBMA) in 2009; we ultimately
                used those data to calculate an updated TC specialty risk factor. We
                applied the updated TC specialty risk factor to suppliers of TC-only
                services. In the CY 2015 final rule with comment period (79 FR 67595),
                RBMA voluntarily submitted updated MP premium information collected
                from IDTFs in 2014, and requested that we use the data for calculating
                the CY 2015 MP RVUs for TC-only services. We declined to utilize the
                data and stated that we believe further study is necessary and we would
                consider this matter and propose any changes through future rulemaking.
                We continue to believe that data for a broader set of TC-only services
                are needed, and are working to acquire a broader set of data.
                    For CY 2020, we propose to assign a risk factor of 1.00 for TC-only
                services, which corresponds to the lowest physician specialty-level
                risk factor. We assigned the risk factor of 1.00 to the TC-only
                services because we do not have sufficient comparable professional
                liability premium data for the full range of clinicians that furnish
                TC-only services. In lieu of comprehensive, comparable data, we propose
                to assign 1.00, the lowest physician specialty-level risk factor
                calculated using the updated premium data, as the default minimum risk
                factor. However, we seek information on the most comparable and
                appropriate proxy for the broader set of TC-only services for future
                use, as well as any empirical information that would support assignment
                of an alternative risk factor for these services.
                    Table 11 shows the proposed risk factors by specialty type and
                service risk group.
                BILLING CODE 4120-01-P
                [[Page 40508]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.005
                [[Page 40509]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.006
                BILLING CODE 4120-01-C
                    Step (4): Calculate malpractice RVUs for each CPT/HCPCS code.
                    Resource-based MP RVUs were calculated for each CPT/HCPCS code that
                has work or PE RVUs. The first step was to identify the percentage of
                services furnished by each specialty for each respective CPT/HCPCS
                code. This
                [[Page 40510]]
                percentage was then multiplied by each respective specialty's risk
                factor as calculated in Step 3. The products for all specialties for
                the CPT/HCPCS code were then added together, yielding a specialty-
                weighted service specific risk factor reflecting the weighted
                malpractice costs across all specialties furnishing that procedure. The
                service specific risk factor was multiplied by the greater of the work
                RVU or clinical labor portion of the direct PE RVU for that service, to
                reflect differences in the complexity and risk-of-service between
                services.
                    Low volume service codes: As we discussed above in this proposed
                rule, for low volume services code, we finalized the proposal in the CY
                2018 PFS final rule (82 FR 53000 through 53006) to apply the list of
                expected specialties instead of the claims-based specialty mix for low
                volume services to address stakeholder concerns about the year to year
                variability in PE and MP RVUs for low volume services (which also
                includes no volume services); these are defined as codes that have 100
                allowed services or fewer. These service-level overrides are used to
                determine the specialty for low volume procedures for both PE and MP.
                    In the CY 2018 PFS final rule (82 FR 53000 through 53006), we also
                finalized our proposal to eliminate general use of an MP-specific
                specialty-mix crosswalk for new and revised codes. However, we
                indicated that we would continue to consider, in conjunction with
                annual recommendations, specific recommendations regarding specialty
                mix assignments for new and revised codes, particularly in cases where
                coding changes are expected to result in differential reporting of
                services by specialty, or where the new or revised code is expected to
                be low-volume. Absent such information, the specialty mix assumption
                for a new or revised code would derive from the analytic crosswalk in
                the first year, followed by the introduction of actual claims data,
                which is consistent with our approach for developing PE RVUs.
                    For CY 2020, we are soliciting public comment on the list of
                expected specialties. We also note that the list has been updated to
                include a column indicating if a service is identified as a low volume
                service for CY 2020, and therefore, whether or not the service-level
                override is being applied for CY 2020. The proposed list of codes and
                expected specialties is available on our website under downloads for
                the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    Step (5): Rescale for budget neutrality.
                    The statute requires that changes to fee schedule RVUs must be
                budget neutral. Thus, the last step is to adjust for relativity by
                rescaling the proposed MP RVUs so that the total proposed resource
                based MP RVUs are equal to the total current resource based MP RVUs
                scaled by the ratio of the pools of the proposed and current MP and
                work RVUs. This scaling is necessary to maintain the work RVUs for
                individual services from year to year while also maintaining the
                overall relationship among work, PE, and MP RVUs.
                    Specialties Excluded from Ratesetting Calculation: In section II.B.
                of this proposed rule, Determination of Practice Expense Relative Value
                Units, we discuss specialties that are excluded from ratesetting for
                the purposes of calculating PE RVUs. We are proposing to treat those
                excluded specialties in a consistent manner for the purposes of
                calculating MP RVUs. We note that all specialties are included for
                purposes of calculating the final BN adjustment. The list of
                specialties excluded from the ratesetting calculation for the purpose
                of calculating the PE RVUs that we are proposing to also exclude for
                the purpose of calculating MP RVUs is available in section II.B. of
                this proposed rule, Determination of Practice Expense Relative Value
                Units. The proposed resource based MP RVUs are shown in Addendum B,
                which is available on the CMS website under the downloads section of
                the CY 2020 PFS rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                    Because a different share of the resources involved in furnishing
                PFS services is reflected in each of the three fee schedule components,
                implementation of the resource-based MP RVU update will have much
                smaller payment effects than implementing updates of resource-based
                work RVUs and resource-based PE RVUs. On average, work represents about
                50.9 percent of payment for a service under the fee schedule, PE about
                44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change
                in PE RVUs or work RVUs for a service would result in a change in
                payment of about 11 to 13 percent. In contrast, a corresponding 25
                percent change in MP values for a service would yield a change in
                payment of only about 1 percent. Estimates of the effects on payment by
                specialty type can be found in section VI. of this proposed rule,
                Regulatory Impact Analysis.
                    Additional information on our proposed methodology for updating the
                MP RVUs is available in the ``Interim Report for the CY 2020 Update of
                GPCIs and MP RVUs for the Medicare Physician Fee Schedule,'' which is
                available on the CMS website under the downloads section of the CY 2020
                PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                D. Geographic Practice Cost Indices (GPCIs)
                1. Background
                    Section 1848(e)(1)(A) of the Act requires us to develop separate
                Geographic Practice Cost Indices (GPCIs) to measure relative cost
                differences among localities compared to the national average for each
                of the three fee schedule components (that is, work, practice expense
                (PE), and malpractice (MP)). We discuss the localities established
                under the PFS below in this section. Although the statute requires that
                the PE and MP GPCIs reflect full relative cost differences, section
                1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
                one-quarter of the relative cost differences compared to the national
                average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
                1.5 work GPCI floor for services furnished in Alaska beginning January
                1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
                GPCI floor for services furnished in frontier states (as defined in
                section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
                Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor
                for the work GPCIs, which was set to expire at the end of 2017. Section
                50201 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
                123, enacted February 9, 2018) amended the statute to extend the 1.0
                floor for the work GPCIs through CY 2019 (that is, for services
                furnished no later than December 31, 2019).
                    Section 1848(e)(1)(C) of the Act requires us to review and, if
                necessary, adjust the GPCIs at least every 3 years. Section
                1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed
                since the date of the last previous GPCI adjustment, the adjustment to
                be applied in the first year of the next adjustment shall be \1/2\ of
                the adjustment that otherwise would be made. Therefore, since the
                previous GPCI update was implemented in CYs 2017 and 2018, we are
                proposing to phase in \1/2\ of the latest GPCI adjustment in CY 2020.
                [[Page 40511]]
                    We have completed a review of the GPCIs and are proposing new GPCIs
                in this proposed rule. We also calculate a geographic adjustment factor
                (GAF) for each PFS locality. The GAFs are a weighted composite of each
                PFS localities work, PE and MP expense GPCIs using the national GPCI
                cost share weights. While we do not actually use GAFs in computing the
                fee schedule payment for a specific service, they are useful in
                comparing overall areas costs and payments. The actual effect on
                payment for any actual service would deviate from the GAF to the extent
                that the proportions of work, PE and MP RVUs for the service differ
                from those of the GAF.
                    As noted above, section 50201 of the BBA of 2018 extended the 1.0
                work GPCI floor for services furnished only through December 31, 2019.
                Therefore, the proposed CY 2020 work GPCIs and summarized GAFs do not
                reflect the 1.0 work floor. However, as required by sections
                1848(e)(1)(G) and (I) of the Act, the 1.5 work GPCI floor for Alaska
                and the 1.0 PE GPCI floor for frontier states are permanent, and
                therefore, applicable in CY 2020. See Addenda D and E to this proposed
                rule for the CY 2020 proposed GPCIs and summarized proposed GAFs
                available on the CMS website under the supporting documents section of
                the CY 2020 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                2. Payment Locality Background
                    Prior to 1992, Medicare payments for physicians' services were made
                under the reasonable charge system. Payments under this system largely
                reflected the charging patterns of physicians, which resulted in large
                differences in payment for physicians' services among types of
                services, physician specialties and geographic payment areas.
                    Local Medicare carriers initially established 210 payment
                localities, to reflect local physician charging patterns and economic
                conditions. These localities changed little between the inception of
                Medicare in 1967 and the beginning of the PFS in 1992. In 1994, we
                undertook a study that culminated in a comprehensive locality revision
                (based on locality resource cost differences as reflected by the GPCIs)
                that we implemented in 1997. The development of the current locality
                structure is described in detail in the CY 1997 PFS final rule (61 FR
                34615) and the subsequent final rule with comment period (61 FR 59494).
                The revised locality structure reduced the number of localities from
                210 to 89, and increased the number of statewide localities from 22 to
                34.
                    Section 220(h) of the Protecting Access to Medicare Act (PAMA)
                (Pub. L. 113-93, enacted April 1, 2014) required modifications to the
                payment localities in California for payment purposes beginning with
                2017. As a result, in the CY 2017 PFS final rule (81 FR 80265 through
                80268) we established 23 additional localities, increasing the total
                number of PFS localities from 89 to 112. The 112 payment localities
                include 34 statewide areas (that is, only one locality for the entire
                state) and 75 localities in the other 16 states, with 10 states having
                two localities, two states having three localities, one state having
                four localities, and three states having five or more localities. The
                remainder of the 112 PFS payment localities are comprised as follows:
                The combined District of Columbia, Maryland, and Virginia suburbs;
                Puerto Rico; and the Virgin Islands. We note that the localities
                generally represent a grouping of one or more constituent counties.
                    The current 112 fee schedule areas are defined alternatively by
                state boundaries (for example, Wisconsin), metropolitan areas (for
                example, Metropolitan St. Louis, MO), portions of a metropolitan area
                (for example, Manhattan), or rest-of-state areas that exclude
                metropolitan areas (for example, Rest of Missouri). This locality
                configuration is used to calculate the GPCIs that are in turn used to
                calculate locality adjusted payments for physicians' services under the
                PFS.
                    As stated in the CY 2011 PFS final rule with comment period (75 FR
                73261), changes to the PFS locality structure would generally result in
                changes that are budget neutral within a state. For many years, before
                making any locality changes, we have sought consensus from among the
                professionals whose payments would be affected. We refer readers to the
                CY 2014 PFS final rule with comment period (78 FR 74384 through 74386)
                for further discussion regarding additional information about locality
                configuration considerations.
                3. GPCI Update
                    As required by the statute, we developed GPCIs to measure relative
                cost differences among payment localities compared to the national
                average for each of the three fee schedule components (that is, work,
                PE, and MP). We describe the data sources and methodologies we use to
                calculate each of the three GPCIs below in this section. Additional
                information on the CY 2020 GPCI update is available in an interim
                report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
                for the Medicare Physician Fee Schedule,'' on our website located under
                the supporting documents section for the CY 2020 PFS proposed rule at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                a. Work GPCIs
                    The work GPCIs are designed to reflect the relative cost of
                physician labor by Medicare PFS locality. As required by statute, the
                work GPCI reflects one quarter of the relative wage differences for
                each locality compared to the national average.
                    To calculate the work GPCIs, we use wage data for seven
                professional specialty occupation categories, adjusted to reflect one-
                quarter of the relative cost differences for each locality compared to
                the national average, as a proxy for physicians' wages. Physicians'
                wages are not included in the occupation categories used in calculating
                the work GPCI because Medicare payments are a key determinant of
                physicians' earnings. Including physician wage data in calculating the
                work GPCIs would potentially introduce some circularity to the
                adjustment since Medicare payments typically contribute to or influence
                physician wages. That is, including physicians' wages in the physician
                work GPCIs would, in effect, make the indices, to some extent,
                dependent upon Medicare payments.
                    The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
                on professional earnings data from the 2000 Census. However, for the CY
                2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
                and earnings data were not available from the more recent Census
                because the ``long form'' was discontinued. Therefore, we used the
                median hourly earnings from the 2006 through 2008 Bureau of Labor
                Statistics (BLS) Occupational Employment Statistics (OES) wage data as
                a replacement for the 2000 Census data. The BLS OES data meet several
                criteria that we consider to be important for selecting a data source
                for purposes of calculating the GPCIs. For example, the BLS OES wage
                and employment data are derived from a large sample size of
                approximately 200,000 establishments of varying sizes nationwide from
                every metropolitan area and can be easily accessible to the public at
                no cost. Additionally, the BLS OES is updated regularly, and includes a
                comprehensive set of occupations and industries (for example, 800
                occupations in 450 industries). For the CY 2014 GPCI update, we used
                updated BLS OES data (2009 through 2011) as a
                [[Page 40512]]
                replacement for the 2006 through 2008 data to compute the work GPCIs;
                and for the CY 2017 GPCI update, we used updated BLS OES data (2011
                through 2014) as a replacement for the 2009 through 2011 data to
                compute the work GPCIs.
                    Because of its reliability, public availability, level of detail,
                and national scope, we believe the BLS OES data continue to be the most
                appropriate source of wage and employment data for use in calculating
                the work GPCIs (and as discussed below, the employee wage component and
                purchased services component of the PE GPCI). Therefore, for the
                proposed CY 2020 GPCI update, we used updated BLS OES data (2014
                through 2017) as a replacement for the 2011 through 2014 data to
                compute the work GPCIs.
                b. Practice Expense (PE) GPCIs
                    The PE GPCIs are designed to measure the relative cost difference
                in the mix of goods and services comprising PEs (not including MP
                expenses) among the PFS localities as compared to the national average
                of these costs. Whereas the physician work GPCIs (and as discussed
                later in this section, the MP GPCIs) are comprised of a single index,
                the PE GPCIs are comprised of four component indices (employee wages;
                purchased services; office rent; and equipment, supplies and other
                miscellaneous expenses). The employee wage index component measures
                geographic variation in the cost of the kinds of skilled and unskilled
                labor that would be directly employed by a physician practice. Although
                the employee wage index adjusts for geographic variation in the cost of
                labor employed directly by physician practices, it does not account for
                geographic variation in the cost of services that typically would be
                purchased from other entities, such as law firms, accounting firms,
                information technology consultants, building service managers, or any
                other third-party vendor. The purchased services index component of the
                PE GPCI (which is a separate index from employee wages) measures
                geographic variation in the cost of contracted services that physician
                practices would typically buy. For more information on the development
                of the purchased service index, we refer readers to the CY 2012 PFS
                final rule with comment period (76 FR 73084 through 73085). The office
                rent index component of the PE GPCI measures relative geographic
                variation in the cost of typical physician office rents. For the
                medical equipment, supplies, and miscellaneous expenses component, we
                believe there is a national market for these items such that there is
                not significant geographic variation in costs. Therefore, the
                equipment, supplies and other miscellaneous expense cost index
                component of the PE GPCI is given a value of 1.000 for each PFS
                locality.
                    For the previous update to the GPCIs (implemented in CY 2017), we
                used 2011 through 2014 BLS OES data to calculate the employee wage and
                purchased services indices for the PE GPCI. As discussed previously in
                this section, because of its reliability, public availability, level of
                detail, and national scope, we continue to believe the BLS OES is the
                most appropriate data source for collecting wage and employment data.
                Therefore, in calculating the proposed CY 2020 GPCI update, we used
                updated BLS OES data (2014 through 2017) as a replacement for the 2011
                through 2014 data for purposes of calculating the employee wage
                component and purchased service index component of the PE GPCI. In
                calculating the proposed CY 2020 GPCI update, for the office rent index
                component of the PE GPCI we used the most recently available, 2013
                through 2017, American Community Survey (ACS) 5-year estimates as a
                replacement for the 2009 through 2013 ACS data.
                c. Malpractice Expense (MP) GPCIs
                    The MP GPCIs measure the relative cost differences among PFS
                localities for the purchase of professional liability insurance (PLI).
                The MP GPCIs are calculated based on insurer rate filings of premium
                data for $1 million to $3 million mature claims-made policies (policies
                for claims made rather than losses occurring during the policy term).
                For the CY 2017 GPCI update, we used 2014 and 2015 malpractice premium
                data. The proposed CY 2020 MP GPCI update reflects premium data
                presumed in effect as of December 30, 2017. We note that we finalized a
                few technical refinements to the MP GPCI methodology in CY 2017, and
                refer readers to the CY 2017 PFS final rule (81 FR 80270) for
                additional discussion.
                d. GPCI Cost Share Weights
                    For CY 2020 GPCIs, we are proposing to continue to use the current
                cost share weights for determining the PE GPCI values and locality
                GAFs. We refer readers to the CY 2014 PFS final rule with comment
                period (78 FR 74382 through 74383), for further discussion regarding
                the 2006-based MEI cost share weights revised in CY 2014 that we also
                finalized for use in the CY 2017 GPCI update.
                    The proposed GPCI cost share weights for CY 2020 are displayed in
                Table 12.
                      Table 12--Proposed Cost Share Weights for CY 2020 GPCI Update
                ------------------------------------------------------------------------
                                                                        Proposed CY 2020
                         Expense category              Current cost    cost share weight
                                                     share weight (%)         (%)
                ------------------------------------------------------------------------
                Work..............................             50.866             50.866
                Practice Expense..................             44.839             44.839
                    --Employee Compensation.......             16.553             16.553
                    --Office Rent.................             10.223             10.223
                    --Purchased Services..........              8.095              8.095
                    --Equipment, Supplies, Other..              9.968              9.968
                Malpractice Insurance.............              4.295              4.295
                                                   -------------------------------------
                    Total.........................            100.000            100.000
                ------------------------------------------------------------------------
                e. PE GPCI Floor for Frontier States
                    Section 10324(c) of the Affordable Care Act added a new
                subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
                PE GPCI floor for physicians' services furnished in frontier states
                effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
                the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
                physicians' services furnished in states determined to be frontier
                states. In general, a frontier state is one in which at least 50
                percent of the counties are ``frontier counties,'' which are those that
                [[Page 40513]]
                have a population per square mile of less than 6. For more information
                on the criteria used to define a frontier state, we refer readers to
                the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
                FR 50160 through 50161). There are no changes in the states identified
                as Frontier States for the CY 2020 PFS proposed rule. The qualifying
                states are: Montana; Wyoming; North Dakota; South Dakota; and Nevada.
                In accordance with statute, we would apply a 1.0 PE GPCI floor for
                these states in CY 2020.
                f. Methodology for Calculating GPCIs in the U.S. Territories
                    Prior to CY 2017, for all the island territories other than Puerto
                Rico, the lack of comprehensive data about unique costs for island
                territories had minimal impact on GPCIs because we used either the
                Hawaii GPCIs (for the Pacific territories: Guam; American Samoa; and
                Northern Mariana Islands) or used the unadjusted national averages (for
                the Virgin Islands). In an effort to provide greater consistency in the
                calculation of GPCIs given the lack of comprehensive data regarding the
                validity of applying the proxy data used in the States in accurately
                accounting for variability of costs for these island territories, in
                the CY 2017 PFS final rule (81 FR 80268 through 80270), we finalized a
                policy to treat the Caribbean Island territories (the Virgin Islands
                and Puerto Rico) in a consistent manner. We do so by assigning the
                national average of 1.0 to each GPCI index for both Puerto Rico and the
                Virgin Islands. We refer readers to the CY 2017 PFS final rule for a
                comprehensive discussion of this policy.
                g. California Locality Update to the Fee Schedule Areas Used for
                Payment Under Section 220(h) of the Protecting Access to Medicare Act
                    Section 220(h) of the PAMA added a new section 1848(e)(6) to the
                Act that modified the fee schedule areas used for payment purposes in
                California beginning in CY 2017. Prior to CY 2017, the fee schedule
                areas used for payment in California were based on the revised locality
                structure that was implemented in 1997 as previously discussed.
                Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that
                the fee schedule areas used for payment in California must be
                Metropolitan Statistical Areas (MSAs) as defined by the Office of
                Management and Budget (OMB) as of December 31 of the previous year; and
                section 1848(e)(6)(A)(ii) of the Act required that all areas not
                located in an MSA must be treated as a single rest-of-state fee
                schedule area. The resulting modifications to California's locality
                structure increased its number of localities from 9 under the current
                locality structure to 27 under the MSA-based locality structure;
                although for the purposes of payment the actual number of localities
                under the MSA-based locality structure is 32. We refer readers to the
                CY 2017 PFS final rule (81 FR 80267) for a detailed discussion of this
                operational consideration.
                    Section 1848(e)(6)(D) of the Act defined transition areas as the
                fee schedule areas for 2013 that were the rest-of-state locality, and
                locality 3, which was comprised of Marin County, Napa County, and
                Solano County. Section 1848(e)(6)(B) of the Act specified that the GPCI
                values used for payment in a transition area are to be phased in over 6
                years, from 2017 through 2022, using a weighted sum of the GPCIs
                calculated under the new MSA-based locality structure and the GPCIs
                calculated under the current PFS locality structure. That is, the GPCI
                values applicable for these areas during this transition period are a
                blend of what the GPCI values would have been for California under the
                current locality structure, and what the GPCI values would be for
                California under the MSA-based locality structure. For example, in CY
                2020, which represents the fourth year, the applicable GPCI values for
                counties that were previously in rest-of-state or locality 3 and are
                now in MSAs are a blend of \2/3\ of the GPCI value calculated for the
                year under the MSA-based locality structure, and \1/3\ of the GPCI
                value calculated for the year under the current locality structure. The
                proportions continue to shift by \1/6\ in each subsequent year so that,
                by CY 2021, the applicable GPCI values for counties within transition
                areas are a blend of \5/6\ of the GPCI value for the year under the
                MSA-based locality structure, and \1/6\ of the GPCI value for the year
                under the current locality structure. Beginning in CY 2022, the
                applicable GPCI values for counties in transition areas are the values
                calculated solely under the new MSA-based locality structure. For
                clarity, we reiterate that this incremental phase-in is only applicable
                to those counties that are in transition areas that are now in MSAs,
                which are only some of the counties in the 2013 California rest-of
                state locality and locality 3.
                    Additionally, section 1848(e)(6)(C) of the Act establishes a hold
                harmless for transition areas beginning with CY 2017 whereby the
                applicable GPCI values for a year under the new MSA-based locality
                structure may not be less than what they would have been for the year
                under the current locality structure. There are a total of 58 counties
                in California, 50 of which are in transition areas as defined in
                section 1848(e)(6)(D) of the Act. The eight counties that are not
                within transition areas are: Orange; Los Angeles; Alameda; Contra
                Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
                    For the purposes of calculating budget neutrality and consistent
                with the PFS budget neutrality requirements as specified under section
                1848(c)(2)(B)(ii)(II) of the Act, we finalized the policy to start by
                calculating the national GPCIs as if the current localities are still
                applicable nationwide; then, for the purposes of payment in California,
                we override the GPCI values with the values that are applicable for
                California consistent with the requirements of section 1848(e)(6) of
                the Act. This approach is consistent with the implementation of the
                GPCI floor provisions that have previously been implemented--that is,
                as an after-the-fact adjustment that is implemented for purposes of
                payment after both the GPCIs and PFS budget neutrality have already
                been calculated.
                    Additionally, section 1848(e)(1)(C) of the Act requires that, if
                more than 1 year has elapsed since the date of the last previous GPCI
                adjustment, the adjustment to be applied in the first year of the next
                adjustment shall be \1/2\ of the adjustment that otherwise would be
                made. However, since section 1848(e)(6)(B) of the Act provides for a
                gradual phase in of the GPCI values under the new MSA-based locality
                structure for California, specifically in one-sixth increments over 6
                years, if we were to also apply the requirement to phase in \1/2\ of
                the adjustment in year 1 of the GPCI update then the first year
                increment would effectively be \1/12\. Therefore, in CY 2017, we
                finalized a policy that the requirement at section 1848(e)(1)(C) of the
                Act to phase in \1/2\ of the adjustment in year 1 of the GPCI update
                would not apply to counties that were previously in the rest-of-state
                or locality 3 and are now in MSAs that are subject to the blended
                phase-in as described above in this section. We reiterate that this is
                only applicable through CY 2021 since, beginning in CY 2022, the GPCI
                values for such areas in an MSA would be fully based on the values
                calculated under the new MSA-based locality structure for California.
                For a comprehensive discussion of this provision, transition areas, and
                operational considerations, we refer readers to the CY 2017 PFS final
                rule (81 FR 80265 through 80268).
                [[Page 40514]]
                h. Refinements to the GPCI Methodology
                    In the process of calculating GPCIs for the purposes of this
                proposed rule, we identified two technical refinements to the
                methodology that yield improvements over the current method; these
                refinements are applicable to the work GPCI and the employee wage index
                and purchased services index components of the PE GPCI. We are
                proposing to weight by total employment when computing county median
                wages for each occupation code which addresses the fact that the
                occupation wage can vary by industry within a county. Additionally, we
                are also proposing to use a weighted average when calculating the final
                county-level wage index; this removes the possibility that a county
                index would imply a wage of 0 for any occupation group not present in
                the county's data. These proposed methodological refinements yield
                improved mathematical precision. Additional information on the GPCI
                methodology and the proposed refinements are available in the interim
                report, ``Interim Report for the CY 2020 Update of GPCIs and MP RVUs
                for the Medicare Physician Fee Schedule'' on our website located under
                the supporting documents section of the CY 2020 PFS proposed rule at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                i. Proposed GPCI Update Summary
                    As explained above in the Background section above, the periodic
                review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of
                the Act. At each update, the proposed GPCIs are published in the PFS
                proposed rule to provide an opportunity for public comment and further
                revisions in response to comments prior to implementation. The proposed
                CY 2020 updated GPCIs for the first and second year of the 2-year
                transition, along with the GAFs, are displayed in Addenda D and E to
                this proposed rule available on our website under the supporting
                documents section of the CY 2020 PFS proposed rule web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                E. Potentially Misvalued Services Under the PFS
                1. Background
                    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
                periodic review, not less often than every 5 years, of the RVUs
                established under the PFS. Section 1848(c)(2)(K) of the Act requires
                the Secretary to periodically identify potentially misvalued services
                using certain criteria and to review and make appropriate adjustments
                to the relative values for those services. Section 1848(c)(2)(L) of the
                Act also requires the Secretary to develop a process to validate the
                RVUs of certain potentially misvalued codes under the PFS, using the
                same criteria used to identify potentially misvalued codes, and to make
                appropriate adjustments.
                    As discussed in section II.N. of this proposed rule, Valuation of
                Specific Codes, each year we develop appropriate adjustments to the
                RVUs taking into account recommendations provided by the RUC, MedPAC,
                and other stakeholders. For many years, the RUC has provided us with
                recommendations on the appropriate relative values for new, revised,
                and potentially misvalued PFS services. We review these recommendations
                on a code-by-code basis and consider these recommendations in
                conjunction with analyses of other data, such as claims data, to inform
                the decision-making process as authorized by law. We may also consider
                analyses of work time, work RVUs, or direct PE inputs using other data
                sources, such as Department of Veteran Affairs (VA), National Surgical
                Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons
                (STS), and the Merit-based Incentive Payment System (MIPS) data. In
                addition to considering the most recently available data, we assess the
                results of physician surveys and specialty recommendations submitted to
                us by the RUC for our review. We also consider information provided by
                other stakeholders. We conduct a review to assess the appropriate RVUs
                in the context of contemporary medical practice. We note that section
                1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
                other techniques to determine the RVUs for physicians' services for
                which specific data are not available and requires us to take into
                account the results of consultations with organizations representing
                physicians who provide the services. In accordance with section 1848(c)
                of the Act, we determine and make appropriate adjustments to the RVUs.
                    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed
                the importance of appropriately valuing physicians' services, noting
                that misvalued services can distort the market for physicians'
                services, as well as for other health care services that physicians
                order, such as hospital services. In that same report, MedPAC
                postulated that physicians' services under the PFS can become misvalued
                over time. MedPAC stated, ``When a new service is added to the
                physician fee schedule, it may be assigned a relatively high value
                because of the time, technical skill, and psychological stress that are
                often required to furnish that service. Over time, the work required
                for certain services would be expected to decline as physicians become
                more familiar with the service and more efficient in furnishing it.''
                We believe services can also become overvalued when PE declines. This
                can happen when the costs of equipment and supplies fall, or when
                equipment is used more frequently than is estimated in the PE
                methodology, reducing its cost per use. Likewise, services can become
                undervalued when physician work increases or PE rises.
                    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since
                MedPAC made the initial recommendations, CMS and the RUC have taken
                several steps to improve the review process. Also, section
                1848(c)(2)(K)(ii) of the Act augments our efforts by directing the
                Secretary to specifically examine, as determined appropriate,
                potentially misvalued services in the following categories:
                     Codes that have experienced the fastest growth.
                     Codes that have experienced substantial changes in PE.
                     Codes that describe new technologies or services within an
                appropriate time period (such as 3 years) after the relative values are
                initially established for such codes.
                     Codes which are multiple codes that are frequently billed
                in conjunction with furnishing a single service.
                     Codes with low relative values, particularly those that
                are often billed multiple times for a single treatment.
                     Codes that have not been subject to review since
                implementation of the fee schedule.
                     Codes that account for the majority of spending under the
                PFS.
                     Codes for services that have experienced a substantial
                change in the hospital length of stay or procedure time.
                     Codes for which there may be a change in the typical site
                of service since the code was last valued.
                     Codes for which there is a significant difference in
                payment for the
                [[Page 40515]]
                same service between different sites of service.
                     Codes for which there may be anomalies in relative values
                within a family of codes.
                     Codes for services where there may be efficiencies when a
                service is furnished at the same time as other services.
                     Codes with high intraservice work per unit of time.
                     Codes with high PE RVUs.
                     Codes with high cost supplies.
                     Codes as determined appropriate by the Secretary.
                    Section 1848(c)(2)(K)(iii) of the Act also specifies that the
                Secretary may use existing processes to receive recommendations on the
                review and appropriate adjustment of potentially misvalued services. In
                addition, the Secretary may conduct surveys, other data collection
                activities, studies, or other analyses, as the Secretary determines to
                be appropriate, to facilitate the review and appropriate adjustment of
                potentially misvalued services. This section also authorizes the use of
                analytic contractors to identify and analyze potentially misvalued
                codes, conduct surveys or collect data, and make recommendations on the
                review and appropriate adjustment of potentially misvalued services.
                Additionally, this section provides that the Secretary may coordinate
                the review and adjustment of any RVU with the periodic review described
                in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
                the Act specifies that the Secretary may make appropriate coding
                revisions (including using existing processes for consideration of
                coding changes) that may include consolidation of individual services
                into bundled codes for payment under the PFS.
                2. Progress in Identifying and Reviewing Potentially Misvalued Codes
                    To fulfill our statutory mandate, we have identified and reviewed
                numerous potentially misvalued codes as specified in section
                1848(c)(2)(K)(ii) of the Act, and we intend to continue our work
                examining potentially misvalued codes in these areas over the upcoming
                years. As part of our current process, we identify potentially
                misvalued codes for review, and request recommendations from the RUC
                and other public commenters on revised work RVUs and direct PE inputs
                for those codes. The RUC, through its own processes, also identifies
                potentially misvalued codes for review. Through our public nomination
                process for potentially misvalued codes established in the CY 2012 PFS
                final rule with comment period, other individuals and stakeholder
                groups submit nominations for review of potentially misvalued codes as
                well. Individuals and stakeholder groups may submit codes for review
                under the potentially misvalued codes initiative to CMS in one of two
                ways. Nominations may be submitted to CMS via email or through postal
                mail. Email submissions should be sent to the CMS emailbox
                [email protected], with the phrase ``Potentially
                Misvalued Codes'' in the subject line. Physical letters for nominations
                should be sent via the U.S. Postal Service to the Centers for Medicare
                and Medicaid Service, Mail Stop: C4-01-26, 7500 Security Blvd.,
                Baltimore, Maryland 21244. Envelopes containing the nomination letters
                must be labeled ``Attention: Division of Practitioner Services,
                Potentially Misvalued Codes''. Nominations for consideration in our
                next annual rule cycle should be received by our February 10th
                deadline. Since CY 2009, as a part of the annual potentially misvalued
                code review and Five-Year Review process, we have reviewed
                approximately 1,700 potentially misvalued codes to refine work RVUs and
                direct PE inputs. We have assigned appropriate work RVUs and direct PE
                inputs for these services as a result of these reviews. A more detailed
                discussion of the extensive prior reviews of potentially misvalued
                codes is included in the Medicare Program; Payment Policies Under the
                Physician Fee Schedule, Five-Year Review of Work Relative Value Units,
                Clinical Laboratory Fee Schedule: Signature on Requisition, and Other
                Revisions to Part B for CY 2012; Final Rule (76 FR 73052 through 73055)
                (hereinafter referred to as the CY 2012 PFS final rule with comment
                period). In the CY 2012 PFS final rule with comment period (76 FR 73055
                through 73958), we finalized our policy to consolidate the review of
                physician work and PE at the same time, and established a process for
                the annual public nomination of potentially misvalued services.
                    In the Medicare Program; Revisions to Payment Policies Under the
                Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the
                Requirement for Termination of Non-Random Prepayment Complex Medical
                Review and Other Revisions to Part B for CY 2013 (77 FR 68892)
                (hereinafter referred to as the CY 2013 PFS final rule with comment
                period), we built upon the work we began in CY 2009 to review
                potentially misvalued codes that have not been reviewed since the
                implementation of the PFS (so-called ``Harvard-valued codes''). In the
                Medicare Program; Revisions to Payment Policies Under the Physician Fee
                Schedule and Other Revisions to Part B for CY 2009; and Revisions to
                the Amendment of the E-Prescribing Exemption for Computer Generated
                Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter
                referred to the CY 2009 PFS proposed rule), we requested
                recommendations from the RUC to aid in our review of Harvard-valued
                codes that had not yet been reviewed, focusing first on high-volume,
                low intensity codes. In the fourth Five-Year Review (76 FR 32410), we
                requested recommendations from the RUC to aid in our review of Harvard-
                valued codes with annual utilization of greater than 30,000 services.
                In the CY 2013 PFS final rule with comment period, we identified
                specific Harvard-valued services with annual allowed charges that total
                at least $10,000,000 as potentially misvalued. In addition to the
                Harvard-valued codes, in the CY 2013 PFS final rule with comment period
                we finalized for review a list of potentially misvalued codes that have
                stand-alone PE (codes with physician work and no listed work time and
                codes with no physician work that have listed work time).
                    In the Medicare Program; Revisions to Payment Policies under the
                Physician Fee Schedule and Other Revisions to Part B for CY 2016 final
                rule with comment period (80 FR 70886) (hereinafter referred to as the
                CY 2016 PFS final rule with comment period), we finalized for review a
                list of potentially misvalued services, which included eight codes in
                the neurostimulators analysis-programming family (CPT codes 95970-
                95982). We also finalized as potentially misvalued 103 codes identified
                through our screen of high expenditure services across specialties.
                    In the Medicare Program; Revisions to Payment Policies under the
                Physician Fee Schedule and Other Revisions to Part B for CY 2017;
                Medicare Advantage Bid Pricing Data Release; Medicare Advantage and
                Part D Medical Loss Ratio Data Release; Medicare Advantage Provider
                Network Requirements; Expansion of Medicare Diabetes Prevention Program
                Model; Medicare Shared Savings Program Requirements final rule (81 FR
                80170) (hereinafter referred to as the CY 2017 PFS final rule), we
                finalized for review a list of potentially misvalued services, which
                included eight codes in the end-stage renal disease home dialysis
                family (CPT codes 90963-90970). We also finalized as potentially
                misvalued 19 codes
                [[Page 40516]]
                identified through our screen for 0-day global services that are
                typically billed with an evaluation and management (E/M) service with
                modifier 25.
                    In the CY 2018 PFS final rule, we finalized arthrodesis of
                sacroiliac joint (CPT code 27279) as potentially misvalued. Through the
                use of comment solicitations with regard to specific codes, we also
                examined the valuations of other services, in addition to, new
                potentially misvalued code screens (82 FR 53017 through 53018).
                3. CY 2020 Identification and Review of Potentially Misvalued Services
                    In the CY 2012 PFS final rule with comment period (76 FR 73058), we
                finalized a process for the public to nominate potentially misvalued
                codes. In the CY 2015 PFS final rule with comment period (79 FR 67606
                through 67608), we modified this process whereby the public and
                stakeholders may nominate potentially misvalued codes for review by
                submitting the code with supporting documentation by February 10th of
                each year. Supporting documentation for codes nominated for the annual
                review of potentially misvalued codes may include the following:
                     Documentation in peer reviewed medical literature or other
                reliable data that demonstrate changes in physician work due to one or
                more of the following: Technique, knowledge and technology, patient
                population, site-of-service, length of hospital stay, and work time.
                     An anomalous relationship between the code being proposed
                for review and other codes.
                     Evidence that technology has changed physician work.
                     Analysis of other data on time and effort measures, such
                as operating room logs or national and other representative databases.
                     Evidence that incorrect assumptions were made in the
                previous valuation of the service, such as a misleading vignette,
                survey, or flawed crosswalk assumptions in a previous evaluation.
                     Prices for certain high cost supplies or other direct PE
                inputs that are used to determine PE RVUs are inaccurate and do not
                reflect current information.
                     Analyses of work time, work RVU, or direct PE inputs using
                other data sources (for example, VA, NSQIP, the STS National Database,
                and the MIPS data).
                     National surveys of work time and intensity from
                professional and management societies and organizations, such as
                hospital associations.
                    We evaluate the supporting documentation submitted with the
                nominated codes and assess whether the nominated codes appear to be
                potentially misvalued codes appropriate for review under the annual
                process. In the following year's PFS proposed rule, we publish the list
                of nominated codes and indicate for each nominated code whether we
                agree with its inclusion as a potentially misvalued code. The public
                has the opportunity to comment on these and all other proposed
                potentially misvalued codes. In that year's final rule, we finalize our
                list of potentially misvalued codes.
                a. Public Nominations
                    We received three submissions that nominated codes for review under
                the potentially misvalued code initiative, prior to our February 10,
                2019 deadline. In addition to three public nominations, CMS also
                nominated one additional code for review.
                    One commenter requested that CMS consider CPT code 10005 (Fine
                needle aspiration biopsy, including ultrasound guidance; first lesion)
                and CPT code 10021 (Fine needle aspiration biopsy, without imaging
                guidance; first lesion) for nomination as potentially misvalued. We
                note that these two CPT codes were recently reviewed within a family of
                13 similar codes. Our review of these codes and our rationale for
                finalizing the current values are discussed extensively in the CY 2019
                PFS final rule (83 FR 59517). For CPT code 10021, the RUC recommended a
                32 percent reduction from its previous physician time and a 5 percent
                reduction in the work RVU. The commenter disagreed with this change and
                stated that there was a change in intensity of the procedure now as
                compared to what it was in 1995 when this code was last evaluated. The
                commenter also stated that there was a change in intensity of the work
                performed due to use of more complicated equipment, more stringent
                specimen sampling that allow for extensive examination of smaller and
                deeper lesions within the body. The commenter disagreed with the CMS'
                crosswalked CPT code 36440 (Push blood transfusion, patient 2 years or
                younger) and presented CPT codes 40490 (Biopsy of lip) and 95865
                (Needle measurement and recording of electrical activity of muscles of
                voice box) as more appropriate crosswalks.
                    Another commenter requested that CMS consider HCPCS code G0166
                (External counterpulsation, per treatment session) as potentially
                misvalued. This code was reviewed for the CY 2019 PFS final rule (83 FR
                59578), and the work RVU and direct PE inputs as recommended by the AMA
                RUC were finalized by CMS. We finalized the valuation of this code with
                no refinements. However, the commenter noted that the PE inputs that
                were considered for this code did not fully reflect the total resources
                required to deliver the service. We will review the commenter's
                submission of additional new data and public comments received in
                combination with what was previously presented in the CY 2019 PFS final
                rule.
                    CMS nominated CPT code 76377 (3D rendering with interpretation and
                reporting of computed tomography, magnetic resonance imaging,
                ultrasound, or other tomographic modality with image postprocessing
                under concurrent supervision; requiring image postprocessing on an
                independent workstation) as potentially misvalued. CPT code 76376 (3D
                rendering with interpretation and reporting of computed tomography,
                magnetic resonance imaging, ultrasound, or other tomographic modality
                with image postprocessing under concurrent supervision; not requiring
                image postprocessing on an independent workstation) was reviewed by the
                AMA RUC at the April 2018 RUC meeting. However, CPT code 76377, which
                is very similar to CPT code 76376, was not reviewed, and is likely now
                misvalued, in light of the similarities between the two codes. The
                specialty societies noted that the two codes are different because they
                are utilized by different patient populations (as evidenced by the ICD-
                10 diagnoses); however, we view both codes to be similar enough that
                CPT code 76377 should be reviewed to maintain relativity in the code
                family.
                    We are proposing the aforementioned public and CMS nominated codes
                as potentially misvalued and welcome public comment on these codes.
                    Another commenter provided information to CMS in which they stated
                that the work involved in furnishing services represented by the
                office/outpatient evaluation and management (E/M) code set (CPT codes
                99201-99215) has changed sufficiently to warrant revaluation.
                Specifically, the commenter stated that these codes have not been
                reviewed in over 12 years and in that time have suffered passive
                devaluation as more and more procedures and other services have been
                added to the CPT code set, which are subsequently valued in a budget
                neutral manner, through notice and comment rulemaking, on the Medicare
                PFS. The commenter also stated that re-evaluation of these codes is
                critical to the success
                [[Page 40517]]
                of CMS' objective of advancing value-based care through the
                introduction of advanced alternative payment models (APMs) as these
                APMs rely on the underlying E/M codes as the basis for payment or
                reference price for bundled payments.
                    We acknowledge the points made by the commenter, and continue to
                consider the best ways to recognize the significant changes in
                healthcare practice as discussed by the commenter. We agree, in
                principle, that the existing set of office/outpatient E/M CPT codes may
                not be correctly valued. In recent years, we have specifically
                considered how best to update and revalue the E/M codes, which
                represent a significant proportion of PFS expenditures, and have also
                engaged in ongoing dialogue with the practitioner community. In the CY
                2019 PFS proposed and final rules, in part due to these ongoing
                stakeholder discussions, we proposed and finalized changes to E/M
                payment and documentation requirements to implement policy objectives
                focused on reducing provider documentation burden (83 FR 59625).
                Concurrently, the CPT Editorial Panel, under similar burden reduction
                guiding principles, convened a workgroup and proposed to refine and
                revalue the existing E/M office/outpatient code set. We thank the
                commenter for the views represented in their comment. As stated earlier
                in this section, we agree in principle that the existing set of office/
                outpatient E/M CPT codes may not be correctly valued, and therefore, we
                will continue to consider opportunities to revalue these codes, in
                light of their significance to payment for services billed under
                Medicare.
                    Table 13 lists the HCPCS and CPT codes that we are proposing as
                potentially misvalued.
                     Table 13--HCPCS and CPT Codes Proposed as Potentially Misvalued
                ------------------------------------------------------------------------
                            CPT/HCPCS code                     Short description
                ------------------------------------------------------------------------
                10005................................  Fna bx w/us gdn 1st les.
                10021................................  Fna bx w/o img gdn 1st les.
                76377................................  3d render w/intrp postproces.
                G0166................................  Extrnl counterpulse, per tx.
                ------------------------------------------------------------------------
                F. Payment for Medicare Telehealth Services Under Section 1834(m) of
                the Act
                    As discussed in this rule and in prior rulemaking, several
                conditions must be met for Medicare to make payment for telehealth
                services under the PFS. For further details, see the full discussion of
                the scope of Medicare telehealth services in the CY 2018 PFS final rule
                (82 FR 53006) and in 42 CFR 410.78 and 414.65.
                1. Adding Services to the List of Medicare Telehealth Services
                    In the CY 2003 PFS final rule with comment period (67 FR 79988), we
                established a process for adding services to or deleting services from
                the list of Medicare telehealth services in accordance with section
                1834(m)(4)(F)(ii) of the Act. This process provides the public with an
                ongoing opportunity to submit requests for adding services, which are
                then reviewed by us. Under this process, we assign any submitted
                request to add to the list of telehealth services to one of the
                following two categories:
                     Category 1: Services that are similar to professional
                consultations, office visits, and office psychiatry services that are
                currently on the list of telehealth services. In reviewing these
                requests, we look for similarities between the requested and existing
                telehealth services for the roles of, and interactions among, the
                beneficiary, the physician (or other practitioner) at the distant site
                and, if necessary, the telepresenter, a practitioner who is present
                with the beneficiary in the originating site. We also look for
                similarities in the telecommunications system used to deliver the
                service; for example, the use of interactive audio and video equipment.
                     Category 2: Services that are not similar to those on the
                current list of telehealth services. Our review of these requests
                includes an assessment of whether the service is accurately described
                by the corresponding code when furnished via telehealth and whether the
                use of a telecommunications system to furnish the service produces
                demonstrated clinical benefit to the patient. Submitted evidence should
                include both a description of relevant clinical studies that
                demonstrate the service furnished by telehealth to a Medicare
                beneficiary improves the diagnosis or treatment of an illness or injury
                or improves the functioning of a malformed body part, including dates
                and findings, and a list and copies of published peer reviewed articles
                relevant to the service when furnished via telehealth. Our evidentiary
                standard of clinical benefit does not include minor or incidental
                benefits.
                    Some examples of clinical benefit include the following:
                     Ability to diagnose a medical condition in a patient
                population without access to clinically appropriate in-person
                diagnostic services.
                     Treatment option for a patient population without access
                to clinically appropriate in-person treatment options.
                     Reduced rate of complications.
                     Decreased rate of subsequent diagnostic or therapeutic
                interventions (for example, due to reduced rate of recurrence of the
                disease process).
                     Decreased number of future hospitalizations or physician
                visits.
                     More rapid beneficial resolution of the disease process
                treatment.
                     Decreased pain, bleeding, or other quantifiable symptom.
                     Reduced recovery time.
                    The list of telehealth services, including the proposed additions
                described later in this section, can be located on the CMS website at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                    Historically, requests to add services to the list of Medicare
                telehealth services had to be submitted and received no later than
                December 31 of each calendar year to be considered for the next
                rulemaking cycle. However, beginning in CY 2019 we stated that for CY
                2019 and onward, we intend to accept requests through February 10,
                consistent with the deadline for our receipt of code valuation
                recommendations from the RUC. For example, to be considered during PFS
                rulemaking for CY 2021, requests to add services to the list of
                Medicare telehealth services must be submitted and received by February
                10, 2020. Each request to add a service to the list of Medicare
                telehealth services must include any supporting documentation the
                requester wishes us to consider as we review the request. Because we
                use the annual PFS rulemaking process as the vehicle to make changes to
                the list of Medicare telehealth services, requesters should be advised
                that any information submitted as part of a request is subject to
                public disclosure for this purpose. For more information on submitting
                a request to add services to the list of Medicare telehealth services,
                including where to mail these requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
                2. Requests To Add Services to the List of Telehealth Services for CY
                2020
                    Under our current policy, we add services to the telehealth list on
                a Category 1 basis when we determine that they are similar to services
                on the existing telehealth list for the roles of,
                [[Page 40518]]
                and interactions among, the beneficiary, physician (or other
                practitioner) at the distant site and, if necessary, the telepresenter.
                As we stated in the CY 2012 PFS final rule with comment period (76 FR
                73098), we believe that the Category 1 criteria not only streamline our
                review process for publicly requested services that fall into this
                category, but also expedite our ability to identify codes for the
                telehealth list that resemble those services already on this list.
                    We did not receive any requests from the public for additions to
                the Medicare Telehealth list for CY 2020. We believe that the vast
                majority of services under the PFS that can be appropriately furnished
                as Medicare telehealth services have already been added to the list.
                    However, there are three HCPCS G-codes describing new services
                being proposed in section II.H. of this rule for CY 2020 which we
                believe are sufficiently similar to services currently on the
                telehealth list to be added on a Category 1 basis. Therefore, we are
                proposing to add the face-to-face portions of the following services to
                the telehealth list on a Category 1 basis for CY 2020:
                     HCPCS code GYYY1: Office-based treatment for opioid use
                disorder, including development of the treatment plan, care
                coordination, individual therapy and group therapy and counseling; at
                least 70 minutes in the first calendar month.
                     HCPCS code GYYY2: Office-based treatment for opioid use
                disorder, including care coordination, individual therapy and group
                therapy and counseling; at least 60 minutes in a subsequent calendar
                month.
                     HCPCS code GYYY3: Office-based treatment for opioid use
                disorder, including care coordination, individual therapy and group
                therapy and counseling; each additional 30 minutes beyond the first 120
                minutes (List separately in addition to code for primary procedure).
                    Similar to our addition of the required face-to-face visit
                component of TCM services to the Medicare Telehealth list in the CY
                2014 PFS final rule with comment period (78 FR 74403), since HCPCS
                codes GYYY1, GYYY2, and GYYY3 include face-to-face psychotherapy
                services, we believe that the face-to-face portions of these services
                are sufficiently similar to services currently on the list of Medicare
                telehealth services for these services to be added under Category 1.
                Specifically, we believe that the psychotherapy portions of the bundled
                codes are similar to the psychotherapy codes described by CPT codes
                90832 and 90853, which are currently on the Medicare telehealth
                services list. We note that like certain other non-face-to-face PFS
                services, the other components of HCPCS codes GYYY1-3 describing care
                coordination are commonly furnished remotely using telecommunications
                technology, and do not require the patient to be present in-person with
                the practitioner when they are furnished. As such, we do not need to
                consider whether the non-face-to-face aspects of HCPCS codes GYYY1-3
                are similar to other telehealth services. Were these components of
                HCPCS codes GYYY1-3 separately billable, they would not need to be on
                the Medicare telehealth list to be covered and paid in the same way as
                services delivered without the use of telecommunications technology.
                    As discussed in the CY 2019 PFS final rule (83 FR 59496), we note
                that section 2001(a) of the SUPPORT Act (Pub. L. 115-271, October 24,
                2018) amended section 1834(m) of the Act, adding a new paragraph (7)
                that removes the geographic limitations for telehealth services
                furnished on or after July 1, 2019, for individuals diagnosed with a
                substance use disorder (SUD) for the purpose of treating the SUD or a
                co-occurring mental health disorder. Section 1834(m)(7) of the Act also
                allows telehealth services for treatment of a diagnosed SUD or co-
                occurring mental health disorder to be furnished to individuals at any
                telehealth originating site (other than a renal dialysis facility),
                including in a patient's home. Section 2001(a) of the SUPPORT Act
                additionally amended section 1834(m) of the Act to require that no
                originating site facility fee will be paid in instances when the
                individual's home is the originating site. We believe that adding HCPCS
                codes GYYY1, GYYY2, and GYYY3 will complement the existing policies
                related to flexibilities in treating SUDs under Medicare Telehealth.
                    We note that we welcome public nominations for additions to the
                Medicare telehealth list. More information on the nomination process is
                posted under the Telehealth section of the CMS website, which can be
                accessed at the following web address https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
                G. Medicare Coverage for Opioid Use Disorder Treatment Services
                Furnished by Opioid Treatment Programs (OTPs)
                1. Overview
                    Opioid use disorder (OUD) and deaths from prescription and illegal
                opioid overdoses have reached alarming levels. The Centers for Disease
                Control and Prevention (CDC) estimated 47,000 overdose deaths were from
                opioids in 2017 and 36 percent of those deaths were from prescription
                opioids.\1\ OUD has become a public health crisis. On October 26, 2017,
                Acting Health and Human Services Secretary, Eric D. Hargan declared a
                nationwide public health emergency on the opioid crisis as requested by
                President Donald Trump.\2\ This public health emergency was renewed by
                Secretary Alex M. Azar II on January 24, 2018, April 24, 2018, July 23,
                2018, and October 21, 2018, January 17, 2019 and most recently, on
                April 19, 2019.\3\
                ---------------------------------------------------------------------------
                    \1\ https://www.cdc.gov/drugoverdose/data/index.html.
                    \2\ https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.
                    \3\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/opioid-19apr2019.aspx.
                ---------------------------------------------------------------------------
                    The Medicare population, including individuals who are eligible for
                both Medicare and Medicaid, has the fastest growing prevalence of OUD
                compared to the general adult population, with more than 300,000
                beneficiaries diagnosed with OUD in 2014.\4\ An effective treatment for
                OUD is known as medication-assisted treatment (MAT). The Substance
                Abuse and Mental Health Services Administration (SAMHSA) defines MAT as
                the use of medication in combination with behavioral health services to
                provide an individualized approach to the treatment of substance use
                disorder, including opioid use disorder (42 CFR 8.2). Currently,
                Medicare covers medications for MAT, including buprenorphine,
                buprenorphine-naloxone combination products, and extended-release
                injectable naltrexone under Part B or Part D, but does not cover
                methadone. Medicare also covers counseling and behavioral therapy
                services that are reasonable and necessary and furnished by
                practitioners that can bill and receive payment under Medicare.
                ---------------------------------------------------------------------------
                    \4\ https://jamanetwork.com/journals/jamapsychiatry/fullarticle/2535238.
                ---------------------------------------------------------------------------
                    Historically, Medicare has not covered methadone for MAT because of
                the unique manner in which this drug is dispensed and administered.
                Medicare Part B covers physician-administered drugs, drugs used in
                [[Page 40519]]
                conjunction with durable medical equipment, and certain other
                statutorily specified drugs. Medicare Part D covers drugs that are
                dispensed upon a prescription by a pharmacy. Methadone for MAT is not a
                drug administered by a physician under the incident to benefit like
                other MAT drugs (that is, implanted buprenorphine or injectable
                extended-release naltrexone) and therefore has not previously been
                covered by Medicare Part B. Methadone for MAT is also not a drug
                dispensed by a pharmacy like certain other MAT drugs (that is
                buprenorphine or buprenorphine-naloxone combination products) and
                therefore is not covered under Medicare Part D. Methadone for MAT is a
                schedule II controlled substance that is highly regulated because it
                has a high potential for abuse which may lead to severe psychological
                or physical dependence. As a result, methadone for MAT can only be
                dispensed and administered by an opioid treatment program (OTP) as
                provided under section 303(g)(1) of the Controlled Substances Act (21
                U.S.C. 823(g)(1)) and 42 CFR part 8. Additionally, OTPs, which are
                healthcare entities that focus on providing MAT for people diagnosed
                with OUD, were not previously entities that could bill and receive
                payment from Medicare for the services they furnish. Therefore, there
                has historically been a gap in Medicare coverage of MAT for OUD since
                methadone (one of the three FDA-approved drugs for MAT) has not been
                covered.
                    Section 2005 of the Substance Use-Disorder Prevention that Promotes
                Opioid Recovery and Treatment for Patients and Communities Act (the
                SUPPORT Act) (Pub. L. 115-271, enacted October 24, 2018) added a new
                section 1861(jjj) to the Act, establishing a new Part B benefit
                category for OUD treatment services furnished by an OTP beginning on or
                after January 1, 2020. Section 1861(jjj)(1) of the Act defines OUD
                treatment services as items and services furnished by an OTP (as
                defined in section 1861(jjj)(2)) for treatment of OUD. Section 2005 of
                the SUPPORT Act also amended the definition of ``medical and other
                health services'' in section 1861(s) of the Act to provide for coverage
                of OUD treatment services and added a new section 1834(w) to the Act
                and amended section 1833(a)(1) of the Act to establish a bundled
                payment to OTPs for OUD treatment services furnished during an episode
                of care beginning on or after January 1, 2020.
                    OTPs must have a current, valid certification from SAMHSA to
                satisfy the Controlled Substances Act registration requirement under 21
                U.S.C. 823(g)(1). To obtain SAMHSA certification, OTPs must have a
                valid accreditation by an accrediting body approved by SAMHSA, and must
                be certified by SAMHSA as meeting federal opioid treatment standards in
                42 CFR 8.12. There are currently about 1,700 OTPs nationwide.\5\ All
                states except Wyoming have OTPs. Approximately 74 percent of patients
                receiving services from OTPs receive methadone for MAT, with the vast
                majority of the remaining patients receiving buprenorphine.\6\
                ---------------------------------------------------------------------------
                    \5\ https://dpt2.samhsa.gov/treatment/directory.aspx.
                    \6\ https://wwwdasis.samhsa.gov/dasis2/nssats.htm.
                ---------------------------------------------------------------------------
                    Many payers currently cover MAT services for treatment of OUD.
                Medicaid \7\ is one of the largest payers of medications for substance
                use disorder (SUD), including methadone for MAT provided in OTPs.\8\
                OUD treatment services and MAT are also covered by other payers such as
                TRICARE and private insurers. TRICARE established coverage and payment
                for MAT and OUD treatment services furnished by OTPs in late 2016 (81
                FR 61068). In addition, as discussed in the ``Patient Protection and
                Affordable Care Act; HHS Notice of Benefit and Payment Parameters for
                2020'' proposed rule, many qualified health plans covered MAT
                medications for plan year 2018 (84 FR 285).
                ---------------------------------------------------------------------------
                    \7\ Medicaid provides health care coverage to 65.9 million
                Americans, including low-income adults, children, pregnant women,
                elderly adults and people with disabilities. Medicaid is
                administered by states, according to federal requirements, and is
                funded jointly by states and the federal government. States have the
                flexibility to administer the Medicaid program to meet their own
                state needs within the Medicaid program parameters set forth in
                federal statute and regulations. As a result, there is variation in
                how each state implements its programs.
                    \8\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
                ---------------------------------------------------------------------------
                    In the CY 2019 PFS final rule (83 FR 59497), we included a Request
                for Information (RFI) to solicit public comments on the implementation
                of the new Medicare benefit category for OUD treatment services
                furnished by OTPs established by section 2005 of the SUPPORT Act. We
                received 9 public comments. Commenters were generally supportive of the
                new benefit and expanding access to OUD treatment for Medicare
                beneficiaries. We received feedback that the bundled payments to OTPs
                should recognize the intensity of services furnished in the initiation
                stages, durations of care, the needs of patients with more complex
                needs, costs of emerging technologies, and use of peer support groups.
                We also received feedback that costs associated with care coordination
                among the beneficiary's practitioners should be included in the bundled
                payment given the myriad of health issues beneficiaries with OUD face.
                We considered this feedback as we developed our proposals for
                implementing the new benefit category for OUD treatment services
                furnished by OTPs and the proposed bundled payments for these services.
                    To implement section 2005 of the SUPPORT Act, we are proposing to
                establish rules to govern Medicare coverage of and payment for OUD
                treatment services furnished in OTPs. In the following discussion, we
                propose to establish definitions of OUD treatment services and OTP for
                purposes of the Medicare Program. We also propose a methodology for
                determining Medicare payment for such services provided by OTPs. We are
                proposing to codify these policies in a new section of the regulations
                at Sec.  410.67. For a discussion about Medicare enrollment
                requirements and the proposed program integrity approach for OTPs, we
                refer readers to section III.H. Medicare Enrollment of Opioid Treatment
                Programs, in this proposed rule.
                2. Proposed Definitions
                a. Opioid Use Disorder Treatment Services
                    The SUPPORT Act amended section 1861 of the Act by adding a new
                subsection (jjj)(1) that defines ``opioid use disorder treatment
                services'' as the items and services that are furnished by an OTP for
                the treatment of OUD, as set forth in subparagraphs (A) through (F) of
                section 1861(jjj)(1) of the Act which include:
                     Opioid agonist and antagonist treatment medications
                (including oral, injected, or implanted versions) that are approved by
                the Food and Drug Administration (FDA) under section 505 of the Federal
                Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 355) for use in the
                treatment of OUD;
                     Dispensing and administration of such medications, if
                applicable;
                     Substance use counseling by a professional to the extent
                authorized under state law to furnish such services;
                     Individual and group therapy with a physician or
                psychologist (or other mental health professional to the extent
                authorized under state law);
                     Toxicology testing; and
                     Other items and services that the Secretary determines are
                appropriate (but in no event to include meals or transportation).
                    As described previously, section 1861(jjj)(1)(A) of the Act defines
                covered OUD treatment services to include oral,
                [[Page 40520]]
                injected, and implanted opioid agonist and antagonist medications
                approved by FDA under section 505 of the FFDCA for use in the treatment
                of OUD. There are three drugs currently approved by the FDA for the
                treatment of opioid dependence: Buprenorphine, methadone, and
                naltrexone.\9\ FDA notes that all three of these medications have been
                demonstrated to be safe and effective in combination with counseling
                and psychosocial support and that those seeking treatment for an OUD
                should be offered access to all three options as this allows providers
                to work with patients to select the medication best suited to an
                individual's needs.\10\ Each of these medications is discussed below in
                more detail.
                ---------------------------------------------------------------------------
                    \9\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
                    \10\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
                ---------------------------------------------------------------------------
                    Buprenorphine is FDA-approved for acute and chronic pain in
                addition to opioid dependence. It is listed by the Drug Enforcement
                Administration (DEA) as a Schedule III controlled substance because of
                its moderate to low potential for physical and psychological
                dependence.\11\ \12\ The medication's partial agonist properties allow
                for its use in opioid replacement therapy, which is a process of
                treating OUD by using a substance, for example, buprenorphine or
                methadone, to substitute for a stronger full agonist opioid.\13\
                Buprenorphine drug products that are currently FDA-approved and
                marketed for the treatment of opioid dependence include oral
                buprenorphine and naloxone \14\ films and tablets, an extended-release
                buprenorphine injection for subcutaneous use, and a buprenorphine
                implant for subdermal administration.\15\ In most patients with opioid
                dependence, the initial oral dose is 2 to 4 mg per day with a
                maintenance dose of 8-12 mg per day.\16\ Dosing for the extended-
                release injection is 300 mg monthly for the first 2 months followed by
                a maintenance dose of 100 mg monthly.\17\ The extended-release
                injection is indicated for patients who have initiated treatment with
                an oral buprenorphine product for a minimum of 7 days.\18\ The
                buprenorphine implant consists of four rods containing 74.2 mg of
                buprenorphine each, and provides up to 6 months of treatment for
                patients who are clinically stable on low-to-moderate doses of an oral
                buprenorphine-containing product.\19\ Currently, federal regulations
                permit buprenorphine to be prescribed or dispensed by qualifying
                physicians and qualifying other practitioners at office-based practices
                and dispensed in OTPs.\20\ \21\
                ---------------------------------------------------------------------------
                    \11\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
                    \12\ https://www.dea.gov/drug-scheduling.
                    \13\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
                    \14\ Naloxone is added to buprenorphine in order to reduce its
                abuse potential and limit diversion.
                    \15\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
                    \16\ https://www.ncbi.nlm.nih.gov/books/NBK459126/.
                    \17\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
                    \18\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf.
                    \19\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204442s006lbl.pdf.
                    \20\ https://www.fda.gov/Drugs/NewsEvents/ucm611659.htm.
                    \21\ 21 U.S.C. 823(g)(2).
                ---------------------------------------------------------------------------
                    Methadone is FDA-approved for management of severe pain in addition
                to opioid dependence. It is listed by the DEA as a Schedule II
                controlled substance because of its high potential for abuse, with use
                potentially leading to severe psychological or physical dependence.\22\
                \23\ Methadone drug products that are FDA-approved for the treatment of
                opioid dependence include oral methadone concentrate and tablets.\24\
                In patients with opioid dependence, the total daily dose of methadone
                on the first day of treatment should not ordinarily exceed 40 mg,
                unless the program physician documents in the patient's record that 40
                milligrams did not suppress opioid abstinence, with clinical stability
                generally achieved at doses between 80 to 120 mg/day.\25\ By law,
                methadone can only be dispensed through an OTP certified by SAMHSA.\26\
                ---------------------------------------------------------------------------
                    \22\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
                    \23\ https://www.dea.gov/drug-scheduling.
                    \24\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
                    \25\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017116s032lbl.pdf.
                    \26\ https://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.
                ---------------------------------------------------------------------------
                    Naltrexone is FDA-approved to treat alcohol dependence in addition
                to opioid use disorder.\27\ Unlike buprenorphine and methadone, which
                activate opioid receptors, naltrexone binds and blocks opioid receptors
                and reduces opioid cravings.\28\ Therefore, naltrexone is not a
                scheduled substance; there is no abuse and diversion potential with
                naltrexone.29 30 The naltrexone drug product that is FDA-
                approved for the treatment of opioid dependence is an extended-release,
                intramuscular injection.\31\ The recommended dose is 380 mg delivered
                intramuscularly every 4 weeks or once a month after the patient has
                achieved an opioid-free duration of a minimum of 7-10 days.\32\
                Naltrexone can be prescribed by any health care provider who is
                licensed to prescribe medications.\33\
                ---------------------------------------------------------------------------
                    \27\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
                    \28\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
                    \29\ https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf.
                    \30\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
                    \31\ https://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm600092.htm.
                    \32\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021897s042lbl.pdf.
                    \33\ https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone.
                ---------------------------------------------------------------------------
                    We propose that the OUD treatment services that may be furnished by
                OTPs include the first five items and services listed in the statutory
                definition described above, specifically the medications approved by
                the FDA under section 505 of the FFDCA for use in the treatment of OUD;
                the dispensing and administration of such medication, if applicable;
                substance use counseling; individual and group therapy; and toxicology
                testing. We also propose to use our discretion under section
                1861(jjj)(1)(F) of the Act to include other items and services that the
                Secretary determines are appropriate to include the use of
                telecommunications for certain services, as discussed later in this
                section. We propose to codify this definition of OUD treatment services
                furnished by OTPs at Sec.  410.67(b). As part of this definition, we
                also propose to specify that an OUD treatment service is an item or
                service that is furnished by an OTP that meets the applicable
                requirements to participate in the Medicare Program and receive
                payment.
                    We seek comment on any other items and services (not including
                meals or transportation as they are statutorily prohibited) currently
                covered and paid for under Medicare Part B when furnished by Medicare-
                enrolled providers/suppliers that the Secretary should consider adding
                to this definition, including any evidence supporting the impact of the
                use of such items and services in the treatment of OUD and enumeration
                of their costs. We are particularly interested in public feedback on
                whether intake activities, which may include services such as an
                initial physical examination, initial assessments and preparation of a
                treatment plan, as well as periodic assessments, should be included in
                the definition of OUD treatment services. Additionally, we understand
                that while the current FDA-approved medications under section 505 of
                the FFDCA for the treatment of OUD are opioid agonists and antagonist
                medications, other
                [[Page 40521]]
                medications that are not opioid agonist and antagonist medications,
                including drugs and biologicals, could be developed for the treatment
                of OUD in the future. We would like public feedback on whether there
                are any drug development efforts in the pipeline that could result in
                medications intended for use in the treatment of OUD with a novel
                mechanism of action that does not involve opioid agonist and antagonist
                mechanisms (that is, outside of activating and/or blocking opioid
                receptors). We also welcome comment on how medications that may be
                approved by the FDA in the future for use in the treatment of OUD with
                a novel mechanism of action, such as medications approved under section
                505 of the FFDCA to treat OUD and biological products licensed under
                section 351 of the Public Health Service Act to treat OUD, should be
                considered in the context of OUD treatment services provided by OTPs,
                and whether CMS should use the discretion afforded under section
                1861(jjj)(1)(F) of the Act to include such medications in the
                definition of OUD treatment services given the possibility that such
                medications could be approved in the future.
                b. Opioid Treatment Program
                    Section 2005 of the SUPPORT Act also amended section 1861 of the
                Act by adding a new subsection (jjj)(2) to define an OTP as an entity
                meeting the definition of OTP in 42 CFR 8.2 or any successor regulation
                (that is, a program or practitioner engaged in opioid treatment of
                individuals with an opioid agonist treatment medication registered
                under 21 U.S.C. 823(g)(1)), that meets the additional requirements set
                forth in subparagraphs (A) through (D) of section 1861(jjj)(2) of the
                Act. Specifically that the OTP:
                     Is enrolled under section 1866(j) of the Act;
                     Has in effect a certification by SAMHSA for such a
                program;
                     Is accredited by an accrediting body approved by SAMHSA;
                and
                     Meets such additional conditions as the Secretary may find
                necessary to ensure the health and safety of individuals being
                furnished services under such program and the effective and efficient
                furnishing of such services.
                    These requirements are discussed in more detail in this section.
                (1) Enrollment
                    As discussed previously, under section 1861(jjj)(2)(A) of the Act,
                an OTP must be enrolled in Medicare to receive Medicare payment for
                covered OUD treatment services under section 1861(jjj)(1) of the Act.
                We refer the reader to section III.H. of this proposed rule, Medicare
                Enrollment of Opioid Treatment Programs, for further details on our
                proposed policies related to enrollment of OTPs.
                (2) Certification by SAMHSA
                    As provided in section 1861(jjj)(2)(B) of the Act, OTPs must be
                certified by SAMHSA to furnish Medicare-covered OUD treatment services.
                SAMHSA has created a system to certify and accredit OTPs, which is
                governed by 42 CFR part 8, subparts B and C. This regulatory framework
                allows SAMHSA to focus its oversight efforts on improving treatment
                rather than solely ensuring that OTPs are meeting regulatory criteria,
                and preserves states' authority to regulate OTPs. To be certified by
                SAMHSA, OTPs must comply with the federal opioid treatment standards as
                outlined in Sec.  8.12, be accredited by a SAMHSA-approved
                accreditation body, and comply with any other conditions for
                certification established by SAMHSA. Specifically, SAMHSA requires OTPs
                to provide the following services:
                     General--OTPs shall provide adequate medical, counseling,
                vocational, educational, and other assessment and treatment services.
                     Initial medical examination services--OTPs shall require
                each patient to undergo a complete, fully documented physical
                evaluation by a program physician or a primary care physician, or an
                authorized healthcare professional under the supervision of a program
                physician, before admission to the OTP.
                     Special services for pregnant patients--OTPs must maintain
                current policies and procedures that reflect the special needs of
                patients who are pregnant. Prenatal care and other gender specific
                services for pregnant patients must be provided either by the OTP or by
                referral to appropriate healthcare providers.
                     Initial and periodic assessment services--Each patient
                accepted for treatment at an OTP shall be assessed initially and
                periodically by qualified personnel to determine the most appropriate
                combination of services and treatment.
                     Counseling services--OTPs must provide adequate substance
                abuse counseling to each patient as clinically necessary by a program
                counselor, qualified by education, training, or experience to assess
                the patient's psychological and sociological background.
                     Drug abuse testing services--OTPs must provide adequate
                testing or analysis for drugs of abuse, including at least eight random
                drug abuse tests per year, per patient in maintenance treatment, in
                accordance with generally accepted clinical practice. For patients in
                short-term detoxification treatment, defined in 42 CFR 8.2 as
                detoxification treatment not in excess of 30 days, the OTP shall
                perform at least one initial drug abuse test. For patients receiving
                long-term detoxification treatment, the program shall perform initial
                and monthly random tests on each patient.
                    The provisions governing recordkeeping and patient confidentiality
                at Sec.  8.12(g)(1) require that OTPs shall establish and maintain a
                recordkeeping system that is adequate to document and monitor patient
                care. All records are required to be kept confidential in accordance
                with all applicable federal and state requirements. The requirements at
                Sec.  8.12(g)(2) state that OTPs shall document in each patient's
                record that the OTP made a good faith effort to review whether or not
                the patient is enrolled in any other OTP. A patient enrolled in an OTP
                shall not be permitted to obtain treatment in any other OTP except in
                exceptional circumstances, which is determined by the medical director
                or program physician of the OTP in which the patient is enrolled (42
                CFR 8.12(g)(2)). Additionally, the requirements at Sec.  8.12(h)
                address medication administration, dispensing, and use.
                    SAMHSA requires that OTPs shall ensure that opioid agonist
                treatment medications are administered or dispensed only by a
                practitioner licensed under the appropriate state law and registered
                under the appropriate state and federal laws to administer or dispense
                opioid drugs, or by an agent of such a practitioner, supervised by and
                under the order of the licensed practitioner. OTPs shall use only those
                opioid agonist treatment medications that are approved by the FDA for
                use in the treatment of OUD. They must maintain current procedures that
                are adequate to ensure that the dosing requirements are met, and each
                opioid agonist treatment medication used by the program is administered
                and dispensed in accordance with its approved product labeling.
                    At Sec.  8.12(i), regarding unsupervised or ``take-home'' use of
                opioid agonist treatment medications, SAMHSA has specified that OTPs
                must follow requirements specified by SAMHSA to limit the potential for
                diversion of opioid agonist treatment medications to the illicit market
                when dispensed to patients as take-homes, including maintaining current
                procedures to identify the theft or diversion of take-
                [[Page 40522]]
                home medications. The requirements at Sec.  8.12(j) for interim
                maintenance treatment, state that the program sponsor of a public or
                nonprofit private OTP subject to the approval of SAMHSA and the state,
                may place an individual, who is eligible for admission to comprehensive
                maintenance treatment, in interim maintenance treatment if the
                individual cannot be placed in a public or nonprofit private
                comprehensive program within a reasonable geographic area and within 14
                days of the individual's application for admission to comprehensive
                maintenance treatment. Patients in interim maintenance treatment are
                permitted to receive daily dosing, but take-homes are not permitted.
                During interim maintenance treatment, initial treatment plans and
                periodic treatment plan evaluations are not required and a primary
                counselor is not required to be assigned to the patient. The OTP must
                be able to transfer these patients from interim maintenance into
                comprehensive maintenance treatment within 120 days. Interim
                maintenance treatment must be provided in a manner consistent with all
                applicable federal and state laws.
                    The SAMHSA requirements at Sec.  8.12(b) address administrative and
                organizational structure, requiring that an OTP's organizational
                structure and facilities shall be adequate to ensure quality patient
                care and meet the requirements of all pertinent federal, state, and
                local laws and regulations. At a minimum, each OTP shall formally
                designate a program sponsor and medical director who is a physician who
                is licensed to practice medicine in the jurisdiction in which the OTP
                is located. The program sponsor shall agree on behalf of the OTP to
                adhere to all requirements set forth in 42 CFR part 8, subpart C and
                any regulations regarding the use of opioid agonist treatment
                medications in the treatment of OUD, which may be promulgated in the
                future. The medical director shall assume responsibility for
                administering all medical services performed by the OTP. In addition,
                the medical director shall be responsible for ensuring that the OTP is
                in compliance with all applicable federal, state, and local laws and
                regulations.
                    The provision governing patient admission criteria at Sec.  8.12(e)
                requires that an OTP shall maintain current procedures designed to
                ensure that patients are admitted to maintenance treatment by qualified
                personnel who have determined, using accepted medical criteria such as
                those listed in the Diagnostic and Statistical Manual of Mental
                Disorders, including that the person has an OUD, and that the person
                has had an OUD at least 1 year before admission for treatment. If under
                18 years of age, the patient is required to have had two documented
                unsuccessful attempts at short-term detoxification or drug-free
                treatment within a 12-month period and have the written consent of a
                parent, legal guardian or responsible adult designated by the relevant
                state authority to be eligible for maintenance treatment.
                    To ensure continuous quality improvement, the requirements at Sec.
                8.12(c) state that an OTP must maintain current quality assurance and
                quality control plans that include, among other things, annual reviews
                of program policies and procedures and ongoing assessment of patient
                outcomes and a current Diversion Control Plan as part of its quality
                assurance program.
                    The requirements at Sec.  8.12(d) with respect to staff
                credentials, state that each person engaged in the treatment of OUD
                must have sufficient education, training, and experience, or any
                combination thereof, to enable that person to perform the assigned
                functions.
                    In addition to meeting the criteria described above, OTPs must
                apply to SAMHSA for certification. As part of the conditions for
                certification, SAMHSA specifies that OTPs shall:
                     Comply with all pertinent state laws and regulations.
                     Allow inspections and surveys by duly authorized employees
                of SAMHSA, by accreditation bodies, by the DEA, and by authorized
                employees of any relevant State or federal governmental authority.
                     Comply with the provisions of 42 CFR part 2 (regarding
                confidentiality of substance use disorder patient records).
                     Notify SAMHSA within 3 weeks of any replacement or other
                change in the status of the program sponsor or medical director.
                     Comply with all regulations enforced by the DEA under 21
                CFR chapter II, and be registered by the DEA before administering or
                dispensing opioid agonist treatment medications.
                     Operate in accordance with federal opioid treatment
                standards and approved accreditation elements.
                    Furthermore, SAMHSA has issued additional guidance for OTPs that
                describes how programs can achieve and maintain compliance with federal
                regulations.\34\
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                    \34\ https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf.
                ---------------------------------------------------------------------------
                (3) Accreditation of OTPs by a SAMHSA-Approved Accrediting Body
                    As provided in section 1861(jjj)(2)(C) of the Act, OTPs must be
                accredited by a SAMHSA-approved accrediting body in order to furnish
                Medicare-covered OUD treatment services. In 2001, the Department of
                Health and Human Services (HHS) and SAMHSA issued final regulations to
                establish a new oversight system for the treatment of substance use
                disorders with MAT (42 CFR part 8). SAMHSA-approved accrediting bodies
                evaluate OTPs and perform site visits to ensure SAMHSA's opioid
                dependency treatment standards are met. SAMHSA also requires OTPs to be
                accredited by a SAMHSA-approved accrediting body (42 CFR 8.11).
                    The SAMHSA regulations establish procedures for an entity to apply
                to become a SAMHSA-approved accrediting body (42 CFR 8.3). When
                determining whether to approve an applicant as an accreditation body,
                SAMHSA examines the following:
                     Evidence of the nonprofit status of the applicant (that
                is, of fulfilling Internal Revenue Service requirements as a nonprofit
                organization) if the applicant is not a state governmental entity or
                political subdivision;
                     The applicant's accreditation elements or standards and a
                detailed discussion showing how the proposed accreditation elements or
                standards will ensure that each OTP surveyed by the applicant is
                qualified to meet or is meeting each of the federal opioid treatment
                standards set forth in Sec.  8.12;
                     A detailed description of the applicant's decision-making
                process, including:
                    ++ Procedures for initiating and performing onsite accreditation
                surveys of OTPs;
                    ++ Procedures for assessing OTP personnel qualifications;
                    ++ Copies of an application for accreditation, guidelines,
                instructions, and other materials the applicant will send to OTPs
                during the accreditation process;
                    ++ Policies and procedures for notifying OTPs and SAMHSA of
                deficiencies and for monitoring corrections of deficiencies by OTPs;
                for suspending or revoking an OTP's accreditation; and to ensure
                processing of applications for accreditation and for renewal of
                accreditation within a timeframe approved by SAMHSA; and;
                    ++ A description of the applicant's appeals process to allow OTPs
                to contest adverse accreditation decisions.
                     Policies and procedures established by the accreditation
                body to avoid conflicts of interest, or the appearance of conflicts of
                interest;
                [[Page 40523]]
                     A description of the education, experience, and training
                requirements for the applicant's professional staff, accreditation
                survey team membership, and the identification of at least one licensed
                physician on the applicant's staff;
                     A description of the applicant's training policies;
                     Fee schedules, with supporting cost data;
                     Satisfactory assurances that the applicant will comply
                with the requirements of Sec.  8.4, including a contingency plan for
                investigating complaints under Sec.  8.4(e);
                     Policies and procedures established to protect
                confidential information the applicant will collect or receive in its
                role as an accreditation body; and
                     Any other information SAMHSA may require.
                    SAMHSA periodically evaluates the performance of accreditation
                bodies primarily by inspecting a selected sample of the OTPs accredited
                by the accrediting body and by evaluating the accreditation body's
                reports of surveys conducted, to determine whether the OTPs surveyed
                and accredited by the accreditation body are in compliance with the
                federal opioid treatment standards. There are currently six SAMHSA-
                approved accreditation bodies.\35\
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                    \35\ https://www.samhsa.gov/medication-assisted-treatment/opioid-treatment-accrediting-bodies/approved.
                ---------------------------------------------------------------------------
                (4) Provider Agreement
                    Section 2005(d) of the SUPPORT Act amends section 1866(e) of the
                Act by adding a new paragraph (3) which includes opioid treatment
                programs (but only with respect to the furnishing of opioid use
                disorder treatment services) as a ``provider of services'' for purposes
                of section 1866 of the Act. All providers of services under section
                1866 of the Act must enter into a provider agreement with the Secretary
                and comply with other requirements specified in that section. These
                requirements are implemented at 42 CFR part 489. Therefore, we are
                proposing to amend part 489 to include OTPs (but only with respect to
                the furnishing of opioid use disorder treatment services) as a
                provider. Specifically, we are proposing to add OTPs (but only with
                respect to the furnishing of opioid use disorder treatment services) to
                the list of providers in Sec.  489.2. This addition makes clear that
                the other requirements specified in Section 1866, and implemented in
                part 489, which include the limits on charges to beneficiaries, would
                apply to OTPs (with respect to the furnishing of opioid use disorder
                treatment services). We are also proposing additional changes to make
                clear that certain parts of part 489, which implement statutory
                requirements other than section 1866 of the Act, do not apply to OTPs.
                For example, since we are not proposing any conditions of participation
                for OTPs, we are proposing to amend Sec.  489.10(a), which states that
                providers specified in Sec.  489.2 must meet conditions of
                participation, to add that OTPs must meet the requirements set forth in
                part 489 and elsewhere in that chapter. In addition, we are proposing
                to specify that the effective date of the provider agreement is the
                date on which CMS accepts a signed agreement (proposed amendment to
                Sec.  489.13(a)(2)), and is not dependent on surveys or an accrediting
                organization's determination related to conditions of participation.
                Finally, as noted earlier in the preamble, OTPs are required to be
                certified by SAMHSA and accredited by an accrediting body approved by
                SAMHSA. In Sec.  489.53, we are proposing to create a basis for
                termination of the provider agreement if the OTP no longer meets the
                requirements set forth in part 489 or elsewhere in that chapter
                (including if it no longer has a SAMHSA certification or accreditation
                by a SAMHSA-approved accrediting body). Finally, we are also proposing
                to revise 42 CFR part 498 to ensure that OTPs have access to the appeal
                process in case of an adverse determination concerning continued
                participation in the Medicare program. Specifically, we are amending
                the definition of provider in Sec.  498.2 to include OTPs. We are
                continuing to review the application of the provider agreement
                requirements to OTPs and may make further amendments to parts 489 and
                498 as necessary to ensure that the existing provider agreement
                regulations are applied to OTPs consistent with our proposals and
                Section 2005 of the SUPPORT Act.
                (5) Additional Conditions
                    As provided in section 1861(jjj)(2)(D) of the Act, to furnish
                Medicare-covered OUD treatment services, OTPs must meet any additional
                conditions as the Secretary may find necessary to ensure the health and
                safety of individuals being furnished services under such program and
                the effective and efficient furnishing of such services. The
                comprehensive OTP standards for certification of OTPs address the same
                topics as would be addressed by CMS supplier standards, such as client
                assessment and the services required to be provided. Furthermore, the
                detailed process established by SAMHSA for selecting and overseeing its
                accreditation organizations is similar to the accrediting organization
                oversight process that would typically be established by CMS. Thus, we
                believe the existing SAMHSA certification and accreditation
                requirements are both appropriate and sufficient to ensure the health
                and safety of individuals being furnished services by OTPs, as well as
                the effective and efficient furnishing of such services. We also
                believe that creating additional conditions at this time for
                participation in Medicare by OTPs could create unnecessary regulatory
                duplication and could be potentially burdensome for OTPs. Therefore,
                CMS is not proposing any additional conditions for participation in
                Medicare by OTPs at this time. We welcome public comments on this
                proposed approach, including input on whether there are any additional
                conditions that should be required for OTPs furnishing Medicare-covered
                OUD treatment services.
                (6) Proposed Definition of Opioid Treatment Program
                    We propose to define ``opioid treatment program'' at Sec.
                410.67(b) as an entity that is an opioid treatment program as defined
                in 42 CFR 8.2 (or any successor regulation) and meets the applicable
                requirements for an OTP. We propose to codify this definition at Sec.
                410.67(b). In addition, we propose that for an OTP to participate and
                receive payment under the Medicare program, the OTP must be enrolled
                under section 1866(j) of the Act, have in effect a certification by
                SAMHSA for such a program, and be accredited by an accrediting body
                approved by SAMHSA. We are also proposing that an OTP must have a
                provider agreement as required by section 1866(a) of the Act. We
                propose to codify these requirements at Sec.  410.67(c). We welcome
                public comments on the proposed definition of OTP and the proposed
                Medicare requirements for OTPs.
                3. Proposed Bundled Payments for OUD Treatment Services
                    Section 1834(w) of the Act, added by section 2005 of the SUPPORT
                Act, directs the Secretary to pay to the OTP an amount that is equal to
                100 percent of a bundled payment for OUD treatment services that are
                furnished by the OTP to an individual during an episode of care. We are
                proposing to establish bundled payments for OUD treatment services
                which, as discussed above, would include the medications approved by
                the FDA under section 505
                [[Page 40524]]
                of the FFDCA for use in the treatment of OUD; the dispensing and
                administration of such medication, if applicable; substance use
                counseling; individual and group therapy; and toxicology testing. In
                calculating the proposed bundled payments, we propose to apply separate
                payment methodologies for the drug component (which includes the
                medications approved by the FDA under section 505 of the FFDCA for use
                in the treatment of OUD) and the non-drug component (which includes the
                dispensing and administration of such medications, if applicable;
                substance use counseling; individual and group therapy; and toxicology
                testing) of the bundled payments. We propose to calculate the full
                bundled payment rate by combining the drug component and the non-drug
                components. Below, we discuss our proposals for determining the bundled
                payments for OUD treatment services. As part of this discussion, we
                address payment rates for these services under the Medicaid and TRICARE
                programs, duration of the episode of care for which the bundled payment
                is made (including partial episodes), methodology for determining
                bundled payment rates for the drug and non-drug components, site of
                service, coding and beneficiary cost sharing. We propose to codify the
                methodology for determining the bundled payment rates for OUD treatment
                services at Sec.  410.67(d).
                a. Review of Medicaid and TRICARE Programs
                    Section 1834(w)(2) of the Act, added by section 2005(c) of the
                SUPPORT Act, provides that in developing the bundled payment rates for
                OUD treatment services furnished by OTPs, the Secretary may consider
                payment rates paid to the OTPs for comparable services under the state
                plans under title XIX of the Act (Medicaid) or under the TRICARE
                program under chapter 55 of title 10 of the United States Code
                (U.S.C.). The payments for comparable services under TRICARE and
                Medicaid programs are discussed below. We understand that many private
                payers cover services furnished by OTPs, and welcome comment on the
                scope of private payer OTP coverage and the payment rates private
                payers have established for OTPs furnishing comparable OUD treatment
                services. We may consider this information as part of the development
                of the final bundled payment rates for OUD treatment services furnished
                by OTPs in the final rule.
                (1) TRICARE
                    In the ``TRICARE: Mental Health and Substance Use Disorder
                Treatment'' final rule, which appeared in the September 2, 2016 Federal
                Register (81 FR 61068) (hereinafter referred to as the 2016 TRICARE
                final rule), the Department of Defense (DOD) finalized its methodology
                for determining payments for services furnished to TRICARE
                beneficiaries by an OTP in the regulations at 32 CFR 199.14(a)(2)(ix).
                The payments are also described in Chapter 7, Section 5 and Chapter 1,
                Section 15 of the TRICARE Reimbursement Manual 6010.61-M, April 1,
                2015. As discussed in the 2016 TRICARE final rule, a number of
                commenters indicated that they believed the rates established by DOD
                are near market rates and acceptable (81 FR 61079).
                    In the 2016 TRICARE final rule, DOD established separate payment
                methodologies for treatment in OTPs based on the particular medication
                being administered. DOD finalized a weekly all-inclusive per diem rate
                for OTPs when furnishing methadone for MAT. Under 32 CFR
                199.14(a)(2)(ix)(A)(3)(i), this weekly rate includes the cost of the
                drug and the cost of related non-drug services (that is, the costs
                related to the intake/assessment, drug dispensing and screening and
                integrated psychosocial and medical treatment and supportive services),
                hereafter referred as the non-drug services. We note that the services
                included in the TRICARE weekly bundle are generally comparable to the
                definition of OUD treatment services in Section 2005 of the SUPPORT
                Act. The weekly all-inclusive per diem rate for these services was
                determined based on preliminary review of industry billing practices
                (which included Medicaid and other third-party payers) for the
                dispensing of methadone, including an estimated daily drug cost of $3
                and a daily estimated cost of $15 for the non-drug services. These
                daily costs were converted to an estimated weekly per diem rate of $126
                ($18 per day x 7 days) in the 2016 TRICARE final rule. Under 32 CFR
                199.14(a)(2)(iv)(C)(S), this rate is updated annually by the Medicare
                hospital inpatient prospective payment system (IPPS) update factor. The
                2019 TRICARE weekly per diem rate for methadone treatment in an OTP is
                $133.15.\36\ Beneficiary cost-sharing consists of a flat copayment that
                may be applied to this weekly rate.
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                    \36\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
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                    DOD also established payment rates for other medications used for
                MAT (buprenorphine and extended-release injectable naltrexone) to allow
                OTPs to bill for the full range of medications available. Under 32 CFR
                199.14(a)(2)(ix)(A)(3)(ii), DOD established a fee-for-service payment
                methodology for buprenorphine and extended-release injectable
                naltrexone because they are more likely to be prescribed and
                administered in an office-based treatment setting but are still
                available for treatment furnished in an OTP. DOD stated in the 2016
                TRICARE final rule (81 FR 61080) that treatment with buprenorphine and
                naltrexone is more variable in dosage and frequency than with
                methadone. Therefore, TRICARE pays for these medications and the
                accompanying non-drug services separately on a fee-for-service basis.
                Buprenorphine is paid based on 95 percent of average wholesale price
                (AWP) and the non-drug component is paid on a per visit basis at an
                estimated cost of $22.50 per visit. Extended-release injectable
                naltrexone is paid at the average sales price (ASP) plus a drug
                administration fee while the non-drug services are also paid at an
                estimated per visit cost of $22.50. DOD also reserved discretion to
                establish the payment methodology for new drugs and biologicals that
                may become available for the treatment of SUDs in OTPs.
                    DOD instructed that OTPs use the ``Alcohol and/or other drug use
                services, not otherwise specified'' H-code for billing the non-drug
                services when buprenorphine or naltrexone is used, and required OTPs to
                also include both the J-code and the National Drug Code (NDC) for the
                drug used, as well as the dosage and acquisition cost on the claim
                form.\37\ Drugs listed on Medicare's Part B ASP files are paid using
                the ASP.\38\ Drugs not appearing on the Medicare ASP file are paid at
                the lesser of billed charges or 95 percent of the AWP.\39\ Using this
                methodology, TRICARE estimated a daily drug cost of $10 for
                buprenorphine and a monthly drug cost of $1,129 for extended-release
                injectable naltrexone.\40\
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                    \37\ 81 FR 61080.
                    \38\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
                    \39\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
                    \40\ 81 FR 61080.
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                [[Page 40525]]
                (2) Medicaid (Title XIX)
                    States have the flexibility to administer the Medicaid program to
                meet their own needs within the Medicaid program parameters set forth
                in federal statute and regulations. All states cover and pay for some
                form of medications for medication-assisted treatment of OUD under
                their Medicaid programs. However, as of 2018, only 42 states covered
                methadone for MAT for OUD under their Medicaid programs.\41\ We note
                that section 1006(b) of the SUPPORT Act amends sections 1902 and 1905
                of the Social Security Act to require that Medicaid State plans cover
                all drugs approved under section 505 of the FFDCA to treat OUD,
                including methadone, and all biological products licensed under section
                351 of the Public Health Service Act to treat OUD, beginning October 1,
                2020. This requirement sunsets on September 30, 2025.
                ---------------------------------------------------------------------------
                    \41\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
                ---------------------------------------------------------------------------
                    In reviewing Medicaid payments for OUD treatment services furnished
                by OTPs in a few states, we found significant variation in the MAT
                coverage, OUD treatment services, and payment structure among the
                states. Thus, it is difficult to identify a standardized Medicaid
                payment amount for OTP services. A number of factors such as the unit
                of payment, types of services bundled within a payment code, and how
                MAT services are paid varied among the states. For example, for
                treatment of OUD using methadone for MAT, most OTPs bill under HCPCS
                code H0020 (Alcohol and/or drug services; methadone administration and/
                or service (provision of the drug by a licensed program)) under the
                Medicaid program; however, the unit of payment varies by state from
                daily, weekly, or monthly. For example, the unit of payment in
                California is daily for methadone treatment,\42\ while the unit of
                payment in Maryland for methadone maintenance is weekly,\43\ and
                Vermont uses a monthly unit \44\ of payment of these OUD treatment
                items and services.
                ---------------------------------------------------------------------------
                    \42\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
                    \43\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
                    \44\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
                ---------------------------------------------------------------------------
                    For the other MAT drugs, all states cover buprenorphine and the
                buprenorphine-naloxone medications; \45\ however, fewer than 70 percent
                cover the implanted or extended-release injectable versions of
                buprenorphine.\46\ In addition, all states cover the extended-release
                injectable naltrexone.\47\ We also found that many states pay different
                rates based on the specific type of drug used for MAT.
                ---------------------------------------------------------------------------
                    \45\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
                    \46\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
                    \47\ https://store.samhsa.gov/system/files/medicaidfinancingmatreport.pdf.
                ---------------------------------------------------------------------------
                    Non-drug items and services may be included in a bundled payment
                with the drug or paid separately, depending on the state, and can
                include dosing, dispensing and administration of the drug, individual
                and group counseling, and toxicology testing. In some states, certain
                services such as assessments, individual and group counseling, and
                toxicology testing can be billed separately. For example, some states
                (such as Maryland,\48\ Texas,\49\ and California) \50\ separately
                reimburse for individual and group counseling services, while other
                states (such as Vermont \51\ and New Mexico) \52\ included these
                services in the OUD bundled payment.
                ---------------------------------------------------------------------------
                    \48\ https://health.maryland.gov/bhd/Documents/Rebundling%20Initiative%209-6-16.pdf.
                    \49\ http://www.tmhp.com/News_Items/2018/11-Nov/11-16-18%20Substance%20Use%20Disorder%20Benefits%20to%20Change%20for%20Texas%20Medicaid%20January%201,%202019.pdf.
                    \50\ https://www.dhcs.ca.gov/formsandpubs/Documents/MHSUDS%20Information%20Notices/MHSUDS_Information_Notices_2018/MHSUDS_Information_Notice_18_037_SPA_Rates_Exhibit.pdf.
                    \51\ http://www.healthvermont.gov/sites/default/files/documents/pdf/ADAP_Medicaid%20Rate%20Sheet.pdf.
                    \52\ http://www.hsd.state.nm.us/uploads/FileLinks/e7cfb008157f422597cccdc11d2034f0/MAT_Proposed_reimb_MAD_website_pdf.pdf.
                    https://stre.samhsa.gov/system/files/medicaidfinancingmatreport.pdfnm.us/uploads/FileLinks/c78b68d063e04ce5adffe29376ff402e/12_10_MAT_OTC_Clinics_Supp_09062012__2_.pdf.
                ---------------------------------------------------------------------------
                b. Aspects of the Bundle
                (1) Duration of Bundle
                    Section 1834(w)(1) of the Act requires the Secretary to pay an OTP
                an amount that is equal to 100 percent of the bundled payment for OUD
                treatment services that are furnished by the OTP to an individual
                during an episode of care (as defined by the Secretary) beginning on or
                after January 1, 2020. We are proposing that the duration of an episode
                of care for OUD treatment services would be a week (that is, a
                contiguous 7-day period that may start on any day of the week). This is
                similar to the structure of the TRICARE bundled payment to OTPs for
                methadone, which is based on a weekly bundled rate (81 FR 61079), as
                well as the payments by some state Medicaid programs. Given this
                similarity to existing coding structures, we believe a weekly duration
                for an episode of care would be most familiar to OTPs and therefore the
                least disruptive to adopt. We welcome comments on whether we should
                consider a daily or monthly bundled payment. We are proposing to define
                an episode of care at Sec.  410.67(b) as a 1 week (contiguous 7-day)
                period.
                    We recognize that patients receiving MAT are often on this
                treatment regimen for an indefinite amount of time and therefore, we
                are not proposing any maximum number of weeks during an overall course
                of treatment for OUD.
                (a) Requirements for an Episode
                    We note that SAMHSA requires OTPs to have a treatment plan for each
                patient that identifies the frequency with which items and services are
                to be provided (Sec.  8.12(f)(4)). We recognize that there is a range
                of service intensity depending on the severity of a patient's OUD and
                stage of treatment and therefore, a ``full weekly bundle'' may consist
                of a very different frequency of services for a patient in the initial
                phase of treatment compared to a patient in the maintenance phase of
                treatment, but that we would still consider the requirements to bill
                for the full weekly bundle to be met if the patient is receiving the
                majority of the services identified in their treatment plan at that
                time. However, for the purposes of valuation, we assumed one substance
                use counseling session, one individual therapy session, and one group
                therapy session per week and one toxicology test per month. Given the
                anticipated changes in service intensity over time based on the
                individual patient's needs, we expect that treatment plans would be
                updated to reflect these changes or noted in the patient's medical
                record, for example, in a progress note. In cases where the OTP has
                furnished the majority (51 percent or more) of the services identified
                in the patient's current treatment plan (including any changes noted in
                the patient's medical record) over the course of a week, we propose
                that it could bill for a full weekly bundle. We are proposing to codify
                the payment methodology for full episodes of care (as well as partial
                episodes of care and non-drug episodes of care, as discussed below) in
                Sec.  410.67(d)(2).
                (b) Partial Episode of Care
                    We understand that there may be instances in which a beneficiary
                does not receive all of the services expected in a given week due to
                any number of issues, including, for example, an inpatient
                hospitalization during which a
                [[Page 40526]]
                beneficiary would not be able to go to the OTP or inclement weather
                that impedes access to transportation. To provide more accurate payment
                to OTPs in cases where a beneficiary is not able to or chooses not to
                receive all items and services described in their treatment plan or the
                OTP is unable to furnish services, for example, in the case of a
                natural disaster, we are proposing to establish separate payment rates
                for partial episodes that correspond with each of the full weekly
                bundles. In cases where the OTP has furnished at least one of the items
                or services (for example, dispensing one day of an oral MAT medication
                or one counseling session or one toxicology test) but less than 51
                percent of the items and services included in OUD treatment services
                identified in the patient's current treatment plan (including any
                changes noted in the patient's medical record) over the course of a
                week, we propose that it could bill for a partial weekly bundle. In
                cases in which the beneficiary does not receive a drug during the
                partial episode, we propose that the code describing a non-drug partial
                weekly bundle must be used. For example, the OTP could bill for a
                partial episode in instances where the OTP is transitioning the
                beneficiary from one OUD medication to another and therefore the
                beneficiary is receiving less than a week of one type of medication. In
                those cases, two partial episodes could be billed, one for each of the
                medications, or one partial episode and one full episode, if all
                requirements for billing are met. We intend to monitor this issue and
                will consider whether we would need to make changes to this policy in
                future rulemaking to ensure that the billing for partial episodes is
                not being abused. We are proposing to define a partial episode of care
                in Sec.  410.67(b) and to codify the payment methodology for partial
                episodes in Sec.  410.67(d). We seek comments on our proposed approach
                to full and partial episodes, including the threshold that should be
                applied to determine when an OTP may bill for the full weekly bundle
                versus a partial episode. We also seek comment on the minimum threshold
                that should be applied to determine when a partial episode could be
                billed (for example, at least one item or service, or an alternative
                threshold such as 10 or 25 percent of the items and services included
                in OUD treatment services identified in the patient's current treatment
                plan (including any changes noted in the patient's medical record) over
                the course of a week). We also welcome feedback regarding whether any
                other payers of OTP services allow for billing partial bundles and what
                thresholds they use.
                (c) Non-Drug Episode of Care
                    In addition to the bundled payments for full and partial episodes
                of care that are based on the medication administered for treatment
                (and include both a drug and non-drug component described in detail
                below), we are proposing to establish a non-drug episode of care to
                provide a mechanism for OTPs to bill for non-drug services, including
                substance use counseling, individual and group therapy, and toxicology
                testing that are rendered during weeks when a medication is not
                administered, for example, in cases where a patient is being treated
                with injectable buprenorphine or naltrexone on a monthly basis or has a
                buprenorphine implant. We are proposing to codify this non-drug episode
                of care at Sec.  410.67(d).
                (2) Drug and Non-Drug Components
                    As discussed above, in establishing the bundled payment rates, we
                propose to develop separate payment methodologies for the drug
                component and the non-drug (which includes the dispensing and
                administration of such medication, if applicable; substance use
                counseling; individual and group therapy; and toxicology testing)
                components of the bundled payment. Each of these components is
                discussed in this section.
                (a) Drug Component
                    As discussed previously, the cost of medications used by OTPs to
                treat OUD varies widely. Creating a single bundled payment rate that
                does not reflect the type of drug used could result in access issues
                for beneficiaries who might be best served by treatment using a more
                expensive medication. As a result, we believe that the significant
                variation in the cost of these drugs needs to be reflected adequately
                in the bundled payment rates for OTP services to avoid impairing access
                to appropriate care.
                    Section 1834(w)(2) of the Act states that the Secretary may
                implement the bundled payment to OTPs though one or more bundles based
                on a number of factors, including the type of medication provided (such
                as buprenorphine, methadone, extended-release injectable naltrexone, or
                a new innovative drug). Accordingly, consistent with the discretion
                afforded under section 1834(w)(2) of the Act, and after consideration
                of payment rates paid to OTPs for comparable services by other payers
                as discussed above, we propose to base the OTP bundled payment rates,
                in part, on the type of medication used for treatment. Specifically, we
                propose the following categories of bundled payments to reflect those
                drugs currently approved by the FDA under section 505 of the FFDCA for
                use in treatment of OUD:
                     Methadone (oral).
                     Buprenorphine (oral).
                     Buprenorphine (injection).
                     Buprenorphine (implant).
                     Naltrexone (injection).
                    In addition, we propose to create a category of bundled payment
                describing a drug not otherwise specified to be used for new drugs (as
                discussed further below). We are also proposing a non-drug bundled
                payment to be used when medication is not administered (as discussed
                further below). We believe creating these categories of bundled
                payments based on the drug used for treatment would strike a reasonable
                balance between recognizing the variable costs of these medications and
                the statutory requirement to make a bundled payment for OTP services.
                We propose to codify this policy of establishing the categories of
                bundled payments based on the type of opioid agonist and antagonist
                treatment medication in Sec.  410.67(d)(1).
                i. New Drugs
                    We anticipate that there may be new FDA-approved opioid agonist and
                antagonist treatment medications to treat OUD in the future. In the
                scenario where an OTP furnishes MAT using a new FDA-approved opioid
                agonist or antagonist medication for OUD treatment that is not
                specified in one of our existing codes, we propose that OTPs would bill
                for the episode of care using the medication not otherwise specified
                (NOS) code, HCPCS code GXXX9 (or GXXX19 for a partial episode). In such
                cases, we propose to use the typical or average maintenance dose to
                determine the drug cost for the new bundle. Then, we propose that
                pricing would be determined based on the relevant pricing methodology
                as described later in this section (section II.G.) of the proposed rule
                or invoice pricing in the event the information necessary to apply the
                relevant pricing methodology is not available. For example, in the case
                of injectable and implantable drugs, which are generally covered and
                paid for under Medicare Part B, we propose to use the methodology in
                section 1847A of the Act (which bases most payments on ASP). For oral
                medications, which are generally covered and paid for under Medicare
                Part D, we propose to use ASP-based payment when we receive
                manufacturer-submitted ASP data for
                [[Page 40527]]
                these drugs. In the event that we do not receive manufacturer-submitted
                ASP pricing data, we are considering several potential pricing
                mechanisms (as discussed further below) to estimate the payment amounts
                for oral drugs typically paid for under Medicare Part D but that would
                become OTP drugs paid under Part B when used as part of MAT furnished
                in an OTP. We are not proposing a specific pricing mechanism at this
                time for the situation in which we do not receive manufacturer-
                submitted ASP pricing data, but are requesting public comment on
                several potential approaches for estimating the acquisition cost and
                payment amounts for these drugs. We will consider the comments received
                in developing our final policy for determining these drug prices. If
                the information necessary to apply the alternative pricing methodology
                chosen for the oral drugs is also not available to price the new
                medication, we propose to use invoice pricing until either ASP pricing
                data or the information necessary to apply the chosen pricing
                methodology becomes available to price the medication. We are proposing
                to codify this approach for determining the amount of the bundled
                payment for new medications in Sec.  410.67(d)(2).The medication NOS
                code would be used until CMS has the opportunity to consider through
                rulemaking establishing a unique bundled payment for episodes of care
                during which the new drug is furnished. We welcome comments on this
                proposed approach to the treatment of new drugs used for MAT in OTPs.
                    As discussed above, we also welcome comments on how new medications
                that may be approved by the FDA in the future for use in the treatment
                of OUD with a novel mechanism of action (for example, not an opioid
                agonist and/or antagonist), such as medications approved under section
                505 of the FFDCA to treat OUD and biological products licensed under
                section 351 of the Public Health Service Act to treat OUD, should be
                considered in the context of OUD treatment services provided by OTPs.
                We additionally welcome comments on how such new drugs with a novel
                mechanism of action should be priced, and specifically whether pricing
                for these new non-opioid agonist and/or antagonist medications should
                be determined using the same pricing methodology proposed for new
                opioid agonist and antagonist treatment medications, described above or
                whether an alternative pricing methodology should be used.
                (b) Non-Drug Component
                i. Counseling, Therapy, Toxicology Testing, and Drug Administration
                    As discussed above, the bundled payment is for OUD treatment
                services furnished during the episode of care, which we are proposing
                to define as the FDA-approved opioid agonist and antagonist treatment
                medications, the dispensing and administration of such medications (if
                applicable), substance use disorder counseling by a professional to the
                extent authorized under state law to furnish such services, individual
                and group therapy with a physician or psychologist (or other mental
                health professional to the extent authorized under state law), and
                toxicology testing. The non-drug component of the OUD treatment
                services includes all items and services furnished during an episode of
                care except for the medication.
                    Under the SAMSHA certification standards at Sec.  8.12(f)(5), OTPs
                must provide adequate substance abuse counseling to each patient as
                clinically necessary. We note that section 1861(jjj)(1)(C) of the Act,
                as added by section 2005(b) of the SUPPORT Act defines OUD treatment
                services as including ``substance use counseling by a professional to
                the extent authorized under state law to furnish such services.''
                Therefore, professionals furnishing therapy or counseling services for
                OUD treatment must be operating within state law and scope of practice.
                These professionals could include licensed professional counselors,
                licensed clinical alcohol and drug counselors, and certified peer
                specialists that are permitted to furnish this type of therapy or
                counseling by state law and scope of practice. To the extent that the
                individuals furnishing therapy or counseling services are not
                authorized under state law to furnish such services, the therapy or
                counseling services would not be covered as OUD treatment services.
                    Additionally, under SAMSHA certification standards at Sec.
                8.12(f)(6), OTPs are required to provide adequate testing or analysis
                for drugs of abuse, including at least eight random drug abuse tests
                per year, per patient in maintenance treatment, in accordance with
                generally accepted clinical practice. These drug abuse tests (which are
                identified as toxicology tests in the definition of OUD treatment
                services in section 1861(jjj)(1)(E) of the Act) are used for
                diagnosing, monitoring and evaluating progress in treatment. The
                testing typically includes tests for opioids and other controlled
                substances. Urinalysis is primarily used for this testing; however,
                there are other types of testing such as hair or fluid analysis that
                could be used. We note that any of these types of toxicology tests
                would be considered to be OUD treatment services and would be included
                in the bundled payment for services furnished by an OTP.
                    The non-drug component of the bundle also includes the cost of drug
                dispensing and/or administration, as applicable. Additional details
                regarding our proposed approach for pricing this aspect of the non-drug
                component of the bundle are included in our discussion of payment rates
                later in this section.
                ii. Other Services
                    As discussed earlier, we are proposing to define OUD treatment
                services as those items and services that are specifically enumerated
                in section 1861(jjj)(1) of the Act, including services that are
                furnished via telecommunications technology, and are seeking comment on
                any other items and services we might consider including as OUD
                treatment services under the discretion given to the Secretary in
                subparagraph (F) of that section to determine other appropriate items
                and services. If we were to finalize a definition of OUD treatment
                services that includes any other items or services, such as intake
                activities or periodic assessments as discussed above, we would
                consider whether any changes to the payment rates for the bundled
                payments are necessary. See below for additional discussion related to
                how we could price these services.
                (3) Adjustment to Bundled Payment Rate for Additional Counseling or
                Therapy Services
                    In addition to the items and services already included in the
                proposed bundles, we recognize that counseling and therapy are
                important components of MAT and that patients may need to receive
                counseling and/or therapy more frequently at certain points in their
                treatment. We seek to ensure that patients have access to these needed
                services. Accordingly, we are proposing to adjust the bundled payment
                rates through the use of an add-on code in order to account for
                instances in which effective treatment requires additional counseling
                or group or individual therapy to be furnished for a particular patient
                that substantially exceeds the amount specified in the patient's
                individualized treatment plan. As noted previously, we understand that
                there is variability in the frequency of services a patient might
                receive in a given week depending on the patient's severity and stage
                of treatment; however, we assume
                [[Page 40528]]
                that a typical case might include one substance use counseling session,
                one individual therapy session, and one group therapy session per week.
                We further understand that the frequency of services will vary among
                patients and will change over time based on the individual patient's
                needs. We expect that the patient's treatment plan or the medical
                record will be updated to reflect when there are changes in the
                expected frequency of medically necessary services based on the
                patient's condition and following such an update, the add-on code
                should no longer be billed if the frequency of the patient's counseling
                and/or therapy services is consistent with the treatment plan or
                medical record. In the case of unexpected or unforeseen circumstances
                that are time-limited, resolve quickly, and do not lead to updates to
                the treatment plan, we expect that the medical necessity for billing
                the add-on code would be documented in the medical record. This add-on
                code (HCPCS code GXX19) would describe each additional 30 minutes of
                counseling or group or individual therapy furnished in a week of MAT,
                which could be billed in conjunction with the codes describing the full
                episode of care or the partial episodes. For example, there may be some
                weeks when a patient has a relapse or unexpected psychosocial stressors
                arise that warrant additional reasonable and necessary counseling
                services that were not foreseen at the time that the treatment plan was
                developed. Additionally, we note that there may be situations in which
                the add-on code could be billed in conjunction with the code for a
                partial episode; for example, if a patient requires prolonged
                counseling services on the initial day of treatment, but does not
                return for any of the other services specified in their treatment plan,
                such as daily medication dispensing, for the remainder of that week. We
                acknowledge that an unintended consequence of using the treatment plan
                is a potential incentive for OTPs to document minimal counseling and/or
                therapy needs for a beneficiary, thereby resulting in increased
                opportunity for billing the add-on code. We expect that OTPs will
                ensure that treatment plans reflect the full scope of services expected
                to be furnished during an episode of care and that they will update
                treatment plans regularly to reflect changes. We intend to monitor this
                issue and will consider whether we need to make changes to this policy
                through future rulemaking to ensure that this adjustment is not being
                abused. We welcome comments on the proposed add-on code and the
                threshold for billing. We propose to codify this adjustment to the
                bundled payment rate for additional counseling or therapy services in
                Sec.  410.67(d)(3)(i).
                (4) Site of Service (Telecommunications)
                    In recent years, we have sought to decrease barriers to access to
                care by furthering policies that expand the use of communication
                technologies. In the CY 2019 PFS final rule (83 FR 59482), we finalized
                new separate payments for communication technology-based services,
                including a virtual check-in and a remote evaluation of pre-recorded
                patient information. SAMHSA's federal guidelines (https://store.samhsa.gov/system/files/pep15-fedguideotp.pdf) for OTPs refer to
                the CMS guidance on telemedicine and also state that OTPs are advised
                to proceed with full understanding of requirements established by state
                or health professional licensing boards. SAMHSA's federal guidelines
                for OTPs state that exceptional attention needs to be paid to data
                security and privacy in this evolving field. Telemedicine services
                should, under no circumstances, expand the scope of practice of a
                healthcare professional or permit practice in a jurisdiction (the
                location of the patient) where the provider is not licensed.
                    We are proposing to allow OTPs to furnish the substance use
                counseling, individual therapy, and group therapy included in the
                bundle via two-way interactive audio-video communication technology, as
                clinically appropriate, in order to increase access to care for
                beneficiaries. We believe this is an appropriate approach because, as
                discussed previously, we expect the telehealth services that will be
                furnished by OTPs will be similar to the Medicare telehealth services
                furnished under section 1834(m) of the Act, and the use of two-way
                interactive audio-video communication technology is required for these
                Medicare telehealth services under Sec.  410.78(a)(3). By allowing use
                of communication technology in furnishing these services, OTPs in rural
                communities or other health professional shortage areas could
                facilitate treatment through virtual care coming from an urban or other
                external site; however, we note that the physicians and other
                practitioners furnishing these services would be required to comply
                with all applicable requirements related to professional licensing and
                scope of practice.
                    We note that section 1834(m) of the Act applies only to Medicare
                telehealth services furnished by a physician or other practitioner.
                Because OUD treatment services furnished by an OTP are not considered
                to be services furnished by a physician or other practitioner, the
                restrictions of section 1834(m) of the Act would not apply.
                Additionally, we note that counseling or therapy furnished via
                communication technology as part of OUD treatment services furnished by
                an OTP must not be separately billed by the practitioner furnishing the
                counseling or therapy because these services would already be paid
                through the bundled payment made to the OTP.
                    We are proposing to include language in Sec.  410.67(b) in the
                definition of opioid use disorder treatment services to allow OTPs to
                use two-way interactive audio-video communication technology, as
                clinically appropriate, in furnishing substance use counseling and
                individual and group therapy services, respectively. We invite comment
                as to whether this proposal, including whether furnishing these
                services through communication technology is clinically appropriate. We
                also invite public comment on other components of the bundle that may
                be clinically appropriate to be furnished via communication technology,
                while also considering SAMHSA's guidance that OTPs should pay
                exceptional attention to data security and privacy.
                (5) Coding
                    We are proposing to adopt a coding structure for OUD treatment
                services that varies by the medication administered. To operationalize
                this approach, we are proposing to establish G codes for weekly bundles
                describing treatment with methadone, buprenorphine oral, buprenorphine
                injectable, buprenorphine implants (insertion, removal, and insertion/
                removal), extended-release injectable naltrexone, a non-drug bundle,
                and one for a medication not otherwise specified. We also propose to
                establish partial episode G codes to correspond with each of those
                bundles, respectively. Additionally, we propose to create an add-on
                code to describe additional counseling that is furnished beyond the
                amount specified in the patient's treatment plan. As discussed above,
                we are seeking comment on whether to include intake activities and
                periodic assessments in the definition of OUD treatment services. Were
                we to finalize including these activities in the definition of OUD
                treatment services, we welcome feedback on whether we should consider
                modifying the payment associated with the bundle or creating add-on
                codes for services such as the
                [[Page 40529]]
                initial physical examination, initial assessments and preparation of a
                treatment plan, periodic assessments or additional toxicology testing,
                and if so, what inputs we might consider in pricing such services, such
                as payment amounts for similar services under the PFS or Clinical Lab
                Fee Schedule (CLFS). For example, to price the initial assessment,
                medical examination, and development of a treatment plan, we could
                crosswalk to the Medicare payment rate for a level 3 Evaluation and
                Management (E/M) visit for a new patient and to price the periodic
                assessments, we could crosswalk to the Medicare payment rate for a
                level 3 E/M visit for an established patient. To price additional
                toxicology testing, we could crosswalk to the Medicare payment for
                presumptive drug testing, such as that described by CPT code 80305.
                Additionally, we welcome feedback on whether we should consider
                creating codes to describe bundled payments that include only the cost
                of the drug and drug administration as applicable in order to account
                for beneficiaries who are receiving interim maintenance treatment (as
                described previously in this section) or other situations in which the
                beneficiary is not receiving all of the services described in the full
                bundles.
                    Regarding the non-drug bundle, we note that this code would be
                billed for services furnished during an episode of care or partial
                episode of care when a medication is not administered. For example,
                when a patient receives a buprenorphine injection on a monthly basis,
                the OTP will only require payment for the medication during the first
                week of the month when the injection is given, and therefore, would
                bill the code describing the bundle that includes injectable
                buprenorphine during the first week of the month and would bill the
                code describing the non-drug bundle for the remaining weeks in that
                month for services such as substance use counseling, individual and
                group therapy, and toxicology testing.
                    As discussed previously, we propose that the codes describing the
                bundled payment for an episode of care with a medication not otherwise
                specified, HCPCS codes GXXX9 and GXX18, should be used when the OTP
                furnishes MAT with a new opioid agonist or antagonist treatment
                medication approved by the FDA under section 505 of the FFDCA for the
                treatment of OUD. OTPs would use these codes until we have the
                opportunity to propose and finalize a new G code to describe the
                bundled payment for treatment using that drug and price it accordingly
                in the next rulemaking cycle. We note that the code describing the
                weekly bundle for a medication not otherwise specified should not be
                used when the drug being administered is not a new opioid agonist or
                antagonist treatment medication approved by the FDA under section 505
                of the FFDCA for the treatment of OUD, and therefore, for which
                Medicare would not have the authority to make payment since section
                1861(jjj)(1)(A) of the Act requires that the medication must be an
                opioid agonist or antagonist treatment medication approved by the FDA
                under section 505 of the FFDCA for the treatment of OUD. Given the
                program integrity concerns regarding the potential for misuse of such a
                code, we also welcome comments as to whether this code is needed.
                    The codes and long descriptors for the proposed OTP bundled
                services are:
                     HCPCS code GXXX1: Medication assisted treatment,
                methadone; weekly bundle including dispensing and/or administration,
                substance use counseling, individual and group therapy, and toxicology
                testing, if performed (provision of the services by a Medicare-enrolled
                Opioid Treatment Program).
                     HCPCS code GXXX2: Medication assisted treatment,
                buprenorphine (oral); weekly bundle including dispensing and/or
                administration, substance use counseling, individual and group therapy,
                and toxicology testing if performed (provision of the services by a
                Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXXX3: Medication assisted treatment,
                buprenorphine (injectable); weekly bundle including dispensing and/or
                administration, substance use counseling, individual and group therapy,
                and toxicology testing if performed (provision of the services by a
                Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXXX4: Medication assisted treatment,
                buprenorphine (implant insertion); weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing if performed (provision of the services
                by a Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXXX5: Medication assisted treatment,
                buprenorphine (implant removal); weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing if performed (provision of the services
                by a Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXXX6: Medication assisted treatment,
                buprenorphine (implant insertion and removal); weekly bundle including
                dispensing and/or administration, substance use counseling, individual
                and group therapy, and toxicology testing if performed (provision of
                the services by a Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXXX7: Medication assisted treatment,
                naltrexone; weekly bundle including dispensing and/or administration,
                substance use counseling, individual and group therapy, and toxicology
                testing if performed (provision of the services by a Medicare-enrolled
                Opioid Treatment Program).
                     HCPCS code GXXX8: Medication assisted treatment, weekly
                bundle not including the drug, including substance use counseling,
                individual and group therapy, and toxicology testing if performed
                (provision of the services by a Medicare-enrolled Opioid Treatment
                Program).
                     HCPCS code GXXX9: Medication assisted treatment,
                medication not otherwise specified; weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing, if performed (provision of the
                services by a Medicare-enrolled Opioid Treatment Program).
                     HCPCS code GXX10: Medication assisted treatment,
                methadone; weekly bundle including dispensing and/or administration,
                substance use counseling, individual and group therapy, and toxicology
                testing if performed (provision of the services by a Medicare-enrolled
                Opioid Treatment Program); partial episode. Do not report with GXXX1.
                     HCPCS code GXX11: Medication assisted treatment,
                buprenorphine (oral); weekly bundle including dispensing and/or
                administration, substance use counseling, individual and group therapy,
                and toxicology testing if performed (provision of the services by a
                Medicare-enrolled Opioid Treatment Program); partial episode. Do not
                report with GXXX2.
                     HCPCS code GXX12: Medication assisted treatment,
                buprenorphine (injectable); weekly bundle including dispensing and/or
                administration, substance use counseling, individual and group therapy,
                and toxicology testing if performed (provision of the services by a
                Medicare-enrolled Opioid Treatment Program); partial episode. Do not
                report with GXXX3.
                [[Page 40530]]
                     HCPCS code GXX13: Medication assisted treatment,
                buprenorphine (implant insertion); weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing if performed (provision of the services
                by a Medicare-enrolled Opioid Treatment Program); partial episode (only
                to be billed once every 6 months). Do not report with GXXX4.
                     HCPCS code GXX14: Medication assisted treatment,
                buprenorphine (implant removal); weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing if performed (provision of the services
                by a Medicare-enrolled Opioid Treatment Program); partial episode. Do
                not report with GXXX5.
                     HCPCS code GXX15: Medication assisted treatment,
                buprenorphine (implant insertion and removal); weekly bundle including
                dispensing and/or administration, substance use counseling, individual
                and group therapy, and toxicology testing if performed (provision of
                the services by a Medicare-enrolled Opioid Treatment Program); partial
                episode. Do not report with GXXX6.
                     HCPCS code GXX16: Medication assisted treatment,
                naltrexone; weekly bundle including dispensing and/or administration,
                substance use counseling, individual and group therapy, and toxicology
                testing if performed (provision of the services by a Medicare-enrolled
                Opioid Treatment Program); partial episode. Do not report with GXXX7.
                     HCPCS code GXX17: Medication assisted treatment, weekly
                bundle not including the drug, including substance use counseling,
                individual and group therapy, and toxicology testing if performed
                (provision of the services by a Medicare-enrolled Opioid Treatment
                Program); partial episode. Do not report with GXXX8.
                     HCPCS code GXX18: Medication assisted treatment,
                medication not otherwise specified; weekly bundle including dispensing
                and/or administration, substance use counseling, individual and group
                therapy, and toxicology testing, if performed (provision of the
                services by a Medicare-enrolled Opioid Treatment Program); partial
                episode. Do not report with GXXX9.
                     HCPCS code GXX19: Each additional 30 minutes of counseling
                or group or individual therapy in a week of medication assisted
                treatment, (provision of the services by a Medicare-enrolled Opioid
                Treatment Program); List separately in addition to code for primary
                procedure.
                    See Table 15 for proposed valuations for HCPCS codes GXXX1-GXX19.
                We propose that only an entity enrolled with Medicare as an OTP could
                bill these codes. Additionally, we propose that OTPs would be limited
                to billing only these codes describing bundled payments, and may not
                bill for other codes, such as those paid under the PFS.
                (6) Payment Rates
                    The codes describing the proposed OTP bundled services (HCPCS codes
                GXXX1-GXX19) would be assigned flat dollar payment amounts, which are
                listed in Table 15. As discussed previously, section 2005 of the
                SUPPORT Act amended the definition of ``medical and other health
                services'' in section 1861(s) of the Act to provide for coverage of OUD
                treatment services furnished by an OTP and also added a new section
                1834(w) to the Act and amended section 1833(a)(1) of the Act to
                establish a bundled payment to OTPs for OUD treatment services
                furnished during an episode of care beginning on or after January 1,
                2020. Therefore, OUD treatment services and the payments for such
                services are wholly separate from physicians' services, as defined
                under section 1848(j)(3) of the Act, and for which payment is made
                under the section 1848 of the Act. Because OUD treatment services are
                not considered physicians' services and are paid outside the PFS, they
                would not be priced using relative value units (RVUs).
                    Consistent with section 1834(w) of the Act, which requires the
                Secretary to make a bundled payment for OUD treatment services
                furnished by OTPs, we are proposing to build the payment rates for OUD
                treatment services by combining the cost of the drug and the non-drug
                components (as applicable) into a single bundled payment as described
                in more detail below.
                (a) Drug Component
                    As part of determining a payment rate for these proposed bundles
                for OUD treatment services, a dosage of the applicable medication must
                be selected in order to calculate the costs of the drug component of
                the bundle. We propose to use the typical or average maintenance dose,
                as discussed earlier in this section, to determine the drug costs for
                each of the proposed bundles. As dosing for some, but not all, of these
                drugs varies considerably, this approach attempts to strike an
                appropriate balance between high- and low-dose drug regimens in the
                context of a bundled payment. Specifically, we propose to calculate
                payment rates using a 100 mg daily dose for methadone, a 10 mg daily
                dose for oral buprenorphine, a 100 mg monthly dose for the extended-
                release buprenorphine injection, four rods each containing 74.2 mg of
                buprenorphine for the 6-month buprenorphine implant, and a 380 mg
                monthly dose for extended-release injectable naltrexone. We invite
                public comments on our proposal to use the typical maintenance dose in
                order to calculate the drug component of the bundled payment rate for
                each of the proposed codes. We also seek comment on the specific
                typical maintenance dosage level that we have identified for each drug,
                and a process for identifying the typical maintenance dose for new
                opioid agonist or antagonist treatment medication approved by the FDA
                under section 505 of the FFDCA when such medications are billed using
                the medication NOS code, such as using the FDA-approved prescribing
                information or a review of the published, preferably peer-reviewed,
                literature. We note that the bundled payment rates are intended to be
                comprehensive with respect to the drugs provided; therefore, we do not
                intend to include any other amounts related to drugs, other than for
                administration, as discussed below. This means, for example, that we
                would not pay for drug wastage, which we do not anticipate to be
                significant in the OTP setting.
                i. Potential Drug Pricing Data Sources
                    Payment structures that are closely tailored to the provider's
                actual acquisition cost reduce the likelihood that a drug will be
                chosen primarily for a reason that is unrelated to the clinical care of
                the patient, such as the drug's profit margin for a provider. We are
                proposing to estimate an OTP's costs for the drug component of the
                bundles based on available data regarding drug costs rather than a
                provider-specific cost-to-charge ratio or another more direct
                assessment of facility or industry-specific drug costs. OTPs do not
                currently report costs associated with their services to the Medicare
                program, and we do not believe that a cost-to-charge ratio based on
                such reported information could be available for a significant period
                of time. Furthermore, we are unaware of any industry-specific data that
                may be used to more accurately assess the prices at which OTPs acquire
                the medications used for OUD treatment. Therefore, at this time, we are
                proposing to estimate an OTP's costs for the drugs used in MAT based on
                other available data sources, rather than applying a cost-to-charge
                ratio or
                [[Page 40531]]
                another more direct assessment of drug acquisition cost, though we
                intend to continue to explore alternate ways to gather this
                information. As described in greater detail below, we propose that the
                payment amounts for the drug component of the bundles be based on CMS
                pricing mechanisms currently in place. We request comment on other
                potential data sources for pricing OUD treatment medications either
                generally or specifically with respect to acquisition by OTPs. In the
                case of oral drugs that we are proposing to include in the OTP bundled
                payments and for which we do not receive manufacturer-submitted ASP
                data, we are considering several potential approaches for determining
                the payment amounts for the drug component of the bundles. Although we
                are not proposing a specific pricing mechanism at this time, we are
                soliciting comments on several different approaches, and we intend to
                develop a final policy for determining the payment amount for the drug
                component of the relevant bundles after considering the comments
                received.
                    In considering the payment amount for the drug component of each of
                the bundled payments that include a drug, we will begin by breaking the
                drugs into two categories based on their current coverage and payment
                by Medicare. First, we discuss the injectable and implantable drugs,
                which are generally covered and paid for under Medicare Part B, and
                then discuss the oral medications, which are generally covered and paid
                for under Medicare Part D.\53\ Buprenorphine (injection), buprenorphine
                (implant), and naltrexone (injection) would fall into the former
                category and methadone and buprenorphine (oral) would fall into the
                latter category.
                ---------------------------------------------------------------------------
                    \53\ Because, by law, methadone used in MAT cannot be dispensed
                by a pharmacy, it is not currently considered a Part D drug when
                used for MAT. Methadone used for this purpose can be dispensed only
                through an OTP certified by SAMHSA. However, methadone dispensed for
                pain may be considered a Part D drug and can be dispensed by a
                pharmacy.
                ---------------------------------------------------------------------------
                ii. Part B Drugs
                    Part B includes a limited drug benefit that encompasses drugs and
                biologicals described in section 1861(t) of the Act. Currently, covered
                Part B drugs fall into three general categories: Drugs furnished
                incident to a physician's services, drugs administered via a covered
                item of durable medical equipment, and other drugs specified by statute
                (generally in section 1861(s)(2) of the Act). Types of providers and
                suppliers that are paid for all or some of the Medicare-covered Part B
                drugs that they furnish include physicians, pharmacies, durable medical
                equipment suppliers, hospital outpatient departments, and end-stage
                renal disease (ESRD) facilities.
                    The majority of Part B drug expenditures are for drugs furnished
                incident to a physician's service. Drugs furnished incident to a
                physician's service are typically injectable drugs that are
                administered in a non-facility setting (covered under section
                1861(s)(2)(A) of the Act) or in a hospital outpatient setting (covered
                under section 1861(s)(2)(B) of the Act). The statute (sections
                1861(s)(2)(A) and 1861(s)(2)(B) of the Act) limits ``incident to''
                services to drugs that are not usually self-administered; self-
                administered drugs, such as orally administered tablets and capsules
                are not paid for under the ``incident to'' provision. Payment for drugs
                furnished incident to a physician's service falls under section 1842(o)
                of the Act. In accordance with section 1842(o)(1)(C) of the Act,
                ``incident to'' drugs furnished in a non-facility setting are paid
                under the methodology in section 1847A of the Act. ``Incident to''
                drugs furnished in a facility setting also are paid using the
                methodology in section 1847A of the Act when it has been incorporated
                under the relevant payment system (for example, the Hospital Outpatient
                Prospective Payment System (OPPS) \54\).
                ---------------------------------------------------------------------------
                    \54\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
                ---------------------------------------------------------------------------
                    In most cases, determining payment using the methodology in section
                1847A of the Act means payment is based on the ASP plus a statutorily
                mandated 6 percent add-on. The payment for these drugs does not include
                costs for administering the drug to the patient (for example, by
                injection or infusion); payments for these physician and hospital
                services are made separately, and the payment amounts are determined
                under the PFS \55\ and the OPPS, respectively. The ASP payment amount
                determined under section 1847A of the Act reflects a volume-weighted
                ASP for all NDCs that are assigned to a HCPCS code. The ASP is
                calculated quarterly using manufacturer-submitted data on sales to all
                purchasers (with limited exceptions as articulated in section
                1847A(c)(2) of the Act such as sales at nominal charge and sales exempt
                from best price) with manufacturers' rebates, discounts, and price
                concessions reflected in the manufacturer's determination of ASP.
                ---------------------------------------------------------------------------
                    \55\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
                ---------------------------------------------------------------------------
                    Although the Part B drug benefit is generally considered to be
                limited in scope, it includes many categories of drugs and encompasses
                a variety of care settings and payment methodologies. In addition to
                the ``incident to'' drugs described above, Part B also covers and pays
                for certain oral drugs with specific benefit categories defined under
                section 1861(s) of the Act including certain oral anti-cancer drugs and
                certain oral antiemetic drugs. In accordance with section 1842(o)(1) of
                the Act or through incorporation under the relevant payment system as
                discussed above, most of these oral Part B drugs are also paid based on
                the ASP methodology described in section 1847A of the Act.
                    However, at times Part B drugs are paid based on wholesale
                acquisition cost (WAC) as authorized under section 1847A(c)(4) of the
                Act \56\ or average manufacturer price (AMP)-based price substitutions
                as authorized under section 1847A(d) of the Act.\57\ Also, in
                accordance with section 1842(o) of the Act, other payment methodologies
                may be applied to determine the payment amount for certain Part B
                drugs, for example, AWP-based payments (using current AWP) are made for
                influenza, pneumococcal pneumonia, and hepatitis B vaccines.\58\ We
                also use current AWP to make payment under the OPPS for very new drugs
                without an ASP.\59\ Contractors may also make independent payment
                amount determinations in situations where a national price is not
                available for physician and other supplier claims and for drugs that
                are specifically excluded from payment based on section 1847A of the
                Act (for example, radiopharmaceuticals as noted in section 303(h) of
                the Medicare Prescription Drug, Improvement and Modernization Act of
                2003 (MMA) (Pub. L. 108-173, enacted December 8, 2003). In such cases,
                pricing may be determined based on compendia or invoices.\60\
                ---------------------------------------------------------------------------
                    \56\ See 75 FR 73465-73466, the section titled Partial Quarter
                ASP data.
                    \57\ See 77 FR 69140.
                    \58\ Section 1842(o)(1)(A)(iv) of the Act.
                    \59\ 80 FR 70426 and 80 FR 70442-3; Medicare Claims Processing
                Manual 100-04, Chapter 17, Section 20.1.3.
                    \60\ Medicare Claims Processing Manual 100-04, Chapter 17,
                Section 20.1.3.
                ---------------------------------------------------------------------------
                    While most Part B drugs are paid based on the ASP methodology,
                MedPAC has noted that the ASP methodology may encourage the use of more
                expensive drugs because the 6 percent add-on generates more revenue
                [[Page 40532]]
                for more expensive drugs.\61\ The ASP payment amount also does not vary
                based on the price an individual provider or supplier pays to acquire
                the drug. The statute does not identify a reason for the additional 6
                percent add-on above ASP; however, as noted in the MedPAC report (and
                by sources cited in the report), the add-on is needed to account for
                handling and overhead costs and/or for additional mark-up in the
                distribution channels that are not captured in the manufacturer-
                reported ASP.\62\
                ---------------------------------------------------------------------------
                    \61\ See MedPAC Report to the Congress: Medicare and the Health
                Care Delivery System June 2015, pages 65-72.
                    \62\ Ibid.
                ---------------------------------------------------------------------------
                    We propose to use the methodology in section 1847A of the Act
                (which bases most payments on ASP) to set the payment rates for the
                ``incident to'' drugs. However, we propose to limit the payment amounts
                for ``incident to'' drugs to 100 percent of the volume-weighted ASP for
                a HCPCS code instead of 106 percent of the volume-weighted ASP for a
                HCPCS code. We believe limiting the add-on will incentivize the use of
                the most clinically appropriate drug for a given patient. In addition,
                we understand that many OTPs purchase directly from drug manufacturers,
                thereby limiting the markup from distribution channels. We also propose
                to use the same version of the quarterly manufacturer-submitted data
                used for calculating the most recently posted ASP data files in
                preparing the CY 2020 payment rates for OTPs. Please note that the
                quarterly ASP Drug Pricing Files include ASP plus 6 percent payment
                amounts.\63\ Accordingly, we would adjust these amounts consistent with
                our proposal to limit the payment amounts for these drugs to 100
                percent of the volume-weighted ASP for a HCPCS code. Proposed payment
                rates are provided below in this section of this proposed rule. A
                discussion of the proposed annual payment update methodology is also
                provided below. We propose to codify the ASP payment methodology for
                the drug component at Sec.  410.67(d)(2). We solicit public comment on
                these proposals, as well as on using alternative ASP-based payments to
                price these drugs, such as a rolling average of the past year's ASP
                payment rates.
                ---------------------------------------------------------------------------
                    \63\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
                ---------------------------------------------------------------------------
                iii. Oral Drugs
                    We propose to use ASP-based payment, which would be determined
                based on ASP data that have been calculated consistent with the
                provisions in 42 CFR part 414, subpart 800, to set the payment rates
                for the oral product categories when we receive manufacturer-submitted
                ASP data for these drugs. We believe that using the ASP pricing data
                for oral OTP drugs currently covered under Part D \64\ would facilitate
                the computation of the estimated costs of these drugs. However, we do
                not collect ASP pricing information under section 1927(b) of the Act
                for these drugs. We request public comment on whether manufacturers
                would be willing to submit ASP pricing data for OTP drugs currently
                covered under Part D on a voluntary basis.
                ---------------------------------------------------------------------------
                    \64\ Please note that methadone is not currently considered a
                Part D drug when used for MAT. Methadone used for this purpose can
                be dispensed only through an OTP certified by SAMHSA. However,
                methadone dispensed for pain may be considered a Part D drug.
                ---------------------------------------------------------------------------
                    We also propose to limit the payment amounts for oral drugs to 100
                percent of the volume-weighted ASP for a HCPCS code instead of 106
                percent of the volume-weighted ASP for a HCPCS code. We believe
                limiting the add-on will incentivize the use of the most clinically
                appropriate drug for a given patient. In addition, we understand that
                many OTPs purchase directly from drug manufacturers, thereby limiting
                the markup from distribution channels. We propose to use the same
                version of the quarterly manufacturer-submitted data used for
                calculating the most recently posted ASP data files in preparing the CY
                2020 payment rates for OTPs. Please note that the quarterly ASP Drug
                Pricing Files include ASP plus 6 percent payment amounts.\65\
                Accordingly, we would adjust these amounts consistent with our proposal
                to limit the payment amounts for these drugs to 100 percent of the
                volume-weighted ASP for a HCPCS code. Proposed payment rates are
                provided below in this section of this proposed rule. A discussion of
                the proposed annual payment update methodology is also provided below.
                We propose to codify the ASP payment methodology for the drug component
                at Sec.  410.67(d)(2). We solicit public comment on these proposals, as
                well as on using alternative ASP-based payments to price these drugs,
                such as a rolling average of the past year's ASP payment rates.
                ---------------------------------------------------------------------------
                    \65\ See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html.
                ---------------------------------------------------------------------------
                    In the event that we do not receive manufacturer-submitted ASP
                pricing data, we are considering several potential pricing mechanisms
                to estimate the payment amounts for oral drugs typically paid for under
                Medicare Part D but that would become OTP drugs paid under Part B when
                used as part of MAT in an OTP. We are not proposing a specific pricing
                mechanism for these drugs at this time, but are requesting public
                comment on the following potential approaches for estimating the
                acquisition cost and payment amounts for these drugs and on alternative
                approaches. We will consider the comments received in developing our
                final policy for determining these drug prices.
                Approach 1: The Methodology in Section 1847A of the Act
                    One approach for estimating the cost of the drugs that are
                currently covered under Part D and for which ASP data are not available
                would be to use the methodology in section 1847A of the Act. Please see
                above for a discussion of the methodology in section 1847A of the Act.
                Under the methodology in section 1847A of the Act, when ASP data are
                not available, this option would price drugs using, for example, WAC or
                invoice pricing.
                Approach 2: Medicare's Part D Prescription Drug Plan Finder Data
                    On January 28, 2005, we issued the ``Medicare Program; Medicare
                Prescription Drug Benefit'' final rule (70 FR 4194) which implemented
                the Medicare voluntary prescription drug benefit, as enacted by section
                101 of the MMA. Beginning on January 1, 2006, a prescription drug
                benefit program was available to beneficiaries with much broader drug
                coverage than was previously provided under Part B to include: Brand-
                name prescription drugs and biologicals, generic drugs, biosimilars,
                vaccines, and medical supplies associated with the injection of
                insulin.\66\ This prescription drug benefit is offered to Medicare
                beneficiaries through Medicare Advantage Drug Plans (MA-PDs) and stand-
                alone Prescription Drug Plans (PDPs). The prescription drug benefit
                under Medicare Part D is administered based on the ``negotiated
                prices'' of covered Part D drugs. Under Sec.  423.100 of the Part D
                regulations, the negotiated price of a Part D drug equals the amount
                paid by the Part D sponsor (or its pharmacy benefit manager) to the
                pharmacy at the point-of-sale for that drug. Typically, these Part D
                ``negotiated prices'' are based on AWP minus a percentage for brand
                drugs or either the maximum allowable cost, which is based on
                proprietary methodologies used to establish the same payment for
                therapeutically equivalent products marketed by multiple labelers with
                different AWPs,
                [[Page 40533]]
                or the Generic Effective Rate, which guarantees aggregate minimum
                reimbursement (for example, AWP-85 percent). The negotiated price under
                Part D also includes a dispensing fee (for example, $1-$2), which is
                added to the cost of the drug.
                ---------------------------------------------------------------------------
                    \66\ See section 1860D-2(e) of the Act.
                ---------------------------------------------------------------------------
                    Many of the beneficiaries who choose to enroll in Part D drug plans
                must pay premiums, deductibles, and copayments/co-insurance. The
                Medicare Prescription Drug Plan Finder is an online tool available at
                http://www.medicare.gov. This web tool allows beneficiaries to make
                informed choices about enrolling in Part D plans by comparing the
                plans' benefit packages, premiums, formularies, pharmacies, and pricing
                data. PDPs and MA-PDs are required to submit this information to CMS
                for posting on the Medicare Drug Plan Finder. The database structure
                provides the drug pricing and pharmacy network information necessary to
                accurately communicate plan information in a comparative format. The
                Medicare Prescription Drug Plan Finder displays information on
                pharmacies that are contracted to participate in the sponsors' network
                as either retail or mail order pharmacies.
                    Another approach for estimating the cost of the drugs that are
                currently covered under Part D and for which ASP data are not available
                would be to use data retrieved from the online Medicare Prescription
                Drug Plan Finder. For example, the Part D drug prices for each drug
                used by an OTP as part of MAT could be estimated based on a national
                average price charged by all Part D plans and their network pharmacies.
                However, the prices listed in the Medicare Prescription Drug Plan
                Finder generally reflect the prices that are negotiated by larger
                buying groups, as larger pharmacies often have significant buying power
                and smaller pharmacies generally contract with a pharmacy services
                administrative organization (PSAO). As a result, our primary concern
                with this pricing approach is that such prices may fail to reflect the
                drug prices that smaller OTP facilities may pay in acquiring these
                drugs and could therefore disadvantage these facilities. If we were to
                select this pricing approach for oral drugs for which ASP data are not
                available, we would anticipate setting the pricing for these drugs
                using the most recent Medicare Drug Plan Finder data available at the
                drafting of the CY 2020 PFS final rule. We note that, for the Part B
                ESRD prospective payment system (PPS) outlier calculation, which
                provides ESRD facilities with additional payment in situations where
                the costs for treating patients exceed an established threshold under
                the ESRD PPS, we chose to adopt the ASP methodology in section 1847A of
                the Act, and the other pricing methodologies under section 1847A of the
                Act, as appropriate, when ASP data are not available, to price the
                renal dialysis drugs and biological products that were or would have
                been separately billable under Part B prior to implementation of the
                ESRD PPS,\67\ and the national average drug prices based on the
                Medicare Prescription Drug Plan Finder as the data source for pricing
                the renal dialysis drugs or biological products that were or would have
                been separately covered under Part D prior to implementation of the
                ESRD PPS.\68\
                ---------------------------------------------------------------------------
                    \67\ 82 FR 50742 through 50745.
                    \68\ 75 FR 49142.
                ---------------------------------------------------------------------------
                    We believe that all of the MAT drugs proposed for inclusion in the
                OTP benefit that are currently covered under Part D have clinical
                treatment indications beyond MAT such as for the treatment of pain.\69\
                These drugs will continue to be covered under Part D for these other
                indications. Buprenorphine will continue to be covered under Part D for
                MAT as well. Consequently, Part D pricing information should continue
                to be available for these drugs and could be used in the computation of
                payment under the approach discussed above.
                ---------------------------------------------------------------------------
                    \69\ For example, while methadone is not covered by Medicare
                Part D for MAT, methadone dispensed for pain may be considered a
                Part D drug.
                ---------------------------------------------------------------------------
                    Because, by law, methadone used in MAT cannot be dispensed by a
                pharmacy, it is not currently considered a Part D drug when used for
                MAT. Methadone used for this purpose can be dispensed only through an
                OTP certified by SAMHSA. However, methadone dispensed for pain may be
                considered a Part D drug and can be dispensed by a pharmacy.
                Accordingly, we also seek comment on the applicability of Part D
                payment rates for methadone dispensed by a pharmacy to methadone
                dispensed by an OTP for MAT.
                Approach 3: Wholesale Acquisition Cost (WAC)
                    Another approach for estimating the cost of the oral drugs that we
                propose to include as part of the bundled payments but for which ASP
                data are not available would be to use WAC. Section 1847A(c)(6)(B) of
                the Act defines WAC as the manufacturer's list price for the drug to
                wholesalers or direct purchasers in the U.S., not including prompt pay
                or other discounts, rebates, or reductions in price, for the most
                recent month for which the information is available, as reported in
                wholesale price guides or other publications of drug pricing data. As
                noted above in the discussion of Part B drugs, WAC is used as the basis
                for pricing some Part B drugs; for example, it is used when it is less
                than ASP in the case of single source drugs (section 1847A(b)(4) of the
                Act) and in cases where ASP is unavailable during the first quarter of
                sales (section 1847A(c)(4) of the Act).
                    Because WAC is the manufacturer's list price to wholesalers, we
                believe that it is more reflective of the price paid by the end user
                than the AWP. As a result, we believe that this pricing mechanism would
                be consistent with pricing that currently occurs for drugs that are
                separately billable under Part B. However, we have concerns about the
                fact that WAC does not include prompt pay or other discounts, rebates,
                or reductions in price. If we select this option to estimate the cost
                of certain drugs, we would develop pricing using the most recent data
                files available at the drafting of the CY 2020 PFS final rule.
                Approach 4: National Average Drug Acquisition Cost (NADAC)
                    Another approach for estimating the cost of the oral drugs that we
                propose to include as part of the bundled payments but for which ASP
                data are not available would be to use Medicaid's NADAC survey. This
                survey provides another national drug pricing benchmark. CMS conducts
                surveys of retail community pharmacy prices, including drug ingredient
                costs, to develop the NADAC pricing benchmark. The NADAC was designed
                to create a national benchmark that is reflective of the prices paid by
                retail community pharmacies to acquire prescription and over-the-
                counter covered outpatient drugs and is available for consideration by
                states to assist with their individual pharmacy payment policies.
                    State Medicaid agencies reimburse pharmacy providers for prescribed
                covered outpatient drugs dispensed to Medicaid beneficiaries. The
                reimbursement formula consists of two parts: (1) Drug ingredient costs;
                and (2) a professional dispensing fee. In a final rule with comment
                period titled ``Medicaid Program; Covered Outpatient Drugs,'' which
                appeared in the February 1, 2016 Federal Register (81 FR 5169), we
                revised the methodology that state Medicaid programs use to determine
                drug ingredient costs, establishing an Actual Acquisition Cost (AAC)
                based determination, as opposed to a determination based on estimated
                acquisition costs (EAC). AAC is defined
                [[Page 40534]]
                at 42 CFR 447.502 as the agency's determination of the pharmacy
                providers' actual prices paid to acquire drugs marketed or sold by
                specific manufacturers. As explained in the Covered Outpatient Drugs
                final rule with comment period (81 FR 5175), CMS believes shifting from
                an EAC to an AAC based determination of ingredient costs is more
                consistent with the dictates of section 1902(a)(30)(A) of the Act. In
                2010, a working group within the National Association of State Medicaid
                Directors (NASMD) recommended the establishment of a single national
                pricing benchmark based on average drug acquisition costs. Pricing
                metrics based on actual drug purchase prices provide greater accuracy
                and transparency in how drug prices are established and are more
                resistant to manipulation. The NASMD requested that CMS coordinate,
                develop, and support this benchmark.
                    Section 1927(f) of the Act provides, in part, that CMS may contract
                with a vendor to conduct monthly surveys with respect to prices for
                covered outpatient drugs dispensed by retail community pharmacies. We
                entered into a contract with Myers & Stauffer, LLC to perform a monthly
                nationwide retail price survey of retail community pharmacy covered
                outpatient drug prices (CMS-10241, OMB 0938-1041) and to provide states
                with weekly updates on pricing files, that is, the NADAC files. The
                NADAC survey process focuses on drug ingredient costs for retail
                community pharmacies. The survey collects acquisition costs for covered
                outpatient drugs purchased by retail pharmacies, which include invoice
                prices from independent and chain retail community pharmacies. The
                survey data provide information that CMS uses to assure compliance with
                federal requirements. We believe NADAC data could be used to set the
                prices for the oral drugs furnished by OTPs for which ASP data are not
                available. Survey data on invoice prices provide the closest pricing
                metric to ASP that we are aware of. However, similar to the other
                available pricing metrics, we have concerns about the applicability of
                retail pharmacy prices to the acquisition costs available to OTPs since
                we have no evidence to suggest that these entities would be able to
                acquire drugs at a similar price point. If we select this option, we
                would develop pricing using the most recent data files available at the
                drafting of the CY 2020 PFS final rule.
                Alternative Methadone Pricing: TRICARE
                    We are also considering an approach for estimating the cost of
                methadone using the amount calculated by TRICARE. As discussed above in
                this section of this proposed rule, the TRICARE rates for medications
                used in OTPs to treat opioid use disorder are spelled out in the 2016
                TRICARE final rule (81 FR 61068); in the regulations at Sec.
                199.14(a)(2)(ix); and in Chapter 7, Section 5 and Chapter 1, Section 15
                of the TRICARE Reimbursement Manual 6010.61-M, April 1, 2015.
                    In the 2016 TRICARE final rule, DOD established separate payment
                methodologies for OTPs based on the particular medication being
                administered for treatment.\70\ Based on TRICARE's review of industry
                billing practices, the initial weekly bundled rate for administration
                of methadone included a daily drug cost of $3, which is subject to an
                update factor.\71\
                ---------------------------------------------------------------------------
                    \70\ 81 FR 61079.
                    \71\ 81 FR 61079.
                ---------------------------------------------------------------------------
                    This option would only be applicable for methadone because TRICARE
                has developed a fee-for-service payment methodology for buprenorphine
                and naltrexone.\72\ In the 2016 TRICARE final rule, the DOD stated that
                the payments for buprenorphine and naltrexone are more variable in
                dosage and frequency for both the drug and non-drug services.\73\
                Accordingly, TRICARE pays for drugs listed on Medicare's Part B ASP
                files, such as the injectable and implantable versions of buprenorphine
                using the ASP; drugs not appearing on the Medicare ASP file, such as
                oral buprenorphine, are priced at the lesser of billed charges or 95
                percent of the AWP.\74\
                ---------------------------------------------------------------------------
                    \72\ 81 FR 61080.
                    \73\ 81 FR 61080.
                    \74\ https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/C7S5.html; https://manuals.health.mil/pages/DisplayManualHtmlFile/TR15/30/AsOf/TR15/c1s15.html2FM10546.
                ---------------------------------------------------------------------------
                    We believe that pricing methadone consistent with the TRICARE
                payment rate may provide a reasonable payment amount for methadone when
                ASP data are not available. As DOD noted in the 2016 TRICARE final
                rule, ``a number of commenters indicated that they believed the rates
                DOD proposed for OTPs' services are near market rates and are
                acceptable.'' \75\
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                    \75\ 81 FR 61080.
                ---------------------------------------------------------------------------
                    We are proposing to codify this proposal to apply an alternative
                approach for determining the payment rate for oral drugs only if ASP
                data are not available in Sec.  410.67(d)(2). We request public comment
                on the potential alternative approaches set forth above for estimating
                the cost of oral drugs that we propose to include as part of the
                bundled payments but for which ASP data are not available, including
                any other alternate sources of data to estimate the cost of these oral
                MAT drugs. Payment rates based on these different options are set forth
                in Table 14. We will consider the comments received on these different
                potential approaches when deciding on the approach that we will use to
                determine the payment rates for these drugs in the CY 2020 PFS final
                rule. We also invite public comment on any other potential data sources
                for estimating the provider acquisition costs of OTP drugs currently
                paid under either Part B or Part D. As noted previously, we welcome
                comments on how new drugs with a novel mechanism of action should be
                priced, and specifically whether pricing for non-opioid agonist and/or
                antagonist medications should be determined using the same pricing
                methodology, including the alternatives discussed above, as would be
                used for medications included in the proposed definition of OUD
                treatment services.
                    TABLE 14--Estimated * Initial Drug Payment Rates for Each Pricing
                                                Approach
                ------------------------------------------------------------------------
                                                                      Estimated initial
                    Pricing approach (or        Estimated initial    weekly drug payment
                        alternative)           weekly drug payment        for oral
                                                  for methadone         buprenorphine
                ------------------------------------------------------------------------
                Proposal: ASP-Based Payment.  ASPs currently not    ASPs currently not
                                               reported.             reported.
                Approach 1: The Methodology   $29.61..............  $117.68.
                 in Section 1847A of the Act.
                Approach 2: Medicare's Part   22.47...............  97.65.
                 D Prescription Drug Plan
                 Finder Data.
                Approach 3: WAC.............  27.93...............  111.02.
                Approach 4: NADAC...........  11.76...............  97.02.
                [[Page 40535]]
                
                Alternative Methadone         22.19...............  N/A.
                 Pricing: TRICARE.
                ------------------------------------------------------------------------
                * The estimated payment amounts in this table are based on data files
                  posted at the time of the drafting of this proposed rule. We would
                  develop the final pricing for CY 2020 using the most recent data files
                  available at the drafting of the CY 2020 PFS final rule.
                (b) Non-Drug Component
                    To price the non-drug component of the bundled payments, we are
                proposing to use a crosswalk to the non-drug component of the TRICARE
                weekly bundled rate for services furnished when a patient is prescribed
                methadone. As described above, in 2016, TRICARE finalized a weekly
                bundled rate for administration of methadone that included a daily drug
                cost of $3, along with a $15 per day cost for non-drug services (that
                is, the costs related to the intake/assessment, drug dispensing and
                screening and integrated psychosocial and medical treatment and
                supportive services). The daily projected per diem cost ($18/day) was
                converted to a weekly rate of $126 ($18/day x 7 days) (81 FR 61079).
                TRICARE updates the weekly bundled methadone rate for OTPs annually
                using the Medicare update factor used for other mental health care
                services rendered (that is, the Inpatient Prospective Payment System
                update factor) under TRICARE (81 FR 61079). The updated amount for CY
                2019 to $133.15 (of which $22.19 is the methadone cost and the
                remainder, $110.96, is for the non-drug services).\76\ We believe using
                the TRICARE weekly bundled rate is a reasonable approach to setting the
                payment rate for the non-drug component of the bundled payments to
                OTPs, particularly given the time constraints in developing a payment
                methodology prior to the January 1, 2020 effective date of this new
                Medicare benefit category. The TRICARE rate is an established national
                payment rate that was established through notice and comment
                rulemaking. As a result, OTPs and other interested parties had an
                opportunity to present information regarding the costs of these
                services. Furthermore the TRICARE rate describes a generally similar
                bundle of services to those services that are included in the
                definition of OUD treatment services in section 1861(jjj)(1) of the
                Act. We recognize that there are differences in the patient population
                for TRICARE compared with the Medicare beneficiary population. However,
                as OTP services have not previously been covered by Medicare, it is not
                clear what impact, if any, these differences would have on the cost of
                the services included in the non-drug component of the proposed bundled
                payments. We are proposing to codify the methodology for determining
                the payment rate for the non-drug component of the bundled payments
                using the TRICARE weekly rate for non-drug services at Sec.
                410.67(d)(2). As part of this proposal, we would plan to monitor
                utilization of non-drug services by Medicare beneficiaries and, if
                needed, would consider in future rulemaking ways we could tailor the
                TRICARE payment rate for these non-drug services to the Medicare
                population, including dually eligible beneficiaries.
                ---------------------------------------------------------------------------
                    \76\ https://health.mil/Military-Health-Topics/Business-Support/Rates-and-Reimbursement/MHSUD-Facility-Rates.
                ---------------------------------------------------------------------------
                    Because the TRICARE payment rate for the non-drug services included
                in its weekly bundled rate for methadone includes daily administration
                of methadone, as part of our proposed approach we would adjust the
                TRICARE payment rate for non-drug services for most of the other
                bundled payments to more accurately reflect the cost of administering
                the other drugs used in MAT. For the oral buprenorphine bundled
                payment, we propose to retain the same amount as the rate for the
                methadone bundled payment based on an assumption that this drug is also
                being dispensed daily. We understand that patients who have stabilized
                may be given 7-14 day supplies of oral buprenorphine at a time, but for
                the purposes of developing the proposed rates, we valued this service
                to include daily drug dispensing to account for cases where daily drug
                dispensing is occurring. For the injectable drugs (buprenorphine and
                naltrexone), we propose to subtract from the non-drug component, an
                amount that is comparable to the dispensing fees paid by several state
                Medicaid programs ($10.50) for a week of daily dispensing of methadone.
                This adjustment accounts for the fact that these injectable drugs are
                not oral drugs that are dispensed daily; we would then instead add the
                fee that Medicare pays for the administration of an injection (which is
                currently $16.94 under the CY 2019 non-facility Medicare payment rate
                for CPT code 96372). We propose to update the amount of this adjustment
                annually using the same methodology that we are proposing to use to
                update the non-drug component of the bundled payments.
                    Similarly, the payment rates for the non-drug component of the
                codes for the weekly bundled payments for buprenorphine implants would
                be adjusted to add an amount for insertion and/or removal based on a
                direct crosswalk to the non-facility payment rates under the Medicare
                PFS for the insertion, removal, or insertion and removal of these
                implants, which describe the physician work, practice expense (PE), and
                malpractice costs associated with these procedures, and to remove the
                costs of daily drug dispensing (determined based on the dispensing fees
                paid by several state Medicaid programs for a week of daily dispensing
                of methadone, currently $10.50). For HCPCS code GXXX5, we would use a
                crosswalk to the rate for HCPCS code G0516 (Insertion of non-
                biodegradable drug delivery implants, 4 or more (services for subdermal
                rod implant)); for HCPCS code GXXX6, we would use a crosswalk to the
                rate for HCPCS code G0517 (Removal of non-biodegradable drug delivery
                implants, 4 or more (services for subdermal implants)); and for HCPCS
                code GXXX7, we would use a crosswalk to the rate for HCPCS code G0518
                (Removal with reinsertion, non-biodegradable drug delivery implants, 4
                or more (services for subdermal implants)). The amounts for HCPCS codes
                G0516, G0517 and G0518 under the CY 2019 non-facility Medicare payment
                rate are $111.00, $126.86, and $204.70, respectively.
                    In order to determine the payment rates for the code describing a
                non-drug bundled payment, HCPCS code GXXX8, we propose to use a
                crosswalk to the reimbursement rate for the non-drug services included
                in the TRICARE weekly bundled rate for administration of methadone,
                adjusted to subtract the cost of methadone dispensing (using an amount
                that is comparable to the dispensing fees paid by several state
                Medicaid programs for a week of daily dispensing of methadone, which is
                currently $10.50).
                    We propose that the payment rate for the add-on code, HCPCS code
                GXX19, would be based on 30 minutes of
                [[Page 40536]]
                substance use counseling and valued based on a crosswalk to the rates
                set by state Medicaid programs for similar services.
                i. Medication Not Otherwise Specified
                    We would expect the non-drug component for medication not otherwise
                specified bundled payments (HCPCS code GXXX9) to be consistent with the
                pricing methodology for the other bundled payments and therefore, be
                based on a crosswalk to the TRICARE rate, adjusted for any applicable
                administration and dispensing fees. For example, for oral medications,
                we would use the rate for the non-drug services included in the TRICARE
                methadone bundle, based on an assumption that the drug is also being
                dispensed daily. For the injectable medications, we would adjust the
                TRICARE payment rate for non-drug services using the same methodology
                we are proposing for injectable medications above (to subtract an
                amount for daily dispensing and add the non-facility Medicare payment
                rate for administration of the injection). For implantable medications,
                we would also use the same methodology we propose above, with the same
                crosswalked non-facility Medicare payment rates (for insertion,
                removal, and insertion and removal). We welcome comments on all of the
                proposed pricing methodologies described in this section. As noted
                above, we also welcome comments on how new drugs with a novel mechanism
                of action (that is, drugs that are not opioid agonists and/or
                antagonists) should be priced. We additionally welcome comments on how
                the price of the non-drug component of such bundled payments should be
                determined, in particular the dispensing and/or administration fees,
                including whether the methodology we propose above for determining the
                payment rate for the non-drug component of an episodes of are that
                includes a new opioid agonist and antagonist medication (which is based
                on whether the drug is oral, injectable, or implantable) would be
                appropriate to use for these new drugs.
                (c) Partial Episode of Care
                    For HCPCS codes GXX10 and GXX11 (codes describing partial episodes
                for methadone and oral buprenorphine), we propose that the payment
                rates for the non-drug component would be calculated by taking one half
                of the payment rate for the non-drug component for the corresponding
                weekly bundles. We chose one half as the best approximation of the
                median cost of the services furnished during a partial episode
                consistent with our proposal above to make a partial episode bundled
                payment when the majority of services described in a beneficiary's
                treatment plan are not furnished during a specific episode of care.
                However, we welcome comment on other methods that could be used to
                calculate these payment rates. We propose that the payment rates for
                the drug component of these partial episode bundles would be calculated
                by taking one half of the payment rate for the drug component of the
                corresponding weekly bundles.
                    For HCPCS codes GXX12 and GXX16 (codes describing partial episodes
                for injectable buprenorphine and naltrexone), we propose that the
                payment rates for the drug component would be the same as the payment
                rate for the drug component of the full weekly bundle so that the OTP
                would be reimbursed for the cost of the drug that is given at the start
                of the episode. For the non-drug component, we propose that the payment
                rate would be calculated as follows: The TRICARE non-drug component
                payment rate ($110.96), adjusted to remove the cost of daily
                administration of an oral drug ($10.50), then divided by two; that
                amount would be added to the fee that Medicare pays for the
                administration of an injection (which is currently $16.94 under the CY
                2019 non-facility Medicare payment rate for CPT code 96372).
                    For HCPCS codes GXX13, GXX14, GXX15 (codes describing partial
                episodes for the buprenorphine implant insertion, removal, and
                insertion and removal, respectively) we propose that the payment rates
                for drug component would be the same as the payment rate for the
                corresponding weekly bundle. For the non-drug component, we propose
                that the payment rate would be calculated as follows: The TRICARE non-
                drug component payment rate ($110.96), adjusted to remove the cost of
                daily administration of an oral drug ($10.50), then divided by two;
                that amount would be added to the Medicare non-facility payment rate
                for the insertion, removal, or insertion and removal of the implants,
                respectively (based on the non-facility rates for HCPCS codes G0516,
                G0517, and G0518, which are currently $111.00, $126.86, and $204.70,
                respectively).
                    For HCPCS code GXX17 (code describing a non-drug partial episode of
                care), we propose that the payment rate would be calculated by taking
                one half of the payment rate for the corresponding weekly bundle.
                    We propose that the payment rate for the code describing partial
                episodes for a medication not otherwise specified (HCPCS code GXX18)
                would be calculated based on whether the medication is oral, injectable
                or implantable, following the methodology described above. For oral
                drugs, we would follow the methodology described for HCPCS codes GXX10
                and GXX11. For injectable drugs, we would follow the methodology
                described for HCPCS codes GXX12 and GXX16. For implantable drugs, we
                would follow the methodology described for HCPCS codes GXX13, GXX14,
                and GXX15. We welcome comments on how partial episodes of care using
                new drugs with a novel mechanism of action (that is, non-opioid agonist
                and/or antagonist treatment medications) should be priced. For example,
                we could use the same approach described previously for pricing new
                opioid agonist and antagonist medications not otherwise specified,
                which is to follow the methodology based on whether the drug is oral,
                injectable or implantable.
                BILLING CODE 4120-01-P
                [[Page 40537]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.007
                [[Page 40538]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.008
                [[Page 40539]]
                [GRAPHIC] [TIFF OMITTED] TP14AU19.009
                BILLING CODE 4120-01-C
                (8) Place of Service (POS) Code for Services Furnished at OTPs
                    We are creating a new POS code specific to OTPs since there are no
                existing POS codes that specifically describe OTPs. Claims for OTP
                services would include this place of service code. We note that POS
                codes are available for use by all payers. We are not proposing to make
                any differential payment based on the use of this new POS code. Further
                guidance will be issued regarding the POS code that should be used by
                OTPs.
                c. Duplicative Payments Under Parts B or D
                    Section 1834(w)(1) of the Act, added by section 2005(c) of the
                SUPPORT Act, requires the Secretary to ensure, as determined
                appropriate by the Secretary, that no duplicative payments are made
                under Part B or Part D for items and services furnished by an OTP. We
                note that many of the individual items or services provided by OTPs
                that would be included in the bundled payment rates under our proposal
                may also be appropriately available to beneficiaries through other
                Medicare benefits. Although we recognize the potential for significant
                program integrity concerns when similar items or services are payable
                under separate Medicare benefits, we also believe that it is important
                that any efforts to prevent duplicative payments not inadvertently
                restrict Medicare beneficiaries' access to other Medicare benefits even
                for the time period they are being treated by an OTP. For example, we
                believe that a beneficiary receiving counseling or therapy as part of
                an OTP bundle of services may also be receiving medically reasonable
                and necessary counseling or therapy as part of a physician's service
                during the same time period. Similarly, we believe there could be
                circumstances where Medicare beneficiaries with OUD could receive
                treatment and/or medication from non-OTP entities that would not result
                in duplicative payments, presuming that both the OTP and the other
                entity appropriately furnished separate medically necessary services or
                items. Consequently, we do not believe that provision of the same kinds
                of services by both an OTP and a separate provider or supplier would
                itself constitute a duplicative payment.
                    We believe that duplicative payments would result from the
                submission of claims to Medicare leading to payment for drugs furnished
                to a Medicare beneficiary and the associated dispensing fees on a
                certain date of service to both an OTP and another provider or supplier
                under a different benefit. In these circumstances, we would consider
                only one of the claims to be paid for appropriately. Accordingly, for
                purposes of implementing section 1834(w)(1) of the Act, we propose to
                consider payment for medications delivered, administered or dispensed
                to the beneficiary as part of the OTP bundled payment to be a
                duplicative payment if delivery, administration or dispensing of the
                same medications was also separately paid under Medicare Parts B or D.
                We propose to codify this policy at Sec.  410.67(d)(4). We understand
                that some OTPs negotiate arrangements whereby community pharmacies
                supply MAT-related medications to OTPs. If the OTP provides medically
                necessary MAT-related medications as part of an episode of care, we
                would expect the OTP to take measures to ensure that there is no claim
                for payment for these drugs other than as part of the OTP bundled
                payment. (For example, the MAT drugs billed by an OTP as part of a
                bundled payment should not be reported to or paid under a Part D plan.)
                We expect that OTPs will take reasonable steps to ensure that the items
                and services furnished under their care are not reported or billed
                under a different Medicare benefit. CMS intends to monitor for
                duplicative payments, and would take appropriate action as needed when
                such duplicative payments are identified. Therefore, we are proposing
                that in cases where a payment for drugs used as part of an OTP's
                treatment plan is identified as being a duplicative payment because the
                same costs were paid under a different Medicare benefit, CMS will
                generally recoup the duplicative payment made to the OTP as the OTP
                would be in the best position to know whether or not the drug that is
                included as part of the beneficiary's treatment plan is furnished by
                the OTP or by another provider or supplier given that the OTP is
                responsible for managing the beneficiary's overall OUD treatment. We
                propose to codify this policy at Sec.  410.67(d)(4). CMS notes that
                this general approach would not preclude CMS or other auditors from
                conducting appropriate oversight of duplicative payments made to the
                other provider or suppliers, particularly in cases of fraud and/or
                abuse.
                [[Page 40540]]
                d. Cost Sharing
                    Section 2005(c) of the SUPPORT Act amends section 1833(a)(1) of the
                Act, relating to payment of Part B services, by adding a new
                subparagraph (CC), which specifies with respect to OUD treatment
                services furnished by an OTP during an episode of care that the amount
                paid shall be equal to the amount payable under section 1834(w) of the
                Act less any copayment required as specified by the Secretary. Section
                1834(w) of the Act, which was also added by section 2005(c) of the
                SUPPORT Act, requires that the Secretary pay an amount that is equal to
                100 percent of a bundled payment under this part for OUD treatment
                services. Given these two provisions, we believe that there is
                flexibility for CMS to set the copayment amount for OTP services either
                at zero or at an amount above zero. Therefore, we are proposing to set
                the copayment at zero for a time-limited duration (for example, for the
                duration of the national opioid crisis), as we believe this would
                minimize barriers to patient access to OUD treatment services. Setting
                the copayment at zero also ensures OTP providers receive the full
                Medicare payment amount for Medicare beneficiaries if secondary payers
                are not available or do not pay the copayment, especially for those
                dually eligible for Medicare and Medicaid.\77\ We intend to continue to
                monitor the opioid crisis in order to determine at what point in the
                future a copayment may be imposed. At such a time we deem appropriate,
                we would institute cost sharing through future notice and comment
                rulemaking. We welcome feedback from the public on our proposal to set
                the copayment at zero for a time-limited duration, such as for the
                duration of the national opioid crisis, and any other metrics CMS might
                consider using to determine when to start requiring a copayment. In
                developing our proposed approach, we also considered other
                alternatives, such as setting the copayment at a fixed fee calculated
                based on 20 percent of the payment rate for the bundle, consistent with
                the standard copayment requirement for other Part B services, or
                applying a flat dollar copayment amount similar to TRICARE's copayment;
                however, we recognize that setting the copayment for OUD services at a
                non-zero amount could create a barrier to access to treatment for many
                beneficiaries. We propose to codify the proposed copayment amount of
                zero at Sec.  410.67(e). We welcome feedback on our proposal to set the
                copayment amount for OTP services at zero, and on the alternatives
                considered, including whether we should consider any of these
                alternatives for CY 2020 or future years.
                ---------------------------------------------------------------------------
                    \77\ For those dually eligible individuals in the Qualified
                Medicare Beneficiary program (7.7 million of the 12 million dually
                eligible individuals in 2017), state Medicaid programs cover the
                Medicare Part A and B deductible and coinsurance. However, section
                4714 of the Balanced Budget Act of 1997 (Pub. L. 105-33) provides
                discretion for states to pay Medicare cost-sharing only if the
                Medicaid payment rate for the service is above the Medicare paid
                amount for the service. Since most states opt for this discretion,
                and most Medicaid rates are lower than Medicare's, states often do
                not pay the provider for the Medicare cost-sharing amount. Providers
                are further prohibited from collecting the Medicare cost-sharing
                amount from the beneficiary, effectively having to take a discount
                compared to the amount received for other Medicare beneficiaries.
                ---------------------------------------------------------------------------
                    Separately, we note that the Part B deductible would apply for OUD
                treatment services, as mandated for all Part B services by section
                1833(b) of the Act.
                4. Adjustments to Bundled Payment Rates for OUD Treatment Services
                    The costs of providing OUD treatment services will likely vary over
                time and depending on the geographic location where the services are
                furnished. Below we discuss our proposed adjustments to the bundled
                payment rates to account for these factors.
                a. Locality Adjustment
                    Section 1834(w)(2) of the Act, as added by section 2005(c) of the
                SUPPORT Act provides that the Secretary may implement the bundled
                payment for OUD treatment services furnished by OTPs through one or
                more bundles based on the type of medications, the frequency of
                services, the scope of services furnished, characteristics of the
                individuals furnished such services, or other factors as the Secretary
                determines appropriate. The cost for the provision of OTP treatment
                services, like many other healthcare services covered by Medicare, will
                likely vary across the country based upon the differing cost in a given
                geographic locality. To account for such geographic cost differences in
                the provision of services, in a number of payment systems, Medicare
                routinely applies geographic locality adjustments to the payment rates
                for particular services. As we believe OTP treatment services will also
                be subject to varying cost based upon the geographic locality where the
                services are furnished, we propose to apply a geographic locality
                adjustment to the bundled payment rate for OTP treatment services.
                Below, we discuss our proposed approach with respect to the drug
                component (which reflects payment for the drug) and the non-drug
                component (which reflects payment for all other services furnished to
                the beneficiary by the OTP, such as drug administration, counseling,
                toxicology testing, etc.) of the bundled payment.
                (1) Drug Component
                    Because our proposed approaches for pricing the MAT drugs included
                in the bundles all reflect national pricing, and because there is no
                geographic adjustment factor applied to the payment of Part B drugs
                under the ASP methodology, we do not believe that it is necessary to
                adjust the drug component of the bundled payment rates for OTP services
                based upon geographic locality. Therefore, we are proposing not to
                apply a geographic locality adjustment to the drug component of the
                bundled payment rate for OTP services.
                (2) Non-Drug Component
                    Unlike the national pricing of drugs, the costs for the services
                included in the non-drug component of the OTP bundled payment for OUD
                treatments are not constant across all geographic localities. For
                example, OTPs' costs for rent or employee wages could vary
                significantly across different localities and could potentially result
                in disparate costs for the services included in the non-drug component
                of OUD treatment services. Because the costs of furnishing the services
                included in the non-drug component of the OTP bundled payment for OUD
                treatment services will vary based upon the geographic locality in
                which the services are provided, we believe it would be appropriate to
                apply a geographic locality adjustment to the non-drug component of the
                bundled payments. We believe that the geographic variation in cost of
                the non-drug services provided by OTPs will be similar to the
                geographic variation in the cost of services furnished in physician
                offices. Therefore, to account for the differential costs of OUD
                treatment services across the country, we are proposing to adjust the
                non-drug component of the bundled payment rates for OUD treatment
                services using an approach similar to the established methodology used
                to geographically adjust payments under the PFS based upon the location
                where the service is furnished. The PFS currently provides for an
                adjustment to the payment for PFS services based upon the fee schedule
                area in which the service is provided through the use of Geographic
                Practice Cost Indices (GPCIs), which measure the relative cost
                differences among localities compared to the national average for each
                of the
                [[Page 40541]]
                three fee schedule components (work, PE, and malpractice).
                    Although we are proposing to adjust the non-drug component of the
                OUD treatment services using an approach similar to the established
                methodology used to adjust PFS payment for geographic locality, because
                GPCIs provide for the application of geographic locality adjustments to
                the three distinct components of PFS services, and the OTP bundled
                payment is a flat rate payment for all OUD treatment services furnished
                during an episode of care, a single factor would be required to apply
                the geographic locality adjustment to the non-drug component of the OTP
                bundled payment rate. Therefore, to apply a geographic locality
                adjustment to the non-drug component of the OTP bundled payment for OUD
                treatment services through a single factor, we are proposing to use the
                Geographic Adjustment Factor (GAF) at Sec.  414.26. Specifically, we
                are proposing to use the GAF to adjust the payment for the non-drug
                component of the OTP bundled payment to reflect the costs of furnishing
                the non-drug component of OUD treatment services in each of the PFS fee
                schedule areas. The GAF is calculated using the GPCIs under the PFS,
                and is used to account for cost differences in furnishing physicians'
                services in differing geographic localities. The GAF is calculated for
                each fee schedule area as the weighted composite of all three GPCIs
                (work, PE, and malpractice) for that given locality using the national
                GPCI cost share weights. In developing this proposal, we also
                considered geographically adjusting the payment for the non-drug
                component of the OTP bundled payment using only the PE GPCI value for
                each fee schedule area. However, because the the non-drug component of
                OUD treatment services is comprised of work, PE, and malpractice
                expenses, we ultimately decided to propose using the GAF as we believe
                the weighted composite of all three GPCIs reflected in the GAF would be
                the more appropriate geographic adjustment factor to reflect geographic
                variations in the cost of furnishing these services.
                    The GAF, which is determined under Sec.  414.26, is further
                discussed earlier in section II.D.1. of this proposed rule and the
                specific GAF values for each payment locality are posted in Addendum D
                to this proposed rule. In developing the proposed geographic locality
                adjustment for the non-drug component of the OUD treatment services
                payment rate, we also considered other potential locality adjustments,
                such as the Inpatient Prospective Payment System (IPPS) hospital wage
                index. However, we have opted to propose using the GAF as we believe
                the services provided in an OTP more closely resemble the services
                provided at a physician office than the services provided in other
                settings, such as inpatient hospitals. We propose to codify using the
                GAF to adjust the non-drug component of the OTP bundled payments to
                reflect the cost differences in furnishing these services in differing
                geographic localities at Sec.  410.67(d)(3)(ii). We invite public
                comment on our proposal to adjust the non-drug component of the OTP
                bundled payments for geographic variations in the costs of furnishing
                OUD treatment services using the GAF. We also welcome comments on any
                factors, other than the GAF, that could be used to make this payment
                adjustment.
                    Additionally, we note that the majority of OTPs operate in urban
                localities. In light of this fact, we are interested in receiving
                information on whether rural areas have appropriate access to treatment
                for OUD. We are particularly interested in any potential limitations on
                access to care for OUD in rural areas and whether there are additional
                adjustments to the proposed bundled payments that should be made to
                account for the costs incurred by OTPs in furnishing OUD treatment
                services in rural areas. We invite public comment on this issue and
                potential solutions we could consider adopting to address this
                potential issue through future rulemaking.
                b. Annual Update
                    Section 1834(w)(3) of the Act, as added by section 2005(c) of the
                SUPPORT Act, requires that the Secretary provide an update each year to
                the OTP bundled payment rates. To fulfill this statutory requirement,
                we are proposing to apply a blended annual update, comprised of
                distinct updates for the drug and non-drug components of the bundled
                payment rates, to account for the differing rate of growth in the
                prices of drugs relative to other services. We propose that this
                blended annual update for the OTP bundled payment rates would first
                apply for determining the CY 2021 OTP bundled payment rates. The
                specific details of the proposed updates for the drug and non-drug
                components respectively are discussed in this section.
                (1) Drug Component
                    As stated above, we are proposing to establish the pricing of the
                drug component of the OTP bundled payment rates for OUD treatment
                services based on CMS pricing mechanisms currently in place. To
                recognize the potential change in costs of the drugs used in MAT from
                year to year and to fulfill the requirement to provide an annual update
                to the OTP bundled payment rates, we are proposing to update the
                payment for the drug component based upon the changes in drug costs
                reported under the pricing mechanism used to establish the pricing of
                the drug component of the applicable bundled payment rate, as discussed
                earlier. As an example, if we were to finalize our proposal to price
                the drug component of the bundled payment rate for episodes of care
                that include injectable and implantable drugs generally covered and
                paid under Medicare Part B using ASP data, the pricing of the drug
                component for these OTP bundled payments, would be updated using the
                most recently available ASP data at the time of ratesetting for the
                applicable calendar year. Similarly, if we finalize our proposal to
                price the drug component of the bundled payment rate for episodes of
                care that include oral drugs using ASP data, if such data are
                available, we would also update the pricing of the drug component using
                the most recently available ASP data at the time of ratesetting for the
                applicable calendar year. Previously, we also discussed a number of
                alternative data sources that could be used to price oral drugs in the
                drug component of OTP bundled payments in cases when we do not receive
                manufacturer-submitted ASP pricing data. As an example, if we were to
                use NADAC data as discussed as one of the alternatives, to determine
                the payment for the drug component of the bundled payment for oral
                drugs in cases when we do not have manufacturer-submitted ASP pricing
                data, this payment rate would also be updated using the most recently
                available NADAC data at the time of ratesetting for the applicable
                calendar year. We propose to codify this methodology for determining
                the annual update to the payment rate for the drug component at Sec.
                410.67(d)(3)(i).
                    In developing the proposal to annually update the pricing of the
                drug component of the OUD treatment services payment rate, we also
                considered other methodologies, including applying a single uniform
                update factor to the drug and non-drug components of the proposed
                payment rates. We ultimately determined not to propose the use of a
                single uniform update factor, because we believe that it is important
                to apply an annual update to the payment rates that recognizes the
                differing rate of growth of drug costs
                [[Page 40542]]
                compared to the rate of growth in the cost of the other services. In
                addition, we also considered annually updating the pricing of the drug
                component of the OUD treatment services payment rate via an established
                update factor such as the Producer Price Index (PPI) for chemicals and
                allied products, analgesics (WPU06380202). The PPI for chemicals and
                allied products, analgesics is a subset of the PPI produced by the
                Bureau of Labor Statistics, which measures the average change over time
                in the selling prices received by domestic producers for their output.
                Ultimately we decided against updating the pricing of the drug
                component of the OUD treatment services payment rate via an established
                update factor such as the PPI in favor of our proposed approach because
                we believe the proposed approach updated the pricing of the drug
                component of the OUD treatment services payment rate in the manner most
                familiar to stakeholders. We invite public comment on our proposed
                approach to updating the drug component of the bundled payment rates.
                We also seek comment on possible alternate methodologies for updating
                the drug component of the payment rate for OUD treatment services, such
                as use of the PPI for chemicals and allied products, analgesics.
                (2) Non-Drug Component
                    To account for the potential changing costs of the services
                included in the non-drug component of the bundled payment rates for OUD
                treatment services, we are proposing to update the non-drug component
                of the bundled payment for OUD treatment services based upon the
                Medicare Economic Index (MEI). The MEI is defined in section 1842(i)(3)
                of the Act and the methodology for computing the MEI is described in
                Sec.  405.504(d). The MEI is used to update the payment rates for
                physician services under section 1842(b)(3) of the Act, which states
                that prevailing charge levels beginning after June 30, 1973, may not
                exceed the level from the previous year except to the extent that the
                Secretary finds, on the basis of appropriate economic index data, that
                such a higher level is justified by year-to-year economic changes. The
                MEI is a fixed-weight input price index that reflects the physicians'
                own time and the physicians' practice expenses, with an adjustment for
                the change in economy-wide, private nonfarm business multifactor
                productivity. The MEI was last revised in the CY 2014 PFS final rule
                with comment period (78 FR 74264). In developing the proposed update
                factor for the non-drug component of the OUD treatment services payment
                rate, we considered other potential update factors, such as the Bureau
                of Labor Statistics Consumer Price Index for All Items for Urban
                Consumers (Bureau of Labor Statistics #CUUR0000SA0 (https://www.bls.gov/cpi/data.htm) and the IPPS hospital market basket reduced
                by the multifactor productivity adjustment. The Consumer Price Index
                for All Items (CPI-U) is a measure of the average change over time in
                the prices paid by urban consumers for a market basket of consumer
                goods and services. However, we concluded that a healthcare-specific
                update factor, such as the MEI, would be more appropriate for OTPs than
                the CPI-U, which measures general inflation, as the MEI would more
                accurately reflect the change in the prices of goods and services
                included in the non-drug component of the OTP bundled payments.
                    Similarly, we believe the MEI would be more appropriate than the
                IPPS market basket to update the non-drug component of the bundled
                payment rates as the services provided by an OTP more closely resemble
                the services provided at a physician office than the services provided
                by an inpatient hospital. Accordingly, we propose to update the payment
                amount for the non-drug component of each of the bundled payment rates
                for OUD treatment services furnished by OTPs based upon the most
                recently available historical annual growth in the MEI available at the
                time of rulemaking. We propose to codify this proposal at Sec.
                410.67(d)(3)(iii). We invite public comment on this proposal.
                H. Bundled Payments Under the PFS for Substance Use Disorders
                1. Background and Proposal
                    In the CY 2019 PFS proposed rule (83 FR 35730), we solicited
                comment on creating a bundled episode of care payment for management
                and counseling treatment for substance use disorders. We received
                approximately 50 comments on this topic, most of which were supportive
                of creating a separate bundled payment for these services. Some
                commenters recommended focusing the bundle on services related to
                medication assisted treatment (MAT) used in treatment for opioid use
                disorder (OUD). Several commenters also recommended that we establish
                higher payment amounts for patients with more complex needs who require
                more intensive services and management, and also expressed concern that
                an episode of care that limited the duration of treatment would not be
                conducive to treating OUD, given the chronic nature of this disorder.
                Other commenters recommended that we establish separate bundled
                payments for treatment of substance use disorders that does, and does
                not, involve MAT.
                    In response to the public comments, we are proposing to establish
                bundled payments for the overall treatment of OUD, including
                management, care coordination, psychotherapy, and counseling
                activities. We note that, if a patient's treatment involves MAT, this
                proposed bundled payment would not include payment for the medication
                itself. Billing and payment for medications under Medicare Part B or
                Part D would remain unchanged. Additionally, payment for medically
                necessary toxicology testing would not be included in the proposed OUD
                bundle, and would continue to be billed separately under the Clinical
                Lab Fee Schedule. We are also proposing in this proposed rule to
                implement the new Medicare Part B benefit added by section 2005 of the
                SUPPORT Act for coverage of certain services furnished by Opioid
                Treatment Programs (OTPs) beginning in CY 2020. We believe the proposed
                bundled payment under the PFS for OUD treatment described below will
                create an avenue for physicians and other health professionals to bill
                for a bundle of services that is similar to the new bundled OUD
                treatment services benefit, but not furnished by an OTP. By creating a
                separate bundled payment for these services under the PFS, we hope to
                incentivize increased provision of counseling and care coordination for
                patients with OUD in the office setting, thereby expanding access to
                OUD care.
                    To implement this new bundled payment, we are proposing to create
                two HCPCS G-codes to describe monthly bundles of services that include
                overall management, care coordination, individual and group
                psychotherapy and counseling for office-based OUD treatment. Although
                we considered proposing weekly-reported codes to describe a bundle of
                services that would align with the proposed OTP bundle, we believe that
                monthly-reported codes will better align with the practice and billing
                of other types of care management services furnished in office settings
                and billed under the PFS (for example, behavioral health integration
                (BHI) services). We believe monthly-reported codes would be less
                administratively burdensome for practitioners, and more likely to be
                consistent with care management and prescribing patterns in the office
                setting (as compared with an OTP) given the increased use of long-
                acting MAT drugs (such as injectable naltrexone or
                [[Page 40543]]
                implanted buprenorphine) in the office setting compared to the OTP
                setting. Based on feedback we received through the comment
                solicitation, we are proposing to create a code to describe the initial
                month of treatment, which would include intake activities and
                development of a treatment plan, as well as assessments to aid in
                development of the treatment plan in addition to care coordination,
                individual therapy, group therapy, and counseling; a code to describe
                subsequent months of treatment including care coordination, individual
                therapy, group therapy, and counseling; and an add-on code that could
                be billed in circumstances when effective treatment requires additional
                resources for a particular patient that substantially exceed the
                resources included in the base codes. In other words, the add-on code
                would address extraordinary circumstances that are not contemplated by
                the bundled code. We acknowledge that the course of treatment for OUD
                is variable, and in some instances, the first several months of
                treatment may be more resource intensive. We welcome comments on
                whether we should consider creating a separately billable code or codes
                to describe additional resources involved in furnishing OUD treatment-
                related services after the first month, for example, when substantial
                revisions to the treatment plan are needed, and what resource inputs we
                might consider in setting values for such codes.
                    We believe that, in general, bundled payments create incentives to
                provide efficient care by mitigating incentives tied to volume of
                services furnished, and that these incentives can be undermined by
                creating separate billing mechanisms to account for higher resource
                costs for particular patients. However, we share some of the concerns
                raised by commenters that an OUD bundle should not inadvertently limit
                the appropriate amount of OUD care furnished to patients with varying
                medical needs. In consideration of this concern, we are proposing to
                create an add-on code to make appropriate payment for additional
                resource costs in order to mitigate the risks that the bundled OUD
                payment might limit clinically-indicated patient care for patients that
                require significantly more care than is in the range of what is typical
                for the kinds of care described by the base codes. However, we are also
                interested in comments regarding ways we might better stratify the
                coding for OUD treatment to reflect the varying needs of patients
                (based on complexity or frequency of services, for example) while
                maintaining the full advantage of the bundled payment, including
                increased efficiency and flexibility in furnishing care.
                    We anticipate that these services would often be billed by
                addiction specialty practitioners, but note that these codes are not
                limited to any particular physician or non-physician practitioner
                specialty. Additionally, unlike the codes that describe care furnished
                using the psychiatric collaborative care model (CPT codes 99492, 99493,
                and 99494), which require consultation with a psychiatric consultant,
                we are not proposing to require consultation with a specialist as a
                condition of payment for these codes.
                    The codes and descriptors for the proposed services are:
                     HCPCS code GYYY1: Office-based treatment for opioid use
                disorder, including development of the treatment plan, care
                coordination, individual therapy and group therapy and counseling; at
                least 70 minutes in the first calendar month.
                     HCPCS code GYYY2: Office-based treatment for opioid use
                disorder, including care coordination, individual therapy and group
                therapy and counseling; at least 60 minutes in a subsequent calendar
                month.
                     HCPCS code GYYY3: Office-based treatment for opioid use
                disorder, including care coordination, individual therapy and group
                therapy and counseling; each additional 30 minutes beyond the first 120
                minutes (List separately in addition to code for primary procedure).
                    For the purposes of valuation for HCPCS codes GYYY1 and GYYY2, we
                are assuming two individual psychotherapy sessions per month and four
                group psychotherapy sessions per month; however, we understand that the
                number of therapy and counseling sessions furnished per month will vary
                among patients and also fluctuate over time based on the individual
                patient's needs. Consistent with the methodology for pricing other
                services under the PFS, HCPCS codes GYYY1, GYYY2, and GYYY3 are valued
                based on what we believe to be a typical case, and we understand that
                based on variability in patient needs, some patients will require more
                resources, and some fewer. In order to maintain the advantages inherent
                in developing a payment bundle, we are proposing that the add-on code
                (HCPCS code GYYY3) can only be billed when the total time spent by the
                billing professional and the clinical staff furnishing the OUD
                treatment services described by the base code exceeds double the
                minimum amount of service time required to bill the base code for the
                month. We believe it is appropriate to limit billing of the add-on code
                to situations where medically necessary OUD treatment services for a
                particular patient exceed twice the minimum service time for the base
                code because, as noted above, the add-on code is intended to address
                extraordinary situations where effective treatment requires additional
                resources that substantially exceed the resources included in the base
                codes. For example, the needs of a particular patient in a month may be
                unusually acute, well beyond the needs of the typical patient; or there
                may be some months when psychosocial stressors arise that were
                unforeseen at the time the treatment plan was developed, but warrant
                additional or more intensive therapy services for the patient. We are
                proposing that when the time requirement is met, HCPCS code GYYY3 could
                be billed as an add-on code during the initial month or subsequent
                months of OUD treatment. Practitioners should document the medical
                necessity for the use of the add-on code in the patient's medical
                record. We welcome comments on this proposal.
                    We are proposing to value HCPCS codes GYYY1, GYYY2, and GYYY3 using
                a building block methodology that sums the work RVUs and direct PE
                inputs from codes that describe the component services we believe would
                be typical, consistent with the approach we have previously used in
                valuing monthly care management services that include face-to-face
                services within the payment. For HCPCS code GYYY1, we developed
                proposed inputs using a crosswalk to CPT code 99492 (Initial
                psychiatric collaborative care management, first 70 minutes in the
                first calendar month of behavioral health care manager activities, in
                consultation with a psychiatric consultant, and directed by the
                treating physician or other qualified health care professional, with
                the following required elements: Outreach to and engagement in
                treatment of a patient directed by the treating physician or other
                qualified health care professional; initial assessment of the patient,
                including administration of validated rating scales, with the
                development of an individualized treatment plan; review by the
                psychiatric consultant with modifications of the plan if recommended;
                entering patient in a registry and tracking patient follow-up and
                progress using the registry, with appropriate documentation, and
                participation in weekly caseload consultation with the psychiatric
                [[Page 40544]]
                consultant; and provision of brief interventions using evidence-based
                techniques such as behavioral activation, motivational interviewing,
                and other focused treatment strategies.), which is assigned a work RVU
                of 1.70, plus CPT code 90832 (Psychotherapy, 30 minutes with patient),
                which is assigned a work RVU of 1.50 (assuming two over the course of
                the month), and CPT code 90853 (Group psychotherapy (other than of a
                multiple-family group)), which is assigned a work RVU of 0.59 (assuming
                four over the course of a month), for a work RVU of 7.06. The required
                minimum number of minutes described in HCPCS code GYYY1 is also based
                on a crosswalk to CPT codes 99492. Additionally, for HCPCS code GYYY1,
                we are proposing to use a crosswalk to the direct PE inputs associated
                with CPT code 99492, CPT code 90832 (times two), and CPT code 90853
                (times four). We believe that the work and practice expense described
                by these crosswalk codes is analogous to the services described in
                HCPCS code GYYY1 because HCPCS code GYYY1 includes similar care
                coordination activities as described in CPT code 99492 and bundles in
                the psychotherapy services described in CPT codes 90832 and 90853.
                    We are proposing to value HCPCS code GYYY2 using a crosswalk to CPT
                code 99493 (Subsequent psychiatric collaborative care management, first
                60 minutes in a subsequent month of behavioral health care manager
                activities, in consultation with a psychiatric consultant, and directed
                by the treating physician or other qualified health care professional,
                with the following required elements: Tracking patient follow-up and
                progress using the registry, with appropriate documentation;
                participation in weekly caseload consultation with the psychiatric
                consultant; ongoing collaboration with and coordination of the
                patient's mental health care with the treating physician or other
                qualified health care professional and any other treating mental health
                providers; additional review of progress and recommendations for
                changes in treatment, as indicated, including medications, based on
                recommendations provided by the psychiatric consultant; provision of
                brief interventions using evidence-based techniques such as behavioral
                activation, motivational interviewing, and other focused treatment
                strategies; monitoring of patient outcomes using validated rating
                scales; and relapse prevention planning with patients as they achieve
                remission of symptoms and/or other treatment goals and are prepared for
                discharge from active treatment), which is assigned a work RVU of 1.53,
                plus CPT code 90832, which is assigned a work RVU of 1.50 (assuming two
                over the course of the month), and CPT code 90853, which is assigned a
                work RVU of 0.59 (assuming four over the course of a month), for a work
                RVU of 6.89. The required minimum number of minutes described in HCPCS
                code GYYY2 is also based on a crosswalk to CPT codes 99493. For HCPCS
                code GYYY2, we are proposing to use a crosswalk to the direct PE inputs
                associated with CPT code 99493, CPT code 90832 (times two), and CPT
                code 90853 (times four). We believe that the work and practice expense
                described by these crosswalk codes is analogous to the services
                described in HCPCS code GYYY2 because HCPCS code GYYY2 includes similar
                care coordination activities as described in CPT code 99493 and bundles
                in the psychotherapy services described in CPT codes 90832 and 90853.
                    We are proposing to value HCPCS code GYYY3 using a crosswalk to CPT
                code 99494 (Initial or subsequent psychiatric collaborative care
                management, each additional 30 minutes in a calendar month of
                behavioral health care manager activities, in consultation with a
                psychiatric consultant, and directed by the treating physician or other
                qualified health care professional (List separately in addition to code
                for primary procedure)), which is assigned a work RVU of 0.82. The
                required minimum number of minutes described in HCPCS code GYYY2 is
                also based on a crosswalk to CPT codes 99493. For HCPCS code GYYY3, we
                are proposing to use a crosswalk to the direct PE inputs associated
                with CPT code 99494. We believe that the work and practice expense
                described by this crosswalk code is analogous to the services described
                in HCPCS code GYYY3 because HCPCS code GYYY3 includes similar care
                coordination activities as described in CPT code 99494.
                    For additional details on the proposed direct PE inputs for HCPCS
                codes GYYY1-GYYY3, see Table 22.
                    We understand that many beneficiaries with OUD have comorbidities
                and may require medically-necessary psychotherapy services for other
                behavioral health conditions. In order to avoid duplicative billing, we
                are proposing that, when furnished to treat OUD, CPT codes 90832,
                90834, 90837, and 90853 may not be reported by the same practitioner
                for the same beneficiary in the same month as HCPCS codes GYYY1, GYYY2,
                and GYYY3. We welcome comments on this proposal.
                    We are proposing that practitioners reporting the OUD bundle must
                furnish a separately reportable initiating visit in association with
                the onset of OUD treatment, since the bundle requires a level of care
                coordination that cannot be effective without appropriate evaluation of
                the patient's needs. This is similar to the requirements for chronic
                care management (CCM) services (CPT codes 99487, 99489, 99490, and
                99491) and BHI services (CPT codes 99484, 99492, 99493, and 99494)
                finalized in the CY 2017 PFS final rule (81 FR 80239) The initiating
                visit would establish the beneficiary's relationship with the billing
                practitioner, ensure the billing practitioner assesses the beneficiary
                to determine clinical appropriateness of MAT in cases where MAT is
                being furnished, and provide an opportunity to obtain beneficiary
                consent to receive care management services (as discussed further
                below). We propose that the same services that can serve as the
                initiating visit for CCM services and BHI services can serve as the
                initiating visit for the proposed services described by HCPCS codes
                GYYY1-GYYY3. For new patients or patients not seen by the practitioner
                within a year prior to the commencement of CCM services and BHI
                services, the billing practitioner must initiate the service during a
                ``comprehensive'' E/M visit (levels 2 through 5 E/M visits), annual
                wellness visit (AWV) or initial preventive physical exam (IPPE). The
                face-to-face visit included in transitional care management (TCM)
                services (CPT codes 99495 and 99496) also qualifies as a
                ``comprehensive'' visit for CCM and BHI initiation. We propose that
                these visits could similarly serve as the initiating visit for OUD
                services.
                    We are proposing that the counseling, therapy, and care
                coordination described in the proposed OUD treatment codes could be
                provided by professionals who are qualified to provide the services
                under state law and within their scope of practice ``incident to'' the
                services of the billing physician or other practitioner. We are also
                proposing that the billing clinician would manage the patient's overall
                care, as well as supervise any other individuals participating in the
                treatment, similar to the structure of the BHI codes describing the
                psychiatric collaborative care model finalized in the CY 2017 PFS final
                rule (81 FR 80229), in which services are reported by a treating
                physician or other qualified health care professional and include the
                services of the treating physician or other qualified health care
                professional,
                [[Page 40545]]
                as well as the services of other professionals who furnish services
                incident to the services of the treating physician or other qualified
                health care professional. Additionally, we are proposing to add these
                codes to the list of designated care management services for which we
                allow general supervision of the non-face-to-face portion of the
                required services. Consistent with policies for other separately
                billable care management services under the PFS, because these proposed
                OUD treatment bundles include non-face-to-face care management
                components, we are proposing that the billing practitioner or clinical
                staff must document in the beneficiary's medical record that they
                obtained the beneficiary's consent to receive the services, and that,
                as part of the consent, they informed the beneficiary that there is
                cost sharing associated with these services, including potential
                deductible and coinsurance amounts, for both in-person and non-face-to-
                face services that are provided.
                    We are also proposing to allow any of the individual therapy, group
                therapy and counseling services included in HCPCS codes GYYY1, GYYY2,
                and GYYY3 to be furnished via telehealth, as clinically appropriate, in
                order to increase access to care for beneficiaries. As discussed in
                section II.F. of this proposed rule regarding Telehealth Services, like
                certain other non-face-to-face PFS services, the components of HCPCS
                codes GYYY1 through GYYY3 describing care coordination are commonly
                furnished remotely using telecommunications technology, and do not
                require the patient to be present in-person with the practitioner when
                they are furnished. As such, these services are not considered
                telehealth services for purposes of Medicare, and we do not need to
                consider whether the non-face-to-face aspects of HCPCS codes GYYY1
                through GYYY3 are similar to other telehealth services. If the non-
                face-to-face components of HCPCS codes GYYY1 through GYYY3 were
                separately billable, they would not need to be on the Medicare
                telehealth list to be covered and paid in the same way as services
                delivered without the use of telecommunications technology.
                    Section 2001(a) of the SUPPORT Act amended section 1834(m) of the
                Act, adding a new paragraph (7) that removes the geographic limitations
                for telehealth services furnished on or after July 1, 2019, to an
                individual with a substance use disorder (SUD) diagnosis for purposes
                of treatment of such disorder or co-occurring mental health disorder.
                The new paragraph at section 1834(m)(7) of the Act also allows
                telehealth services for treatment of a diagnosed SUD or co-occurring
                mental health disorder to be furnished to individuals at any telehealth
                originating site (other than a renal dialysis facility), including in a
                patient's home. As discussed in section II.F. of this proposed rule,
                Telehealth Services, we are proposing to add HCPCS codes GYYY1, GYYY2,
                and GYYY3 to the list of Medicare Telehealth services. Because certain
                required services (such as individual psychotherapy or group
                psychotherapy services) that are included in the proposed OUD bundled
                payment codes would be furnished to treat a diagnosed SUD, and would
                ordinarily require a face-to-face encounter, they could be furnished
                more broadly as telehealth services as permitted under section
                1834(m)(7) of the Act.
                    For these proposed services described above (HCPCS codes GYYY1,
                GYYY2, and GYYY3), we seek comment on how these potential codes,
                descriptors, and payment rates align with state Medicaid coding and
                payment rates for the purposes of state payment of cost sharing for
                Medicare-Medicaid dually eligible individuals. Additionally, we
                understand that treatment for OUD can vary, and that MAT alone has
                demonstrated efficacy. In cases where a medication such as
                buprenorphine or naltrexone is used to treat OUD alone, without therapy
                or counseling, we note that existing applicable codes can be used to
                furnishing and bill for that care (for example, using E/M visits, in
                lieu of billing the bundled OUD codes proposed here).
                    As discussed in section II.G. of this proposed rule, Medicare
                Coverage for Certain Services Furnished by Opioid Treatment Programs,
                we are proposing to set the copayment at zero for OUD services
                furnished by an OTP, given the flexibility in section 1834(w)(1) of the
                Act for us to set the copayment amount for OTP services either at zero
                or at an amount above zero. We note that we do not have the statutory
                authority to eliminate the deductible and coinsurance requirements for
                the bundled OUD treatment services under the PFS. We acknowledge the
                potential impact of coinsurance on patient health care decisions and
                intend to monitor its impact if these proposals were to be finalized.
                    Finally, we recognize that historically, the CPT Editorial Panel
                has frequently created CPT codes describing services that we originally
                established using G-codes and adopted them through the CPT Editorial
                Panel process. We note that we would consider new using any available
                CPT coding to describe services similar to those described here in
                future rulemaking, as early as CY 2021. We would consider and adopt any
                such CPT codes through subsequent rulemaking.
                    Additionally, we understand that in some cases, OUD can first
                become apparent to practitioners in the emergency department setting.
                We recognize that there is not specific coding that describes diagnosis
                of OUD or the initiation of, or referral for, MAT in the emergency
                department setting. We are seeking comment on the use of MAT in the
                emergency department setting, including initiation of MAT and the
                potential for either referral or follow-up care, as well as the
                potential for administration of long-acting MAT agents in this setting,
                in order to better understand typical practice patterns to help inform
                whether we should consider making separate payment for such services in
                future rulemaking. We welcome feedback from stakeholders and the public
                on other potential bundles describing services for other substance use
                disorders for our consideration in future rulemaking.
                2. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers
                (FQHCs)
                    In the CY 2018 PFS final rule (82 FR 53169 through 53180), we
                established payment for General Care Management (CCM) services using
                HCPCS G0511 which is an RHC and FQHC-specific G code for at least 20
                minutes of CCM, complex CCM, or general behavioral health services.
                Payment for this code is currently set at the average of the non-
                facility, non-geographically adjusted payment rates for CPT codes
                99490, 99487, 99491, and 99484. The types of chronic conditions that
                are eligible for care management services include mental health or
                behavioral health conditions, including substance use disorders.
                    In the CY 2018 PFS final rule with comment period (82 FR 53169
                through 53180), we also established payment for psychiatric
                Collaborative Care Services (CoCM) using HCPCS code G0512, which is an
                RHC and FQHC specific G-code for at least 70 minutes in the first
                calendar month, and at least 60 minutes in subsequent calendar months
                of psychiatric CoCM services. Payment for this code is set at the
                average of the non-facility, non-geographically adjusted rates for CPT
                codes 99492 and 99493. The psychiatric CoCM model of care may be used
                to treat patients with any behavioral health condition that is being
                treated by the billing practitioner, including substance use disorders.
                [[Page 40546]]
                    RHCs and FQHCs can also bill for individual psychotherapy services
                using CPT codes 90791, 90792, 90832, 90834, 90837, 90839, or 90845,
                which are billable visits under the RHC all-inclusive rate (AIR) and
                FQHC Prospective Payment System (PPS) when furnished by an RHC or FQHC
                practitioner. If a qualified mental health service is furnished on the
                same day as a qualified primary care service, the RHC or FQHC can bill
                for 2 visits.
                    RHCs and FQHCs are engaged primarily in providing services that are
                furnished typically in a physician's office or an outpatient clinic. As
                a result of the proposed bundled payment under the PFS for OUD
                treatment furnished by physicians, we reviewed the applicability of
                RHCs and FQHCs furnishing and billing for similar services.
                Specifically, we considered establishing a new RHC and FQHC specific G
                code for OUD treatment with the payment rate set at the average of the
                non-facility, non-geographically adjusted payment rates for GYYY1 and
                GYYY2, beginning on January 1, 2020. The requirements to bill the
                services would be similar to the requirements under the PFS for GYYY1
                and GYYY2, including that an initiating visit with a primary care
                practitioner must occur within one year before OUD services begin, and
                that consent be obtained before services are furnished.
                    However, because RHCs and FQHCs that choose to furnish OUD services
                can continue to report these individual codes when treating OUD, and
                can also offer their patients comprehensive care coordination services
                using HCPCS codes G0511 and G0512, we do not believe that adding a new
                and separate code to report a bundle of OUD services is necessary.
                Therefore, we are not proposing to add a new G code for a bundle of OUD
                service.
                I. Physician Supervision for Physician Assistant (PA) Services
                1. Background
                    Section 4072(e) of the Omnibus Budget Reconciliation Act of 1986
                (Pub. L. 99-509, October 21, 1986), added section 1861(s)(2)(K)(i) of
                the Act to establish a benefit for services furnished by a physician
                assistant (PA) under the supervision of a physician. We have
                interpreted this physician supervision requirement in the regulation at
                Sec.  410.74(a)(2)(iv) to require PA services to be furnished under the
                general supervision of a physician. This general supervision
                requirement was based upon another longstanding regulation at Sec.
                410.32(b)(3)(i) that defines three levels of supervision for diagnostic
                tests, which are general, direct and personal supervision. Of these
                three supervision levels, general supervision is the most lenient.
                Specifically, the general supervision requirement means that PA
                services must be furnished under a physician's overall direction and
                control, but the physician's presence is not required during the
                performance of PA services.
                    In the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we
                published a request for information (RFI) on CMS flexibilities and
                efficiencies. In response to this RFI, commenters including PA
                stakeholders informed us about recent changes in the practice of
                medicine for PAs, particularly regarding physician supervision. These
                commenters also reached out separately to CMS with their concerns. They
                stated that PAs are now practicing more autonomously, like nurse
                practitioners (NPs) and clinical nurse specialists (CNSs), as members
                of medical teams that often consist of physicians, nonphysician
                practitioners and other allied health professionals. This changed
                approach to the delivery of health care services involving PAs has
                resulted in changes to scope of practice laws for PAs regarding
                physician supervision across some states. According to these
                commenters, some states have already relaxed their requirements for PAs
                related to physician supervision, some states have made changes and are
                now silent about their physician supervision requirements, while other
                states have not yet changed their PA scope of practice in terms of
                their physician supervision requirements. Overall, these commenters
                believe that as states continue to make changes to their physician
                supervision requirements for PAs, the Medicare requirement for general
                supervision of PA services may become increasingly out of step with
                current medical practice, imposing a more stringent standard than state
                laws governing physician supervision of PA services. Furthermore, as
                currently defined, stakeholders have suggested that the supervision
                requirement is often misinterpreted or misunderstood in a manner that
                restricts PAs' ability to practice to the full extent of their
                education and expertise. The stakeholders have suggested that the
                current regulatory definition of physician supervision as it applies to
                PAs could inappropriately restrict the practice of PAs in delivering
                their professional services to the Medicare population.
                    We note that we have understood our current policy to require
                general physician supervision for PA services to fulfill the statutory
                physician supervision requirement; and we believe that general
                physician supervision gives PAs flexibility to furnish their
                professional services without the need for a physician's physical
                presence or availability. Nonetheless, we appreciate the concerns
                articulated by stakeholders. To more fully understand the current
                landscape for medical practice involving PA services and how the
                current regulatory definition may be problematic, we invite public
                comments on specific examples of changes in state law and state scope
                of practice rules that enable PAs to practice more broadly such that
                those rules are in tension with the Medicare requirement for general
                physician supervision of PA services that has been in place since the
                inception of the PA benefit category under Medicare law.
                    Given the commenters' understanding of ongoing changes underway to
                the state scope of practice laws regarding physician supervision of PA
                services, commenters on our CY 2018 RFI have requested that CMS
                reconsider its interpretation of the statutory requirement that PA
                services must be furnished under the supervision of a physician to
                allow PAs to operate similarly to NPs and CNSs, who are required by
                section 1861(s)(2)(K)(ii) of the Act to furnish their services ``in
                collaboration'' with a physician. In general, we have interpreted
                collaboration for this purpose at Sec. Sec.  410.75(c)(3) and
                410.76(c)(3) of our regulations to mean a process in which an NP or CNS
                (respectively) works with one or more physicians to deliver health care
                services within the scope of the practitioner's expertise, with medical
                direction and appropriate supervision as provided by state law in which
                the services are performed. The commenters stated that allowing PA
                services to be furnished using such a collaborative process would offer
                PAs the flexibility necessary to deliver services more effectively
                under today's health care system in accordance with the scope of
                practice in the state(s) where they practice, rather than being limited
                by the system that was in place when PA services were first covered
                under Medicare Part B over 30 years ago.
                2. Proposal
                    After considering the comments we received on the RFI, as well as
                information we received regarding the scope of practice laws in some
                states regarding supervision requirements for PAs, we are proposing to
                revise the regulation at Sec.  410.74 that establishes physician
                supervision requirements for PAs. Specifically, we are proposing to
                [[Page 40547]]
                revise Sec.  410.74(a)(2) to provide that the statutory physician
                supervision requirement for PA services at section 1861(s)(2)(K)(i) of
                the Act would be met when a PA furnishes their services in accordance
                with state law and state scope of practice rules for PAs in the state
                in which the services are furnished, with medical direction and
                appropriate supervision as provided by state law in which the services
                are performed. In the absence of state law governing physician
                supervision of PA services, the physician supervision required by
                Medicare for PA services would be evidenced by documentation in the
                medical record of the PA's approach to working with physicians in
                furnishing their services. Consistent with current rules, such
                documentation would need to be available to CMS, upon request. This
                proposed change would substantially align the regulation on physician
                supervision for PA services at Sec.  410.74(a)(2) with our current
                regulations on physician collaboration for NP and CNS services at
                Sec. Sec.  410.75(c)(3) and 410.76(c)(3). We continue to engage with
                key stakeholders on this issue and receive information on the expanded
                role of nonphysician practitioners as members of the medical team. As
                we are informed about transitions in state law and state scope of
                practice governing physician supervision, as well as changes in the way
                that PAs practice, we acknowledge the state's role and autonomy to
                establish, uphold, and enforce their state laws and PA scope of
                practice requirements to ensure that an appropriate level of physician
                oversight occurs when PAs furnish their professional services to
                Medicare Part B patients. Our policy proposal on this issue largely
                defers to state law and state scope of practice and enables states the
                flexibility to develop requirements for PA services that are unique and
                appropriate for their respective state, allowing the states to be
                accountable for the safety and quality of health care services that PAs
                furnish.
                J. Review and Verification of Medical Record Documentation
                1. Background
                    In an effort to reduce mandatory and duplicative medical record
                evaluation and management (E/M) documentation requirements, we
                finalized an amended regulatory provision at 42 CFR part 415, subpart
                D, in the CY 2019 PFS final rule (83 FR 59653 through 59654).
                Specifically, Sec.  415.172(a) requires as a condition of payment under
                the PFS that the teaching physician (as defined in Sec.  415.152) must
                be present during certain portions of services that are furnished with
                the involvement of residents (individuals who are training in a
                graduate medical education program). Section 415.174(a) provides for an
                exception to the teaching physician presence requirements in the case
                of certain E/M services under certain conditions, but requires that the
                teaching physician must direct and review the care provided by no more
                than four residents at a time. Sections 415.172(b) and 415.174(a)(6),
                respectively require that the teaching physician's presence and
                participation in services involving residents must be documented in the
                medical record. We amended these regulations to provide that a
                physician, resident, or nurse may document in the patient's medical
                record that the teaching physician presence and participation
                requirements were met. As a result, for E/M visits furnished beginning
                January 1, 2019, the extent of the teaching physician's participation
                in services involving residents may be demonstrated by notes in the
                medical records made by a physician, resident, or nurse.
                    For the same burden reduction purposes, we issued CR 10412,
                Transmittal 3971 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3971CP.pdf on February 2, 2018, which
                revised a paragraph in our manual instructions on ``Teaching Physician
                Services'' at Pub. 100-04, Medicare Claims Processing Manual, Chapter
                12, Section 100.1.1B., to reduce duplicative documentation requirements
                by allowing a teaching physician to review and verify (sign/date) notes
                made by a student in a patient's medical record for E/M services,
                rather than having to re-document the information, largely duplicating
                the student's notes. We issued corrections to CR 10412 through
                Transmittal 4068 https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4068CP.pdf and re-issued the CR on May 31,
                2018. Pub. 100-04, Medicare Claims Processing Manual, Chapter 12,
                Section 100 contains a list of definitions pertinent to teaching
                physician services. Following these amendments to our regulations and
                manual, certain stakeholders raised concerns about the definitions in
                this section, particularly those for teaching physician, student, and
                documentation; and when considered in conjunction with the
                interpretation of the manual provision at Pub. 100-04, Medicare Claims
                Processing Manual, Chapter 12, Section 100.1.1B., which addresses
                documentation of E/M services involving students. While there is no
                regulatory definition of student, the manual instruction defines a
                student as an individual who participates in an accredited educational
                program (for example, a medical school) that is not an approved
                graduate medical education (GME) program. The manual instructions also
                specify that a student is never considered to be an intern or a
                resident, and that Medicare does not pay for services furnished by a
                student (see Section 100.1.1B. for a discussion concerning E/M service
                documentation performed by students).
                    We are aware that nonphysician practitioners who are authorized
                under Medicare Part B to furnish and be paid for all levels of E/M
                services are seeking similar relief from burdensome E/M documentation
                requirements that would allow them to review and verify medical record
                notes made by their students, rather than having to re-document the
                information. These nonphysician practitioners include nurse
                practitioners (NPs), clinical nurse specialists (CNSs), and certified
                nurse-midwives (CNMs), collectively referred to hereafter for purposes
                of this discussion as advanced practice registered nurses (APRNs), as
                well as physician assistants (PAs). Subsequent to the publication of
                the CY 2019 PFS final rule (83 FR 59653 through 59654), through
                feedback from listening sessions hosted by CMS' Documentation
                Requirements Simplification workgroup, we began to hear concerns from a
                variety of stakeholders about the requirements for teaching physician
                review and verification of documentation added to the medical record by
                other individuals. Physician and nonphysician practitioner stakeholders
                expressed concern about the scope of the changes to Sec. Sec.
                415.172(b) and 415.174(a)(6) which authorize only a physician,
                resident, or nurse to include notes in the medical record to document
                E/M services furnished by teaching physicians, because they believed
                that students and other members of the medical team should be similarly
                permitted to provide E/M medical record documentation. In addition to
                students, these stakeholders indicated that ``other members of the
                medical team'' could include individuals who the teaching physician,
                other physicians, PA and APRN preceptors designate as being appropriate
                to document services in the medical record, which the billing
                practitioner would then review and verify, and rely upon for billing
                purposes.
                    Subsequent to the publication of the student documentation manual
                [[Page 40548]]
                instruction change at section 100.1.1B of the Medicare Claims
                Processing Manual, representatives of PAs and APRNs requested
                clarification about whether PA and APRN preceptors and their students
                were subject to the same E/M documentation requirements as teaching
                physicians and their medical students. These stakeholders suggested
                that the reference to ``student'' in the manual instruction on E/M
                documentation provided by students is ambiguous because it does not
                specify ``medical student''. These stakeholders also suggested that the
                definition of ``student'' in section 100 of this manual instruction is
                ambiguous because PA and APRN preceptors also educate students who are
                individuals who participate in an accredited educational program that
                is not an approved GME program. Accordingly, these stakeholders
                expressed concern that the uncertainty throughout the health care
                industry, including among our contractors, concerning the student E/M
                documentation review and verification policy under these manual
                guidelines results in unequal treatment as compared to teaching
                physicians. The stakeholders stated that depending on how the manual
                instruction is interpreted, PA and APRN preceptors may be required to
                re-document E/M services in full when their students include notes in
                the medical records, without having the same option that teaching
                physicians do to simply review and verify medical student
                documentation.
                2. Proposal
                    After considering the concerns expressed by these stakeholders, we
                believe it would be appropriate to provide broad flexibility to the
                physicians, PAs and APRNs (regardless of whether they are acting in a
                teaching capacity) who document and who are paid under the PFS for
                their professional services. Therefore, we propose to establish a
                general principle to allow the physician, the PA, or the APRN who
                furnishes and bills for their professional services to review and
                verify, rather than re-document, information included in the medical
                record by physicians, residents, nurses, students or other members of
                the medical team. This principle would apply across the spectrum of all
                Medicare-covered services paid under the PFS. Because this proposal is
                intended to apply broadly, we propose to amend regulations for teaching
                physicians, physicians, PAs, and APRNs to add this new flexibility for
                medical record documentation requirements for professional services
                furnished by physicians, PAs and APRNs in all settings. We invite
                comments on this proposal.
                    Specifically, to reflect our simplified and standardized approach
                to medical record documentation for all professional services furnished
                by physicians, PAs and APRNs paid under the PFS, we are proposing to
                amend Sec. Sec.  410.20 (Physicians' services), 410.74 (PA services),
                410.75 (NP services), 410.76 (CNS services) and 410.77 (CNM services)
                to add a new paragraph entitled, ``Medical record documentation.'' This
                paragraph would specify that, when furnishing their professional
                services, the clinician may review and verify (sign/date) notes in a
                patient's medical record made by other physicians, residents, nurses,
                students, or other members of the medical team, including notes
                documenting the practitioner's presence and participation in the
                services, rather than fully re-documenting the information. We note
                that, while the proposed change addresses who may document services in
                the medical record, subject to review and verification by the
                furnishing and billing clinician, it does not modify the scope of, or
                standards for, the documentation that is needed in the medical record
                to demonstrate medical necessity of services, or otherwise for purposes
                of appropriate medical recordkeeping.
                    We are also proposing to make conforming amendments to Sec. Sec.
                415.172(b) and 415.174(a)(6) to also allow physicians, residents,
                nurses, students, or other members of the medical team to enter
                information in the medical record that can then be reviewed and
                verified by a teaching physician without the need for re-documentation.
                We invite comments on these proposed amendments to our regulations.
                K. Care Management Services
                1. Background
                    In recent years, we have updated PFS payment policies to improve
                payment for care management and care coordination. Working with the CPT
                Editorial Panel and other clinicians, we have expanded the suite of
                codes describing these services. New CPT codes were created that
                distinguish between services that are face-to-face; represent a single
                encounter, monthly service or both; are timed services; represent
                primary care versus specialty care; address specific conditions; and
                represent the work of the billing practitioner, their clinical staff,
                or both (see Table 16). Additional information regarding recent new
                codes and associated PFS payment rules is available on our website at
                https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
                           Table 16--Summary of Special Care Management Codes
                ------------------------------------------------------------------------
                                Service                              Summary
                ------------------------------------------------------------------------
                Care Plan Oversight (CPO) (also          Supervision of home health,
                 referred to as Home Health               hospice, per month.
                 Supervision, Hospice Supervision)
                 (HCPCS Codes G0181, G0182).
                ESRD Monthly Services (CPT Codes 90951-  ESRD management, with and
                 70).                                     without face-to-face visits,
                                                          by age, per month.
                Transitional Care Management (TCM)       Management of transition from
                 (adopted in 2013) (CPT Codes 99495,      acute care or certain
                 99496).                                  outpatient stays to a
                                                          community setting, with face-
                                                          to-face visit, once per
                                                          patient within 30 days post-
                                                          discharge.
                Chronic Care Management (CCM) (adopted   Management of all care for
                 in 2015, 2017, 2019) (CPT Codes 99487,   patients with two or more
                 99489, 99490, 99491).                    serious chronic conditions,
                                                          timed, per month.
                Advance Care Planning (ACP) (adopted in  Counseling/discussing advance
                 2016) (CPT Codes 99497, 99498).          directives, face-to-face,
                                                          timed.
                Behavioral Health Integration (BHI)      Management of behavioral health
                 (adopted in 2017) (CPT Codes 99484,      conditions(s), timed, per
                 99492, 99493, 99494).                    month.
                Assessment/Care Planning for Cognitive   Assessment and care planning of
                 Impairment (adopted in 2017) (CPT Code   cognitive impairment, face-to-
                 99483).                                  face visit.
                Prolonged Evaluation & Management (E/M)  Non-face-to-face E&M work
                 Without Direct Patient Contact           related to a face-to-face
                 (adopted in 2017) (CPT Codes 99358,      visit, timed.
                 99359).
                [[Page 40549]]
                
                Remote Patient Monitoring (adopted in    Review and analysis of patient-
                 2019) (CPT Code 99091).                  generated health data, timed,
                                                          per 30 days.
                Interprofessional Consultation (adopted  Inter-practitioner
                 in 2019) (CPT Codes 99446, 99447,        consultation.
                 99448, 99449, 99451, 99452).
                ------------------------------------------------------------------------
                    Based on our review of the Medicare claims data we estimate that
                approximately 3 million unique beneficiaries (9 percent of the Medicare
                fee-for-service (FFS) population) receive these services annually, with
                higher use of chronic care management (CCM), transitional care
                management (TCM), and advance care planning (ACP) services. We believe
                gaps remain in coding and payment, such as for care management of
                patients having a single, serious, or complex chronic condition. In
                this proposed rule, we continue our ongoing work in this area through
                code set refinement related to TCM services and CCM services, in
                addition to proposing new coding for principal care management (PCM)
                services, and addressing chronic care remote physiologic monitoring
                (RPM) services.
                2. Transitional Care Management (TCM) Services
                    Utilization of TCM services has increased each year since CMS
                established coding and began paying separately for TCM services.
                Specifically, there were almost 300,000 TCM professional claims during
                2013, the first year of TCM services, and almost 1.3 million
                professional claims during 2018, the most recent year of complete
                claims data. However, based upon an analysis of claims data by Bindman
                and Cox,\78\ utilization of TCM services is low when compared to the
                number of Medicare beneficiaries with eligible discharges.
                Additionally, Bindman and Cox noted that the beneficiaries who received
                TCM services demonstrated reduced readmission rates, lower mortality,
                and decreased health care costs. Based upon these findings, we believe
                that increasing utilization of TCM services could positively affect
                patient outcomes.
                ---------------------------------------------------------------------------
                    \78\ Bindman, AB, Cox DF. Changes in health care costs and
                mortality associated with transitional care management services
                after a discharge among Medicare beneficiaries [published online
                July 30, 2018]. JAMA Intern Med, doi:10.1001/
                jamainternmed.2018.2572.
                ---------------------------------------------------------------------------
                    In developing a proposal designed to increase utilization of TCM
                services, we considered possible factors contributing to low
                utilization. Bindman and Cox identified two likely contributing
                factors: The administrative burdens associated with billing TCM
                services and the payment amount to physicians for services.
                    We focused initially on the requirements for billing TCM services.
                In reviewing the TCM billing requirements, we noted that we had
                established in the CY 2013 PFS final rule with comment period a list of
                57 HCPCS codes that cannot be billed during the 30-day period covered
                by TCM services by the same practitioner reporting TCM (77 FR 68990).
                This list mirrored reporting restrictions put in place by the CPT
                Editorial Panel for the TCM codes upon their creation. At the time we
                established separate payment for the TCM CPT codes, we agreed with the
                CPT Editorial Panel that the services described by the 57 codes could
                be overlapping and duplicative with TCM in their definition and scope;
                although, many of these codes were not separately payable or covered
                under the PFS so even if they were reported for PFS payment, they would
                not be have been separately paid (see, for example, 77 FR 68985). In
                response to those concerns, we adopted billing restrictions to avoid
                duplicative billing and payment for covered services. In our recent
                analysis of the services associated with the 57 codes, we found that
                the majority of codes on the list remain either bundled, noncovered by
                Medicare, or invalid for Medicare payment purposes. Table 17 provides
                detailed information regarding the subset of these codes that would be
                separately payable under the PFS (Status Indicator ``A'') and, as such,
                are the focus of this year's CY 2020 proposed policy for TCM. Fourteen
                (14) codes on the list represent active codes that are paid separately
                under the PFS and that upon reconsideration, we believe may not
                substantially overlap with TCM services and should be separately
                payable alongside TCM. For example, CPT code 99358 (Prolonged E/M
                service before and/or after direct patient care; first hour; non-face-
                to-face time spent by a physician or other qualified health care
                professional on a given date providing prolonged service) would allow
                the physician or other qualified healthcare professional extra time to
                review records and manage patient support services after the face-to-
                face visit required as part of TCM services. CPT code 99091 (Collection
                & interpretation of physiologic data, requiring a minimum of 30 minutes
                each 30 days) would permit the physician or other qualified healthcare
                professional to collect and analyze physiologic parameters associated
                with the patient's chronic disease.
                    Thus, after review of the services described by these 14 HCPCS
                codes, we believe these codes, when medically necessary, may complement
                TCM services rather than substantially overlap or duplicate services.
                We also believe removing the billing restrictions associated with these
                codes may increase utilization of TCM services.
                  Table 17--14 HCPCS Codes That Currently Cannot Be Billed Concurrently
                    With TCM by the Same Practitioner and Are Active Codes Payable by
                                              Medicare PFS
                ------------------------------------------------------------------------
                           Code family              HCPCS code         Descriptor
                ------------------------------------------------------------------------
                Prolonged Services without Direct        99358  Prolonged E/M service
                 Patient Contact.                                before and/or after
                                                                 direct patient care;
                                                                 first hour; non-face-to-
                                                                 face time spent by a
                                                                 physician or other
                                                                 qualified health care
                                                                 professional on a given
                                                                 date providing
                                                                 prolonged service.
                                                         99359  Prolonged E/M service
                                                                 before and/or after
                                                                 direct patient care;
                                                                 each additional 30
                                                                 minutes beyond the
                                                                 first hour of prolonged
                                                                 services.
                [[Page 40550]]
                
                Home and Outpatient International        93792  Patient/caregiver
                 Normalized Ratio (INR)                  93793   training for initiation
                 Monitoring Services.                            of home INR monitoring.
                                                                Anticoagulant management
                                                                 for a patient taking
                                                                 warfarin; includes
                                                                 review and
                                                                 interpretation of a new
                                                                 home, office, or lab
                                                                 INR test result,
                                                                 patient instructions,
                                                                 dosage adjustment and
                                                                 scheduling of
                                                                 additional test(s).
                End Stage Renal Disease Services         90960  ESRD related services
                 (patients who are 20+ years).                   monthly with 4 or more
                                                                 face-to-face visits per
                                                                 month; for patients 20
                                                                 years and older.
                                                         90961  ESRD related services
                                                                 monthly with 2-3 face-
                                                                 to-face visits per
                                                                 month; for patients 20
                                                                 years and older.
                                                         90962  ESRD related services
                                                                 with 1 face-to-face
                                                                 visit per month; for
                                                                 patients 20 years and
                                                                 older.
                                                         90966  ESRD related services
                                                                 for home dialysis per
                                                                 full month; for
                                                                 patients 20 years and
                                                                 older.
                                                         90970  ESRD related services
                                                                 for dialysis less than
                                                                 a full month of
                                                                 service; per day; for
                                                                 patient 20 years and
                                                                 older.
                Interpretation of Physiological          99091  Collection &
                 Data.                                           interpretation of
                                                                 physiologic data,
                                                                 requiring a minimum of
                                                                 30 minutes each 30
                                                                 days.
                Complex Chronic Care Management          99487  Complex Chronic Care
                 Services.                               99489   with 60 minutes of
                                                                 clinical staff time per
                                                                 calendar month.
                                                                Complex Chronic Care;
                                                                 additional 30 minutes
                                                                 of clinical staff time
                                                                 per month.
                Care Plan Oversight Services.....        G0181  Physician supervision of
                                                                 a patient receiving
                                                                 Medicare-covered
                                                                 services provided by a
                                                                 participating home
                                                                 health agency (patient
                                                                 not present) requiring
                                                                 complex and
                                                                 multidisciplinary care
                                                                 modalities within a
                                                                 calendar month; 30+
                                                                 minutes.
                                                         G0182  Physician supervision of
                                                                 a patient receiving
                                                                 Medicare-covered
                                                                 hospice services (Pt
                                                                 not present) requiring
                                                                 complex and
                                                                 multidisciplinary care
                                                                 modalities; within a
                                                                 calendar month; 30+
                                                                 minutes.
                ------------------------------------------------------------------------
                    Thus, with the goal of increasing medically appropriate use of TCM
                services, we are proposing to revise our billing requirements for TCM
                by allowing TCM codes to be billed concurrently with any of these
                codes. Before we finalize such a rule, however, we seek comment on
                whether overlap of services exists, and if so, which services should be
                restricted from being billed concurrently with TCM. We also seek
                comment on whether any overlap would depend upon whether the same or a
                different practitioner reports the services. We note that CPT reporting
                rules generally apply at the practitioner level, and we are seeking
                input from stakeholders as to whether our policy should differ based on
                whether it is the same or a different practitioner reporting the
                services. We are seeking comment on whether the newest CPT code in the
                chronic care management services family (CPT code 99491 for CCM by a
                physician or other qualified health professional, established in 2019)
                overlaps with TCM or should be reportable and separately payable in the
                same service period.
                    As part of our analysis of the utilization data for TCM services,
                we also examined how current payment rates for TCM might negatively
                affect the appropriate utilization of TCM services, an idea proposed by
                Bindman and Cox. CPT code 99495 (Transitional Care Management services
                with the following required elements: Communication (direct contact,
                telephone, electronic) with the patient and/or caregiver within two
                business days of discharge; medical decision making of at least
                moderate complexity during the service period; face-to-face visit
                within 14 calendar days of discharge) and CPT code 99496 (Transitional
                Care Management services with the following required elements:
                Communication (direct contact, telephone, electronic) with the patient
                and/or caregiver within two business days of discharge; medical
                decision making of at least high complexity during the service period;
                face-to-face visit within 7 calendar days of discharge) were resurveyed
                during 2018 as part of a regular RUC review of new technologies or
                services. For this RUC resurvey, several years of claims data were
                available and clinicians had more experience to inform their views
                about the work required to furnish TCM services. Based upon the results
                of the 2018 RUC survey of the two TCM codes, the RUC recommended a
                slight increase in work RVUs for both codes. We believe the results
                from the new survey will better reflect the work involved in furnishing
                TCM services as care management services. Thus, also for CY 2020, we
                are proposing the RUC-recommended work RVU of 2.36 for CPT code 99495
                and the RUC-recommended work RVU of 3.10 for CPT code 99496. We are not
                proposing any direct PE refinements to the RUC's recommendations for
                this code family.
                3. Chronic Care Management (CCM) Services
                    CCM services are comprehensive care coordination services per
                calendar month, furnished by a physician or non-physician practitioner
                (NPP) managing overall care and their clinical staff, for patients with
                two or more serious chronic conditions. There are currently two subsets
                of codes: One for non-complex chronic care management (starting in
                2015, with a new code for 2019) and a set of codes for complex chronic
                care management (starting in 2017). Table 17 provides a high-level
                summary of the CCM service elements.
                    Early data show that, in general, CCM services are increasing
                patient and practitioner satisfaction, saving costs and enabling solo
                practitioners to remain in independent practice.\79\ Utilization has
                reached approximately 75 percent of the level we initially assumed
                under the PFS when we began paying for CCM services separately under
                the PFS. While these are positive results, we believe that CCM services
                (especially complex CCM services) continue to be underutilized. In
                addition, we note that, at the February 2019 CPT Editorial Panel
                meeting, certain specialty associations requested refinements to the
                existing CCM codes, and consideration of their proposal was postponed.
                Also, we have heard from some stakeholders suggesting that the
                [[Page 40551]]
                time increments for non-complex CCM performed by clinical staff should
                be changed to recognize finer increments of time, and that certain
                requirements related to care planning are unclear. Based on our
                consideration of this ongoing feedback, we believe some of the
                refinements requested by specialty associations and other stakeholders
                may be necessary to improve payment accuracy, reduce unnecessary burden
                and help ensure that beneficiaries who need CCM services have access to
                them. Accordingly, we are proposing the following changes to the CCM
                code set for CY 2020.
                ---------------------------------------------------------------------------
                    \79\ https://innovation.cms.gov/Files/reports/chronic-care-mngmt-finalevalrpt.pdf.
                ---------------------------------------------------------------------------
                a. Non-Complex CCM Services by Clinical Staff (CPT Code 99490, HCPCS
                Codes GCCC1 and GCCC2)
                    Currently, the clinical staff CPT code for non-complex CCM, CPT
                code 99490 (Chronic care management services, at least 20 minutes of
                clinical staff time directed by a physician or other qualified health
                care professional, per calendar month, with the following required
                elements: Multiple (two or more) chronic conditions expected to last at
                least 12 months, or until the death of the patient; chronic conditions
                place the patient at significant risk of death, acute exacerbation/
                decompensation, or functional decline; comprehensive care plan
                established, implemented, revised, or monitored.) describes 20 or more
                minutes of clinical staff time spent performing chronic care management
                activities under the direction of a physician/qualified health care
                professional. When we initially adopted this code for payment and, in
                feedback we have since received, a number of stakeholders suggested
                that CMS undervalued the PE RVU because we assumed that the minimum
                time for the code (20 minutes of clinical staff time) would be typical
                (see, for example, 79 FR 67717 through 67718). In the CY 2017 PFS final
                rule with comment period, we continued to consider whether the payment
                amount for CPT code 99490 is appropriate, given the amount of time
                typically spent furnishing CCM services (81 FR 80243 through 80244). We
                adopted the complex CCM codes for payment beginning in CY 2017, in
                part, to pay more appropriately for services furnished to beneficiaries
                requiring longer service times.
                    There are two CPT codes for complex CCM:
                     CPT code 99487 (Complex chronic care management services,
                with the following required elements: Multiple (two or more) chronic
                conditions expected to last at least 12 months, or until the death of
                the patient; chronic conditions place the patient at significant risk
                of death, acute exacerbation/decompensation, or functional decline;
                establishment or substantial revision of a comprehensive care plan;
                moderate or high complexity medical decision making; 60 minutes of
                clinical staff time directed by physician or other qualified health
                care professional, per calendar month. (Complex chronic care management
                services of less than 60 minutes duration, in a calendar month, are not
                reported separately); and
                     CPT code 99489 (each additional 30 minutes of clinical
                staff time directed by a physician or other qualified health care
                professional, per calendar month (List separately in addition to code
                for primary procedure).
                    Complex CCM describes care management for patients who require not
                only more clinical staff time, but also complex medical decision-
                making. Some stakeholders continue to recommend that, in addition to
                separate payment for the complex CCM codes, we should create an add-on
                code for non-complex CCM, such that non-complex CCM would be defined
                and valued in 20-minute increments of time with additional payment for
                each additional 20 minutes, or extra payment for 20 to 40 minutes of
                clinical staff time spent performing care management activities.
                    We agree that coding changes that identify additional time
                increments would improve payment accuracy for non-complex CCM.
                Accordingly, we propose to adopt two new G codes with new increments of
                clinical staff time instead of the existing single CPT code (CPT code
                99490). The first G code would describe the initial 20 minutes of
                clinical staff time, and the second G code would describe each
                additional 20 minutes thereafter. We intend these would be temporary G
                codes, to be used for PFS payment instead of CPT code 99490 until the
                CPT Editorial Panel can consider revisions to the current CPT code set.
                We would consider adopting any CPT code(s) once the CPT Editorial Panel
                completes its work. We acknowledge that imposing a transitional period
                during which G codes would be used under the PFS in lieu of the CPT
                codes is potentially disruptive, and are seeking comment on whether the
                benefit of proceeding with the proposed G codes outweighs the burden of
                transitioning to their use in the intervening year(s) before a decision
                by the CPT Editorial Panel.
                    We are proposing that the base code would be HCPCS code GCCC1
                (Chronic care management services, initial 20 minutes of clinical staff
                time directed by a physician or other qualified health care
                professional, per calendar month, with the following required elements:
                Multiple (two or more) chronic conditions expected to last at least 12
                months, or until the death of the patient; chronic conditions place the
                patient at significant risk of death, acute exacerbation/
                decompensation, or functional decline; and comprehensive care plan
                established, implemented, revised, or monitored. (Chronic care
                management services of less than 20 minutes duration, in a calendar
                month, are not reported separately)). We propose a work RVU of 0.61 for
                HCPCS code GCCC1, which we crosswalked from CPT code 99490. We believe
                these codes have a similar amount of work since they would have the
                same intra-service time of 15 minutes.
                    We propose an add-on HCPCS code GCCC2 (Chronic care management
                services, each additional 20 minutes of clinical staff time directed by
                a physician or other qualified health care professional, per calendar
                month (List separately in addition to code for primary procedure). (Use
                GCCC2 in conjunction with GCCC1). (Do not report GCCC1, GCCC2 in the
                same calendar month as GCCC3, GCCC4, 99491)). We are proposing a work
                RVU of 0.54 for HCPCS code GCCC2 based on a crosswalk to CPT code 11107
                (Incisional biopsy of skin (eg, wedge) (including simple closure, when
                performed); each separate/additional lesion (List separately in
                addition to code for primary procedure)), which has a work RVU of 0.54,
                which we believe accurately reflects the work associated with each
                additional 20 minutes of CCM services. Both codes have the same
                intraservice time of 15 minutes. We note that the nature of the PFS
                relative value system is such that all services are appropriately
                subject to comparisons to one another. Although codes that describe
                clinically similar services are sometimes stronger comparator codes,
                codes need not share the same site of service, patient population, or
                utilization level to serve as an appropriate crosswalk. In this case,
                CPT code 11107 shares a similar work intensity to proposed HCPCS code
                GCCC2. Furthermore, although HCPCS codes GCCC1 and GCCC2 share the same
                intraservice time, add-on codes often have lower intensity than the
                base codes because they describe the continuation of an already
                initiated service.
                    We are soliciting public comment on whether we should limit the
                number of times this add-on code (HCPCS code GCCC2) can be reported in
                a given service period for a given beneficiary. It
                [[Page 40552]]
                is not clear how often more than 40 minutes of clinical staff time is
                currently spent or is medically necessary. In addition, once 60 minutes
                of clinical staff time is spent, many or most patients might also
                require complex medical decision-making, and such patients would be
                already described under existing coding for complex CCM. A limit (such
                as allowing the add-on code to be reported only once per service period
                per beneficiary) may be appropriate in order to maintain distinctions
                between complex and non-complex CCM, as well as appropriately limit
                beneficiary cost sharing and program spending to medically necessary
                services. We note that complex CCM already describes (in part) 60 or
                more minutes of clinical staff time in a service period. We are seeking
                comment on whether and how often beneficiaries who do not require
                complex CCM (for example, do not require the complex medical decision
                making that is part of complex CCM) would need 60 or more minutes of
                non-complex CCM clinical staff time and thereby warrant more than one
                use of HCPCS code GCCC2 within a service period.
                b. Complex CCM Services (CPT Codes 99487 and 99489, and HCPCS Codes
                GCCC3 and GCCC4)
                    Currently, the CPT codes for complex CCM include in the code
                descriptors a requirement for establishment or substantial revision of
                the comprehensive care plan (see above). The code descriptors for
                complex CCM also include moderate to high complexity medical decision-
                making (moderate to high complexity medical decision-making is an
                explicit part of the services). We propose to adopt two new G codes
                that would be used for billing under the PFS instead of CPT codes 99487
                and 99489, and that would not include the service component of
                substantial care plan revision. We believe it is not necessary to
                explicitly include substantial care plan revision because patients
                requiring moderate to high complexity medical decision making
                implicitly need and receive substantial care plan revision. The service
                component of substantial care plan revision is potentially duplicative
                with the medical decision making service component and, therefore, we
                believe it is unnecessary as a means of distinguishing eligible
                patients. Instead of CPT code 99487, we propose to adopt HCPCS code
                GCCC3 (Complex chronic care management services, with the following
                required elements: Multiple (two or more) chronic conditions expected
                to last at least 12 months, or until the death of the patient; chronic
                conditions place the patient at significant risk of death, acute
                exacerbation/decompensation, or functional decline; comprehensive care
                plan established, implemented, revised, or monitored; moderate or high
                complexity medical decision making; 60 minutes of clinical staff time
                directed by physician or other qualified health care professional, per
                calendar month. (Complex chronic care management services of less than
                60 minutes duration, in a calendar month, are not reported
                separately)). We are proposing a work RVU of 1.00 for HCPCS code GCCC3,
                which is a crosswalk to CPT code 99487.
                    Instead of CPT code 99489, we propose to adopt HCPCS code GCCC4
                (each additional 30 minutes of clinical staff time directed by a
                physician or other qualified health care professional, per calendar
                month (List separately in addition to code for primary procedure).
                (Report GCCC4 in conjunction with GCCC3). (Do not report GCCC4 for care
                management services of less than 30 minutes additional to the first 60
                minutes of complex chronic care management services during a calendar
                month)). We are proposing a work RVU of 0.50 for HCPCS code GCCC4,
                which is a crosswalk to CPT code 99489.
                    We intend these would be temporary G codes to remain in place until
                the CPT Editorial Panel can consider revising the current code
                descriptors for complex CCM services. We would consider adopting any
                new or revised complex CCM CPT code(s) once the CPT Editorial Panel
                completes its work. We acknowledge that imposing a transitional period
                during which G codes would be used under the PFS in lieu of the CPT
                codes is potentially disruptive. We are seeking comment on whether the
                benefit of proceeding with the proposed G codes outweighs the burden of
                transitioning to their use in the intervening year(s) before a decision
                by the CPT Editorial Panel.
                c. Typical Care Plan
                    In 2013, in working with the physician community to develop and
                propose the CCM codes for PFS payment, the medical community
                recommended and CMS agreed that adequate care planning is integral to
                managing patients with multiple chronic conditions. We stated our
                belief that furnishing care management to beneficiaries with multiple
                chronic conditions requires complex and multidisciplinary care
                modalities that involve, among other things, regular physician
                development and/or revision of care plans and integration of new
                information into the care plan (78 FR 43337). In the CY 2014 PFS final
                rule with comment period (78 FR 74416 through 74418), consistent with
                recommendations CMS received in 2013 from the AMA's Complex Chronic
                Care Coordination Workgroup, we finalized a CCM scope of service
                element for a patient-centered plan of care with the following
                characteristics: It is a comprehensive plan of care for all health
                problems and typically includes, but is not limited to, the following
                elements: Problem list; expected outcome and prognosis; measurable
                treatment goals; cognitive and functional assessment; symptom
                management; planned interventions; medical management; environmental
                evaluation; caregiver assessment; community/social services ordered;
                how the services of agencies and specialists unconnected to the
                practice will be directed/coordinated; identify the individuals
                responsible for each intervention, requirements for periodic review;
                and when applicable, revisions of the care plan.
                    The CPT Editorial Panel also incorporated and adopted this language
                in the prefatory language for Care Management Services codes (page 49
                of the 2019 CPT Codebook) including CCM services.
                    As we continue to consider the need for potential refinements to
                the CCM code set, we have heard that there is still some confusion in
                the medical community regarding what a care plan typically includes. We
                have re-reviewed this language for CCM, and we believe there may be
                aspects of the typical care plan language we adopted for CCM that are
                redundant or potentially unduly burdensome. We note that because these
                are ``typical'' care plan elements, these elements do not comprise a
                set of strict requirements that must be included in a care plan for
                purposes of billing for CCM services; the elements are intended to
                reflect those that are typically, but perhaps not always, included in a
                care plan as medically appropriate for a particular beneficiary.
                Nevertheless, we are proposing to eliminate the phrase ``community/
                social services ordered, how the services of agencies and specialists
                unconnected to the practice will be directed/coordinated, identify the
                individuals responsible for each intervention'' and insert the phrase
                ``interaction and coordination with outside resources and practitioners
                and providers.'' We believe simpler language would describe the
                important work of interacting and coordinating with resources external
                to the practice. While it is preferable, when feasible, to identify who
                is responsible for
                [[Page 40553]]
                interventions, it may be difficult to maintain an up-to-date listing of
                responsible individuals especially when they are outside of the
                practice, for example, when there is staff turnover or assignment
                changes.
                    Our proposed new language would read: The comprehensive care plan
                for all health issues typically includes, but is not limited to, the
                following elements:
                     Problem list.
                     Expected outcome and prognosis.
                     Measurable treatment goals.
                     Cognitive and functional assessment.
                     Symptom management.
                     Planned interventions.
                     Medical management.
                     Environmental evaluation.
                     Caregiver assessment.
                     Interaction and coordination with outside resources and
                practitioners and providers.
                     Requirements for periodic review.
                     When applicable, revision of the care plan.
                    We welcome feedback on our proposal, including language that would
                best guide practitioners as they decide what to include in their
                comprehensive care plan for CCM recipients.
                    Additional information regarding the existing requirements for
                billing CCM, including links to prior rules, is available on our
                website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html.
                4. Principal Care Management (PCM) Services
                    A gap we identified in coding and payment for care management
                services is care management for patients with only one chronic
                condition. The current CCM codes require patients to have two or more
                chronic conditions. These codes are primarily billed by practitioners
                who are managing a patient's total care over a month, including primary
                care practitioners and some specialists such as cardiologists or
                nephrologists. We have heard from a number of stakeholders, especially
                those in specialties that use the office/outpatient E/M code set to
                report the majority of their services, that there can be significant
                resources involved in care management for a single high risk disease or
                complex chronic condition that is not well accounted for in existing
                coding (FR 78 74415). This issue has also been raised by the
                stakeholder community in proposal submissions to the Physician-Focused
                Payment Model Technical Advisory Committee (PTAC), which are available
                at https://aspe.hhs.gov/ptac-physician-focused-payment-model-technical-advisory-committee. Therefore, we are proposing separate coding and
                payment for Principal Care Management (PCM) services, which describe
                care management services for one serious chronic condition. A
                qualifying condition would typically be expected to last between three
                months and a year, or until the death of the patient, may have led to a
                recent hospitalization, and/or place the patient at significant risk of
                death, acute exacerbation/decompensation, or functional decline.
                    While we are not proposing any restrictions on the specialties that
                could bill for PCM, we expect that most of these services would be
                billed by specialists who are focused on managing patients with a
                single complex chronic condition requiring substantial care management.
                We expect that, in most instances, initiation of PCM would be triggered
                by an exacerbation of the patient's complex chronic condition or recent
                hospitalization such that disease-specific care management is
                warranted. We anticipate that in the majority of instances, PCM
                services would be billed when a single condition is of such complexity
                that it could not be managed as effectively in the primary care
                setting, and instead requires management by another, more specialized,
                practitioner. For example, a typical patient may present to their
                primary care practitioner with an exacerbation of an existing chronic
                condition. While the primary care practitioner may be able to provide
                care management services for this one complex chronic condition, it is
                also possible that the primary care practitioner and/or the patient
                could instead decide that another clinician should provide relevant
                care management services. In this case, the primary care practitioner
                would still oversee the overall care for the patient while the
                practitioner billing for PCM services would provide care management
                services for the specific complex chronic condition. The treating
                clinician may need to provide a disease-specific care plan or may need
                to make frequent adjustments to the patient's medication regimen. The
                expected outcome of PCM is for the patient's condition to be stabilized
                by the treating clinician so that overall care management for the
                patient's condition can be returned to the patient's primary care
                practitioner. If the beneficiary only has one complex chronic condition
                that is overseen by the primary care practitioner, then the primary
                care practitioner would also be able to bill for PCM services. We are
                proposing that PCM services include coordination of medical and/or
                psychosocial care related to the single complex chronic condition,
                provided by a physician or clinical staff under the direction of a
                physician or other qualified health care professional.
                    We anticipate that many patients will have more than one complex
                chronic condition. If a clinician is providing PCM services for one
                complex chronic condition, management of the patient's other conditions
                would continue to be managed by the primary care practitioner while the
                patient is receiving PCM services for a single complex condition. It is
                also possible that the patient could receive PCM services from more
                than one clinician if the patient experiences an exacerbation of more
                than one complex chronic condition simultaneously.
                    For CY 2020, we are proposing to make separate payment for PCM
                services via two new G codes: HCPCS code GPPP1 (Comprehensive care
                management services for a single high-risk disease, e.g., Principal
                Care Management, at least 30 minutes of physician or other qualified
                health care professional time per calendar month with the following
                elements: One complex chronic condition lasting at least 3 months,
                which is the focus of the care plan, the condition is of sufficient
                severity to place patient at risk of hospitalization or have been the
                cause of a recent hospitalization, the condition requires development
                or revision of disease-specific care plan, the condition requires
                frequent adjustments in the medication regimen, and/or the management
                of the condition is unusually complex due to comorbidities) and HCPCS
                code GPPP2 (Comprehensive care management for a single high-risk
                disease services, e.g., Principal Care Management, at least 30 minutes
                of clinical staff time directed by a physician or other qualified
                health care professional, per calendar month with the following
                elements: One complex chronic condition lasting at least 3 months,
                which is the focus of the care plan, the condition is of sufficient
                severity to place patient at risk of hospitalization or have been cause
                of a recent hospitalization, the condition requires development or
                revision of disease-specific care plan, the condition requires frequent
                adjustments in the medication regimen, and/or the management of the
                condition is unusually complex due to comorbidities). HCPCS code GPPP1
                would be reported when, during the calendar month, at least 30 minutes
                of physician or other qualified health care provider time is spent on
                comprehensive care management for a
                [[Page 40554]]
                single high risk disease or complex chronic condition. HCPCS code GPPP2
                would be reported when, during the calendar month, at least 30 minutes
                of clinical staff time is spent on comprehensive management for a
                single high risk disease or complex chronic condition.
                    For HCPCS code GPPP1, we are proposing a crosswalk to the work
                value associated with CPT code 99217 (Observation care discharge day
                management (This code is to be utilized to report all services provided
                to a patient on discharge from outpatient hospital ``observation
                status'' if the discharge is on other than the initial date of
                ``observation status.'' To report services to a patient designated as
                ``observation status'' or ``inpatient status'' and discharged on the
                same date, use the codes for Observation or Inpatient Care Services
                [including Admission and Discharge Services, 99234-99236 as
                appropriate])) as we believe these values most accurately reflect the
                resource costs associated when the billing practitioner performs PCM
                services. CPT code 99217 has the same intraservice time as HCPCS code
                GPPP1 and the physician work is of similar intensity. Therefore, we are
                proposing a work RVU of 1.28 for HCPCS code GPPP1.
                    For HCPCS code GPPP2 we are proposing a crosswalk to the work and
                PE inputs associated with CPT code 99490 (clinical staff non-complex
                CCM) as we believe these values reflect the resource costs associated
                with the clinician's direction of clinical staff who are performing the
                PCM services, and the intraservice times and intensity of the work for
                the two codes would be the same. Therefore, we are proposing a work RVU
                of 0.61 for HCPCS code GPPP2.
                    While we are proposing separate coding and payment for PCM services
                performed by clinical staff with the oversight of the billing
                professional and services furnished directly by the billing
                professional, we are seeking comment on whether both codes are
                necessary to appropriately describe and bill for PCM services. We note
                that we are basing this coding structure on the codes for CCM services
                with CPT code 99491 reflecting care management by the billing
                professional and CPT code 99490 reflecting care management by clinical
                staff directed by a physician or other qualified health care
                professional.
                    We acknowledge that we are concurrently proposing revisions for
                both complex and non-complex CCM services. Were we not to finalize the
                proposed changes for both complex and non-complex CCM services, we
                believe that the overall structure and description of the CCM services
                remain close enough to serve as a model for the coding structure and
                description of services for the proposed PCM services. We are seeking
                public comment on whether it would be appropriate to create an add-on
                code for additional time spent each month (similar to HCPCS code GCCC2
                discussed above) when PCM services are furnished by clinical staff
                under the direction of the billing practitioner.
                    While we believe that PCM services describe a situation where a
                patient's condition is severe enough to require care management for a
                single complex chronic condition beyond what is described by CCM or
                performed in the primary care setting, we are concerned that a possible
                unintended consequence of making separate payment for care management
                for a single chronic condition is that a patient with multiple chronic
                conditions could have their care managed by multiple practitioners,
                each only billing for PCM, which could potentially result in fragmented
                patient care, overlaps in services, and duplicative services. While we
                are not proposing additional requirements for the proposed PCM
                services, we did consider alternatives such as requiring that the
                practitioner billing PCM must document ongoing communication with the
                patient's primary care practitioner to demonstrate that there is
                continuity of care between the specialist and primary care settings, or
                requiring that the patient have had a face-to-face visit with the
                practitioner billing PCM within the prior 30 days to demonstrate that
                they have an ongoing relationship. We are seeking comment on whether
                requirements such as these are necessary or appropriate, and whether
                there should be additional requirements to prevent potential care
                fragmentation or service duplication.
                    Due to the similarity between the description of the PCM and CCM
                services, both of which involve non-face-to-face care management
                services, we are proposing that the full CCM scope of service
                requirements apply to PCM, including documenting the patient's verbal
                consent in the medical record. We are seeking comment on whether there
                are required elements of CCM services that the public and stakeholders
                believe should not be applicable to PCM, and should be removed or
                altered. A high level summary of these requirements is available in
                Table 18 and available at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf. Both the initiating visit and the patient's
                verbal consent are necessary as not all patients who meet the criteria
                to receive separately billable PCM services may want to receive these
                services. The beneficiary should be educated as to what PCM services
                are and any cost sharing that may apply. Additionally, as practitioners
                have informed us that beneficiary cost sharing is a significant barrier
                to provision of other care management services, we are seeking comment
                on how best to educate practitioners and beneficiaries on the benefits
                of PCM services.
                    Additionally, we are proposing to add GPPP2 to the list of
                designated care management services for which we allow general
                supervision as described in our regulation at Sec.  410.26(b)(5). Due
                to the potential for duplicative payment, we are proposing that PCM
                could not be billed by the same practitioner for the same patient
                concurrent with certain other care management services, such as CCM,
                behavioral health integration services, and monthly capitated ESRD
                payments. We are also proposing that PCM would not be billable by the
                same practitioner for the same patient during a surgical global period,
                as we believe those resource costs would already be included in the
                valuation of the global surgical code.
                           Table 18--Chronic Care Management Services Summary
                ------------------------------------------------------------------------
                                          CCM Service Summary *
                -------------------------------------------------------------------------
                Verbal Consent:
                     Inform regarding availability of the service; that only one
                     practitioner can bill per month; the right to stop services
                     effective at the end of any service period; and that cost sharing
                     applies (if no supplemental insurance).
                     Document that consent was obtained.
                Initiating Visit for New Patients (separately paid).
                Certified Electronic Health Record (EHR) Use:
                     Structured Recording of Core Patient Information Using
                     Certified EHR (demographics, problem list, medications, allergies).
                [[Page 40555]]
                
                24/7 Access (``On Call'' Service).
                Designated Care Team Member.
                Comprehensive Care Management:
                     Systematic needs assessment (medical and psychosocial).
                     Ensure receipt of preventive services.
                     Medication reconciliation, management and oversight of self-
                     management.
                Comprehensive Electronic Care Plan:
                     Plan is available timely within and outside the practice
                     (can include fax).
                     Copy of care plan to patient/caregiver (format not
                     prescribed).
                     Establish, implement, revise or monitor the plan.
                Management of Care Transitions/Referrals (e.g., discharges, ED visit
                 follow up, referrals):
                     Create/exchange continuity of care document(s) timely
                     (format not prescribed).
                Home- and Community-Based Care Coordination:
                     Coordinate with any home- and community-based clinical
                     service providers, and document communication with them regarding
                     psychosocial needs and functional deficits.
                Enhanced Communication Opportunities:
                     Offer asynchronous non-face-to-face methods other than
                     telephone, such as secure email.
                ------------------------------------------------------------------------
                * All elements that are medically reasonable and necessary must be
                  furnished during the month, but all elements do not necessarily apply
                  every month. Consent need only be obtained once, and initiating visits
                  are only for new patients or patients not seen within a year prior to
                  initiation of CCM.
                    We are also seeking comment on any potential for duplicative
                payment between the proposed PCM services and other services, such as
                interprofessional consultation services (CPT codes 99446-99449
                (Interprofessional telephone/internet/electronic health record
                assessment and management service provided by a consultative physician,
                including a verbal and written report to the patient's treating/
                requesting physician or other qualified health care professional), CPT
                code 99451 (Interprofessional telephone/internet/electronic health
                record assessment and management service provided by a consultative
                physician, including a written report to the patient's treating/
                requesting physician or other qualified health care professional, 5
                minutes or more of medical consultative time), and CPT code 99452
                (Interprofessional telephone/internet/electronic health record referral
                service(s) provided by a treating/requesting physician or other
                qualified health care professional, 30 minutes)) or remote patient
                monitoring (CPT code 99091 (Collection and interpretation of
                physiologic data (e.g., ECG, blood pressure, glucose monitoring)
                digitally stored and/or transmitted by the patient and/or caregiver to
                the physician or other qualified health care professional, qualified by
                education, training, licensure/regulation (when applicable) requiring a
                minimum of 30 minutes of time, each 30 days), CPT code 99453 (Remote
                monitoring of physiologic parameter(s) (e.g., weight, blood pressure,
                pulse oximetry, respiratory flow rate), initial; set-up and patient
                education on use of equipment), and CPT code 99457 (Remote physiologic
                monitoring treatment management services, 20 minutes or more of
                clinical staff/physician/other qualified health care professional time
                in a calendar month requiring interactive communication with the
                patient/caregiver during the month)).
                5. Chronic Care Remote Physiologic Monitoring Services
                    Chronic Care remote physiologic monitoring (RPM) services involve
                the collection, analysis, and interpretation of digitally collected
                physiologic data, followed by the development of a treatment plan, and
                the managing of a patient under the treatment plan. The current CPT
                code 99457 is a treatment management code, billable after 20 minutes or
                more of clinical staff/physician/other qualified professional time with
                a patient in a calendar month.
                    In September 2018, the CPT Editorial Panel revised the CPT code
                structure for CPT code 99457 effective beginning in CY 2020. The new
                code structure retains CPT code 99457 as a base code that describes the
                first 20 minutes of the treatment management services, and uses a new
                add-on code to describe subsequent 20 minute intervals of the service.
                The new code descriptors for CY 2020 are: CPT code 99457 (Remote
                physiologic monitoring treatment management services, clinical staff/
                physician/other qualified health care professional time in a calendar
                month requiring interactive communication with the patient/caregiver
                during the month; initial 20 minutes) and CPT code 994X0 (Remote
                physiologic monitoring treatment management services, clinical staff/
                physician/other qualified health care professional time in a calendar
                month requiring interactive communication with the patient/caregiver
                during the month; additional 20 minutes).
                    In considering the work RVUs for the new add-on CPT code 994X0, we
                first considered the value of its base code. We previously valued the
                base code at 0.61 work RVUs. Given the value of the base code, we do
                not agree with the RUC-recommended work RVU of 0.61 for the add-on
                code. Instead, we are proposing a work RVU of 0.50 for the add-on code.
                This value is supported by CPT code 88381 (Microdissection (i.e.,
                sample preparation of microscopically identified target); manual),
                which has the same intraservice and total times of 20 minutes with an
                XXX global period and work RVU of 0.53, as well as the survey value at
                the 25th percentile. We are proposing the RUC-recommended direct PE
                inputs for CPT code 994X0.
                    Finally, we are proposing that RPM services reported with CPT codes
                99457 and 994X0 may be furnished under general supervision rather than
                the currently required direct supervision. Because care management
                services include establishing, implementing, revising, or monitoring
                treatment plans, as well as providing support services, and because RPM
                services (that is, CPT codes 99457 and 994X0) include establishing,
                implementing, revising, and monitoring a specific treatment plan for a
                patient related to one or more chronic conditions that are monitored
                remotely, we believe that CPT codes 99457 and 994X0 should be included
                as designated care management services. Designated care management
                services can be furnished under general
                [[Page 40556]]
                supervision. Section 410.26(b)(5) of our regulations states that
                designated care management services can be furnished under the general
                supervision of the ``physician or other qualified health care
                professional (who is qualified by education, training, licensure/
                regulation and facility privileging)'' (see also 2019 CPT Codebook,
                page xii) when these services or supplies are provided incident to the
                services of a physician or other qualified healthcare professional. The
                physician or other qualified healthcare professional supervising the
                auxiliary personnel need not be the same individual treating the
                patient more broadly. However, only the supervising physician or other
                qualified healthcare professional may bill Medicare for incident to
                services.
                6. Comment Solicitation on Consent for Communication Technology-Based
                Services
                    In the CY 2019 PFS Final Rule, CMS finalized separate payment for a
                number of services that could be furnished via telecommunications
                technology. Specifically, CMS finalized HCPCS code G2010 (Remote
                evaluation of recorded video and/or images submitted by an established
                patient (e.g., store and forward), including interpretation with
                follow-up with the patient within 24 business hours, not originating
                from a related E/M service provided within the previous 7 days nor
                leading to an E/M service or procedure within the next 24 hours or
                soonest available appointment)), HCPCS code G2012 (Brief communication
                technology-based service, e.g. virtual check-in, by a physician or
                other qualified health care professional who can report evaluation and
                management services, provided to an established patient, not
                originating from a related E/M service provided within the previous 7
                days nor leading to an E/M service or procedure within the next 24
                hours or soonest available appointment; 5-10 minutes of medical
                discussion)), CPT codes 99446-99449 (Interprofessional telephone/
                internet/electronic health record assessment and management service
                provided by a consultative physician, including a verbal and written
                report to the patient's treating/requesting physician or other
                qualified health care professional), CPT code 99451 (Interprofessional
                telephone/internet/electronic health record assessment and management
                service provided by a consultative physician, including a written
                report to the patient's treating/requesting physician or other
                qualified health care professional, 5 minutes or more of medical
                consultative time), and CPT code 99452 (Interprofessional telephone/
                internet/electronic health record referral service(s) provided by a
                treating/requesting physician or other qualified health care
                professional, 30 minutes).
                    As discussed in that rule, (83 FR 59490-59491), while a few
                commenters suggested that it would be less burdensome to obtain a
                general consent for multiple services at once, we stipulated that
                verbal consent must be documented in the medical record for each
                service furnished so that the beneficiary is aware of any applicable
                cost sharing. This is similar to the requirements for other non-face-
                to-face care management services under the PFS.
                    We have continued to hear from stakeholders that requiring advance
                beneficiary consent for each of these services is burdensome. For HCPCS
                codes G2010 and G2012, stakeholders have stated that it is difficult
                and burdensome to obtain consent at the outset of each of what are
                meant to be brief check-in services. For CPT codes 99446-99449, 99451
                and 99452, practitioners have informed us that it is particularly
                difficult for the consulting practitioner to obtain consent from a
                patient they have never seen. Given our longstanding goals to reduce
                burden and promote the use of communication technology-based services,
                we are seeking comment on whether a single advance beneficiary consent
                could be obtained for a number of communication technology-based
                services. During the consent process, the practitioner would make sure
                the beneficiary is aware that utilization of these services will result
                in a cost sharing obligation. We are seeking comment on the appropriate
                interval of time or number of services for which consent could be
                obtained, for example, for all these services furnished within a 6
                month or one year period, or for a set number of services, after which
                a new consent would need to be obtained. We are also seeking comment on
                the potential program integrity concerns associated with allowing
                advance consent and how best to minimize those concerns.
                7. Rural Health Clinics (RHCs) and Federally-Qualified Health Centers
                (FQHCs)
                    RHCs and FQHCs are paid for general care management services using
                HCPCS code G0511, which is an RHC and FQHC-specific G-code for 20
                minutes or more of CCM services, complex CCM services, or general
                behavioral health services. Payment for this service is set at the
                average of the national, non-facility payment rates for CPT codes
                99490, 99487, and 99484. We are proposing to use the non-facility
                payment rates for HCPCS codes GCCC1 and GCCC3 instead of the non-
                facility payment rates for CPT codes 99490 and 99487, respectively, if
                these changes are finalized for practitioners billing under the PFS. We
                note that we are not proposing any changes in the valuation of these
                codes. Upon finalization, the payment for HCPCS code G0511 would be set
                at the average of the national, non-facility payment rates for HCPCS
                codes GCCC1 and GCCC3 and CPT code 99484.
                L. Coinsurance for Colorectal Cancer Screening Tests
                    Section 1861(pp) of the Act defines ``colorectal cancer screening
                tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act,
                ``screening flexible sigmoidoscopy'' and ``screening colonoscopy'' are
                two of the recognized procedures. Among other things, section
                1861(pp)(1)(D) of the Act authorizes the Secretary to include other
                tests or procedures in the definition, and modifications to the tests
                and procedures described under this subsection, ``with such frequency
                and payment limits, as the Secretary determines appropriate, in
                consultation with appropriate organizations.'' Section 1861(s)(2)(R) of
                the Act includes these colorectal cancer screening tests in the
                definition of the medical and other health services that fall within
                the scope of Medicare Part B benefits described in section 1832(a)(1)
                of the Act. Section 1861(ddd)(3) of the Act includes these colorectal
                cancer screening services within the definition of ``preventive
                services.'' In addition, section 1833(a)(1)(Y) of the Act provides for
                payment for preventive services recommended by the United States
                Preventive Services Task Force (USPSTF) with a grade of A or B under
                the PFS at 100 percent of the lesser of the actual charge or the fee
                schedule amount for these colorectal cancer screening tests, and under
                the OPPS at 100 percent of the OPPS payment amount. As such, there is
                no beneficiary responsibility for coinsurance for recommended
                colorectal cancer screening tests as defined in section 1861(pp)(1) of
                the Act.
                    Under these statutory provisions, we have issued regulations
                governing payment for colorectal cancer screening tests at 42 CFR
                410.152(l)(5). We pay 100 percent of the Medicare payment amount
                established under the applicable payment methodology for the setting
                for providers and suppliers, and beneficiaries are not required to pay
                Part B coinsurance.
                [[Page 40557]]
                    In addition to screening tests, which typically are furnished to
                patients in the absence of signs or symptoms of illness or injury,
                Medicare also covers various diagnostic tests (Sec.  410.32). In
                general, diagnostic tests must be ordered by the physician or
                practitioner who is treating the beneficiary, and who uses the results
                of the diagnostic test in the management of the patient's specific
                medical problem. Under Part B, Medicare may cover flexible
                sigmoidoscopies and colonoscopies as diagnostic tests when those tests
                are reasonable and necessary as specified in section 1862(a)(1)(A) of
                the Act. When these services are furnished as diagnostic tests rather
                than as screening tests, patients are responsible for the Part B
                coinsurance (normally 20 percent) associated with these services.
                    We define ``colorectal cancer screening tests'' in our regulation
                at Sec.  410.37(a)(1) to include ``flexible screening sigmoidoscopies''
                and ``screening colonoscopies, including anesthesia furnished in
                conjunction with the service.'' Under our current policies, we exclude
                from the definition of colorectal screening services colonoscopies and
                sigmoidoscopies that begin as a screening service, but where a polyp or
                other growth is found and removed as part of the procedure. The
                exclusion of these services from the definition of colorectal cancer
                screening services is based upon separate provisions of the statute
                dealing with the detection of lesions or growths during procedures (62
                FR 59048, 59082, October 31, 1997). Section 1834(d)(2)(D) of the Act
                provides that if, during the course of a screening flexible
                sigmoidoscopy, a lesion or growth is detected which results in a biopsy
                or removal of the lesion or growth, payment under Medicare Part B shall
                not be made for the screening flexible sigmoidoscopy but shall be made
                for the procedure classified as a flexible sigmoidoscopy with such
                biopsy or removal. Similarly, section 1834(d)(3)(D) of the Act that
                provides if, during the course of a screening colonoscopy, a lesion or
                growth is detected which results in a biopsy or removal of the lesion
                or growth, payment under Medicare Part B shall not be made for the
                screening colonoscopy but shall be made for the procedure classified as
                a colonoscopy with such biopsy or removal.
                    Because we interpret sections 1834(d)(2)(C)(ii) and
                1834(d)(3)(C)(ii) of the Act to require us to pay for these tests as
                diagnostic tests, rather than as screening tests, the 100 percent
                payment rate for recommended preventive services under section
                1833(a)(1)(Y) of the Act, as codified in our regulation at Sec.
                410.152(l)(5), would not apply to those diagnostic procedures. As such,
                beneficiaries are responsible for the usual coinsurance that applies to
                the services (20 or 25 percent of the cost of the services depending on
                the setting).
                    Under section 1833(b) of the Act, before making payment under
                Medicare Part B for expenses incurred by a beneficiary for covered Part
                B services, beneficiaries must first meet the applicable deductible for
                the year. Section 4104 of the Affordable Care Act (that is, the Patient
                Protection and Affordable Care Act (Pub. L. 111-148, enacted March 23,
                2010), and the Health Care and Education Reconciliation Act of 2010
                (Pub. L. 111-152, enacted March 30, 2010), collectively referred to as
                the ``Affordable Care Act'') amended section 1833(b)(1) of the Act to
                make the deductible inapplicable to expenses incurred for certain
                preventive services that are recommended with a grade of A or B by the
                USPSTF, including colorectal cancer screening tests as defined in
                section 1861(pp) of the Act. Section 4104 of the Affordable Care Act
                also added a sentence at the end of section 1833(b)(1) of the Act
                specifying that the exception to the deductible shall apply with
                respect to a colorectal cancer screening test regardless of the code
                that is billed for the establishment of a diagnosis as a result of the
                test, or for the removal of tissue or other matter or other procedure
                that is furnished in connection with, as a result of, and in the same
                clinical encounter as the screening test. Although the Affordable Care
                Act addressed the applicability of the deductible in the case of a
                colorectal cancer screening test that involves biopsy or tissue
                removal, it did not alter the coinsurance provision in section 1833(a)
                of the Act for such procedures. Although public commenters encouraged
                the agency to also eliminate the coinsurance in these circumstances,
                the agency found that the statute did not provide for elimination of
                the coinsurance (75 FR 73170, 73431, November 29, 2010).
                    Beneficiaries have continued to contact us noting their
                ``surprise'' that a coinsurance (20 or 25 percent depending on the
                setting) applies when they expected to receive a colorectal screening
                procedure to which coinsurance does not apply, but instead received
                what Medicare considers to be a diagnostic procedure because polyps
                were discovered and removed. Similarly, physicians have also expressed
                concerns about the reactions of beneficiaries when they are informed
                that they will be responsible for coinsurance if polyps are discovered
                and removed during what they expected to be a screening procedure to
                which coinsurance does not apply. Other stakeholders and some members
                of Congress have regularly expressed to us that they consider the
                agency's policy on coinsurance for colorectal screening procedures
                during which tissue is removed to be a misinterpretation of the law.
                    Over the years, we have released a wide variety of publicly
                available educational materials that explain the Medicare preventive
                services benefits as part of our overall outreach activities to
                Medicare beneficiaries. These materials contain a complete description
                of the Medicare preventive services benefits, including information on
                colorectal cancer screening, and also provide relevant details on the
                applicability of cost sharing. These materials can be found at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243319.html. We believe that the
                information in these materials can be instrumental in continuing to
                educate physicians and beneficiaries about cost sharing obligations in
                order to mitigate instances of ``surprise'' billing. We invite comment
                on whether we should consider establishing a requirement that the
                physician who plans to furnish a colorectal cancer screening notify the
                patient in advance that a screening procedure could result in a
                diagnostic procedure if polyps are discovered and removed, and that
                coinsurance may apply. We specifically invite comment on whether we
                should require the physician, or their staff, to provide a verbal
                notice with a notation in the medical record, or whether we should
                consider a different approach to informing patients of the copay
                implications, such as a written notice with standard language that we
                would require the physician, or their staff, to provide to patients
                prior to a colorectal cancer screening. We note that we would consider
                adopting such a requirement in the final rule in accordance with public
                comments. We also invite comment on what mechanism, if any, we should
                consider using to monitor compliance with a notification requirement if
                we decide to finalize one for CY 2020 or through future rulemaking.
                [[Page 40558]]
                M. Therapy Services
                1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate
                Therapy
                a. Background
                    In the CY 2019 PFS proposed and final rules (83 FR 34850; 83 FR
                59654 and 59661), we discussed the statutory requirements of section
                50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-
                123, February 9, 2018). Beginning January 1, 2018, section 50202 of the
                BBA of 2018 repealed the Medicare outpatient therapy caps and the
                therapy cap exceptions process, while retaining the cap amounts as
                limitations and requiring medical review to ensure that therapy
                services are furnished when appropriate. Section 50202 of the BBA of
                2018 amended section 1833(g) of the Act by adding a new paragraph
                (7)(A) requiring that after expenses incurred for the beneficiary's
                outpatient therapy services for the year have exceeded one or both of
                the previous therapy cap amounts, all therapy suppliers and providers
                must continue to use an appropriate modifier on claims. We implemented
                this provision by continuing to require use of the existing KX
                modifier. By using the KX modifier on the claim, the therapy supplier
                or provider is attesting that the services are medically necessary and
                that supportive justification is documented in the medical record. As
                with the incurred expenses for the prior therapy cap amounts, there is
                one amount for physical therapy (PT) and speech language pathology
                (SLP) services combined, and a separate amount for occupational therapy
                (OT) services. These KX modifier threshold amounts are indexed annually
                by the Medicare Economic Index (MEI). After the beneficiary's incurred
                expenditures for outpatient therapy services exceed the KX modifier
                threshold amount for the year, claims for outpatient therapy services
                without the KX modifier are denied.
                    Section 50202 of the BBA of 2018 also added a new paragraph 7(B) to
                section 1833(g) of the Act which retained the targeted medical review
                (MR) process for 2018 and subsequent years, but established a lower
                threshold amount of $3,000 rather than the $3,700 threshold amount that
                had applied for the original manual MR process established by section
                3005(g) of the Middle Class Tax Relief and Jobs Creation Act of 2012
                (MCTRJCA) (Pub. L. 112-96, February 22, 2012). The manual MR process
                with a threshold amount of $3,700 was replaced by the targeted MR
                process with the same threshold amount through amendments made by
                section 202 of the Medicare Access and CHIP Reauthorization Act of 2015
                (MACRA) (Pub. L. 114-10, April 16, 2015).
                    With the latest amendments made by the BBA of 2018, for CY 2018
                (and each successive calendar year until 2028, at which time it is
                indexed annually by the MEI), the MR threshold is $3,000 for PT and SLP
                services and $3,000 for OT services. For purposes of applying the
                targeted MR process, we use a criteria-based process for selecting
                providers and suppliers that includes factors such as a high percentage
                of patients receiving therapy beyond the medical review threshold as
                compared to peers. For information on the targeted medical review
                process, please visit https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/TherapyCap.html.
                    In the CY 2019 PFS final rule (83 FR 59661), when discussing our
                tracking and accrual process for outpatient therapy services in the
                section on the KX Threshold Amounts, we noted that we track each
                beneficiary's incurred expenses for therapy services annually by
                applying the PFS-based payment amount for each service less any
                applicable multiple procedure reduction for CMS-designated ``always
                therapy'' services. We also stated that we use the PFS rates to accrue
                expenses for therapy services provided in critical access hospitals
                (CAHs) as required by section 1833(g)(6)(B) of the Act, added by
                section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub.
                L. 112-240, January 2, 2013). As discussed below, we mistakenly
                indicated that this statutory requirement was extended by subsequent
                legislation, including section 50202 of the BBA of 2018.
                b. Proposed Regulatory Revisions
                    While we explained and implemented the changes required by section
                50202 of the BBA of 2018 in CY 2019 PFS rulemaking (83 FR 34850; 83 FR
                59654 and 59661), we did not codify those changes in regulation text.
                We are now proposing to revise the regulations at Sec. Sec.  410.59
                (outpatient occupational therapy) and 410.60 (physical therapy and
                speech-language pathology) to incorporate the changes made by section
                50202 of the BBA of 2018. We propose to add a new paragraph (e)(1)(v)
                to Sec. Sec.  410.59 and 410.60 to clarify that the specified amounts
                of annual per-beneficiary incurred expenses are no longer applied as
                limitations but as threshold amounts above which services require, as a
                condition of payment, inclusion of the KX modifier; and that use of the
                KX modifier confirms that the services are medically necessary as
                justified by appropriate documentation in the patient's medical record.
                We propose to amend paragraph (e)(2) in Sec. Sec.  410.59 and 410.60 to
                specify the therapy services and amounts that are accrued for purposes
                of applying the KX modifier threshold, including the continued accrual
                of therapy services furnished by CAHs directly or under arrangements at
                the PFS-based payment rates. We are also proposing to amend paragraph
                (e)(3) in Sec. Sec.  410.59 and 410.60 for the purpose of applying the
                medical review threshold to clarify the threshold amounts and the
                applicable years for both the manual MR process originally established
                through section 3005(g) of MCTRJCA and the targeted MR process
                established by the MACRA, and including the changes made through
                section 50202 of the BBA of 2018 as discussed previously.
                    In the CY 2019 PFS final rule (83 FR 59661), we incorrectly stated
                that section 1833(g)(6)(B) of the Act continues to require that we
                accrue expenses for therapy services furnished by CAHs at the PFS rate
                because the provision, originally added by section 603(b) of the ATRA,
                was extended by subsequent legislation, including section 50202 of the
                BBA of 2018. The requirement in section 1833(g)(6)(B) of the Act was
                actually time-limited to services furnished in CY 2013. To apply the
                therapy caps (and now the KX modifier thresholds) after the expiration
                of the requirement in 1833(g)(6)(B) of the Act, we needed a process to
                accrue the annual expenses for therapy services furnished by CAHs and,
                in the CY 2014 PFS final rule with comment period, we elected to
                continue the process prescribed in section 1833(g)(6)(B) of the Act (78
                FR 74405 through 74410).
                2. Proposed Payment for Outpatient PT and OT Services Furnished by
                Therapy Assistants
                a. Background
                    Section 53107 of the BBA of 2018 added a new subsection 1834(v) to
                the Act to require in paragraph (1) that, for services furnished on or
                after January 1, 2022, payment for outpatient physical and occupational
                therapy services for which payment is made under sections 1848 or
                1834(k) of the Act which are furnished in whole or in part by a therapy
                assistant must be paid at 85 percent of the amount that is otherwise
                applicable. Section 1834(v)(2) of the Act further required that we
                establish a modifier to identify these services by January 1, 2019, and
                that claims for outpatient therapy services furnished in
                [[Page 40559]]
                whole or in part by a therapy assistant must include the modifier
                effective for dates of service beginning on January 1, 2020. Section
                1834(v)(3) of the Act required that we implement the subsection through
                notice and comment rulemaking.
                    In the CY 2019 PFS proposed and final rules (83 FR 35850 through
                35852 and 83 FR 59654 through 50660, respectively), we established two
                modifiers--one to identify services furnished in whole or in part by a
                physical therapist assistant (PTA) and the other to identify services
                furnished in whole or in part by an occupational therapy assistant
                (OTA). The modifiers are defined as follows:
                     CQ Modifier: Outpatient physical therapy services
                furnished in whole or in part by a physical therapist assistant.
                     CO Modifier: Outpatient occupational therapy services
                furnished in whole or in part by an occupational therapy assistant.
                    In the CY 2019 PFS final rule, we clarified that the CQ and CO
                modifiers are required to be used when applicable for services
                furnished on or after January 1, 2020, on the claim line of the service
                alongside the respective GP or GO therapy modifier to identify services
                furnished under a PT or OT plan of care. The GP and GO therapy
                modifiers, along with the GN modifier for speech-language pathology
                (SLP) services, have been used since 1998 to track and accrue the per-
                beneficiary incurred expenses amounts to different therapy caps, now KX
                modifier thresholds, one amount for PT and SLP services combined and a
                separate amount for OT services. We also clarified in the CY 2019 PFS
                final rule that the CQ and CO modifiers will trigger application of the
                reduced payment rate for outpatient therapy services furnished in whole
                or in part by a PTA or OTA, beginning for services furnished in CY
                2022.
                    In response to public comments on the CY 2019 PFS proposed rule, we
                did not finalize our proposed definition of ``furnished in whole or in
                part by a PTA or OTA'' as a service for which any minute of a
                therapeutic service is furnished by a PTA or OTA. Instead, we finalized
                a de minimis standard under which a service is considered to be
                furnished in whole or in part by a PTA or OTA when more than 10 percent
                of the service is furnished by the PTA or OTA.
                    We also explained in the CY 2019 PFS proposed and final rules (83
                FR 35850 through 35852 and 83 FR 59654 through 59660, respectively)
                that the CQ and CO modifiers would not apply to claims for outpatient
                therapy services that are furnished by, or incident to the services of,
                physicians or nonphysician practitioners (NPPs) including nurse
                practitioners, physician assistants, and clinical nurse specialists.
                This is because our regulations for outpatient physical and
                occupational therapy services require that an individual furnishing
                outpatient therapy services incident to the services of a physician or
                NPP must meet the qualifications and standards for a therapist. As
                such, only therapists and not therapy assistants can furnish outpatient
                therapy services incident to the services of a physician or NPP (83 FR
                59655 through 59656); and, the new PTA and OTA modifiers cannot be used
                on the line of service of the professional claim when the rendering NPI
                identified on the claim is a physician or an NPP. We also intend to
                revise our manual provisions at Pub. 100-02, Medicare Benefit Policy
                Manual (MBPM), Chapter 15, section 230, as appropriate, to reflect
                requirements for the new CQ and CO modifiers that will be used to
                identify services furnished in whole or in part by a PTA or OTA
                starting in CY 2020. We anticipate amending these manual provisions for
                CY 2020 to reflect the policies we adopt through the CY 2020 PFS notice
                and comment rulemaking process.
                    In PFS rulemaking for CY 2019, we identified certain situations
                when the therapy assistant modifiers do apply. The modifiers are
                applicable to:
                     Therapeutic portions of outpatient therapy services
                furnished by PTAs/OTAs, as opposed to administrative or other non-
                therapeutic services that can be performed by others without the
                education and training of OTAs and PTAs.
                     Services wholly furnished by PTAs or OTAs without physical
                or occupational therapists.
                     Evaluative services that are furnished in part by PTAs/
                OTAs (keeping in mind that PTAs/OTAs are not recognized to wholly
                furnish PT and OT evaluation or re-evaluations).
                    We also identified some situations when the therapy assistant
                modifiers do not apply. They do not apply when:
                     PTAs/OTAs furnish services that can be done by a
                technician or aide who does not have the training and education of a
                PTA/OTA.
                     Therapists exclusively furnish services without the
                involvement of PTAs/OTAs.
                    Finally, we noted that we would be further addressing application
                of the modifiers for therapy assistant services and the 10 percent de
                minimis standard more specifically in PFS rulemaking for CY 2020,
                including how the modifiers are applied in different scenarios for
                different types of services.
                b. Applying the CQ and CO Modifiers
                    CMS interprets the references in section 1834(v)(1) and (2) of the
                Act to outpatient physical therapy ``service'' and outpatient
                occupational therapy ``service'' to mean a specific procedure code that
                describes a PT or OT service. This interpretation makes sense because
                section 1834(v)(2) of the Act requires the use of a modifier to
                identify on each request for payment, or bill submitted for an
                outpatient therapy service furnished in whole or in part by a PTA/OTA.
                For purposes of billing, each outpatient therapy service is identified
                by a procedure code.
                    To apply the de minimis standard under which a service is
                considered to be furnished in whole or in part by a PTA or OTA when
                more than 10 percent of the service is furnished by the PTA or OTA, we
                propose to make the 10 percent calculation based on the respective
                therapeutic minutes of time spent by the therapist and the PTA/OTA,
                rounded to the nearest whole minute. The minutes of time spent by a
                PTA/OTA furnishing a therapeutic service can overlap partially or
                completely with the time spent by a physical or occupational therapist
                furnishing the service. We propose that the total time for a service
                would be the total time spent by the therapist (whether independent of,
                or concurrent with, a PTA/OTA) plus any additional time spent by the
                PTA/OTA independently furnishing the therapeutic service. When deciding
                whether the therapy assistant modifiers apply, we propose that if the
                PTA/OTA participates in the service concurrently with the therapist for
                only a portion of the total time that the therapist delivers a service,
                the CQ/CO modifiers apply when the minutes furnished by the therapy
                assistant are greater than 10 percent of the total minutes spent by the
                therapist furnishing the service. If the PTA/OTA and the therapist each
                separately furnish portions of the same service, we propose that the
                CQ/CO modifiers would apply when the minutes furnished by the therapy
                assistant are greater than 10 percent of the total minutes--the sum of
                the minutes spent by the therapist and therapy assistant--for that
                service. We propose to apply the CQ/CO modifier policies to all
                services that would be billed with the respective GP or GO therapy
                modifier. We believe this is appropriate because it is the same way
                that CMS currently identifies physical therapy or occupational therapy
                services for purposes of accruing incurred expenses for the thresholds
                and targeted review process.
                [[Page 40560]]
                    For purposes of deciding whether the 10 percent de minimis standard
                is exceeded, we offer two different ways to compute this. The first is
                to divide the PTA/OTA minutes by the total minutes for the service--
                which is (a) the therapist's total time when PTA/OTA minutes are
                furnished concurrently with the therapist, or (b) the sum of the PTA/
                OTA and therapist minutes when the PTA/OTA's services are furnished
                separately from the therapist; and then to multiply this number by 100
                to calculate the percentage of the service that involves the PTA/OTA.
                We propose to round to the nearest whole number so that when this
                percentage is 11 percent or greater, the 10 percent de minimis standard
                is exceeded and the CQ/CO modifier is applied. The other method is
                simply to divide the total time for the service (as described above) by
                10 to identify the 10 percent de minimis standard, and then to add one
                minute to identify the number of minutes of service by the PTA/OTA that
                would be needed to exceed the 10 percent standard. For example, where
                the total time of a service is 60 minutes, the 10 percent standard is
                six (6) minutes, and adding one minute yields seven (7) minutes. Once
                the PTA/OTA furnishes at least 7 minutes of the service, the CQ/CO
                modifier is required to be added to the claim for that service. As
                noted above, we propose to round the minutes and percentages of the
                service to the nearest whole integer. For example, when the total time
                for the service is 45 minutes, the 10 percent calculation would be 4.5
                which would be rounded up to 5, and the PTA/OTA's contribution would
                need to meet or exceed 6 minutes before the CQ/CO modifier is required
                to be reported on the claim. See Table 19 for minutes needed to meet or
                exceed using the ``simple'' method with typical times for the total
                time of a therapy service.
                                       Table 19--Simple Method for Determining When CQ/CO Modifiers Apply
                ----------------------------------------------------------------------------------------------------------------
                                        Method Two: simple method to apply 10 percent de minimis standard
                -----------------------------------------------------------------------------------------------------------------
                                               Determine the 10 percent
                Total Time * examples using      standard by dividing      Round 10 percent standard   PTA/OTA Minutes needed to
                typical service total times    service Total Time by 10      to next whole integer        exceed--apply CQ/CO
                ----------------------------------------------------------------------------------------------------------------
                                       10                          1.0                         1.0                         2.0
                                       15                          1.5                         2.0                         3.0
                                       20                          2.0                         2.0                         3.0
                                       30                          3.0                         3.0                         4.0
                                       45                          4.5                         5.0                         6.0
                                       60                          6.0                         6.0                         7.0
                                       75                          7.5                         8.0                         9.0
                ----------------------------------------------------------------------------------------------------------------
                Total Time equals total therapist minutes plus any PTA/OTA independent minutes. Concurrent minutes: When PTA/
                  OTA's minutes are furnished concurrently with the therapist, total time equals the total minutes of the
                  therapist's service. Separate minutes: When PTA/OTA's minutes are furnished separately from the minutes
                  furnished by the therapist, total time equals the sum of the minutes of the service furnished by the PT/OT
                  plus the minutes of the service furnished separately by the PTA/OTA.
                    We want to clarify that the 10 percent de minimis standard, and
                therefore the CQ/CO modifiers, are not applicable to services in which
                the PTA/OTA did not participate. To the extent that the PTA/OTA and the
                physical therapist/occupational therapist (PT/OT) separately furnish
                different services that are described by procedure codes defined in 15-
                minute increments, billing examples and proposed policies are included
                below in Scenario Two.
                    As we indicated in the CY 2019 PFS final rule, we are addressing
                more specifically in this proposed rule the application of the 10
                percent de minimis standard in various clinical scenarios to decide
                when the CQ/CO modifiers apply. We acknowledge that application of the
                10 percent de minimis standard can work differently depending on the
                types of services and scenarios involving both the PTA/OTA and the PT/
                OT. Therapy services are typically furnished in multiple units of the
                same or different services on a given treatment day, which can include
                untimed services (not billable in multiple units) and timed services
                that are defined by codes described in 15-minute intervals. The
                majority of the untimed services that therapists bill for fall into
                three categories: (1) Evaluative procedures, (2) group therapy, and (3)
                supervised modalities. We discuss each of these in greater detail
                below. Only one (1) unit can be reported in the claim field labeled
                ``units'' for each procedure code representing an untimed service. The
                preponderance of therapy services, though, are billed using codes that
                are described in 15-minute increments. These services are typically
                furnished to a patient on a single day in multiple units of the same
                and/or different services. Under our current policy, the total number
                of units of one or more timed services that can be added to a claim
                depends on the total time for all the 15-minute timed codes that were
                delivered to a patient on a single date of service. We address our
                proposals for applying the CQ/CO modifiers using the 10 percent de
                minimis standard, along with applicable billing scenarios, by category
                below. In each of these scenarios, we assume that the PTA/OTA minutes
                are for therapeutic services.
                     Evaluations and re-evaluations: CPT codes 97161 through
                97163 for physical therapy evaluations for low, moderate, and high
                complexity level, and CPT code 97164 for physical therapy re-
                evaluation; and CPT codes 97165 through 97167 for occupational therapy
                evaluations for low, moderate, and high complexity level, and CPT 97168
                for occupational therapy re-evaluation. These PT and OT evaluative
                procedures are untimed codes and cannot be billed in multiple units--
                one unit is billed on the claim. As discussed in CY 2019 PFS rulemaking
                (83 FR 35852 and 83 FR 59656) and noted above, PTAs/OTAs are not
                recognized to furnish evaluative or assessment services, but to the
                extent that they furnish a portion of an evaluation or re-evaluation
                (such as completing clinical labor tasks for each code) that exceeds
                the 10 percent de minimis standard, the appropriate therapy assistant
                modifier (CQ or CO) must be used on the claim. We note that it is
                possible for the PTA/OTA to furnish these minutes either concurrently
                or separately from the therapist. For example, when the PTA/OTA assists
                the PT/OT concurrently for a 5-minute portion of the 30 minutes that a
                PT or OT spent furnishing an evaluation (for example, CPT code 97162
                for moderate complexity PT evaluation or CPT code 97165 for a low
                complexity OT evaluation--each have a typical therapist face-to-face
                time of 30
                [[Page 40561]]
                minutes), the respective CQ or CO modifier is applied to the service
                because the 5 minutes surpasses the 10 percent de minimis standard. In
                other words, 10 percent of 30 minutes is 3 minutes, and the CQ or CO
                modifier applies if the PTA/OTA furnishes more than 3 minutes, meaning
                at least 4 minutes, of the service. If the PTA/OTA separately furnishes
                a portion of the service that takes 5 minutes (for example, performing
                clinical labor tasks such as obtaining vital signs, providing self-
                assessment tool to the patient and verifying its completion), and then
                the PT/OT separately (without the PTA/OTA) furnishes a 30 minute face-
                to-face evaluative procedure--bringing the total time of the service to
                35 minutes (the sum of the separate PTA/OTA minutes, that is, 5
                minutes, plus the 30-minute therapist service), the CQ or CO modifier
                would be applied to the service because the 5 minutes of OTA/PTA time
                exceeds 10 percent of the 35 total minutes for the service. In other
                words, 10 percent of 35 minutes is 3.5 minutes which is rounded up to 4
                minutes. The CQ or CO modifier would apply when the PTA/OTA furnishes 5
                or more minutes of the service, as discussed above and referenced in
                Table 19.
                     Group Therapy: CPT code 97150 (requires constant
                attendance of therapist or assistant, or both). CPT code 97150
                describes a service furnished to a group of 2 or more patients. Like
                evaluative services, this code is an untimed service and cannot be
                billed in multiple units on the claim, so one unit of the service is
                billed for each patient in the group. For the group service, the CQ/CO
                modifier would apply when the PTA/OTA wholly furnishes the service
                without the therapist. The CQ/CO modifier would also apply when the
                total minutes of the service furnished by the PTA/OTA (whether
                concurrently with, or separately from, the therapist), exceed 10
                percent of the total time, in minutes, of the group therapy service
                (that is, the total minutes of service spent by the therapist (with or
                without the PTA/OTA) plus any minutes spent by the PTA/OTA separately
                from the therapist). For example, the modifiers would apply when the
                PTA/OTA participates concurrently with the therapist for 5 minutes of a
                total group therapy service time of 40-minutes (based on the time of
                the therapist); or when the PTA/OTA separately furnishes 5 minutes of a
                total group time of 40 minutes (based on the sum of minutes of the PTA/
                OTA (5) and therapist (35)).
                     Supervised Modalities: CPT codes 97010 through 97028, and
                HCPCS codes G0281, G0183, and G0329. Modalities, in general, are
                physical agents that are applied to body tissue in order to produce a
                therapeutic change through various forms of energy, including but not
                limited to thermal, acoustic, light, mechanical or electric. Supervised
                modalities, for example vasopneumatic devices, paraffin bath, and
                electrical stimulation (unattended), do not require the constant
                attendance of the therapist or supervised therapy assistant, unlike the
                modalities defined in 15-minute increments that are discussed in the
                below category. When a supervised modality, such as whirlpool (CPT code
                97022), is provided without the direct contact of a PT/OT and/or PTA/
                OTA, that is, it is furnished entirely by a technician or aide, the
                service is not covered and cannot be billed to Medicare. Supervised
                modality services are untimed, so only one unit of the service can be
                billed regardless of the number of body areas that are treated. For
                example, when paraffin bath treatment is provided to both of the
                patient's hands, one unit of CPT code 97018 can be billed, not two. For
                supervised modalities, the CQ or CO modifier would apply to the service
                when the PTA/OTA fully furnishes all the minutes of the service, or
                when the minutes provided by the PTA or OTA exceed 10 percent of total
                minutes of the service. For example, the CQ/CO modifiers would apply
                when either (1) the PTA/OTA concurrently furnishes 2 minutes of a total
                8-minute service by the therapist furnishing paraffin bath treatment
                (HCPCS code 97018) because 2 minutes is greater than 10 percent of 8
                minutes (0.8 minute, or 1 minute after rounding); or (2) the PTA/OTA
                furnishes 3 minutes of the service separately from the therapist who
                furnishes 5 minutes of treatment for a total time of 8 minutes (total
                time equals the sum of the PT/OT minutes plus the separate PTA/OTA
                minutes) because 3 minutes is greater than 10 percent of 8 total
                minutes (0.8 minute rounded to 1 minute).
                     Services defined by 15-minute increments/units: These
                timed codes are included in the following current CPT code ranges: CPT
                codes 97032 through 97542--including the subset of codes for modalities
                in the series CPT codes 97032 through 97036; and, codes for procedures
                in the series CPT codes 97110-97542; CPT codes 97750-97755 for tests
                and measurements; and CPT codes: 97760-97763 for orthotic management
                and training and prosthetic training. Based on CPT instructions for
                these codes, the therapist (or their supervised therapy assistant, as
                appropriate) is required to furnish the service directly in a one-on-
                one encounter with the patient, meaning they are treating only one
                patient during that time. Examples of modalities requiring one-on-one
                patient contact include electrical stimulation (attended), CPT code
                97032, and ultrasound, CPT code 97035. Examples of procedures include
                therapeutic exercise, CPT code 97110, neuromuscular reeducation, CPT
                97112, and gait training, CPT code 97116.
                    Our policy for reporting of service units with HCPCS codes for both
                untimed services and timed services (that is, only those therapy
                services defined in 15-minute increments) is explained in section 20.2
                of Chapter 5 of the Medicare Claims Processing Manual (MCPM). To bill
                for services described by the timed codes (hereafter, those codes
                described per each 15-minutes) furnished to a patient on a date of
                service, the therapist or therapy assistant needs to first identify all
                timed services furnished to a patient on that day, and then total all
                the minutes of all those timed codes. Next, the therapist or therapy
                assistant needs to identify the total number of units of timed codes
                that can be reported on the claim for the physical or occupational
                therapy services for a patient in one treatment day. Once the number of
                billable units is identified, the therapist or therapy assistant
                assigns the appropriate number of unit(s) to each timed service code
                according to the total time spent furnishing each service. For example,
                to bill for one 15-minute unit of a timed code, the qualified
                professional (the therapist or therapy assistant) must furnish at least
                8 minutes and up to 22 minutes of the service; to bill for 2 units, at
                least 23 minutes and up to 37 minutes, and to bill for 3 units, at
                least 38 minutes and up to 52 minutes. We note that these minute ranges
                are applicable when one service, or multiple services, defined by timed
                codes are furnished by the qualified professional on a treatment day.
                We understand that the therapy industry often refers to these billing
                conventions as the ``eight-minute rule.'' The idea is that when a
                therapist or therapy provider bills for one or more units of services
                that are described by timed codes, the therapist's direct, one-on-one
                patient contact time would average 15 minutes per unit. This idea is
                also the basis for the work values we have established for these timed
                codes. Our current policies for billing of timed codes and related
                documentation do not take into consideration whether a service is
                furnished ``in whole or in
                [[Page 40562]]
                part'' by a PTA/OTA, or otherwise address the application of the CQ/CO
                modifier when the 10 percent de minimis standard is exceeded, for those
                services in which both the PTA/OTA and the PT/OT work together to
                furnish a service or services.
                    To support the number of 15-minute timed units billed on a claim
                for each treatment day, we require that the total timed-code treatment
                time be documented in the medical record, and that the treatment note
                must document each timed service, whether or not it is billed, because
                the unbilled timed service(s) can impact billing. The minutes that each
                service is furnished can be, but are not required to be, documented. We
                also require that each untimed service be documented in the treatment
                note in order to support these services billed on the claim; and, that
                the total treatment time for each treatment day be documented--
                including minutes spent providing services represented by the timed
                codes (the total timed-code treatment time) and the untimed codes. To
                minimize burden, we are not proposing changes to these documentation
                requirements in this proposed rule.
                    Beginning January 1, 2020, in order to provide support for
                application of the CQ/CO modifier(s) to the claim as required by
                section 1834(v)(2)(B) of the Act and our proposed regulations at
                Sec. Sec.  410.59(a)(4) and 410.60(a)(4), we propose to add a
                requirement that the treatment notes explain, via a short phrase or
                statement, the application or non-application of the CQ/CO modifier for
                each service furnished that day. We would include this documentation
                requirement in subsection in Chapter 15, MBPM, section 220.3.E on
                treatment notes. Because the CQ/CO modifiers also apply to untimed
                services, our proposal to revise our documentation requirement for the
                daily treatment note extends to those codes and services as well. For
                example, when PTAs/OTAs assist PTs/OTs to furnish services, the
                treatment note could state one of the following, as applicable: (a)
                ``Code 97110: CQ/CO modifier applied--PTA/OTA wholly furnished''; or,
                (b) ``Code 97150: CQ/CO modifier applied--PTA/OTA minutes = 15%''; or
                ``Code 97530: CQ/CP modifier not applied--PTA/OTA minutes less than 10%
                standard.'' For those therapy services furnished exclusively by
                therapists without the use of PTAs/OTA, the PT/OT could note one of the
                following: ``CQ/CO modifier NA'', or ``CQ/CO modifier NA--PT/OT fully
                furnished all services.'' Given that the minutes of service furnished
                by or with the PTA/OTA and the total time in minutes for each service
                (timed and untimed) are used to decide whether the CQ/CO modifier is
                applied to a service, we seek comment on whether it would be
                appropriate to require documentation of the minutes as part of the CQ/
                CO modifier explanation as a means to avoid possible additional burden
                associated with a contractor's medical review process conducted for
                these services. We are also interested in hearing from therapists and
                therapy providers about current burden associated with the medical
                review process based on our current policy that does not require the
                times for individual services to be documented. Based on comments
                received, if we were to adopt a policy to include documentation of the
                PTA/OTA minutes and total time (TT) minutes, the CQ/CO modifier
                explanation could read similar to the following: ``Code 97162 (TT = 30
                minutes): CQ/CO modifier not applied--PTA/OTA minutes (3) did not
                exceed the 10 percent standard.''
                    To recap, under our proposed policy, therapists or therapy
                assistants would apply the therapy assistant modifiers to the timed
                codes by first following the usual process to identify all procedure
                codes for the 15-minute timed services furnished to a beneficiary on
                the date of service, add up all the minutes of the timed codes
                furnished to the beneficiary on the date of service, decide how many
                total units of timed services are billable for the beneficiary on the
                date of service (based on time ranges in the chart in the manual), and
                assign billable units to each billable procedure code. The therapist or
                therapy assistant would then need to decide for each billed procedure
                code whether or not the therapy assistant modifiers apply.
                    As previously explained, the CQ/CO modifier does not apply if all
                units of a procedure code were furnished entirely by the therapist;
                and, where all units of the procedure code were furnished entirely by
                the PTA/OTA, the appropriate CQ/CO modifier would apply. When some
                portion of the billed procedure code is furnished by the PTA/OTA, the
                therapist or therapy assistant would need to look at the total minutes
                for all the billed units of the service, and compare it to the minutes
                of the service furnished by the PTA/OTA as described above in order to
                decide whether the 10 percent de minimis standard is exceeded. If the
                minutes of the service furnished by the PTA/OTA are more than 10
                percent of the total minutes of the service, the therapist or therapy
                assistant would assign the appropriate CQ or CO modifier. We would make
                clarifying technical changes to chapter 5, section 20.2 of the MCPM to
                reflect the policies adopted through in this rulemaking related to the
                application or non-application of the therapy assistant modifiers. We
                anticipate that we will add examples to illustrate when the applicable
                therapy assistant modifiers must be applied, similar to the examples
                provided below.
                    We are providing the following examples of clinical scenarios to
                illustrate how the 10 percent de minimis standard would be applied
                under our proposals when therapists and their assistants work together
                concurrently or separately to treat the same patient on the same day.
                These examples reflect how the therapist or therapy provider would
                decide whether the CQ or CO therapy assistant modifier should be
                included when billing for one or more service units of the 15-minute
                timed codes. In the following scenarios, ``PT'' is used to represent
                physical therapist and ``OT'' is used to refer to an occupational
                therapist for ease of reference; and, the services of the PTA/OTA are
                assumed to be therapeutic in nature, and not services that a technician
                or aide without the education and training of a PTA/OTA could provide.
                     Scenario One: Where only one service, described by a
                single HCPCS code defined in 15-minute increments, is furnished in a
                treatment day:
                    (1) The PT/OT and PTA/OTA each separately, that is individually and
                exclusively, furnish minutes of the same therapeutic exercise service
                (HCPCS code 97110) in different time frames: The PT/OT furnishes 7
                minutes and the PTA furnishes 7 minutes for a total of 14 minutes, one
                unit can be billed using the total time minute range of at least 8
                minutes and up to 22 minutes.
                    Billing Example: One 15-minute unit of HCPCS code 97110 is reported
                on the claim with the CQ/CO modifier to signal that the time of the
                service furnished by the PTA/OTA (7 minutes) exceeded 10 percent of the
                14-minute total service time (1.4 minutes rounded to 1 minute, so the
                modifier would apply if the PTA/OTA had furnished 2 or more minutes of
                the service).
                    (2) The PT/OT and PTA/OTA each separately, exclusive of the other,
                furnish minutes of the same therapeutic exercise service (HCPCS code
                97110) in different time frames: The PT/OT furnishes 20 minutes and the
                PTA/OTA furnishes 25 minutes for a total of 45 minutes, three units can
                be billed using the total time minute range of at least 38 minutes and
                up to 52 minutes.
                    Billing Example: All three units of CPT code 97110 are reported on
                the claim with the corresponding CQ/CO modifier because the 25 minutes
                [[Page 40563]]
                furnished by the PTA/OTA exceeds 10 percent of the 45-minute total
                service time (4.5 minutes rounded to 5 minutes, so the modifier would
                apply if the PTA/OTA had furnished 6 or more minutes of the service).
                    (3) The PTA/OTA works concurrently with the respective PT/OT as a
                team to furnish the same neuromuscular reeducation service (HCPCS code
                97112) for a 30-minute session, resulting in 2 billable units of the
                service (at least 23 minutes and up to 37 minutes).
                    Billing Example: Both units of HCPCS code 97112 are reported with
                the appropriate CQ or CO modifier because the service time furnished by
                the PTA/OTA (30 minutes) exceeded 10 percent of the 30-minute total
                service time (3 minutes, so the modifier would apply if the PTA/OTA had
                furnished 4 or more minutes of the service).
                     Scenario Two: When services that are represented by
                different procedure codes are furnished. Follow our current policy to
                identify the procedure codes to bill and the units to bill for the
                service(s) provided for the most time. We propose that when the PT/OT
                and the PTA/OTA each independently furnish a service defined by a
                different procedure code for the same number of minutes, for example 10
                minutes, for a total time of 20 minutes, qualifying for 1 unit to be
                billed (at least 8 minutes up to 23 minutes), the code for the service
                furnished by the PT/OT is selected to break the tie--one unit of that
                service would be billed without the CQ/CO modifier.
                    (1) When only one unit of a service can be billed (requires a
                minimum of 8 minutes but less than 23 minutes):
                    (a) The PT/OT independently furnishes 15 minutes of manual therapy
                (HCPCS code 97140) and the PTA/OTA independently furnishes 7 minutes of
                therapeutic exercise (HCPCS code 97110). One unit of HCPCS code 97140
                can be billed (at least 8 minutes and up to 22 minutes).
                    Billing Example: One unit of HCPCS code 97140 is billed without the
                CQ/CO modifier because the PT/OT exclusively (without the PTA/OTA)
                furnished a full unit of a service defined by 15-minute time interval
                (current instructions require ``1'' unit to be reported). The 7 minutes
                of a different service delivered solely by the PTA/OTA do not result in
                a billable service. Both services, though, are documented in the
                medical record, noting which services were furnished by the PT/OT or
                PTA/OTA; and, the 7 minutes of HCPCS code 97110 would be included in
                the total minutes of timed codes that are considered when identifying
                the procedure codes and units of each that can be billed on the claim.
                    (b) If instead, the PT/OT independently furnished 7 minutes of CPT
                code 97140 and the PTA/OTA independently furnished a full 15-minutes of
                CPT code 97110, one unit of CPT code 97110 is billed and the CQ/CO
                modifier is applied; the 7 minutes of the PT/OT service (CPT code
                97140) do not result in billable service, but all the minutes are
                documented and included in the total minutes of the timed codes that
                are considered when identifying the procedure codes and units of each
                that can be billed on the claim.
                    (c) If the PT/OT and PTA/OTA each independently furnish an equal
                number of minutes of CPT codes 97140 and 97110, respectively, that is
                less than the full 15-minute mark, and the total minutes of the timed
                codes qualify for billing one unit of a service, the code furnished by
                the PT/OT would be selected to break the tie and billed without a CQ/CO
                modifier because the PT/OT furnished that service independently of the
                PTA/OTA.
                    If instead the PT/OT furnishes an 8-minute service (CPT code 97140)
                and the PTA/OTA delivers a 13-minute service (CPT code 97110), one unit
                of the 13-minute PTA/OTA-delivered service (CPT code 97110) would be
                billed consistent with our current policy to bill the service with the
                greater time; and the service would be billed with a CQ/CO modifier
                because the PTA/OTA furnished the service independently.
                    (2) When two or more units can be billed (requires a minimum of 23
                minutes), follow current instructions for billing procedure codes and
                units for each timed code.
                    (a) The PT/OT furnishes 20 minutes of neuromuscular reeducation
                (CPT code 97112) and the PTA/OTA furnishes 8 minutes of therapeutic
                exercise (CPT code 97110) for a total of 28 minutes, which permits two
                units of the timed codes to be billed (at least 23 minutes and up to 37
                minutes).
                    Billing Example: Following our usual process for billing for the
                procedure codes and units based on services furnished with the most
                minutes, one unit of each procedure code would be billed--one unit of
                CPT code 97112 is billed without a CQ/CO modifier and one unit of CPT
                code 97110 is billed with a CQ/CO modifier. This is because, under our
                current policy, the two billable units of timed codes are allocated
                among procedure codes by assigning the first 15 minutes of service to
                code 97112 (the code with the highest number of minutes), which leaves
                another 13 minutes of timed services: 5 minutes of code 97112 (20 minus
                15) and 8 minutes of code 97110. Since the 8 minutes of code 97110 is
                greater than the remaining 5 minutes of code 97112, the second billable
                unit of service would be assigned to 97110. The CQ/CO modifier would
                not apply to CPT code 97112 because the therapist furnished all minutes
                of that service independently. The CQ/CO modifier would apply to CPT
                code 97110 because the PTA/OTA furnished all minutes of that service
                independently.
                    (b) The PT/OT furnishes 32 minutes of neuromuscular reeducation
                (CPT code 97112), the PT/OT and the PTA/OTA each separately furnish 12
                minutes and 14 minutes, respectively, of therapeutic exercise (CPT code
                97110) for a total of 26 minutes, and the PTA/OTA independently
                furnishes 12 minutes of self-care (CPT code 97535) for a total of 70
                minutes of timed code services, permitting five units to be billed (68-
                82 minutes). Under our current policy, the five billable units would be
                assigned as follows: Two units to CPT code 97112, two units to CPT code
                97110, and one unit to CPT code 97535.
                    Billing Example: The two units of CPT code 97112 would be billed
                without a CQ/CO modifier because all 32 minutes of that service were
                furnished independently by the PT/OT. The two units of CPT code 97110
                would be billed with the CQ/CO modifier because the PTA/OTA's 14
                minutes of the service are greater than 10 percent of the 26 total
                minutes of the service (2.6 minutes which is rounded to 3 minutes, so
                the modifiers would apply if the PTA/OTA furnished 4 or more minutes of
                the service), and the one unit of CPT code 97535 would be billed with a
                CQ/CO modifier because the PTA/OTA independently furnished all minutes
                of that service.
                    (c) The PT/OT independently furnishes 12 minutes of neuromuscular
                reeducation activities (CPT code 97112) and the PTA/OTA independently
                furnishes 8 minutes of self-care activities (CPT code 97535) and 7
                minutes of therapeutic exercise (CPT code 97110)--the total treatment
                time of 27 minutes allows for two units of service to be billed (at
                least 23 minutes and up to 37 minutes). Under our current policy, the
                two billable units would be assigned as follows: One unit of CPT code
                97112 and one unit of CPT code 97535.
                    Billing Example: The one unit of HCPCS code 97112 would be billed
                without the CQ/CO modifier because it was furnished independently by
                the PT/OT; and, the one unit of CPT code 97535 is billed with the CQ/CO
                modifier because it was independently furnished
                [[Page 40564]]
                by the PTA/OTA. In this example, CPT code 97110 is not billable;
                however, the minutes for all three codes are documented and counted
                toward the total time of the timed code services furnished to the
                patient on the date of service.
                    (d) The PT/OT furnishes 15 minutes of each of two services
                described by CPT codes 97112 and 97535, and is assisted by the PTA/OTA
                who furnishes 3 minutes of each service concurrently with the PT/OT.
                The total time of 30 minutes allows two 15-minute units to be billed--
                one unit each of CPT code 97112 and CPT code 97535.
                    Billing Example: Both CPT codes 97112 and 97535 are billed with the
                applicable CQ/CO modifier because the time the PTA/OTA spent assisting
                the PT/OT for each service exceeds 10 percent of the 15-minute total
                time for each service (1.5 minutes which is rounded to 2 minutes, so
                that the modifiers apply if the PTA/OTA furnishes 3 or more minutes of
                the service).
                c. Proposed Regulatory Provisions
                    In accordance with section 1834(v)(2)(B) of the Act, we are
                proposing to amend Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for
                outpatient physical and occupational therapy services, respectively,
                and Sec.  410.105(d) for physical and occupational therapy services
                furnished by comprehensive outpatient rehabilitation facilities (CORFs)
                as authorized under section 1861(cc) of the Act, to establish as a
                condition of payment that claims for services furnished in whole or in
                part by an OTA or PTA must include a prescribed modifier; and that
                services will not be considered furnished in part by an OTA or PTA
                unless they exceed 10 percent of the total minutes for that service,
                beginning for services furnished on and after January 1, 2020. To
                implement section 1834(v)(1) of the Act, we are proposing to amend
                Sec. Sec.  410.59(a)(4) and 410.60(a)(4) for outpatient physical and
                occupational therapy services, respectively, and at Sec.  410.105(d)
                for physical and occupational therapy services furnished by CORFs to
                specify that claims from physical and occupational therapists in
                private practice paid under section 1848 of the Act and from providers
                paid under section 1834(k) of the Act for physical therapy and
                occupational therapy services that contain a therapy assistant
                modifier, are paid at 85 percent of the otherwise applicable payment
                amount for the service for dates of service on and after January 1,
                2022. As specified in the CY 2019 PFS final rule, we also note that the
                CQ or CO modifier is to be applied alongside the corresponding GP or GO
                therapy modifier that is required on each claim line of service for
                physical therapy or occupational therapy services. Beginning for dates
                of service and after January 1, 2020, claims missing the corresponding
                GP or GO therapy modifier will be rejected/returned to the therapist or
                therapy provider so they can be corrected and resubmitted for
                processing.
                    As discussed in the CY 2019 PFS proposed and final rules (see 83 FR
                35850 and 83 FR 59654), we established that the reduced payment rate
                under section 1834(v)(1) of the Act for the outpatient therapy services
                furnished in whole or in part by therapy assistants is not applicable
                to outpatient therapy services furnished by CAHs, for which payment is
                made under section 1834(g) of the Act. We would like to take this
                opportunity to clarify that we do not interpret section 1834(v) of the
                Act to apply to outpatient physical therapy or occupational therapy
                services furnished by CAHs, or by other providers for which payment for
                outpatient therapy services is not made under section 1834(k) of the
                Act based on the PFS rates.
                N. Valuation of Specific Codes
                1. Background: Process for Valuing New, Revised, and Potentially
                Misvalued Codes
                    Establishing valuations for newly created and revised CPT codes is
                a routine part of maintaining the PFS. Since the inception of the PFS,
                it has also been a priority to revalue services regularly to make sure
                that the payment rates reflect the changing trends in the practice of
                medicine and current prices for inputs used in the PE calculations.
                Initially, this was accomplished primarily through the 5-year review
                process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
                2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
                2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year
                review process, revisions in RVUs were proposed and finalized via
                rulemaking. In addition to the 5-year reviews, beginning with CY 2009,
                CMS and the RUC identified a number of potentially misvalued codes each
                year using various identification screens, as discussed in section
                II.E. of this proposed rule, Potentially Misvalued Services under the
                PFS. Historically, when we received RUC recommendations, our process
                had been to establish interim final RVUs for the potentially misvalued
                codes, new codes, and any other codes for which there were coding
                changes in the final rule with comment period for a year. Then, during
                the 60-day period following the publication of the final rule with
                comment period, we accepted public comment about those valuations. For
                services furnished during the calendar year following the publication
                of interim final rates, we paid for services based upon the interim
                final values established in the final rule. In the final rule with
                comment period for the subsequent year, we considered and responded to
                public comments received on the interim final values, and typically
                made any appropriate adjustments and finalized those values.
                    In the CY 2015 PFS final rule with comment period (79 FR 67547), we
                finalized a new process for establishing values for new, revised and
                potentially misvalued codes. Under the new process, we include proposed
                values for these services in the proposed rule, rather than
                establishing them as interim final in the final rule with comment
                period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the
                new process was applicable to all codes, except for new codes that
                describe truly new services. For CY 2017, we proposed new values in the
                CY 2017 PFS proposed rule for the vast majority of new, revised, and
                potentially misvalued codes for which we received complete RUC
                recommendations by February 10, 2016. To complete the transition to
                this new process, for codes for which we established interim final
                values in the CY 2016 PFS final rule with comment period (81 FR 80170),
                we reviewed the comments received during the 60-day public comment
                period following release of the CY 2016 PFS final rule with comment
                period (80 FR 70886), and reproposed values for those codes in the CY
                2017 PFS proposed rule.
                    We considered public comments received during the 60-day public
                comment period for the proposed rule before establishing final values
                in the CY 2017 PFS final rule. As part of our established process, we
                will adopt interim final values only in the case of wholly new services
                for which there are no predecessor codes or values and for which we do
                not receive recommendations in time to propose values.
                    As part of our obligation to establish RVUs for the PFS, we
                thoroughly review and consider available information including
                recommendations and supporting information from the RUC, the Health
                Care Professionals Advisory Committee (HCPAC), public commenters,
                medical literature, Medicare claims data, comparative databases,
                comparison with other codes
                [[Page 40565]]
                within the PFS, as well as consultation with other physicians and
                healthcare professionals within CMS and the federal government as part
                of our process for establishing valuations. Where we concur that the
                RUC's recommendations, or recommendations from other commenters, are
                reasonable and appropriate and are consistent with the time and
                intensity paradigm of physician work, we propose those values as
                recommended. Additionally, we continually engage with stakeholders,
                including the RUC, with regard to our approach for accurately valuing
                codes, and as we prioritize our obligation to value new, revised, and
                potentially misvalued codes. We continue to welcome feedback from all
                interested parties regarding valuation of services for consideration
                through our rulemaking process.
                2. Methodology for Establishing Work RVUs
                    For each code identified in this section, we conduct a review that
                included the current work RVU (if any), RUC-recommended work RVU,
                intensity, time to furnish the preservice, intraservice, and
                postservice activities, as well as other components of the service that
                contribute to the value. Our reviews of recommended work RVUs and time
                inputs generally include, but have not been limited to, a review of
                information provided by the RUC, the HCPAC, and other public
                commenters, medical literature, and comparative databases, as well as a
                comparison with other codes within the PFS, consultation with other
                physicians and health care professionals within CMS and the federal
                government, as well as Medicare claims data. We also assess the
                methodology and data used to develop the recommendations submitted to
                us by the RUC and other public commenters and the rationale for the
                recommendations. In the CY 2011 PFS final rule with comment period (75
                FR 73328 through 73329), we discussed a variety of methodologies and
                approaches used to develop work RVUs, including survey data, building
                blocks, crosswalks to key reference or similar codes, and magnitude
                estimation (see the CY 2011 PFS final rule with comment period (75 FR
                73328 through 73329) for more information). When referring to a survey,
                unless otherwise noted, we mean the surveys conducted by specialty
                societies as part of the formal RUC process.
                    Components that we use in the building block approach may include
                preservice, intraservice, or postservice time and post-procedure
                visits. When referring to a bundled CPT code, the building block
                components could include the CPT codes that make up the bundled code
                and the inputs associated with those codes. We use the building block
                methodology to construct, or deconstruct, the work RVU for a CPT code
                based on component pieces of the code. Magnitude estimation refers to a
                methodology for valuing work that determines the appropriate work RVU
                for a service by gauging the total amount of work for that service
                relative to the work for a similar service across the PFS without
                explicitly valuing the components of that work. In addition to these
                methodologies, we frequently utilize an incremental methodology in
                which we value a code based upon its incremental difference between
                another code and another family of codes. The statute specifically
                defines the work component as the resources in time and intensity
                required in furnishing the service. Also, the published literature on
                valuing work has recognized the key role of time in overall work. For
                particular codes, we refine the work RVUs in direct proportion to the
                changes in the best information regarding the time resources involved
                in furnishing particular services, either considering the total time or
                the intraservice time.
                    Several years ago, to aid in the development of preservice time
                recommendations for new and revised CPT codes, the RUC created
                standardized preservice time packages. The packages include preservice
                evaluation time, preservice positioning time, and preservice scrub,
                dress and wait time. Currently, there are preservice time packages for
                services typically furnished in the facility setting (for example,
                preservice time packages reflecting the different combinations of
                straightforward or difficult procedure, and straightforward or
                difficult patient). Currently, there are three preservice time packages
                for services typically furnished in the nonfacility setting.
                    We developed several standard building block methodologies to value
                services appropriately when they have common billing patterns. In cases
                where a service is typically furnished to a beneficiary on the same day
                as an evaluation and management (E/M) service, we believe that there is
                overlap between the two services in some of the activities furnished
                during the preservice evaluation and postservice time. Our longstanding
                adjustments have reflected a broad assumption that at least one-third
                of the work time in both the preservice evaluation and postservice
                period is duplicative of work furnished during the E/M visit.
                    Accordingly, in cases where we believe that the RUC has not
                adequately accounted for the overlapping activities in the recommended
                work RVU and/or times, we adjust the work RVU and/or times to account
                for the overlap. The work RVU for a service is the product of the time
                involved in furnishing the service multiplied by the intensity of the
                work. Preservice evaluation time and postservice time both have a long-
                established intensity of work per unit of time (IWPUT) of 0.0224, which
                means that 1 minute of preservice evaluation or postservice time
                equates to 0.0224 of a work RVU.
                    Therefore, in many cases when we remove 2 minutes of preservice
                time and 2 minutes of postservice time from a procedure to account for
                the overlap with the same day E/M service, we also remove a work RVU of
                0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
                time had already been accounted for in the work RVU. The RUC has
                recognized this valuation policy and, in many cases, now addresses the
                overlap in time and work when a service is typically furnished on the
                same day as an E/M service.
                    The following paragraphs contain a general discussion of our
                approach to reviewing RUC recommendations and developing proposed
                values for specific codes. When they exist we also include a summary of
                stakeholder reactions to our approach. We note that many commenters and
                stakeholders have expressed concerns over the years with our ongoing
                adjustment of work RVUs based on changes in the best information we had
                regarding the time resources involved in furnishing individual
                services. We have been particularly concerned with the RUC's and
                various specialty societies' objections to our approach given the
                significance of their recommendations to our process for valuing
                services and since much of the information we used to make the
                adjustments is derived from their survey process. We are obligated
                under the statute to consider both time and intensity in establishing
                work RVUs for PFS services. As explained in the CY 2016 PFS final rule
                with comment period (80 FR 70933), we recognize that adjusting work
                RVUs for changes in time is not always a straightforward process, so we
                have applied various methodologies to identify several potential work
                values for individual codes.
                    We have observed that for many codes reviewed by the RUC,
                recommended work RVUs have appeared to be incongruous with recommended
                assumptions regarding the resource costs in time. This has been the
                case for
                [[Page 40566]]
                a significant portion of codes for which we recently established or
                proposed work RVUs that are based on refinements to the RUC-recommended
                values. When we have adjusted work RVUs to account for significant
                changes in time, we have started by looking at the change in the time
                in the context of the RUC-recommended work RVU. When the recommended
                work RVUs do not appear to account for significant changes in time, we
                have employed the different approaches to identify potential values
                that reconcile the recommended work RVUs with the recommended time
                values. Many of these methodologies, such as survey data, building
                block, crosswalks to key reference or similar codes, and magnitude
                estimation have long been used in developing work RVUs under the PFS.
                In addition to these, we sometimes use the relationship between the old
                time values and the new time values for particular services to identify
                alternative work RVUs based on changes in time components.
                    In so doing, rather than ignoring the RUC-recommended value, we
                have used the recommended values as a starting reference and then
                applied one of these several methodologies to account for the
                reductions in time that we believe were not otherwise reflected in the
                RUC-recommended value. If we believe that such changes in time are
                already accounted for in the RUC's recommendation, then we do not make
                such adjustments. Likewise, we do not arbitrarily apply time ratios to
                current work RVUs to calculate proposed work RVUs. We use the ratios to
                identify potential work RVUs and consider these work RVUs as potential
                options relative to the values developed through other options.
                    We do not imply that the decrease in time as reflected in survey
                values should always equate to a one-to-one or linear decrease in newly
                valued work RVUs. Instead, we believe that, since the two components of
                work are time and intensity, absent an obvious or explicitly stated
                rationale for why the relative intensity of a given procedure has
                increased, significant decreases in time should be reflected in
                decreases to work RVUs. If the RUC's recommendation has appeared to
                disregard or dismiss the changes in time, without a persuasive
                explanation of why such a change should not be accounted for in the
                overall work of the service, then we have generally used one of the
                aforementioned methodologies to identify potential work RVUs, including
                the methodologies intended to account for the changes in the resources
                involved in furnishing the procedure.
                    Several stakeholders, including the RUC, have expressed general
                objections to our use of these methodologies and deemed our actions in
                adjusting the recommended work RVUs as inappropriate; other
                stakeholders have also expressed general concerns with CMS refinements
                to RUC-recommended values in general. In the CY 2017 PFS final rule (81
                FR 80272 through 80277), we responded in detail to several comments
                that we received regarding this issue. In the CY 2017 PFS proposed rule
                (81 FR 46162), we requested comments regarding potential alternatives
                to making adjustments that would recognize overall estimates of work in
                the context of changes in the resource of time for particular services;
                however, we did not receive any specific potential alternatives. As
                described earlier in this section, crosswalks to key reference or
                similar codes are one of the many methodological approaches we have
                employed to identify potential values that reconcile the RUC-recommend
                work RVUs with the recommended time values when the RUC-recommended
                work RVUs did not appear to account for significant changes in time. In
                response to comments in the CY 2019 PFS final rule (83 FR 59515), we
                clarify that terms ``reference services'', ``key reference services'',
                and ``crosswalks'' as described by the commenters are part of the RUC's
                process for code valuation. These are not terms that we created, and we
                do not agree that we necessarily must employ them in the identical
                fashion for the purposes of discussing our valuation of individual
                services that come up for review. However, in the interest of
                minimizing confusion and providing clear language to facilitate
                stakeholder feedback, we will seek to limit the use of the term,
                ``crosswalk,'' to those cases where we are making a comparison to a CPT
                code with the identical work RVU.
                    We look forward to continuing to engage with stakeholders and
                commenters, including the RUC, as we prioritize our obligation to value
                new, revised, and potentially misvalued codes; and will continue to
                welcome feedback from all interested parties regarding valuation of
                services for consideration through our rulemaking process. We refer
                readers to the detailed discussion in this section of the proposed
                valuation considered for specific codes. Table 20 contains a list of
                codes and descriptors for which we are proposing work RVUs; this
                includes all codes for which we received RUC recommendations by
                February 10, 2019. The proposed work RVUs, work time and other payment
                information for all CY 2020 payable codes are available on the CMS
                website under downloads for the CY 2020 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
                3. Methodology for the Direct PE Inputs To Develop PE RVUs
                a. Background
                    On an annual basis, the RUC provides us with recommendations
                regarding PE inputs for new, revised, and potentially misvalued codes.
                We review the RUC-recommended direct PE inputs on a code by code basis.
                Like our review of recommended work RVUs, our review of recommended
                direct PE inputs generally includes, but is not limited to, a review of
                information provided by the RUC, HCPAC, and other public commenters,
                medical literature, and comparative databases, as well as a comparison
                with other codes within the PFS, and consultation with physicians and
                health care professionals within CMS and the federal government, as
                well as Medicare claims data. We also assess the methodology and data
                used to develop the recommendations submitted to us by the RUC and
                other public commenters and the rationale for the recommendations. When
                we determine that the RUC's recommendations appropriately estimate the
                direct PE inputs (clinical labor, disposable supplies, and medical
                equipment) required for the typical service, are consistent with the
                principles of relativity, and reflect our payment policies, we use
                those direct PE inputs to value a service. If not, we refine the
                recommended PE inputs to better reflect our estimate of the PE
                resources required for the service. We also confirm whether CPT codes
                should have facility and/or nonfacility direct PE inputs and refine the
                inputs accordingly.
                    Our review and refinement of the RUC-recommended direct PE inputs
                includes many refinements that are common across codes, as well as
                refinements that are specific to particular services. Table 21 details
                our proposed refinements of the RUC's direct PE recommendations at the
                code-specific level. In section II.B. of this proposed rule,
                Determination of Practice Expense Relative Value Units (PE RVUs), we
                address certain proposed refinements that would be common across codes.
                Proposed refinements to particular codes are addressed in the portions
                of this section that are dedicated to particular codes. We note
                [[Page 40567]]
                that for each refinement, we indicate the impact on direct costs for
                that service. We note that, on average, in any case where the impact on
                the direct cost for a particular refinement is $0.35 or less, the
                refinement has no impact on the PE RVUs. This calculation considers
                both the impact on the direct portion of the PE RVU, as well as the
                impact on the indirect allocator for the average service. We also note
                that approximately half of the refinements listed in Table 21 result in
                changes under the $0.35 threshold and are unlikely to result in a
                change to the RVUs.
                    We also note that the proposed direct PE inputs for CY 2020 are
                displayed in the CY 2020 direct PE input files, available on the CMS
                website under the downloads for the CY 2020 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
                displayed there have been used in developing the proposed CY 2020 PE
                RVUs as displayed in Addendum B.
                b. Common Refinements
                (1) Changes in Work Time
                    Some direct PE inputs are directly affected by revisions in work
                time. Specifically, changes in the intraservice portions of the work
                time and changes in the number or level of postoperative visits
                associated with the global periods result in corresponding changes to
                direct PE inputs. The direct PE input recommendations generally
                correspond to the work time values associated with services. We believe
                that inadvertent discrepancies between work time values and direct PE
                inputs should be refined or adjusted in the establishment of proposed
                direct PE inputs to resolve the discrepancies.
                (2) Equipment Time
                    Prior to CY 2010, the RUC did not generally provide CMS with
                recommendations regarding equipment time inputs. In CY 2010, in the
                interest of ensuring the greatest possible degree of accuracy in
                allocating equipment minutes, we requested that the RUC provide
                equipment times along with the other direct PE recommendations, and we
                provided the RUC with general guidelines regarding appropriate
                equipment time inputs. We appreciate the RUC's willingness to provide
                us with these additional inputs as part of its PE recommendations.
                    In general, the equipment time inputs correspond to the service
                period portion of the clinical labor times. We clarified this principle
                over several years of rulemaking, indicating that we consider equipment
                time as the time within the intraservice period when a clinician is
                using the piece of equipment plus any additional time that the piece of
                equipment is not available for use for another patient due to its use
                during the designated procedure. For those services for which we
                allocate cleaning time to portable equipment items, because the
                portable equipment does not need to be cleaned in the room where the
                service is furnished, we do not include that cleaning time for the
                remaining equipment items, as those items and the room are both
                available for use for other patients during that time. In addition,
                when a piece of equipment is typically used during follow-up
                postoperative visits included in the global period for a service, the
                equipment time would also reflect that use.
                    We believe that certain highly technical pieces of equipment and
                equipment rooms are less likely to be used during all of the preservice
                or postservice tasks performed by clinical labor staff on the day of
                the procedure (the clinical labor service period) and are typically
                available for other patients even when one member of the clinical staff
                may be occupied with a preservice or postservice task related to the
                procedure. We also note that we believe these same assumptions would
                apply to inexpensive equipment items that are used in conjunction with
                and located in a room with non-portable highly technical equipment
                items since any items in the room in question would be available if the
                room is not being occupied by a particular patient. For additional
                information, we refer readers to our discussion of these issues in the
                CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
                2015 PFS final rule with comment period (79 FR 67639).
                (3) Standard Tasks and Minutes for Clinical Labor Tasks
                    In general, the preservice, intraservice, and postservice clinical
                labor minutes associated with clinical labor inputs in the direct PE
                input database reflect the sum of particular tasks described in the
                information that accompanies the RUC-recommended direct PE inputs,
                commonly called the ``PE worksheets.'' For most of these described
                tasks, there is a standardized number of minutes, depending on the type
                of procedure, its typical setting, its global period, and the other
                procedures with which it is typically reported. The RUC sometimes
                recommends a number of minutes either greater than or less than the
                time typically allotted for certain tasks. In those cases, we review
                the deviations from the standards and any rationale provided for the
                deviations. When we do not accept the RUC-recommended exceptions, we
                refine the proposed direct PE inputs to conform to the standard times
                for those tasks. In addition, in cases when a service is typically
                billed with an E/M service, we remove the preservice clinical labor
                tasks to avoid duplicative inputs and to reflect the resource costs of
                furnishing the typical service.
                    We refer readers to section II.B. of this proposed rule,
                Determination of Practice Expense Relative Value Units (PE RVUs), for
                more information regarding the collaborative work of CMS and the RUC in
                improvements in standardizing clinical labor tasks.
                (4) Recommended Items That Are Not Direct PE Inputs
                    In some cases, the PE worksheets included with the RUC's
                recommendations include items that are not clinical labor, disposable
                supplies, or medical equipment or that cannot be allocated to
                individual services or patients. We addressed these kinds of
                recommendations in previous rulemaking (78 FR 74242), and we do not use
                items included in these recommendations as direct PE inputs in the
                calculation of PE RVUs.
                (5) New Supply and Equipment Items
                    The RUC generally recommends the use of supply and equipment items
                that already exist in the direct PE input database for new, revised,
                and potentially misvalued codes. However, some recommendations include
                supply or equipment items that are not currently in the direct PE input
                database. In these cases, the RUC has historically recommended that a
                new item be created and has facilitated our pricing of that item by
                working with the specialty societies to provide us copies of sales
                invoices. For CY 2020, we received invoices for several new supply and
                equipment items. Tables 22 and 23 detail the invoices received for new
                and existing items in the direct PE database. As discussed in section
                II.B. of this proposed rule, Determination of Practice Expense Relative
                Value Units, we encouraged stakeholders to review the prices associated
                with these new and existing items to determine whether these prices
                appear to be accurate. Where prices appear inaccurate, we encouraged
                stakeholders to submit invoices or other information to improve the
                accuracy of pricing for these items in the direct PE database by
                February 10th of the following year for consideration in future
                rulemaking, similar to our process for consideration of RUC
                recommendations.
                [[Page 40568]]
                    We remind stakeholders that due to the relativity inherent in the
                development of RVUs, reductions in existing prices for any items in the
                direct PE database increase the pool of direct PE RVUs available to all
                other PFS services. Tables 22 and 23 also include the number of
                invoices received and the number of nonfacility allowed services for
                procedures that use these equipment items. We provide the nonfacility
                allowed services so that stakeholders will note the impact the
                particular price might have on PE relativity, as well as to identify
                items that are used frequently, since we believe that stakeholders are
                more likely to have better pricing information for items used more
                frequently. A single invoice may not be reflective of typical costs and
                we encourage stakeholders to provide additional invoices so that we
                might identify and use accurate prices in the development of PE RVUs.
                    In some cases, we do not use the price listed on the invoice that
                accompanies the recommendation because we identify publicly available
                alternative prices or information that suggests a different price is
                more accurate. In these cases, we include this in the discussion of
                these codes. In other cases, we cannot adequately price a newly
                recommended item due to inadequate information. Sometimes, no
                supporting information regarding the price of the item has been
                included in the recommendation. In other cases, the supporting
                information does not demonstrate that the item has been purchased at
                the listed price (for example, vendor price quotes instead of paid
                invoices). In cases where the information provided on the item allows
                us to identify clinically appropriate proxy items, we might use
                existing items as proxies for the newly recommended items. In other
                cases, we included the item in the direct PE input database without any
                associated price. Although including the item without an associated
                price means that the item does not contribute to the calculation of the
                final PE RVU for particular services, it facilitates our ability to
                incorporate a price once we obtain information and are able to do so.
                (6) Service Period Clinical Labor Time in the Facility Setting
                    Generally speaking, our direct PE inputs do not include clinical
                labor minutes assigned to the service period because the cost of
                clinical labor during the service period for a procedure in the
                facility setting is not considered a resource cost to the practitioner
                since Medicare makes separate payment to the facility for these costs.
                We address proposed code-specific refinements to clinical labor in the
                individual code sections.
                (7) Procedures Subject to the Multiple Procedure Payment Reduction
                (MPPR) and the OPPS Cap
                    We note that the public use files for the PFS proposed and final
                rules for each year display the services subject to the MPPR for
                diagnostic cardiovascular services, diagnostic imaging services,
                diagnostic ophthalmology services, and therapy services. We also
                include a list of procedures that meet the definition of imaging under
                section 1848(b)(4)(B) of the Act, and therefore, are subject to the
                OPPS cap for the upcoming calendar year. The public use files for CY
                2020 are available on the CMS website under downloads for the CY 2020
                PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
                For more information regarding the history of the MPPR policy, we refer
                readers to the CY 2014 PFS final rule with comment period (78 FR 74261
                through 74263). For more information regarding the history of the OPPS
                cap, we refer readers to the CY 2007 PFS final rule with comment period
                (71 FR 69659 through 69662).
                4. Proposed Valuation of Specific Codes for CY 2020
                (1) Tissue Grafting Procedures (CPT Codes 15X00, 15X01, 15X02, 15X03,
                and 15X04)
                    CPT code 20926 (Tissue grafts, other (e.g., paratenon, fat,
                dermis)), was identified through a review of services with anomalous
                sites of service when compared to Medicare utilization data. The CPT
                Editorial Panel subsequently replaced CPT code 20926 with five codes in
                the Integumentary section to better describe tissue grafting
                procedures.
                    We are proposing the RUC-recommended work RVUs of 6.68 for CPT code
                15X00 (Grafting of autologous soft tissue, other, harvested by direct
                excision (e.g., fat, dermis, fascia)), 6.73 for CPT code 15X01
                (grafting of autologous fat harvested by liposuction technique to
                trunk, breasts, scalp, arms, and/or legs; 50cc or less injectate), 2.50
                for CPT code 15X02 (grafting of autologous fat harvested by liposuction
                technique to trunk, breasts, scalp, arms, and/or legs; each additional
                50cc injectate, or part thereof (list separately in addition to code
                for primary procedure)), 6.83 for CPT code 15X03 (grafting of
                autologous fat harvested by liposuction technique to face, eyelids,
                mouth, neck, ears, orbits, genitalia, hands, and/or feet; 25cc or less
                injectate), and 2.41 for CPT code 15X04 (grafting of autologous fat
                harvested by liposuction technique to face, eyelids, mouth, neck, ears,
                orbits, genitalia, hands, and/or feet; each additional 25cc injectate,
                or part thereof (list separately in addition to code for primary
                procedure)).
                    We are proposing the RUC-recommended direct PE inputs for this code
                family without refinement.
                (2) Drug Delivery Implant Procedures (CPT Codes 11981, 11982, 11983,
                206X0, 206X1, 206X2, 206X3, 206X4, and 206X5)
                    CPT codes 11980-11983 were identified as potentially misvalued
                since the majority specialty found in recent claims data differs from
                the two specialties that originally surveyed the codes. The current
                valuation of CPT code 11980 (Subcutaneous hormone pellet implantation
                (implantation of estradiol and/or testosterone pellets beneath the
                skin)) was reaffirmed by the RUC as the physician work had not changed
                since the last review. The CPT Editorial Panel revised the other three
                existing codes in the family and created six additional add-on codes to
                describe orthopaedic drug delivery. These codes were surveyed and
                reviewed for the October 2018 RUC meeting.
                    CPT code 11980 (Subcutaneous hormone pellet implantation
                (implantation of estradiol and/or testosterone pellets beneath the
                skin)) with the current work value of 1.10 RVUs and 12 minutes of
                intraservice time, and 27 minutes of total time, was determined to be
                unchanged since last reviewed and was recommended by the RUC to be
                maintained. We concur. We also are not proposing any direct PE
                refinements to CPT code 11980. CPT code 11981 (Insertion, non-
                biodegradable drug delivery implant) has a current work RVU of 1.48,
                with 39 minutes of total physician time. The specialty society survey
                recommended a work RVU of 1.30, with 31 minutes of total physician time
                and 5 minutes of intraservice time. The RUC recommended a work RVU of
                1.30 (25th percentile), with 30 minutes of total physician time and 5
                minutes of intraservice time. For comparable reference CPT codes to CPT
                code 11981, the RUC and the survey respondents had selected CPT code
                55876 (Placement of interstitial device(s) for radiation therapy
                guidance (e.g., fiducial markers, dosimeter), prostate (via needle, any
                approach), single or multiple (work RVU = 1.73, 20 minutes intraservice
                time and 59 total minutes)) and CPT code 57500 (Biopsy of cervix,
                [[Page 40569]]
                single or multiple, or local excision of lesion, with or without
                fulguration (separate procedure) (work RVU = 1.20, 15 minutes
                intraservice time and 29 total minutes)). The RUC further offers for
                comparison, CPT code 67515 (Injection of medication or other substance
                into Tenon's capsule (work RVU = 1.40 (from CY 2018), 5 minutes
                intraservice time and 21 minutes total time)), CPT code 12013 (Simple
                repair of superficial wounds of face, ears, eyelids, nose, lips and/or
                mucous membranes; 2.6 cm to 5.0 cm (work RVU = 1.22 and 27 total
                minutes)) and CPT code 12004 (Simple repair of superficial wounds of
                scalp, neck, axillae, external genitalia, trunk and/or extremities
                (including hands and feet); 7.6 cm to 12.5 cm) (work RVU = 1.44 and 29
                total minutes)). In addition, we offer CPT code 67500 (Injection of
                medication into cavity behind eye) (work RVU = 1.18 and 5 minutes
                intraservice time and 33 total minutes) for reference. Given that the
                CPT code 11981 incurs a 23 percent reduction in the new total physician
                time and with reference to CPT code 67500, we are proposing a work RVU
                of 1.14, and accept the survey recommended 5 minutes for intraservice
                time and 30 minutes of total time. We are not proposing any direct PE
                refinements to CPT code 11981.
                    CPT code 11982 (Removal, non-biodegradable drug delivery implant)
                has a current work RVU of 1.78, with 44 minutes of total physician
                time. The specialty society survey recommended a work RVU of 1.70 RVU,
                with 10 minutes of intraservice time and 34 minutes of total physician
                time. The RUC also recommended a work RVU of 1.70, with 10 minutes of
                intraservice time and 33 minutes of total physician time. The RUC
                confirmed that removal (CPT code 11982), requires more intraservice
                time to perform than the insertion (CPT code 11981). For comparable
                reference codes to CPT code 11982, the RUC and the survey respondents
                had selected CPT code 54150 (Circumcision, using clamp or other device
                with regional dorsal penile or ring block) (work RVU = 1.90, 15 minutes
                intraservice time and 45 total minutes)) and CPT code 12004 (Simple
                repair of superficial wounds of scalp, neck, axillae, external
                genitalia, trunk and/or extremities (including hands and feet); 7.6 cm
                to 12.5 cm) (work RVU = 1.44, with 17 minutes intraservice time and 29
                minutes total time)). We offer CPT code 64486 (Injections of local
                anesthetic for pain control and abdominal wall analgesia on one side)
                (work RVU = 1.27, 10 minutes intraservice time and 35 total minutes))
                for reference. Given that the CPT code 11982 incurs a 25 percent
                reduction in the new total physician time and with reference to CPT
                code 64486, we are proposing a work RVU of 1.34, and accept the RUC-
                recommended 10 minutes for intraservice time and 33 minutes of total
                time. We are not proposing any direct PE refinements to CPT code 11982.
                    CPT code 11983 (Removal with reinsertion, non-biodegradable drug
                delivery implant) has a current work RVU of 3.30, with 69 minutes of
                total physician time. The specialty society survey recommended a work
                RVU of 2.50 RVU, with 15 minutes of intraservice time and 41 minutes of
                total physician time. The RUC also recommended a work RVU of 2.10, with
                15 minutes of intraservice time and 40 minutes of total physician time.
                The RUC confirmed that CPT code 11983 requires more intraservice time
                to perform than the insertion CPT code 11981. For comparable reference
                codes to CPT code 11983, the RUC and the survey respondents had
                selected CPT code 55700 (Biopsy, prostate; needle or punch, single or
                multiple, any approach) (work RVU = 2.50, 15 minutes intraservice time
                and 35 total minutes)), CPT code 54150 (Circumcision, using clamp or
                other device with regional dorsal penile or ring block) (work RVU =
                1.90, 15 minutes intraservice time and 45 total minutes)) and CPT code
                52281 (Cystourethroscopy, with calibration and/or dilation of urethral
                stricture or stenosis, with or without meatotomy, with or without
                injection procedure for cystography, male or female) (work RVU = 2.75
                and 20 minutes intraservice time and 46 minutes total time)). We offer
                CPT code 62324 (Insertion of indwelling catheter and administration of
                substance into spinal canal of upper or middle back) (work RVU = 1.89,
                15 minutes intraservice time and 43 total minutes)) for reference.
                Given that the CPT code 11983 incurs a 42 percent reduction in new
                total physician time and with reference to CPT code 62324, we are
                proposing a work RVU of 1.91, and accept the RUC-recommended 15 minutes
                for intraservice time and 40 minutes of total time. We are not
                proposing any direct PE refinements to CPT code 11983.
                    The new proposed add-on CPT codes 206X0-206X5 are intended to be
                typically reported with CPT codes 11981-11983, with debridement or
                arthrotomy procedures done primarily by orthopedic surgeons. The
                specialty society's survey for CPT code 206X0 (Manual preparation and
                insertion of drug delivery device(s), deep (e.g., subfascial)) found a
                2.00 work RVU value at the median and a 1.50 work RVU value at the 25th
                percentile, with 20 minutes of intraservice time and 30 minutes of
                total physician time, for the preparation of the antibiotic powder and
                cement, rolled into beads and threaded onto suture for insertion into
                the infected bone. The RUC recommended a work RVU of 1.50, with 20
                minutes of intraservice time and 27 minutes of total physician time.
                The RUC's reference CPT codes included CPT code 11047 (Debridement,
                bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or
                fascia, if performed); each additional 20 sq cm, or part thereof) (work
                RVU = 1.80, and 30 minutes intraservice time)), CPT codes 64484
                (Injection(s), anesthetic agent and/or steroid, transforaminal
                epidural, with imaging guidance (fluoroscopy or CT); lumbar or sacral,
                each additional level) (work RVU = 1.00 and 10 minutes intraservice
                time)), and CPT code 36227 (Selective catheter placement, external
                carotid artery, unilateral, with angiography of the ipsilateral
                external carotid circulation and all associated radiological
                supervision and interpretation) (work RVU = 2.09 and 20 minutes
                intraservice time)). Our review of similar add-on CPT codes yielded CPT
                code 64634 (Destruction of upper or middle spinal facet joint nerves
                with imaging guidance) (work RVU = 1.32 and 20 minutes intraservice
                time)). We are proposing for CPT code 206X0, a work RVU of 1.32, and
                accept the RUC-recommended 20 minutes of intraservice time and 20
                minutes of total time.
                    The specialty society's survey for CPT code 206X1 (Manual
                preparation and insertion of drug delivery device(s), intramedullary)
                found a 3.25 work RVU value at the median and a 2.50 work RVU value at
                the 25th percentile, with 25 minutes of intraservice time and 38
                minutes of total physician time, for the preparation of the
                ``antibiotic nail'' ready for insertion into the intramedullary canal
                with fluoroscopic guidance. The RUC recommended a work RVU of 2.50,
                with 25 minutes of intraservice time and 32 minutes of total physician
                time. The RUC's reference CPT codes included CPT code 11047
                (Debridement, bone (includes epidermis, dermis, subcutaneous tissue,
                muscle and/or fascia, if performed); each additional 20 sq cm, or part
                thereof) (work RVU = 1.80, and 30 minutes intraservice time)), CPT code
                57267 (Insertion of mesh or other prosthesis for repair of pelvic floor
                defect, each site (anterior, posterior compartment), vaginal approach
                (work
                [[Page 40570]]
                RVU = 4.88 and 45 minutes intraservice time)), and CPT code 36227
                (Selective catheter placement, external carotid artery, unilateral,
                with angiography of the ipsilateral external carotid circulation and
                all associated radiological supervision and interpretation (work RVU =
                2.09 and 15 minutes intraservice time)). We find that the reference CPT
                code 11047, with 30 minutes of intraservice time, is suitable, but we
                adjust our proposed work RVU of 1.70 to account for the 25 minutes,
                instead of our reference code's 30 minutes of intraservice time (and
                the 32 minutes of total time), for CPT code 206X1.
                    The specialty society's survey for CPT code 206X2 (Manual
                preparation and insertion of drug delivery device(s), intra-articular)
                found a 4.00 work RVU value at the median and a 2.60 work RVU value at
                the 25th percentile, with 30 minutes of intraservice time and 45
                minutes of total physician time, for the preparation of the antibiotic
                cement inserted into a pre-fabricated silicone mold, when after setting
                up, will be cemented to the end of the bone (with the joint). The RUC
                recommended a work RVU of 2.60, with 30 minutes of intraservice time
                and 37 minutes of total physician time. The RUC's reference CPT codes
                included CPT code 11047 (Debridement, bone (includes epidermis, dermis,
                subcutaneous tissue, muscle and/or fascia, if performed); each
                additional 20 sq cm, or part thereof (work RVU = 1.80, and 30 minutes
                intraservice time)), CPT code 57267 (Insertion of mesh or other
                prosthesis for repair of pelvic floor defect, each site (anterior,
                posterior compartment), vaginal approach (work RVU = 4.88 and 45
                minutes intraservice time)), and CPT code 36227 (Selective catheter
                placement, external carotid artery, unilateral, with angiography of the
                ipsilateral external carotid circulation and all associated
                radiological supervision and interpretation (work RVU = 2.09 and 20
                minutes intraservice time)). We find that the reference CPT code 11047,
                with 30 minutes of intraservice time, is a suitable guide and we are
                proposing the work RVU of 1.80 with the RUC-recommended 30 minutes of
                intraservice time and 37 minutes of total time, for CPT code 206X2.
                    The specialty society's survey for CPT code 206X3 (Removal of drug
                delivery device(s), deep (e.g., subfascial)) found a 1.75 work RVU
                value at the median and a 1.13 work RVU value at the 25th percentile,
                with 15 minutes of intraservice time and 18 minutes of total physician
                time. The work includes a marginal dissection to expose the drug
                delivery device and to remove it. The RUC recommended a work RVU of
                1.13, with 18 minutes of total physician time and 15 minutes of
                intraservice time. The RUC's reference CPT codes included CPT code
                11047 (Debridement, bone (includes epidermis, dermis, subcutaneous
                tissue, muscle and/or fascia, if performed); each additional 20 sq cm,
                or part thereof (work RVU = 1.80, and 30 minutes intraservice time)),
                CPT code 64484 (Injection(s), anesthetic agent and/or steroid,
                transforaminal epidural, with imaging guidance (fluoroscopy or CT);
                lumbar or sacral, each additional level (work RVU = 1.00 and 10 minutes
                intraservice time)), and CPT code 64480 (Injection(s), anesthetic agent
                and/or steroid, transforaminal epidural, with imaging guidance
                (fluoroscopy or CT); cervical or thoracic, each additional level (work
                RVU = 1.20 and 15 minutes intraservice time)). We are proposing the
                RUC-recommended work RVU of 1.13 with 15 minutes of intraservice time
                and 18 minutes of total time for 206X3.
                    The specialty society's survey for CPT code 206X4 (Removal of drug
                delivery device(s), intramedullary) found a 2.50 work RVU value at the
                median and a 1.80 work RVU value at the 25th percentile, with 20
                minutes of intraservice time and 28 minutes of total physician time.
                The work includes a marginal dissection, in addition to what was in the
                base procedure, to loosen and expose the drug delivery device and to
                remove it, any remaining drug delivery device shards that may have
                broken off. The RUC recommended a work RVU of 1.80, with 20 minutes of
                intraservice time and 23 minutes of total physician time. The RUC's
                reference CPT codes included CPT code 11047 (Debridement, bone
                (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia,
                if performed); each additional 20 sq cm, or part thereof (work RVU =
                1.80, and 30 minutes intraservice time)), CPT codes 37253
                (Intravascular ultrasound (noncoronary vessel) during diagnostic
                evaluation and/or therapeutic intervention, including radiological
                supervision and interpretation; each additional noncoronary vessel
                (work RVU = 1.44 and 20 minutes intraservice time)), and CPT code 36227
                (Selective catheter placement, external carotid artery, unilateral,
                with angiography of the ipsilateral external carotid circulation and
                all associated radiological supervision and interpretation (work RVU =
                2.09 and 15 minutes intraservice time)). We are proposing the RUC-
                recommended work RVU of 1.80 with 20 minutes of intraservice time and
                23 minutes of total time for 206X4.
                    The specialty society's survey for CPT code 206X5 (Removal of drug
                delivery device(s), intra-articular) found a 3.30 work RVU value at the
                median and a 2.15 work RVU value at the 25th percentile, with 25
                minutes of intraservice time and 28 minutes of total physician time.
                The work includes the removal of the intra-articular drug delivery
                device that is cemented to both sides of the joint without removing too
                much bone in the process. The RUC recommended a work RVU of 2.15, with
                25 minutes of intraservice time and 28 minutes of total physician time.
                The RUC's reference CPT codes included CPT code 11047 (Debridement,
                bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or
                fascia, if performed); each additional 20 sq cm, or part thereof (work
                RVU = 1.80, and 30 minutes intraservice time)), CPT code 36476
                (Endovenous ablation therapy of incompetent vein, extremity, inclusive
                of all imaging guidance and monitoring, percutaneous, radiofrequency;
                subsequent vein(s) treated in a single extremity, each through separate
                access sites (work RVU = 2.65 and 30 minutes intraservice time)), and
                CPT code 36227 (Selective catheter placement, external carotid artery,
                unilateral, with angiography of the ipsilateral external carotid
                circulation and all associated radiological supervision and
                interpretation (work RVU = 2.09 and 15 minutes intraservice time)). We
                are proposing the RUC-recommended work RVU of 2.15 with 25 minutes of
                intraservice time and 28 minutes of total time for 206X5.
                (3) Bone Biopsy Trocar-Needle (CPT Codes 20220 and 20225)
                    In October 2017, CPT code 20225 (Biopsy, bone, trocar, or needle;
                deep (e.g., vertebral body, femur)) was identified as being performed
                by a different specialty than the one that originally surveyed this
                service. CPT code 20220 (Biopsy, bone, trocar, or needle; superficial
                (e.g., ilium, sternum, spinous process, ribs)) was added as part of the
                family, and both codes were surveyed and reviewed for the January 2019
                RUC meeting.
                    We disagree with the RUC-recommended work RVU of 1.93 for CPT code
                20220 and we are proposing a work RVU of 1.65 based on a crosswalk to
                CPT code 47000 (Biopsy of liver, needle; percutaneous). CPT code 47000
                shares the same intraservice time of 20 minutes with CPT code 20220 and
                has slightly higher total time at 55 minutes as compared to 50 minutes.
                It
                [[Page 40571]]
                is also one of the top reference codes selected by the survey
                respondents. In our review of CPT code 20220, we noted that the
                recommended intraservice time is decreasing from 22 minutes to 20
                minutes (9 percent reduction), and that the recommended total time is
                increasing from 49 minutes to 50 minutes (2 percent increase). However,
                the RUC-recommended work RVU is increasing from 1.27 to 1.93, which is
                an increase of 52 percent. Although we do not imply that the decrease
                in time as reflected in survey values must equate to a one-to-one or
                linear decrease in the valuation of work RVUs, we believe that since
                the two components of work are time and intensity, changes in surveyed
                work time should be appropriately reflected in the proposed work RVUs.
                    In the case of CPT code 20220, we believe that it would be more
                accurate to propose a work RVU of 1.65, based on a crosswalk to CPT
                code 47000, to account for the decrease in the surveyed intraservice
                work time. We believe that the work carried out by the practitioner in
                CPT code 47000 is potentially more intense than the work performed in
                CPT code 20220, as the reviewed code is a superficial bone biopsy as
                opposed to the non-superficial biopsy taking place on an internal organ
                (the liver) described by CPT code 47000. We also note that the survey
                respondents considered CPT code 47000 to have similar intensity to CPT
                code 20220: 50 percent or more of the survey respondents rated the two
                codes as ``identical'' under the categories of Mental Effort and
                Judgment, Physical Effort Required, and Psychological Stress, along
                with a plurality of survey respondents rating the two codes as
                identical in the category of Technical Skill Required. We believe that
                this provides further support for our belief that CPT code 20220 should
                be crosswalked to CPT code 47000 at the same work RVU of 1.65.
                    We disagree with the RUC-recommended work RVU of 3.00 for CPT code
                20225 and we are proposing a work RVU of 2.45 based on a crosswalk to
                CPT code 30906 (Control nasal hemorrhage, posterior, with posterior
                nasal packs and/or cautery, any method; subsequent). CPT code 30906
                shares the same intraservice time of 30 minutes and has 1 fewer minute
                of total time as compared to CPT code 20225. When reviewing this code,
                we observed a pattern similar to what we had seen with CPT code 20220.
                We note that the recommended intraservice time for CPT code 20225 is
                decreasing from 60 minutes to 30 minutes (50 percent reduction), and
                the recommended total time is decreasing from 135 minutes to 64 minutes
                (53 percent reduction); however, the RUC-recommended work RVU is
                increasing from 1.87 to 3.00, which is an increase of about 60 percent.
                As we noted earlier, we do not believe that the decrease in time as
                reflected in survey values must equate to a one-to-one or linear
                decrease in the valuation of work RVUs, and we are not proposing a
                linear decrease in the work valuation based on these time ratios.
                Indeed, we agree with the RUC recommendation that the work RVU of CPT
                code 20225 should increase over the current valuation. However, we
                believe that since the two components of work are time and intensity,
                significant decreases in time should be appropriately reflected in
                changes to the work RVUs, and we do not believe that it would be
                accurate to propose the recommended work RVU of 3.00 given the
                significant decreases in surveyed work time.
                    Instead, we believe that it would be more accurate to propose a
                work RVU of 2.45 for CPT code 20225 based on a crosswalk to CPT code
                30906. We note that this proposed work RVU is a very close match to the
                intraservice time ratio between the two codes in the family; we are
                proposing a work RVU of 1.65 for CPT code 20220 with 20 minutes of
                intraservice work time, and a work RVU of 2.45 for CPT code 20225 with
                30 minutes of intraservice work time. (The exact intraservice time
                ratio calculates to a work RVU of 2.47.) We believe that the proposed
                work RVUs maintain the relative intensity of the two codes in the
                family, and better preserve relativity with the rest of the codes on
                the PFS.
                    For the direct PE inputs, we are proposing to replace the bone
                biopsy device (SF055) supply with the bone biopsy needle (SC077) in CPT
                code 20225. We note that this code currently makes use of the bone
                biopsy needle, and there was no rationale provided in the recommended
                materials to explain why it would now be typical for the bone biopsy
                needle to be replaced by the bone biopsy device. We are proposing to
                maintain the use of the current supply item. We are also proposing to
                adopt a 90 percent utilization rate for the use of the CT room (EL007)
                equipment in CPT code 20225. We previously finalized a policy in the CY
                2010 PFS final rule (74 FR 61754 through 61755) to increase the
                equipment utilization rate to 90 percent for expensive diagnostic
                equipment priced at more than $1 million, and specifically cited the
                use of CT and MRI equipment which would be subject to this utilization
                rate.
                (4) Trigger Point Dry Needling (CPT Codes 205X1 and 205X2)
                    For CY 2020, the CPT Editorial Panel approved two new codes to
                report dry needling of musculature trigger points. These codes were
                surveyed and reviewed by the HCPAC for the January 2019 RUC meeting.
                    We disagree with the HCPAC-recommended work RVU of 0.45 for CPT
                code 205X1 (Needle insertion(s) without injection(s), 1 or 2 muscle(s))
                and we are proposing a work RVU of 0.32 based on a crosswalk to CPT
                code 36600 (Arterial puncture, withdrawal of blood for diagnosis). CPT
                code 36600 shares the identical intraservice time, total time, and
                intensity with CPT code 205X1, which makes it an appropriate choice for
                a crosswalk. In our review of CPT code 205X1, we compared the procedure
                to the top reference code chosen by the survey participants, CPT code
                97140 (Manual therapy techniques (e.g., mobilization/manipulation,
                manual lymphatic drainage, manual traction), 1 or more regions, each 15
                minutes). This therapy procedure has 50 percent more intraservice time
                than CPT code 205X1, as well as higher total time; however, the
                recommended work RVU of 0.45 was higher than the work RVU of 0.43 for
                the top reference code from the survey. We did not agree that CPT code
                205X1 should be valued at a higher rate, and therefore, we are
                proposing a work RVU of 0.32 based on the aforementioned crosswalk to
                CPT code 36600.
                    We disagree with the HCPAC-recommended work RVU of 0.60 for CPT
                code 205X2 (Needle insertion(s) without injection(s), 3 or more
                muscle(s)) and we are proposing a work RVU of 0.48 based on a crosswalk
                to CPT codes 97113 (Therapeutic procedure, 1 or more areas, each 15
                minutes; aquatic therapy with therapeutic exercises) and 97542
                (Wheelchair management (e.g., assessment, fitting, training), each 15
                minutes). Both of these codes share the same work RVU of 0.48 and the
                same intraservice time of 15 minutes as CPT code 205X2, with CPT code
                97113 having two fewer minutes of total time and CPT code 97542 having
                two additional minutes of total time. We note that this proposed work
                RVU is an exact match of the intraservice time ratio between the two
                codes in the family; we are proposing a work RVU of 0.32 for CPT code
                205X1 with 10 minutes of intraservice work time, and a work RVU of 0.48
                for CPT code 205X2 with 15 minutes of intraservice work time. We also
                considered crosswalking the work RVU of CPT code 205X2 to the
                [[Page 40572]]
                top reference code from the survey, CPT code 97140, at a work RVU of
                0.43. However, we chose to employ the crosswalk to CPT codes 97113 and
                97542 at a work RVU of 0.48 instead, due to the fact that the survey
                respondents indicated that CPT code 205X2 was more intense than CPT
                code 97140.
                    We are also proposing to designate CPT codes 205X1 and 205X2 as
                ``always therapy'' procedures, and we are soliciting comments on this
                designation. We are proposing the RUC-recommended direct PE inputs for
                all codes in the family.
                (5) Closed Treatment Vertebral Fracture (CPT Code 22310)
                    This service was identified through a screen of services with a
                negative IWPUT and Medicare utilization over 10,000 for all services or
                over 1,000 for Harvard valued and CMS/Other source codes.
                    For CPT code 22310 (Closed treatment of vertebral body fracture(s),
                without manipulation, requiring and including casting or bracing), we
                disagree with the recommended work RVU of 3.75 because we do not
                believe that this reduction in work RVU from the current value of 3.89
                is commensurate with the RUC-recommended a 33-minute reduction in
                intraservice time and a 105-minute reduction in total time. While we
                understand that the RUC considers the current Harvard study time values
                for this service to be invalid estimations, we believe that a further
                reduction in work RVUs is warranted given the significance of the RUC-
                recommended reduction in physician time. We believe that it would be
                more accurate to propose a work RVU of 3.45 with a crosswalk to CPT
                code 21073 (Manipulation of temporomandibular joint(s) (TMJ),
                therapeutic, requiring an anesthesia service (i.e., general or
                monitored anesthesia care)), which has an identical intraservice time
                and similar total time as those proposed by the RUC for CPT code 22310,
                as we believe that this better accounts for the decrease in the
                surveyed work time.
                    For the direct PE inputs, we are proposing to refine the equipment
                time for the power table (EF031) to conform to our established standard
                for non-highly technical equipment.
                (6) Tendon Sheath Procedures (CPT Codes 26020, 26055, and 26160)
                    The RUC identified these services through a screen of services with
                a negative IWPUT and Medicare utilization over 10,000 for all services
                or over 1,000 for Harvard valued and CMS/Other source codes. For CPT
                code 26020 (Drainage of tendon sheath, digit and/or palm, each), we do
                not agree with the RUC-recommended work RVU of 7.79 based on the survey
                median. While we agree that the survey data validate an increase in
                work RVU, we see no compelling reason that this service would be
                significantly more intense to furnish than services of similar time
                values. Therefore, we are proposing a work RVU of 6.84 which is the
                survey 25th percentile. As further support for this value, we note that
                it falls between the work RVUs of CPT code 28122 (Partial excision
                (craterization, saucerization, sequestrectomy, or diaphysectomy) bone
                (e.g., osteomyelitis or bossing); tarsal or metatarsal bone, except
                talus or calcaneus), with a work RVU of 6.76, and CPT code 28289
                (Hallux rigidus correction with cheilectomy, debridement and capsular
                release of the first metatarsophalangeal joint; without implant), with
                a work RVU of 6.90; both codes have intraservice time values that are
                identical to, and total time values that are similar to, the RUC-
                recommended time values for CPT code 26020.
                    For CPT code 26055 (Tendon sheath incision (e.g., for trigger
                finger)), we do not agree with the RUC recommendation to increase the
                work RVU to 3.75 despite a reduction in physician time. Instead, we are
                proposing to maintain the current work RVU of 3.11; we are supporting
                this based on a total time increment methodology between the CPT code
                26020 and CPT code 26055. The total time ratio between the recommended
                time of 119 minutes and the recommended 262 minutes for code 26020
                equals 45 percent, and 45 percent of our proposed RVU of 6.84 for CPT
                code 26020 equals a work RVU of 3.10, which we believe validates the
                current work RVU of 3.11. We are proposing the RUC-recommended work RVU
                of 3.57 for CPT code 26160 (Excision of lesion of tendon sheath or
                joint capsule (e.g., cyst, mucous cyst, or ganglion), hand or finger).
                We note that our proposed work RVUs validate the RUC's contention that
                CPT code 26160 is slightly more intense to perform than CPT code 26055.
                    For the direct PE inputs, we are proposing to refine the quantity
                of the impervious staff gown (SB027) supply from 2 to 1 for CPT codes
                26055 and 26160. We believe that the second impervious staff gown
                supply is duplicative due to the inclusion of this same supply in the
                surgical cleaning pack (SA043). The recommended materials state that a
                gown is worn by the practitioner and one assistant, which are provided
                by one standalone gown and a second gown in the surgical cleaning pack.
                (7) Closed Treatment Fracture--Hip (CPT Code 27220)
                    This service was identified through a screen of services with a
                negative IWPUT and Medicare utilization over 10,000 for all services or
                over 1,000 for Harvard valued and CMS/Other source codes. For CPT code
                27220 (Closed treatment of acetabulum (hip socket) fracture(s); without
                manipulation), we disagree with the RUC-recommended work RVU of 6.00
                based on the survey median value, because we do not believe that this
                reduction in work RVU from the current value of 6.83 is commensurate
                with the RUC-recommended a 19-minute reduction in intraservice time and
                an 80-minute reduction in total time. While we understand that the RUC
                considers the current Harvard study time values for this service to be
                invalid estimations, we believe that a further reduction in work RVUs
                is warranted given the significance of the RUC-recommended reduction in
                physician time. We believe that it would be more accurate to propose
                the survey 25th percentile work RVU of 5.50, and we are supporting this
                value with a crosswalk to CPT code 27267 (Closed treatment of femoral
                fracture, proximal end, head; without manipulation) to account for the
                decrease in the surveyed work time.
                    For the direct PE inputs, we are proposing to refine the equipment
                time for the power table (EF031) to conform to our established standard
                for non-highly technical equipment.
                (8) Arthrodesis--Sacroliliac Joint (CPT Code 27279)
                    In the CY 2018 PFS final rule (82 FR 53017), CPT code 27279
                (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive
                (indirect visualization), with image guidance, includes obtaining bone
                graft when performed, and placement of transfixing device) was
                nominated for review by stakeholders as a potentially misvalued
                service. We stated that CPT code 27279 is potentially misvalued, and
                that a comprehensive review of the code values was warranted. This code
                was subsequently reviewed by the RUC. According to the specialty
                societies, the previous 2014 survey of CPT code 27279, was based on
                flawed methodology that resulted in an underestimation of
                intraoperative intensity. When CPT code 27279 was surveyed in 2014,
                there was a low rate of response. Due to the dearth of survey data and
                the RUC's agreement with the specialty society at the time that the
                [[Page 40573]]
                survey respondents had somewhat overvalued the work involved in
                performing this service, the RUC used a crosswalk to CPT code 62287
                (Decompression procedure, percutaneous, of nucleus pulposus of
                intervertebral disc, any method utilizing needle based technique to
                remove disc material under fluoroscopic imaging or other form of
                indirect visualization, with discography and/or epidural injection(s)
                at the treated level(s), when performed, single or multiple levels,
                lumbar) to recommend a work RVU of 9.03. The specialty societies
                indicated that with increased and broader utilization of this
                technique, the 2018 survey is a more robust assessment of physician
                work and intensity and provides more data with which to make a
                crosswalk recommendation. According to the RUC, there is no compelling
                evidence that the physician work, intensity or complexity has changed
                for this service.
                    We are proposing to maintain the current work RVU of 9.03 as
                recommended by the RUC. A stakeholder stated that maintaining this RVU
                would constitute the continued undervaluation of this service, and that
                this would incentivize use of a more intensive and invasive procedure,
                CPT code 27280 (Arthrodesis, open, sacroiliac joint, including
                obtaining bone graft, including instrumentation, when performed), as
                well as incentivize this service to be inappropriately furnished on an
                inpatient basis. This stakeholder has requested that, in the interest
                of protecting patient access, we implement payment parity between the
                two services by proposing to crosswalk the work RVU of CPT code 27279
                to that of CPT code 27280, which has a work RVU of 20.00. While we are
                proposing the RUC-recommended work RVU, we are soliciting public
                comment on whether an alternative valuation of 20.00 would be more
                appropriate. This alternative valuation would recognize relative parity
                between these two services in terms of the work inherent in furnishing
                them.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                27279.
                (9) Pericardiocentesis and Pericardial Drainage (CPT Code 3X000, 3X001,
                3X002, and 3X003)
                    CPT code 33015 (Tube pericardiostomy) was identified as potentially
                misvalued on a Relativity Assessment Workgroup (RAW) screen of codes
                with a negative IWPUT and Medicare utilization over 10,000 for all
                services or over 1,000 for Harvard valued and CMS or other source
                codes. In September 2018, the CPT Editorial Panel deleted four existing
                codes and created four new codes to describe periodcardiocentesis
                drainage procedures to differentiate by age and to include imaging
                guidance.
                    We are proposing to refine the work RVU for all four codes in the
                family. We disagree with the RUC-recommended work RVU of 5.00 for CPT
                code 3X000 (Pericardiocentesis, including imaging guidance, when
                performed) and are proposing a work RVU of 4.40 based on a crosswalk to
                CPT code 43244 (Esophagogastroduodenoscopy, flexible, transoral; with
                band ligation of esophageal/gastric varices). CPT code 43244 shares the
                same intraservice time of 30 minutes with CPT code 3X000 and has a
                slightly longer total time of 81 minutes as compared to 75 minutes for
                the reviewed code. In our review of CPT code 3X000, we noted that the
                recommended intraservice time as compared to the current initial
                pericardiocentesis procedure (CPT code 33010) is increasing from 24
                minutes to 30 minutes (25 percent), and the recommended total time is
                remaining the same at 75 minutes; however, the RUC-recommended work RVU
                is increasing from 1.99 to 5.00, which is an increase of 151 percent.
                Although we did not imply that the decrease in time as reflected in
                survey values must equate to a one-to-one or linear increase in the
                valuation of work RVUs, we believe that since the two components of
                work are time and intensity, modest increases in time should be
                appropriately reflected with a commensurate increase the work RVUs. We
                also conducted a search in the RUC database among 0-day global codes
                with 30 minutes of intraservice time and comparable total time of 65-85
                minutes. Our search identified 49 codes and all 49 of these codes had a
                work RVU lower than 5.00. We do not believe that it would serve the
                interests of relativity to establish a new maximum work RVU for this
                range of time values.
                    As a result, we believe that it is more accurate to propose a work
                RVU of 4.40 for CPT code 3X000 based on a crosswalk to CPT code 43244
                to account for these modest increases in the surveyed work time as
                compared to the predecessor pericardiocentesis codes. We are aware that
                CPT code 3X000 is bundling imaging guidance into the new procedure,
                which was not included in the previous pericardiocentesis codes.
                However, we do not believe that the recoding of the services in this
                family has resulted in an increase in their intensity, only a change in
                the way in which they will be reported, and therefore, we do not
                believe that it would serve the interests of relativity to propose the
                RUC-recommended work values for all of the codes in this family. We
                also note that, through the bundling of some of these frequently
                reported services, it is reasonable to expect that the new coding
                system will achieve savings via elimination of duplicative assumptions
                of the resources involved in furnishing particular servicers. For
                example, a practitioner would not be carrying out the full preservice
                work twice for CPT codes 33010 and 76930, but preservice times were
                assigned to both codes under the old coding. We believe the new coding
                assigns more accurate work times, and thus, reflects efficiencies in
                resource costs that existed but were not reflected in the services as
                they were previously reported. If the addition of imaging guidance had
                made the new CPT codes significantly more intense to perform, we
                believe that this would have been reflected in the surveyed work times,
                which were largely unchanged from the predecessor codes.
                    We disagree with the RUC-recommended work RVU of 5.50 for CPT code
                3X001 (Pericardial drainage with insertion of indwelling catheter,
                percutaneous, including fluoroscopy and/or ultrasound guidance, when
                performed; 6 years and older without congenital cardiac anomaly) and
                are proposing a work RVU of 4.62 based on a crosswalk to CPT code 52234
                (Cystourethroscopy, with fulguration (including cryosurgery or laser
                surgery) and/or resection of; SMALL bladder tumor(s) (0.5 up to 2.0
                cm)). CPT code 52234 shares the same intraservice time of 30 minutes
                with CPT code 3X001 and has 2 additional minutes of total time at 79
                minutes as compared to 77 minutes for the reviewed code. In our review
                of CPT code 3X001, we noted many of the same issues that we had raised
                with CPT code 3X000, in particular with the increase in the work RVU
                greatly exceeding the increase in the surveyed work times as compared
                to the predecessor pericardiocentesis codes. We searched the RUC
                database again for 0-day global codes with 30 minutes of intraservice
                time and comparable total time of 67-87 minutes. Our search identified
                43 codes and again all 43 of these codes had a work RVU lower than
                5.50. As we stated with regard to CPT code 3X000, we do not believe
                that it would serve the interests of relativity to establish a new
                maximum work RVU for this range of time values. We believe that it is
                more accurate to propose a work RVU of 4.62 for CPT code 3X001 based on
                a crosswalk to CPT code 52234 based on the same rationale that we
                [[Page 40574]]
                detailed with regards to CPT code 3X000.
                    We disagree with the RUC-recommended work RVU of 6.00 for CPT code
                3X002 (Pericardial drainage with insertion of indwelling catheter,
                percutaneous, including fluoroscopy and/or ultrasound guidance, when
                performed; birth through 5 years of age, or any age with congenital
                cardiac anomaly) and are proposing a work RVU of 5.00 based on the
                survey 25th percentile value. In our review of CPT code 3X002, we noted
                many of the same issues that we had raised with CPT codes 3X000 and
                3X001, in particular with the increase in the work RVU greatly
                exceeding the increase in the surveyed work times as compared to the
                predecessor pericardiocentesis codes. The recommended work RVU of 6.00
                was based on a crosswalk to CPT code 31603 (Tracheostomy, emergency
                procedure; transtracheal), which shares the same intraservice time of
                30 minutes with CPT code 3X002 and very similar total time. While we
                agree that CPT code 31603 is a close match to the surveyed work times
                for CPT code 3X002, we do not believe that it is the most accurate
                choice for a crosswalk due to the fact that CPT code 31603 is a clear
                outlier in work valuation. We searched for 0-day global codes in the
                RUC database with 30 minutes of intraservice time and a comparable 90-
                120 minutes of total time. There were 21 codes that met this criteria,
                and the recommended crosswalk to CPT code 31603 had the highest work
                RVU of any of these codes at the recommended 6.00. Furthermore, there
                was only one other code with a work RVU above 5.00, another
                tracheostomy procedure described by CPT code 31600 (Tracheostomy,
                planned (separate procedure)) at a work RVU of 5.56. None of the other
                codes had a work RVU higher than 4.69, and the median work RVU of the
                group comes out to only 4.00. The two tracheostomy procedures have work
                RVUs more than a full standard deviation above any of the other codes
                in this group of 0-day global procedures.
                    We do not mean to suggest that the work RVU for a given service
                must always fall in the middle of a range of codes with similar time
                values. We recognize that it would not be appropriate to develop work
                RVUs solely based on time given that intensity is also an element of
                work. Were we to disregard intensity altogether, the work RVUs for all
                services would be developed based solely on time values and that is
                definitively not the case, as indicated by the many services that share
                the same time values but have different work RVUs. However, we also do
                not believe that it would serve the interests of relativity by
                crosswalking the work RVU of CPT code 3X002 to tracheostomy procedures
                that are higher than anything else in this group of codes, procedures
                that we believe to be outliers due to the serious risk of patient
                mortality associated with their performance. We believe that it is this
                patient risk which is responsible for the otherwise anomalously high
                intensity in CPT codes 31600 and 31603. Therefore, we are proposing a
                work RVU of 5.00 for CPT code 3X002 based on the survey 25th
                percentile, which we believe more accurately captures both the time and
                intensity associated with the procedure.
                    We disagree with the RUC-recommended work RVU of 5.00 for CPT code
                3X003 (Pericardial drainage with insertion of indwelling catheter,
                percutaneous, including CT guidance) and are proposing a work RVU of
                4.29 based on the survey 25th percentile value. In our review of CPT
                code 3X003, we noted many of the same issues that we had raised with
                CPT codes 3X000-3X002, in particular with the increase in the work RVU
                greatly exceeding the increase in the surveyed work times as compared
                to the predecessor pericardiocentesis codes. We searched for 0-day
                global codes in the RUC database with 30 minutes of intraservice time
                (slightly higher than the 28 minutes of intraservice time in CPT code
                3X003) and a comparable 70-100 minutes of total time. Our search
                identified 45 codes and again all 45 of these codes had a work RVU
                lower than 5.00, which led us to believe that the recommended work RVU
                for CPT code 3X003 was overvalued. We also compared CPT code 3X003 to
                the most similar code in the family, CPT code 3X001, and noted that the
                survey respondents indicated that CPT code 3X003 should have a lower
                work RVU at both the survey 25th percentile and survey median values.
                Therefore, we are proposing a work RVU of 4.29 for CPT code 3X003 based
                on the survey 25th percentile value. We are supporting this proposal
                with a reference to CPT code 31254 (Nasal/sinus endoscopy, surgical
                with ethmoidectomy; partial (anterior)), a recently-reviewed code with
                an intraservice work time of 30 minutes, a total time of 84 minutes,
                and a work RVU of 4.27.
                    The RUC did not recommend and we are not proposing any direct PE
                inputs for the codes in this family.
                (10) Pericardiotomy (CPT Codes 33020 and 33025)
                    CPT code 33020 (Pericardiotomy for removal of clot or foreign body
                (primary procedure)) was identified as potentially misvalued on a
                Relativity Assessment Workgroup (RAW) screen of codes with a negative
                IWPUT and Medicare utilization over 10,000 for all services or over
                1,000 for Harvard valued and CMS or other source codes. The RAW
                determined that CPT code 33020 should be surveyed for April 2018; CPT
                code 33025 (Creation of pericardial window or partial resection for
                drainage) was included for review as part of this code family.
                    We disagree with the RUC-recommended work RVU of 14.31 (25th
                percentile survey value) for CPT code 33020 and are proposing a work
                RVU of 12.95. Our proposed work RVU is based on a crosswalk to CPT code
                58700 (Salpingectomy, complete or partial, unilateral or bilateral
                (separate procedure)), which has an identical work RVU of 12.95,
                identical 60 minutes intraservice time, and near identical total time
                values as CPT code 33020.
                    In our review of CPT code 33020, we note that the RUC-recommended
                intraservice time is decreasing from 85 minutes to 60 minutes (29
                percent reduction), and that the RUC- recommended total time is
                decreasing from 565 minutes to 321 minutes (43 percent reduction).
                However, the RUC-recommended work RVU is only decreasing from 14.95 to
                14.31, which is a reduction of less than 5 percent. Although we do not
                imply that the decrease in time as reflected in survey values must
                equate to a one-to-one or linear decrease in the valuation of work
                RVUs, we believe that since the two components of work are time and
                intensity, significant decreases in time should be appropriately
                reflected in decreases to work RVUs. In the case of CPT code 33020, we
                believe that it would be more accurate to propose a work RVU of 12.95,
                based on a crosswalk to CPT code 58700 to account for these decreases
                in surveyed work times.
                    For CPT code 33025, the RUC recommended a work RVU of 13.20 (survey
                25th percentile value). Although we disagree with the RUC-recommended
                work RVU of 13.20, based on RUC survey results and the time resources
                involved in furnishing these two procedures we agree that the relative
                difference in work RVUs between CPT codes 33020 and 33025 is equivalent
                to the RUC-recommended incremental difference of 1.11 less work RVUs.
                Therefore, we are proposing a work RVU of 11.84 based on a reference to
                CPT code 34712 (Transcatheter delivery of enhanced fixation devices(s)
                to the endograft (e.g., anchor, screw,
                [[Page 40575]]
                tack) and all associated radiological supervision and interpretation),
                which has a work RVU of 12.00, identical intraservice time of 60
                minutes, and similar total time as CPT code 33025.
                    In reviewing CPT code 33025, we note that the RUC-recommended
                intraservice time is decreasing from 66 minutes to 60 minutes (9
                percent reduction), and that the RUC-recommended total time is
                decreasing from 410 minutes to 301 minutes (27 percent reduction).
                However, the RUC-recommended work RVU is only decreasing from 13.70 to
                13.20, which is a reduction of less than 5 percent. Although we do not
                imply that the decrease in time as reflected in survey values must
                equate to a one-to-one or linear decrease in the valuation of work
                RVUs, we believe that since the two components of work are time and
                intensity, significant decreases in time should be appropriately
                reflected in decreases to work RVUs. In the case of CPT code 33025, we
                believe that it would be more accurate to propose a work RVU of 11.84,
                based on less the incremental difference of 1.11 work RVUs between CPT
                codes 33020 and 33025 and a crosswalk to CPT code 34712 to account for
                these decreases in surveyed work times.
                    We are proposing the RUC-recommended direct PE inputs for all the
                codes in this family.
                (11) Transcatheter Aortic Valve Replacement (TAVR) (CPT Codes 33361,
                33362, 33363, 33364, 33365, and 33366)
                    In October 2016, the RUC's RAW reviewed codes that had been flagged
                in the period from October 2011 to April 2012, using 3 years of
                available Medicare claims data (2013, 2014 and preliminary 2015 data).
                The RUC workgroup determined that the technology for these
                transcatheter aortic valve replacement (TAVR) services was evolving, as
                the typical site of service had shifted from being provided in academic
                centers to private centers, and the RUC recommended that CPT codes
                33361-33366 be resurveyed for physician work and practice expense.
                These six codes were surveyed and reviewed at the April 2018 RUC
                meeting using a survey methodology that reflected the unique nature of
                these codes. CPT codes 33361-33366 are currently the only codes on the
                PFS where the -62 co-surgeon modifier is required 100 percent of the
                time.
                    We are proposing the RUC-recommended work RVU for all six of the
                codes in this family. We are proposing a work RVU of 22.47 for CPT code
                33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with
                prosthetic valve; percutaneous femoral artery approach), a work RVU of
                24.54 for CPT code 33362 (Transcatheter aortic valve replacement (TAVR/
                TAVI) with prosthetic valve; open femoral artery approach), a work RVU
                of 25.47 for CPT code 33363 (Transcatheter aortic valve replacement
                (TAVR/TAVI) with prosthetic valve; open axillary artery approach), a
                work RVU of 25.97 for CPT code 33364 (Transcatheter aortic valve
                replacement (TAVR/TAVI) with prosthetic valve; open iliac artery
                approach), a work RVU of 26.59 for CPT code 33365 (Transcatheter aortic
                valve replacement (TAVR/TAVI) with prosthetic valve; transaortic
                approach (e.g., median sternotomy, mediastinotomy)), and a work RVU of
                29.35 for CPT code 33366 (Transcatheter aortic valve replacement (TAVR/
                TAVI) with prosthetic valve; transapical exposure (e.g., left
                thoracotomy)).
                    Although we have some concerns that the RUC-recommended work RVUs
                for these six codes do not match the decreases in surveyed work time,
                we recognize that the technology described by the TAVR procedures is in
                the process of being adopted by a much wider audience, and that there
                will be greater intensity on the part of the practitioner when this
                particular new technology is first being adopted. However, we intend to
                continue examining whether these services are appropriately valued, in
                light of the proposed national coverage determination proposing to use
                TAVR for the treatment of symptomatic aortic valve stenosis that we
                posted on March 26, 2019. We will also consider any further
                improvements to the valuation of these services, as their use becomes
                more commonplace, through future notice and comment rulemaking. The
                text of the proposed national coverage determination is available on
                the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=293.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (12) Aortic Graft Procedures (CPT Codes 338XX, 338X1, 33863, 33864,
                338X2, and 33866)
                    In 2017, CPT created a new add-on code, CPT code 33866 (Aortic
                hemiarch graft including isolation and control of the arch vessels,
                beveled open distal aortic anastomosis extending under one or more of
                the arch vessels, and total circulatory arrest or isolated cerebral
                perfusion (List separately in addition to code for primary procedure)).
                For CY 2019, we finalized the RUC's recommended work RVU for this code
                on an interim basis (83 FR 59528). CPT revised the code set to develop
                distinct codes for ascending aortic repair for dissection and ascending
                aortic repair for other ascending aortic disease such as aneurysms and
                congenital anomalies, creating two new codes, as well as revaluating
                the two other codes in the family.
                    For CPT code 338XX (Ascending aorta graft, with cardiopulmonary
                bypass, includes valve suspension, when performed; for aortic
                dissection), we disagree with the RUC-recommended work RVU of 65.00,
                because the RUC is recommending an increase in work RVU that is not
                commensurate with a reduction in physician time, and because we do not
                believe that the RUC's recommendation that this service be increased to
                a value that would place it among the highest valued of all services of
                similar physician time is appropriate; we think a comparison to other
                services of similar time indicates that the RUC's recommended increase
                overstates the work. Instead, we are proposing to increase the work RVU
                to 63.40 based on a crosswalk to CPT code 61697 (Surgery of complex
                intracranial aneurysm, intracranial approach; carotid circulation). For
                CPT code 338X1 (Ascending aorta graft, with cardiopulmonary bypass,
                includes valve suspension, when performed; for aortic disease other
                than dissection (e.g., aneurysm)), we disagree with the RUC-recommended
                work RVU of 50.00, because we do not believe it adequately reflects the
                recommended decrease in physician time, and because we do not believe
                this service should be assigned a value that is among the highest of
                all 90-day global services with similar physician time values. Instead,
                we are proposing a work RVU of 45.13 based on a crosswalk to CPT code
                33468 (Tricuspid valve repositioning and plication for Ebstein
                anomaly), which is a code with an identical intraservice time and
                similar total time value.
                    For CPT code 33863 (Ascending aorta graft, with cardiopulmonary
                bypass, with aortic root replacement using valved conduit and coronary
                reconstruction (e.g., Bentall)), according to the RUC, the survey
                respondents underestimated the intraservice time of the procedure and
                the RUC recommended a work RVU of 59.00 based on the 75th percentile of
                survey responses for intraservice time. We believe the use of the
                survey 75th percentile value to be problematic, as the intraservice
                time values should generally reflect the survey median. We are
                requesting that this code be
                [[Page 40576]]
                resurveyed to determine more accurate physician time values, and we are
                proposing to maintain the current RVU of 58.79 for CY 2020. For CPT
                code 33864 (Ascending aorta graft, with cardiopulmonary bypass with
                valve suspension, with coronary reconstruction and valve-sparing aortic
                root remodeling (e.g., David Procedure, Yacoub procedure)), we do not
                agree with the RUC-recommended work RVU of 63.00, because we believe
                this increase is not justified given that the intraservice time is not
                changing from its current value, and the physician total time value is
                decreasing. Therefore, we are proposing to maintain the current work
                RVU of 60.08 for this service.
                    For CPT code 338X2 (Transverse aortic arch graft, with
                cardiopulmonary bypass, with profound hypothermia, total circulatory
                arrest and isolated cerebral perfusion with reimplantation of arch
                vessel(s) (e.g., island pedicle or individual arch vessel
                reimplantation)), we disagree with the RUC's recommended work RVU of
                65.75. While we agree that an increase in work RVU is justified, as
                discussed above, we believe that the use of the 75th percentile of
                physician intraservice work time is problematic, and believe such a
                significant increase in work RVU is not validated. Therefore, we are
                proposing a less significant increase to 60.88 using the RUC-
                recommended difference in work value between CPT code 338X1 and the
                code in question, CPT code 338X2 (a difference of 15.75). As further
                support for this value, we note that it falls between CPT codes 33782
                (Aortic root translocation with ventricular septal defect and pulmonary
                stenosis repair (i.e., Nikaidoh procedure); without coronary ostium
                reimplantation), which has a work RVU of 60.08, and CPT code 43112
                (Total or near total esophagectomy, with thoracotomy; with
                pharyngogastrostomy or cervical esophagogastrostomy, with or without
                pyloroplasty (i.e., McKeown esophagectomy or tri-incisional
                esophagectomy)), which has a work RVU of 62.00. Both of these
                bracketing reference codes have similar intraservice and total time
                values. For CPT code 33X01 (Aortic hemiarch graft including isolation
                and control of the arch vessels, beveled open distal aortic anastomosis
                extending under one or more of the arch vessels, and total circulatory
                arrest or isolated cerebral perfusion (List separately in addition to
                code for primary procedure)), we are proposing the RUC-recommended work
                RVU of 17.75.
                    For the direct PE inputs, we are proposing to refine the clinical
                labor to align with the number of post-operative visits. Thus, we are
                proposing to add 12 minutes of clinical labor time for ``Discharge day
                management'' for CPT codes 338X1, 33863, 33864, and 338X2, as each of
                these codes include a 99238 discharge visit within their global periods
                that should be reflected in the clinical labor inputs.
                (13) Iliac Branched Endograft Placement (CPT Codes 34X00 and 34X01)
                    For CY 2018, the CPT Editorial Panel created a family of 20 new and
                revised codes that redefined coding for endovascular repair of the
                aorta and iliac arteries. The iliac branched endograft technology has
                become more mainstream over time, and two new CPT codes were created to
                capture the work of iliac artery endovascular repair with an iliac
                branched endograft. These two new codes were surveyed and reviewed for
                the January 2019 RUC meeting.
                    We are proposing the RUC-recommended work RVU of 9.00 for CPT code
                34X00 (Endovascular repair of iliac artery at the time of aorto-iliac
                artery endograft placement by deployment of an iliac branched endograft
                including pre-procedure sizing and device selection, all ipsilateral
                selective iliac artery catheterization(s), all associated radiological
                supervision and interpretation, and all endograft extension(s)
                proximally to the aortic bifurcation and distally in the internal
                iliac, external iliac, and common femoral artery(ies), and treatment
                zone angioplasty/stenting, when performed, for rupture or other than
                rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous
                malformation, penetrating ulcer, traumatic disruption), unilateral) and
                the RUC-recommended work RVU of 24.00 for CPT code 34X01 (Endovascular
                repair of iliac artery, not associated with placement of an aorto-iliac
                artery endograft at the same session, by deployment of an iliac
                branched endograft, including pre-procedure sizing and device
                selection, all ipsilateral selective iliac artery catheterization(s),
                all associated radiological supervision and interpretation, and all
                endograft extension(s) proximally to the aortic bifurcation and
                distally in the internal iliac, external iliac, and common femoral
                artery(ies), and treatment zone angioplasty/stenting, when performed,
                for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection,
                arteriovenous malformation, penetrating ulcer), unilateral).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (14) Exploration of Artery (CPT Codes 35701, 35X01, and 35X01)
                    CPT code 35701 (Exploration not followed by surgical repair,
                artery; neck (e.g., carotid, subclavian)) was identified via a screen
                for services with a ne.g.ative IWPUT and Medicare utilization over
                10,000 for all services or over 1,000 for Harvard valued and CMS/Other
                source codes. In September 2018, the CPT Editorial Panel revised one
                code, added two new codes, and deleted three existing codes in the
                family to report major artery exploration procedures and to condense
                the code set due to low frequency.
                    We are proposing the RUC-recommended work RVU for all three codes
                in the family. We are proposing a work RVU of 7.50 for CPT code 35701,
                a work RVU of 7.12 for CPT code 35X00 (Exploration not followed by
                surgical repair, artery; upper extremity (e.g., axillary, brachial,
                radial, ulnar)), and a work RVU of 7.50 for CPT code 35X01 (Exploration
                not followed by surgical repair, artery; lower extremity (e.g., common
                femoral, deep femoral, superficial femoral, popliteal, tibial,
                peroneal)).
                    For the direct PE inputs, we are proposing to refine the clinical
                labor, supplies, and equipment to match the number of office visits
                contained in the global periods of the codes under review. We are
                proposing to refine the clinical labor time for the ``Post-operative
                visits (total time)'' (CA039) activity from 36 minutes to 27 minutes
                for CPT codes 35701 and 35X00, and from 63 minutes to 27 minutes for
                CPT code 35X01. Each of these CPT codes contains a single postoperative
                level 2 office visit (CPT code 99212) in its global period, and 27
                minutes of clinical labor is the time associated with this office
                visit. We are proposing to refine the equipment time for the exam table
                (EF023) to the same time of 27 minutes for each code to match the
                clinical labor time. Finally, we are also proposing to refine the
                quantity of the minimum multi-specialty visit pack (SA048) from 2 to 1
                for CPT code 35X01 to match the single postoperative visit in the
                code's global period. We believe that the additional direct PE inputs
                in the recommended materials were an accidental oversight due to
                revisions that took place at the RUC meeting following the approval of
                the PE inputs for these codes.
                (15) Intravascular Ultrasound (CPT Codes 37252 and 37253)
                    In CY 2014, the CPT Editorial Panel deleted CPT codes 37250
                (Ultrasound evaluation of blood vessel during
                [[Page 40577]]
                diagnosis or treatment )and 37251 (Ultrasound evaluation of blood
                vessel during diagnosis or treatment) and created new bundled codes
                37252 (Intravascular ultrasound (noncoronary vessel) during diagnostic
                evaluation and/or therapeutic intervention, including radiological
                supervision and interpretation; initial noncoronary vessel) and 37253
                (Intravascular ultrasound (noncoronary vessel) during diagnostic
                evaluation and/or therapeutic intervention, including radiological
                supervision and interpretation; each additional noncoronary vessel) to
                describe intravascular ultrasound (IVUS). CPT codes 37252 and 37253
                were reviewed at the January 2015 RUC meeting. The RUC's recommendation
                for these codes were to result in an overall work savings that should
                have been redistributed back to the Medicare conversion factor. The
                codes have had a 44 percent increase in work RVUs over the old codes,
                CPT codes 37250 and 37251, from 2015 to 2016 and the utilization has
                doubled from that of the previous coding structure, not considering the
                radiological activities. In April 2018, the RUC reviewed this code
                family and determined the utilization of the bundling of these services
                was underestimated. Consequently, the RUC recommended that these
                services be surveyed for October 2018. The RUC indicated that the
                specialty societies should research why there was such an increase in
                the utilization. Accordingly, the specialty society surveyed these ZZZ-
                day global codes, and the survey results indicated the intraservice and
                total work times, along with the work RVU should remain the same
                despite the underestimation in utilization.
                    We disagreed with the RUC-recommended work RVU of 1.80 for CPT code
                37252 and are proposing a work RVU of 1.55 based on a crosswalk to CPT
                code 19084. CPT code 19084 is a recently reviewed code with 20 minutes
                of intraservice time and 25 minutes of total time. In reviewing CPT
                code 37252, we note, as mentioned above, that in CY 2015 the specialty
                society stated that bundling this service would achieve savings.
                However, since 2015 observed utilization for CPT code 37252 has greatly
                exceeded proposed estimates, thus we are proposing to restore work
                neutrality to the intravascular ultrasound code family to achieve the
                initial estimated savings.
                    For CPT code 37253, we disagreed with the RUC-recommended work RVU
                of 1.44 and we are proposing a work RVU of 1.19. Although we disagreed
                with the RUC-recommended work RVU, we note the relative difference in
                work between CPT codes 37252 and 37253 is an interval of 0.36 RVUs.
                Therefore, we are proposing a work RVU of 1.19 for CPT code 37253,
                based on the recommended interval of 0.36 fewer RVUs than our proposed
                work RVU of 1.55 for CPT code 37252.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (16) Stab Phlebectomy of Varicose Veins (CPT Codes 37765 and 37766)
                    These services were identified in February 2008 via the High Volume
                Growth screen, for services with a total Medicare utilization of 1,000
                or more that have increased by at least 100 percent from 2004 through
                2006. The RUC subsequently recommended monitoring and reviewing changes
                in utilization over multiple years. In October 2017, the RUC
                recommended that this service be surveyed for April 2018. We are
                proposing the RUC-recommended work RVUs of 4.80 for CPT code 37765
                (Stab phlebectomy of varicose veins, 1 extremity; 10-20 stab incisions)
                and 6.00 for CPT code 37766 (Stab phlebectomy of varicose veins, 1
                extremity; more than 20 incisions). We are proposing the RUC-
                recommended direct PE inputs for all codes in the family.
                (17) Biopsy of Mouth Lesion (CPT Code 40808)
                    CPT code 40808 (Biopsy, vestibule of mouth) was identified via a
                screen for services with a negative IWPUT and Medicare utilization over
                10,000 for all services or over 1,000 for Harvard valued and CMS/Other
                source codes.
                    We disagree with the RUC's recommended work RVU of 1.05 with a
                crosswalk to CPT code 11440 (Excision, other benign lesion including
                margins, except skin tag (unless listed elsewhere), face, ears,
                eyelids, nose, lips, mucous membrane; excised diameter 0.5 cm or less),
                as we believe this increase in work RVU is not commensurate with the
                RUC-recommended 5-minute reduction in intraservice time and a 10-minute
                reduction in total time. While we understand that the RUC considers the
                current time values for this service to be invalid estimations, we do
                not see compelling evidence that would indicate that an increase in
                work RVU that would be concurrent with a reduction in physician time is
                appropriate. Therefore, we are proposing to maintain the current work
                RVU of 1.01, and note that implementing the current work RVU with the
                RUC-recommended revised physician time values would correct the
                negative IWPUT anomaly.
                    For the direct PE inputs, we are proposing to refine the clinical
                labor time for the ``Prepare room, equipment and supplies'' (CA013)
                activity to 3 minutes and to refine the clinical labor time for the
                ``Confirm order, protocol exam'' (CA014) activity to 0 minutes. As we
                detailed when discussing this issue in the CY 2019 PFS final rule (83
                FR 59463 through 59464), CPT code 40808 does not include the old
                clinical labor task ``Patient clinical information and questionnaire
                reviewed by technologist, order from physician confirmed and exam
                protocoled by radiologist'' on a prior version of the PE worksheet, nor
                does the code contain any clinical labor for the CA007 activity
                (``Review patient clinical extant information and questionnaire''). CPT
                code 40808 does not appear to be an instance where an old clinical
                labor task was split into two new clinical labor activities, and we
                continue to believe that in these cases the 3 total minutes of clinical
                staff time would be more accurately described by the CA013 ``Prepare
                room, equipment and supplies'' activity code. We also note that there
                is no effect on the total clinical labor direct costs in these
                situations, since the same 3 minutes of clinical labor time is still
                being furnished.
                    We are also proposing to refine the equipment time for the
                electrocautery-hyfrecator (EQ110) to conform to our established
                standard for non-highly technical equipment.
                (18) Transanal Hemorrhoidal Dearterialization (CPT Codes 46945, 46946,
                and 46X48)
                    We are proposing the RUC-recommended work RVU for all three codes
                in the family. We are proposing a work RVU of 3.69 for CPT code 46945
                (Hemorrhoidectomy, internal, by ligation other than rubber band; single
                hemorrhoid column/group, without imaging guidance), a work RVU of 4.50
                for CPT code 46946 (2 or more hemorrhoid columns/groups, without
                imaging guidance), and a work RVU of 5.57 for CPT code 46X48
                (Hemorrhoidectomy, internal, by transanal hemorrhoidal
                dearterialization, 2 or more hemorrhoid columns/groups, including
                ultrasound guidance, with mucopexy when performed).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (19) Preperitoneal Pelvic Packing (CPT Codes 490X1 and 490X2)
                    In May 2018, the CPT Editorial Panel approved the addition of two
                codes for preperitoneal pelvic packing, removal
                [[Page 40578]]
                and/or repacking for hemorrhage associated with pelvic trauma. These
                new codes were surveyed and reviewed for the October 2018 RUC meeting.
                    We disagree with the RUC-recommended work RVU of 8.35 for CPT code
                490X1 (Preperitoneal pelvic packing for hemorrhage associated with
                pelvic trauma, including local exploration) and are proposing a work
                RVU of 7.55 based on a crosswalk to CPT code 52345 (Cystourethroscopy
                with ureteroscopy; with treatment of ureteropelvic junction stricture
                (e.g., balloon dilation, laser, electrocautery, and incision)). We are
                also proposing to reduce the immediate postservice work time from 60
                minutes to 45 minutes, which results in a total work time of 140
                minutes for this procedure. We believe that the survey respondents
                overstated the immediate postservice work time that would typically be
                required to perform CPT code 490X1, which we investigated by comparing
                this new service against the existing 0-day global codes on the PFS. We
                found that among the roughly 1,100 codes with 0-day global periods,
                only 21 codes had an immediate postservice work time of 60 minutes or
                longer. The 21 codes that fell into this category had significantly
                higher intraservice work times than CPT code 490X1, with an average
                intraservice work time of 111 minutes as compared to the 45 minutes of
                intraservice work time in CPT code 490X1. Generally speaking, it is
                extremely rare for a service to have more immediate postservice work
                time than intraservice work time, and in fact only 28 out of the
                roughly 1,100 codes with 0-day global periods had more immediate
                postservice work time than intraservice work time. While we agree that
                each service on the PFS is its own unique entity, these comparisons to
                other 0-day global codes suggest that the survey respondents
                overestimated the amount of immediate postservice work time that would
                typically be associated with CPT code 490X1.
                    As a result, we believe that it would be more accurate to reduce
                the immediate postservice work time to 45 minutes and to propose a work
                RVU of 7.55 based on a crosswalk to CPT code 52345. This crosswalk code
                shares an intraservice work time of 45 minutes and a similar total time
                of 135 minutes after taking into account the reduced immediate
                postservice work time that we are proposing for CPT code 490X1. We
                searched the RUC database for 0-day global procedures with 45 minutes
                of intraservice work time, and at the recommended work RVU of 8.35, CPT
                code 490X1 would establish a new maximum value, higher than all of the
                79 other codes that fall into this category. We recognize that CPT code
                490X1 describes a preperitoneal pelvic packing service associated with
                pelvic trauma, and that this is a difficult and intensive procedure
                that rightly has a higher work RVU than many of these other 0-day
                global codes. However, we believe that it better maintains relativity
                to propose a crosswalk to CPT code 52345 at a work RVU of 7.55, which
                would still assign this code the second-highest work RVU among all 0
                day global codes with 45 minutes of intraservice work time, as opposed
                to proposing the survey median work RVU of 8.35 at a rate higher than
                anything in the current RUC database.
                    We disagree with the RUC-recommended work RVU of 6.73 for CPT code
                490X2 (Re-exploration of pelvic wound with removal of preperitoneal
                pelvic packing including repacking, when performed) and are proposing a
                work RVU of 5.70 based on the 25th percentile survey value. We believe
                that the survey 25th percentile work RVU more accurately describes the
                work of re-exploring this type of pelvic wound, and by proposing the
                survey 25th percentile we are maintaining the general increment in RVUs
                between the two codes in the family (a difference of 1.62 RVUs as
                recommended by the RUC as compared to 1.85 RVUs as proposed here). We
                are supporting this valuation with a reference to CPT code 39401
                (Mediastinoscopy; includes biopsy(ies) of mediastinal mass (e.g.,
                lymphoma), when performed), a recently reviewed code from CY 2015 which
                shares the same intraservice time of 45 minutes, a slightly higher
                total time of 142 minutes and a lower work RVU of 5.44.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (20) Cystourethroscopy Insertion Transprostatic Implant (CPT Codes
                52441 and 52442)
                    In 2005, the AMA RUC began the process of flagging services that
                represent new technology or new services as they were presented to the
                AMA/Specialty Society RVS Update Committee. This service was reviewed
                at the October 2018 RAW meeting, and the RAW indicated that the
                utilization is increasing and questioned the time required to perform
                these services. These two codes were surveyed and reviewed for the
                January 2019 RUC meeting.
                    We disagree with the RUC-recommended work RVU of 4.50 (current
                value) for CPT code 52441 (Cystourethroscopy, with insertion of
                permanent adjustable transprostatic implant; single implant) and are
                proposing a work RVU of 4.00. This proposed work RVU is based on a
                crosswalk from recently reviewed CPT code 58562 (Hysterscopy, surgical;
                with removal of impacted foreign body), which has a work RVU of 4.00,
                and an identical 25 minutes of intraservice time as CPT code 52441.
                    We disagree with the RUC-recommended work RVU of 1.20 (current
                value) for CPT code 52442 (Cystourethroscopy, with insertion of
                permanent adjustable transprostatic implant; each additional permanent
                adjustable transprostatic implant (List separately in addition to code
                for primary procedure)) and are proposing a work RVU of 1.01. This
                proposed work RVU is based on a crosswalk from CPT code 36218
                (Selective catheter placement, arterial system; additional second
                order, third order, and beyond, thoracic or brachiocephalic branch,
                within a vascular family (List in addition to code for initial second
                or third order vessel as appropriate)), which has a work RVU of 1.01,
                and an identical 15 minutes of intraservice time as CPT code 52442. The
                RUC survey showed a reduction in time, and the work should reflect
                these changes.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family without refinement.
                (21) Orchiopexy (CPT Code 54640)
                    The CPT Editorial Panel revised existing CPT code 54640 to describe
                an additional approach for orchiopexy (scrotal) and to clearly indicate
                that hernia repair is separately reportable. This code was surveyed and
                reviewed for the January 2019 RUC meeting.
                    We are proposing to maintain the current work RVU of 7.73 as
                recommended by the RUC. We are proposing the RUC-recommended direct PE
                inputs for CPT code 54640 without refinement.
                (22) Radiofrequency Neurootomy Sacroiliac Joint (CPT Codes 6XX00,
                6XX01)
                    In September 2018, the CPT Editorial Panel created two new codes to
                describe injection and radiofrequency ablation of the sacroiliac joint
                with image guidance for somatic nerve procedures. We are proposing the
                RUC-recommended work RVU of 1.52 for CPT code 6XX00 (Injection(s),
                anesthetic agent(s) and/or steroid; nerves innervating the sacroiliac
                joint, with image guidance (i.e., fluoroscopy or computed tomography))
                and the RUC-recommended work RVU of 3.39 for CPT code 6XX01
                (Radiofrequency ablation, nerves innervating the sacroiliac joint, with
                [[Page 40579]]
                image guidance (i.e., fluoroscopy or computed tomography)).
                    For the direct PE inputs, we are proposing to refine the quantity
                of the ``needle, 18-26g 1.5-3.5in, spinal'' (SC028) supply from 3 to 1
                for CPT code 6XX00. There are no spinal needles in use in the reference
                code associated with CPT code 6XX00, and there was no explanation in
                the recommended materials explaining why three such needles would be
                typical for this procedure. We agree that the service being performed
                in CPT code 6XX00 would require a spinal needle, but we do not believe
                that the use of three such needles would be typical.
                    We are proposing to refine the quantity of the ``cannula
                (radiofrequency denervation) (SMK-C10)'' (SD011) supply from 4 to 2 for
                CPT code 6XX01. We do not believe that the use of 4 of these cannula
                would be typical for the procedure, as the reference code currently
                used for destruction by neurolytic agent contains only a single
                cannula. We believe that the nerves would typically be ablated one at a
                time using this cannula, as opposed to ablating four of them
                simultaneously as suggested in the recommended direct PE inputs. We
                also searched in the RUC database for other CPT codes that made use of
                the SD011 supply, and out of the seven codes that currently use this
                item, none of them include more than 2 cannula. As a result, we are
                proposing to refine the supply quantity to 2 cannula to match the
                highest amount contained in an existing code on the PFS. We are also
                refining the equipment time for the ``radiofrequency kit for
                destruction by neurolytic agent'' (EQ354) equipment from 164 minutes to
                82 minutes. The RUC's equipment time recommendation was predicated on
                the use of 4 of the SD011 supplies for 41 minutes apiece, and we are
                refining the equipment time to reflect our supply refinement to 2
                cannula. It was unclear in the recommended materials as to whether the
                radiofrequency kit equipment was in use simultaneously or sequentially
                along with the cannula supplies, and therefore, we are soliciting
                comments on the typical use of this equipment.
                    Finally, we are proposing to refine the equipment time for the
                technologist PACS workstation (ED050) equipment to match our standard
                equipment time formulas, which results in an increase of 5 minutes of
                equipment time for both codes.
                (23) Lumbar Puncture (CPT Codes 62270, 622X0, 62272, and 622X1)
                    In October 2017, these services were identified as being performed
                by a different specialty than the specialty that originally surveyed
                this service. In January 2018, the RUC recommended that these services
                be referred to CPT to bundle image guidance. At the September 2018 CPT
                Editorial Panel meeting, the Panel created two new codes to bundle
                diagnostic and therapeutic lumbar puncture with fluoroscopic or CT
                image guidance and revised the existing diagnostic and therapeutic
                lumbar puncture codes so they would only be reported without
                fluoroscopic or CT guidance.
                    For CPT code 62270 (Spinal puncture, lumbar, diagnostic), we
                disagree with the RUC-recommended work RVU of 1.44 and we are proposing
                a work RVU of 1.22 based on a crosswalk to CPT code 40490 (Biopsy of
                lip). CPT code 40490 has the same intraservice time of 15 minutes and 2
                additional minutes of total time. In reviewing CPT code 62270, we noted
                that the recommended intraservice time is decreasing from 20 minutes to
                15 minutes (25 percent reduction), and the recommended total time is
                decreasing from 40 minutes to 32 minutes (20 percent reduction);
                however, the RUC-recommended work RVU is increasing from 1.37 to 1.44,
                which is an increase of just over 5 percent. Although we do not imply
                that the decrease in time as reflected in survey values must equate to
                a one-to-one or linear decrease in the valuation of work RVUs, we
                believe that since the two components of work are time and intensity,
                significant decreases in time should be appropriately reflected in
                decreases to work RVUs. In the case of CPT code 62270, we believed that
                it was more accurate to propose a work RVU of 1.22 based on a crosswalk
                to CPT code 40490 to account for these decreases in the surveyed work
                time.
                    For CPT code 622X0 (Spinal puncture, lumbar, diagnostic; with
                fluoroscopic or CT guidance), we disagree with the RUC-recommended work
                RVU of 1.95 and we are proposing a work RVU of 1.73. Although we
                disagree with the RUC-recommended work RVU, we note that the relative
                difference in work between CPT codes 62270 and 622X0 is equivalent to
                an interval of 0.51 RVUs. Therefore, we are proposing a work RVU of
                1.73 for CPT code 622X0, based on the recommended interval of 0.51
                additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
                    For CPT code 62272 (Spinal puncture, therapeutic, for drainage of
                cerebrospinal fluid (by needle or catheter), we disagree with the RUC-
                recommended work RVU of 1.80 and we are proposing a work RVU of 1.58.
                Although we disagree with the RUC-recommended work RVU, we note that
                the relative difference in work between CPT codes 62270 and 622X0 is
                equivalent to the RUC-recommended interval of 0.36 RVUs. Therefore, we
                are proposing a work RVU of 1.58 for CPT code 62272, based on the
                recommended interval of 0.36 additional RVUs above our proposed work
                RVU of 1.22 for CPT code 62270.
                    For CPT code 622X1 (Spinal puncture, therapeutic, for drainage of
                cerebrospinal fluid (by needle or catheter); with fluoroscopic or CT
                guidance), we disagree with the RUC-recommended work RVU of 2.25 and we
                are proposing a work RVU of 2.03. Although we disagree with the RUC-
                recommended work RVU, we note that the relative difference in work
                between CPT codes 62270 and 622X1 is equivalent to the recommended
                interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 2.03
                for CPT code 622X1, based on the recommended interval of 0.81
                additional RVUs above our proposed work RVU of 1.22 for CPT code 62270.
                (24) Electronic Analysis of Implanted Pump (CPT Codes 62367, 62368,
                62369, and 62370)
                    CPT code 62368 (Electronic analysis of programmable, implanted pump
                for intrathecal or epidural drug infusion (includes evaluation of
                reservoir status, alarm status, drug prescription status); with
                reprogramming) was identified by the RUC on a list of services which
                were originally surveyed by one specialty but are now typically
                performed by a different specialty. It was reviewed along with three
                other codes in the family for PE only at the April 2018 RUC meeting.
                The RUC did not recommend work RVUs for these codes and we are not
                proposing to change the current work RVUs.
                    For the direct PE inputs, we are proposing to remove the minimum
                multi-specialty visit pack (SA048) from CPT code 62370 as a duplicative
                supply due to the fact that this code is typically billed with an E/M
                or other evaluation service.
                (25) Somatic Nerve Injection (CPT Codes 64400, 64408, 64415, 64416,
                64417, 64420, 64421, 64425, 64430, 64435, 64445, 64446, 64447, 64448,
                64449, and 64450)
                    In May 2018, the CPT Editorial Panel approved the revision of
                descriptors and guidelines for the codes in this family and the
                deletion of three CPT codes to clarify reporting (i.e., separate
                reporting of imaging guidance, number of units and a change from a 0-
                day global to ZZZ for one of the CPT codes in this
                [[Page 40580]]
                family). This family of services describe the injection of an
                anesthetic agent(s) and/or steroid into a nerve plexus, nerve, or
                branch; reported once per nerve plexus, nerve, or branch as described
                in the descriptor regardless of the number of injections performed
                along the nerve plexus, nerve, or branch described by the code.
                    CPT codes 64400 (Injection(s), anesthetic agent(s); trigeminal
                nerve, each branch (ie ophthalmic, maxillary, mandibular)), 64408
                (Injection(s), anesthetic agent(s), and/or steroid; vagus nerve), 64415
                (Injection(s), anesthetic agent(s) and/or steroid; brachial plexus),
                64416 (Injection(s), anesthetic agent(s) and/or steroid; brachial
                plexus, continuous infusion by catheter (including catheter
                placement)), 64417 (Injection(s), anesthetic agent(s) and/or steroid;
                axillary nerve), 64420 (Injection(s), anesthetic agent(s) and/or
                steroid; intercostal nerve, single level), 64421 (Injection(s),
                anesthetic agent(s) and/or steroid; intercostal nerves, each additional
                level (List separately in addition to code for primary procedure)),
                64425 (Injection(s), anesthetic agent(s) and/or steroid; ilioinguinal,
                iliohypogastric nerves), 64430 (Injection(s), anesthetic agent(s) and/
                or steroid; pudendal nerve), 64435 (Injection(s), anesthetic agent(s)
                and/or steroid; paracervical (uterine) nerve), 64445 (Injection(s),
                anesthetic agent(s) and/or steroid; sciatic nerve), 64446
                (Injection(s), anesthetic agent(s) and/or steroid; sciatic nerve,
                continuous infusion by catheter (including catheter placement)), 64447
                (Injection(s), anesthetic agent(s); femoral nerve), 64448
                (Injection(s), anesthetic agent(s) and/or steroid; femoral nerve,
                continuous infusion by catheter (including catheter placement)), 64449
                (Injection(s), anesthetic agent(s) and/or steroid; lumbar plexus,
                posterior approach, continuous infusion by catheter (including catheter
                placement)), and 64450 (Injection(s), anesthetic agent(s); other
                peripheral nerve or branch) were reviewed for work and PE at the
                October 2018 RUC meeting. The PE for CPT code 64450 was re-reviewed
                during the RUC January 2019 meeting.
                    During the October 2018 RUC presentation for this family of
                services, the specialty societies stated that CPT codes 64415, 64416,
                64417, 64446, 66447, and 64448 were reported with CPT code 76942
                (Ultrasonic guidance for needle placement (e.g., biopsy, aspiration,
                injection, localization device), imaging supervision and
                interpretation) more than 50 percent of the time. Specifically, 76
                percent with CPT code 64415, 85 percent with CPT code 64416, 68 percent
                with CPT code 64417, 77 percent with CPT code 64446, 77 percent with
                CPT code 66447, and 79 percent with CPT code 64448. It was also noted
                in the RUC recommendations that this overlap was accounted for in the
                RUC recommendations submitted for these services. Furthermore, the RUC
                recommendations sated that the RUC referred CPT codes 64415, 64416,
                64417, 64446, 64447 and 64448 to be bundled with ultrasound guidance,
                CPT code 76942 to the CPT Editorial Panel for CPT 2021.
                    In reviewing this family of services, our proposed work and PE
                values for CPT codes 64415, 64416, 64417, 64446, 64447 and 64448 do not
                consider the overlap of imaging as noted in the RUC recommendations. We
                note that the RUC recommendations did not include values to support the
                valuation for the bundling of imaging in their work or PE
                recommendations and that the CPT code descriptors do not state that
                imaging is included.
                    For CY 2020, we are proposing the RUC-recommended work RVUs for CPT
                codes 64417 (work RVU of 1.27), 64435 (work RVU of 0.75), 64447 (work
                RVU of 1.10), and 64450 (work RVU of 0.75), the RUC reaffirmed work RVU
                of 0.94 for CPT code 64405 (Injection, anesthetic agent; greater
                occipital nerve), which is the current work RVU finalized in the CY
                2019 final rule (83 FR 59542), and the RUC reaffirmed work RVU of 1.10
                for CPT code 64418 (Injection, anesthetic agent; suprascapular nerve),
                which is the current work RVU value finalized in the CY 2018 final rule
                (82 FR 53054). Although we are proposing the RUC reaffirmed work RVUs
                for these two codes, as submitted in the RUC recommendations, we note
                that comparable codes in this family of services have lower work RVUs.
                Thus, these two codes may have become misvalued since their last
                valuation, as they were not resurveyed under this code family during
                the October 2018 RUC meeting.
                    In continuing our review of this code family, we disagree with the
                RUC-recommended work RVU of 1.00 for CPT code 64400 and are proposing a
                work RVU of 0.75, to maintain rank order in this code family. Our
                proposed work RVU is based on a crosswalk to another code in this
                family, CPT code 64450, which has an identical work RVU of 0.75 and
                near identical intraservice and total time values to CPT code 64400.
                    We note that the RUC-recommended intraservice time decreased from
                37 to 6 minutes (84 percent reduction) and the RUC-recommended total
                time decreased from 69 to 20 minutes (71 percent reduction) for CPT
                code 64400. However, the RUC-recommended work RVU only decreased by
                0.11, a 10 percent reduction. We do not believe the RUC-recommended
                work RVU appropriately accounts for the substantial reductions in the
                surveyed work times for the procedure. Although we do not imply that
                the decrease in time as reflected in survey values must always equate
                to a one-to-one or linear decrease in the valuation of work RVUs, we
                believe that since the two components of work and time are intensity,
                absent an obvious or explicitly stated rationale for why the relative
                intensity of a given procedure has increased, significant decreases in
                time should be reflected in decreases to work RVUs. In the case of CPT
                code 64400, we believe that it would be more accurate to propose a work
                RVU of .075 based on a crosswalk to CPT code 64450, which has an
                identical work RVU of 0.75 and near identical intraservice and total
                times to CPT code 64400. We further note that our proposed work RVU
                maintains rank order in this code family among comparable codes.
                    For CPT code 64408, we disagree with the RUC-recommended work RVU
                of 0.90 and are proposing a work RVU of 0.75, to maintain rank order in
                this code family. Our proposed work RVU is based on a crosswalk to
                another code in this family, CPT code 64450, which has an identical
                work RVU of 0.75, and near identical intraservice and total time values
                to CPT code 64408.
                    We note that the RUC-recommended intraservice time decreased from
                16 to 5 minutes (69 percent reduction) and RUC-recommended total time
                decreased from 36 to 20 minutes (44 percent reduction) for CPT code
                64408. Although the RUC-recommended work RVU decreased by 0.51, a 36
                percent reduction, we do not believe the RUC-recommended work RVU
                appropriately accounts for the substantial reductions in the surveyed
                work times for the procedure. Although we do not imply that the
                decrease in time as reflected in survey values must always equate to a
                one-to-one or linear decrease in the valuation of work RVUs, we believe
                that since the two components of work and time are intensity, absent an
                obvious or explicitly stated rationale for why the relative intensity
                of a given procedure has increased, significant decreases in time
                should be reflected in decreases to work RVUs. In the case of CPT code
                64408, we believe that it would be more accurate to propose a work RVU
                of .075, based on a crosswalk CPT code 64450,
                [[Page 40581]]
                to account for these decrease in the surveyed work times. We further
                note that our proposed work RVU maintains rank order in this code
                family among comparable codes.
                    For CPT code 64415, we disagree with the RUC-recommended work RVU
                of 1.42 and are proposing a work RVU of 1.35, based on our time ratio
                methodology and further supported by a reference to CPT code 49450
                (Replacement of gastrostomy or cecostomy (or other colonic) tube,
                percutaneous, under fluoroscopic guidance including contrast
                injections(s), image documentation and report), which has a work RVU of
                1.36 and similar intraservice and total time values to CPT code 64415.
                    We note that the RUC-recommended intraservice time decreased from
                15 to 12 minutes (20 percent reduction) and RUC-recommended total time
                decreased from 44 to 40 minutes (9 percent reduction). However, the
                RUC-recommended work RVU only decreased by 0.06, which is a 4 percent
                reduction. We do not believe the RUC-recommended work RVU appropriately
                accounts for the substantial reductions in the surveyed work times for
                the procedure. Although we do not imply that the decrease in time as
                reflected in survey values must always equate to a one-to-one or linear
                decrease in the valuation of work RVUs, we believe that since the two
                components of work and time are intensity, absent an obvious or
                explicitly stated rationale for why the relative intensity of a given
                procedure has increased, significant decreases in time should be
                reflected in decreases to work RVUs. In the case of CPT code 64415, we
                believe that it would be more accurate to propose a work RVU of 1.35,
                based on our time ratio methodology and a reference to CPT code 49450,
                to account for these decrease in the surveyed work times.
                    For CPT code 64416, we disagree with the RUC-recommended work RVU
                of 1.81 and are proposing a work RVU of 1.48, based on our time ratio
                methodology and further supported by a bracket of CPT code 62270
                (Spinal puncture, lumbar, diagnostic), which has a work RVU of 1.37,
                identical intraservice, and similar total time to CPT code 64416 and
                CPT code 91035 (Esophagus, gastroesophageal reflux test; with mucosal
                attached telemetry pH electrode placement, recording, analysis and
                interpretation), which has a work RVU of 1.59, identical intraservice,
                and near identical total time values to CPT code 64416.
                    We note that while the RUC-recommended intraservice time remained
                unchanged, the RUC-recommended total time decreased from 60 to 49
                minutes (18 percent reduction). However, the RUC recommended
                maintaining the current work RVU of 1.81. We do not believe the RUC-
                recommended work RVU appropriately accounts for the substantial
                reductions in the surveyed total time for the procedure. Although we do
                not imply that the decrease in time as reflected in survey values must
                always equate to a one-to-one or linear decrease in the valuation of
                work RVUs, we believe that since the two components of work and time
                are intensity, absent an obvious or explicitly stated rationale for why
                the relative intensity of a given procedure has increased, significant
                decreases in time should be reflected in decreases to work RVUs. In the
                case of CPT code 64416, we believe that it would be more accurate to
                propose a work RVU of 1.48, based on our time ratios methodology and a
                bracket of CPT code 62270 and CPT code 91035, to account for these
                decreases in the surveyed work times.
                    For CPT code 64420, we disagree with the RUC-recommended work RVU
                of 1.18 and are proposing a work RVU of 1.08, based on our time ratio
                methodology and further supported by a reference to CPT code 12011
                (Simple repair of superficial wounds of face, ears, eyelids, nose, lips
                and/or mucous membranes; 2.5 cm or less), which has a work RVU of 1.07
                and similar intraservice and total time values to CPT code 64420.
                    We note that the RUC-recommended intraservice time decreased from
                17 to 10 minutes (41 percent reduction) and the RUC-recommended total
                time decreased from 37 to 34 minutes (8 percent reduction). However,
                the RUC recommended to maintaining the current work RVU of 1.18. We do
                not believe the RUC-recommended work RVU appropriately accounts for the
                substantial reductions in the surveyed work times for the procedure.
                Although we do not imply that the decrease in time as reflected in
                survey values must always equate to a one-to-one or linear decrease in
                the valuation of work RVUs, we believe that since the two components of
                work and time are intensity, absent an obvious or explicitly stated
                rationale for why the relative intensity of a given procedure has
                increased, significant decreases in time should be reflected in
                decreases to work RVUs. In the case of CPT code 64420, we believe that
                it would be more accurate to propose a work RVU of 1.08 based on our
                times ratio methodology and a crosswalk to CPT code 12011, to account
                for these decreases in the surveyed work times.
                    For CPT code 64421, we disagree with the RUC-recommended work RVU
                of 0.60 and are proposing a work RVU of 0.50, based on our time ratio
                methodology and to maintain rank order among comparable codes in the
                family. Our proposed work RVU is further supported by a crosswalk to
                CPT code 15276 (Application of skin substitute graft to face, scalp,
                eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or
                multiple digits, total wound surface area up to 100 sq cm; each
                additional 25 sq cm wound surface area, or part thereof (List
                separately in addition to code for primary procedure)), which has a
                work RVU of 0.50 and identical intraservice and total times to CPT code
                64421.
                    We note that our time ratio methodology suggests the code is better
                valued at 0.50. Furthermore, the RUC-recommended work RVU of 0.60
                creates a rank order anomaly in the code family. In the case of CPT
                code 64421, we believe that it would be more accurate to propose a work
                RVU of 0.50, based on our time ratio methodology and a crosswalk to CPT
                code 15276, to maintain rank order among comparable codes in the
                family.
                    For CPT code 64425, we disagree with the RUC-recommended work RVU
                of 1.19 and are proposing a work RVU of 1.00, to maintain rank order
                among comparable codes in the family, based on a bracket of CPT code
                12001 (Simple repair of superficial wounds of scalp, neck, axillae,
                external genitalia, trunk and/or extremities (including hands and
                feet); 2.5 cm or less) which has a work RVU of 0.84 and near identical
                intraservice and total time values to CPT code 64425 and CPT code 30901
                (Control nasal hemorrhage, anterior, simple (limited cautery and/or
                packing) any method), which has a work RVU of 1.10 and near identical
                intraservice and total times to CPT code 64425.
                    We note that the RUC-recommended work RVU of 1.19 creates a rank
                order anomaly in the code family. In the case of CPT code 64425, we
                believe that it would be more accurate to propose a work RVU of 1.00,
                based on a bracket of CPT codes 12001 and 30901 to maintain rank order
                among comparable codes in the family.
                    For CPT code 64430, we disagree with the RUC-recommended work RVU
                of 1.15 and are proposing a work RVU of 1.00, to maintain rank order
                among comparable codes in the family, based on a bracket of CPT code
                45330 (Sigmoidoscopy, flexible; diagnostic, including collection of
                specimen(s) by brushing or washing, when performed (separate
                procedure)), which has a work RVU of 0.84 and near identical
                [[Page 40582]]
                intraservice and total time values to CPT code 64430 and CPT code 31576
                (Laryngoscopy, flexible; with biopsy(ies)), which has a work RVU of
                1.89 and near identical intraservice and total time values to CPT code
                64430.
                    We note that the RUC-recommended intraservice time decreased from
                17 to 10 minutes (41 percent reduction) and the RUC-recommended total
                time increased from 39 to 43 minutes (10 percent increase). While the
                RUC-recommended work RVU is decreasing by 0.31, a 21 percent reduction,
                we do not believe the RUC-recommended work RVU appropriately accounts
                for the substantial reductions in the surveyed intraservice work time
                for the procedure. Although we do not imply that the decrease in time
                as reflected in survey values must always equate to a one-to-one or
                linear decrease in the valuation of work RVUs, we believe that since
                the two components of work and time are intensity, absent an obvious or
                explicitly stated rationale for why the relative intensity of a given
                procedure has increased, significant decreases in time should be
                reflected in decreases to work RVUs. In the case of CPT code 64430, we
                believe that it would be more accurate to propose a work RVU of 1.00,
                based on a bracket of CPT codes 45300 and 31576 to account for these
                decreases in surveyed work times and to maintain rank order among
                comparable codes in this family.
                    For CPT code 64445, we disagree with the RUC-recommended work RVU
                of 1.18 and are proposing a work RVU of 1.00, based on our time ratio
                methodology and to maintain rank order among comparable codes in the
                family. Our proposed work RVU is based on a bracket of CPT code 12001
                (Simple repair of superficial wounds of scalp, neck, axillae, external
                genitalia, trunk and/or extremities (including hands and feet); 2.5 cm
                or less), which has a work RVU of 0.84 and near identical intraservice
                and total times to CPT code 64445 and CPT code 30901 (Control nasal
                hemorrhage, anterior, simple (limited cautery and/or packing) any
                method), which has a work RVU of 1.10 and near identical intraservice
                and total time values to CPT code 64445.
                    We note that the RUC-recommended intraservice time decreased from
                15 to 10 minutes (33 percent reduction) and the RUC-recommended total
                time decreased from 48 to 24 minutes (50 percent reduction). While the
                RUC-recommended work RVU is decreasing by 0.30, a 21 percent reduction,
                we do not believe the RUC-recommended work RVU appropriately accounts
                for the substantial reductions in the surveyed intraservice work time
                for the procedure. Although we do not imply that the decrease in time
                as reflected in survey values must always equate to a one-to-one or
                linear decrease in the valuation of work RVUs, we believe that since
                the two components of work and time are intensity, absent an obvious or
                explicitly stated rationale for why the relative intensity of a given
                procedure has increased, significant decreases in time should be
                reflected in decreases to work RVUs. In the case of CPT code 64445, we
                believe that it would be more accurate to propose a work RVU of 1.00,
                based on a bracket of CPT codes 12001 and 30901 to account for these
                decreases in surveyed work times and to maintain rank order among
                comparable codes in the family.
                    For CPT code 64446, we disagree with the RUC-recommended work RVU
                of 1.54 and are proposing a work RVU of 1.36 based on our time ratios
                methodology and further supported by a reference to CPT code 51710
                (Change of cystostomy tube; complicated), which has a near identical
                work RVU of 1.35 and near identical intraservice and total time values
                to CPT code 64446.
                    We note that RUC-recommended intraservice time decreased from 20 to
                15 minutes (25 percent reduction) and the RUC-recommended total time
                decreased from 64 to 40 minutes (38 percent reduction). While the RUC-
                recommended work RVU is decreasing by 0.27, a 15 percent reduction, we
                do not believe the RUC-recommended work RVU appropriately accounts for
                the substantial reductions in the surveyed intraservice work time for
                the procedure. Although we do not imply that the decrease in time as
                reflected in survey values must always equate to a one-to-one or linear
                decrease in the valuation of work RVUs, we believe that since the two
                components of work and time are intensity, absent an obvious or
                explicitly stated rationale for why the relative intensity of a given
                procedure has increased, significant decreases in time should be
                reflected in decreases to work RVUs. In the case of CPT code 64446, we
                believe that it would be more accurate to propose a work RVU of 1.36,
                based on our time ratios methodology and a reference to CPT code 51710
                to account for these decreases in surveyed times and to maintain rank
                order among comparable codes in the family.
                    For CPT code 64448, we disagree with the RUC-recommended work RVU
                of 1.55 and are proposing a work RVU of 1.41, based our time ratio
                methodology and a reference to CPT code 27096 (Injection procedure for
                sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy
                or CT) including arthrography when performed), which has a work RVU of
                1.48 and near identical intraservice time and identical total time
                values to CPT code 64448.
                    We note that RUC-recommended intraservice time decreased from 15 to
                13 minutes (13 percent reduction) and the RUC-recommended total time
                decreased from 55 to 38 minutes (62 percent reduction). While the RUC-
                recommended work RVU is only decreasing by 0.08, which is only a 5
                percent reduction. We do not believe the RUC-recommended work RVU
                appropriately accounts for the substantial reductions in the surveyed
                intraservice work time for the procedure. Although we do not imply that
                the decrease in time as reflected in survey values must always equate
                to a one-to-one or linear decrease in the valuation of work RVUs, we
                believe that since the two components of work and time are intensity,
                absent an obvious or explicitly stated rationale for why the relative
                intensity of a given procedure has increased, significant decreases in
                time should be reflected in decreases to work RVUs. In the case of CPT
                code 64448, we believe that it would be more accurate to propose a work
                RVU of 1.41, based on our time ratios methodology and a crosswalk to
                CPT code 27096 to account for these decreases in surveyed times and to
                maintain rank order among comparable codes in the family.
                    For CPT code 64449, we disagree with the RUC-recommended work RVU
                of 1.55 and are proposing a work RVU of 1.27, based our time ratio
                methodology and a reference to CPT code 11755 (Biopsy of nail unit (eg,
                plate, bed, matrix, hyponychium, proximal and lateral nail folds)
                (separate procedure)), which has a work RVU of 1.25 and near identical
                intraservice and total times to CPT code 64449.
                    We note that RUC-recommended intraservice time decreased from 20 to
                14 minutes (30 percent reduction) and the RUC-recommended total time
                decreased from 60 to 38 minutes (37 percent reduction). While the RUC-
                recommended work RVU is decreasing by 0.26, a 14 percent reduction, we
                do not believe the RUC-recommended work RVU appropriately accounts for
                the substantial reductions in the surveyed intraservice work time for
                the procedure. Although we do not imply that the decrease in time as
                reflected in survey values must always equate to a one-to-one or linear
                decrease in the valuation of work RVUs, we believe that since the two
                components of work and time are intensity, absent an obvious or
                explicitly stated rationale for why the relative intensity of a given
                procedure has increased, significant decreases in time should be
                reflected in decreases to
                [[Page 40583]]
                work RVUs. In the case of CPT code 64449, we believe that it would be
                more accurate to propose a work RVU of 1.27, based on our time ratios
                methodology and a reference to CPT code 11755 to account for these
                decreases in surveyed times and to maintain rank order among comparable
                codes in the family.
                    For the direct PE inputs, we are proposing to remove the clinical
                labor time for the ``Confirm availability of prior images/studies''
                (CA006) activity for CPT code 64450. This code does not currently
                include this clinical labor time, and unlike the new code, CPT code
                64XX1, in the Genicular Injection and RFA code family, in which the PE
                for CPT code 64450 was resurveyed at the January 2019 RUC for PE, CPT
                code 64450 does not include imaging guidance in its code descriptor.
                When CPT code 64450 is performed with imaging guidance, it would be
                billed together with a separate imaging code that already includes
                clinical labor time for confirming the availability of prior images. As
                a result, it would be duplicative to include this clinical labor time
                in CPT code 64450. We are also proposing to refine the clinical labor
                time for the ``Assist physician or other qualified healthcare
                professional--directly related to physician work time (100 percent)''
                (CA018) activity from 10 to 5 minutes for CPT code 64450, to match the
                intraservice work time and proposing to refine the equipment times in
                accordance with our standard equipment time formulas for CPT code
                64450.
                    Additionally, we are proposing to refine the clinical labor time
                for the ``provide education/obtain consent'' (CA011) from 3 minutes to
                2 minutes, for CPT codes 64400, 64408, 64415, 64417, 64420, 64425,
                64430, 64435, 64445, 64447 and 64450, to conform to the standard for
                this clinical labor task. We are also proposing to refine the equipment
                time in accordance with our standard equipment time formula for these
                codes. We note that there were no RUC-recommended direct PE inputs
                provided for CPT codes 64416, 64446, and 64448.
                (26) Genicular Injection and RFA (CPT Codes 64640, 64XX0, and 64XX1)
                    In May 2018, the CPT Editorial Panel approved the addition of two
                codes to report injection of anesthetic and destruction of genicular
                nerves by neurolytic agent. In October 2018, the RUC discussed the
                issues surrounding the survey of this family of services and supported
                the specialty societies' request for CPT codes 64640 (Destruction by
                neurolytic agent; other peripheral nerve or branch), 64XX0
                (Injection(s), anesthetic agent(s) and/or steroid; genicular nerve
                branches including imaging guidance, when performed), and 64XX1
                (Destruction by neurolytic agent genicular nerve branches including
                imaging guidance, when performed) to be resurveyed and presented at the
                January 2019 RUC meeting, based on their concern that many survey
                respondents appeared to be confused about the number of nerve branch
                injections involved with these three codes. The RUC resurveyed these
                services at the January 2019 RUC meeting.
                    For CY 2020, we are proposing the RUC-recommended work RVUs for two
                of the three codes in this family. We are proposing the RUC-recommended
                work RVU of 1.98 (25th percentile survey value) for CPT code 64640 and
                the RUC-recommended work RVU of 1.52 (25th percentile survey value) for
                CPT code of 64XX0.
                    For CPT code 64XX1, we disagree with the RUC-recommended work RVU
                of 2.62, which is higher than the 25th percentile survey value, a work
                RVU 2.50, and are proposing a work RVU of 2.50 (25th percentile survey
                value) based on a reference to CPT code 11622 (Excision, malignant
                lesion including margins, trunk, arms, or legs; excised diameter 1.1 to
                2.0 cm), which has a work RVU of 2.41 and near identical intraservice
                and total times to CPT code 64XX1.
                    In our review of CPT code 64XX1, we examined the intraservice time
                ratio for the new code, CPT code 64XX1, in relation to an existing code
                in this family of services, CPT code 64640. CPT code 64XX1 has a RUC-
                recommended work RVU of 2.62, 25 minutes of intraservice time, and 74
                minutes of total time. CPT code 64640 has a RUC-recommended work RVU of
                1.98, 20 minutes of intraservice time, and 64 minutes of total time. To
                derive our proposed work RVU of 2.50, we calculated the intraservice
                time ratio between these two codes, which is a calculated value of
                1.25, and applied this ratio times the RUC-recommended work RVU of 1.98
                for CPT code 64650, which resulted in a calculated value of 2.48. This
                value is nearly identical to the January 2018 RUC 25th percentile
                survey value for CPT code 64XX1, a work RVU of 2.50. Our proposed work
                RVU of 2.50 is further supported by a reference to CPT code 11622.
                    For the direct PE inputs, we are proposing to remove the clinical
                labor time for the ``Confirm availability of prior images/studies''
                (CA006) activity for CPT code 64640. This code does not currently
                include this clinical labor time, and unlike the new code in the family
                (CPT code 64XX1), CPT code 64640 does not include imaging guidance in
                its code descriptor. When CPT code 64640 is performed with imaging
                guidance, it would be billed together with a separate imaging code that
                already includes clinical labor time for confirming the availability of
                prior images. As a result, it would be duplicative to include this
                clinical labor time in CPT code 64640. We are proposing to refine the
                clinical labor time for the ``Assist physician or other qualified
                healthcare professional--directly related to physician work time (100
                percent)'' (CA018) activity from 25 to 20 minutes for CPT code 64640,
                to match the intraservice work time. We are also proposing to refine
                the equipment times in accordance with our standard equipment time
                formulas for CPT code 64640.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                64XX0 without refinement.
                    For CPT code 64XX1, we are proposing to refine the quantity of the
                ``cannula (radiofrequency denervation) (SMK-C10)'' (SD011) supply from
                3 to 1. We do not believe that the use of 3 of this supply item would
                be typical for the procedure. We note that the RUC recommendations for
                another code in this family, CPT code 64640 only contains 1 of this
                supply item. We believe that the nerves would typically be ablated one
                at a time using this cannula, as opposed to ablating three of them
                simultaneously as suggested in the recommended direct PE inputs. We
                also searched in the RUC database for other CPT codes that made use of
                the SD011 supply, and out of the seven codes that currently use this
                item, none of them include more than 2 cannula. As a result, we are
                proposing to refine the supply quantity to 2 cannula to match the
                highest amount contained in an existing code on the PFS. We are also
                refining the equipment time for the ``radiofrequency kit for
                destruction by neurolytic agent'' (EQ354) equipment from 141 minutes to
                47 minutes. The equipment time recommendation was predicated on the use
                of 3 of the SD011 supplies for 47 minutes apiece, and we are refining
                the equipment time to reflect our supply refinement to 1 cannula. It
                was unclear in the RUC recommendation materials as to whether the
                radiofrequency kit equipment was in use simultaneously or sequentially
                along with the cannula supplies, and therefore, we are soliciting
                comments on the typical use of this equipment.
                [[Page 40584]]
                (27) Cyclophotocoagulation (CPT Codes 66711, 66982, 66983, 66984,
                66X01, and 66X02)
                    In October 2017, CPT codes 66711 (Ciliary body destruction;
                cyclophotocoagulation, endoscopic) and 66984 (Extracapsular cataract
                removal with insertion of intraocular lens prosthesis (1 stage
                procedure), manual or mechanical technique (e.g., irrigation and
                aspiration or phacoemulsification) were identified as codes reported
                together 75 percent of the time or more. The RUC reviewed action plans
                to determine whether a code bundle solution should be developed for
                these services. In January 2018, the RUC recommended to refer to CPT to
                bundle 66711 with 66984 for CPT 2020. In May 2018, the CPT Editorial
                Panel revised three codes and created two new codes, CPT codes 66X01
                (Extracapsular cataract removal with insertion of intraocular lens
                prosthesis (1-stage procedure), manual or mechanical technique (e.g.,
                irrigation and aspiration or phacoemulsification), complex, requiring
                devices or techniques not generally used in routine cataract surgery
                (e.g., iris expansion device, suture support for intraocular lens, or
                primary posterior capsulorrhexis) or performed on patients in the
                amblyogenic developmental stage; with endoscopic cyclophotocoagulation)
                and 66X02 (Extracapsular cataract removal with insertion of intraocular
                lens prosthesis (1 stage procedure), manual or mechanical technique
                (e.g., irrigation and aspiration or phacoemulsification); with
                endoscopic cyclophotocoagulation) to differentiate cataract procedures
                performed with and without endoscopic cyclophotocoagulation.
                    The codes discussed above and CPT codes 66982 (Extracapsular
                cataract removal with insertion of intraocular lens prosthesis (1-stage
                procedure), manual or mechanical technique (e.g., irrigation and
                aspiration or phacoemulsification), complex, requiring devices or
                techniques not generally used in routine cataract surgery (e.g., iris
                expansion device, suture support for intraocular lens, or primary
                posterior capsulorrhexis) or performed on patients in the amblyogenic
                developmental stage) and 66983 (Intracapsular cataract extraction with
                insertion of intraocular lens prosthesis (1 stage procedure)) were
                reviewed at the January 2019 RUC meeting.
                    For CY 2020, we are proposing the RUC-recommended work RVU of 10.25
                for CPT code 66982, the RUC recommendation to contractor-price CPT code
                66983, and the RUC-recommended work RVU of 7.35 for CPT code 66984. We
                disagree with the RUC recommendations for CPT codes 66711, 66X01, and
                66X02.
                    For CPT code 66711, we disagree with the RUC-recommended work RVU
                of 6.36 and are proposing a work RVU of 5.62, based on crosswalk to CPT
                code 28285 (Correction, hammertoe (e.g., interphalangeal fusion,
                partial or total phalangectomy), which has an identical work RVU of
                5.62, and similar intraservice and total times.
                    In our review of CPT code 66711, we note that the recommended
                intraservice time is decreasing from 20 minutes to 10 minutes (33
                percent reduction), and that the recommended total time is decreasing
                from 192 minutes to 191 minutes (0.5 percent reduction). While the RUC-
                recommended work RVU is decreasing from 7.93 to 6.36, which is a 20
                percent reduction, we do not believe it appropriately accounts for the
                decreases in survey time. Time ratio methodology suggest that CPT code
                66711 is better valued at a work RVU of 5.29, thus it is overvalued
                with consideration to the decreases in survey times. Although we do not
                imply that the decrease in time as reflected in survey values must
                equate to a one-to-one or linear decrease in the valuation of work
                RVUs, we believe that since the two components of work are time and
                intensity, significant decreases in time should be appropriately
                reflected in decreases to work RVUs. In the case of CPT code 66711, we
                believe that it would be more accurate to propose a work RVU of 5.62,
                based on our time ratio methodology and a crosswalk to CPT code 28285
                to account for these decreases in surveyed work times.
                    For CPT code 66X01, the RUC recommended a work RVU of 13.15, we
                disagree with the RUC-recommended work RVU and are proposing
                contractor-pricing for this code. In reviewing this code, we note that
                the RUC recommendation survey values do not support the RUC-recommended
                work RVU of 13.15 and furthermore, the RUC recommendations do not
                include a crosswalk to support the RUC-recommended work RVU. The RUC
                recommendations noted a lack of potential crosswalk codes due to the
                complete lack of similarly intense major surgical procedures comparable
                in the amount of skin-to-skin time, operating room time and amount of
                post-operative care. We note that the RUC-recommended work RVU of 13.15
                is higher than similarly timed codes on the PFS. Given that lack of
                both survey data and a crosswalk to support the RUC-recommended work
                RVU for this new code, and that the RUC-recommended work RVU of 13.15
                is higher than similarly timed codes on the PFS, we believe it is more
                appropriate to propose contractor-pricing for CPT code 66X01. We also
                note that the RUC recommended contractor-pricing for another code in
                this family, CPT code 66983, which we are proposing for CY 2020.
                    For CPT code 66X02, the RUC recommended a work RVU of 10.25, we
                disagree with the RUC-recommended work RVU and are proposing
                contractor-pricing for this code. In reviewing this code, we note that
                the RUC recommendation survey values do not support the RUC-recommended
                work RVU of 10.25. Furthermore, we are concerned with the RUC
                recommended crosswalk, CPT code 67110 (Repair of retinal detachment; by
                injection of air or other gas (e.g., pneumatic retinopexy), which is
                the same crosswalk used to support the RUC-recommended work RVU of
                10.25 for another code in this family, CPT code 66982. CPT code 67110
                has 30 minutes of intraservice time and 196 minutes of total time.
                Although CPT code 67110 has the identical intraservice time to CPT
                codes 66982 and 66X02, we note that CPT code 67110 has 196 minutes of
                total time, which is 21 minutes less than the 175 minutes of total time
                of CPT code 66982, and 6 minutes less than the 202 minutes of total
                time of CPT Code 66X02. However, the RUC is recommending the same work
                RVU of 10.25 for CPT codes 66982 and 66X02, supported by the same
                crosswalk to CPT code 67110.
                    Given that lack of survey data and our concern for the RUC-
                recommended crosswalk to support the RUC-recommended work RVU of 10.25
                for CPT code 66X02, we believe it is appropriate to propose contractor-
                pricing for CPT code 66X02. We also note that the RUC recommended
                contractor-pricing for another code in this family, CPT code 66983,
                which we are prosing for CY 2020.
                    We are proposing to remove all the direct PE inputs for CPT codes
                66X01 and 66X02, given our proposal for contractor-pricing for these
                codes. We are proposing the RUC-recommended direct PE inputs for the
                other codes in this family.
                (28) X-Ray Exam--Sinuses (CPT Codes 70210 and 70220)
                    CPT code 70210 (Radiologic examination, sinuses, paranasal, less
                than 3 views) and CPT code 70220 (Radiologic examination, sinuses,
                paranasal, complete, minimum of 3 views) were identified as potentially
                misvalued through a screen for
                [[Page 40585]]
                Medicare services with utilization of 30,000 or more annually. These
                two codes were first reviewed by the RUC in April 2018, but were
                subsequently surveyed by the specialty societies and reviewed again by
                the RUC in January 2019.
                    The RUC recommended a work RVU for CPT code 70210 of 0.20, which is
                a slight increase over the current work RVU for this code (0.17). The
                RUC's recommendation is consistent with 25th percentile of survey
                results and is based on a comparison of the survey code with the two
                key reference services. The first key reference service, CPT code 71046
                (Radiologic examination, chest; 2 views), has a work RVU of 0.22, 4
                minutes of intraservice time, and 6 minutes of total time. The RUC
                noted that the survey code has one minute less intraservice and total
                time compared with the first key reference service (CPT code 71046),
                which accounts for the slightly lower work RVU for the survey code. The
                RUC also compared CPT code 70210 to CPT code 70355 (Orthopantogram
                (e.g., panoramic X-ray)), with a work RVU of 0.20, 5 minutes of
                intraservice time, and 6 minutes of total time. Although the
                intraservice and total times are lower for CPT code 70210 than for CPT
                code 70355, the work is slightly more intense for the survey code,
                according to the RUC, justifying an identical work RVU of 0.20 for CPT
                code 70210. We disagree with the RUC's recommendation to increase the
                work RVU for CPT code 70210 from the current value (0.17) to 0.20 for
                two main reasons. First, the total time (5 minutes) for this code has
                not changed from the current total time and without a corresponding
                explanation for an increase in valuation despite maintaining the same
                total time, we do are not convinced that the work RVU for this code
                should increase. In addition, we note that based on a general
                comparison of CPT codes with identical intraservice time and total time
                (approximately 23 comparison codes, excluding those currently under
                review), a work RVU of 0.20 would establish a new upper threshold among
                this cohort. We are proposing to maintain the work RVU for CPT code
                70210 of 0.17 work RVUs, bracketed by two services. On the upper side,
                we identified CPT code 73501 (Radiologic examination, hip, unilateral,
                with pelvis when performed; 1 view) with a work RVU of 0.18, and on the
                lower side, we identified CPT code 73560 (Radiologic examination, knee;
                1 or 2 views) with a work RVU of 0.16. For CPT code 70220, we are
                proposing the RUC-recommended work RVU of 0.22.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (29) X-Ray Exam--Skull (CPT Codes 70250 and 70260)
                    CPT code 70250 (Radiologic examination, skull, less than 4 views)
                was identified as potentially misvalued through a screen of Medicare
                services with utilization of 30,000 or more annually. CPT code 70260
                (Radiologic examination, skull; complete, minimum of 4 views) was
                included as part of the same family. These two codes were first
                reviewed by the RUC in April 2018, but were subsequently surveyed by
                the specialty societies and reviewed by the RUC again in January 2019.
                    The RUC-recommended work RVU for CPT code 70250 is 0.20, which is a
                slight decrease from the current work RVU for this code (0.24). The
                decrease, according to the RUC, reflects a slightly lower total time
                required to furnish the service (from 7 minutes to 5 minutes) and is
                consistent with the 25th percentile work RVU from the survey results.
                The RUC-recommended work RVU is bracketed by two CPT codes: Top key
                reference service, CPT code 71046 (Radiologic examination, chest; 2
                views) with 4 minutes of intraservice time, 6 minutes total time, and a
                work RVU of 0.22; and key reference service, CPT code 73562 (Radiologic
                examination, knee; 3 views), with intraservice time of 4 minutes, total
                time of 6 minutes, and a work RVU of 0.18. The RUC noted that while the
                survey code has less time than CPT code 71046, the work is slightly
                more intense due to anatomical and contextual complexity. The survey
                code is also more intense compared with the second key reference
                service, CPT code 73562, according to the RUC, because of the higher
                level of technical skill involved in an X-ray of the skull (axial
                skeleton) compared with an X-ray of the knee (appendicular skeleton).
                The RUC further indicated that a comparison between the survey code and
                CPT codes with a work RVU of 0.18 would not be appropriate given the
                higher level of complexity associated with an X-ray of the skull than
                with other CPT codes that have similar times. We disagree with the
                recommended work RVU of 0.20 for CPT code 70250. The total time for
                furnishing the service has decreased by 2 minutes while the description
                of the work involved in furnishing the service has not changed. This
                suggests that a value closer to the total time ratio (TTR) calculation
                (0.17 work RVU) might be more appropriate. In addition, a search of CPT
                codes with 3 minutes of intraservice time and 5 minutes of total time
                indicates that the maximum work RVU for codes with these times is 0.18,
                meaning that a work RVU of 0.20 would establish a new relative high
                work RVU for codes with these times. We believe that a crosswalk to CPT
                code 73501 (Radiologic examination, hip, unilateral, with pelvis when
                performed; 1 view) with a work RVU of 0.18, 3 minutes of intraservice
                time, and 5 minutes of total time, accurately reflects both the time
                and intensity of furnishing the service described by CPT code 70250.
                Therefore, we are proposing a work RVU of 0.18 for CPT code 70250.
                    The RUC recommended a work RVU of 0.29 for CPT code 70260, which is
                lower than the current work RVU of 0.34. The survey times for
                furnishing the service are 4 minutes of intraservice time and 7 minutes
                total time, compared with the current intraservice time and total time
                of 7 minutes. However, in developing their recommendation, the RUC
                reduced the total time for this code from 7 minutes to 6 minutes.
                Although the RUC's recommended work RVU reflects the 25th percentile of
                survey results, the survey 25th percentile is based on an additional
                minute of total time compared with the RUC's total time for this CPT
                code. Moreover, since we are proposing a lower work RVU for the base
                code for this family (work RVU of 0.18 for CPT code 70250), we believe
                a lower work RVU for CPT code 70260 is warranted. To identify an
                alternative value, we calculated the increment between the current work
                RVU for CPT code 72050 (work RVU of 0.24) and the current work RVU for
                CPT code 72060 (work RVU of 0.34) and applied it to the CMS proposed
                work RVU for CPT code 70250 (0.18 + 0.10) to calculate a work RVU of
                0.28. We believe that applying this increment is a better reflection of
                the work time and intensity involved in furnishing CPT code 70260. We
                are proposing a work RVU for CPT code 70260 of 0.28.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (30) X-Ray Exam--Neck (CPT Code 70360)
                    CPT code 70360 (Radiologic examination; neck, soft tissue) was
                identified as potentially misvalued through a screen of CPT codes with
                annual Medicare utilization of 30,000 or more. CPT code 70360 was first
                reviewed by the RUC in April 2018 but was subsequently surveyed by the
                specialty societies and reviewed by the RUC again in January 2019.
                    The RUC recommended a work RVU of 0.20 for CPT code 70360, which is
                an increase over the current work RVU
                [[Page 40586]]
                (0.17). To support their recommendation, the RUC cited the survey key
                reference service, CPT code 71046 (Radiologic examination, chest; 2
                views), with a work RVU of 0.22, 4 minutes of intraservice time, and 6
                minutes of total time. They noted that the key reference code has one
                minute higher intraservice and total time, accounting for the slightly
                higher work RVU compared with the survey code, CPT code 70360. The RUC
                also cited the second highest key reference service, CPT code 73562
                (Radiologic examination, knee; 3 views) with a work RVU of 0.18,
                intraservice time of 4 minutes, and total time of 6 minutes. They noted
                that, while the survey code has lower intraservice time (3 minutes) and
                total time (5 minutes) compared with CPT code 73562, the survey code is
                more complex than the key reference service, thereby supporting a
                higher work RVU for the survey code (CPT code 70360) of 0.20. We do not
                agree with the RUC that the work RVU for CPT code 70360 should increase
                from 0.17 to 0.20. The total time for the CPT code, as recommended by
                the RUC (5 minutes), is unchanged from the existing total time. Without
                a corresponding discussion of why the current work RVU is insufficient,
                we do not agree that there should be an increase in the work RVU.
                Furthermore, although the RUC's recommendation is consistent with the
                25th percentile of survey results for the work RVU, the total time from
                the survey results was 6 minutes, not the RUC-recommended time of 5
                minutes. When we looked at CPT codes with identical times to the survey
                code for a crosswalk, we identified CPT code 73552 (Radiologic
                examination, femur; minimum 2 views), with a work RVU of 0.18. We
                believe this is a more appropriate valuation for CPT code 70360 and we
                are proposing a work RVU for this CPT code of 0.18.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                70360.
                (31) X-Ray Exam--Spine (CPT Codes 72020, 72040, 72050, 72052, 72070,
                72072, 72074, 72080, 72100, 72110, 72114, and 72120)
                    CPT codes 72020 (Radiologic examination spine, single view, specify
                level) and 72072 (Radiologic examination, spine; thoracic, 3 views)
                were identified through a screen of CMS/Other Source codes with
                Medicare utilization greater than 100,000 services annually. The code
                family was expanded to include 10 additional CPT codes to be reviewed
                together as a group: CPT code 72040 (Radiologic examination, spine,
                cervical; 2 or 3 views), CPT code 72050 (Radiologic examination, spine,
                cervical; 4 or 5 views), CPT code 72052 (Radiologic examination, spine
                cervical; 6 or more views), CPT code 72070 (Radiologic examination
                spine; thoracic, 2 views), CPT code 72074 (Radiologic examination,
                spine; thoracic, minimum of 4 views), CPT code 72080 (Radiologic
                examination, spine; thoracolumbar junction, minimum of 2 views), CPT
                code 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views),
                CPT code 72110 (Radiologic examination, spine, lumbosacral; minimum of
                4 views), CPT code 72114 (Radiologic examination, spine, lumbosacral;
                complete, including bending views, minimum of 6 views), and CPT code
                72120 (Radiologic examination, spine, lumbosacral; bending views only,
                2 or 3 views). This family of CPT codes was originally valued by the
                specialty societies using a crosswalk methodology approved by the RUC
                Research Subcommittee. However, after we expressed concern about the
                use of this approach for valuing work and PE, the specialty society
                agreed to survey these codes and the RUC reviewed them again in January
                2019.
                    For the majority of CPT codes in this family, the RUC recommended a
                work RVU that is slightly different (higher or lower) than the current
                work RVU. Three CPT codes in this family are maintaining the current
                work RVU. We are proposing the RUC-recommended work RVU for all 12 CPT
                codes in this family as follows: CPT code 72020 (work RVU = 0.16); CPT
                code 72040 (work RVU = 0.22); CPT code 72050 (work RVU = 0.27); CPT
                code 72052 (work RVU = 0.30); CPT code 72070 (work RVU = 0.20); CPT
                code 72072 (work RVU = 0.23); CPT code 72074 (work RVU = 0.25); 72080
                (work RVU = 0.21); CPT code 72100 (work RVU = 0.22); CPT code 72110
                (work RVU =0.26); CPT code 72114 (work RVU = 0.30); and CPT code 72120
                (work RVU = 0.22).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (32) CT-Orbit-Ear-Fossa (CPT Codes 70480, 70481, and 70482)
                    In October 2017, the RAW requested that AMA staff develop a list of
                CMS/Other codes with Medicare utilization of 30,000 or more. CPT code
                70480 (Computed tomography (CT), orbit, sella, or posterior fossa or
                outer, middle, or inner ear; without contrast material) was identified.
                In addition, the code family was expanded to include two related CT
                codes, CPT code 70481 (Computed tomography, orbit, sella, or posterior
                fossa or outer, middle, or inner ear; with contrast material) and CPT
                code 70482 (Computed tomography, orbit, sella, or posterior fossa or
                outer, middle, or inner ear; without contrast material followed by
                contrast material(s) and further sections). In 2018, the RUC
                recommended this code family be surveyed.
                    For CPT code 70840, we disagree with the RUC-recommended work RVU
                of 1.28 and propose instead a work RVU of 1.13. We are proposing a
                lower work RVU because 1.13 represents the commensurate 12 percent
                decrease in work time reflected in survey values. We reference the work
                RVUs of CPT codes 72128 (Computed tomography, chest, spine; without
                dye) and 71250 (Computed tomography, thorax without dye) both of which
                have the same intraservice time (that is, 15 minutes) as CPT code 70840
                but longer total times (that is, 25 minutes versus 22 minutes). We
                believe that CPT code 72128 with a work RVU of 1.0 and CPT code 71250
                with a work RVU of 1.16 more accurately reflect the relative work
                values of CPT code 70840.
                    We also disagree with the RUC-recommended work RVU of 1.13 for CPT
                code 70481. Instead, we are proposing a work RVU of 1.06 for CPT code
                70481. As with CPT code 70840, we are proposing a lower work RVU for
                CPT code 70481 because a work RVU of 1.06 is commensurate with the 23
                percent decrease in surveyed total time from 26 to 20 minutes. We
                believe CPT code 76641 (Ultrasound, breast, unilateral) with a work RVU
                of 0.73 and CPT code 70460 (Computed Tomography, head or brain, without
                contrast) with a work RVU of 1.13 serve as appropriate references for
                our proposed work RVU for CPT code 70841. Although CPT codes 76641 and
                70460 have longer total times at 22 minutes and lower intraservice
                times at 12 minutes, we believe they better reflect the relative work
                value of CPT code 70481 with a proposed work RVU of 1.06, total time of
                20 minutes, and intraservice time of 13 minutes.
                    For the third code in the family, CPT code 70482, we are proposing
                the RUC-recommended work RVU of 1.27.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (33) CT Spine (CPT Codes 72125, 72126, 72127, 72128, 72129, 72130,
                72131, 72132, and 72133)
                    CPT code 72132 (Computed tomography, lumbar spine; with contrast
                material) was identified as potentially misvalued on a screen of CMS/
                Other codes with Medicare
                [[Page 40587]]
                utilization of 30,000 or more. Eight other spine CT codes were
                identified as part of the family, and they were surveyed and reviewed
                together at the April 2018 RUC meeting.
                    We are proposing the RUC-recommended work RVU for eight of the nine
                codes in the family. We are proposing a work RVU of 1.22 for CPT code
                72126 (Computed tomography, cervical spine; with contrast material), a
                work RVU of 1.27 for CPT code 72127 (Computed tomography, cervical
                spine; without contrast material, followed by contrast material(s) and
                further sections), a work RVU of 1.00 for CPT code 72128 (Computed
                tomography, thoracic spine; without contrast material), a work RVU of
                1.22 for CPT code 72129 (Computed tomography, thoracic spine; with
                contrast material), a work RVU of 1.27 for CPT code 72130 (Computed
                tomography, thoracic spine; without contrast material, followed by
                contrast material(s) and further sections), a work RVU of 1.00 for CPT
                code 72131 (Computed tomography, lumbar spine; without contrast
                material), a work RVU of 1.22 for CPT code 72132 (Computed tomography,
                lumbar spine; with contrast material), and a work RVU of 1.27 for CPT
                code 72133 (Computed tomography, lumbar spine; without contrast
                material, followed by contrast material(s) and further sections).
                    We disagree with the RUC-recommended work RVU of 1.07 for CPT code
                72125 (Computed tomography, cervical spine; without contrast material)
                and we are proposing a work RVU of 1.00 to match the other without
                contrast codes in the family. The cervical spine CT procedure described
                by CPT code 72125 shares the identical surveyed work time as the
                thoracic spine CT procedure described by CPT code 72128 and the lumbar
                spine CT procedure described by CPT code 72131, and we believe that
                this indicates that these three CPT codes should share the same work
                RVU of 1.00. Our proposed work RVU would also match the pattern
                established by the rest of the codes in this family, in which the
                contrast procedures (CPT codes 72126, 72129, and 72132) share a
                proposed work RVU of 1.22 and the without/with contrast procedures (CPT
                codes 72127, 72130, and 72133) share a proposed work RVU of 1.27.
                    We recognize that the RUC has stated that they believe CPT code
                72125 to be a more complex study than CPT codes 72128 and 72131 because
                the cervical spine is subject to an increased number of injuries and
                there are a larger number of articulations to evaluate. This was the
                basis for their recommendation that this code should be valued slightly
                higher than the other without contrast codes. However, if CPT code
                72125 has a more difficult patient population and requires a larger
                number of articulations to evaluate as compared to CPT codes 72128 and
                72131, we do not understand why this was not reflected in the surveyed
                work times, which were identical for the three procedures. We believe
                that if the intensity of the procedure were higher due to these
                additional difficulties, it would be reflected in a longer surveyed
                work time. In addition, the survey respondents selected a higher work
                RVU for CPT code 72131 than CPT code 72125 at both the survey 25th
                percentile (1.20 to 1.18) and survey median values (1.39 to 1.28),
                which does not suggest that CPT code 72125 should be valued at a higher
                rate.
                    We also note that the surveyed intraservice work time for CPT code
                72125 is decreasing from 15 minutes to 12 minutes, and we believe that
                this provides additional support for a slight reduction in the work RVU
                to match the other without contrast codes in the family. We recognize
                that adjusting work RVUs for changes in time is not always a
                straightforward process and that the intensity associated with changes
                in time is not necessarily always linear, which is why we apply various
                methodologies to identify several potential work values for individual
                codes. However, we want to reiterate that we believe it would be
                irresponsible to ignore changes in time based on the best data
                available and that we are statutorily obligated to consider both time
                and intensity in establishing work RVUs for PFS services. For
                additional information regarding the use of prior work time values in
                our methodology, we refer readers to our discussion of the subject in
                the CY 2017 PFS final rule (81 FR 80273 through 80274).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (34) X-Ray Exam--Pelvis (CPT Codes 72170 and 72190)
                    CPT code 72190 (Radiologic examination, pelvis; complete, minimum
                of 3 views) was identified as potentially misvalued through a screen of
                CMS/Other codes with Medicare utilization of 30,000 or more annually.
                CPT code 72170 (Radiologic examination, pelvis; 1 or 2 views) was added
                as part of the family. The RUC originally reviewed these two codes
                after specialty societies employed a crosswalk methodology to value
                work and PE. However, after we expressed concern about the use of this
                approach, the specialty society agreed to survey the codes and the RUC
                reviewed them again at the meeting in January 2019.
                    The RUC recommended a work RVU of 0.17 for CPT code 72170, which
                maintains the current value. For CPT code 72190, the RUC recommended a
                work RVU of 0.25, which is slightly higher than the current value
                (0.21). We are proposing the RUC-recommended values for these two CPT
                codes.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (35) X-Ray Exam--Sacrum (CPT Codes 72200, 72202, and 72220)
                    CPT code 72220 (Radiologic examination, sacrum and coccyx, minimum
                of 2 views) was identified on a screen of CMS/Other source codes with
                Medicare utilization greater than 100,000 annually. CPT codes 72200
                (Radiologic examination, sacroiliac joints; less than 3 views) and
                72202 (Radiologic examination, sacroiliac joints; 3 or more views) were
                also included for review as part of the same family of codes. These
                three codes were originally valued by the specialty societies using a
                crosswalk methodology approved by the RUC Research Subcommittee.
                However, after we expressed concern about the use of this approach for
                valuing work and PE, the specialty society agreed to survey these codes
                and the RUC reviewed them again in January 2019.
                    For CPT code 72200, the RUC is recommending a work RVU of 0.20,
                which is higher than the current work RVU (0.17). To support their
                recommendation, the RUC compared the survey code to the key reference
                service, CPT code 73522 (Radiologic examination, hips, bilateral, with
                pelvis when performed; 3-4 views), with a work RVU of 0.29, 5 minutes
                of intraservice time and 7 minutes of total time. The intraservice and
                total times for the key reference service are one minute higher than
                the survey code (4 minutes intraservice time, 6 minutes total time for
                CPT code 72200) and the survey code is less intense, according to the
                RUC, thereby supporting a slightly lower work RVU of 0.20 for CPT code
                72200. The second key reference service is CPT code 73562 (Radiologic
                examination, knee; 3 views), with 4 minutes of intraservice time, 6
                minutes of total time, and a work RVU of 0.18. The RUC noted that this
                second key reference service is less intense to furnish than the survey
                code, which justifies a slightly lower work RVU despite identical
                intraservice time (4 minutes) and total time (6 minutes). The
                [[Page 40588]]
                RUC supported their recommendation of a work RVU for CPT code 72200 of
                0.20 with two bracketing codes: CPT code 93042 (Rhythm ECG, 1-3 leads;
                interpretation and report only) with work RVU of 0.15, and CPT code
                70355 (Orthopantogram (e.g. panoramic x-ray)) with a work RVU of 0.20
                (which is identical to the RUC-recommended work RVU for CPT code 72200
                but has one additional minute of intraservice time). A work RVU of 0.20
                is consistent with the work RVU estimated by the TTR and reflects the
                25th percentile of survey results. Nevertheless, we do not agree that
                there is sufficient justification for an increase in work RVU for CPT
                code 72200. We are concerned that the large variation in specialty
                societies' survey times is indicative of differences in patient
                population, practice workflow, or even possibly some ambiguity
                associated with the survey vignette. We also note that the 25th
                percentile of survey results are based on the overall survey total
                time, which is 8 minutes, rather than the RUC's recommended 6 minutes.
                The time parameters for furnishing the service affect all other points
                of comparison for purpose of valuing the code, including TTR,
                identification of potential crosswalks, and increment calculations. We
                found no corresponding explanation for the variability in survey times,
                leading us to question why there should be an increase in work RVU from
                the current value. Therefore, we are proposing to maintain the current
                work RVU for CPT code 72200 at 0.17.
                    For CPT code 72202, the RUC recommended a work RVU of 0.26, which
                is considerably higher than the current work RUV for this code of 0.19.
                The RUC supported their recommendation with two key reference services.
                The first is CPT code 73522 (Radiologic examination, hips, bilateral,
                with pelvis when performed; 3-4 views) with 5 minutes intraservice
                time, 7 minutes total time, and a work RVU of 0.29. They note that this
                code has an additional minute for intraservice and total time compared
                with the survey code, reflecting the additional views associated with
                evaluating bilateral hip joints. The second key reference service is
                CPT code 73562 (Radiologic examination, knee; 3 views) with 4 minutes
                intraservice time, 6 minutes total time, and a work RVU of 0.18. The
                RUC notes that the survey code has the same times but requires more
                intensity and includes an additional view compared with the reference
                service, which justifies a higher work RVU for the survey code. We
                disagree with the RUC's recommended work RVU for CPT code 72202. Given
                that there is no change in the total time required to furnish the
                service and there is no corresponding description of an increase in the
                intensity of the work relative to the existing value, we do not believe
                an increase of 0.07 work RVUs is warranted. The TTR calculation yields
                a work RVU of .019, suggesting that a value closer to the current work
                RVU would be more appropriate. In addition, since we consider the RUC-
                recommended work RVU for this code as an incremental change from the
                prior code in this family, we believe that an increase of 0.06 over the
                proposed work RVU of 0.18 for CPT code 72200, which yields a work RVU
                of 0.23, is a better reflection of the time and intensity required to
                furnish CPT code 72202. Our proposed value work RVU of 0.23 is
                bracketed by CPT code 73521 (Radiologic examination, hips, bilateral,
                with pelvis when performed; 2 views) on the lower end (work RVU = .22),
                and CPT code 74021 (Radiologic examination, abdomen; 3 or more views),
                on the higher end (work RVU = 0.27). CPT code 73521 has the same times
                as the survey code but describes a bilateral service with 2 views,
                which is slightly less intense. CPT code 74021 also has identical times
                but involves X-ray of the abdomen with 3 views, a slightly higher
                intensity than the survey code.
                    The RUC-recommended work RVU for CPT code 72220 is 0.20, which
                reflects an increase over the current work RVU for this code (0.17).
                The key reference service from the survey results is CPT code 73522
                (Radiologic examination, hips, bilateral, with pelvis when performed,
                2-4 views), with a work RVU of 0.29, 5 minutes intraservice time, and 7
                minutes total time. The RUC noted that the recommended work RVU for CPT
                code 72220 has a lower value than the top key reference code (CPT code
                73522) because of the shorter time and lower intensity involved in
                furnishing the survey code. The second highest key reference service,
                CPT code 73562 (Radiologic examination, knee; 3 views) has a work RVU
                of 0.18 with 4 minutes of intraservice time and 6 minutes of total
                time. The RUC notes that this second key reference service has a lower
                work RVU than the survey code despite having a slightly higher
                intraservice time and total time because it involves an X-ray of just
                one knee. We disagree with the RUC's recommended increase in the work
                RVU for CPT code 72220 from 0.17 to 0.20. We note that there is no
                change in the total time required to furnish the service. We also note
                that a work RVU of 0.20 for CPT code 72220 would place it near the
                maximum work RVU for CPT codes with identical intraservice time (3
                minutes) and total time (5 minutes). Instead, we are proposing to
                maintain the work RVU for this service at 0.17, which is consistent
                with our proposal to maintain the current work RVU for CPT code 72200
                at 0.17 as well.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (36) X-Ray Exam--Clavicle-Shoulder (CPT Codes 73000, 73010, 73020,
                73030, and 73050)
                    CPT code 73030 (Radiologic examination, shoulder; complete, minimum
                of 2 views) was identified as potentially misvalued through a screen of
                services with more than 100,000 utilization annually. CPT codes 73000
                (Radiologic examination; clavicle, complete), 73010 (Radiologic
                examination; scapula, complete), 73020 (Radiologic examination,
                shoulder; 1 view), and 73050 (Radiologic examination, acromioclavicular
                joints, bilateral, with or without weighted distraction) were included
                for review as part of the same family. We are proposing the RUC-
                recommended work RVUs for all five codes in this family as follows: CPT
                code 73000 (work RVU = 0.16); CPT code 73010 (work RVU = 0.17); CPT
                code 73020 (work RVU = 0.15); CPT code 73030 (work RVU = 0.18); and CPT
                code 73050 (work RVU = 0.18).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (37) CT Lower Extremity (CPT Codes 73700, 73701, and 73702)
                    CPT code 73701 (Computed tomography, lower extremity; with contrast
                material(s)) was identified as potentially misvalued on a screen of
                CMS/Other codes with Medicare utilization of 30,000 or more. Two other
                lower extremity CT codes were identified as part of the family, and
                they were surveyed and reviewed together at the April 2018 RUC meeting.
                    We are proposing the RUC-recommended work RVU for all three codes
                in this family. We are proposing a work RVU of 1.00 for CPT code 73700
                (Computed tomography, lower extremity; without contrast material), a
                work RVU of 1.16 for CPT code 73701 (Computed tomography, lower
                extremity; with contrast material(s)), and a work RVU of 1.22 for CPT
                code 73702 (Computed tomography, lower extremity; without contrast
                material, followed by contrast material(s) and further sections).
                [[Page 40589]]
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (38) X-Ray Elbow-Forearm (CPT Codes 73070, 73080, and 73090)
                    CPT codes 73070 (Radiologic examination, elbow; 2 views) and 73090
                (Radiologic examination; forearm, 2 views) were identified on a screen
                of CMS/Other source codes with Medicare utilization greater than
                100,000 services annually. CPT code 73080 (Radiologic examination,
                elbow; complete, minimum of 3 views) was included for review as part of
                the same code family. All three CPT codes in this family were
                originally valued by the specialty societies using a crosswalk
                methodology approved by the RUC research committee. However, after we
                expressed concern about the use of this approach for valuing work and
                PE, the specialty society agreed to survey the codes and the RUC
                reviewed them again at the meeting in January 2019. We are proposing
                the RUC-recommended work RVU for all three codes in this family as
                follows: CPT code 73070 (work RVU = 0. 16); CPT code 73080 (work RVU =
                0.17); and CPT code 73090 (work RVU = 0.16).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (39) X-Ray Heel (CPT Code 73650)
                    CPT code 73650 (Radiologic examination; calcaneous, minimum of 2
                views) was identified on a screen of CMS/Other source codes with
                Medicare utilization greater than 100,000 services annually. CPT code
                73650 was originally valued by the specialty societies using a
                crosswalk methodology approved by the RUC Research Subcommittee.
                However, after we expressed concern about the use of this approach for
                valuing work and PE, the specialty society agreed to survey the code
                and the RUC reviewed it again in January 2019. For CPT code 73650, we
                are proposing the RUC-recommended work RVU of 0.16. We are also
                proposing the RUC-recommended direct PE inputs for CPT code 73650.
                (40) X-Ray Toe (CPT Code 73660)
                    CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views)
                was identified on a screen of CMS/Other source codes with Medicare
                utilization greater than 100,000 services annually. CPT code 73660 was
                originally valued by the specialty societies using a crosswalk
                methodology approved by the RUC Research Subcommittee. However, after
                we expressed concern about the use of this approach for valuing work
                and PE, the specialty society agreed to survey the code and the RUC
                reviewed it again in January 2019. We are proposing the RUC-recommended
                work RVU for this code of 0.13 for CPT code 73660. We are also
                proposing the RUC-recommended direct PE inputs for CPT code 73660.
                (41) Upper Gastrointestinal Tract Imaging (CPT Codes 74210, 74220,
                74230, 74X00, 74240, 74246, and 74X01)
                    These services were identified through a list of list of CMS/Other
                codes with Medicare utilization of 30,000 or more. The CPT Editorial
                Panel subsequently revised this code set in order to conform to other
                families of radiologic examinations.
                    We are proposing the RUC-recommended work RVUs of 0.59 for CPT code
                74210 (Radiologic examination, pharynx and/or cervical esophagus,
                including scout neck radiograph(s) and delayed image(s), when
                performed, contrast (e.g., barium) study), 0.60 for CPT code 74220
                (Radiologic examination, esophagus, including scout chest radiograph(s)
                and delayed image(s), when performed; single-contrast (e.g., barium)
                study), 0.70 for CPT code 74X00 (Radiologic examination, esophagus,
                including scout chest radiograph(s) and delayed image(s), when
                performed; double-contrast (e.g., high-density barium and effervescent
                agent) study), 0.53 for CPT code 74230 (Radiologic examination,
                swallowing function, with cineradiography/videoradiography, including
                scout neck radiograph(s) and delayed image(s), when performed, contrast
                (e.g., barium) study), 0.80 for CPT code 74240 (Radiologic examination,
                upper gastrointestinal tract, including scout abdominal radiograph(s)
                and delayed image(s), when performed; single-contrast (e.g., barium)
                study) 0.90 for CPT code 74246 (Radiologic examination, upper
                gastrointestinal tract, including scout abdominal radiograph(s) and
                delayed image(s), when performed; double-contrast (e.g., high-density
                barium and effervescent agent) study, including glucagon, when
                administered), and 0.70 for CPT code 74X01 (Radiologic examination,
                upper gastrointestinal tract, including scout abdominal radiograph(s)
                and delayed image(s), when performed; with small intestine follow-
                through study, including multiple serial images (List separately in
                addition to code for primary procedure)). We are also proposing the
                reaffirmed work RVU of 0.59 for CPT code 74210 (Radiologic examination,
                pharynx and/or cervical esophagus, including scout neck radiograph(s)
                and delayed image(s), when performed, contrast (e.g., barium) study)
                and the reaffirmed work RVU of 0.53 for CPT code 74230 (Radiologic
                examination, swallowing function, with cineradiography/
                videoradiography, including scout neck radiograph(s) and delayed
                image(s), when performed, contrast (e.g., barium) study).
                    For the direct PE clinical labor input CA021 ``Perform procedure/
                service--NOT directly related to physician work time,'' we note that no
                rationale was given for the RUC-recommended times for these codes, and
                we are requesting comment on the appropriateness of the RUC-recommended
                clinical labor times for this activity of 13 minutes, 13 minutes, 15
                minutes, 15 minutes, 19 minutes, 22 minutes, and 15 minutes for CPT
                codes 74210, 74220, 74X00, 74230, 74240, and 74246, respectively. In
                addition, for CPT code 74230, we are proposing to refine the clinical
                labor times for the ``Prepare room, equipment and supplies'' (CA013)
                and ``Prepare, set-up and start IV, initial positioning and monitoring
                of patient'' (CA016) activity codes to the standard values of 2 minutes
                each, as well as to refine the equipment times to reflect these changes
                in clinical labor.
                (42) Lower Gastrointestinal Tract Imaging (CPT Codes 74250, 74251,
                74270, and 74280)
                    These services were identified through a list CMS/Other codes with
                Medicare utilization of 30,000 or more. We are proposing the RUC-
                recommended work RVUs of 0.81 for CPT code 74250 (Radiologic
                examination, small intestine, including multiple serial images and
                scout abdominal radiograph(s), when performed; single-contrast (e.g.,
                barium) study), 1.17 for CPT code 74251 (Radiologic examination, small
                intestine, including multiple serial images and scout abdominal
                radiograph(s), when performed; double-contrast (e.g., high-density
                barium and air via enteroclysis tube) study, including glucagon, when
                administered), 1.04 for 74270 (Radiologic examination, colon, including
                scout abdominal radiograph(s) and delayed image(s), when performed;
                single-contrast (e.g., barium) study), and 1.26 for CPT code 74280
                (Radiologic examination, colon, including scout abdominal radiograph(s)
                and delayed image(s), when performed; double-contrast (e.g., high
                density barium and air) study, including glucagon, when administered).
                [[Page 40590]]
                    For the direct PE clinical labor input CA021 ``Perform procedure/
                service--NOT directly related to physician work time,'' we note that no
                rationale was given for the recommended times for these codes, and we
                are requesting comment on the appropriateness of the RUC-recommended
                clinical labor times for this activity of 19 minutes, 30 minutes, 25
                minutes, and 36 minutes for CPT codes 74250, 74251, 74270, and 74280,
                respectively. In addition, we are proposing to refine the equipment
                time for the room, radiographic-fluoroscopic (EL014) for CPT code 74250
                to conform to our established standard for highly technical equipment
                and to match the rest of the codes in the family.
                (43) Urography (CPT Code 74425)
                    The physician time and work described by CPT code 74425 (Urography,
                antegrade (pyelostogram, nephrostogram, loopogram), radiological
                supervision and interpretation) was combined with services describing
                genitourinary catheter procedures in CY 2016, resulting in CPT codes
                50431 (Injection procedure for antegrade nephrostogram and/or
                ureterogram, complete diagnostic procedure including imaging guidance
                (e.g., ultrasound and fluoroscopy) and all associated radiological
                supervision and interpretation; existing access) and 50432 (Placement
                of nephrostomy catheter, percutaneous, including diagnostic
                nephrostogram and/or ureterogram when performed, imaging guidance
                (e.g., ultrasound and/or fluoroscopy) and all associated radiological
                supervision and interpretation). CPT code 74425 was not deleted at the
                time, but the RUC agreed with the specialty societies that 2 years of
                Medicare claims data should be available for analysis before the code
                was resurveyed for valuation to allow for any changes in the
                characteristics and process involved in furnishing the service
                separately from the genitourinary catheter procedures. The specialty
                society surveyed CPT code 74425 and reviewed the results with the RUC
                in October 2018.
                    The results of the specialty society surveys indicated a large
                increase in the amount of time required to furnish the service and,
                correspondingly, to the work RVU. The total time for CPT code 74425
                based on the survey results was 34 minutes, an increase of 25 minutes
                over the current total time of 9 minutes. In reviewing the survey
                results, the RUC revised the total time for this CPT code to 24
                minutes, with a recommended work RVU of 0.51. The reason for the large
                increase in time according to the RUC, is a change in the typical
                patient profile in which the typical patient is one with an ileal
                conduit through which nephrostomy tubes have been placed for post-
                operative obstruction. Based on the described change in patient
                population and increased time required to furnish the service, we are
                proposing the RUC-recommended work RVU of 0.51 for CPT code 74425.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                74425.
                (44) Abdominal Aortography (CPT Codes 75625 and 75630)
                    In October 2017, the RAW requested that AMA staff compile a list of
                CMS/Other codes with Medicare utilization of 30,000 or more. In January
                2018, the RUC recommended to survey these services for the October 2018
                RUC meeting. Subsequently, the specialty society surveyed these codes.
                    We disagree with the RUC-recommended work RVU of 1.75 for CPT code
                75625 (Aortography, abdominal, by serialography, radiological
                supervision and interpretation). In reviewing CPT code 75625, we note
                that the key reference service, CPT Code 75710 (Angiography, extremity,
                unilateral, radiological supervision and interpretation), has 10
                additional minutes of intraservice time, 10 additional minutes of total
                time and the same work RVU, which would indicate the RUC-recommended
                work RVU of 1.75 appears to be overvalued. When we compared the
                intraservice time ratio between the RUC-recommended time of 30 minutes
                and the reference code intraservice time of 40 minutes we found a ratio
                of 25 percent. 25 percent of the reference code work RVU of 1.75 equals
                a work RVU of 1.31. When we compared the total service time ratio
                between the RUC-recommended time of 60 minutes and the reference code
                total service time of 70 minutes we found a ratio of 14 percent. 14
                percent of the reference code work RVU of 1.75 equals a work RVU of
                1.51. Therefore, we believe an accurate value would lie between 1.31
                and 1.52 RVUs. In looking for a comparative code, we have identified
                CPT code 38222. CPT Code 38222 is a recently reviewed CPT code with the
                identical intraservice and total times. As a result, we believe that it
                is more accurate to propose a work RVU of 1.44 based on a crosswalk to
                CPT code 38222.
                    In case of CPT code 75630 (Aortography, abdominal plus bilateral
                iliofemoral lower extremity, catheter, by serialography, radiological
                supervision and interpretation), we are proposing the RUC-recommended
                value of 2.00 RVUs.
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (45) Angiography (CPT Codes 75726 and 75774)
                    We are proposing the RUC-recommend work RVU for both codes in this
                family. We are proposing a work RVU of 2.05 for CPT code 75726
                (Angiography, visceral, selective or supraselective (with or without
                flush aortogram), radiological supervision and interpretation), a work
                RVU of 1.01 for CPT code 75774 (Angiography, selective, each additional
                vessel studied after basic examination, radiological supervision and
                interpretation (List separately in addition to code for primary
                procedure).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (46) X-Ray Exam Specimen (CPT Code 76098)
                    CPT code 70098 was reviewed by the RUC based on a request from the
                American College of Radiology (ACR) to determine whether CPT code 76098
                was undervalued because of the assumption that the service is typically
                furnished concurrently with a placement of localization device service
                (CPT codes 19281 through 19288 each representing a different imaging
                modality). In a letter to the RUC, ACR expressed concern about the
                appropriateness of a codes valuation process in which physician time
                and intensity for a code are reduced to account for overlap with codes
                that are furnished to a patient on the same day. During the April 2018
                RUC meeting, the specialty societies requested a work RVU of 0.40 for
                CPT code 76098, with intraservice time of 5 minutes and total time of
                15 minutes. Currently, this service has a work RVU of 0.16, with 5
                minutes of total time and no available intraservice time. In April
                2018, the RUC and the specialty society agreed that additional analysis
                of the data was warranted in consideration of the relatively large
                change in survey time and work RVU for this service. The RUC agreed to
                review the CPT code (CPT code 76098) again in October 2018.
                    The RUC recommended a work RVU, based on the October 2018 meeting,
                of 0.31 for CPT code 76098, which represents an increase over the
                current value (0.16) but a decrease relative to the specialty society's
                original request of 0.40. The intraservice time for this CPT code is 5
                minutes, and the total time is 11 minutes. Based on the parameters we
                [[Page 40591]]
                typically use to review and evaluate RUC recommendations, which rely
                heavily on survey data, we agree that a work RVU of 0.31 for a CPT code
                with 5 minutes intraservice and 11 minutes total time is consistent
                with other CPT codes with similar times and levels of intensity. We are
                proposing the RUC-recommended work RVU for CPT code 76098 of 0.31.
                    We share the ACR's interest in establishing or clarifying
                parameters that indicate when CPT codes that are furnished concurrently
                by the same provider should be valued to account for the overlap in
                physician work time and intensity, and even PE. We are broadly
                interested in stakeholder feedback and suggestions about what those
                parameters might be and whether or how they should affect code
                valuation.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                76098.
                (47) 3D Rendering (CPT Code 76376)
                    CPT code 76376 (3D rendering with interpretation and reporting of
                computed tomography, magnetic resonance imaging, ultrasound, or other
                tomographic modality with image postprocessing under concurrent
                supervision; not requiring image postprocessing on an independent
                workstation) was identified as potentially misvalued on a screen of
                codes with a negative intraservice work per unit of time (IWPUT), with
                2016 estimated Medicare utilization over 10,000 for RUC reviewed codes
                and over 1,000 for Harvard valued and CMS/Other source codes. It was
                surveyed and reviewed at the April 2018 RUC meeting.
                    We are proposing the RUC-recommended work RVU of 0.20 for CPT code
                76376. We are also proposing the RUC-recommended direct PE inputs for
                CPT code 76376.
                (48) Ultrasound Exam--Chest (CPT Code 76604)
                    CPT code 76604 (Ultrasound, chest (includes mediastinum), real time
                with image documentation) was identified as potentially misvalued on a
                screen of CMS/Other codes with Medicare utilization of 30,000 or more.
                It was surveyed and reviewed for the April 2018 RUC meeting.
                    We are proposing the RUC-recommended work RVU of 0.59 for CPT code
                76604. We are also proposing the RUC-recommended direct PE inputs for
                CPT code 76604.
                (49) X-Ray Exam--Bone (CPT Codes 77073, 77074, 77075, 77076, and 77077)
                    CPT codes 77073 (Bone length studies (orthoroentgenogram,
                scanogram)), 77075 (Radiologic examination, osseous survey; complete
                (axial and appendicular skeleton)), and 77077 (Joint survey, single
                view, 2 or more joints) were identified as potentially misvalued on a
                screen of CMS/Other codes with Medicare utilization of 30,000 or more.
                CPT codes 77074 (Radiologic examination, osseous survey; limited (e.g.,
                for metastases)) and 77076 (Radiologic examination, osseous survey,
                infant) were reviewed as part of the same family.
                    We are proposing the RUC-recommended work RVUs for all five CPT
                codes in this family as follows: CPT code 77073 (work RVU = 0.26); CPT
                code 77074 (work RVU = 0.44); CPT code 77075 (work RVU = 0.55); CPT
                code 77076 (work RVU = 0.70); and CPT code 77077 (work RVU = 0.33).
                    We are proposing the RUC-recommended direct PE inputs for all codes
                in the family.
                (50) SPECT-CT Procedures (CPT Codes 78800, 78801, 78802, 78803, 78804,
                788X0, 788X1, 788X2, and 788X3)
                    The CPT Editorial Panel revised five codes, created four new codes
                and deleted nine codes to better differentiate between planar
                radiopharmaceutical localization procedures and SPECT, SPECT-CT and
                multiple area or multiple day radiopharmaceutical localization/
                distribution procedures.
                    For CPT code 78800 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed); planar
                limited single area (e.g., head, neck, chest pelvis), single day of
                imaging), we disagree with the RUC recommendation to assign a work RVU
                of 0.70 based on the survey 25th percentile to this code, because we
                believe that it is inconsistent with the RUC-recommended reduction in
                physician time. We are proposing a work RVU of 0.64 based on the
                following total time ratio: The RUC-recommended 27 minutes divided by
                the current 28 minutes multiplied by the current work RVU of 0.66,
                which results in a work RVU of 0.64. We note that this value is
                bracketed by the work RVUs of CPT code 93287 (Peri-procedural device
                evaluation (in person) and programming of device system parameters
                before or after a surgery, procedure, or test with analysis, review and
                report by a physician or other qualified health care professional;
                single, dual, or multiple lead implantable defibrillator system), with
                a work RVU of 0.45, and CPT code 94617 (Exercise test for bronchospasm,
                including pre- and post-spirometry, electrocardiographic recording(s),
                and pulse oximetry), with a work RVU of 0.70. Both of these supporting
                crosswalks have intraservice time values of 10 minutes, and they have
                similar total time values.
                    For CPT code 78801 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed); planar,
                2 or more areas (e.g., abdomen and pelvis, head and chest), 1 or more
                days of imaging or single area imaging over 2 or more days), we
                disagree with the RUC recommendation to maintain the current work RVU
                of 0.79 despite a 22-minute reduction in intraservice time. We believe
                a reduction from the current value is warranted given the recommended
                reduction in physician time, and also to be consistent with other
                services of similar time values. We are proposing a work RVU of 0.73
                based on the RUC-recommended incremental relationship between this code
                and CPT code 78800 (a difference of 0.09 RVU), which we apply to our
                proposed value for the latter code. As support for our proposed work
                RVU of 0.73, we note that it falls between the work RVUs of CPT code
                94617 (Exercise test for bronchospasm, including pre- and post-
                spirometry, electrocardiographic recording(s), and pulse oximetry) with
                a work RVU of 0.70, and CPT code 93280 (Programming device evaluation
                (in person) with iterative adjustment of the implantable device to test
                the function of the device and select optimal permanent programmed
                values with analysis, review and report by a physician or other
                qualified health care professional; dual lead pacemaker system) with a
                work RVU of 0.77.
                    For CPT code 78802 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed); planar,
                whole body, single day of imaging), we disagree with the RUC
                recommendation to maintain the current work RVU of 0.86, as we believe
                that it is inconsistent with a reduction in time values, and because we
                do not agree that a work RVU that is among the highest of other
                services of similar intraservice time values is appropriate. We are
                proposing a work RVU of 0.80 based on the RUC-recommended incremental
                [[Page 40592]]
                relationship between this code and CPT code 78800 (a difference of 0.16
                RVU), which we apply to our proposed value for the latter code. As
                support for our proposed work RVU of 0.80, we note that it falls
                between the work RVUs of CPT code 92520 (Laryngeal function studies
                (i.e., aerodynamic testing and acoustic testing)) with a work RVU of
                0.75, and CPT code 93282 (Programming device evaluation (in person)
                with iterative adjustment of the implantable device to test the
                function of the device and select optimal permanent programmed values
                with analysis, review and report by a physician or other qualified
                health care professional; single lead transvenous implantable
                defibrillator system) with a work RVU of 0.85.
                    For CPT code 78804 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed); planar,
                whole body, requiring 2 or more days of imaging), we disagree with the
                RUC recommendation to maintain the current work RVU of 1.07, as we
                believe that it is inconsistent with a reduction in time values, and
                because this work RVU appears to be valued highly relative to other
                services of similar time values. We are proposing a work RVU of 1.01
                based on the RUC-recommended incremental relationship between this code
                and CPT code 78800 (a difference of 0.37 RVU), which we apply to our
                proposed value for the latter code. As support for our proposed work
                RVU of 1.01, we reference CPT code 91111 (Gastrointestinal tract
                imaging, intraluminal (e.g., capsule endoscopy), esophagus with
                interpretation and report), which has a work RVU of 1.00 and similar
                physician time values.
                    For CPT code 78803 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed);
                tomographic (SPECT), single area (e.g., head, neck, chest pelvis),
                single day of imaging), we disagree with the RUC recommendation to
                increase the work RVU to 1.20 based on the survey 25th percentile to
                this code, because we believe that it is inconsistent with the RUC-
                recommended reduction in physician time. We are proposing to maintain
                the current work RVU of 1.09. We support this value with a reference to
                CPT code 78266 (Gastric emptying imaging study (e.g., solid, liquid, or
                both); with small bowel and colon transit, multiple days), which has a
                work RVU of 1.08, and similar time values.
                    For CPT code 788X0 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed);
                tomographic (SPECT) with concurrently acquired computed tomography (CT)
                transmission scan for anatomical review, localization and
                determination/detection of pathology, single area (e.g., head, neck,
                chest or pelvis), single day of imaging), we disagree with the RUC
                recommendation to assign a work RVU of 1.60 based on the survey 25th
                percentile to this code, as this would value this code more highly than
                services of similar time values. To maintain relativity among services
                in this family, we are proposing a work RVU of 1.49 for CPT code 788X0
                based on the RUC-recommended incremental relationship between CPT code
                788X0 and CPT code 78803 (a difference of 1.09 RVU), which we apply to
                our proposed value for the latter code. As support for our proposed
                work RVU of 1.49, we note that it is bracketed by the work RVUs of CPT
                codes 72195 (Magnetic resonance (e.g., proton) imaging, pelvis; without
                contrast material(s)) with a work RVU of 1.46, and 95861 (Needle
                electromyography; 2 extremities with or without related paraspinal
                areas) with a work RVU of 1.54. The physician time values of these
                services bracket those recommended for CPT code 778X0.
                    For CPT code 788X1 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed);
                tomographic (SPECT), minimum 2 areas (e.g., pelvis and knees, abdomen
                and pelvis), single day of imaging, or single area of imaging over 2 or
                more days), we disagree with the RUC recommendation to assign a work
                RVU of 1.93 based on the survey 50th percentile to this code, as this
                would value this code more highly than services of similar time values.
                To maintain relativity among services in this family, we are proposing
                a work RVU of 1.82 based on the RUC-recommended incremental
                relationship between this code and CPT code 78803 (a difference of 0.73
                RVU), which we apply to our proposed value for the latter code. As
                support for our proposed work RVU of 1.82, we note that it is bracketed
                by the work RVUs of the CPT codes which are members of the same code
                families referenced for the previous CPT code, 788X0: CPT codes 72191
                (Computed tomographic angiography, pelvis, with contrast material(s),
                including noncontrast images, if performed, and image postprocessing)
                with a work RVU of 1.81, and 95863 (Needle electromyography; 3
                extremities with or without related paraspinal areas) with a work RVU
                of 1.87. The physician time values of these services bracket those
                recommended for CPT code 778X1.
                    For CPT code 788X2 (Radiopharmaceutical localization of tumor,
                inflammatory process or distribution of radiopharmaceutical agent(s),
                (includes vascular flow and blood pool imaging when performed);
                tomographic (SPECT) with concurrently acquired computed tomography (CT)
                transmission scan for anatomical review, localization and
                determination/detection of pathology, minimum 2 areas (e.g., pelvis and
                knees, abdomen and pelvis), single day of imaging, or single area of
                imaging over 2 or more days imaging), we disagree with the RUC
                recommendation to assign a work RVU of 2.23 based on the survey 50th
                percentile to this code, as this would value this code more highly than
                services of similar time values. To maintain relativity among services
                in this family, we are proposing a work RVU of 2.12 based on the RUC-
                recommended incremental relationship between this code and CPT code
                78803 (a difference of 1.03 RVU), which we apply to our proposed value
                for the latter code. As support for our proposed work RVU of 2.12, we
                reference CPT code 70554 (Magnetic resonance imaging, brain, functional
                MRI; including test selection and administration of repetitive body
                part movement and/or visual stimulation, not requiring physician or
                psychologist administration), which has a work RVU of 2.11 and
                physician intraservice and total time values that are identical to
                those recommended for this service.
                    For CPT code 788X3 (Radiopharmaceutical quantification
                measurement(s) single area), we disagree with the RUC recommendation to
                assign a work RVU of 0.51 based on the survey 25th percentile to this
                code, because we wish to maintain relativity and proportionality among
                codes of this family. We based our values for the other codes in this
                family on their relative relationship to either CPT code 78800 or
                788X2, depending on the type of service described by the code. For CPT
                code 788X0, which describes a single day of imaging and is thus
                analagous to CPT code 788X3 in terms of units of service, our analysis
                indicates a reduction from the RUC value of approximately 7 percent is
                appropriate. Therefore, we apply a
                [[Page 40593]]
                similar reduction of 7 percent to the RUC-recommended work RVU of 0.51
                to arrive at an RVU of 0.47. We support this value by noting that it is
                bracketed by add-on CPT codes 77001 (Fluoroscopic guidance for central
                venous access device placement, replacement (catheter only or
                complete), or removal (includes fluoroscopic guidance for vascular
                access and catheter manipulation, any necessary contrast injections
                through access site or catheter with related venography radiologic
                supervision and interpretation, and radiographic documentation of final
                catheter position) (List separately in addition to code for primary
                procedure)) with a work RVU of 0.38, and 77002 (Fluoroscopic guidance
                for needle placement (e.g., biopsy, aspiration, injection, localization
                device) (List separately in addition to code for primary procedure)),
                with a work RVU of 0.54. Both of these reference CPT codes have
                intraservice time values that are similar to, and total time values
                that are identical to, those recommended for CPT code 788X3.
                    For the direct PE inputs, we are refining the number of minutes of
                clinical labor allocated to the activity ``Prepare, set-up and start
                IV, initial positioning and monitoring of patient'' to the 2-minute
                standard for CPT codes 78800, 78801, 78802, 78804, 78803, 788X0, 788X1,
                and 788X2, as no rationale was provided for these codes to have times
                above the standard for this activity. We are also refining the
                equipment time formulas to reflect this clinical labor refinement for
                these codes. For CPT codes 78800, 78801, 78802, 78804, 78803, 788X0,
                788X1, and 788X2, we are proposing to refine the equipment times to
                match our standard equipment time formula for the professional PACS
                workstation. For the supply item SM022 ``sanitizing cloth-wipe
                (surface, instruments, equipment),'' we are refining these supplies to
                quantities of 5 each for CPT codes 78801, 78804, and 788X2 to conform
                with other codes in the family.
                (51) Myocardial PET (CPT Codes 78459, 78X29, 78491, 78X31, 78492,
                78X32, 78X33, 78X34, and 78X35)
                    CPT code 78492 was identified via the High Volume Growth screen
                with total Medicare utilization over 10,000 that increased by at least
                100 percent from 2009 through 2014. The CPT Editorial Panel revised
                this code set to reflect newer technology aspects such as wall motion,
                ejection fraction, flow reserve, and technology updates for hardware
                and software. The CPT Editorial Panel deleted a Category III code,
                added six Category I codes, and revised the three existing codes to
                separately identify component services included for myocardial imaging
                using positron emission tomography.
                    For CPT code 78491 (Myocardial imaging, positron emission
                tomography, perfusion study (including ventricular wall motion(s), and/
                or ejection fractions(s), when performed); single study, at rest or
                stress (exercise or pharmacologic)), we disagree with the RUC-
                recommended work RVU of 1.56, which is the survey 25th percentile
                value, as we believe that the 30-minute reduction in intraservice time
                and 15-minute reduction in physician total time does not validate an
                increase in work RVU, and we believe that the significance of the
                reductions in recommended physician time values warrants a reduction in
                work RVU. We are proposing a work RVU of 1.00 based on the following
                total time ratio: The recommended 30 minutes divided by the current 45
                minutes multiplied by the current work RVU of 1.50, which results in a
                work RVU of 1.00. As further support for this value, we note that it
                falls between CPT code 78278 (Acute gastrointestinal blood loss
                imaging), with a work RVU of 0.99, and CPT code 10021 (Fine needle
                aspiration biopsy, without imaging guidance; first lesion), with a work
                RVU of 1.03.
                    For CPT code 78X31 (Myocardial imaging, positron emission
                tomography, perfusion study (including ventricular wall motion(s), and/
                or ejection fractions(s), when performed); single study, at rest or
                stress (exercise or pharmacologic), with concurrently acquired computed
                tomography transmission scan), we disagree with the RUC recommendation
                of 1.67 based on the survey 25th percentile, as we do not agree this
                service would be appropriately valued with an RVU that is among the
                highest of all services of similar times with this global period. We
                are proposing a work RVU of 1.11 by applying the RUC-recommended
                increment between CPT code 78491 and this code, an increment of 0.11,
                to our proposed value of 1.00 for CPT code 78491, thus maintaining the
                RUC's recommended incremental relationship between these codes. As
                further support for this value, we note that it falls between CPT codes
                95977 (Electronic analysis of implanted neurostimulator pulse
                generator/transmitter (e.g., contact group[s], interleaving, amplitude,
                pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
                lockout, patient selectable parameters, responsive neurostimulation,
                detection algorithms, closed loop parameters, and passive parameters)
                by physician or other qualified health care professional; with complex
                cranial nerve neurostimulator pulse generator/transmitter programming
                by physician or other qualified health care professional)), with a work
                RVU of 0.97, and CPT code 93284 (Programming device evaluation (in
                person) with iterative adjustment of the implantable device to test the
                function of the device and select optimal permanent programmed values
                with analysis, review and report by a physician or other qualified
                health care professional; multiple lead transvenous implantable
                defibrillator system), with a work RVU of 1.25; both of these codes
                have similar physician time values.
                    For CPT code 78459 (Myocardial imaging, positron emission
                tomography (PET), metabolic evaluation study (including ventricular
                wall motion(s), and/or ejection fraction(s), when performed) single
                study), we disagree with the RUC recommendation to increase the work
                RVU to 1.61 based on the survey 25th percentile. We believe that the
                magnitude of the recommended reductions in physician time (a 50-minute
                reduction in intraservice time and a 32-minute reduction in total time)
                suggests that this value is overestimated; furthermore, we note that
                the RUC's recommendation is among the highest for all XXX-global period
                codes with similar time values. We are proposing a work RVU of 1.05 by
                applying the RUC-recommended increment between this code and CPT code
                78491, a difference of 0.05, which we apply to our proposed value for
                the latter code. We support our RVU of 1.05 by referencing two CPT
                codes: 10021 (Fine needle aspiration biopsy, without imaging guidance;
                first lesion), and 36440 (Push transfusion, blood, 2 years or younger),
                both of which have work RVUs of 1.03, as well as identical intraservice
                and similar total time values.
                    We disagree with the RUC's recommended valuation of 1.76 for CPT
                code 78X29 (Myocardial imaging, positron emission tomography (PET),
                metabolic evaluation study (including ventricular wall motion(s), and/
                or ejection fraction(s), when performed) single study; with
                concurrently acquired computed tomography transmission scan), which is
                based on the survey 25th percentile, because we believe a work RVU that
                is greater than those of all other services of similar intraservice
                time values is not appropriate. We are proposing a work RVU of 1.20 for
                CPT code 78X29. We are proposing to value CPT code 78X29 with an
                incremental methodology, which preserves the RUC-recommended
                relationship among the codes in this family; the RUC
                [[Page 40594]]
                recommends an increment of 0.20 between CPT code 78X29 and CPT code
                78491. We are proposing to apply this increment to our proposed value
                of 1.00 for CPT code 78491 to arrive at our value of 1.20.
                    We disagree with the RUC's recommendation of 1.80 for CPT code
                78492 (Myocardial imaging, positron emission tomography, perfusion
                study (including ventricular wall motion(s), and/or ejection
                fractions(s), when performed); multiple studies at rest and stress
                (exercise or pharmacologic)) given the magnitude of the recommended
                reduction in physician time values (a 35-minute reduction in
                intraservice time and a 17-minute reduction in total time), and also
                given the fact that the RUC's recommended value would be the highest of
                all codes of this intraservice time and global period. We are proposing
                a work RVU of 1.24 based on the RUC-recommended incremental difference
                between 78491 and 78492 of 0.24, which we add to our proposed value for
                78491 for a work RVU of 1.24. As further support for this value, we
                reference CPT code 95908 (Nerve conduction studies; 3-4 studies), with
                a work RVU of 1.25, similar physician time values.
                    We disagree with the RUC's recommendation of 1.90 for CPT code
                78X32 (Myocardial imaging, positron emission tomography, perfusion
                study (including ventricular wall motion(s), and/or ejection
                fractions(s), when performed); multiple studies at rest and stress
                (exercise or pharmacologic), with concurrently acquired computed
                tomography transmission scan) which is based on a crosswalk to CPT code
                64617 (Chemodenervation of muscle(s); larynx, unilateral, percutaneous
                (e.g., for spasmodic dysphonia), includes guidance by needle
                electromyography, when performed), because the fact that this work RVU
                that is greater than those of all other services of similar
                intraservice time values suggests that it is an overestimate. Instead
                we are proposing a work RVU of 1.34 for CPT code 78X32, based on an
                incremental methodology. We apply the RUC-recommended increment between
                78491 and CPT code 78X32, a difference of 0.34, to our proposed value
                of 1.00 for CPT code 78491, for a value of 1.34. We support this value
                by referencing CPT code 77261 (Therapeutic radiology treatment
                planning; simple), with a work RVU of 1.30, and CPT code 94003
                (Ventilation assist and management, initiation of pressure or volume
                preset ventilators for assisted or controlled breathing; hospital
                inpatient/observation, each subsequent day), with a work RVU of 1.37.
                These codes have similar physician time values.
                    We disagree with the RUC's recommendation of 2.07 for CPT code
                78X33 (Myocardial imaging, positron emission tomography, combined
                perfusion with metabolic evaluation study (including ventricular wall
                motion(s), and/or ejection fraction(s), when performed), dual
                radiotracer (e.g., myocardial viability)), because we believe the fact
                that this work RVU is greater than those of all other services of
                similar intraservice time values suggests that it is an overestimate.
                We are proposing a work RVU of 1.51 for CPT code 78X33, based on an
                incremental methodology. We apply the RUC-recommended increment between
                78491 and CPT code 78X33, a difference of 0.51, to our proposed value
                of 1.00 for CPT code 78491, for a value of 1.51. We support this value
                by referencing CPT code 10005 (Fine needle aspiration biopsy, including
                ultrasound guidance; first lesion), with a work RVU of 1.46, and
                similar physician time values.
                    Similarly for CPT code 78X34 (Myocardial imaging, positron emission
                tomography, combined perfusion with metabolic evaluation study
                (including ventricular wall motion(s), and/or ejection fraction(s),
                when performed), dual radiotracer (e.g., myocardial viability); with
                concurrently acquired computed tomography transmission scan), we
                disagree with the RUC's recommendation of 2.26 based on a crosswalk to
                CPT code 71552 (Magnetic resonance (e.g., proton) imaging, chest (e.g.,
                for evaluation of hilar and mediastinal lymphadenopathy); without
                contrast material(s), followed by contrast material(s) and further
                sequences), because we believe the fact that this work RVU is among the
                highest among services of similar intraservice time values suggests
                that it is an overestimate. We are proposing a work RVU of 1.70 by
                applying the RUC-recommended increment between CPT code 78X34 and CPT
                code 78491, which is a difference of 0.70, to our proposed value for
                CPT code 78491 for a value of 1.70. We support this value by
                referencing CPT codes 95924 (Testing of autonomic nervous system
                function; combined parasympathetic and sympathetic adrenergic function
                testing with at least 5 minutes of passive tilt) and 74182 (Magnetic
                resonance (e.g., proton) imaging, abdomen; with contrast material(s)),
                both of which have work RVUs of 1.73.
                    For CPT code 78X35 (Absolute quantitation of myocardial blood flow
                (AQMBF), positron emission tomography, rest and pharmacologic stress
                (List separately in addition to code for primary procedure)), we
                disagree with the RUC recommendation to assign a work RVU of 0.63 to
                this code based on the survey 25th percentile, because we believe a
                comparison to other codes with a global period of ZZZ suggests that
                this is somewhat overvalued, and because we wish to maintain relativity
                and proportionality to other codes in this series. We based our values
                for the other codes in this family on their relative relationships to
                CPT code 78491; for that code our analysis indicates that a reduction
                from the RUC value of roughly \1/3\ is appropriate, based on a ratio of
                the decrease in total time to the current work RVU. Therefore, we apply
                a similar reduction of \1/3\ to the RUC-recommended work RVU of 0.63 to
                arrive at an RVU of approximately 0.42. Applying a reduction that is
                similar to the reduction we think is warranted from the RUC value for
                CPT code 78491 to CPT code 78X35 will maintain consistency in value
                among these services. We believe this work RVU is validated by noting
                that it is bracketed by CPT codes 15272 (Application of skin substitute
                graft to trunk, arms, legs, total wound surface area up to 100 sq cm;
                each additional 25 sq cm wound surface area, or part thereof (List
                separately in addition to code for primary procedure)), with a work RVU
                of 0.33, and 11105 (Punch biopsy of skin (including simple closure,
                when performed); each separate/additional lesion (List separately in
                addition to code for primary procedure)), with a work RVU of 0.45. A
                work RVU of 0.42 is thus consistent with ZZZ global period codes of
                similar physician times.
                    For the direct PE inputs, for several of the equipment items, we
                are proposing to refine the equipment times to conform to our
                established policies for non-highly, as well as for highly technical
                equipment. In addition, we are proposing to refine the equipment times
                to conform to our established policies for PACS Workstation. For the
                new equipment items ER110: ``PET Refurbished Imaging Cardiac
                Configuration'' and ER111: ``PET/CT Imaging Camera Cardiac
                Configuration,'' we are proposing to assume that a 90 percent equipment
                utilization rate is typical, as this would be consistent with our
                equipment utilization assumptions for expensive diagnostic imaging
                equipment. For the supply item SM022 ``sanitizing cloth-wipe (surface,
                instruments, equipment),'' we are refining these supplies to quantities
                of 5 each for CPT codes 78X33 and 78X34 to conform with other codes in
                the family. We are proposing that we will
                [[Page 40595]]
                not price the ``Software and hardware package for Absolute
                Quantitation'' as a new equipment item, due to the fact that the
                submitted invoices included a service contract and a combined software/
                hardware bundle with no breakdown on individual pricing. Based on our
                lack of specific pricing data, we believe that this software is more
                accurately characterized as an indirect PE input that is not
                individually allocable to a particular patient for a particular
                service.
                (52) Cytopathology, Cervical-Vaginal (CPT Code 88141, HCPCS Codes
                G0124, G0141, and P3001)
                    CPT code 88141 (Cytopathology, cervical or vaginal (any reporting
                system), requiring interpretation by physician), HCPCS code G0124
                (Screening cytopathology, cervical or vaginal (any reporting system),
                collected in preservative fluid, automated thin layer preparation,
                requiring interpretation by physician), HCPCS code G0141 (Screening
                cytopathology smears, cervical or vaginal, performed by automated
                system, with manual rescreening, requiring interpretation by
                physician), and HCPCS code P3001 (Screening Papanicolaou smear,
                cervical or vaginal, up to three smears, requiring interpretation by
                physician) were identified as potentially misvalued on a list of CMS or
                other source codes with Medicare utilization of 30,000 or more.
                    In the CY 2000 PFS final rule (64 FR 59408), we finalized a policy
                that it was more appropriate to evaluate the work, PE, and MP RVUs for
                HCPCS codes P3001, G0124, and G0141 identical or comparable to the
                values of CPT code 88141.
                    For CY 2020, the RUC recommended a work RVU of 0.42 for CPT code
                88141 and HCPCS codes G0124, G0141, and P3001, based on the current
                value. We disagree with the RUC-recommended work RVU and are proposing
                a work RVU of 0.26 for all four codes in this family, based on our time
                ratio methodology and a crosswalk to CPT code 93313 (Echocardiography,
                transesophageal, real-time with image documentation (2D) (with or
                without M-mode recording); placement of transesophageal probe only),
                which has an identical work RVU of 0.26, identical intraservice and
                total work times values to CPT code 88141 and HCPCS codes G0124, and
                G0141, and similar intraservice and total time values to HCPCS code
                P3001.
                    In reviewing this family of codes, we note that the intraservice
                and total work times for CPT code 88141 and HCPCS codes G0124, and
                G0141 are decreasing from 16 minutes to 10 minutes (38 percent
                reduction) and the intraservice and total work times for HCPCS code
                P3001 are decreasing from 16 minutes to 12 minutes (25 percent
                reduction). However, the RUC recommended a work RVU of 0.42 for all
                four codes in this family, based on the maintaining the current work
                RVU. Although we do not imply that the decrease in time as reflected in
                survey values must equate to a one-to-one or linear decrease in the
                valuation of work RVUs, we believe that since the two components of
                work are time and intensity, significant decreases in time should be
                appropriately reflected in decreases to work RVUs. In the case of CPT
                code 88141 and HCPCS codes G0124, G0141, and P3001, we believe that it
                would be more accurate to propose a work RVU of 0.26, based on our time
                ratio methodology and a crosswalk to CPT code 93313 to account for
                these decreases in the surveyed work times.
                    For the direct PE inputs, we are proposing to refine the clinical
                labor time for the ``Perform regulatory mandated quality assurance
                activity'' (CA033) activity from 7 minutes to 5 minutes for all four
                codes in the family. We believe that these quality assurance activities
                would not typically take 7 minutes to perform, given that similar
                federally mandated MQSA activities were recommended and finalized at a
                time of 4 minutes for CPT codes 77065-77067 in CY 2017 (81 FR 80314-
                80316), and other related regulatory compliance activities were
                recommended and finalized at a time of 5 minutes for CPT codes 78012-
                78014 in CY 2013 (77 FR 69037). To preserve relativity between
                services, we are proposing a clinical labor time of 5 minutes for the
                codes in this family based on this prior allocation of clinical labor
                time.
                    We are also proposing to remove the 1-minute of clinical labor time
                for the ``File specimen, supplies, and other materials'' (PA008)
                activity from all four codes under the rationale that this task is a
                form of indirect PE. As we stated in the CY 2017 PFS final rule (81 FR
                80324), we agree that filing specimens is an important task, and we
                agree that these would take more than zero minutes to perform. However,
                we continue to believe that these activities are correctly categorized
                under indirect PE as administrative functions, and therefore, we do not
                recognize the filing of specimens as a direct PE input, and we do not
                consider this task as typically performed by clinical labor on a per-
                service basis.
                    We are proposing to refine the equipment time for the compound
                microscope (EP024) equipment to 10 minutes for all four codes in the
                family to match the work time of the procedures. The recommended
                materials for this code family state that the compound microscope is
                utilized by the pathologist, and therefore, we believe that the 10-
                minute work time of the procedures would be the most accurate equipment
                time to propose.
                (53) Biofeedback Training (CPT Codes 908XX and 909XX)
                    CPT code 90911 (Biofeedback training, perineal muscles, anorectal
                or urethral sphincter, including EMG and/or manometry) was identified
                as potentially misvalued on a RAW screen of codes with a negative IWPUT
                and Medicare utilization over 10,000 for all services or over 1,000 for
                Harvard valued and CMS or other source codes. In September 2018, the
                CPT Editorial Panel replaced this code with two new codes to describe
                biofeedback training initial 15 minutes of one-on-one patient contact
                and each additional 15 minutes of biofeedback training.
                    We are proposing the RUC-recommended work RVU of 0.90 for CPT code
                908XX (Biofeedback training, perineal muscles, anorectal or urethral
                sphincter, including EMG and/or manometry when performed; initial 15
                minutes of one-on-one patient contact), as well as the RUC-recommended
                work RVU of 0.50 for CPT code 909XX (Biofeedback training, perineal
                muscles, anorectal or urethral sphincter, including EMG and/or
                manometry when performed; each additional 15 minutes of one-on-one
                patient contact). For the direct PE inputs, we are proposing to refine
                the equipment time for the power table (EF031) equipment in CPT code
                908XX to conform to our established standard for non-highly technical
                equipment.
                    We are also proposing to designate CPT codes 908XX and 909XX as
                ``sometimes therapy'' procedures which means that an appropriate
                therapy modifier is always required when this service is furnished by
                therapists. For more information we direct readers to the Therapy Code
                List section of the CMS website at https://www.cms.gov/Medicare/Billing/TherapyServices/AnnualTherapyUpdate.html.
                (54) Corneal Hysteresis Determination (CPT Code 92145)
                    In 2005, the AMA RUC began the process of flagging services that
                represent new technology or new services as they were presented to the
                AMA/Specialty Society RVS Update Committee. The AMA RUC reviewed this
                service at the October 2018 RAW meeting, and indicated that the
                [[Page 40596]]
                utilization is continuing to increase for this service. This code was
                surveyed and reviewed for the January 2019 RUC meeting.
                    We are proposing the work RVU of 0.10 as recommended by the RUC. We
                are also proposing the RUC-recommended direct PE inputs for CPT code
                92145 without refinement.
                (55) Computerized Dynamic Posturography (CPT Codes 92548 and 92XX0)
                    CPT code 92548 (Computerized dynamic posturography) was identified
                via the negative IWPUT screen. CPT revised one code and added another
                code to more accurately describe the current clinical work and
                equipment necessary to provide this service.
                    We do not agree with the RUC's recommended work RVUs of 0.76 for
                CPT code 92548 (Computerized dynamic posturography sensory organization
                test (CDP-SOT), 6 conditions (i.e., eyes open, eyes closed, visual
                sway, platform sway, eyes closed platform sway, platform and visual
                sway), including interpretation and report), or 0.96 for CPT code 92XX0
                (Computerized dynamic posturography sensory organization test (CDP-
                SOT), 6 conditions (i.e., eyes open, eyes closed, visual sway, platform
                sway, eyes closed platform sway, platform and visual sway), including
                interpretation and report; with motor control test (MCT) and adaptation
                test (ADT)). For CPT code 92548, we agree that an increase in work RVU
                is warranted; however, we believe the surveyed time values suggest an
                increase of a less significant magnitude than that recommended. We are
                proposing a work RVU of 0.67 based on the intraservice time ratio: we
                divide the RUC-recommended intraservice time value of 20 by the current
                value of 15 and multiply the product by the current work RVU of 0.50
                for a ratio of 0.67. As a supporting crosswalk, we note that our value
                is greater than the work RVU of 0.60 for CPT code 93316
                (Transesophageal echocardiography for congenital cardiac anomalies;
                placement of transesophageal probe only), which has identical
                intraservice and total times.
                    We are proposing to maintain relativity between these two codes by
                valuing CPT code 92XX0 by applying the RUC-recommended incremental
                difference between the two codes, a difference of 0.20, to our proposed
                value of 0.66 for CPT code 93316; therefore, we are proposing a work
                RVU of 0.87 for CPT code 92XX0. As further support for this value, we
                note that it falls between the work RVUs of CPT codes 95972 (Electronic
                analysis of implanted neurostimulator pulse generator/transmitter
                (e.g., contact group[s], interleaving, amplitude, pulse width,
                frequency [Hz], on/off cycling, burst, magnet mode, dose lockout,
                patient selectable parameters, responsive neurostimulation, detection
                algorithms, closed loop parameters, and passive parameters) by
                physician or other qualified health care professional; with complex
                spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator
                pulse generator/transmitter programming by physician or other qualified
                health care professional), with a work RVU of 0.80, and CPT code 38207
                (Transplant preparation of hematopoietic progenitor cells;
                cryopreservation and storage), with a work RVU of 0.89.
                    We are proposing the RUC-recommended direct PE inputs for these
                codes without refinement.
                (56) Auditory Function Evaluation (CPT Codes 92626 and 92627)
                    CPT code 92626 (Evaluation of auditory function for surgically
                implanted device(s), candidacy or post-operative status of a surgically
                implanted device(s); first hour) appeared on the RAW 2016 high volume
                growth screen. In 2017, it was identified through a CMS request. CPT
                code 92627 (Evaluation of auditory function for surgically implanted
                device(s), candidacy or post-operative status of a surgically implanted
                device(s); each additional 15 minutes) the add-on code for CPT code for
                92626, also was included in the CMS request to review audiology
                services.
                    For CY 2020, we are proposing the HCPAC-recommended work RVU of
                1.40 for CPT code 92626, which is identical to its current RVU. We are
                also proposing the HCPAC-recommended work RVU of 0.33 for the add-on
                code, CPT code 92627. We are proposing the RUC-recommended direct PE
                inputs for all codes in the family.
                (57) Septostomy (CPT Codes 92992 and 92993)
                    CPT codes 92992 (Atrial septectomy or septostomy; transvenous
                method, balloon (e.g., Rashkind type) (includes cardiac
                catheterization)) and 92993 (Atrial septectomy or septostomy; blade
                method (Park septostomy) (includes cardiac catheterization)) were
                nominated as potentially misvalued services. These services are
                typically performed on children, a non-Medicare population, and are
                currently contractor-priced. These codes were surveyed and reviewed for
                the January 2019 RUC meeting.
                    We are proposing to maintain contractor pricing for CPT codes 92992
                and 92993, as recommended by the RUC. These codes will be referred to
                the CPT Editorial Panel for revision and potential deletion. We are
                also proposing a change from 90-day to 0-day global period status for
                these two procedures, also as recommended by the RUC.
                (58) Opthalmoscopy (CPT Codes 92X18 and 92X19)
                    CPT code 92225 was identified as potentially misvalued on a screen
                of codes with a negative IWPUT, with 2016 estimated Medicare
                utilization over 10,000 for RUC reviewed codes and over 1,000 for
                Harvard valued and CMS/Other source codes. In February 2018, the CPT
                Editorial Panel deleted CPT codes 92225 and 92226 and created two new
                codes to specify what portion of the eye is examined for a service
                beyond the normal comprehensive eye exam.
                    We are proposing the RUC-recommended work RVUs of 0.40 for CPT code
                92X18 (Ophthalmoscopy, extended, with retinal drawing and scleral
                depression of peripheral retinal disease (e.g., for retinal tear,
                retinal detachment, retinal tumor) with interpretation and report,
                unilateral or bilateral) and 0.26 for CPT code 92X19 (Ophthalmoscopy,
                extended, with drawing of optic nerve or macula (e.g., for glaucoma,
                macular pathology, tumor) with interpretation and report, unilateral or
                bilateral).
                    We are proposing the RUC-recommended direct PE inputs for this code
                family without refinement.
                (59) Remote Interrogation Device Evaluation (CPT Codes 93297, 93298,
                93299, and HCPCS Code GTTT1)
                    When the RUC previously reviewed the CPT code 93299 at the January
                2017 RUC meeting, the specialty society submitted PE inputs for CPT
                code 93299 (Interrogation device evaluation(s), (remote) up to 30 days;
                implantable cardiovascular physiologic monitor system or subcutaneous
                cardiac rhythm monitor system, remote data acquisitions(s), receipt of
                transmissions and technician review, technical support and distribution
                of results); the PE Subcommittee and RUC accepted the society
                recommendations. In the CY 2018 PFS final rule (82 FR 53064), we did
                not finalize our proposal to establish national pricing for CPT code
                93299 and the code remained contractor-priced.
                    At the October 2018 RUC meeting, the RUC re-examined CPT code
                93299. CPT codes 93297 (Interrogation device evaluation(s), (remote) up
                to 30 days; implantable cardiovascular physiologic
                [[Page 40597]]
                monitor system, including analysis of 1 or more recorded physiologic
                cardiovascular data elements from all internal and external sensors,
                analysis, review(s) and report(s) by a physician or other qualified
                health care professional) and 93298 (Interrogation device
                evaluation(s), remote up to 30 days; subcutaneous cardiac rhythm
                monitor system, including analysis or recorded heart rhythm data,
                analysis, review(s) and report(s) by a physician or other qualified
                health care professional) were added to this family of services. These
                three codes were reviewed for practice expense only.
                    CPT codes 93297 and 93298 are work-only codes and CPT code 93299 is
                meant to serve as the catch-all for both 30-day remote monitoring
                services. The RUC is unclear why the code family was designed this way,
                noting it may have been a way to allow for the possibility that the
                technical work would be provided by vendors, but they noted that this
                is not how the service is currently provided. Stating that in the
                decade since these codes were created, it has become clear that
                implantable cardiovascular monitor (ICM) and implantable loop recorder
                (ILR) services are very different and the PE cannot be appropriately
                captured for both services in a single technical code. They noted that
                CPT codes 93297-93299 will be placed on the new technology/new services
                list and be re-reviewed by the RUC in 3 years to ensure correct
                calculation and utilization assumptions. It was noted in the RUC
                recommendations that the specialty society intended to submit a coding
                proposal to the CPT Editorial Panel to delete CPT code 93299, as it
                will no longer be necessary to have a separate code for PE if CPT codes
                93297 and 93298 are allocated direct PE in CY 2020.
                    In our review of these services, we note that the RUC
                recommendations did not provide a detailed description of the clinical
                labor tasks being performed or detailed information on the typical use
                of the supply and equipment used when furnishing these services. These
                details are important in order for us to review if the RUC-recommended
                PE inputs are appropriate to furnish these services. The RUC submitted
                PE inputs (which were not previously included) for the work-only CPT
                codes 93297 and 93298, but did not include details to substantiate
                these recommended PE inputs for any of the three codes in this family.
                    Additionally, we are concerned with the appropriateness of the
                RUC's reference code, CPT code 93296 (Interrogation device
                evaluation(s) (remote), up to 90 days; single, dual, or multiple lead
                pacemaker system, leadless pacemaker system, or implantable
                defibrillator system, remote data acquisition(s), receipt of
                transmissions and technician review, technical support and distribution
                of results). CPT code 93296 is for remote monitoring over a 90-day
                period, but was used as a reference to derive the RUC-recommended
                direct PE inputs for CPT codes 93297-93299, which are for remote
                monitoring over a 30-day period.
                    For the CY 2020 direct PE inputs, we are proposing to remove the
                clinical labor time for ``Perform procedure/service--not directly
                related to physician work time'' (CA021); to remove the requested
                quantity for the supply ``Paper, laser printing (each sheet)'' (SK057);
                and to refine the equipment times in accordance with our standard
                equipment time formulas for CPT codes 93297 and 93298.
                    Although we are not proposing to allocate direct PE inputs for CPT
                codes 93297 and 93298, we are seeking additional comment on the
                appropriateness of CPT code 93296 as the reference code, details on the
                clinical labor tasks, and more information on the typical use of the
                supply and equipment used to furnish these services. For example, it
                was unclear in the RUC recommendations how many patients are monitored
                concurrently. As an additional example, it was unclear in the RUC
                recommendations as to what tasks are involved when clinical staff
                engage with the patient throughout the month to perform education about
                the device and re-education protocols after the initial enrollment.
                    The CPT Editorial Panel is deleting CPT code 93299 for CY 2020. We
                note this differs from the RUC recommendations for this code from the
                October 2018 meeting, which stated that the specialty society intended
                to submit a coding proposal to the CPT Editorial Panel to delete CPT
                code 93299, as it would no longer be necessary to have a separate code
                for PE, if CPT codes 93297 and 93298 are allocated direct PE for CY
                2020. Given that we are proposing to not allocate direct PE inputs for
                CPT code 93297 and 93298 for CY 2020 and CPT code 93299 is being
                deleted for CY 2020, we are proposing to create a G-code to describe
                the services previously furnished under CPT code 93299. We are
                proposing to create HCPCS code GTTT1 (Interrogation device
                evaluation(s), (remote) up to 30 days; implantable cardiovascular
                physiologic monitor system, implantable loop recorder system, or
                subcutaneous cardiac rhythm monitor system, remote data acquisition(s),
                receipt of transmissions and technician review, technical support and
                distribution of results), to describe the services previously furnished
                under CPT code 93299, effective for CY 2020.
                (60) Duplex Scan Arterial Inflow-Venous Outflow (CPT Codes 93X00 and
                93X01)
                    In September 2018, the CPT Editorial Panel recommended replacing
                one HCPCS code (G0365) with two new codes to describe the duplex scan
                of arterial inflow and venous outflow for preoperative vessel
                assessment prior to creation of hemodialysis access for complete
                bilateral and unilateral study. We are proposing the RUC-recommended
                work RVU of 0.80 for CPT code 93X00 (Duplex scan of arterial inflow and
                venous outflow for preoperative vessel assessment prior to creation of
                hemodialysis access; complete bilateral study), as well as the RUC-
                recommended work RVU of 0.50 for CPT code 93X01 (Duplex scan of
                arterial inflow and venous outflow for preoperative vessel assessment
                prior to creation of hemodialysis access; complete unilateral study).
                    For the direct PE inputs, we are proposing to refine the clinical
                labor time for the ``Prepare room, equipment and supplies'' (CA013)
                activity from 4 minutes to 2 minutes for both codes in the family. Two
                minutes is the standard time for this clinical labor activity, and 2
                minutes is also the time assigned for this activity in the reference
                code, CPT code 93990 (Duplex scan of hemodialysis access (including
                arterial inflow, body of access and venous outflow)). There was no
                rationale provided in the recommended materials indicating why this
                additional clinical labor time would be typical for the procedures, and
                therefore, we are proposing to refine to the standard time of 2
                minutes. We are also proposing to adjust the equipment times to conform
                to this change in the clinical labor time.
                (61) Myocardial Strain Imaging (CPT Code 933X0)
                    The CPT Editorial Panel deleted one Category III code and created
                one new Category I add-on code CPT code 933X0 to describe the work of
                myocardial strain imaging performed in supplement to transthoracic
                echocardiography services. We are proposing the RUC-recommended work
                RVU of 0.24.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                933X0. However, we note that no rationale was given for the RUC-
                recommended 12 minutes of clinical labor time for the activity CA021
                [[Page 40598]]
                ``Perform procedure/service,'' and we are requesting comment on the
                appropriateness of this allocated time value.
                (62) Lung Function Test (CPT Code 94200)
                    The RUC recommended this service for survey because it appeared on
                a list of CMS/Other codes with Medicare utilization of 30,000 or more.
                According to the RUC, this service is typically reported with an E/M
                service and another pulmonary function test, and the RUC-recommended
                times would appropriately account for any overlap with other services.
                The RUC stated that the intraservice time involves reading and
                interpreting the test to determine if a significant interval change has
                occurred and then generating a report, which supports the 5 minutes of
                physician work indicated in the survey. The RUC did not agree with the
                specialty society that communication of the report required an
                additional 2 minutes of physician time over the postservice time
                included in the other services reported on the same day. The RUC
                reduced the postservice time from 2 minutes to 1 minute because the
                service requires minimal time to enter the results into the medical
                record and communicate the results to the patient and the referring
                physician. Based in part on these reductions in physician time, the RUC
                recommended a reduction in work RVU from the current value with a
                crosswalk to CPT code 95905 (Motor and/or sensory nerve conduction,
                using preconfigured electrode array(s), amplitude and latency/velocity
                study, each limb, includes F-wave study when performed, with
                interpretation and report).
                    For CPT code 94200 (Maximum breathing capacity, maximal voluntary
                ventilation), we are proposing the RUC-recommended work RVU of 0.05. A
                stakeholder stated that the RUC's recommended work RVU understates the
                costs inherent in performing this service, and that the survey 25th
                percentile value of 0.10 is more accurate for this service. While we
                are proposing the RUC-recommended 0.05, we are soliciting public
                comment on this stakeholder-recommended potential alternative value.
                    We are proposing the RUC-recommended direct PE inputs for CPT code
                94200 without refinement.
                (63) Long-Term EEG Monitoring (CPT Codes 95X01, 95X02, 95X03, 95X04,
                95X05, 95X06, 95X07, 95X08, 95X09, 95X10, 95X11, 95X12, 95X13, 95X14,
                95X15, 95X16, 95X17, 95X18, 95X19, 95X20, 95X21, 95X22, and 95X23)
                    In January 2017, the RUC identified CPT code 95951 via the high
                volume growth screen, which considers if the service has total Medicare
                utilization of 10,000 or more and if utilization has increased by at
                least 100 percent from 2009 through 2014. The RUC recommended that this
                service be referred to the CPT Editorial Panel for needed changes,
                including code deletions, revision of code descriptors, and the
                addition of new codes to this family. In May 2018, the CPT Editorial
                Panel approved the revision of one code, deletion of five codes, and
                addition of 23 new codes for reporting long-term EEG professional and
                technical services.
                    We are proposing the RUC-recommended work RVU for six of the
                professional component codes in this family. We are proposing a work
                RVU of 3.86 for CPT code 95X18 (Electroencephalogram, continuous
                recording, physician or other qualified health care professional review
                of recorded events, complete study; greater than 36 hours, up to 60
                hours of EEG recording, without video), a work RVU of 4.70 for CPT code
                95X19 (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, complete
                study; greater than 36 hours, up to 60 hours of EEG recording, with
                video), a work RVU of 4.75 for CPT code 95X20 (Electroencephalogram,
                continuous recording, physician or other qualified health care
                professional review of recorded events, complete study; greater than 60
                hours, up to 84 hours of EEG recording, without video), a work RVU of
                6.00 for CPT code 95X21 (Electroencephalogram, continuous recording,
                physician or other qualified health care professional review of
                recorded events, complete study; greater than 60 hours, up to 84 hours
                of EEG recording, with video), a work RVU of 5.40 for CPT code 95X22
                (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, complete
                study; greater than 84 hours of EEG recording, without video) and a
                work RVU of 7.58 for CPT code 95X23 (Electroencephalogram, continuous
                recording, physician or other qualified health care professional review
                of recorded events, complete study; greater than 84 hours of EEG
                recording, with video).
                    We are also proposing the RUC-recommended work RVU of 0.00 for the
                13 technical component codes in the family: CPT code 95X01
                (Electroencephalogram (EEG) continuous recording, with video when
                performed, set-up, patient education, and take down when performed,
                administered in-person by EEG technologist, minimum of 8 channels), CPT
                code 95X02 (Electroencephalogram (EEG) without video, review of data,
                technical description by EEG technologist, 2-12 hours; unmonitored),
                CPT code 95X03 (Electroencephalogram (EEG) without video, review of
                data, technical description by EEG technologist, 2-12 hours; with
                intermittent monitoring and maintenance), CPT code 95X04
                (Electroencephalogram (EEG) without video, review of data, technical
                description by EEG technologist, 2-12 hours; with continuous, real-time
                monitoring and maintenance), CPT code 95X05 (Electroencephalogram (EEG)
                without video, review of data, technical description by EEG
                technologist, each increment of 12-26 hours; unmonitored), CPT code
                95X06 (Electroencephalogram (EEG) without video, review of data,
                technical description by EEG technologist, each increment of 12-26
                hours; with intermittent monitoring and maintenance), CPT code 95X07
                (Electroencephalogram (EEG) without video, review of data, technical
                description by EEG technologist, each increment of 12-26 hours; with
                continuous, real-time monitoring and maintenance), CPT code 95X08
                (Electroencephalogram with video (VEEG), review of data, technical
                description by EEG technologist, 2-12 hours; unmonitored), CPT code
                95X09 (Electroencephalogram with video (VEEG), review of data,
                technical description by EEG technologist, 2-12 hours; with
                intermittent monitoring and maintenance), CPT code 95X10
                (Electroencephalogram with video (VEEG), review of data, technical
                description by EEG technologist, 2-12 hours; with continuous, real-time
                monitoring and maintenance), CPT code 95X11 (Electroencephalogram with
                video (VEEG), review of data, technical description by EEG
                technologist, each increment of 12-26 hours; unmonitored), CPT code
                95X12 (Electroencephalogram with video (VEEG), review of data,
                technical description by EEG technologist, each increment of 12-26
                hours; with intermittent monitoring and
                [[Page 40599]]
                maintenance), and CPT code 95X13 (Electroencephalogram with video
                (VEEG), review of data, technical description by EEG technologist, each
                increment of 12-26 hours; with continuous, real-time monitoring and
                maintenance).
                    We disagree with the RUC-recommended work RVU of 2.00 for CPT code
                95X14 (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, 2-12
                hours of EEG recording; without video) and we are proposing a work RVU
                of 1.85 based on a crosswalk to CPT code 93314 (Echocardiography,
                transesophageal, real-time with image documentation (2D) (with or
                without M-mode recording); image acquisition, interpretation and report
                only). CPT code 93314 is a recently-reviewed code with 2 additional
                minutes of intraservice time and 4 additional minutes of total time as
                compared to CPT code 95X14. When considering the work RVU for CPT code
                95X14, we looked to the second reference code chosen by the survey
                participants, CPT code 95957 (Digital analysis of electroencephalogram
                (EEG) (e.g., for epileptic spike analysis)). This code has 2 additional
                minutes of intraservice time and 9 additional minutes of total time as
                compared to CPT code 95X14, yet has a work RVU of 1.98, lower than the
                recommended work RVU of 2.00. These time values suggested that CPT code
                95X14 would be more accurately valued at a work RVU slightly below the
                1.98 of CPT code 95957. We also looked at the intraservice time ratio
                between CPT code 95X14 and some of its predecessor codes. The
                intraservice time ratio with CPT code 95953 (Monitoring for
                localization of cerebral seizure focus by computerized portable 16 or
                more channel EEG, electroencephalographic (EEG) recording and
                interpretation, each 24 hours, unattended) suggests a similar potential
                work RVU of 1.91 (28 minutes divided by 45 minutes times a work RVU of
                3.08). Based on this information, we are proposing a work RVU of 1.85
                for CPT code 95X14 based on the aforementioned crosswalk to CPT code
                93314.
                    We disagree with the RUC-recommended work RVU of 2.50 for CPT code
                95X15 (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, analysis
                of spike and seizure detection, interpretation, and report, 2-12 hours
                of EEG recording; with video (VEEG)) and we are proposing a work RVU of
                2.35. Although we disagree with the RUC-recommended work RVU, we concur
                that the relative difference in work between CPT codes 95X14 and 95X15
                is equivalent to the recommended interval of 0.50 RVUs. Therefore, we
                are proposing a work RVU of 2.35 for CPT code 95X15, based on the
                recommended interval of 0.50 additional RVUs above our proposed work
                RVU of 1.85 for CPT code 95X14. We are supporting this work RVU with a
                reference to CPT code 99310 (Subsequent nursing facility care, per day,
                for the evaluation and management of a patient, which requires at least
                2 of the 3 key components), which shares the same intraservice time of
                35 minutes and the identical work RVU of 2.35. CPT code 99310 is a
                lower intensity procedure but has increased total work time as compared
                to CPT code 95X15.
                    We disagree with the RUC-recommended work RVU of 3.00 for CPT code
                95X16 (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, analysis
                of spike and seizure detection, each increment of greater than 12
                hours, up to 26 hours of EEG recording, interpretation and report after
                each 24-hour period; without video) and we are proposing a work RVU of
                2.60 based on a crosswalk to CPT code 99219 (Initial observation care,
                per day, for the evaluation and management of a patient, which requires
                3 key components). CPT code 99219 shares the same intraservice time of
                40 minutes and has a slightly higher total time as compared to CPT code
                95X16. We also note that the observation care described by CPT code
                99219 shares some clinical similarities to the long term EEG monitoring
                described by CPT code 95X16, although we note as always that the nature
                of the PFS relative value system is such that all services are
                appropriately subject to comparisons to one another, and that codes do
                not need to share the same site of service, patient population, or
                utilization level to serve as an appropriate crosswalk.
                    In addition, we believe that the proposed crosswalk to CPT code
                99219 at a work RVU of 2.60 more accurately captures the intensity of
                CPT code 95X16. At the recommended work RVU of 3.00, the intensity of
                CPT code 95X16 is anomalously high in comparison to the rest of the
                family, higher than any of the other professional component codes. We
                have no reason to believe that the 24-hour EEG monitoring done without
                video as described in CPT code 95X16 would be notably more intense than
                the other codes in the same family. Furthermore, the recommendations
                for this code family specifically state that the codes that describe
                video EEG monitoring are more intense than the codes that describe non-
                video EEG monitoring. However, at the recommended work RVU for CPT code
                95X16, this non-video form of EEG monitoring had the highest intensity
                in the family. At our proposed work RVU of 2.60, the intensity of CPT
                code 95X16 is no longer anomalously high in comparison to the rest of
                the family, and also remains lower than the intensity of the 24 hour
                EEG monitoring with video procedure described by CPT code 95X17.
                    We disagree with the RUC-recommended work RVU of 3.86 for CPT code
                95X17 (Electroencephalogram, continuous recording, physician or other
                qualified health care professional review of recorded events, analysis
                of spike and seizure detection, each increment of greater than 12
                hours, up to 26 hours of EEG recording, interpretation and report after
                each 24-hour period; with video (VEEG)) and we are proposing a work RVU
                of 3.50 based on the survey 25th percentile value. The RUC-recommended
                work RVU of 3.86 was based on a crosswalk to CPT code 99223 (Initial
                hospital care, per day, for the evaluation and management of a patient,
                which requires 3 key components), a code that shares the same
                intraservice time of 55 minutes but has 15 additional minutes of total
                time as compared to CPT code 95X17, at 90 minutes as compared to 75
                minutes. We disagree with the use of this crosswalk, as the 15 minutes
                of additional total time in CPT code 99223 result in a higher work
                valuation that overstates the work RVU of CPT code 95X17. These 15
                additional minutes of preservice and postservice work time in the
                recommended crosswalk code have a calculated work RVU of 0.34 under the
                building block methodology; subtracting out this work RVU of 0.34 from
                the crosswalk code's work RVU of 3.86 results in an estimated work RVU
                of 3.52, which is nearly identical to the survey 25th percentile work
                RVU of 3.50. Similarly, if we were to calculate a total time ratio
                between CPT code 95X17 and the recommended crosswalk code 99223, it
                would produce a noticeably lower work RVU of 3.22 (75 minutes divided
                by 90 minutes times a work RVU of 3.86). Based on this rationale, we do
                not believe that it would serve the interests of relativity to propose
                a work RVU of 3.86 based on the recommended crosswalk.
                    Instead, we are proposing a work RVU of 3.50 for CPT code 95X17
                based on the
                [[Page 40600]]
                survey 25th percentile value. We note that among the predecessor codes
                for this family, CPT code 95956 (Monitoring for localization of
                cerebral seizure focus by cable or radio, 16 or more channel telemetry,
                electroencephalographic (EEG) recording and interpretation, each 24
                hours, attended by a technologist or nurse) has a higher intraservice
                time of 60 minutes and a higher total time of 105 minutes at a work RVU
                of 3.61. This prior valuation of CPT code 95956 does not support the
                RUC-recommended work RVU of 3.86 for CPT code 95X17, but does support
                the proposed work RVU of 3.50 at the slightly lower newly surveyed work
                times. We also note that at the recommended work RVU of 3.86, the
                intensity of CPT code 95X17 was anomalously high in comparison to the
                rest of the family, the second-highest intensity as compared to the
                other professional component codes. We have no reason to believe that
                the 24 hour EEG monitoring done with video as described in CPT code
                95X17 would be notably more intense than the other codes in the same
                family. At our proposed work RVU of 3.50, the intensity of CPT code
                95X17 is no longer anomalously high in comparison to the rest of the
                family, while still remaining slightly higher than the intensity of the
                24 hour EEG monitoring performed without video procedure described by
                CPT code 95X16.
                    For the direct PE inputs, we are proposing to make a series of
                refinements to the clinical labor times of CPT code 95X01. Many of the
                clinical labor times for this CPT code were derived using a survey
                process and were recommended to CMS at the survey median values. This
                was in contrast to the typical process for recommended direct PE
                inputs, where the inputs are usually based on either standard times or
                carried over from reference codes. We believe that when surveys are
                used to recommended direct PE inputs, we must apply a similar process
                of scrutiny to that used in assessing the work RVUs that are
                recommended based on a survey methodology. We have long expressed our
                concerns over the validity of the survey results used to produce work
                RVU recommendations, such as in the CY 2011 PFS final rule (75 FR
                73328), and we have noted that over the past decade the AMA RUC has
                increasingly chosen to recommend the survey 25th percentile work RVU
                over the survey median value, potentially responding to the same
                concerns that we have identified.
                    As a result, we believe that when assessing the survey of direct PE
                inputs used to produce many of the recommendations for CPT code 95X01,
                it would be more accurate to propose the survey 25th percentile direct
                PE inputs as opposed to the recommended survey median direct PE inputs.
                Therefore, we are proposing to refine the clinical labor time for the
                ``Provide education/obtain consent'' (CA011) activity from 13 minutes
                to 7 minutes and to refine the clinical labor time for the ``Review
                home care instructions, coordinate visits/prescriptions'' (CA035)
                activity from 10 minutes to 7 minutes. In both of these cases, the
                recommended clinical labor times based on the survey median values are
                more than double the standard time for these activities. Although we
                agree that additional clinical labor time would be required to carry
                out these activities for CPT code 95X01, we do not believe that the
                survey median times would be typical. We are proposing the survey 25th
                percentile times of 7 minutes for each activity as we believe that this
                time would be more typical for obtaining consent and reviewing home
                care instructions.
                    We are also proposing to refine the clinical labor time for the
                ``Complete pre-procedure phone calls and prescription'' (CA005)
                activity from 10 minutes to 3 minutes for CPT code 95X01. This is
                another situation where we are proposing the survey 25th percentile
                clinical labor time of 3 minutes instead of the survey median clinical
                labor time of 10 minutes. However, we also note that many of the tasks
                that fell under the CA005 activity code as described in the PE
                recommendations appear to constitute forms of indirect PE, such as
                collecting supplies for setup and loading equipment and supplies into
                vehicles. Collecting supplies and loading equipment are administrative
                tasks that are not individually allocable to a particular patient for a
                particular service, and therefore, constitute indirect PE under our
                methodology. Due to the fact that many of the tasks described under the
                CA005 activity code are forms of indirect PE, we believe that the RUC-
                recommended survey median clinical labor time of 10 minutes overstates
                the amount of direct clinical labor taking place. We believe that it is
                more accurate to propose the survey 25th percentile clinical labor time
                of 3 minutes for this activity code to reflect the non-administrative
                tasks performed by the clinical staff.
                    We are also proposing to refine the quantity of the non-sterile
                gloves (SB022) supply from 3 to 2 for CPT code 95X01. We note that the
                current reference code, CPT code 95953, uses 2 of these pairs of gloves
                and the survey also stated that 2 pairs of gloves were typical for the
                procedure. Although the recommended materials state that a pair of
                gloves is needed to set up the equipment, to take down the equipment,
                and a third is required for electrode changes, we do not agree that the
                use of a third pair of gloves would be typical given their usage in the
                reference code and in the responses from the survey.
                    We note that we are not proposing to refine many of the other
                clinical labor times for CPT code 95X01, which remain at the survey
                median clinical labor times. Due to the nature of the continuous
                recording EEG service taking place, we agree that the survey median
                clinical labor times of 12 minutes for the ``Prepare room, equipment
                and supplies'' (CA013) activity, 45 minutes for the ``Prepare, set-up
                and start IV, initial positioning and monitoring of patient'' (CA016)
                activity, and 22 minutes for the ``Clean room/equipment by clinical
                staff'' (CA024) activity would be typical for this procedure. We
                reiterate that we assess the direct PE inputs for each procedure
                individually based on our methodology of what would be reasonable and
                medically necessary for the typical patient.
                    For CPT codes 95X02-95X13, we are proposing to refine the clinical
                labor time for the ``Coordinate post-procedure services'' (CA038)
                activity from either 11 minutes to 5 minutes or from 22 minutes to 10
                minutes as appropriate for the CPT code in question. The recommended
                materials for these procedures state that the tasks taking place
                constitute ``Merge EEG and Video files (partially automated program),
                confirm transfer of data, delete from laptop/computer if necessary''.
                We believe that many of the tasks detailed here are administrative in
                nature, consisting of forms of data entry, and therefore, would be
                considered types of indirect PE. We note that when CPT code 95812
                (Electroencephalogram (EEG) extended monitoring; 41-60 minutes) was
                recently reviewed for CY 2017, we finalized the recommended clinical
                labor time of 2 minutes for ``Transfer data to reading station &
                archive data'', a task which we believe to be highly similar. Due to
                the longer duration of the procedures in CPT codes 95X02-95X13, we are
                proposing clinical labor times of 5 minutes and 10 minutes for the
                CA038 activity for these CPT codes. We are also refining the equipment
                time for the Technologist PACS workstation (ED050) to match the
                clinical labor time proposed for the CA038 activity.
                    For the four continuous monitoring procedures, CPT codes 95X04,
                95X07, 95X10, and 95X13, we are proposing to refine the equipment time
                for the
                [[Page 40601]]
                ambulatory EEG review station (EQ016) equipment. The recommended
                equipment time for the ambulatory EEG review station was equal to four
                times the ``Perform procedure/service'' (CA021) clinical labor time
                plus a small amount of extra prep time. We do not agree that it would
                be typical to assign this much equipment time, as it is our
                understanding that one ambulatory EEG review station can be hooked up
                to as many as four monitors at a time for continuous monitoring.
                Therefore, we do not believe that each monitor would require its own
                review station, and that the equipment time should not be equal to four
                times the clinical labor of the ``Perform procedure/service'' (CA021)
                activity. As a result, we are proposing to refine the ambulatory EEG
                review station equipment time from 510 minutes to 150 minutes for CPT
                code 95X04, from 1,480 minutes to 400 minutes for CPT code 95X07, from
                514 minutes to 154 minutes for CPT code 95X10, and from 1,495 minutes
                to 415 minutes for CPT code 95X13.
                    For the 10 professional component procedures, CPT codes 95X14-
                95X23, we are again proposing to refine the equipment time for the
                ambulatory EEG review station (EQ016) equipment. We believe that the
                use of the ambulatory EEG review station is analogous in these
                procedures to the use of the professional PACS workstation (ED053) in
                other procedures, and we are proposing to refine the equipment times
                for these 10 procedures to match our standard equipment time formula
                for the professional PACS workstation. Therefore, we are proposing an
                equipment time for the ambulatory EEG review station equal to half the
                preservice work time (rounded up) plus the intraservice work time for
                CPT codes 95X14 through 95X23. We believe that this equipment time is
                more accurate than the recommended equipment time, which was equal to
                the total work time of the procedures, as the work descriptors for CPT
                codes 95X14-95X23 make no mention of the ambulatory EEG review station
                in the postservice work period.
                    Finally, we are proposing to price the new ``EEG, digital,
                prolonged testing system with remote video, for patient home use''
                (EQ394) equipment at $26,410.95 based on an invoice submission. We did
                not use a second invoice submitted for the new equipment for pricing,
                as it contained a disaggregated list of equipment components and it was
                not clear if they represented the same equipment item as the first
                invoice.
                (64) Health and Behavioral Assessment and Intervention (CPT Codes
                961X0, 961X1, 961X2, 961X3, 961X4, 961X5, 961X6, 961X7, and 961X8)
                    The 2001 Health and Behavior Assessment and Intervention (HBAI) RUC
                valuations were based on the old CPT code 90801 (Psychiatric diagnostic
                interview evaluation), a 60-minute service. The RUC originally
                recommended the Health and Behavior Assessment and Intervention
                procedures to be 15-minute services, approximately equal to one-quarter
                of the value of CPT code 90801, which we finalized without refinements.
                While the RUC may have assumed that these services would typically be
                reported in four, 15-minute services per single patient encounter, in
                actual claims data, there is wide variation in the number of services
                provided and submitted. The RUC reconsidered their rationale for the
                original RUC-recommended valuation of this family of codes in September
                2018. The CPT Editorial Panel deleted the six existing Health and
                Behavior Assessment and Intervention procedure CPT codes and replaced
                them with nine new CPT codes.
                    The six deleted CPT codes include CPT code 96150 (Health and
                behavior assessment (e.g., health-focused clinical interview,
                behavioral observations, psychophysiological monitoring, health-
                oriented questionnaires), each 15 minutes face-to-face with the
                patient; initial assessment), CPT code 96151 (Health and behavior
                assessment (e.g., health-focused clinical interview, behavioral
                observations, psychophysiological monitoring, health-oriented
                questionnaires), each 15 minutes face-to-face with the patient; re-
                assessment), CPT code 96152 (Health and behavior intervention, each 15
                minutes, face-to-face; individual), CPT code 96153 (Health and behavior
                intervention, each 15 minutes, face-to-face; group (2 or more
                patients)), CPT code 96154 (Health and behavior intervention, each 15
                minutes, face-to-face; family (with the patient present)), and CPT code
                96155 (Health and behavior intervention, each 15 minutes, face-to-face;
                family (without the patient present)).
                    The nine replacement HBAI CPT codes include CPT code 961X0 (Health
                behavior assessment, including re-assessment (i.e., health-focused
                clinical interview, behavioral observations, clinical decision
                making)), CPT code 961X1 (Health behavior intervention, individual,
                face-to-face; initial 30 minutes), CPT code 961X2 (Health behavior
                intervention, individual, face-to-face; each additional 15 minutes
                (list separately in addition to code for primary service)), CPT code
                961X3 (Health behavior intervention, group (2 or more patients), face-
                to-face; initial 30 minutes), CPT code 961X4 (Health behavior
                intervention, group (2 or more patients), face-to-face; each additional
                15 minutes (list separately in addition to code for primary service)),
                CPT code 961X5 (Health behavior intervention, family (with the patient
                present), face-to-face; initial 30 minutes), CPT code 961X6 (Health
                behavior intervention, family (with the patient present), face-to-face
                each additional 15 minutes (list separately in addition to code for
                primary service)), CPT code 961X7 (Health behavior intervention, family
                (without the patient present), face-to-face; initial 30 minutes), CPT
                code 961X8 (Health behavior intervention, family (without the patient
                present), face-to-face; each additional 15 minutes (list separately in
                addition to code for primary service)).
                    We are proposing the RUC-recommended work RVUs for each of the
                codes in this family as follows.
                     For CPT code 961X0, we are proposing a work RVU of 2.10.
                     For CPT code 961X1, we are proposing a work RVU of 1.45.
                     For CPT code 961X2, we are proposing a work RVU of 0.50.
                     For CPT code 961X3, we are proposing a work RVU of 0.21.
                     For CPT code 961X4, we are proposing a work RVU of 0.10.
                     For CPT code 961X5, we are proposing a work RVU of 1.55.
                     For CPT code 961X6, we are proposing a work RVU of 0.55.
                     For CPT code 961X7, we are proposing a work RVU of 1.50
                (but this code will be non-covered by Medicare).
                     For CPT code 961X8, we are proposing a work RVU of 0.54
                (but this code will be non-covered by Medicare).
                    We are proposing the RUC-recommended direct PE inputs for all of
                the CPT codes in this family without refinement.
                (66) Cognitive Function Intervention (CPT Codes 971XX and 9XXX0)
                    In 2017, we received HCPAC recommendations for new CPT code 97127
                (Development of cognitive skills to improve attention, memory, problem
                solving, direct patient contact, 1) that described the services under
                CPT code 97532 (Development of cognitive skills to improve attention,
                memory, problem solving, direct patient contact, each 15 minutes). CPT
                code 97532 was scheduled to be deleted and replaced by the new untimed
                code CPT code 97127. In the CY 2018 PFS final rule (82 FR 53074 through
                53076); however, we
                [[Page 40602]]
                suggested that CPT code 97127 as an untimed/per day code did not
                appropriately account for the variable amounts of time spent with a
                patient depending upon the discipline and/or setting and assigned the
                code a procedure status of ``I'' (Invalid). In place of CPT code 97127,
                we established a new HCPCS G-code, G0515 (Development of cognitive
                skills to improve attention, memory, problem solving, direct patient
                contact, each 15 minutes), with a work RVU of 0.44. HCPCS code G0515
                maintained the descriptor and values from the former CPT code 97532.
                    In September 2018, the CPT Editorial Panel revised CPT code 971XX
                (Therapeutic interventions that focus on cognitive function (e.g.,
                attention, memory, reasoning, executive function, problem solving and/
                or pragmatic functioning) and compensatory strategies to manage the
                performance of an activity (e.g., managing time or schedules,
                initiating, organizing and sequencing tasks), direct (one-to-one)
                patient contact; initial 15 minutes) and created an add-on code, CPT
                code 9XXX0 (Therapeutic interventions that focus on cognitive function
                (e.g., attention, memory, reasoning, executive function, problem
                solving and/or pragmatic functioning) and compensatory strategies to
                manage the performance of an activity (e.g., managing time or
                schedules, initiating, organizing and sequencing tasks), direct (one-
                to-one) patient contact; each additional 15 minutes (list separately in
                addition to code for primary procedure)).
                    We are proposing the RUC-recommended work RVUs of 0.50 for CPT code
                971XX and 0.48 for CPT code 9XXX0. We are proposing the RUC-recommended
                direct PE inputs for all codes in the family. We are also proposing to
                designate CPT codes 971XX and 9XXX0 as sometime therapy codes because
                the services might be appropriately furnished by therapists under the
                outpatient therapy services benefit (includes physical therapy,
                occupational therapy, or speech-language pathology) or outside the
                therapy benefit by physicians, NPPs, and psychologists.
                (67) Open Wound Debridement (CPT Codes 97597 and 97598)
                    CPT code 97598 (Debridement (e.g., high pressure waterjet with/
                without suction, sharp selective debridement with scissors, scalpel and
                forceps), open wound, (e.g., fibrin, devitalized epidermis and/or
                dermis, exudate, debris, biofilm), including topical application(s),
                wound assessment, use of a whirlpool, when performed and instruction(s)
                for ongoing care, per session, total wound(s) surface area; each
                additional 20 sq cm, or part thereof) was identified by the RUC on a
                list of services that were originally surveyed by one specialty but are
                now typically performed by a different specialty. It was reviewed along
                CPT code 97597 (Debridement (e.g., high pressure waterjet with/without
                suction, sharp selective debridement with scissors, scalpel and
                forceps), open wound, (e.g., fibrin, devitalized epidermis and/or
                dermis, exudate, debris, biofilm), including topical application(s),
                wound assessment, use of a whirlpool, when performed and instruction(s)
                for ongoing care, per session, total wound(s) surface area; first 20 sq
                cm or less) at the October 2018 RUC meeting.
                    We disagree with the RUC-recommended work RVU of 0.88 for CPT code
                97597 and we are proposing a work RVU of 0.77 based on a crosswalk to
                CPT code 27369 (Injection procedure for contrast knee arthrography or
                contrast enhanced CT/MRI knee arthrography). CPT code 27369 is a
                recently-reviewed code with the same intraservice time of 15 minutes
                and a total time of 28 minutes, one minute fewer than CPT code 97597.
                In reviewing this code, we noted that the recommended intraservice time
                is increasing from 14 minutes to 15 minutes (7 percent), and the
                recommended total time is increasing from 24 minutes to 29 minutes (21
                percent); however, the RUC-recommended work RVU is increasing from 0.51
                to 0.88, which is an increase of 73 percent. Although we did not imply
                that the decrease in time as reflected in survey values must equate to
                a one-to-one or linear increase in the valuation of work RVUs, we
                believe that since the two components of work are time and intensity,
                modest increases in time should be appropriately reflected with a
                commensurate increase the work RVUs. In the case of CPT code 97597, we
                believed that it is more accurate to propose a work RVU of 0.77 based
                on a crosswalk to CPT code 27369 to account for these modest increases
                in the surveyed work time. We also note that even at the proposed work
                RVU of 0.77 the intensity of this procedure as measured by IWPUT is
                increasing by more than 50 percent over the current value.
                    We are proposing the RUC-recommended work RVU of 0.50 for CPT code
                97598. We are also proposing the RUC-recommended direct PE inputs for
                all codes in the family.
                (68) Negative Pressure Wound Therapy (CPT Codes 97607 and 97608)
                    In the CY 2013 final rule with comment period, we created two HCPCS
                codes to provide a payment mechanism for negative pressure wound
                therapy services furnished to beneficiaries using equipment that is not
                paid for as durable medical equipment: G0456 (Negative pressure wound
                therapy, (for example, vacuum assisted drainage collection) using a
                mechanically powered device, not durable medical equipment, including
                provision of cartridge and dressing(s), topical application(s), wound
                assessment, and instructions for ongoing care, per session; total
                wound(s) surface area less than or equal to 50 square centimeters) and
                G0457 (Negative pressure wound therapy, (for example, vacuum assisted
                drainage collection) using a mechanically-powered device, not durable
                medical equipment, including provision of cartridge and dressing(s),
                topical application(s), wound assessment, and instructions for ongoing
                care, per session; total wound(s) surface area greater than 50 sq. cm).
                For CY 2015, the CPT Editorial Panel created CPT codes 97607 (Negative
                pressure wound therapy, (e.g., vacuum assisted drainage collection),
                utilizing disposable, non-durable medical equipment including provision
                of exudate) and 97608 (Negative pressure wound therapy, (e.g., vacuum
                assisted drainage collection), utilizing disposable, non-durable
                medical equipment including provision of exudate) to describe negative
                pressure wound therapy with the use of a disposable system. In
                addition, CPT codes 97605 (Negative pressure wound therapy (e.g.,
                vacuum assisted drainage collection), utilizing durable medical
                equipment (DME), including topical application(s), wound assessment,
                and instruction(s) for ongoing care, per session; total wound(s)
                surface area less than or equal to 50 square centimeters) and 97606
                (Negative pressure wound therapy (e.g., vacuum assisted drainage
                collection), utilizing durable medical equipment (DME), including
                topical application(s), wound assessment, and instruction(s) for
                ongoing care, per session; total wound(s) surface area greater than 50
                square centimeters) were revised to specify the use of durable medical
                equipment. Based upon the revised coding scheme for negative pressure
                wound therapy, we deleted the G-codes. Due to concerns that we had with
                these services, we contractor priced CPT codes 97607 and 97608
                beginning in CY 2015 (79 FR 67670). In the CY 2016 Final Rule (80 FR
                71005),
                [[Page 40603]]
                in response to comment expressing disappointment with CMS' decision to
                contractor price these codes, we noted that there were obstacles to
                developing accurate payment rates for these services within the PE RVU
                methodology, including the indirect PE allocation for the typical
                practitioners who furnish these services and the diversity of the
                products used in furnishing these services.
                    We have received repeated requests from stakeholders, including in
                comment received in response to the CY 2019 PFS final rule, to assign
                an active status to these codes, meaning we would assign rates to the
                codes rather than allowing them to be contractor priced. In that rule,
                (83 FR 59473), we noted that we received a request that CMS should
                assign direct cost inputs and PE RVUs to CPT codes 97607 and 97608, and
                we indicated that we would take this feedback from commenters under
                consideration for future rulemaking.
                    In response to stakeholder feedback, we evaluated the codes and
                determined there was adequate volume to assign an active status. We are
                proposing to assign an active status to CPT codes 97607 and 97608 and
                we are proposing the work RVUs as recommended by the RUC that we
                received for CY 2015 when the CPT Editorial Panel created these codes.
                Thus, we are proposing a work RVU of 0.41 for CPT code 97607 and a work
                RVU of 0.46 for CPT code 97608. Similarly, we are proposing the RUC-
                recommended direct PE inputs originally for CY 2015 with the following
                refinement: For the clinical labor activity ``check dressings & wound/
                home care instructions/coordinate office visits/prescriptions,'' we are
                refining the clinical labor time to the standard 2 minutes for this
                task. In addition, the direct inputs for these codes include the new
                supply item, ``kit, negative pressure wound therapy, disposable.'' A
                search of publicly available commercial pricing data indicates that a
                unit price of approximately $100 is appropriate, and therefore, we are
                proposing this price for this supply item. If more accurate invoices
                are available, we are soliciting such invoices to more accurately price
                it.
                (69) Ultrasonic Wound Assessment (CPT Code 97610)
                    In 2005, the AMA RUC began the process of flagging services that
                represent new technology or new services as they were presented to the
                Committee. CPT code 97610 (Low frequency, non-contact, non-thermal
                ultrasound, including topical application(s), when performed, wound
                assessment, and instruction(s) for ongoing care, per day) was flagged
                for CPT 2015 and reviewed at the October 2018 RAW meeting. The
                Workgroup indicated that the utilization is continuing to increase for
                this service, and recommended that it be resurveyed for physician work
                and practice expense for the January 2019 RUC meeting.
                    We are proposing the RUC-recommend work 0.40 for CPT code 97610. We
                are also proposing the RUC-recommended direct PE inputs for CPT code
                97610.
                (70) Online Digital Evaluation Service (e-Visit) (CPT Codes 98X00,
                98X01, and 98X02)
                    In September 2018, the CPT Editorial Panel deleted two codes and
                replaced them with six new non-face-to-face codes to describe patient-
                initiated digital communications that require a clinical decision that
                otherwise typically would have been provided in the office. The HCPAC
                reviewed and made recommendations for CPT code 98X00 (Qualified
                nonphysician healthcare professional online digital evaluation and
                management service, for an established patient, for up to seven days,
                cumulative time during the 7 days; 5-10 minutes), CPT code 98X01
                (Qualified nonphysician healthcare professional online digital
                evaluation and management service, for an established patient, for up
                to seven days, cumulative time during the 7 days; 11-20 minutes), and
                CPT code 98X02 (Qualified nonphysician qualified healthcare
                professional online digital evaluation and management service, for an
                established patient, for up to seven days, cumulative time during the 7
                days; 21 or more minutes). CPT codes 9X0X1-9X0X3 are for practitioners
                who can independently bill E/M services while CPT codes 98X00-98X02 are
                for practitioners who cannot independently bill E/M services.
                    The statutory requirements that govern the Medicare benefit are
                specific regarding which practitioners may bill for E/M services. As
                such, when codes are established that describe E/M services that fall
                outside the Medicare benefit category of the practitioners who may bill
                for that service, we have typically created parallel HCPCS G-codes with
                descriptors that refer to the performance of an ``assessment'' rather
                than an ``evaluation''. We acknowledge that there are qualified non-
                physician health care professionals who will likely perform these
                services. Therefore, for CY 2020, we are proposing separate payment for
                online digital assessments via three HCPCS G-codes that mirror the RUC
                recommendations for CPT codes 98X00-98X02. The proposed HCPCS G codes
                and descriptors are as follows:
                     HCPCS code GNPP1 (Qualified nonphysician healthcare
                professional online assessment, for an established patient, for up to
                seven days, cumulative time during the 7 days; 5-10 minutes);
                     HCPCS code GNPP2 (Qualified nonphysician healthcare
                professional online assessment service, for an established patient, for
                up to seven days, cumulative time during the 7 days; 11-20 minutes);
                and
                     HCPCS code GNPP3 (Qualified nonphysician qualified
                healthcare professional assessment service, for an established patient,
                for up to seven days, cumulative time during the 7 days; 21 or more
                minutes).
                    For CY 2020, we are proposing a work RVU of 0.25 for CPT code
                GNPP1, which reflects the RUC-recommended work RVU for CPT code 98X00.
                For HCPCS codes GNPP2 and GNPP3, we believe that the 25th percentile
                work RVU associated with CPT codes 98X01 and 98X02 respectively, better
                reflects the intensity of performing these services, as well as the
                methodology used to value the other codes in the family, all of which
                use the 25th percentile work RVU. Therefore, we are proposing a work
                RVU of 0.44 for HCPCS code GNPP1 and a work RVU of 0.69 for HCPCS code
                GNPP2.
                    We are proposing the direct PE inputs associated with CPT codes
                98X00, 98X01, and 98X02 for GNPP1, GNPP2, and GNPP3 respectively.
                (71) Emergency Department Visits (CPT Codes 99281, 99282, 99283, 99284,
                and 99285)
                    In the CY 2018 PFS final rule, we finalized a proposal to nominate
                CPT codes 99281-99285 as potentially misvalued based on information
                suggesting that the work RVUs for emergency department visits may not
                appropriately reflect the full resources involved in furnishing these
                services (FR 82 53018.) These five codes were surveyed and reviewed for
                the April 2018 RUC meeting. For CY 2020 we are proposing the RUC-
                recommended work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93
                for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60
                for 99284, and a work RVU of 3.80 for CPT code 99285.
                    The RUC did not recommend and we are not proposing any direct PE
                inputs for the codes in this family.
                [[Page 40604]]
                (72) Self-Measured Blood Pressure Monitoring (CPT Codes 99X01, 99X02,
                93784, 93786, 93788, and 93790)
                    In September 2018, the CPT Editorial Panel created two new codes
                and revised four other codes to describe self-measured blood pressure
                monitoring services and to differentiate self-measured blood pressuring
                monitoring services from ambulatory blood pressure monitoring services.
                The first of the two new codes that describe self-measured blood
                pressure monitoring is CPT code 99X01 (Self-measured blood pressure
                using a device validated for clinical accuracy; patient education/
                training and device calibration) and is a PE only code. The second code
                is 99X02 (Self-measured blood pressure using a device validated for
                clinical accuracy; separate self-measurements of two readings, one
                minute apart, twice daily over a 30-day period (minimum of 12
                readings), collection of data reported by the patient and/or caregiver
                to the physician or other qualified health care professional, with
                report of average systolic and diastolic pressures and subsequent
                communication of a treatment plan to the patient).
                    The remaining four codes, which monitor ambulatory blood pressure