Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program

 
CONTENT

Federal Register, Volume 83 Issue 145 (Friday, July 27, 2018)

Federal Register Volume 83, Number 145 (Friday, July 27, 2018)

Proposed Rules

Pages 35704-36368

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-14985

Page 35703

Vol. 83

Friday,

No. 145

July 27, 2018

Part II

Book 2 of 2 Books

Pages 35703-36398

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Parts 405, 410, 411, et al.

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program; Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, and 495

CMS-1693-P

RIN 0938-AT31

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies 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.

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 10, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-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-1693-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-1693-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT: Jamie Hermansen, (410) 786-2064, for any physician payment issues not identified below.

Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-

1804, for issues related to evaluation and management (E/M) payment, communication technology-based services and telehealth services.

Isadora Gil, (410) 786-4532, for issues related to payment rates for nonexcepted items and services furnished by nonexcepted off-

campus provider-based departments of a hospital, and work relative value units (RVUs).

Ann Marshall, (410) 786-3059, for issues related to E/M documentation guidelines.

Geri Mondowney, (410) 786-1172, or Donta Henson, (410) 786-1947, for issues related to geographic price cost indices (GPCIs).

Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-

4735, for issues related to malpractice RVUs.

Patrick Sartini, (410) 786-9252, for issues related to radiologist assistants.

Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, impacts, and conversion factor.

Pamela West, (410) 786-2302, for issues related to therapy services.

Edmund Kasaitis, (410) 786-0477, for issues related to reduction of wholesale acquisition cost (WAC)-based payment.

Sarah Harding, (410) 786-4001, or Craig Dobyski, (410) 786-4584, for issues related to aggregate reporting of applicable information for clinical laboratory fee schedule.

Amy Gruber, (410) 786-1542, or Glenn McGuirk, (410) 786-5723, for issues related to the ambulance fee schedule.

Corinne Axelrod, (410) 786-5620, for issues related to care management services and communication technology-based services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, for issues related to appropriate use criteria for advanced diagnostic imaging services.

David Koppel, (214) 767-4403, for issues related to Medicaid Promoting Interoperability Program.

Fiona Larbi, (410) 786-7224, for issues related to the Medicare Shared Savings Program Quality Measures.

Matthew Edgar, (410) 786-0698, for issues related to the physician self-referral law.

Molly MacHarris, (410) 786-4461, for inquiries related to Merit-

based Incentive Payment System (MIPS).

Benjamin Chin, (410) 786-0679, for inquiries related to Alternative Payment Models (APMs).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Provisions of the Proposed Rule for PFS

  1. Background

  2. Determination of Practice Expense (PE) Relative Value Units (RVUs)

  3. Determination of Malpractice Relative Value Units (RVUs)

  4. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services

  5. Potentially Misvalued Services Under the PFS

  6. Radiologist Assistants

  7. Payment Rates Under the Medicare PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital

  8. Valuation of Specific Codes

    I. Evaluation & Management (E/M) Visits

  9. Teaching Physician Documentation Requirements for Evaluation and Management Services

  10. Solicitation of Public Comments on the Low Expenditure Threshold Component of the Applicable Laboratory Definition Under the Medicare Clinical Laboratory Fee Schedule (CLFS)

    L. GPCI Comment Solicitation

  11. Therapy Services

  12. Part B Drugs: Application of an Add-On Percentage for Certain Wholesale Acquisition Cost (WAC)-Based Payments

    III. Other Provisions of the Proposed Rule

  13. Clinical Laboratory Fee Schedule

  14. Proposed Changes to the Regulations Associated With the Ambulance Fee Schedule

  15. Payment for Care Management Services and Communication Technology-Based Services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

  16. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

  17. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs)

  18. Medicare Shared Savings Program Quality Measures

  19. Physician Self-Referral Law

  20. CY 2019 Updates to the Quality Payment Program

    IV. Requests for Information

  21. Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange Through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers

  22. Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information

    V. Collection of Information Requirements

    VI. Response to Comments

    VII. Regulatory Impact Analysis

    Regulations Text

    Appendix 1: Proposed MIPS Quality Measures

    Appendix 2: Improvement Activities

    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-

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    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 2019 PFS Proposed Rule, refer to item CMS-1693-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 2017 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

  23. 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 (Pub. L. 115-123, enacted on February 9, 2018), related to Medicare Part B payment, applicable to services furnished in CY 2019. 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 2019 for the PFS, and other Medicare Part B payment policies, 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 includes discussions and proposals regarding:

    Potentially Misvalued Codes.

    Communication Technology-Based Services.

    Valuation of New, Revised, and Misvalued Codes.

    Payment Rates under the PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital.

    E/M Visits.

    Therapy Services.

    Clinical Laboratory Fee Schedule.

    Ambulance Fee Schedule--Provisions in the Bipartisan Budget Act of 2018.

    Appropriate Use Criteria for Advanced Diagnostic Imaging Services.

    Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs).

    Medicare Shared Savings Program Quality Measures.

    Physician Self-Referral Law.

    CY 2019 Updates to the Quality Payment Program.

    Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers.

    Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information.

    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 VII. of this proposed rule.

    II. Provisions of the Proposed Rule for the PFS

  24. 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 on November 25, 1991 (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 Relative Values

    1. Work RVUs

      The work RVUs established for the initial fee schedule, which was 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

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      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.

    2. 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) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA 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 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 facility resources 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.

    3. Malpractice RVUs

      Section 4505(f) of the BBA 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.

    4. 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.

      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.

    5. Application of Budget Neutrality to Adjustments of RVUs

      As described in section VII. of this proposed rule, 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

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      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.

  25. Determination of Practice Expense (PE) Relative Value Units (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

    1. 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 Five-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).

    2. 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 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 2019 PFS Proposed Rule PE/HR'' on the CMS website under downloads for the CY

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      2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      For CY 2019, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2017. These specialties are Hospitalists and Advanced Heart Failure and Transplant Cardiology. 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:

      Hospitalists from Emergency Medicine.

      Advanced Heart Failure and Transplant Cardiology from Cardiology.

      The proposal is reflected in the ``CY 2019 PFS Proposed Rule PE/

      HR'' file available on the CMS website under the supporting data files for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    3. 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 to 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 (see section II.B.2.b of this proposed rule). 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 incorporated 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 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 2019 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.

      Page 35709

      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 proposed 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 proposal 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 proposal to apply these service-level overrides for both PE and MP, rather than one or the other category.

      For CY 2019, we are proposing to add 28 additional codes that we have identified as low volume services to the list of codes for which we assign the expected specialty. Based on our own medical review and input from the RUC and from specialty societies, we are proposing to assign the expected specialty for each code as indicated in Table 1. For each of these codes, only the professional component (reported with the -26 modifier) is nationally priced. The global and technical components are priced by the Medicare Administrative Contractors (MACs) which establish RVUs and payment amounts for these services. The list of codes that we are proposing to add is displayed in Table 1.

      Table 1--New Additions to Expected Specialty List for Low Volume Services

      ----------------------------------------------------------------------------------------------------------------

      2017

      CPT code Mod Short descriptor Expected specialty Utilization

      ----------------------------------------------------------------------------------------------------------------

      70557........................ 26 Mri brain w/o dye........... Diagnostic Radiology... 126

      70558........................ 26 Mri brain w/dye............. Diagnostic Radiology... 32

      74235........................ 26 Remove esophagus obstruction Gastroenterology....... 10

      74301........................ 26 X-rays at surgery add-on.... Diagnostic Radiology... 73

      74355........................ 26 X-ray guide intestinal tube. Diagnostic Radiology... 11

      74445........................ 26 X-ray exam of penis......... Urology................ 26

      74742........................ 26 X-ray fallopian tube........ Diagnostic Radiology... 5

      74775........................ 26 X-ray exam of perineum...... Diagnostic Radiology... 80

      75801........................ 26 Lymph vessel x-ray arm/leg.. Diagnostic Radiology... 114

      75803........................ 26 Lymph vessel x-ray arms/leg. Diagnostic Radiology... 41

      75805........................ 26 Lymph vessel x-ray trunk.... Diagnostic Radiology... 50

      75810........................ 26 Vein x-ray spleen/liver..... Diagnostic Radiology... 46

      76941........................ 26 Echo guide for transfusion.. Obstetrics/Gynecology.. 15

      76945........................ 26 Echo guide villus sampling.. Obstetrics/Gynecology.. 31

      76975........................ 26 Gi endoscopic ultrasound.... Gastroenterology....... 49

      78282........................ 26 Gi protein loss exam........ Diagnostic Radiology... 8

      79300........................ 26 Nuclr rx interstit colloid.. Diagnostic Radiology... 2

      86327........................ 26 Immunoelectrophoresis assay. Pathology.............. 24

      87164........................ 26 Dark field examination...... Pathology.............. 30

      88371........................ 26 Protein western blot tissue. Pathology.............. 2

      93532........................ 26 R & l heart cath congenital. Cardiology............. 28

      93533........................ 26 R & l heart cath congenital. Cardiology............. 36

      93561........................ 26 Cardiac output measurement.. Cardiology............. 28

      93562........................ 26 Card output measure subsq... Cardiology............. 38

      93616........................ 26 Esophageal recording........ Cardiology............. 38

      93624........................ 26 Electrophysiologic study.... Cardiology............. 51

      95966........................ 26 Meg evoked single........... Neurology.............. 72

      95967........................ 26 Meg evoked each addl........ Neurology.............. 61

      ----------------------------------------------------------------------------------------------------------------

      Page 35710

      The complete list of expected specialty assignments for individual low volume services, including the proposed assignments for the codes identified in Table 1, is available on our website under downloads for the CY 2019 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 final 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 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 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.

      Page 35711

      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

      prosthetistdashorthotist.

      54........................... Medical supply company not included in

      51, 52, or 53.

      55........................... Individual certified orthotist.

      56........................... Individual certified prosthetist.

      57........................... Individual certified

      prosthetistdashorthotist.

      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.

      B2........................... Pedorthic personnel.

      B3........................... Medical supply company with pedorthic

      personnel.

      ------------------------------------------------------------------------

      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).

      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

      ----------------------------------------------------------------------------------------------------------------

      Modifier Description Volume adjustment Time adjustment

      ----------------------------------------------------------------------------------------------------------------

      80, 81, 82......................... Assistant at Surgery.... 16%..................... Intraoperative portion.

      AS................................. Assistant at Surgery-- 14% (85% * 16%)......... Intraoperative portion.

      Physician Assistant.

      50 or LT and RT.................... Bilateral Surgery....... 150%.................... 150% of work time.

      51................................. Multiple Procedure...... 50%..................... Intraoperative portion.

      52................................. Reduced Services........ 50%..................... 50%.

      53................................. Discontinued Procedure.. 50%..................... 50%.

      54................................. Intraoperative Care only Preoperative + Preoperative +

      Intraoperative Intraoperative

      Percentages on the portion.

      payment files used by

      Medicare contractors to

      process Medicare claims.

      55................................. Postoperative Care only. Postoperative Percentage Postoperative portion.

      on the payment files

      used by Medicare

      contractors to process

      Medicare claims.

      Page 35712

      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)caret 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 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 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 illustrates an alternative rate.

      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 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 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 2019. The interest rates are listed in Table 4.

      Table 4--SBA Maximum Interest Rates

      ------------------------------------------------------------------------

      Interest

      Price Useful life rate (%)

      ------------------------------------------------------------------------

      $50K............................... $50K............................... 7+ Years............... 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 2019 direct PE input database, which is available on the CMS website under downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    4. 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

      Page 35713

      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 proposal 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 proposal 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.

      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.

      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 for CY 2018, to facilitate rulemaking for CY 2019, 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 cross-walked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      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. These RUC-reviewed codes do not currently have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets.

      As a result, we are proposing 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. If we had received RUC recommendations for codes that currently include clinical labor time for the ``Confirm order, protocol exam'' clinical labor task, we would have left the recommended clinical labor times unchanged, but there were no such codes reviewed for CY 2019. We 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 used in the calculation of PE RVUs.

    5. 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

      Page 35714

      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 proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have 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. But, 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 CY 2018 (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 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 is to create an administratively simple scheme that will be easier to maintain and help to reduce administrative burden. We look forward to receiving detailed recommendations from expert stakeholders regarding the scope equipment items that would be typically required for each scope category, as well as the proper pricing for each scope.

      (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, and indicated our intention to address these changes in CY 2019 to incorporate feedback from expert stakeholders.

      (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 2019

      We understand that the RUC has convened a Scope Equipment Reorganization Workgroup that will be incorporating 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 are proposing to delay proposals for any further changes to scope equipment until CY 2020 so that we can incorporate the feedback from the aforementioned workgroup. However,

      Page 35715

      we are proposing to update the price of the scope video system (ES031) from its current price of $33,391 to a price of $36,306 to reflect the addition of the LED light and miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories, as we explained in detail in the CY 2018 PFS final rule (82 FR 52992 through 52993). We are also proposing to update the name of the ES031 equipment item from ``video system, endoscopy (processor, digital capture, monitor, printer, cart)'' 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.

    6. Balloon Sinus Surgery Kit (SA106) Comment Solicitation

      Several stakeholders contacted CMS with regard to the use of the kit, sinus surgery, balloon (maxillary, frontal, or sphenoid) (SA106) supply in CPT codes 31295 (Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation)), transnasal or via canine fossa), 31296 (Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation)), and 31297 (Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation)). The stakeholders stated that the price of the SA106 supply (currently $2,599.86) had decreased significantly since it was priced through rulemaking for CY 2011 (75 FR 73351 through 75532), and that the Medicare payment for these three CPT codes using the supply no longer seemed to be in proportion to what the kits cost. They also indicated that the same catheter could be used to treat multiple sinuses rather than being a disposable one-time use supply. The stakeholders stated that marketing firms and sales representatives are advertising these CPT codes as a method for generating additional profits due to the payment for the procedures exceeding the resources typically needed to furnish the services, and requested that CMS investigate the use of the SA106 supply in these codes.

      We appreciate the information supplied by the stakeholders regarding the use of the balloon sinus surgery kit. When CPT codes 31295-31297 were initially reviewed during the CY 2011 and CY 2012 PFS rulemaking cycles (75 FR 73251, and 76 FR 73184 through 73186, respectively), we expressed our reservations about the pricing and the typical quantity of this supply item used in furnishing these services. The RUC recommended for the CY 2012 rulemaking cycle that CMS remove the balloon sinus surgery kit from each of these codes and implement separately billable alpha-numeric HCPCS codes to allow practitioners to be paid the cost of the disposable kits per patient encounter instead of per CPT code. We stated at the time, and we continue to believe, that this option presents a series of potential problems that we have addressed previously in the context of the broader challenges regarding our ability to price high cost disposable supply items. (For a discussion of this issue, we direct the reader to our discussion in the CY 2011 PFS final rule with comment period (75 FR 73251)). We stated at the time that since the balloon sinus surgery kits can be used when furnishing more than one service to the same beneficiary on the same day, we believed that it would be appropriate to include 0.5 balloon sinus surgery kits for each of the three codes, and we have maintained this 0.5 supply quantity when CPT codes 31295-31297 were recently reviewed again in CY 2018.

      In light of the additional information supplied by the stakeholders, we are soliciting comments on two aspects of the use of the balloon sinus surgery kit (SA106) supply. First, we are soliciting comments on whether the 0.5 supply quantity of the balloon sinus surgery kit in CPT codes 31295-31297 would be typical for these procedures. We are concerned that the same kit can be used when furnishing more than one service to the same beneficiary on the same day, and that even the 0.5 supply quantity may be overstating the resources typically needed to furnish each service. Second, we are soliciting comments on the pricing of the balloon sinus surgery kit, given that we have received letters stating that the price has decreased since the initial pricing in the CY 2011 final rule. See Table 5 for the current component pricing of the balloon sinus surgery kit.

      Table 5--Balloon Sinus Surgery Kit (SA106) Price

      ----------------------------------------------------------------------------------------------------------------

      Supply components Quantity Unit Price

      ----------------------------------------------------------------------------------------------------------------

      kit, sinus surgery, balloon (maxillary, .............. kit............................... $2599.86

      frontal, or sphenoid).

      Sinus Guide Catheter........................ 1 item.............................. 444.00

      Sinus Balloon Catheter...................... 1 item.............................. 820.80

      Sinus Illumination System (100 cm lighted 1 item.............................. 454.80

      guidewire).

      Light Guide Cable (8 ft).................... 1 item.............................. 514.80

      ACMI/Stryker Adaptor........................ 1 item.............................. 42.00

      Sinus Guide Catheter Handle................. 1 item.............................. 66.00

      Sinus Irrigation Catheter (22 cm)........... 1 item.............................. 150.00

      Sinus Balloon Catheter Inflation Device..... 1 item.............................. 89.46

      Extension Tubing (High Pressure) (20 in).... 1 item.............................. 18.00

      ----------------------------------------------------------------------------------------------------------------

      We are interested in any information regarding possible changes in the pricing for this kit or its individual components since the initial pricing we adopted in CY 2011.

    7. Technical Corrections to Direct PE Input Database and Supporting Files

      Subsequent to the publication of the CY 2018 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We are proposing to correct these inconsistencies as described in this proposed rule and reflected in the CY 2019 proposed direct PE input database displayed on the CMS website under downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      For CY 2019, we are proposing to address the following inconsistencies:

      The RUC alerted us that there are 165 CPT codes billed with an office E/M code more than 50 percent of the time in the nonfacility setting that have more minimum multi-specialty visit supply packs (SA048) than post-operative visits included in the code's global period. This indicates that either the inclusion of office E/M services was not accounted for in the code's global period when these codes were initially reviewed by the PE Subcommittee, or

      Page 35716

      that the PE Subcommittee initially approved a minimum multi-specialty visit supply pack for these codes without considering the resulting overlap of supplies between SA048 and the E/M supply pack (SA047). The RUC regarded these overlapping supply packs as a duplication, due to the fact that the quantity of the SA048 supply exceeded the number of postoperative visits, and requested that CMS remove the appropriate number of supply item SA048 from 165 codes. After reviewing the quantity of the SA048 supply pack included for the codes in question, we are proposing to refine the quantity of minimum multi-specialty visit packs as displayed in Table 6.

      Table 6--Proposed Refinements--Minimum Multispecialty Visit Pack (SA048)

      ----------------------------------------------------------------------------------------------------------------

      Proposed CY

      CY 2018 2019

      Number of nonfacility nonfacility

      CPT code post-op office quantity of quantity of

      visits minimum visit minimum visit

      pack (SA048) pack (SA048)

      ----------------------------------------------------------------------------------------------------------------

      10040........................................................... 1 2 1

      10060........................................................... 1 2 1

      10061........................................................... 2 3 2

      10080........................................................... 1 2 1

      10120........................................................... 1 2 1

      10121........................................................... 1 2 1

      10180........................................................... 1 2 1

      11200........................................................... 1 2 1

      11300........................................................... 0 1 0

      11301........................................................... 0 1 0

      11302........................................................... 0 1 0

      11303........................................................... 0 1 0

      11306........................................................... 0 1 0

      11307........................................................... 0 1 0

      11310........................................................... 0 1 0

      11311........................................................... 0 1 0

      11312........................................................... 0 1 0

      11400........................................................... 1 2 1

      11750........................................................... 1 2 1

      11900........................................................... 0 1 0

      11901........................................................... 0 1 0

      12001........................................................... 0 1 0

      12002........................................................... 0 1 0

      12004........................................................... 0 1 0

      12011........................................................... 0 1 0

      12013........................................................... 0 1 0

      16020........................................................... 0 1 0

      17000........................................................... 1 2 1

      17004........................................................... 1 2 1

      17110........................................................... 1 2 1

      17111........................................................... 1 2 1

      17260........................................................... 1 2 1

      17270........................................................... 1 2 1

      17280........................................................... 1 2 1

      19100........................................................... 0 1 0

      20005........................................................... 1 2 1

      20520........................................................... 1 2 1

      21215........................................................... 6 7 6

      21550........................................................... 1 2 1

      21920........................................................... 1 2 1

      22310........................................................... 1.5 2.5 1.5

      23500........................................................... 2.5 3.5 2.5

      23570........................................................... 2.5 3.5 2.5

      23620........................................................... 3 4 3

      24500........................................................... 4 5 4

      24530........................................................... 4 5 4

      24650........................................................... 3 4 3

      24670........................................................... 3 4 3

      25530........................................................... 3 4 3

      25600........................................................... 5 6 5

      25605........................................................... 5 6 5

      25622........................................................... 3.5 4.5 3.5

      25630........................................................... 3 4 3

      26600........................................................... 4 5 4

      26720........................................................... 2 3 2

      26740........................................................... 2.5 3.5 2.5

      26750........................................................... 2 3 2

      27508........................................................... 4 5 4

      27520........................................................... 3.5 4.5 3.5

      Page 35717

      27530........................................................... 4 5 4

      27613........................................................... 1 2 1

      27750........................................................... 3.5 4.5 3.5

      27760........................................................... 4 5 4

      27780........................................................... 3.5 4.5 3.5

      27786........................................................... 3.5 4.5 3.5

      27808........................................................... 4 5 4

      28190........................................................... 1 2 1

      28400........................................................... 3 4 3

      28450........................................................... 2.5 3.5 2.5

      28490........................................................... 1.5 2.5 1.5

      28510........................................................... 1.5 2.5 1.5

      30901........................................................... 0 1 0

      30903........................................................... 0 1 0

      30905........................................................... 0 1 0

      31000........................................................... 1 2 1

      31231........................................................... 0 1 0

      31233........................................................... 0 1 0

      31235........................................................... 0 1 0

      31238........................................................... 0 1 0

      31525........................................................... 0 1 0

      31622........................................................... 0 1 0

      32554........................................................... 0 1 0

      36600........................................................... 0 1 0

      38220........................................................... 0 1 0

      40490........................................................... 0 1 0

      42800........................................................... 1 2 1

      43200........................................................... 0 1 0

      45330........................................................... 0 1 0

      46040........................................................... 3 4 3

      46050........................................................... 1 2 1

      46083........................................................... 1 2 1

      46320........................................................... 0.5 1.5 0.5

      46600........................................................... 0 1 0

      46604........................................................... 0 1 0

      46900........................................................... 1 2 1

      51102........................................................... 0 2 0

      51701........................................................... 0 1 0

      51702........................................................... 0 1 0

      51703........................................................... 0 1 0

      51710........................................................... 0 1 0

      51725........................................................... 0 1 0

      51736........................................................... 0 1 0

      51741........................................................... 0 1 0

      51792........................................................... 0 1 0

      51798........................................................... 0 1 0

      52000........................................................... 0 1 0

      52001........................................................... 0 1 0

      52214........................................................... 0 1 0

      52265........................................................... 0 1 0

      52281........................................................... 0 1 0

      52285........................................................... 0 1 0

      53601........................................................... 0 1 0

      53621........................................................... 0 1 0

      53660........................................................... 0 1 0

      53661........................................................... 0 1 0

      54050........................................................... 1 2 1

      54056........................................................... 1 2 1

      54100........................................................... 0 1 0

      54235........................................................... 0 1 0

      54450........................................................... 0 1 0

      55000........................................................... 0 1 0

      56405........................................................... 1 2 1

      56605........................................................... 0 1 0

      56820........................................................... 0 1 0

      57061........................................................... 1 2 1

      57100........................................................... 0 1 0

      Page 35718

      57420........................................................... 0 1 0

      57500........................................................... 0 1 0

      57505........................................................... 1 2 1

      62252........................................................... 0 1 0

      62367........................................................... 0 1 0

      62368........................................................... 0 1 0

      62370........................................................... 0 1 0

      64413........................................................... 0 1 0

      64420........................................................... 0 1 0

      64450........................................................... 0 1 0

      64611........................................................... 1 2 1

      69000........................................................... 1 2 1

      69100........................................................... 0 1 0

      69145........................................................... 1.5 2.5 1.5

      69210........................................................... 0 1 0

      69420........................................................... 1 2 1

      69433........................................................... 1 2 1

      69610........................................................... 1 2 1

      93292........................................................... 0 1 0

      93303........................................................... 0 1 0

      94667........................................................... 0 1 0

      95044........................................................... 0 0.028 0

      95870........................................................... 0 1 0

      95921........................................................... 0 1 0

      95922........................................................... 0 1 0

      95924........................................................... 0 1 0

      95972........................................................... 0 1 1

      96904........................................................... 0 1 1

      ----------------------------------------------------------------------------------------------------------------

      In general, we are proposing to align the number of minimum multi-

      specialty visit packs with the number of post-operative office visits included in these codes. We are not proposing any supply pack quantity refinements for CPT codes 11100, 95974, or 95978 since they are being deleted for CY 2019. We are also not proposing any supply pack quantity refinements for CPT codes 45300, 46500, 57150, 57160, 58100, 64405, 95970, or HCPCS code G0268 since these codes were reviewed by the RUC this year and their previous direct PE inputs will be superseded by the new direct PE inputs we establish through this rulemaking process for CY 2019.

      A stakeholder notified us regarding a potential rank order anomaly in the direct PE inputs established for the Shaving of Epidermal or Dermal Lesions code family through PFS rulemaking for CY 2013. Three of these CPT codes describe benign shave removal of increasing lesion sizes: CPT code 11310 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less), CPT code 11311 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm), and CPT code 11312 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm). Each of these codes has a progressively higher work RVU corresponding to the increasing lesion diameter, and the recommended direct PE inputs also increase progressively from CPT codes 11310 to 11311 to 11312. However, the nonfacility PE RVU we established for CPT code 11311 is lower than the nonfacility PE RVU for CPT code 11310, which the stakeholder suggested may represent a rank order anomaly.

      We reviewed the direct PE inputs for CPT code 11311 and found that there were clerical inconsistencies in the data entry that resulted in the assignment of the lower nonfacility PE RVU for CPT code 11311. We propose to revise the direct PE inputs to reflect the ones previously finalized through rulemaking for CPT code 11311.

      In CY 2018, we inadvertently assigned too many minutes of clinical labor time for the ``Obtain vital signs'' task to three therapy codes, given that these codes are typically billed in multiple units and in conjunction with other therapy codes for the same patient on the same day, and we do not believe that it would be typical for clinical staff to obtain vital signs for each time a code is reported. The codes are: CPT code 97124 (Therapeutic procedure, 1 or more areas, each 15 minutes; massage, including effleurage, petrissage and/or tapotement (stroking, compression, percussion)); CPT code 97750 (Physical performance test or measurement (e.g., musculoskeletal, functional capacity), with written report, each 15 minutes); and CPT code 97755 (Assistive technology assessment (e.g., to restore, augment or compensate for existing function, optimize functional tasks and/or maximize environmental accessibility), direct one-on-one contact, with written report, each 15 minutes).

      Therefore, we are proposing to refine the ``Obtain vital signs'' clinical labor task for these three codes back to their previous times of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 97755. We are also proposing to refine the equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the change in the clinical labor time.

      We received a letter from a stakeholder alerting us to an anomaly in

      Page 35719

      the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate procedure)). The stakeholder stated that the inclusion of an endoscope disinfector, rigid or fiberoptic, w-cart equipment item (ES005) was inadvertently overlooked in the recommendations for CPT code 52000 when it was reviewed during PFS rulemaking for CY 2017, and that the equipment would be necessary for endoscope sterilization. The stakeholder requested that this essential piece of equipment should be added to the direct PE inputs for CPT code 52000.

      After reviewing the direct PE inputs for this code, we agree with the stakeholder and we are proposing to add the endoscope disinfector (ES005) to CPT code 52000, and to add 22 minutes of equipment time for that item to match the equipment time of the other non-scope items included in this code.

    8. 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 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 2019, we are proposing the following price updates for existing direct PE inputs.

      We are proposing to update the price of four supplies 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 2019 for these items instead of being phased in over 4 years. For the details of these proposed price updates, please refer to section II.H of this proposed rule Table 16: Invoices Received for Existing Direct PE Inputs.

      (1) Market-Based Supply and Equipment Pricing Update

      Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) 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, as added by the PAMA, 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 has 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 proposed 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 FY 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 StrategyGen did not have market share for commercial products, then they used a weighted average (weighted by sample size) of the commercial price and GSA price for the RP. The impact of the GSA price may be nominal in some of these cases since it is proportionate to the commercial samples sizes.

      3. Otherwise, if single price points existed from alternate supplier sites, the RP was the weighted average of the commercial price and the GSA price.

      4. Finally, if no data were available for commercial products, the GSA average price was used as the RP; and when StrategyGen could find no market research for a particular piece of equipment or supply item, the current CMS prices were used as the RP.

      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 indicate 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 will 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

      Page 35720

      RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year.

      After reviewing the StrategyGen report, we are proposing to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen. 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, we are proposing 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-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 are proposing 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 are proposing 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 proposed transition from the current to the fully-implemented new pricing is provided in Table 7.

      Table 7--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 are proposing 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 are also proposing 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 are proposing 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 are proposing 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 are also proposing to phase in any updated pricing we establish during 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 is 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 believe that implementing the proposed updated prices with a 4-

      year phase-in will 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 welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. We are particularly interested in comments regarding the supply and equipment pricing for CPT codes 95165 and 95004 that are frequently used by the Allergy/Immunology specialty. The Allergy/

      Immunology specialty was disproportionately affected by the updated pricing, even with a 4-year phase-in. The direct PE costs for CPT code 95165 would go down from $8.43 to $8.17 as a result of the updated supply and equipment pricing information. This would result in the PE RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking feedback on the supply and equipment pricing for the affected codes typically performed by this specialty and whether the direct PE inputs should be reviewed along with the pricing. The full report from the contractor, including the updated supply and equipment pricing as it is proposed to be implemented over the proposed 4-year transition period, will be made available as a public use file displayed on the CMS website

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      under downloads for the CY 2019 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      To maintain relativity between the clinical labor, supplies, and equipment portions of the PE methodology, we believe that the rates for the clinical labor staff should also be updated along with the updated pricing for supplies and equipment. We seek public comment regarding whether to update the clinical labor wages used in developing PE RVUs in future calendar years during the 4-year pricing transition for supplies and equipment, or whether it would be more appropriate to update the clinical labor wages at a later date following the conclusion of the transition for supplies and equipment, for example, to avoid other potentially large shifts in PE RVUs during the 4-year pricing transition period.

      (2) Breast Biopsy Software (EQ370)

      Following the publication of the CY 2018 PFS final rule, a stakeholder contacted us and requested that we update the price for the Breast Biopsy software (EQ370) equipment. This equipment item currently lacks a price in the direct PE database, and when an invoice for the Breast Biopsy software was first submitted during the CY 2014 PFS rule, we stated that this item served clinical functions similar to other items already included in the Magnetic Resonance (MR) room equipment package (EL008) included in the same CPT codes under review. Therefore, we did not create new direct PE inputs for this equipment item (78 FR 74344 through 74345). The stakeholder suggested that this software is used to subtract the imaging raw data series from the MRI Scanner, reformat the images in multiple planes to allow accurate targeting of the lesion to be biopsied, identify the location of a fiducial marker on the patient's skin, and then target the location of the enhancing lesion to be biopsied. The stakeholder requested that EQ370 be renamed as ``Breast MRI computer aided detection and biopsy guidance software'' and added to existing CPT codes 19085 (Biopsy, breast, with placement of breast localization device(s) (e.g., clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance), 19086 (Biopsy, breast, with placement of breast localization device(s) (e.g., clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including magnetic resonance guidance), 19287 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including magnetic resonance guidance), and 19288 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including magnetic resonance guidance), as well as adding the equipment to two newly created MR breast codes with CAD, CPT codes 77X51 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral) and 77X52 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; bilateral). The stakeholder supplied an invoice with a purchase price of $52,275 for the equipment.

      After reviewing the use of the Breast Biopsy software (EQ370) equipment in these six codes, we are not proposing to update the price or add the software to these procedures. As we stated in the CY 2014 PFS final rule with comment period (78 FR 74345), we continue to believe that equipment item EQ370 serves clinical functions similar to other items already included in the MR room equipment package (EL008), and that it would be duplicative to include this Breast Biopsy software as a separate direct PE input. We also note that the RUC recommendations for the new CPT codes 77X51 and 77X52 do not include EQ370 in the recommended equipment for these procedures, and we do not have any reason to believe that the inclusion of additional Breast Biopsy software beyond what is already contained in the MR room equipment package would be typical. However, we will update the name of the EQ370 equipment item from ``Breast Biopsy software'' to the requested ``Breast MRI computer aided detection and biopsy guidance software'' to help better describe the equipment in question.

      (3) 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 2019, we note 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 this proposed rule, and would consider any invoices received after February 10 or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.

      4. 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 2019, we are proposing to continue with the second year of the transition of this adjustment to the standard process for allocating indirect PE.

  26. Determination of Malpractice Relative Value Units (RVUs)

    1. Overview

    Section 1848(c) of the Act requires that the payment amount for 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

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    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).

    To determine MP RVUs for individual PFS services, our MP methodology is composed of three factors: (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 RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.

    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, 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 3 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 risk factor to individual codes based on the same utilization assumptions we make regarding the 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-specific 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.

    In CY 2017, we finalized the 8th GPCI update, which reflected updated MP premium data. We did not propose to use the updated MP premium data to propose updates for CY 2017 to the specialty risk factors used in the calculation of MP RVUs because it was inconsistent with the policy we previously finalized in the CY 2016 PFS final rule with comment period. That is, we indicated that the specialty-specific 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. However, we solicited comment on whether we should consider doing so, perhaps as early as for CY 2018, prior to the fourth review and update of MP RVUs that must occur no later than CY 2020. After consideration of the comments received, we stated in the CY 2017 PFS final rule that we would consider the possibility of using the updated MP data to update the specialty risk factors used in the calculation of the MP RVUs prior to the next 5-year update in future rulemaking (81 FR 80191 through 80192).

    In the CY 2018 PFS proposed rule, we proposed to use the updated MP data to update the specialty risk factors used in calculation of the MP RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018 PFS final rule (82 FR 53000 through 53006), after consideration of the comments received and some differences we observed in the descriptions on the raw rate filings as compared to how those data were categorized to conform with the CMS specialties, we did not finalize our proposal to use the updated MP data. We are required to review, and if necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback provided by commenters in response to the CY 2018 PFS proposed rule, and we are seeking additional comment regarding the next MP RVU update which must occur by CY 2020. Specifically, we are seeking comment on how we might improve the way that specialties in the state-level raw rate filings data are crosswalked for categorization into CMS specialty codes which are used to develop the specialty-level risk factors and the MP RVUs.

  27. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services

    The health care community uses the term ``telehealth'' broadly to refer to medical services furnished via communication technology. Under current PFS payment rules, Medicare routinely pays for many of these kinds of services. This includes some kinds of remote patient monitoring (either as separate services or as parts of bundled services), interpretations of diagnostic tests when furnished remotely, and, under conditions specified in section 1834(m) of the Act, services that would otherwise be furnished in person but are instead furnished via real-time, interactive communication technology. Over the past several years, CMS has also established several PFS policies to explicitly pay for non-face-to-face services included as part of ongoing care management.

    While all of the kinds of services stated above might be called ``telehealth'' by patients, other payers and health care providers, we have generally used the term ``Medicare telehealth services'' to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real-time telecommunication technology. Section 1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary to specify additional Medicare telehealth services using an annual process to add or delete services from the Medicare telehealth list. Section 1834(m)(4)(C) of the Act limits the scope of Medicare telehealth services for which payment may be made to those furnished to a beneficiary who is located in certain types of originating sites in certain, mostly rural, areas. Section 1834(m)(1) of the Act permits only physicians and certain other types of practitioners to furnish and be paid for Medicare telehealth services. Although section 1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add services to, and delete services from, the list of telehealth services based on the established annual process, it does not provide any authority to change the limitations relating to geography, patient setting, or type of furnishing practitioner because these requirements are specified in statute. However, we note that sections 50302, 50324, and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) have modified or removed the limitations relating to geography and patient setting for certain telehealth services, including for certain home dialysis end-stage renal disease-related services, services furnished by practitioners in certain Accountable Care Organizations, and acute stroke-related services, respectively.

    In the CY 2018 PFS proposed rule, we sought information from the public regarding ways that we might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies. Commenters were very supportive of CMS expanding access to these kinds of services. Many

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    commenters noted that Medicare payment for telehealth services is restricted by statute, but encouraged CMS to recognize and support technological developments in healthcare.

    We believe that the provisions in section 1834(m) of the Act apply particularly to the kinds of professional services explicitly enumerated in the statutory provisions, like professional consultations, office visits, and office psychiatry services. Generally, the services we have added to the telehealth list are similar to these kinds of services. As has long been the case, certain other kinds of services that are furnished remotely using communications technology are not considered ``Medicare telehealth services'' and are not subject to the restrictions articulated in section 1834(m) of the Act. This is true for services that were routinely paid separately prior to the enactment of the provisions in section 1834(m) of the Act and do not usually include patient interaction (such as remote interpretation of diagnostic imaging tests), and for services that were not discretely defined or separately paid for at the time of enactment and that do include patient interaction (such as chronic care management services).

    As we considered the concerns expressed by commenters about the statutory restrictions on Medicare telehealth services, we recognized that the concerns were not limited to the barriers to payment for remotely furnished services like those described by the office visit codes. The commenters also expressed concerns pertaining to the limitations on appropriate payment for evolving physicians' services that are inherently furnished via communication technology, especially as technology and its uses have evolved in the decades since the Medicare telehealth services statutory provision was enacted.

    In recent years, we have sought to recognize significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients, and have relied on the medical community to identify and define discrete physicians' services through the CPT Editorial Panel (82 FR 53163). In response to our comment solicitation on Medicare telehealth services in the CY 2018 PFS proposed rule (82 FR 53012), commenters provided many suggestions for how CMS could expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies, such as waiving portions of the statutory restrictions using demonstration authority. After considering those comments we recognize that concerns regarding the provisions in section 1834(m) of the Act may have been limiting the degree to which the medical community developed coding for new kinds of services that inherently utilize communication technology. We have come to believe that section 1834(m) of the Act does not apply to all kinds of physicians' services whereby a medical professional interacts with a patient via remote communication technology. Instead, we believe that section 1834(m) of the Act applies to a discrete set of physicians' services that ordinarily involve, and are defined, coded, and paid for as if they were furnished during an in-person encounter between a patient and a health care professional.

    For CY 2019, we are aiming to increase access for Medicare beneficiaries to physicians' services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. Accordingly, we have several proposals for modernizing Medicare physician payment for communication technology-

    based services, described below. These services would not be subject to the limitations on Medicare telehealth services in section 1834(m) of the Act because, as we have explained, we do not consider them to be Medicare telehealth services; instead, they would be paid under the PFS like other physicians' services. Additionally, we note that in furnishing these proposed services, practitioners would need to comply with any applicable privacy and security laws, including the HIPAA Privacy Rule.

    1. Brief Communication Technology-Based Service, e.g., Virtual Check-In (HCPCS Code GVCI1)

    The traditional office visit codes describe a broad range of physicians' services. Historically, we have considered any routine non-

    face-to-face communication that takes place before or after an in-

    person visit to be bundled into the payment for the visit itself. In recent years, we have recognized payment disparities that arise when the amount of non-face-to-face work for certain kinds of patients is disproportionately higher than for others, and created coding and separate payment to recognize care management services such as chronic care management and behavioral health integration services (81 FR 80226). We now recognize that advances in communication technology have changed patients' and practitioners' expectations regarding the quantity and quality of information that can be conveyed via communication technology. From the ubiquity of synchronous, audio/video applications to the increased use of patient-facing health portals, a broader range of services can be furnished by health care professionals via communication technology as compared to 20 years ago.

    Among these services are the kinds of brief check-in services furnished using communication technology that are used to evaluate whether or not an office visit or other service is warranted. When these kinds of check-in services are furnished prior to an office visit, then we would currently consider them to be bundled into the payment for the resulting visit, such as through an evaluation and management (E/M) visit code. However, in cases where the check-in service does not lead to an office visit, then there is no office visit with which the check-in service can be bundled. To the extent that these kinds of check-ins become more effective at addressing patient concerns and needs using evolving technology, we believe that the overall payment implications of considering the services to be broadly bundled becomes more problematic. This is especially true in a resource-based relative value payment system. Effectively, the better practitioners are in leveraging technology to furnish effective check-

    ins that mitigate the need for potentially unnecessary office visits, the fewer billable services they furnish. Given the evolving technological landscape, we believe this creates incentives that are inconsistent with current trends in medical practice and potentially undermines payment accuracy.

    Therefore, we are proposing to pay separately, beginning January 1, 2019, for a newly defined type of physicians' service furnished using communication technology. This service would be billable when a physician or other qualified health care professional has a brief non-

    face-to-face check-in with a patient via communication technology, to assess whether the patient's condition necessitates an office visit. We understand that the kinds of communication technology used to furnish these kinds of services has broadened over time and has enhanced the capacity for medical professionals to care for patients. We are seeking comment on what types of communication technology are utilized by physicians or other qualified health care professionals in furnishing these

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    services, including whether audio-only telephone interactions are sufficient compared to interactions that are enhanced with video or other kinds of data transmission.

    The proposed code would be described as GVCI1 (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). We further propose that in instances when the brief communication technology-based service originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, that this service would be considered bundled into that previous E/M service and would not be separately billable, which is consistent with code descriptor language for CPT code 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian 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) on which this service is partially modeled. We propose that in instances when the brief communication technology-based service leads to an E/M in-person service with the same physician or other qualified health care professional, this service would be considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable. We also note that this service could be used as part of a treatment regimen for opioid use disorders and other substance use disorders, since there are several components of Medication Assisted Therapy (MAT) that could be done virtually, or to assess whether the patient's condition requires an office visit.

    We propose pricing this distinct service at a rate lower than existing E/M in-person visits to reflect the low work time and intensity and to account for the resource costs and efficiencies associated with the use of communication technology. We expect that these services would be initiated by the patient, especially since many beneficiaries would be financially liable for sharing in the cost of these services. For the same reason, we believe it is important for patients to consent to receiving these services, and we are specifically seeking comment on whether we should require, for example, verbal consent that would be noted in the medical record for each service. We are also proposing that this service can only be furnished for established patients because we believe that the practitioner needs to have an existing relationship with the patient, and therefore, basic knowledge of the patient's medical condition and needs, in order to perform this service. We are not proposing to apply a frequency limit on the use of this code by the same practitioner with the same patient, but we want to ensure that this code is appropriately utilized for circumstances when a patient needs a brief non-face-to-face check-in to assess whether an office visit is necessary. We are seeking comment on whether it would be clinically appropriate to apply a frequency limitation on the use of this code by the same practitioner with the same patient, and on what would be a reasonable frequency limitation. We are also seeking comment on the timeframes under which this service would be separately billable compared to when it would be bundled. We believe the general construct of bundling the services that lead directly to a billable visit is important, but we are concerned that establishing strict timeframes may create unintended consequences regarding scheduling of care. For example, we do not want to bundle only the services that occur within 24 hours of a visit only to see a significant number of visits occurring at 25 hours after the initial service. In order to mitigate these incentives, we are seeking comment on whether we should consider broadening the window of time and/or circumstances in which this service should be bundled into the subsequent related visit. We note that these services, like any other physicians' service, would need to be medically reasonable and necessary in order to be paid by Medicare. We are seeking comment on how clinicians could best document the medical necessity of this service, consistent with documentation requirements necessary to demonstrate the medical necessity of any service under the PFS. For details related to developing utilization estimates for these services, see section VII. Regulatory Impact Analysis, of this proposed rule. For additional details related to valuation of these services, see section II.H. Valuation of Specific Codes, of this proposed rule. We are seeking comment on our proposed definition and valuation of this code.

    2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code GRAS1)

    Stakeholders have requested that CMS make separate Medicare payment when a physician uses recorded video and/or images captured by a patient in order to evaluate a patient's condition. These services involve what is referred to under section 1834(m) of the Act as ``store-and-forward'' communication technology that provides for the ``asynchronous transmission of health care information.'' We note that we believe these services involve pre-recorded patient-generated still or video images. Other types of patient-generated information, such as information from heart rate monitors or other devices that collect patient health marker data, could potentially be reported with CPT codes that describe remote patient monitoring. Under section 1834(m) of the Act, payment for telehealth services furnished using such store-

    and-forward technology is permitted only under Federal telemedicine demonstration programs conducted in Alaska or Hawaii, and these telehealth services remain subject to the other statutory restrictions governing Medicare telehealth services. Much like the virtual check-in described above, these services are not meant to substitute for an in-

    person service currently separately payable under the PFS, and therefore, are distinct from the telehealth services described under section 1834(m) of the Act. Effective January 1, 2019, we are proposing to create specific coding that describes the remote professional evaluation of patient-transmitted information conducted via pre-

    recorded ``store and forward'' video or image technology. These services would not be subject to the Medicare telehealth restrictions in section 1834(m) of the Act, and the valuation would reflect the resource costs associated with furnishing services utilizing communication technology.

    Much like the brief communication technology-based services discussed above, these services may be used to determine whether or not an office visit or other service is warranted. When the review of the patient-submitted image and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we propose that this remote service would be considered bundled into that office visit and therefore would not be separately billable. We further propose

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    that in instances when the remote service originates from a related E/M service provided within the previous 7 days by the same physician or qualified health care professional, that this service would be considered bundled into that previous E/M service and also would not be separately billable. In summary, we propose this service to be a stand-

    alone service that could be separately billed to the extent that there is no resulting E/M office visit and there is no related E/M office visit within the previous 7 days of the remote service being furnished. The proposed coding and separate payment for this service is consistent with the progression of technology and its impact on the practice of medicine in recent years, and would result in increased access to services for Medicare beneficiaries. The proposed code for this service would be described as GRAS1 (Remote evaluation of recorded video and/or images submitted by the patient (e.g., store and forward), including interpretation with verbal 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). We are seeking comment as to whether these services should be limited to established patients; or whether there are certain cases, like dermatological or ophthalmological services, where it might be appropriate for a new patient to receive these services. For example, when a patient seeks care for a specific skin condition from a dermatologist with whom she does not have a prior relationship, and part of the inquiry is an assessment of whether the patient needs an in-person visit, the patient could share, and the dermatologist could remotely evaluate, pre-recorded information. We also note that this service is distinct from the brief communication technology-based service described above in that this service involves the practitioner's evaluation of a patient-generated still or video image, and the subsequent communication of the resulting response to the patient, while the brief communication technology-based service describes a service that occurs in real time and does not involve the transmission of any recorded image.

    For details related to developing utilization estimates for these services, see section VII. Regulatory Impact Analysis, of this proposed rule. For further discussion related to valuation of this service, please see the section II.H. Valuation of Specific Codes, of this proposed rule. We are seeking public comment on our proposed definition and valuation of the code.

    3. Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 99446, 99447, 99448, and 99449)

    As part of our standard rulemaking process, we received recommendations from the RUC to assist in establishing values for six CPT codes that describe interprofessional consultations. In 2013, CMS received recommendations from the RUC for CPT codes 99446 (Interprofessional telephone/internet 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; 5-10 minutes of medical consultative discussion and review), 99447 (Interprofessional telephone/internet 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; 11-20 minutes of medical consultative discussion and review), 99448 (Interprofessional telephone/internet 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; 21-30 minutes of medical consultative discussion and review), and 99449 (Interprofessional telephone/internet 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; 31 minutes or more of medical consultative discussion and review). CMS declined to make separate payment, stating in the CY 2014 PFS final rule with comment period that these kinds of services are considered bundled (78 FR 74343). For CY 2019, the CPT Editorial Panel created two new codes to describe additional consultative services, including a code describing the work of the treating physician when initiating a consult, and the RUC recommended valuation for new codes, CPT codes 994X0 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and 994X6 (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 or more minutes of medical consultative time). The RUC also reaffirmed their prior recommendations for the existing CPT codes. The six codes describe assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a consulting physician or qualified healthcare professional with specific specialty expertise to assist with the diagnosis and/or management of the patient's problem without the need for the patient's face-to-face contact with the consulting physician or qualified healthcare professional. Currently, the resource costs associated with seeking or providing such a consultation are considered bundled, which in practical terms means that specialist input is often sought through scheduling a separate visit for the patient when a phone or internet-

    based interaction between the treating practitioner and the consulting practitioner would have been sufficient. We believe that proposing payment for these interprofessional consultations performed via communications technology such as telephone or internet is consistent with our ongoing efforts to recognize and reflect medical practice trends in primary care and patient-centered care management within the PFS.

    Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have recognized the changing focus in medical practice toward managing patients' chronic conditions, many of which particularly challenge the Medicare population, including heart disease, diabetes, respiratory disease, breast cancer, allergies, Alzheimer's disease, and factors associated with obesity. We have expressed concerns that the current E/

    M coding does not adequately reflect the changes that have occurred in medical practice, and the activities and resource costs associated with the treatment of these complex patients in the primary care setting. In the years since 2012, we have acknowledged the shift in medical practice away from an episodic treatment-based approach to one that involves comprehensive patient-centered care management, and have taken steps through rulemaking to better reflect that approach in payment under the PFS. In CY 2013, we established new codes to pay separately for transitional care management (TCM)

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    services. Next, we finalized new coding and separate payment beginning in CY 2015 for chronic care management (CCM) services provided by clinical staff (81 FR 80226). In the CY 2017 PFS final rule, we established separate payment for complex CCM services, an add-on code to the visit during which CCM is initiated to reflect the work of the billing practitioner in assessing the beneficiary and establishing the CCM care plan, and established separate payment for Behavioral Health Integration (BHI) services (81 FR 80226 through 80227).

    As part of this shift in medical practice, and with the proliferation of team-based approaches to care that are often facilitated by electronic medical record technology, we believe that making separate payment for interprofessional consultations undertaken for the benefit of treating a patient will contribute to payment accuracy for primary care and care management services. We are proposing separate payment for these services, discussed in section II.H. Valuation of Specific Codes, of this proposed rule.

    While we are proposing to make separate payment for these services because we believe they describe resource costs directly associated with seeking a consultation for the benefit of the beneficiary, we do have concerns about how these services can be distinguished from activities undertaken for the benefit of the practitioner, such as information shared as a professional courtesy or as continuing education. We do not believe that those examples would constitute a service directly attributable to a single Medicare beneficiary, and therefore neither the Medicare program nor the beneficiary should be responsible for those costs. We are therefore seeking comment on our assumption that these are separately identifiable services, and the extent to which they can be distinguished from similar services that are nonetheless primarily for the benefit of the practitioner. We note that there are program integrity concerns around making separate payment for these interprofessional consultation services, including around CMS' or its contractors' ability to evaluate whether an interprofessional consultation is reasonable and necessary under the particular circumstances. We are seeking comment on how best to minimize potential program integrity issues, and are particularly interested in information on whether these types of services are paid separately by private payers and if so, what controls or limitations private payers have put in place to ensure these services are billed appropriately.

    Additionally, since these codes describe services that are furnished without the beneficiary being present, we are proposing to require the treating practitioner to obtain verbal beneficiary consent in advance of these services, which would be documented by the treating practitioner in the medical record, similar to the conditions of payment associated with the care management services under the PFS. Obtaining advance consent includes ensuring that the patient is aware of applicable cost sharing. We welcome comments on this proposal.

    4. Medicare Telehealth Services Under Section 1834(m) of the Act

    1. Billing and Payment for Medicare Telehealth Services Under Section 1834(m) of the Act

      As discussed 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).

    2. 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 below, is included in the Downloads section to this proposed rule 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, 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. To be considered during PFS rulemaking for CY 2020, requests to add services to the list of Medicare telehealth services must be submitted and received by February 10, 2019. Each request to add a service to the list of Medicare telehealth

      Page 35727

      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.

    3. Submitted Requests To Add Services to the List of Telehealth Services for CY 2019

      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, 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 received several requests in CY 2017 to add various services as Medicare telehealth services effective for CY 2019. The following presents a discussion of these requests, and our proposals for additions to the CY 2019 telehealth list. Of the requests received, we found that two services were sufficiently similar to services currently on the telehealth list to be added on a Category 1 basis. Therefore, we are proposing to add the following services to the telehealth list on a Category 1 basis for CY 2019:

      HCPCS codes G0513 and G0514 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; first 30 minutes (list separately in addition to code for preventive service) and (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code G0513 for additional 30 minutes of preventive service).

      We found that the services described by HCPCS codes G0513 and G0514 are sufficiently similar to office visits currently on the telehealth list. We believe that all the components of this service can be furnished via interactive telecommunications technology. Additionally, we believe that adding these services to the telehealth list would make it administratively easier for practitioners who report these services in connection with a preventive service that is furnished via telehealth, as both the base code and the add-on code would be reported with the telehealth place of service.

      We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We are not proposing to add to the Medicare telehealth services list the following procedures for chronic care remote physiologic monitoring, interprofessional internet consultation, and initial hospital care; or to change the requirements for subsequent hospital care or subsequent nursing facility care, for the reasons noted in the paragraphs that follow.

      (1) Chronic Care Remote Physiologic Monitoring: CPT Codes

      CPT code 990X0 (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).

      CPT code 990X1 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days).

      CPT code 994X9 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/

      other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month).

      In the CY 2016 PFS final rule with comment period (80 FR 71064), we responded to a request to add 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) to the Medicare telehealth list. We discussed that the services described by CPT code 99490 can be furnished without the beneficiary's face-to-face presence and using any number of non-

      face-to-face means of communication. We stated that it was therefore unnecessary to add that service to the list of Medicare telehealth services. Similarly, CPT codes 990X0, 990X1, and 994X9 describe services that are inherently non face-to-face. As discussed in section II.H. Valuation of Specific Codes, we instead are proposing to adopt CPT codes 990X0, 990X1, and 994X9 for payment under the PFS. Because these codes describe services that are inherently non face-to-face, we do not consider them Medicare telehealth services under section 1834(m) of the Act; therefore, we are not proposing to add them to the list of Medicare telehealth services.

      (2) Interprofessional Internet Consultation: CPT Codes

      CPT code 994X0 (Interprofessional telephone/internet/

      electronic health record referral service(s) provided by a treating/

      requesting physician or qualified health care professional, 30 minutes).

      CPT code 994X6 (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 or more minutes of medical consultative time).

      As discussed in section II.H. Valuation of Specific Codes, we are proposing to adopt CPT codes 994X0 and 994X6 for payment under the PFS as these are distinct services furnished via communication technology. Because these codes describe services that are inherently non face-to-

      face, we do not consider them as Medicare telehealth services under section 1834(m) of the Act; therefore we are not proposing to add them to the list of Medicare telehealth services for CY 2019.

      (3) Initial Hospital Care Services: CPT Codes

      CPT code 99221 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care

      Page 35728

      with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of low severity.)

      CPT code 99222 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of moderate severity.)

      CPT code 99223 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of high severity.)

      We have previously considered requests to add these codes to the telehealth list. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73315), while initial inpatient consultation services are currently on the list of approved telehealth services, there are no services on the current list of telehealth services that resemble initial hospital care for an acutely ill patient by the admitting practitioner who has ongoing responsibility for the patient's treatment during the course of the hospital stay. Therefore, consistent with prior rulemaking, we do not propose that initial hospital care services be added to the Medicare telehealth services list on a category 1 basis.

      The initial hospital care codes describe the first visit of the hospitalized patient by the admitting practitioner who may or may not have seen the patient in the decision-making phase regarding hospitalization. Based on the description of the services for these codes, we believed it is critical that the initial hospital visit by the admitting practitioner be conducted in person to ensure that the practitioner with ongoing treatment responsibility comprehensively assesses the patient's condition upon admission to the hospital through a thorough in-person examination. Additionally, the requester submitted no additional research or evidence that the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient; therefore, we also do not propose adding initial hospital care services to the Medicare telehealth services list on a Category 2 basis.

      We note that Medicare beneficiaries who are being treated in the hospital setting can receive reasonable and necessary E/M services using other HCPCS codes that are currently on the Medicare telehealth list, including those for subsequent hospital care, initial and follow-

      up telehealth inpatient and emergency department consultations, as well as initial and follow-up critical care telehealth consultations.

      Therefore, we are not proposing to add the initial hospital care services to the list of Medicare telehealth services for CY 2019.

      (4) Subsequent Hospital Care Services: CPT Codes

      CPT code 99231 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit.)

      CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit.)

      CPT code 99233 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is unstable or has developed a significant complication or a significant new problem. Typically, 35 minutes are spent at the bedside and on the patient's hospital floor or unit.)

      CPT codes 99231-99233 are currently on the list of Medicare telehealth services, but can only be billed via telehealth once every 3 days. The requester asked that we remove the frequency limitation. We stated in the CY 2011 PFS final rule with comment period (75 FR 73316) that, while we still believed the potential acuity of hospital inpatients is greater than those patients likely to receive Medicare telehealth services that were on the list at that time, we also believed that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth in order to ensure that hospitalized patients have frequent encounters with their admitting practitioner. We also noted that we continue to believe that the majority of these visits should be in-person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the list of Medicare telehealth services, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns and position on the provision of subsequent hospital care services via telehealth have not changed. Therefore, we are not proposing to remove the frequency limitation on these codes.

      (5) Subsequent Nursing Facility Care Services: CPT Codes

      CPT code 99307 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key

      Page 35729

      components: A problem focused interval history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering, or improving. Typically, 10 minutes are spent at the bedside and on the patient's facility floor or unit.)

      CPT code 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 15 minutes are spent at the bedside and on the patient's facility floor or unit.)

      CPT code 99309 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient has developed a significant complication or a significant new problem. Typically, 25 minutes are spent at the bedside and on the patient's facility floor or unit.)

      CPT code 99310 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A comprehensive interval history; a comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. The patient may be unstable or may have developed a significant new problem requiring immediate physician attention. Typically, 35 minutes are spent at the bedside and on the patient's facility floor or unit.)

      CPT codes 99307-99310 are currently on the list of Medicare telehealth services, but can only be billed via telehealth once every 30 days. The requester asked that we remove the frequency limitation when these services are provided for psychiatric care. We stated in the CY 2011 PFS final rule with comment period (75 FR 73317) that we believed it would be appropriate to permit some subsequent nursing facility care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, but because of our concerns regarding the potential acuity and complexity of SNF inpatients, we limited the provision of subsequent nursing facility care services furnished through telehealth to once every 30 days. Since these codes are used to report care for patients with a variety of diagnoses, including psychiatric diagnoses, we do not think it would be appropriate to remove the frequency limitation only for certain diagnoses. The services described by these CPT codes are essentially the same service, regardless of the patient's diagnosis. We also continue to have concerns regarding the potential acuity and complexity of SNF inpatients, and therefore, we are not proposing to remove the frequency limitation for subsequent nursing facility care services in CY 2019.

      In summary, we are proposing to add the following codes to the list of Medicare telehealth services beginning in CY 2019 on a category 1 basis:

      HCPCS code G0513 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; first 30 minutes (list separately in addition to code for preventive service).

      HCPCS code G0514 (Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code G0513 for additional 30 minutes of preventive service).

      5. Expanding the Use of Telehealth Under the Bipartisan Budget Act of 2018

    4. Expanding Access to Home Dialysis Therapy Under the Bipartisan Budget Act of 2018

      Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 1834(m) of the Act to allow an individual determined to have end-stage renal disease receiving home dialysis to choose to receive certain monthly end-stage renal disease-related (ESRD-related) clinical assessments via telehealth on or after January 1, 2019. The new section 1881(b)(3)(B)(ii) of the Act requires that such an individual must receive a face-to-face visit, without the use of telehealth, at least monthly in the case of the initial 3 months of home dialysis and at least once every 3 consecutive months after the initial 3 months.

      As added by section 50302(b)(1) of the BBA of 2018, subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act include a renal dialysis facility and the home of an individual as telehealth originating sites but only for the purposes of the monthly ESRD-related clinical assessments furnished through telehealth provided under section 1881(b)(3)(B) of the Act. Section 50302(b)(1) also added a new section 1834(m)(5) of the Act which provides that the geographic requirements for telehealth services under section 1834(m)(4)(C)(i) of the Act do not apply to telehealth services furnished on or after January 1, 2019 for purposes of the monthly ESRD-related clinical assessments where the originating site is a hospital-based or critical access hospital-based renal dialysis center, a renal dialysis facility, or the home of an individual. Section 50302(b)(2) of the BBA of 2018 amended section 1834(m)(2)(B)(ii) of the Act to require that no originating site facility fee is to be paid if the home of the individual is the originating site.

      Our current regulation at Sec. 410.78 specifies the conditions that must be met in order for Medicare Part B to pay for covered telehealth services included on the telehealth list when furnished by an interactive telecommunications system. In accordance with the new subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we are proposing to revise our regulation at Sec. 410.78(b)(3) to add a renal dialysis facility and the home of an individual as Medicare telehealth originating sites, but only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. We propose to amend Sec. 414.65(b)(3) to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the patient's home. Additionally, we are proposing to add new Sec. 410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of the Act, added by section 50302 of the BBA

      Page 35730

      of 2018, specifying that the geographic requirements described in section 1834(m)(4)(C)(i) of the Act do not apply with respect to telehealth services furnished on or after January 1, 2019, in originating sites that are hospital-based or critical access hospital-

      based renal dialysis centers, renal dialysis facilities, or the patient's home, respectively under sections 1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section 1881(b)(3)(B) of the Act.

    5. Expanding the Use of Telehealth for Individuals With Stroke Under the Bipartisan Budget Act of 2018

      Section 50325 of the BBA of 2018 amended section 1834(m) of the Act by adding a new paragraph (6) that provides special rules for telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke (acute stroke telehealth services), as determined by the Secretary. Specifically, section 1834(m)(6)(A) of the Act removes the restrictions on the geographic locations and the types of originating sites where acute stroke telehealth services can be furnished. Section 1834(m)(6)(B) of the Act specifies that acute stroke telehealth services can be furnished in any hospital, critical access hospital, mobile stroke units (as defined by the Secretary), or any other site determined appropriate by the Secretary, in addition to the current eligible telehealth originating sites. Section 1834(m)(6)(C) of the Act limits payment of an originating site facility fee to acute stroke telehealth services furnished in sites that meet the usual telehealth restrictions under section 1834(m)(4)(C) of the Act.

      To implement these requirements, we are proposing to create a new modifier that would be used to identify acute stroke telehealth services. The practitioner and, as appropriate, the originating site, would append this modifier when clinically appropriate to the HCPCS code when billing for an acute stroke telehealth service or an originating site facility fee, respectively. We note that section 50325 of the BBA of 2018 did not amend section 1834(m)(4)(F) of the Act, which limits the scope of telehealth services to those on the Medicare telehealth list. Practitioners would be responsible for assessing whether it would be clinically appropriate to use this modifier with codes from the Medicare telehealth list. By billing with this modifier, practitioners would be indicating that the codes billed were used to furnish telehealth services for diagnosis, evaluation, or treatment of symptoms of an acute stroke. We believe that the adoption of a service level modifier is the least administratively burdensome means of implementing this provision for practitioners, while also allowing CMS to easily track and analyze utilization of these services.

      In accordance with section 1834(m)(6)(B) of the Act, as added by section 50325 of the BBA of 2018, we are also proposing to revise Sec. 410.78(b)(3) of our regulations to add mobile stroke unit as a permissible originating site for acute stroke telehealth services. We are proposing to define a mobile stroke unit as a mobile unit that furnishes services to diagnose, evaluate, and/or treat symptoms of an acute stroke and are seeking comment on this definition, as well as additional information on how these units are used in current medical practice. We are therefore proposing that mobile stroke units and the current eligible telehealth originating sites, which include hospitals and critical access hospitals as specified in section 1834(m)(6)(B) of the Act, but excluding renal dialysis facilities and patient homes because they are only allowable originating sites for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, would be permissible originating sites for acute stroke telehealth services.

      We also seek comment on other possible appropriate originating sites for telehealth services furnished for the diagnosis, evaluation, or treatment of symptoms of an acute stroke. Any additional sites would be adopted through future rulemaking. As required under section 1834(m)(6)(C) of the Act, the originating site facility fee would not apply in instances where the originating site does not meet the originating site type and geographic requirements under section 1834(m)(4)(C) of the Act. Additionally, we are proposing to add Sec. 410.78(b)(4)(iv)(B) to specify that the requirements in section 1834(m)(4)(C) of the Act do not apply with respect to telehealth services furnished on or after January 1, 2019, for purposes of diagnosis, evaluation, or treatment of symptoms of an acute stroke.

      6. Modifying Sec. 414.65 Regarding List of Telehealth Services

      In the CY 2015 PFS final rule with comment period, we finalized a proposal to change our regulation at Sec. 410.78(b) by deleting the description of the individual services for which Medicare payment can be made when furnished via telehealth, noting that we revised Sec. 410.78(f) to indicate that a list of Medicare telehealth codes and descriptors is available on the CMS website (79 FR 67602). In accordance with that change, we are proposing a technical revision to also delete the description of individual services and exceptions for Medicare payment for telehealth services in Sec. 414.65, by amending Sec. 414.65(a) to note that Medicare payment for telehealth services is addressed in Sec. 410.78 and by deleting Sec. 414.65(a)(1).

      7. Comment Solicitation on Creating a Bundled Episode of Care for Management and Counseling Treatment for Substance Use Disorders

      There is an evidence base that suggests that routine counseling, either associated with medication assisted treatment (MAT) or on its own, can increase the effectiveness of treatment for substance use disorders (SUDs). According to a study in the Journal of Substance Abuse Treatment,\1\ patients treated with a combination of web-based counseling as part of a substance abuse treatment program demonstrated increased treatment adherence and satisfaction. The federal guidelines for opioid treatment programs describe that MAT and wrap-around psychosocial and support services can include the following services: Physical exam and assessment; psychosocial assessment; treatment planning; counseling; medication management; drug administration; comprehensive care management and supportive services; care coordination; management of care transitions; individual and family support services; and health promotion (https://store.samhsa.gov/shin/content/PEP15-FEDGUIDEOTP/PEP15-FEDGUIDEOTP.pdf). Creating separate payment for a bundled episode of care for components of MAT such as management and counseling treatment for substance use disorders (SUD), including opioid use disorder, treatment planning, and medication management or observing drug dosing for treatment of SUDs under the PFS could provide opportunities to better leverage services furnished with communication technology while expanding access to treatment for SUDs.

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      \1\ Van L. King, Robert K. Brooner, Jessica M. Peirce, Ken Kolodner, Michael S. Kidorf, ``A randomized trial of Web based videoconferencing for substance abuse counseling,'' Journal of Substance Abuse Treatment, Volume 46, Issue 1, 2014, Pages 36-42, http://www.sciencedirect.com/science/article/pii/S0740547213001876.

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      We also believe making separate payment for a bundled episode of care for management and counseling for SUDs could be effective in preventing the need for more acute services. For example, according to the Healthcare

      Page 35731

      Cost and Utilization Project,\2\ Medicare pays for one-third of opioid-

      related hospital stays, and Medicare has seen the largest annual increase in the number of these stays over the past 2 decades. We believe that separate payment for a bundled episode of care could help avoid such hospital admissions by supporting access to management and counseling services that could be important in preventing hospital admissions and other acute care events.

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      \2\ Pamela L. Owens, Ph.D., Marguerite L. Barrett, M.S., Audrey J. Weiss, Ph.D., Raynard E. Washington, Ph.D., and Richard Kronick, Ph.D. ``Hospital Inpatient Utilization Related to Opioid Overuse Among Adults 1993-2012,'' Statistical Brief #177. Healthcare Cost and Utilization Project (HCUP). July 2014. Agency for Healthcare Research and Quality, Rockville, MD, https://www.hcup-us.ahrq.gov/reports/statbriefs/sb177-Hospitalizations-for-Opioid-Overuse.jsp.

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      As indicated above, we are considering whether it would be appropriate to develop a separate bundled payment for an episode of care for treatment of SUDs. We are seeking public comment on whether such a bundled episode-based payment would be beneficial to improve access, quality and efficiency for SUD treatment. Further, we are seeking public comment on developing coding and payment for a bundled episode of care for treatment for SUDs that could include overall treatment management, any necessary counseling, and components of a MAT program such as treatment planning, medication management, and observation of drug dosing. Specifically, we are seeking public comments related to what assumptions we might make about the typical number of counseling sessions as well as the duration of the service period, which types of practitioners could furnish these services, and what components of MAT could be included in the bundled episode of care. We are interested in stakeholder feedback regarding how to define and value this bundle and what conditions of payment should be attached. Additionally, we are seeking comment on whether the concept of a global period, similar to the currently existing global periods for surgical procedures, might be applicable to treatment for SUDs.

      We also seek comment on whether the counseling portion and other MAT components could also be provided by qualified practitioners ``incident to'' the services of the billing physician who would administer or prescribe any necessary medications and manage the overall care, as well as supervise any other counselors participating in the treatment, similar to the structure of the Behavioral Health Integration codes which include services provided by other members of the care team under the direction of the billing practitioner on an ``incident to'' basis (81 FR 80231). We welcome comments on potentially creating a bundled episode of care for management and counseling treatment for SUDs, which we will consider for future rulemaking.

      Additionally, we invite public comment and suggestions for regulatory and subregulatory changes to help prevent opioid use disorder and improve access to treatment under the Medicare program. We seek comment on methods for identifying non-opioid alternatives for pain treatment and management, along with identifying barriers that may inhibit access to these non-opioid alternatives including barriers related to payment or coverage. Consistent with our ``Patients Over Paperwork'' Initiative, we are interested in suggestions to improve existing requirements in order to more effectively address the opioid epidemic.

  28. 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.H. of this proposed rule, 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 Physician Quality Reporting System (PQRS) databases. 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/congressional-testimony/testimony-report-to-the-congress-medicare-payment-policy-march-2006-.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

    Page 35732

    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 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.

    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 CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). 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 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 CY 2009 (73 FR 38589), 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 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 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 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 2019 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. The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10 of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

    Page 35733

    Documentation in peer reviewed medical literature or other reliable data that there have been 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 PQRS databases).

    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 whether we proposed each nominated code 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.

    1. Public Nominations

      We received one submission that nominated several high-volume codes for review under the potentially misvalued code initiative. In their request, the submitter noted a systemic overvaluation of work RVUs in certain procedures and tests based ``on a number of Government Accountability Office (GAO) and the Medicare Payment Advisory Commission (MedPAC) reports, media reports regarding time inflation of specific services, and the January 19, 2017 Urban Institute report for CMS.'' The submitter suggested that the times CMS assumes in estimating work RVUs are inaccurate for procedures, especially due to substantial overestimates of preservice and postservice time, including follow-up inpatient and outpatient visits that do not take place. According to the submitter, the time estimates for tests and some other procedures are primarily overstated as part of the intraservice time. Furthermore, the submitter stated that previous RUC reviews of these services did not result in reductions in valuation that adequately reflected reductions in surveyed times.

      Based on these analyses, the submitter requested that the codes listed in Table 8 be prioritized for reviewed under the potentially misvalued code initiative.

      Table 8--Public Nominations Due to Overvaluation

      ------------------------------------------------------------------------

      CPT code Short description

      ------------------------------------------------------------------------

      27130................................ Total hip arthroplasty.

      27447................................ Total knee arthroplasty.

      43239................................ Egd biopsy single/multiple.

      45385................................ Colonoscopy w/lesion removal.

      70450................................ CT head w/o contrast.

      93000................................ Electrocardiogram complete.

      93306................................ Tte w/doppler complete.

      ------------------------------------------------------------------------

      Another commenter requested that 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)) be reviewed under the potentially misvalued code initiative in order to establish national RVU values for these services under the MPFS. These codes are currently priced by the Medicare Administrative Contractors (MACs).

    2. Update on the Global Surgery Data Collection

      CMS currently bundles payment for postoperative care within 10 or 90 days after many surgical procedures. Historically, we have not collected data on how many postoperative visits are actually performed during the global period. Section 523 of the MACRA added a new paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS to use notice and comment rulemaking to implement a process to collect data on the number and level of postoperative visits and use these data to assess the accuracy of global surgical package valuation. In the CY 2017 PFS final rule, we adopted a policy to collect postoperative visit data.

      Beginning July 1, 2017, CMS required practitioners in groups with 10 or more practitioners in nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to use the no-pay CPT code 99024 (Postoperative follow-up visit, normally included in the surgical package, to indicate that an E/M service was performed during a postoperative period for a reason(s) related to the original procedure) to report postoperative visits. Practitioners who only practice in practices with fewer than 10 practitioners are exempted from required reporting, but are encouraged to report if feasible. The 293 procedures for which reporting is required are those furnished by more than 100 practitioners, and either are nationally furnished more than 10,000 times annually or have more than $10 million in annual allowed charges. A list of the procedures for which reporting is required is updated annually to reflect any coding changes and is posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Global-Surgery-Data-Collection-.html.

      In these nine states, from July 1, 2017 through December 31, 2017, there were 990,581 postoperative visits reported using CPT code 99024. Of the 32,573 practitioners who furnished at least one of the 293 procedures during this period and who, based on Tax Identification Numbers in claims data, were likely to meet the practice size threshold, only 45 percent reported one or more visit using CPT code 99024 during this 6-month period. The share of practitioners who reported any CPT code 99024 claims varied by specialty. Among surgical oncology, hand surgery, and orthopedic surgeons, reporting rates were 92, 90, and 87 percent, respectively. In contrast, the reporting rate for emergency medicine physicians was 4 percent. (See Table 9.)

      Page 35734

      Table 9--Share of Practitioners Who Reported Any CPT Code 99024 Claims, by Specialty

      ----------------------------------------------------------------------------------------------------------------

      Number of

      Practitioner specialty Number of reporting Percent

      practitioners * practitioners ** reporting

      ----------------------------------------------------------------------------------------------------------------

      ALL....................................................... 32,642 14,627 45

      Family practice........................................... 3,912 707 18

      Emergency medicine........................................ 3,612 153 4

      Physician Assistant....................................... 2,751 758 28

      Orthopedic surgery........................................ 2,725 2,360 87

      General surgery........................................... 2,317 1,879 81

      Nurse Practitioner........................................ 2,217 438 20

      Internal medicine......................................... 1,476 161 11

      Ophthalmology............................................. 1,319 1,069 81

      Urology................................................... 1,186 1,014 85

      Dermatology............................................... 1,025 698 68

      Diagnostic radiology...................................... 982 34 3

      Obstetrics/gynecology..................................... 966 612 63

      Otolaryngology............................................ 872 652 75

      Podiatry.................................................. 761 502 66

      Neurosurgery.............................................. 614 512 83

      Cardiology................................................ 574 307 53

      Neurology................................................. 525 19 4

      Vascular surgery.......................................... 405 342 84

      Pathologic anatomy, clinical pathology.................... 355 281 79

      Thoracic surgery.......................................... 320 270 84

      Gastroenterology.......................................... 315 6 2

      Plastic and reconstructive surgery........................ 303 250 83

      Physical medicine and rehabilitation...................... 275 63 23

      Anesthesiology............................................ 254 73 29

      Optometry................................................. 247 158 64

      Pain Management........................................... 247 98 40

      Colorectal surgery........................................ 225 189 84

      Hand surgery.............................................. 214 193 90

      Interventional radiology.................................. 201 19 9

      Interventional Cardiology................................. 195 114 58

      Cardiac surgery........................................... 176 148 84

      Interventional Pain Management............................ 165 55 33

      Surgical oncology......................................... 154 141 92

      Gynecologist/oncologist................................... 143 121 85

      General practice.......................................... 115 37 32

      Peripheral vascular disease, medical or surgical.......... 106 84 79

      Nephrology................................................ 74 9 12

      Critical care............................................. 54 34 63

      Pediatric medicine........................................ 39 4 10

      Infectious disease........................................ 34 3 9

      Maxillofacial surgery..................................... 25 18 72

      Oral surgery.............................................. 20 11 55

      Osteopathic manipulative therapy.......................... 18 6 33

      Hematology/oncology....................................... 16 5 31

      Geriatric medicine........................................ 15 2 13

      Certified clinical nurse specialist....................... 12 1 8

      Unknown physician specialty............................... 12 9 75

      ----------------------------------------------------------------------------------------------------------------

      * Limited to practitioners who performed at least one of the 293 relevant global procedures and were affiliated

      with a tax identification number with 10 or more practitioners.

      ** Practitioners who submitted one or more CPT code 99024 claims between July 1st, 2017 and December 31st, 2017.

      The share of practitioners who reported CPT code 99024 on any claims also varied by state as shown in Table 10.

      Table 10--Share of Practitioners Who Reported Any CPT Code 99024 Claims,

      by State

      ------------------------------------------------------------------------

      Percentage of

      State practitioners *

      reporting **

      ------------------------------------------------------------------------

      ALL................................................... 45

      North Dakota.......................................... 56

      Ohio.................................................. 49

      Rhode Island.......................................... 49

      Florida............................................... 48

      New Jersey............................................ 43

      Louisiana............................................. 42

      Kentucky.............................................. 41

      Oregon................................................ 35

      Nevada................................................ 30

      ------------------------------------------------------------------------

      * Limited to practitioners who performed at least one of the 293

      relevant global procedures and were affiliated with a tax

      identification number with 10 or more practitioners.

      Page 35735

      ** Practitioners who submitted one or more CPT code 99024 claims between

      July 1st, 2017 and December 31st, 2017.

      Among 10-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, only 4 percent had one or more matched visit reported with CPT code 99024. The percentage of 10-day global procedures with a matched visit reported with CPT code 99024 varied by specialty. Among procedures with 10-day global periods performed by hand surgeons, critical care, and obstetrics/gynecology 44, 36, and 23 percent, respectively, of procedures had a matched visit reported using CPT code 99024. In contrast, less than 5 percent of 10-day global procedures performed by many other specialties had a matched visit reported using CPT code 99024. (See Table 11.)

      Table 11--Share of Procedures With Matched Post-Operative Visits

      ----------------------------------------------------------------------------------------------------------------

      Number of 10-day Percentage of 10-

      global day global

      Number of 10-day procedures with procedures with

      Provider specialty global 1 or more 1 or more

      procedures * matched 99024 matched 99024

      claims ** claims **

      ----------------------------------------------------------------------------------------------------------------

      ALL....................................................... 436,063 16,802 4

      Dermatology............................................... 205,594 6,920 3

      Physician Assistant....................................... 57,749 908 2

      Nurse Practitioner........................................ 31,937 509 2

      Family practice........................................... 16,770 629 4

      Ophthalmology............................................. 16,087 1,239 8

      Podiatry.................................................. 12,639 547 4

      General surgery........................................... 12,113 2,095 17

      Diagnostic radiology...................................... 11,650 298 3

      Neurology................................................. 8,075 68 1

      Pain Management........................................... 6,923 210 3

      Emergency medicine........................................ 6,012 209 3

      Internal medicine......................................... 5,883 201 3

      Interventional Pain Management............................ 5,210 106 2

      Anesthesiology............................................ 4,666 105 2

      Otolaryngology............................................ 4,598 383 8

      Interventional radiology.................................. 4,197 89 2

      Physical medicine and rehabilitation...................... 3,546 53 1

      Vascular surgery.......................................... 3,447 256 7

      Gastroenterology.......................................... 2,264 7 0

      Plastic and reconstructive surgery........................ 1,939 403 21

      Colorectal surgery........................................ 1,851 83 4

      General practice.......................................... 1,807 45 2

      Orthopedic surgery........................................ 1,688 318 19

      Optometry................................................. 1,563 45 3

      Urology................................................... 1,276 277 22

      Neurosurgery.............................................. 1,148 241 21

      Nephrology................................................ 1,008 25 2

      Obstetrics/gynecology..................................... 760 171 23

      Cardiology................................................ 456 14 3

      Surgical oncology......................................... 440 41 9

      Pathology................................................. 395 76 19

      Pediatric medicine........................................ 323 4 1

      Neuropsychiatry........................................... 296 2 1

      Thoracic surgery.......................................... 276 40 14

      Gynecologist/oncologist................................... 266 47 18

      Interventional Cardiology................................. 192 5 3

      Peripheral vascular disease, medical or surgical.......... 162 5 3

      Cardiac surgery........................................... 144 25 17

      Hand surgery.............................................. 124 54 44

      Critical care............................................. 85 30 35

      Infectious disease........................................ 67 3 4

      Osteopathic manipulative therapy.......................... 55 1 2

      Psychiatry................................................ 44 0 0

      Geriatric medicine........................................ 43 0 0

      Hospitalist............................................... 42 0 0

      Maxillofacial surgery..................................... 37 5 14

      Oral surgery.............................................. 34 1 3

      Radiation oncology........................................ 31 1 3

      Certified clinical nurse specialist....................... 26 2 8

      Pulmonary disease......................................... 20 2 10

      Hematology/oncology....................................... 19 0 0

      Peripheral vascular disease............................... 17 0 0

      Preventive medicine....................................... 15 0 0

      Pathologic anatomy, clinical pathology.................... 12 1 8

      Page 35736

      Unknown physician specialty............................... 10 3 30

      ----------------------------------------------------------------------------------------------------------------

      * Limited to the 293 procedures where postoperative visit reporting is required and to those performed by

      practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these

      circumstances, multiple procedures performed on a single day and procedures with overlapping global periods

      were excluded.

      ** Matching was based on patient, service dates, and global period duration.

      Among 90-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, 67 percent had one or more matched visit reported using CPT code 99024. Again, this rate varied by specialty as shown in Table 12. Under the PFS, procedures with 90-day global periods have more than one postoperative visit. It should be noted that the rates described in this and prior paragraphs are based on any matched postoperative visit reported using CPT code 99024.

      Table 12--Share of Procedures With Matched Post-Operative Visits, for Procedure Codes With 90-Day Global Periods

      ----------------------------------------------------------------------------------------------------------------

      Number of 90-day Percentage of 90-

      global day global

      Number of 90-day procedures with procedures with

      Provider specialty global 1 or more 1 or more

      procedures* matched 99024 matched 99024

      claims** claims**

      ----------------------------------------------------------------------------------------------------------------

      ALL....................................................... 232,235 156,727 67

      Orthopedic surgery........................................ 71,991 54,876 76

      Ophthalmology............................................. 63,333 41,700 66

      General surgery........................................... 25,593 17,559 69

      Pathologic anatomy, clinical pathology.................... 10,149 4,371 43

      Urology................................................... 8,481 4,828 57

      Dermatology............................................... 7,692 4,160 54

      Neurosurgery.............................................. 6,993 5,256 75

      Cardiology................................................ 5,932 2,388 40

      Vascular surgery.......................................... 5,400 3,552 66

      Hand surgery.............................................. 4,783 3,718 78

      Thoracic surgery.......................................... 3,700 2,859 77

      Cardiac surgery........................................... 2,764 2,183 79

      Plastic and reconstructive surgery........................ 2,500 1,670 67

      Podiatry.................................................. 2,383 1,393 58

      Otolaryngology............................................ 1,692 1,014 60

      Physician Assistant....................................... 1,492 903 61

      Colorectal surgery........................................ 1,316 869 66

      Interventional Cardiology................................. 1,123 500 45

      Peripheral vascular disease, medical or surgical.......... 753 524 70

      Obstetrics/gynecology..................................... 752 469 62

      Surgical oncology......................................... 716 511 71

      Optometry................................................. 402 248 62

      Gynecologist/oncologist................................... 322 219 68

      Internal medicine......................................... 317 133 42

      Emergency medicine........................................ 258 62 24

      Nurse Practitioner........................................ 243 153 63

      General practice.......................................... 217 125 58

      Gastroenterology.......................................... 139 13 9

      Osteopathic manipulative therapy.......................... 131 94 72

      Family practice........................................... 115 65 57

      Critical care............................................. 98 77 79

      Neurology................................................. 87 64 74

      Interventional radiology.................................. 65 22 34

      Unknown physician specialty............................... 60 34 57

      Diagnostic radiology...................................... 50 6 12

      Nephrology................................................ 33 21 64

      Maxillofacial surgery..................................... 29 23 79

      Physical medicine and rehabilitation...................... 26 16 62

      Interventional Pain Management............................ 14 2 14

      Pathology................................................. 13 3 23

      Hematology/oncology....................................... 12 12 100

      Page 35737

      Peripheral vascular disease............................... 10 5 50

      ----------------------------------------------------------------------------------------------------------------

      * Limited to the 293 procedures where post-operative visit reporting is required and to those performed by

      practitioners who work in practices with 10 or more practitioners. Because matching may be unclear in these

      circumstances, multiple procedures performed on a single day and procedures with overlapping global periods

      were excluded.

      ** Matching was based on patient, service dates, and global period duration.

      One potential explanation for these findings is that many practitioners are not consistently reporting postoperative visits using CPT code 99024. We are soliciting suggestions as to how to encourage reporting to ensure the validity of the data without imposing undue burden. Specifically, we are soliciting comments on whether we need to do more to make practitioners aware of their obligation and whether we should consider implementing an enforcement mechanism.

      Given the very small number of postoperative visits reported using CPT code 99024 during 10-day global periods, we are seeking comment on whether or not it might be reasonable to assume that many visits included in the valuation of 10-day global packages are not being furnished, or whether there are alternative explanations for what could be a significant level of underreporting of postoperative visits. For example, we are soliciting comments on whether it is likely that in many cases the practitioner reporting the procedure code is not performing the postoperative visit, or if the postoperative visit is being furnished by a different practitioner. Alternatively, we are soliciting comments on whether it is possible that some or all of the postoperative visits are occurring after the global period ends and are, therefore, reported and paid separately.

      We conducted an analysis to try to assess the extent of underreporting. We identified a set of ``robust reporters'' who appeared to be regularly reporting post-operative visits using CPT code 99024. They were defined as practitioners who (a) furnished 10 or more procedures with 90-day global periods where it is possible for us to match specific procedures to reported post-operative visits without ambiguity, and (b) reported a post-operative visit using CPT code 99024 for at least half of these 90-day global procedures. Among this subset of practitioners and procedures, we found that 87 percent of procedures with 90-day global periods had one or more associated post-operative visits. However, only 16 percent of procedures with a 10-day global period had an associated postoperative visit reported using CPT code 99024. These findings suggest that post-operative visits following procedures with 10-day global periods are not typically being furnished rather than not being reported.

      Under current policy, in cases where practitioners agree on the transfer of care for the postoperative portion of the global period, the surgeon bills only for the surgical care using modifier 54 ``for surgical care only'' and the practitioner who furnishes the postoperative care bills using modifier 55 ``postoperative management only.'' The global surgery payment is then split between the two practitioners. However, practitioners are not required to report these modifiers unless there is a formal transfer of postoperative care. We are also soliciting comments on whether we should consider requiring use of the modifiers in cases where the surgeon does not expect to perform the postoperative visits, regardless of whether or not the transfer of care is formalized.

      We are also seeking comment on the best approach to 10-day global codes for which the preliminary data suggest that postoperative visits are rarely performed by the practitioner reporting the global code. That is, we are seeking comments on whether we should consider changing the global period and reviewing the code valuation.

      Finally, we note that claims-based data collection using CPT code 99024 is intended to collect information on the number of post-

      operative visits but not the level of post-operative visits. We anticipate beginning, in the near future, a separate survey-based data collection effort on the level of post-operative visits including the time, staff, and activities involved in furnishing post-operative visits and non-face-to-face services. The survey component is intended to address concerns from the physician community that information on the number of visits alone cannot capture differences between specialties, specific procedure codes, and setting in terms of the time and effort spent on post-operative visits and non-face-to-face services included in global periods.

      RAND developed a survey that collects information on the time, staff, and activities related to five post-operative visits furnished by sampled practitioners. The CY 2017 PFS final rule (81 FR 80222) described a sampling approach for the survey that would have collected data on post-operative visits related to the full range of procedures with 10-day and 90-day global periods using a stratified random sample of approximately 5,000 practitioners. RAND piloted the post-operative visit survey in a small subsample of practitioners and found a very low response rate. This low response rate raised concerns that the survey would not yield useful or representative information on post-operative visits if the survey were fielded in the full sample.

      In an effort to increase response rate and collect sufficient data on the level of visits associated with at least some procedures with 10-day and 90-day global periods, we refocused the survey effort to collect information on post-operative visits and non-face-to-face services associated with a small number of high-volume procedure codes. The survey sampling frame includes practitioners who perform above a threshold volume of the selected high-volume procedure codes. Practitioner participation in the survey-based data collection effort is important to ensure that CMS collects useful and representative data to understand the range of activities, staff, and time involved in furnishing post-operative visits. Future survey-based data collection may cover post-operative visits and non-face-to-face services associated with a broader range of procedures with 10-day and 90-day global periods.

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  29. Radiologist Assistants

    In accordance with Sec. 410.32(b)(3), except as otherwise provided, all diagnostic X-ray and other diagnostic tests covered under section 1861(s)(3) of the Act and payable under the physician fee schedule must be furnished under at least a general level of physician supervision as defined in paragraph (b)(3)(i) of this regulation. In addition, some of these tests require either direct or personal supervision as defined in paragraph (b)(3)(ii) or (iii) of this regulation, respectively. We list the required minimum physician supervision level for each diagnostic X-ray and other diagnostic test service along with the codes and relative values for these services in the PFS Relative Value File, which is posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Relative-Value-Files.html. For most diagnostic imaging procedures, this required physician supervision level applies only to the technical component (TC) of the procedure.

    In response to the Request for Information on CMS Flexibilities and Efficiencies (RFI) that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173), many commenters recommended that we revise the physician supervision requirements at Sec. 410.32(b) for diagnostic tests with a focus on those that are typically furnished by a radiologist assistant under the supervision of a physician. Specifically, the commenters stated that all diagnostic tests, when performed by radiologist assistants (RAs), can be furnished under direct supervision rather than personal supervision of a physician, and that we should revise the Medicare supervision requirements so that when RAs conduct diagnostic imaging tests that would otherwise require personal supervision, they only need to do so under direct supervision. In addition to increasing efficiency, stakeholders suggested that the current supervision requirements for certain diagnostic imaging services unduly restrict RAs from conducting tests that they are permitted to do under current law in many states.

    After consideration of these comments on the RFI, as well as information provided by stakeholders, we are proposing to revise our regulations to specify that all diagnostic imaging tests may be furnished under the direct supervision of a physician when performed by an RA in accordance with state law and state scope of practice rules. Stakeholders representing the radiology community have provided us with information showing that the RA designation includes registered radiologist assistants (RRAs) who are certified by The American Registry of Radiologic Technologists, and radiology practitioner assistants (RPAs) who are certified by the Certification Board for Radiology Practitioner Assistants. We are proposing to revise our regulation at Sec. 410.32 to add a new paragraph (b)(4) to state that diagnostic tests performed by an RRA or an RPA require only a direct level of physician supervision, when permitted by state law and state scope of practice regulations. We note that for diagnostic imaging tests requiring a general level of physician supervision, this proposal would not change the level of physician supervision to direct supervision. Otherwise, the diagnostic imaging tests must be performed as specified elsewhere under Sec. 410.32(b). We based this proposal on recommendations from the practitioner community which included specific recommendations on how to implement the change. We received information submitted by representatives of the practitioner community, including information on the education and clinical experience of RAs, which we took into consideration in determining if this proposal would pose a significant risk to patient safety, and we determined that it would not. In addition, we considered information provided by stakeholders that indicates that 28 states have statutes or regulations that recognize RAs, and these states have general or direct supervision requirements for RAs.

  30. Payment Rates Under the Medicare PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital

    1. Background

    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that certain items and services furnished by certain off-campus provider-

    based departments (PBDs) (collectively referenced here as nonexcepted items and services furnished by nonexcepted off-campus PBDs) shall not be considered covered outpatient department services for purposes of payment under the Hospital Outpatient Prospective Payment System (OPPS), and payment for those nonexcepted items and services furnished on or after January 1, 2017 shall be made under the applicable payment system under Medicare Part B if the requirements for such payment are otherwise met. These requirements were enacted in section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74). In the CY 2017 OPPS/

    Ambulatory Surgical Center (ASC) final rule with comment period (81 FR 79699 through 79719), we established several policies and provisions to define the scope of nonexcepted items and services in nonexcepted off-

    campus PBDs. We also finalized the PFS as the applicable payment system for most nonexcepted items and services furnished by nonexcepted off-

    campus PBDs. At the same time, we issued an interim final rule with comment period (81 FR 79720 through 79729) in which we established payment policies under the PFS for nonexcepted items and services furnished on or after January 1, 2017. In the following paragraphs, we summarize the policies that we adopted for CY 2017 and CY 2018, and we propose payment policies for CY 2019. For issues related to the excepted status of off-campus PBDs or the excepted status of items and services, please see the CY 2019 OPPS/ASC proposed rule.

    2. Payment Mechanism

    In establishing the PFS as the applicable payment system for most nonexcepted items and services in nonexcepted off-campus PBDs under sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that there was no technological capability, at least in the near term, to allow off-campus PBDs to bill under the PFS for those nonexcepted items and services. Off-campus PBDs bill under the OPPS for their services on an institutional claim, while physicians and other suppliers bill under the PFS on a practitioner claim. The two systems that process these different types of claims, the Fiscal Intermediary Standard System (``FISS'') and the Multi-Carrier System (``MCS'') system, respectively, were not designed to accept or process claims of a different type. To permit an off-campus PBD to bill directly under a different payment system than the OPPS would have required significant changes to these complex systems as well as other systems involved in the processing of Medicare Part B claims. Consequently, we proposed and finalized a policy for CY 2017 and CY 2018 in which nonexcepted off-campus PBDs continue to bill for nonexcepted items and services on the institutional claim utilizing a new claim line modifier ``PN'' to indicate that an item or service is a nonexcepted item or service.

    We implemented requirements under section 1833(t)(1)(B) of the Act for CY 2017 and CY 2018 by applying an overall downward scaling factor, called

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    the PFS Relativity Adjuster to payments for nonexcepted items and services furnished in nonexcepted off campus PBDs. The PFS Relativity Adjuster generally reflects the average (weighted by claim line volume times rate) of the site-specific rate under the PFS compared to the rate under the OPPS (weighted by claim line volume times rate) for nonexcepted items and services furnished in nonexcepted off-campus PBDs. As we have discussed extensively in prior rulemaking (81 FR 97920 through 97929 and 82 FR 53021), we established a new set of site-

    specific payment rates under the PFS that reflect the relative resource cost of furnishing the technical component (TC) of services furnished in nonexcepted off-campus PBDs. For the majority of HCPCS codes, these rates are based on either (1) the difference between the PFS nonfacility payment rate and the PFS facility rate, (2) the technical component, or (3) in instances where payment would have been made only to the facility or to the physician, the full nonfacility rate. The PFS Relativity Adjuster refers to the percentage of the OPPS payment amount paid under the PFS for a nonexcepted item or service to the nonexcepted off-campus PBD.

    To operationalize the PFS Relativity Adjuster as a mechanism to pay for nonexcepted items and services furnished by nonexcepted off-campus PBDs, we adopted the packaging payment rates and multiple procedure payment reduction (MPPR) percentage that applies under the OPPS. We also incorporated the claims processing logic that is used for payments under the OPPS for comprehensive APCs (C-APCs), conditionally and unconditionally packaged items and services, and major procedures. As we noted in the CY 2017 interim final rule (82 FR 53024), we believe that this maintains the integrity of the cost-specific relativity of current payments under the OPPS compared with those under the PFS.

    In CY 2017, we implemented a PFS Relativity Adjuster of 50 percent of the OPPS rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs. For a detailed explanation of how we developed the PFS Relativity Adjuster of 50 percent for CY 2017, including assumptions and exclusions, we refer readers to the CY 2017 OPPS/ASC interim final rule with comment period (81 FR 79720 through 79729). Beginning for CY 2018, we adopted a PFS Relativity Adjuster of 40 percent of the OPPS rate. For a detailed explanation of how we developed the PFS Relativity Adjuster of 40 percent, we refer readers to the CY 2018 PFS final rule (82 FR 53019 through 53042). A brief overview of the general approach we took for CY 2018 and how it differs from the proposal for CY 2019 appears below.

    3. The PFS Relativity Adjuster

    The PFS Relativity Adjuster reflects the overall relativity of the applicable payment rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs under the PFS compared with the rate under the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did not have all of the claims data needed to identify the mix of items and services that would be billed using the ``PN'' modifier. Instead, we analyzed hospital outpatient claims data from January 1 through August 25, 2016, that contained the ``PO'' modifier, which was a new mandatory reporting requirement for CY 2016 for claims that were billed by an off-campus department of a hospital. We limited our analysis to those claims billed on the 13X Type of Bill because those claims were used for Medicare Part B billing under the OPPS. We then identified the 25 most frequently billed major codes that were billed by claim line; that is, items and services that were separately payable or conditionally packaged. Specifically, we restricted our analysis to codes with OPPS status indicators (SI) ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The most frequently billed service with the ``PO'' modifier in CY 2016 was described by HCPCS code G0463 (Hospital outpatient clinic visit for the assessment and management of a patient), which, in CY 2016, was paid under APC 5012 at a rate of $102.12; the total number of claim lines for this service was approximately 6.7 million as of August 2016. Under the PFS, there are ten CPT codes describing different levels of office visits for new and established payments. We compared the payment rate under OPPS for G0463 ($102.12) to the average of the difference between the nonfacility and facility rates for CPT code 99213 (Level III office visit for an established patient) and CPT code 99214 (Level IV office visit for an established patient) in CY 2016 and found that the relative payment difference was approximately 22 percent. We did not include HCPCS code G0463 in our calculation of the PFS Relativity Adjuster for CY 2017 because we were concerned that there was no single, directly comparable code under the PFS. As we stated in the CY 2017 interim final rule (81 FR 79723), we wanted to mitigate the risk of underestimating the overall relativity between the PFS and OPPS rates. From the remaining top 24 most frequently billed codes, we excluded HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under PFS policies, the service was only separately payable under the PFS when no other code was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) because there was no payment for this code under the PFS. For the remaining top 22 codes furnished with the ``PO'' modifier in CY 2016, the average (weighted by claim line volume times rate) of the nonfacility payment rate estimate for the PFS compared to the estimate for the OPPS was 45 percent. We indicated that, because of our inability to estimate the effect of the packaging difference between the OPPS and the PFS, we would assume a 5 percentage point adjustment upward from the calculated amount of 45 percent; therefore, we established the PFS Relativity Adjuster of 50 percent for CY 2017.

    In establishing the PFS Relativity Adjuster for CY 2018, we still did not have claims data for items and services furnished reported with a ``PN'' modifier. However, we updated the list of the 25 most frequently billed HCPCS codes using an entire year (CY 2016) of claims data for services submitted with a ``PO'' modifier and we updated the corresponding utilization weights for the codes used in the analysis. The order and composition of the top 25 separately payable HCPCS codes, based on the full year of claims from CY 2016 submitted with the ``PO'' modifier, changed minimally from the codes we used in our original analysis for the CY 2017 OPPS/ASC interim final rule with comment period. For a detailed list of the HCPCS codes we used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018 PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule (82 FR 53030 through 53031). As noted earlier, in establishing the PFS Relativity Adjuster of 50 percent for CY 2017, we did not include in the weighted average code comparison, the relative rate for the most frequently billed service furnished in off-campus PBDs, HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient), in part to ensure that we were not underestimating the overall relativity between the PFS and the OPPS. In contrast, in the CY 2018 PFS final rule, we stated that our objective for CY 2018 was to ensure that we did not overestimate the appropriate overall payment relativity, and that the payment made to nonexcepted off-campus PBDs better aligned with the

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    services that are most frequently furnished in the setting. Therefore, in addition to using updated claims data, we revised the PFS Relativity Adjuster to incorporate the relative payment rate for HCPCS code G0463 into our analysis. We followed all other exclusions and assumptions that were made in calculating the CY 2017 PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative difference in payment rates. Similar to our stated rationale in the CY 2017 PFS final rule, we increased the PFS Relativity Adjuster to 40 percent, acknowledging the difficulty of estimating the effect of the packaging differences between the OPPS and the PFS.

    4. Proposed Payment Policies for CY 2019

    In prior rulemaking, we stated our expectation that our general approach of adjusting OPPS payments using a single scaling factor, the PFS Relativity Adjuster, would continue to be an appropriate payment mechanism to implement provisions of section 603 of the Bipartisan Budget Act of 2015, and would remain in place until we are able to establish code-specific reductions that represent the technical component of services furnished under the PFS or until we are able to implement system changes needed to enable nonexcepted off-campus PBDs to bill for nonexcepted items and services under the PFS directly (82 FR 53029). As we continue to explore alternative options related to requirements under section 1833(t)(21)(C) of the Act, we believe that this overall approach is still appropriate, and we are proposing to continue to allow nonexcepted off-campus PBDs to bill for nonexcepted items and services on an institutional claim using a ``PN'' modifier until we identify a workable alternative mechanism that would improve payment accuracy.

    We made several adjustments to our methodology for calculating the PFS Relativity Adjuster for CY 2019. Most importantly, we had access to a full year of claims data from CY 2017 for services submitted with the ``PN'' modifier. Incorporating these data allows us to improve the accuracy of the PFS Relativity Adjuster by accounting for the specific mix of nonexcepted items and services furnished in nonexcepted off-

    campus PBDs. In analyzing the CY 2017 claims data, we identified just under 2,000 unique OPPS HCPCS/SI pairs reported in CY 2017 with status indicators ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V''. The data reinforce our previous observation that the single most frequently reported service furnished in nonexcepted off-campus PBDs is HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient). Nearly half (49 percent) of all claim lines for separately payable or conditionally packaged services furnished by nonexcepted off-campus PBDs included HCPCS code G0463 in CY 2017, representing 30 percent of total Medicare payments for separately payable or conditionally packaged services. The top 30 HCPCS/SI combinations accounted for 80 percent of all claim lines and approximately 60 percent of Medicare payments for services that are separately billable. In contrast with prior analyses, we also looked at claims units, which reflects HCPCS/SI combinations that are billed more than once on a claim line. Certain HCPCS codes are much more frequently billed in multiple units than others. For instance, HCPCS code G0463, which appears in nearly half of all claim lines, only represents eight percent of all claims units with a SI for separately payable or conditionally packaged services. The largest differences between the number of claim lines and the number of claims units are for injections and immunizations, which are not typically separately payable or conditionally packaged under the OPPS. For instance, HCPCS code Q9967 (Low osmolar contrast material, 300-399 mg/ml iodine concentration, per ml) was reported in 12,268 claim lines, but 1,168,393 times (claims units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator of ``N'', meaning that there is no separate payment under OPPS (items and services are packaged into APC rates).

    To calculate the PFS Relativity Adjuster using the full range of claims data submitted with a ``PN'' modifier in CY 2017, we first established site-specific rates under the PFS that reflect the technical component (TC) of items and services furnished by nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect our best current estimate of the amount that would have been paid for the service in the office setting under the PFS for practice expenses not associated with the professional component of the service. As discussed in prior rulemaking (81 FR 79720 through 79729), we believe the most appropriate code-level comparison would reflect the technical component (TC) of each HCPCS code under the PFS. However, we do not currently calculate a separate TC rate for all HCPCS codes under the PFS--only for those for which the professional component (PC) and TC of the service are distinct and can be separately billed by two different practitioners or other suppliers under the PFS. For most of the remainder of services that do not have a separately payable TC under the PFS, we estimated the site-specific rate as (1) the difference between the PFS nonfacility rate and the PFS facility rate, or (2) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. As with the PFS rates that we developed when calculating the PFS Relativity Adjuster for CY 2017 and CY 2018, there were large code-level differences between the applicable PFS rate and the OPPS rate.

    In calculating the proposed PFS Relativity Adjuster for CY 2019, we employed the same fundamental methodology that we used to calculate the PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting our analysis to the items and services billed in CY 2017 with a ``PN'' modifier that are separately payable or conditionally packaged under the OPPS (SI = ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'') and compared the rates for these codes under the OPPS with the site-specific rates under the PFS. Next, we imputed PFS rates for a limited number of items and services that are separately payable or conditionally packaged under the OPPS but are contractor priced under the PFS. We also imputed PFS rates for some HCPCS codes that are not separately payable under the OPPS (SI = ``N''), but are separately payable under the PFS. This includes items and services with an indicator status of `X' under the PFS, which are statutorily excluded from payment under the PFS, but may be paid under a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS). We summed the HCPCS-level rates under the PFS across all nonexcepted items and services, weighted by the number of HCPCS claims for each service. Next, we calculated the sum of the HCPCS-level OPPS rate for items and services that are separately payable or conditionally packaged, also weighted by the number of HCPCS claims. We compared the weighted sum of the site-specific PFS rate with the weighted sum of the OPPS rate for items and services reported in CY 2017 and we found that our updated analysis supports maintaining a PFS Relativity Adjuster of 40 percent. In view of this analysis, we propose to continue applying a PFS Relativity Adjuster of 40 percent for CY 2019. Moreover, we propose to maintain this PFS Relativity Adjuster for future years

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    until updated data or other considerations indicate that an alternative adjuster or a change to our approach is warranted, which we would then propose through notice and comment rulemaking. We discuss some of our ongoing data analyses and future plans regarding implementation of section 603 of the Bipartisan Budget Act of 2015 below.

    5. Policies Related to Supervision, Beneficiary Cost-Sharing, and Geographic Adjustments

    In the CY 2018 PFS final rule (81FR 53019 through 53031), we finalized policies related to supervision rules, beneficiary cost sharing, and geographic adjustments. We finalized that supervision rules in nonexcepted off-campus PBDs that furnish nonexcepted items and services are the same as those that apply for hospitals, in general. We also finalized that all beneficiary cost sharing rules that apply under the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the Act continue to apply when payment is made under the PFS for nonexcepted items and services furnished by nonexcepted off-campus PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we finalized the policy to apply the same geographic adjustments used under the OPPS to nonexcepted items and services furnished in nonexcepted off-campus PBDs. We note that we are maintaining these policies as finalized in CY 2018 PFS final rule.

    6. Partial Hospitalization

    1. Partial Hospitalization Services

    Partial hospitalization programs (PHPs) are intensive outpatient psychiatric day treatment programs furnished to patients as an alternative to inpatient psychiatric hospitalization, or as a stepdown to shorten an inpatient stay and transition a patient to a less intensive level of care. Section 1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished by a hospital, to its outpatients, or by a Community Mental Health Center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the proposed implementation of section 603 of Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish PHP services and are ineligible to be provider-based to a hospital, a nonexcepted off-campus PBD would be eligible for PHP payment if the entity enrolls and bills as a CMHC for payment under the OPPS. We further noted that a hospital may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided it meets all Medicare requirements and conditions of participation.

    Commenters expressed concern that without a clear payment mechanism for PHP services furnished by nonexcepted off-campus PBDs, access to partial hospitalization services would be limited, and pointed out the critical role PHPs play in the continuum of mental health care. Many commenters believed that the Congress did not intend for partial hospitalization services to no longer be paid for by Medicare when such services are furnished by nonexcepted off-campus PBDs. Several commenters disagreed with the notion of enrolling as a CMHC in order to receive payment for PHP services. These commenters stated that hospital-based PHPs and CMHCs are inherently different in structure, operation, and payment, and noted that the conditions of participation for hospital departments and CMHCs are different. Several commenters requested that CMS find a mechanism to pay hospital-based PHPs in nonexcepted off-campus PBDs.

    Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC final rule with comment period and interim final rule with comment period (81 FR 79715, 79717, and 79727), we adopted payment for partial hospitalization items and services furnished by nonexcepted off-campus PBDs under the PFS. When billed in accordance with the CY 2017 interim final rule, these partial hospitalization services are paid at the CMHC per diem rate for APC 5853, for providing three or more partial hospitalization services per day (81 FR 79727).

    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 OPPS/ASC final rule with comment period, and the interim final rule with comment period (81 FR 79717 and 79727), we noted that when a beneficiary receives outpatient services in an off-campus department of a hospital, the total Medicare payment for those services is generally higher than when those same services are provided in a physician's office. Similarly, when partial hospitalization services are provided in a hospital-based PHP, Medicare pays more than when those same services are provided by a CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing PHP services is because CMHCs are freestanding entities that are not part of a hospital, but they provide the same PHP services as hospital-based PHPs (81 FR 79727). This is similar to the differences between freestanding entities paid under the PFS that furnish other services also provided by hospital-based entities. Similar to other entities currently paid for their technical component services under the PFS, we believe CMHCs would typically have lower cost structures than hospital-based PHPs, largely due to lower overhead costs and other indirect costs such as administration, personnel, and security. We believe that paying for nonexcepted hospital-based partial hospitalization services at the lower CMHC per diem rate aligns with section 603 of Bipartisan Budget Act of 2015, while also preserving access to PHP services. In addition, nonexcepted off-campus PBDs will not be required to enroll as CMHCs in order to bill and be paid for providing partial hospitalization services. However, a nonexcepted off-campus PBD that wishes to provide PHP services may still enroll as a CMHC if it chooses to do so and meets the relevant requirements. Finally, we recognize that because hospital-

    based PHPs are providing partial hospitalization services in the hospital outpatient setting, they can offer benefits that CMHCs do not have, such as an easier patient transition to and from inpatient care, and easier sharing of health information between the PHP and the inpatient staff.

    In the CY 2018 PFS final rule, we did not require these PHPs to enroll as CMHCs but instead we continued to pay nonexcepted off-campus PBDs providing PHP items and services under the PFS. Further, in that CY 2018 PFS final rule, we continued to adopt the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing three or more PHP services per day in CY 2018 (82 FR 53025 to 53026).

    For CY 2019, we propose to continue to identify the PFS as the applicable payment system for PHP services furnished by nonexcepted off-campus PBDs, and propose to continue to set the PFS payment rate for these PHP services as the per diem rate that would be paid to a CMHC in CY 2019. We further propose to maintain these policies for future years until updated data or other considerations indicate that a change to our approach is warranted, which we would then propose through notice and comment rulemaking.

    7. Future Years

    We continue to believe the amendments made by section 603 of the Bipartisan Budget Act of 2015 were intended to eliminate the Medicare payment incentive for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill

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    under the OPPS for items and services they furnish there. Therefore, we continue to believe the payment policy under this provision should ultimately equalize payment rates between nonexcepted off-campus PBDs and physician offices to the greatest extent possible, while allowing nonexcepted off-campus PBDs to bill in a straight-forward way for services they furnish.

    Under the proposed methodology for CY 2019 as described previously, we use updated claims data for CY 2019, in combination with the expanded number of site specific, technical component rates for nonexcepted items and services furnished in nonexcepted off campus PBDs, in order to ensure that Medicare payment to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs reflects the relative resources involved in furnishing the items and services. We recognize that for certain specialties, service lines, and nonexcepted off-campus PBD types, total Medicare payments for the same services might be either higher or lower when furnished by a nonexcepted off-campus PBD rather than in a physician office. We also note that our approach adopts packaging rules and MPPR rules under the OPPS.

    As noted above, we intend to continue to examine the claims data in order to assess whether a different PFS Relativity Adjuster is warranted and also to consider whether additional adjustments to the methodology are appropriate. In particular, we are monitoring claims for shifts in the mix of services furnished in nonexcepted off campus PBDs that may affect the relativity between the PFS and OPPS. An increase over time in the share of nonexcepted items and services with lower technical component rates under the PFS compared with APC rates under the OPPS might result in a lower PFS Relativity Adjuster, for example. We will also carefully assess annual payment policy updates to the PFS and OPPS fee schedule rules, respectively, to identify changes in overall relativity resulting from any new or modified policies such as expanded packaging under the OPPS or an increase in the number of HCPCS codes with global periods under the PFS. As part of these ongoing efforts, we are also analyzing PFS claims data to identify patterns of services furnished together on the same day. We anticipate that this will ultimately allow us to make refinements to the PFS Relativity Adjuster to better account for the more extensive packaging of services under the OPPS and the potential underreporting of services that are not separately payable under the OPPS but are paid separately under the PFS.

    Another dimension of our ongoing efforts to improve implementation of section 603 of the Bipartisan Budget Act of 2015 is the development and refinement of a new set of payment rates under the PFS that reflect the relative resource costs of furnishing the technical component of items and services furnished in nonexcepted off campus PBDs. Although we believe that our site-specific HCPCS-level rates reflect the best available estimate of the amount that would have been paid for the service in the office setting under the PFS for practice expenses not associated with the professional component of the service, for the majority of HCPCS codes there is no established methodology for separately valuing the resource costs incurred by a provider while furnishing a service from those incurred exclusively by the facility in which the service is furnished. We continue to explore alternatives to our current estimates that would better reflect the TC of services furnished in nonexcepted off campus PBDs. We are broadly interested in stakeholder feedback and recommendations for ways in which CMS can improve pricing and transparency with regard to the differences in the payment rates across sites of service.

    We expect that our continued analyses of claims data and our ongoing exploration of systems changes that are needed to allow nonexcepted off campus PBDs to bill directly for the TC portion of nonexcepted items and services may lead us to consider a different approach for implementing section 603 of the Bipartisan Budget Act of 2015. On the whole, however, we believe that the proposed PFS Relativity Adjuster for CY 2019 of 40 percent would advance the effort to equalize payment rates in the aggregate between physician offices and nonexcepted off-campus PBDs. Maintaining our policy of applying an overall scaling factor to OPPS payments allows hospitals to continue billing through a facility claim form and permits continued use of the packaging rules and cost report-based relative payment rate determinations for nonexcepted services.

  31. 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. 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, 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, 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, we reviewed the comments received during the 60-day public comment period following release of the

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    CY 2016 PFS final rule with comment period, and re-proposed 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. For CY 2017, we did not identify any new codes that described such wholly new services. Therefore, we did not establish any code values on an interim final basis.

    For CY 2018, we generally proposed the RUC-recommended work RVUs for new, revised, and potentially misvalued codes. We proposed these values based on our understanding that the RUC generally considers the kinds of concerns we historically raised regarding appropriate valuation of work RVUs. However, during our review of these recommended values, we identified some concerns similar to those we recognized in prior years. Given the relative nature of the PFS and our obligation to ensure that the RVUs reflect relative resource use, we included descriptions of potential alternative approaches we might have taken in developing work RVUs that differed from the RUC-recommended values. We sought comment on both the RUC-recommended values, as well as the alternatives considered. Several commenters generally supported the proposed use of the RUC-recommended work RVUs, without refinement. Other commenters expressed concern about the effect of the misvalued code reviews on particular specialties and settings and disappointment with our proposed approach for valuing codes for CY 2018. A detailed summary of the comments and our responses can be found in the CY 2018 PFS final rule (82 FR 53033-53035).

    We clarified in response to commenters that we are not relinquishing our obligation to independently establish appropriate RVUs for services paid under the PFS. We will continue to thoroughly review and consider information we receive from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes 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. While generally proposing the RUC-recommended work RVUs for new, revised, and potentially misvalued codes was our approach for CY 2018, we note that we also included alternative values where we believed there was a possible opportunity for increased precision. We also clarified that as part of our obligation to establish RVUs for the PFS, we annually make an independent assessment of the available recommendations, supporting documentation, and other available information from the RUC and other commenters to determine the appropriate 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 will continue to 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 conducted 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 included, but had 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 assessed 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 used in the building block approach may have included 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 used 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 utilized 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 refined 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

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    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 believed that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjusted 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 removed 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 removed a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we did 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 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 used 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 believed that such changes in time were already accounted for in the RUC's recommendation, then we did not made such adjustments. Likewise, we did not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We used the ratios to identify potential work RVUs and considered 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 have believed 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, 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 is 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.

    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 section II.H.4 of this proposed rule for a detailed discussion of the proposed valuation, and alternative valuation considered for specific codes. Table 13 contains a list of codes for which we propose work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2018. The proposed work RVUs, work time and other payment information for all proposed CY 2019 payable codes are available on the CMS website under downloads for the CY 2019 PFS proposed rule. Table 13 also contains

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    the CPT code descriptors for all proposed, new, revised, and potentially misvalued codes discussed in this section.

    3. Methodology for the Direct PE Inputs To Develop PE RVUs

    1. 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 RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 details our refinements of the RUC's direct PE recommendations at the code-

      specific level. In this proposed rule, we address several refinements that are common across codes, and refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note 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 $0.30 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 nearly half of the refinements listed in Table 14 result in changes under the $0.30 threshold and are unlikely to result in a change to the RVUs.

      We also note that the proposed direct PE inputs for CY 2019 are displayed in the CY 2019 direct PE input database, available on the CMS website under the downloads for the CY 2019 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 2019 PE RVUs as displayed in Addendum B.

    2. 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

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      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 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. Some recommendations, however, 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 2019, we received invoices for several new supply and equipment items. Tables 15 and 16 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, we encourage 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 encourage stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database during the 60-day public comment period for this proposed rule. We expect that invoices received outside of the public comment period would be submitted by February 10th of the following year for consideration in future rulemaking, similar to our new process for consideration of RUC recommendations.

      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 15 and 16 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 proposed 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 proposed 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 both the services subject to the MPPR lists on 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 2019 are available on the CMS website under downloads for the CY 2019 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-

      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 69659-69662).

      4. Proposed Valuation of Specific Codes for CY 2019

      (1) Fine Needle Aspiration (CPT Codes 10021, 10X11, 10X12, 10X13, 10X14, 10X15, 10X16, 10X17, 10X18, 10X19, 76492, 77002 and 77021)

      CPT code 10021 was identified as part of the OPPS cap payment proposal in CY 2014 (78 FR 74246-74248), and it was reviewed by the RUC for direct PE inputs only as part of the CY 2016 rule cycle. Afterwards, CPT codes 10021 and 10022 were referred to the CPT Editorial Panel to consider adding additional clarifying language to the code descriptors and to include bundled imaging guidance due to the fact that imaging had become typical with these services. In June 2017, the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, and created nine new codes to describe fine needle aspiration procedures with and without imaging guidance. These ten codes were surveyed and reviewed for the October 2017 and January 2018 RUC meetings. Several imaging services were also reviewed along with the rest of the code family, although only CPT code 77021 was subject to a new survey.

      For CY 2019, we are proposing the RUC-recommended work RVU for seven of the ten codes in this family. Specifically, we are proposing a work RVU of 0.80 for CPT code 10X11 (Fine needle aspiration biopsy; without

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      imaging guidance; each additional lesion), a work RVU of 1.00 for CPT code 10X13 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion), a work RVU of 1.81 for CPT code 10X14 (Fine needle aspiration biopsy, including fluoroscopic guidance; first lesion), a work RVU of 1.18 for CPT code 10X15 (Fine needle aspiration biopsy, including fluoroscopic guidance; each additional lesion), and a work RVU of 1.65 for CPT code 10X17 (Fine needle aspiration biopsy, including CT guidance; each additional lesion). We are also proposing to assign the recommended contractor-priced status to CPT codes 10X18 (Fine needle aspiration biopsy, including MR guidance; first lesion) and 10X19 (Fine needle aspiration biopsy, including MR guidance; each additional lesion) due to low utilization until these services are more widely utilized. In addition, we are proposing the recommended work RVU of 1.50 for CPT code 77021 (Magnetic resonance guidance for needle placement (e.g., for biopsy, fine needle aspiration biopsy, injection, or placement of localization device) radiological supervision and interpretation), as well as proposing to reaffirm the current work RVUs of 0.67 for CPT code 76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine needle aspiration biopsy, injection, localization device), imaging supervision and interpretation) and 0.54 for 77002 (Fluoroscopic guidance for needle placement (e.g., biopsy, fine needle aspiration biopsy, injection, localization device)).

      We disagree with the RUC-recommended work RVU of 1.20 for CPT code 10021 (Fine needle aspiration biopsy; without imaging guidance; first lesion) and are proposing a work RVU of 1.03 based on a direct crosswalk to CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code 36440 is a recently reviewed code with the same intraservice time of 15 minutes and 2 additional minutes of total time. In reviewing CPT code 10021, we noted that the recommended intraservice time is decreasing from 17 minutes to 15 minutes (12 percent reduction), and the recommended total time is decreasing from 48 minutes to 33 minutes (32 percent reduction); however, the RUC-

      recommended work RVU is only decreasing from 1.27 to 1.20, which is a reduction 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 10021, we believe that it would be more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to account for these decreases in the surveyed work time.

      We disagree with the RUC-recommended work RVU of 1.63 for CPT code 10X12 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and are proposing a work RVU of 1.46. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 10021 and 10X12 is equivalent to the recommended interval of 0.43 RVUs. Therefore, we are proposing a work RVU of 1.46 for CPT code 10X12, based on the recommended interval of 0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed increment of 0.43 RVUs above CPT code 10021 is also based on the use of two crosswalk codes: CPT code 99225 (Subsequent observation care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components); and CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components). Both of these codes have the same intraservice time and 1 additional minute of total time as compared with CPT code 10X12, and both crosswalk codes share a work RVU of 1.39.

      We disagree with the RUC-recommended work RVU of 2.43 for CPT code 10X16 (Fine needle aspiration biopsy, including CT guidance; first lesion) and we are proposing a work RVU of 2.26. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 10021 and 10X16 is equivalent to the recommended interval of 1.23 RVUs. Therefore, we are proposing a work RVU of 2.26 for CPT code 10X16, based on the recommended interval of 1.23 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed use of the recommended increment from CPT code 10021 is also based on the use of a crosswalk to CPT code 74263 (Computed tomographic (CT) colonography, screening, including image postprocessing), another CT procedure with 38 minutes of intraservice time and 50 minutes of total time at a work RVU of 2.28.

      We note that the recommended work pool is increasing by approximately 20 percent for the Fine Needle Aspiration family as a whole, while the recommended work time pool for the same codes is only increasing by about 2 percent. Since time is defined as one of the two components of work, we believe that this indicates a discrepancy in the recommended work values. 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 recommended work values for all of the codes in this family. We believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. 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 10022 and 76942, but preservice times were assigned to both of the codes under the old coding. We believe the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed regardless of how the services were previously reported.

      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 for CPT code 77021. This code did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. 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 times in accordance with our standard equipment time formulas.

      (2) Biopsy of Nail (CPT Code 11755)

      CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix, hyponychium, proximal and lateral nail folds) (separate procedure)) was identified as potentially

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      misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, the HCPAC recommended a work RVU of 1.25 based on the survey median value.

      We disagree with the recommended value and are proposing a work RVU of 1.08 for CPT code 11755 based on the survey 25th percentile value. We note that the recommended intraservice time for CPT code 11755 is decreasing from 25 minutes to 15 minutes (40 percent reduction), and the recommended total time for CPT code 11755 is decreasing from 55 minutes to 39 minutes (29 percent reduction); however, the recommended work RVU is only decreasing from 1.31 to 1.25, 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 reflected in decreases to work RVUs. In the case of CPT code 11755, we believe that it would be more accurate to propose the survey 25th percentile work RVU than the survey median to account for these decreases in the surveyed work time.

      The proposed work RVU of 1.08 is also based on a crosswalk to CPT code 11042 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); first 20 sq cm or less), which has a work RVU of 1.01, the same intraservice time of 15 minutes, and a similar total time of 36 minutes. We also note that, generally speaking, working with extremities like nails tends to be less intensive in clinical terms than other services, especially as compared to surgical procedures. We believe that this further supports our proposal of a work RVU of 1.08 for CPT code 11755.

      We are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (3) Skin Biopsy (CPT Codes 11X02, 11X03, 11X04, 11X05, 11X06, and 11X07)

      In CY 2016, CPT codes 11100 (Biopsy of skin, subcutaneous tissue and/or mucous membrane (including simple closure), unless otherwise listed; single lesion) and 11101 (Biopsy of skin, subcutaneous tissue and/or mucous membrane (including simple closure), unless otherwise listed; each separate/additional lesion) were identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. Prior to the January 2016 RUC meeting, the specialty society notified the RUC that its survey data displayed a bimodal distribution of responses with more outliers than usual. The RUC referred CPT codes 11100 and 11101 to the CPT Editorial Panel. In February 2017, the CPT Editorial Panel deleted these two codes and created six new codes for primary and additional biopsy based on the thickness of the sample and the technique utilized.

      For CY 2019, we are proposing the RUC-recommended work RVUs for five of the six codes in the family. We are proposing a work RVU of 0.66 for CPT code 11X02 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), single lesion), a work RVU of 0.83 for CPT code 11X04 (Punch biopsy of skin, (including simple closure when performed), single lesion), a work RVU of 0.45 for CPT code 11X05 (Punch biopsy of skin, (including simple closure when performed), each separate/additional lesion), a work RVU of 1.01 for CPT code 11X06 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), single lesion), and a work RVU of 0.54 for CPT code 11X07 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), each separate/additional lesion).

      For CPT code 11X03 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), each separate/additional lesion), we disagree with the RUC-recommended work RVU of 0.38 and are proposing a work RVU of 0.29. When we compared the RUC-recommended work RVU of 0.38 to other add-on codes in the RUC database, we found that CPT code 11X03 would have the second-highest work RVU for any code with 7 minutes or less of total time, with the recommended work RVU noticeably higher than other related add-on codes, and we did not agree that the tangential biopsy service being performed should have an anomalously high work value in comparison to other similar add-on codes. Our proposed work RVU of 0.29 is based on a crosswalk to CPT code 11201 (Removal of skin tags, multiple fibrocutaneous tags, any area; each additional 10 lesions, or part thereof), a clinically related add-on procedure with 5 minutes of intraservice and total time as opposed to the surveyed 6 minutes for CPT code 11X03. We also noted that the intraservice time ratio between CPT code 11X03 and the recommended reference code, CPT code 11732 (Avulsion of nail plate, partial or complete, simple; each additional nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75 percent ratio when applied to the work RVU of CPT code 11732 also produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we are also supporting the proposed work RVU through a crosswalk to CPT code 33508 (Endoscopy, surgical, including video-assisted harvest of vein(s) for coronary artery bypass procedure), which has a higher intraservice time of 10 minutes but a similar work RVU of 0.31. We believe that our proposed work RVU of 0.29 for CPT code 11X03 better serves the interests of relativity, as well as better fitting with the other recommended work RVUs within this family of codes.

      For the direct PE inputs, we are proposing to remove the 2 minutes of clinical labor time for the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) activity for CPT codes 11X02, 11X04, and 11X06. These codes are typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      We are proposing to refine the quantity of the ``gown, staff, impervious'' (SB024) and the ``mask, surgical, with face shield'' (SB034) supplies from 2 to 1 for CPT codes 11X02, 11X04, and 11X06. We are proposing to remove one gown and one surgical mask from these codes as duplicative since these supplies are also included within the surgical instrument cleaning pack (SA043). We are also proposing to remove all of the supplies in the three add-on procedures (CPT codes 11X03, 11X05, and 11X07) that were not contained in the previous add-on procedure for this family, CPT code 11101. We do not believe that the use of these supplies would be typical for the ``each additional lesion'' add-on codes, as these supplies are all included in the base codes and are not currently utilized in CPT code 11101. We note that the recommended direct PE costs for the three new add-on codes represent an increase of approximately 500 percent from the direct PE costs for CPT code 11101, and believe that this is largely due to the addition of these new supplies.

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      (4) Injection Tendon Origin-Insertion (CPT Code 20551)

      CPT code 20551 (Injection(s); single tendon origin/insertion) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-

      recommended work RVU of 0.75 for CPT code 20551.

      We are proposing to maintain the current work RVU for many of the CPT codes identified as potentially misvalued on the screen of 0-day global services reported with an E/M visit 50 percent of the time or more. We note that regardless of the proposed work valuations for individual codes, which may or may not retain the same work RVU, we continue to have reservations about the valuation of 0-day global services that are typically billed with a separate E/M service with the use of Modifier 25 (indicating that a significant and separately identifiable E/M service was provided on the same day). As we stated in the CY 2017 PFS final rule (81 FR 80204), we continue to believe that the routine billing of separate E/M services in conjunction with a particular code may indicate a possible problem with the valuation of the code bundle, which is intended to include all the routine care associated with the service. We will continue to consider additional ways to address the appropriate valuation for these services.

      For the direct PE inputs, we are proposing to remove the clinical labor time for the ``Provide education/obtain consent'' (CA011) and the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) activities for CPT code 20551. This code is typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for obtaining consent or reviewing home care instructions given that these tasks would typically be done during the same day E/M service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (5) Structural Allograft (CPT Codes 209X3, 209X4, and 209X5)

      In February 2017, the CPT Editorial Panel created three new codes to describe allografts. These codes were designated as add-on codes and revised to more accurately describe the structural allograft procedures they represent. For CY 2019, we are proposing the RUC-recommended work RVUs for all three codes. We are proposing a work RVU of 13.01 for CPT code 209X3 (Allograft, includes templating, cutting, placement and internal fixation when performed; osteoarticular, including articular surface and contiguous bone), a work RVU of 11.94 for CPT code 209X4 (Allograft, includes templating, cutting, placement and internal fixation when performed; hemicortical intercalary, partial (i.e., hemicylindrical)), and a work RVU of 13.00 for CPT code 209X5 (Allograft, includes templating, cutting, placement and internal fixation when performed; intercalary, complete (i.e., cylindrical)).

      These three new codes are all facility-only procedures with no recommended direct PE inputs.

      (6) Knee Arthrography Injection (CPT Code 27X69)

      CPT code 27370 (Injection of contrast for knee arthrography) repeatedly appeared on high volume growth screens between 2008 and 2016, and the RUC expressed concern that the high volume growth for this procedure was likely due to its being reported incorrectly as arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel deleted CPT code 27370 and replaced it with a new code, 27X69, to report injection procedure for knee arthrography or enhanced CT/MRI knee arthrography.

      The RUC recommended a work RVU for CPT code 27X69 of 0.96, which is identical to the work RVU for CPT code 27370 (Injection of contrast for knee arthrography). The RUC's recommendation is based on key reference service, CPT code 23350 (Injection procedure for shoulder arthrography or enhanced CT/MRI shoulder arthrography), with identical intraservice time (15 minutes) and total time (28 minutes) as the new CPT code and a work RVU of 1.00. The RUC notes that its recommendation is lower than the 25th percentile from the survey results, but that the work described by the service should be valued identically with the CPT code being replaced. We disagree with the RUC's recommended work RVU for CPT code 27X69. Both the total (28 minutes) and intraservice (15 minutes) times for the new CPT code are considerably lower than the deleted CPT code 27370. Based on the reduced times and the projected work RVU from the reverse building block methodology (0.60 work RVUs), we believe this CPT code should be valued at 0.77 work RVUs, supported by a crosswalk to CPT code 29075 (Application, cast; elbow to finger (short arm)), with total time of 27 minutes and intraservice time of 15 minutes. Therefore, we are proposing a work RVU of 0.77 for CPT code 27X69.

      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. The predecessor code for 27X69, CPT code 27370, did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. 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 proposing to remove the clinical labor time for the ``Scan exam documents into PACS. Complete exam in RIS system to populate images into work queue'' (CA032) activity. CPT code 27X69 does not include a PACS workstation among the recommended equipment, and the predecessor code 27370 did not previously include time for this clinical labor activity. We believe that data entry activities such as this task would be classified as indirect PE, as they are considered administrative activities and are not individually allocable to a particular patient for a particular service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (7) Application of Long Arm Splint (CPT Code 29105)

      CPT code 29105 (Application of long arm splint (shoulder to hand)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-

      recommended work RVU of 0.80 for CPT code 29105.

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (8) Strapping Lower Extremity (CPT Codes 29540 and 29550)

      CPT codes 29540 (Strapping; ankle and/or foot) and 29550 (Strapping; toes) were identified as potentially misvalued

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      on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-recommended work RVU of 0.25 for CPT code 29550.

      For the direct PE inputs, we are proposing to refine the clinical labor time for the ``Provide education/obtain consent'' (CA011) activity from 3 minutes to 2 minutes for both codes, as this is the standard clinical labor time assigned for patient education and consent. We are also proposing to remove the 2 minutes of clinical labor time for the ``Review home care instructions, coordinate visits/

      prescriptions'' (CA035) activity for both codes. CPT codes 29540 and 29550 are both typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (9) Bronchoscopy (CPT Codes 31623 and 31624)

      CPT code 31623 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with brushing or protected brushings) was identified on a high growth screen of services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. CPT code 31624 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial alveolar lavage) was also included for review as part of the same family of codes. For CY 2019, we are proposing the RUC-

      recommended work RVU of 2.63 for CPT codes 31623 and 31624.

      For the direct PE inputs, we are proposing to refine the clinical labor time for the ``Complete post-procedure diagnostic forms, lab and x-ray requisitions'' (CA027) activity from 4 minutes to 2 minutes for CPT codes 31623 and 31624. Two minutes is the standard time, as well as the current time for this clinical labor activity, and we have no reason to believe that the time to perform this task has increased since the codes were last reviewed. We did not receive any explanation in the recommendations as to why the time for this activity would be doubling over the current values. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 332X0 and 93XX1)

      In September 2017, the CPT Editorial Panel created a code to describe pulmonary wireless sensor implantation and another code for remote care management of patients with an implantable, wireless pulmonary artery pressure sensor monitor. For CY 2019, we are proposing the RUC-recommended work RVU of 6.00 for CPT code 332X0 (Transcatheter implantation of wireless pulmonary artery pressure sensor for long term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed), and the RUC-recommended work RVU of 0.70 for CPT code 93XX1 (Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional).

      We are not proposing any direct PE refinements for this code family.

      (11) Cardiac Event Recorder Procedures (CPT Codes 332X5 and 332X6)

      In February 2017, the CPT Editorial Panel created two new codes replacing cardiac event recorder codes to reflect new technology. For CY 2019, we are proposing the RUC-recommended work RVU of 1.53 for CPT code 332X5 (Insertion, subcutaneous cardiac rhythm monitor, including programming) and the RUC-recommended work RVU of 1.50 for CPT code 332X6 (Removal, subcutaneous cardiac rhythm monitor).

      We are not proposing any direct PE refinements for this code family.

      (12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 335X1)

      In September 2017, the CPT Editorial Panel created one new code to combine the efforts of aortic valve and root replacement with subvalvular left ventricular outflow tract enlargement to allow for an unobstructed left ventricular outflow tract.

      For CY 2019, we are proposing the RUC-recommended work RVU of 64.00 for CPT code 335X1 (Replacement, aortic valve; by translocation of autologous pulmonary valve and transventricular aortic annulus enlargement of the left ventricular outflow tract with valved conduit replacement of pulmonary valve (Ross-Konno procedure)). When this code is re-reviewed in a few years as part of the new technology screen, we look forward to receiving new recommendations on the whole family, including the related Ross and Konno procedures (CPT codes 33413 and 33412 respectively) that were used as references for CPT code 335X1.

      For the direct PE inputs, we are proposing to refine the preservice clinical labor times to match our standards for 90-day global procedures. We are proposing to refine the clinical labor time for the ``Coordinate pre-surgery services (including test results)'' (CA002) activity from 25 minutes to 20 minutes, to refine the clinical labor time for the ``Schedule space and equipment in facility'' (CA003) activity from 12 minutes to 8 minutes, and to refine the clinical labor time for the ``Provide pre-service education/obtain consent'' (CA004) activity from 26 minutes to 20 minutes. We are also proposing to add 15 minutes of clinical labor time for the ``Perform regulatory mandated quality assurance activity (pre-service)'' (CA008) activity. We agree with the recommendation that the total preservice clinical labor time for CPT code 335X1 is unchanged from the two reference codes at 75 minutes. However, we believe that the clinical labor associated with additional coordination between multiple specialties prior to patient arrival is more accurately described through the use of the CA008 activity code than by distributing this 15 minutes amongst the other preservice clinical labor activities. We previously established standard preservice times for 90-day global procedures, and did not want to propose clinical labor times above those standards for CPT code 335X1. We also note that there is no effect on the total clinical labor direct costs in this situation, since the same 15 minutes of preservice clinical labor time is still being furnished.

      (13) Hemi-Aortic Arch Replacement (CPT Code 33X01)

      At the September 2017 CPT Editorial Panel meeting, the Panel created one new add-on code to report hemi-aortic arch graft replacement. For CY 2019, we are proposing the RUC-recommended work RVU of 19.74 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). CPT code

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      33X01 is a facility-only procedure with no recommended direct PE inputs.

      (14) Leadless Pacemaker Procedures (CPT Codes 33X05 and 33X06)

      At the September 2017 CPT Editorial Panel meeting, the Panel replaced the five leadless pacemaker services Category III codes with the addition of two new CPT codes to report transcatheter leadless pacemaker procedures and revised five codes to include evaluation and interrogation services of leadless pacemaker systems.

      For CPT code 33X05 (Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed), we disagree with the recommended work RVU of 8.77 and we are proposing a work RVU of 7.80 based on a direct crosswalk to one of the top reference codes selected by the RUC survey participants, CPT code 33207 (Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); ventricular). This code has the same 60 minutes of intraservice time as CPT code 33X05 and an additional 61 minutes of total time at a work RVU of 7.80. In our review of CPT code 33X05, we noted that this reference code had an additional inpatient hospital visit of CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components) and a full instead of a half discharge visit of CPT code 99238 (Hospital discharge day management; 30 minutes or less) included in its 90-day global period. The combined work RVU of these two visits would be equal to 2.03. However, the recommended work RVU for CPT code 33X05 was 0.97 work RVUs higher than CPT code 33207, despite having fewer of these visits and significantly less surveyed total time. While we acknowledge that CPT code 33X05 is a more intense procedure than CPT code 33207, we do not believe that it should be valued almost a full RVU higher than the reference code given the fewer visits in the global period and the lower surveyed work time.

      Therefore, we are proposing to crosswalk CPT code 33X05 to CPT code 33207 at the same work RVU of 7.80. The proposed work RVU is also supported through a reference crosswalk to CPT code 38542 (Dissection, deep jugular node(s)), which has 60 minutes of intraservice time, 198 minutes of total time, and a work RVU of 7.95. We believe that our proposed work RVU of 7.80 is a more accurate valuation for CPT code 33X05, while still recognizing the greater intensity of this procedure in comparison to its reference code.

      For CPT code 33X06 (Transcatheter removal of permanent leadless pacemaker, right ventricular), we disagree with the RUC-recommended work RVU of 9.56 and we are proposing a work RVU of 8.59. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 33X05 and 33X06 is equivalent to the recommended interval of 0.79 RVUs. Therefore, we are proposing a work RVU of 8.59 for CPT code 33X06, based on the recommended interval of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT code 33X05. We also note that our proposed work RVU for CPT code 33X06 situates it approximately halfway between the two reference codes from the survey, with CPT code 33270 (Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed) having an intraservice time of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33X06 has a surveyed intraservice time of 75 minutes and nearly splits the difference between them at our proposed work RVU of 8.59.

      We are not proposing any direct PE refinements for this code family.

      (15) PICC Line Procedures (CPT Codes 36568, 36569, 36X72, 36X73, and 36584)

      In CY 2016, CPT code 36569 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, without imaging guidance; age 5 years or older) was identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. CPT code 36569 is typically reported with CPT codes 76937 (Ultrasound guidance for vascular access requiring ultrasound evaluation of potential access sites, documentation of selected vessel patency, concurrent realtime ultrasound visualization of vascular needle entry, with permanent recording and reporting) and 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal) and was referred to the CPT Editorial Panel to have the two common imaging codes bundled into the code. In September 2017, the CPT Editorial Panel revised CPT codes 36568 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump; younger than 5 years of age), 36569 and 36584 (Replacement, complete, of a peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, through same venous access, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the replacement) and created two new CPT codes to specify the insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion.

      For CY 2019, we are proposing the RUC-recommended work RVU for two of the CPT codes in the family. We are proposing the RUC-recommended work RVU of 2.11 for CPT code 36568 and the RUC-recommended work RVU of 1.90 for CPT code 36569.

      For CPT code 36X72 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; younger than 5 years of age), we disagree with the RUC-

      recommended work RVU of 2.00 and are proposing a work RVU of 1.82 based on a direct crosswalk to CPT code 50435 (Exchange 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 50435 is a recently reviewed code that also includes radiological supervision and interpretation with similar intraservice and total time values. In our review of CPT code 36X72, we were concerned about the possibility that the recommended work RVU of 2.00 could create a rank order anomaly in terms of intensity with the other codes in the family. We noted that the recommended intraservice time for CPT code 36X72 as compared to CPT code 36568, the most similar code in the family, is decreasing from 38 minutes to 22 minutes (42 percent), and the recommended total time is decreasing from 71 minutes to 51 minutes (38

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      percent); however, the recommended work RVU is only decreasing from 2.11 to 2.00, which is a reduction of just over 5 percent. We also noted that CPT code 36X72 has a lower recommended intraservice time and total time as compared to CPT code 36569, yet has a higher recommended work RVU. Although we do not imply that the decreases 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 reflected in decreases to work RVUs.

      In the case of CPT code 36X72, we believe that it would be more accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 50435 to better fit with the recommended work RVUs for CPT codes 36568 and 36569. The proposed work valuation is also based on the use of three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with biopsy, single or multiple), and CPT code 64644 (Chemodenervation of one extremity; 5 or more muscles). All of these codes were recently reviewed with similar intensity, intraservice time, and total time values, and all three of them also share a work RVU of 1.82.

      For CPT code 36X73 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; age 5 years or older), we disagree with the RUC-recommended work RVU of 1.90 and are proposing a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. In our review of CPT code 36X73, we were again concerned about the possibility that the recommended work RVU of 1.90 could create a rank order anomaly in terms of intensity with the other codes in the family. We noted that the recommended intraservice time for CPT code 36X73 as compared to CPT code 36569, the most similar code in the family, is decreasing from 27 minutes to 15 minutes (45 percent), and the recommended total time is decreasing from 60 minutes to 40 minutes (33 percent); however, the RUC-recommended work RVU is exactly the same for these two codes at 1.90. Although we do not imply that the decreases 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 reflected in decreases to work RVUs.

      In the case of CPT code 36X73, we believe that it would be more accurate to propose a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. These two CPT codes describe the same procedure done with (CPT code 36X73) and without (CPT code 35659) imaging guidance and radiological supervision and interpretation. Because the inclusion of the imaging described by CPT code 36X73 has now become the typical case for this service, we believe that it is more accurate to maintain the current work RVU of 1.70 as opposed to increasing the work RVU to 1.90, especially considering that the new surveyed work time for CPT code 36X73 is lower than the current work time for CPT code 36569. The proposed work RVU of 1.70 is also based on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally inserted central venous catheter; age 5 years or older). This is a recently reviewed code with the same 15 minutes of intraservice time and the same 40 minutes of total time with a work RVU of 1.75.

      For CPT code 36584, we disagree with the RUC-recommended work RVU of 1.47 and are proposing a work RVU of 1.20 based on maintaining the current work RVU. We note that the recommended intraservice time for CPT code 36584 is decreasing from 15 minutes to 12 minutes (20 percent reduction), and the recommended total time is decreasing from 45 minutes to 34 minutes (25 percent reduction); however, the recommended work RVU is increasing from 1.20 to 1.47, an increase of approximately 23 percent. Although we do not imply that the decreases 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 reflected in decreases to work RVUs. We are especially concerned when the recommended work RVU is increasing despite survey results indicating that the work time is decreasing due to a combination of improving technology and greater efficiencies in practice patterns.

      In the case of CPT code 36584, we believe that it would be more accurate to propose a work RVU of 1.20 based on maintaining the current work RVU for the code. Because the inclusion of the imaging has now become the typical case for this service, we believe that it is more accurate to maintain the current work RVU of 1.20 as opposed to increasing the work RVU to 1.47, especially considering that the new surveyed work time for CPT code 36584 is decreasing from the current work time. The proposed work RVU of 1.20 is also based on a crosswalk to CPT code 40490 (Biopsy of lip), which has the same total time of 34 minutes and slightly higher intraservice time at a work RVU of 1.22.

      We note that the RUC-recommended work pool is increasing by approximately 68 percent for the PICC Line Procedures family as a whole, while the RUC-recommended work time pool for the same codes is only increasing by about 22 percent. Since time is defined as one of the two components of work, we believe that this indicates a discrepancy in the recommended work values. 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 believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. 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 three times for CPT codes 36568, 76937, and 77001, but preservice times were assigned to all of the 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.

      For the direct PE inputs, we are proposing to refine the clinical labor time for the ``Prepare, set-up and start IV, initial positioning and monitoring of patient'' (CA016) activity from 4 minutes to 2 minutes for CPT codes 36X72 and 36X73. We note that the two reference codes for the two new codes, CPT codes 36568 and 36569, currently have 2 minutes assigned for this activity, and CPT code 36584 also has a recommended 2 minutes assigned to this same activity. We do not agree that the patient positioning would take twice

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      as long for CPT codes 36X72 and 36X73 as compared to the rest of the family, and are therefore refining both of them to the same 2 minutes of clinical labor time. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 3853X)

      In September 2017, the CPT Editorial Panel created a new code to describe biopsy or excision of inguinofemoral node(s). A parenthetical was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 (Vulvectomy, radical, complete) to instruct separate reporting of code 3853X with radical vulvectomy. This service was previously reported with unlisted codes.

      CPT code 3853X (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)) is a new CPT code describing a lymph node biopsy without complete lymphadenectomy. The RUC recommended a work RVU of 6.74 for CPT code 3853X, with 223 minutes of total time and 65 minutes of intraservice time. We propose the RUC-recommended work RVU of 6.74 for CPT code 3853X. However, we are concerned that this CPT code is described as having a 10-day global period. The two CPT codes that are often reported together with this code, CPT code 56630 (Vulvectomy, radical, partial) and CPT code 56633 (Vulvectomy, radical, complete), are both 90-day global codes. In addition, CPT code 3853X has a discharge visit and two follow up visits in the global period. This is consistent with the number of postoperative visits typically associated with 90-day global codes. Therefore, we propose to assign a 90-day global indicator for CPT code 3853X rather than the 10-day global time period reflected in the RUC recommendation.

      We are not proposing any direct PE refinements for this code family.

      (17) Radioactive Tracer (CPT Code 38792)

      CPT code 38792 (Injection procedure; radioactive tracer for identification of sentinel node) 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. For CY 2019, we are proposing the RUC-

      recommended work RVU of 0.65 for CPT code 38792.

      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. CPT code 38792, as well as its alternate reference code 78300 (Bone and/or joint imaging; limited area), both did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. 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 times in accordance with our standard equipment time formulas.

      (18) Percutaneous Change of G-Tube (CPT Code 43760)

      CPT code 43760 (Change of gastrostomy tube, percutaneous, without imaging or endoscopic guidance) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. It was surveyed for the April 2017 RUC meeting and recommendations for work and direct PE inputs were submitted to CMS. However, the RUC also noted that because the data for CPT code 43760 were bimodal, it might be appropriate to consider changes in the CPT descriptors to better differentiate physician work. In September 2017, the CPT Editorial Panel deleted CPT code 43760 and will use two new codes (43X63 and 43X64) that describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. (See below.) Therefore, we are not proposing work or direct PE values for CPT code 43760.

      (19) Gastrostomy Tube Replacement (CPT Codes 43X63 and 43X64)

      In September 2017, the CPT Editorial Panel created two new codes that describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. These two new codes were surveyed for the January 2018 RUC meeting and recommendations for work and direct PE inputs were submitted to CMS.

      We are proposing a work RVU of 0.75 for CPT code 43X63 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; not requiring revision of gastrostomy tract.) and a work RVU of 1.41 for CPT code 43X64 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; requiring revision of gastrostomy tract.), consistent with the RUC's recommendations for these new CPT codes.

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (20) Diagnostic Proctosigmoidoscopy--Rigid (CPT Code 45300)

      CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)) was identified as potentially misvalued on a screen of 0-

      day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-recommended work RVU of 0.80 for CPT code 45300.

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (21) Hemorrhoid Injection (CPT Code 46500)

      CPT code 46500 (Injection of sclerosing solution, hemorrhoids) 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.

      For CPT code 46500, we disagree with the RUC-recommended work RVU of 2.00 and we are proposing a work RVU of 1.74 based on a direct crosswalk to CPT code 68811 (Probing of nasolacrimal duct, with or without irrigation; requiring general anesthesia). This is another recently-reviewed 10-day global code with the same 10 minutes of intraservice time and slightly higher total time. When CPT code 46500 was previously reviewed as described in the CY 2016 PFS final rule with comment period (80 FR 70963), we finalized a proposal to reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by the same ratio as the

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      reduction in the total work time. In light of the additional evidence provided by this new survey, we agree that the work RVU should be increased from the current value of 1.42. However, we believe that our proposed work RVU of 1.74 based on a crosswalk to CPT code 68811 is more accurate than the RUC-recommended work RVU of 2.00.

      In the most recent survey of CPT code 46500, the intraservice work time remained unchanged at 10 minutes while the total time increased by only 2 minutes, increasing from 59 minutes to 61 minutes (3 percent). However, the RUC-recommended work RVU is increasing from 1.42 to 2.00, an increase of 41 percent, and also an increase of 19 percent over the historic value of 1.69 for CPT code 46500. Although we do not imply that the increase 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, minimal increases in surveyed work time typically should not be reflected in disproportionately large increases to work RVUs. In the case of CPT code 46500, we believe that our crosswalk to CPT code 68811 at a work RVU of 1.74 more accurately maintains relativity with other 10-day global codes on the PFS. We also note that the 3 percent increase in surveyed work time for CPT code 46500 matches a 3 percent increase in the historic work RVU of the code, from 1.69 to 1.74. Therefore, we are proposing a work RVU of 1.74 for CPT code 46500 based on the aforementioned crosswalk.

      For the direct PE inputs, we are proposing to remove 10 minutes of clinical labor time for the ``Assist physician or other qualified healthcare professional--directly related to physician work time (100%)'' (CA018) activity. This clinical labor time is listed twice in the recommendations along with a statement that although the clinical labor has not changed from prior reviews, time for both clinical staff members was inadvertently not included in the previous spreadsheets. We appreciate this notification in the recommendations, and therefore, we are asking for more information about why the clinical labor associated with this additional staff member was left out for previous reviews. We are particularly interested in knowing what activities the additional staff member would be undertaking during the procedure. We are proposing to remove the clinical labor associated with this additional clinical staff member pending the receipt of additional information. We are also proposing to remove 1 impervious staff gown (SB027), 1 surgical mask with face shield (SB034), and 1 pair of shoe covers (SB039) pending more information about the additional clinical staff member.

      We are proposing to remove the clinical labor time for the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) activity. CPT code 46500 is typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (22) Removal of Intraperitoneal Catheter (CPT Code 49422)

      In October 2016, CPT code 49422 (Removal of tunneled intraperitoneal catheter) was identified as a site of service anomaly because Medicare data from 2012-2014 indicated that it was performed less than 50 percent of the time in the inpatient setting, yet included inpatient hospital E/M services within the 10-day global period. The code was resurveyed using a 0-day global period for the April 2017 RUC meeting. For CY 2019, we are proposing the RUC-recommended work RVU of 4.00 for CPT code 49422.

      We are not proposing any direct PE refinements for this code family.

      (23) Dilation of Urinary Tract (CPT Codes 50X39, 50X40, 52334, and 74485)

      In October 2014, the CPT Editorial Panel deleted six codes and created twelve new codes to describe genitourinary catheter procedures and bundle inherent imaging services. In January 2015, the specialty societies indicated that CPT code 50395 (Introduction of guide into renal pelvis and/or ureter with dilation to establish nephrostomy tract, percutaneous), which was identified as part of the family, would be referred to the CPT Editorial Panel to clear up any confusion with overlap in physician work with CPT code 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). In September 2017, the CPT Editorial Panel deleted CPT code 50395 and created two new codes to report dilation of existing tract, and establishment of new access to the collecting system, including percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy), all associated radiological supervision and interpretation, as well as post procedure tube placement when performed.

      The specialty society surveyed the new CPT code 50X39 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation, as well as post procedure tube placement, when performed), and the RUC recommended a total time of 70 minutes, intraservice time of 30 minutes, and a work RVU of 3.37. The RUC indicated that its recommended work RVU for this CPT code is identical to the work RVU of the CPT code being deleted, even though imaging guidance CPT code 74485 has now been bundled into the valuation of the CPT code. The RUC provided two key reference CPT codes to support its recommendation: CPT code 50694 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, without separate nephrostomy catheter) with total time of 111 minutes, intraservice time of 62 minutes, and a work RVU of 5.25; and CPT code 50695 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, with separate nephrostomy catheter), with total time of 124 minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To further support its recommendation, the RUC also referenced CPT code 52287 (Cystourethroscopy, with injection(s) for chemodenervation of the bladder) with total time of 58 minutes, intraservice time of 21 minutes, and a work RVU of 3.37. We disagree with the RUC that the work RVU for this CPT code should be the same as the CPT code being deleted. Survey respondents indicated that the total time for completing the service described by the new CPT code is nearly 30 minutes less than the existing CPT code, even though imaging guidance was described as part of the procedure. We also note that the reference CPT codes both have substantially higher total and intraservice times than CPT code 50X39. We considered a number of parameters to arrive at our proposed work RVU of 2.78, supported by a

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      crosswalk to CPT code 31646 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with therapeutic aspiration of tracheobronchial tree, subsequent, same hospital stay). We examined the intraservice time ratio for the new CPT code in relation to the combination of CPT codes that the service represents and found that this would support a work RVU of 2.55. We also calculated the intraservice time ratio for the new CPT code in relation to each of the two reference CPT codes. For the comparison with CPT code 50694, the intraservice time ratio is 2.54, while the comparison with the second reference CPT code 50695 yields an intraservice time ratio of 2.72. We took the highest of these three values, 2.72, and found a corresponding crosswalk that we believe appropriately values the service described by the new CPT code. Therefore, we are proposing a work RVU of 2.78 for CPT code 50X39.

      The specialty society also surveyed the new CPT code 50X40 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation, as well as post procedure tube placement, when performed; including new access into the renal collecting system) and the RUC recommended a total time of 100 minutes, an intraservice time of 60 minutes, and a work RVU of 5.44. The recommended intraservice time of 60 minutes reflects the 75th percentile of survey results, rather than the median survey time, which is typically used for determining the intraservice time for new CPT codes. The RUC justified the use of the higher intraservice time because they believe the time better represents the additional time needed to introduce the guidewire into the renal pelvis and/or ureter, above and beyond the work involved in performing CPT code 50X39. The RUC compared this CPT code to CPT code 52235 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to 5.0 cm)), with total time of 94 minutes, intraservice time of 45 minutes, and a work RVU of 5.44. The RUC also cited, as support, the second key reference CPT code 50694 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, without separate nephrostomy catheter) with total time 111 minutes, intraservice time 62 minutes, and a work RVU of 5.25. We do not agree with the RUC's recommended work RVU because we believe that the intraservice time for this CPT code should reflect the survey median rather than the 75th percentile. There is no indication that the additional work of imaging guidance was systematically excluded by survey respondents when estimating the time needed to furnish the service. Therefore, we are proposing to reduce the intraservice time for CPT code 50X40 from the RUC-recommended 60 minutes to the survey median time of 45 minutes. We note that this is still 15 minutes more than the intraservice time for CPT code 50X39, primarily for the provider to introduce the guidewire into the renal pelvis and/or ureter. We welcome comments about the amount of time needed to furnish this procedure. With the revised intraservice time of 45 minutes and a total time of 85 minutes, we believe that the RUC-recommended work RVU for this CPT code is overstated. When we apply the increment between the RUC-recommended values for between CPT codes 50X39 and 50X40 (2.07 work RVUs) in addition to our proposed work RVU for CPT code 50X39, we estimate that this CPT code is more accurately represented by a work RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 (Introduction of needle(s) and/or catheter(s), dialysis circuit, with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava, fluoroscopic guidance, radiological supervision and interpretation and image documentation and report; with transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty), which has intraservice time of 40 minutes and total time of 86 minutes. We believe that CPT code 36902 describes a service that is similar to the new CPT code 50X40) and therefore provides a reasonable crosswalk. We are proposing a work RVU of 4.83 for CPT code 50X40.

      We are proposing the RUC-recommended work RVU of 3.37 for CPT code 52334 (Cystourethroscopy with insertion of ureteral guide wire through kidney to establish a percutaneous nephrostomy, retrograde) and the RUC-recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s) or urethra, radiological supervision and interpretation).

      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 52334. This code does not currently include this clinical labor time, and unlike the two new codes in the family (CPT codes 50X39 and 50X40), CPT code 52234 does not include imaging guidance in its code descriptor. When CPT code 52234 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, we believe that it would be duplicative to include this clinical labor time in CPT code 52234.

      (24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 53852, and 538X3)

      In September 2017, the CPT Editorial Panel created a new code (CPT code 538X3) to report transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy. CPT codes 53850 (Transurethral destruction of prostate tissue; by microwave thermotherapy) and 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) were also included for review as part of the same family of codes.

      For CPT code 53850 (Transurethral destruction of prostate tissue; by microwave thermotherapy), the RUC- recommended a work RVU of 5.42, supported by a direct crosswalk to CPT code 33272 (Removal of subcutaneous implantable defibrillator electrode) with a total time of 151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. The RUC indicated that a work RVU of 5.42 accurately reflects the lowest value of the three CPT codes in this family. We are proposing the work RVU of 5.42 for CPT code 53850, as recommended by the RUC.

      The RUC recommended a work RVU of 5.93 for CPT code 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) and for CPT code 538X3 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy). We are proposing the RUC-recommended value of 5.93 for CPT code 53852.

      CPT code 538X3 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy) is a service reflecting

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      the use of a new technology, ``radiofrequency generated water vapor thermotherapy,'' as distinct from CPT code 53852, which describes destruction of tissue by ``radiofrequency thermotherapy.'' The RUC indicated that this CPT code is the most intense of the three CPT codes in this family, thereby justifying a work RVU identical to that of CPT code 53852 despite lower intraservice and total times. The RUC stated that 15 minutes of post service time is appropriate due to greater occurrence of post-procedure hematuria necessitating a longer monitoring time. However, the post-service monitoring time for this CPT code, 15 minutes, is identical to that for CPT code 53852. We do not agree with the explanation provided by the RUC for recommending a work RVU identical to that of CPT code 53852, given that the total time is 5 minutes lower, and the post service times are identical. Both the intraservice time ratio between this new CPT code and CPT code 53852 (4.94) and the total time ratio between the two CPT codes (5.72) suggest that the RUC-recommended work RVU of 5.93 overestimates the work involved in furnishing this service. We reviewed other 90-day global CPT codes with similar times and identified CPT code 24071 (Excision, tumor, soft tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with a total time of 183 minutes, intraservice time of 45 minutes, and a work RVU of 5.70 as an appropriate crosswalk. We believe that this is a better reflection of the work involved in furnishing CPT code 538X3, and therefore, we are proposing a work RVU of 5.70 for this CPT code. We welcome comments about the time and intensity required to furnish this new service. Since this CPT code reflects the use of a new technology, it will be reviewed again in 3 years.

      For the direct PE inputs, we are proposing to add a new supply (SA128: ``kit, Rezum delivery device''), a new equipment item (EQ389: ``generator, water thermotherapy procedure''), and updating the price of two supplies (SA036: ``kit, transurethral microwave thermotherapy'' and SA037: ``kit, transurethral needle ablation (TUNA)'') in response to the submission of invoices. We note that these invoices were submitted along with additional information listing the vendor discount for these supplies and equipment. We appreciate the inclusion of the discounted prices on these invoices, and we encourage other invoice submissions to provide the discounted price as well where available. Based on the market research on supply and equipment pricing carried out by our contractors, we have reason to believe that a vendor discount of 10-15 percent is common on many supplies and equipment. Since we are obligated by statute to establish RVUs for each service as required based on the resource inputs required to furnish the typical case of a service, we have concerns that relying on invoices for supply and equipment pricing absent these vendor discounts may overestimate the resource cost of some services. We encourage the submission of additional invoices that include the discounted price of supplies and equipment to more accurately assess the market cost of these resources. Furthermore, we refer readers to our discussion of the market-based supply and equipment pricing update detailed in section II.B. of this proposed rule.

      (25) Vaginal Treatments (CPT Codes 57150 and 57160)

      CPT codes 57150 (Irrigation of vagina and/or application of medicament for treatment of bacterial, parasitic, or fungoid disease) and 57160 (Fitting and insertion of pessary or other intravaginal support device) were identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-recommended work RVU of 0.50 for CPT code 57150 and the RUC-

      recommended work RVU of 0.89 for CPT code 57160.

      We are not proposing any direct PE refinements for this code family.

      (26) Biopsy of Uterus Lining (CPT Codes 58100 and 58110)

      CPT code 58100 (Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. CPT code 58110 (Endometrial sampling (biopsy) performed in conjunction with colposcopy) was also included for review as part of the same family of codes. For CY 2019, we are proposing the RUC-recommended work RVU of 1.21 for CPT code 58100 and the RUC-recommended work RVU of 0.77 for CPT code 58110.

      For the direct PE inputs, we are proposing to remove the clinical labor time for the ``Review/read post-procedure x-ray, lab and pathology reports'' (CA028) activity for CPT code 58100. This code is typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing reports given that this task would typically be done during the same day E/M service. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (27) Injection Greater Occipital Nerve (CPT Code 64405)

      CPT code 64405 (Injection, anesthetic agent; greater occipital nerve) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-recommended work RVU of 0.94 for CPT code 64405.

      For the direct PE inputs, we are proposing to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.

      (28) Injection Digital Nerves (CPT Code 64455)

      CPT code 64455 (Injection(s), anesthetic agent and/or steroid, plantar common digital nerve(s) (e.g., Morton's neuroma)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-

      recommended work RVU of 0.75 for CPT code 64455.

      For the direct PE inputs, we are proposing to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.

      (29) Removal of Foreign Body--Eye (CPT Codes 65205 and 65210)

      CPT codes 65205 (Removal of foreign body, external eye; conjunctival superficial) and 65210 (Removal of foreign body, external eye; conjunctival embedded (includes concretions), subconjunctival, or scleral nonperforating) were identified as potentially misvalued on a screen of 0-day global services reported with an

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      E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000.

      For CY 2019, we are proposing the RUC-recommended work RVU of 0.49 for CPT code 65205. We note that the recommendations for this code included a statement that the work required to perform CPT code 65205 and the procedure itself had not fundamentally changed since the time of the last review. However, due to the fact that the surveyed intraservice time had decreased from 5 minutes to 3 minutes, the work RVU was lowered from the current value of 0.71 to the recommended work RVU of 0.49, based on a direct crosswalk to CPT code 68200 (Subconjunctival injection). We note that this recommendation appears to have been developed under a methodology similar to our ongoing use of time ratios as one of several methods used to evaluate work. We used time ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options. As we have stated in past rulemaking (such as 82 FR 53032-53033), 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 newly valued work RVUs, as indeed it does not in the case of CPT code 65205 here. Instead, we believed that, since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We appreciate that the RUC-recommended work RVU for CPT code 65205 has taken these changes in work time into account, and we support the use of similar methodologies, where appropriate, in future work valuations.

      For CPT code 65210, we disagree with the RUC-recommended work RVU of 0.75 and we are proposing a work RVU of 0.61 based on a direct crosswalk to CPT code 92511 (Nasopharyngoscopy with endoscope). This crosswalk code has the same intraservice time of 5 minutes and 4 additional minutes of total time as compared to CPT code 65210. We note that the recommended intraservice time for CPT code 65210 is decreasing from 13 minutes to 5 minutes (62 percent reduction), and the recommended total time for CPT code 65210 is decreasing from 25 minutes to 13 minutes (48 percent reduction); however, the RUC-recommended work RVU is only decreasing from 0.84 to 0.75, which is a reduction of about 11 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. However, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs, and we do not believe that the recommended work RVU of 0.75 appropriately reflects these decreases in surveyed work time.

      Our proposed work RVU of 0.61 is also based on a crosswalk to CPT code 51700 (Bladder irrigation, simple, lavage and/or instillation), another recently reviewed code with higher time values and a work RVU of 0.60. We also note that two injection codes (CPT codes 20551 and 64455) were reviewed at the same RUC meeting as CPT code 65210, each of which shared the same intraservice time of 5 minutes and had a higher total time of 21 minutes. Both of these codes had a RUC-recommended work RVU of 0.75, which we are proposing without refinement for CY 2019. Due to the fact that CPT code 65210 has a lower total time and a lower intensity than both of these injection procedures, we did not agree that CPT code 65210 should be valued at the same work RVU of 0.75. We believe that our proposed work RVU of 0.61 based on a crosswalk to CPT code 92511 is a more accurate value for this code.

      For the direct PE inputs, we noted that the RUC-recommended equipment time for the screening lane (EL006) equipment in CPT codes 65205 and 65210 was equal to the total work time in addition to the clinical labor time needed to set up and clean the equipment. We disagree that the screening lane would typically be in use for the total work time, given that this includes the preservice evaluation time and the immediate postservice time. Although we are not currently proposing to refine the equipment time for the screening lane in these two codes, we are soliciting comments on whether the use of the intraservice work time would be more typical than the total work time for CPT codes 65205 and 65210.

      (30) Injection--Eye (CPT Codes 67500, 67505, and 67515)

      CPT code 67515 (Injection of medication or other substance into Tenon's capsule) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. CPT codes 67500 (Retrobulbar injection; medication (separate procedure, does not include supply of medication)) and 67505 (Retrobulbar injection; alcohol) were also included for review as part of the same family of codes. For CY 2019, we are proposing the RUC-recommended work RVU of 1.18 for CPT code 67500.

      For CPT code 67505, we disagree with the RUC-recommended work RVU of 1.18 and we are proposing a work RVU of 0.94 based on a direct crosswalk to CPT code 31575 (Laryngoscopy, flexible; diagnostic). This is a recently reviewed code with the same intraservice time of 5 minutes and 2 fewer minutes of total time as compared to CPT code 67505. We disagreed with the recommendation to propose the same work RVU of 1.18 for both CPT code 67500 and 67505 for several reasons. We noted that the current work RVU of 1.44 for CPT code 67500 is higher than the current work RVU of 1.27 for CPT code 67505, while the current work time of CPT code 67500 is less than the current work time for CPT code 67505. This supported the view that CPT code 67500 should be valued higher than CPT code 67505 due to its greater intensity, which we also found to be supportable on clinical grounds. The typical patient for CPT code 67505 has already lost their sight, and there is less of a concern about accidental blindness as compared to CPT code 67500. At the recommended identical work RVUs, CPT code 67500 has almost triple the intensity of CPT code 67505. Similarly, the intensity does not match our clinical understanding of the complexity and difficulty of the two procedures.

      We also noted that the surveyed total time for CPT code 67505 was 7 minutes less than the surveyed time for CPT code 67500, approximately 21 percent lower. If we were to take the total time ratio between the two codes, it would produce a suggested work RVU of 0.93 (26 minutes divided by 33 minutes times a work RVU of 1.18). This time ratio suggested a work RVU almost identical to the 0.94 value that we determined via a crosswalk to CPT code 31575. Based on the preceding rationale, we are proposing a work RVU of 0.94 for CPT code 67505.

      For CPT code 67515, we disagree with the RUC-recommended work RVU of 0.84 and we are proposing a work RVU of 0.75 based on a crosswalk to CPT code 64450 (Injection, anesthetic agent; other peripheral nerve or branch). The recommended work RVU is based on a direct crosswalk to CPT code 65222 (Removal of foreign body, external eye;

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      corneal, with slit lamp) at a work RVU of 0.84. However, the recommended crosswalk code has more than double the intraservice time of CPT code 67515 at 7 minutes, and we believe that it would be more accurate to use a crosswalk to a code with a more similar intraservice time such as CPT code 64450, which is another type of injection procedure. The proposed work RVU of 0.75 is also based on the use of the intraservice time ratio with the first code in the family, CPT code 67500. The intraservice time ratio between these codes is 0.60 (3 minutes divided by 5 minutes), which yields a suggested work RVU of 0.71 when multiplied by the recommended work RVU of 1.18 for CPT code 67500. We believe that this provides further rationale for our proposed work RVU of 0.75 for CPT code 67515.

      We are not proposing any direct PE refinements for this code family.

      (31) X-Ray 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 on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. The code family was expanded to include ten additional CPT codes to be reviewed together as a group: CPT codes 72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050 (Radiologic examination, spine, cervical; 4 or 5 views), 72052 (Radiologic examination, spine, cervical; 6 or more views), 72070 (Radiologic examination, spine; thoracic, 2 views), 72074 (Radiologic examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic examination, spine, lumbosacral; complete, including bending views, minimum of 6 views), and 72120 (Radiologic examination, spine, lumbosacral; bending views only, 2 or 3 views).

      The radiologic examination procedures described by CPT codes 72020 (Radiologic examination, spine, single view, specify level), 72040 (Radiologic examination, spine, cervical; 2 or 3 views), 72050 (Radiologic examination, spine, cervical; 4 or 5 views), 72052 (Radiologic examination, spine, cervical; 6 or more views), 72070 (Radiologic examination, spine; thoracic, 2 views), 72072 (Radiologic examination, spine; thoracic, 3 views), 72074 (Radiologic examination, spine; thoracic, minimum of 4 views), 72080 (Radiologic examination, spine; thoracolumbar junction, minimum of 2 views), 72100 (Radiologic examination, spine, lumbosacral; 2 or 3 views), 72110 (Radiologic examination, spine, lumbosacral; minimum of 4 views), 72114 (Radiologic examination, spine, lumbosacral; complete, including bending views, minimum of 6 views), 72120 (Radiologic examination, spine, lumbosacral; bending views only, 2 or 3 views), 72200 (Radiologic examination, sacroiliac joints; less than 3 views), 72202 (Radiologic examination, sacroiliac joints; 3 or more views), 72220 (Radiologic examination, sacrum and coccyx, minimum of 2 views), 73070 (Radiologic examination, elbow; 2 views), 73080 (Radiologic examination, elbow; complete, minimum of 3 views), 73090 (Radiologic examination; forearm, 2 views), 73650 (Radiologic examination; calcaneus, minimum of 2 views), and 73660 (Radiologic examination; toe(s), minimum of 2 views) were all identified as potentially misvalued through a screen for CPT codes with high utilization. With approval from the RUC Research Subcommittee, the specialty societies responsible for reviewing these CPT codes did not conduct surveys, but instead employed a ``crosswalk methodology,'' in which they derived physician work and time components for CPT codes by comparing them to similar CPT codes. We recognize that a substantial amount of time and effort is involved in conducting surveys of potentially misvalued CPT codes; however, we have concerns about the quality of the underlying data used to value these CPT codes. The descriptors and other information on which the recommendations are based have themselves not been surveyed, in several instances, since 1995. There is no new information about any of these CPT codes that would allow us to detect any potential improvements in efficiency of furnishing the service or evaluate whether changes in practice patterns have affected time and intensity. We are not categorically opposed to changes in process or methodology that might reduce the burden of conducting surveys, but without the benefit of any additional data, through surveys or otherwise, we are not convinced that there is a basis for evaluating the RUC's recommendations for work RVUs for each of these CPT codes.

      Since all 20 of the CPT codes in this group have very similar intraservice (from 3-5 minutes) and total (ranging from 5-8 minutes) times, we are proposing to use an alternative approach to the valuation of work RVUs for these CPT codes. We calculated the utilization-

      weighted average RUC-recommended work RVU for the 20 CPT codes. The result of this calculation is a work RVU of 0.23, which we propose to apply uniformly to each CPT code: 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, 72120, 72200, 72202, 72220, 73070, 73080, 73090, 73650, and 73660. We recognize that the proposed work RVU for some of these CPT codes may be somewhat lower at the code level than the RUC's recommendation, while the proposed work RVU for other CPT codes may be slightly higher than the RUC's recommended value. We nevertheless believe that the alternative, accepting the RUC's recommendation for each separate CPT code implies a level of precision about the time and intensity of the CPT codes that we have no way to validate.

      For the direct PE inputs, we are proposing to add a patient gown (SB026) supply to CPT code 72120. We noted that all of the other codes in the family that included clinical labor time for the ``Greet patient, provide gowning, ensure appropriate medical records are available'' (CA009) task included a patient gown, and we are proposing to add the patient gown to match the other codes in the family. We believe that the exclusion of the patient gown for CPT code 72120 was most likely due to a clerical error in the recommendations. We are also proposing to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      In our review of the clinical labor time recommended for the ``Perform procedure/service--NOT directly related to physician work time'' (CA021) task, we noted that the standard convention for this family of codes seemed to be 3 minutes of clinical labor time per view being conducted. For example, CPT code 72020 with a single view had 3 minutes of recommended clinical labor time for this activity, while CPT code 72070 with two views had 6 minutes. However, we also noted that for the codes with 2-3 views such as CPT codes 72040 and 72100, the recommended clinical labor time of 9 minutes appears to assume that 3 views would always be typical for the procedure. The same pattern occurred for codes with 4-5 views, which have a

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      recommended clinical labor time of 15 minutes (assuming 5 views is typical), and for codes with 6 or more views, which have a recommended clinical labor time of 21 minutes (assuming 7 views is typical).

      We are not proposing to refine the clinical labor times for this task as we do not have data available to know how many views would be typical for these CPT codes. However, we note that the intraservice clinical labor time has not changed in roughly 2 decades for these X-

      ray services, including during this most recent review, and we believe that improving technology during this span of time may have resulted in greater efficiencies in the procedures. We continue to be interested in data sources regarding the intraservice clinical labor times for services such as these that do not match the physician intraservice time, and we welcome any comments that may be able to provide additional details for the twelve codes under review in this family.

      (32) X-Ray 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 or Other source codes with Medicare utilization greater than 100,000 services 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. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) for a discussion of proposed work RVUs for these codes.

      For the direct PE inputs, we are proposing to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      (33) 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 or Other source codes with Medicare utilization greater than 100,000 services annually. CPT code 73080 (Radiologic examination, elbow; complete, minimum of 3 views) was also included for review as part of the same family of codes. See (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120) above for a discussion of proposed work RVUs for these codes.

      For the direct PE inputs, we are proposing to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      (34) X-Ray Heel (CPT Code 73650)

      CPT code 73650 (Radiologic examination; calcaneus, minimum of 2 views) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. See (31) X-Ray Spine above for a discussion of proposed work RVUs for these codes.

      For the direct PE inputs, we are proposing to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      (35) X-Ray Toe (CPT Code 73660)

      CPT code 73660 (Radiologic examination; toe(s), minimum of 2 views) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. See (31) X-Ray Spine above for a discussion of proposed work RVUs for these codes.

      For the direct PE inputs, we are proposing to add a patient gown (SB026) supply to CPT code 73660. We noted that the other codes in related X-ray code families that included clinical labor time for the ``Greet patient, provide gowning, ensure appropriate medical records are available'' (CA009) task included a patient gown, and we are proposing to add the patient gown to match the other codes in these families. We are also proposing to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      (36) X-Ray Esophagus (CPT Codes 74210, 74220, and 74230)

      CPT code 74220 (Radiologic examination; esophagus) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT codes 74210 (Radiologic examination; pharynx and/or cervical esophagus) and 74230 (Swallowing function, with cineradiography/videoradiography) were also included for review as part of the same family of codes.

      We are proposing the work RVUs recommended by the RUC for the CPT codes in this family as follows: A work RVU 0.59 for CPT code 74210 (Radiologic examination; pharynx and/or cervical esophagus), a work RVU of 0.67 for CPT code 74220 (Radiologic examination; esophagus), and a work RVU of 0.53 for CPT code 74230 (Swallowing function, with cineradiography/videoradiography).

      For the direct PE inputs, we noted that the recommended quantity of the Polibar barium suspension (SH016) supply is increasing from 1 ml to 150 ml for CPT code 74210 and 100 ml are being added to CPT code 74220, which did not previously include this supply. The RUC recommendation states that this supply quantity increase is due to clinical necessity, but does not go into further details about the typical use of the supply. Although we are not proposing to refine the quantity of the Polibar barium suspension at this time, we are seeking additional comment about the typical use of the supply in these procedures. We are also proposing to refine the equipment times for all three codes in accordance with our standard equipment time formulas.

      (37) X-Ray Urinary Tract (CPT Code 74420)

      CPT code 74420 (Urography, retrograde, with or without KUB) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually.

      We are proposing the RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography, retrograde, with or without KUB).

      For the direct PE inputs, we are proposing to remove the 1 minute of clinical labor time for the ``Confirm order, protocol exam'' (CA014) activity. The clinical labor time recommended for this activity is not included in the reference code, nor is it included in any of the two dozen other X-ray codes that were reviewed at the same RUC meeting. There is also no explanation in the recommended materials as to why this clinical labor time would need to be added. We do not believe that this clinical labor would be typical for CPT code 74420, and we are proposing to remove it to match the rest of the X-ray codes. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (38) Fluoroscopy (CPT Code 76000)

      CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour physician or other qualified health care professional time) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. CPT code 76001 (Fluoroscopy, physician or other qualified health care professional time more than 1 hour, assisting a nonradiologic physician or other qualified health care professional) was

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      also included for review as part of the same family of codes. However, due to the fact that supervision and interpretation services have been increasingly bundled into the underlying procedure codes, the RUC concluded that this practice is rare, if not obsolete, and CPT code 76001 was recommended for deletion by the CPT Editorial Panel for CY 2019.

      We are proposing the RUC-recommended work RVU of 0.30 for CPT code 76000 (Fluoroscopy (separate procedure), up to 1 hour physician or other qualified health care professional time, other than 71023 or 71034 (e.g., cardiac fluoroscopy)).

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (39) Echo Exam of Eye Thickness (CPT Code 76514)

      CPT code 76514 (Ophthalmic ultrasound, diagnostic; corneal pachymetry, unilateral or bilateral (determination of corneal thickness)) 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.

      For CPT code 76514, we disagree with the RUC-recommended work RVU of 0.17 and we are proposing a work RVU of 0.14. We note that the recommended intraservice time for CPT code 76514 is decreasing from 5 minutes to 3 minutes (40 percent reduction), and the recommended total time for CPT code 76514 is decreasing from 15 minutes to 5 minutes (67 percent reduction); however, the RUC-recommended work RVU is not decreasing at all and remains at 0.17. 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 reflected in decreases to work RVUs.

      We also note that the RUC recommendations for CPT code 76514 stated that, although the steps in the procedure are unchanged since it was first valued, the workflow has changed. With the advent of smaller and easier to use pachymeters, the technician now typically takes the measurements that used to be taken by the practitioner for CPT code 76514, and the intraservice time was reduced by two minutes to account for the technician performing this service. We believe that this change in workflow indicates that the work RVU for the code should be reduced in some fashion, since some of the work that was previously done by the practitioner is now typically performed by the technician. We have no reason to believe that there is more intensive cognitive work being performed by the practitioner after these measurements are taken since the recommendations indicated that the steps in the procedure are unchanged since this code was first valued.

      Therefore, we are proposing a work RVU of 0.14 for CPT code 76514, which is based on taking half of the intraservice time ratio. We considered applying the intraservice time ratio to CPT code 76514, which would reduce the work RVU to 0.10 based on taking the change in intraservice time (from 5 minutes to 3 minutes) and multiplying this ratio of 0.60 times the current work RVU of 0.17. However, we recognize that the minutes shifted to the clinical staff were less intense than the minutes that remained in CPT code 76514, and therefore, we applied half of the intraservice time ratio for a reduction of 0.03 RVUs to arrive at a proposed work RVU of 0.14. We believe that this proposed value more accurately takes into account the changes in workflow that have caused substantial reductions in the surveyed work time for the procedure.

      We are not proposing any direct PE refinements for this code family.

      (40) Ultrasound Elastography (CPT Codes 767X1, 767X2, and 767X3)

      In September 2017, the CPT Editorial Panel created three new codes describing the use of ultrasound elastography to assess organ parenchyma and focal lesions: CPT codes 767X1 (Ultrasound, elastography; parenchyma), 767X2 (Ultrasound, elastography; first target lesion) and 767X3 (Ultrasound, elastography; each additional target lesion). The most common use of this code set will be for preparing patients with disease of solid organs, like the liver, or lesions within solid organs.

      The RUC recommended a work RVU of 0.59 for CPT code 767X1 (Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 0.59 for CPT code 767X2 (Ultrasound, elastography; first target lesion), and a work RVU of 0.50 for add-on CPT code 767X3 (Ultrasound, elastography; each additional target lesion). We are proposing the RUC- recommended work RVUs for each of these new CPT codes.

      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 for CPT codes 767X1 and 767X2. CPT code 76700 (Ultrasound, abdominal, real time with image documentation; complete), the reference code for these two new codes, did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that these particular services being furnished by the clinical staff have changed in the new codes, only the way in which this clinical labor time has been presented on the PE worksheets. 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 in CPT codes 767X1 and 767X2. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (41) Ultrasound Exam--Scrotum (CPT Code 76870)

      CPT code 76870 (Ultrasound, scrotum and contents) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. We are proposing a work RVU of 0.64 for CPT code 76870 (Ultrasound, scrotum and contents), as recommended by the RUC.

      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. CPT code 76870 did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. 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 under the CA013 room preparation activity. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (42) Contrast-Enhanced Ultrasound (CPT Codes 76X0X and 76X1X)

      In September 2017, the CPT Editorial Panel created two new CPT codes describing the use of intravenous microbubble agents to evaluate

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      suspicious lesions by ultrasound. CPT code 76X0X (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-

      cardiac); initial lesion) is a stand-alone procedure for the evaluation of a single target lesion. CPT code 76X1X (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection) is an add-on code for the evaluation of each additional lesion.

      The two new CPT codes in this family represent a new technology that involves the use of intravenous microbubble agents to evaluate suspicious lesions by ultrasound. The first new CPT code, 76X0X (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion), is the base code for the new add-on CPT code 76X1X (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection). The RUC reviewed the survey results for CPT code 76X0X and recommended total time of 30 minutes and intraservice time of 20 minutes. Their recommendation for a work RVU of 1.62 is based neither on the median of the survey results (1.82) nor the 25th percentile of the survey results (1.27). Instead, the RUC-

      recommended work RVU is based on a crosswalk to CPT code 73719 (Magnetic resonance (e.g., proton) imaging, lower extremity other than joint; with contrast material(s)), which has identical intraservice and total times as the survey CPT code. The RUC also identified a comparison CPT code (CPT code 73222 (Magnetic resonance (e.g., proton) imaging, any joint of upper extremity; with contrast material(s)) with work RVU 1.62 and similar times. For add-on CPT code 76X1X, the RUC recommended a work RVU of 0.85, which is the 25th percentile of survey results, with total and intraservice times of 15 minutes.

      While we generally agree that, particularly in instances where a CPT code represents a new technology or procedure, there may be reason to deviate from survey metrics, we are confused by the logic behind the RUC's recommendation of a work RVU of 1.62 for CPT code 76X0X. When we consider the range of existing CPT codes with 30 minutes total time and 20 minutes intraservice time, we note that a work RVU of 1.62 is among the highest potential crosswalks. We also note that the RUC agreed with the 25th percentile of survey results for the new add-on CPT code, 76X1X, and we do not see why the 25th percentile wouldn't also be appropriate for the base CPT code, 76X0X. Therefore, we are proposing a work RVU of 1.27 for CPT code 76X0X. We identified two CPT codes with total time of 30 minutes and intraservice time of 20 minutes that bracket the proposed work RVU of 1.27: CPT code 93975 (Duplex scan of arterial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; complete study) has a work RVU of 1.16, and CPT code 72270 (Myelography, 2 or more regions (e.g., lumbar/thoracic, cervical/thoracic, lumbar/cervical, lumbar/thoracic/

      cervical), radiological supervision and interpretation) has a work RVU of 1.33. We are proposing the RUC-recommended work RVU of 0.85 for add-

      on CPT code 76X1X.

      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 for CPT code 76X0X. CPT codes 76700 (Ultrasound, abdominal, real time with image documentation; complete) and 76705 (Ultrasound, abdominal, real time with image documentation; limited), the reference codes for this new code, did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that these particular services being furnished by the clinical staff have changed in the new code, only the way in which this clinical labor time has been presented on the PE worksheets. 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 in CPT code 76X0X.

      We are proposing to remove the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76X0X and 76X1X. When these codes were reviewed by the RUC, the conclusion that was reached was to remove this supply and replace it with normal saline. Since the phosphate buffered saline remained in the recommended direct PE inputs, we believe its inclusion may have been a clerical error. We are proposing to remove the supply and soliciting comments on the phosphate buffered saline or a replacement saline solution. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (43) Magnetic Resonance Elastography (CPT Code 76X01)

      The CPT Editorial Panel created a new stand-alone code (76X01) describing the use of magnetic resonance elastography for the evaluation of organ parenchymal pathology. This code will most often be used to evaluate patients with disease of solid organs (for example, cirrhosis of the liver) or pathology within solid organs that manifest with increasing fibrosis or scarring. The goal with magnetic resonance elastography is to evaluate the degree of fibrosis/scarring (that is, stiffness) without having to perform more invasive procedures (for example, biopsy). This technique can be used to characterize the severity of parenchymal disease, follow disease progression, or response to therapy.

      The RUC recommended a work RVU for new CPT code 76X01 (Magnetic resonance (e.g., vibration) elastography) of 1.29, with 15 minutes of intraservice time and 25 minutes of total time. The recommendation is based on a comparison with two reference CPT codes, CPT code 74183 (Magnetic resonance (e.g., proton) imaging, abdomen; without contrast material(s), followed by with contrast material(s) and further sequences) with total time of 40 minutes, intraservice time of 30 minutes, and a work RVU of 2.20; and CPT code 74181 (Magnetic resonance (e.g., proton) imaging, abdomen; without contrast material(s)), which has a total time of 30 minutes, intraservice time of 20 minutes, and a work RVU of 1.46. The RUC stated that both reference CPT codes have higher work values than the new CPT code, which is justified in both cases by higher intra-service times. They note that, despite shorter intraservice and total time, CPT code 76X01 is slightly more intense to perform due to the evaluation of wave propagation images and quantitative stiffness measures. We do not agree with the RUC's recommended work RVU for this CPT code. Using the RUC's two top reference CPT codes as a point of comparison, the intraservice time ratio in both instances suggests that a work RVU closer to 1.10 would be more appropriate. We recognize that the RUC believes the new CPT code is slightly more intense to furnish, but we are concerned about the relativity of this code in comparison with other imaging procedures that have similar intraservice and total times. Instead of the RUC-

      recommended work RVU of 1.29 for CPT code 76X01, we are proposing a work RVU of 1.10, which is based on a direct crosswalk to CPT code 71250 (Computed tomography, thorax; without contrast material). CPT code 71250 has identical intraservice time (15 minutes) and total time (25 minutes) compared to CPT code 76X01, and we

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      believe that the work involved in furnishing both services is similar. We note that CPT code 76X01 describes a new technology and will be reviewed again by the RUC in 3 years.

      For the direct PE inputs, we are proposing to refine the clinical labor time for the ``Prepare room, equipment and supplies'' (CA013) activity from 6 minutes to 5 minutes, and for the ``Prepare, set-up and start IV, initial positioning and monitoring of patient'' (CA016) activity from 4 minutes to 3 minutes. We disagree that this additional clinical labor time would be typical for these activities, which are already above the standard times for these tasks. In both cases, we propose to maintain the current time from the reference CPT code 72195 (Magnetic resonance (e.g., proton) imaging, pelvis; without contrast material(s)) for these clinical labor activities. We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (44) Computed Tomography (CT) Scan for Needle Biopsy (CPT Code 77012)

      CPT code 77012 (Computed tomography guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), radiological supervision and interpretation) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually.

      We are proposing the RUC-recommended work RVU of 1.50 for CPT code 77012 (Computed tomography guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), radiological supervision and interpretation).

      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. CPT code 77012 did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. 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 under the CA013 room preparation activity.

      We are proposing to refine the equipment time for the CT room (EL007) to maintain the current time of 9 minutes. CPT code 77012 is a radiological supervision and interpretation procedure and there has been a longstanding convention in the direct PE inputs, shared by 38 other codes, to assign an equipment time of 9 minutes for the equipment room in these procedures. We do not believe that it would serve the interests of relativity to increase the equipment time for the CT room in CPT code 77012 without also addressing the equipment room time for the other radiological supervision and interpretation procedures. Therefore, we are proposing to maintain the current equipment room time of 9 minutes until this group of procedures can be subject to a more comprehensive review. We are also proposing to refine the equipment time for the Technologist PACS workstation (ED050) in accordance with our standard equipment time formulas.

      (45) Dual-Energy X-Ray Absorptiometry (CPT Code 77081)

      CPT code 77081 (Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; appendicular skeleton (peripheral) (e.g., radius, wrist, heel)) 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. For CY 2019, we are proposing the RUC-recommended work RVU of 0.20 for CPT code 77081.

      We are not proposing any direct PE refinements for this code family.

      (46) Breast MRI With Computer-Aided Detection (CPT Codes 77X49, 77X50, 77X51, and 77X52)

      CPT codes 77058 (Magnetic resonance imaging, breast, without and/or with contrast material(s); unilateral) and 77059 (Magnetic resonance imaging, breast, without and/or with contrast material(s); bilateral) were identified in 2016 on a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. When preparing to survey these codes, the specialties noted that the clinical indications had changed for these exams. The technology had advanced to make computer-aided detection (CAD) typical and these codes did not parallel the structure of other magnetic resonance imaging (MRI) codes. In June 2017 the CPT Editorial Panel deleted CPT codes 0159T, 77058, and 77059 and created four new CPT codes to report breast MRI with and without contrast (including computer-aided detection).

      The RUC recommended a work RVU of 1.45 for CPT code 77X49 (Magnetic resonance imaging, breast, without contrast material; unilateral). This recommendation is based on a comparison with CPT codes 74176 (Computed tomography, abdomen and pelvis; without contrast material) and 74177 (Computed tomography, abdomen and pelvis; with contrast material(s)), which both have similar intraservice and total times in relation to CPT code 77X49. We disagree with the RUC's recommended work RVU because we do not believe that the reduction in total time of 15 minutes between the new CPT code 77X49 and the deleted CPT code 74177 is adequately reflected in its recommendation. While total time has decreased by 15 minutes, the only other difference between the two CPT codes is the change in the descriptor from the phrase `without and/or with contrast material(s)' to `without contrast material,' suggesting that there is less work involved in the new CPT code than in the deleted CPT code. Instead, we are proposing a work RVU of 1.15 for CPT code 77X49, which is similar to the total time ratio between the new CPT code and the deleted CPT code. It is also supported by a crosswalk to CPT code 77334 (Treatment devices, design and construction; complex (irregular blocks, special shields, compensators, wedges, molds or casts)). CPT code 77334 has total time of 35 minutes, intraservice time of 30 minutes, and a work RVU of 1.15.

      CPT code 77X50 (Magnetic resonance imaging, breast, without contrast material; bilateral) describes the same work as CPT code 77X49, but reflects a bilateral rather than the unilateral procedure. The RUC recommended a work RVU of 1.60 for CPT code 77X50. Since we are proposing a different work RVU for the unilateral procedure than the value proposed by the RUC, we believe it is appropriate to recalibrate the work RVU for CPT code 77X50 relative to the RUC's recommended difference in work between the two CPT codes. The RUC's recommendation for the bilateral procedure is 0.15 work RVUs larger than for the unilateral procedure. Therefore, we are proposing a work RVU of 1.30 for CPT code 77X50.

      The RUC recommended a work RVU of 2.10 for CPT code 77X51 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral). CPT code 77X51 is a new CPT code that bundles the deleted CPT code for unilateral breast

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      MRI without and/or with contrast material(s) with CAD, which was previously reported, in addition to the primary procedure CPT code, as CPT code 0159T (computer aided detection, including computer algorithm analysis of MRI image data for lesion detection/characterization, pharmacokinetic analysis, with further physician review for interpretation, breast MRI). Consistent with our belief that the proposed value for the base CPT code in this series of new CPT codes (CPT code 77X49) should be a work RVU of 1.15, we are proposing a work RVU for CPT code 77X51 that adds the RUC-recommended difference in RUC-

      recommended work RVUs between CPT codes 77X49 and 77X51 (0.65 work RVUs) to the proposed work RVU for CPT code 77X49. Therefore, we are proposing a work RVU of 1.80 for CPT code 77X51.

      The last new CPT code in this series, CPT code 77X52 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmoacokinetic analysis) when performed; bilateral) describes the same work as CPT code 77X51, but reflects a bilateral rather than a unilateral procedure. The RUC recommended a work RVU of 2.30 for this CPT code. Similar to the process for valuing work RVUs for CPT code 77X50 and CPT code 77X51, we believe that a more appropriate work RVU is calculated by adding the difference in the RUC recommended work RVU for CPT codes 77X49 and 77X52, to the proposed value for CPT code 77X49. Therefore, we are proposing a work RVU of 2.00 for CPT code 77X52.

      For the direct PE inputs, we are proposing to refine the clinical labor time for the ``Prepare, set-up and start IV, initial positioning and monitoring of patient'' (CA016) activity from 7 minutes to 3 minutes for CPT codes 77X49 and 77X50, and from 9 minutes to 5 minutes for CPT codes 77X51 and 77X52. We note that when the MRI of Lower Extremity codes were reviewed during the previous rule cycle (CPT codes 73718-73720), these codes contained either 3 minutes or 5 minutes of recommended time for this same clinical labor activity. We also note that the current Breast MRI codes that are being deleted and replaced with these four new codes, CPT codes 77058 and 77059, contain 5 minutes of clinical labor time for this same activity. We have no reason to believe that the new codes would require additional clinical labor time for patient positioning, especially given that the recommended clinical labor times are decreasing in comparison to the reference codes for obtaining patient consent (CA011) and preparing the room (CA013). Therefore, we are refining the clinical labor time for the CA016 activity as detailed above to maintain relativity with the current clinical labor times in the reference codes, as well as with other recently reviewed MRI procedures.

      Included in the recommendations for this code family were five new equipment items: CAD Server (ED057), CAD Software (ED058), CAD Software--Additional User License (ED059), Breast coil (EQ388), and CAD Workstation (CPU + Color Monitor) (ED056). We did not receive any invoices for these five equipment items, and as such we do not have any direct pricing information to use in their valuation. We are proposing to use crosswalks to similar equipment items as proxies for three of these new types of equipment until we do have pricing information:

      CAD software (ED058) is crosswalked to flow cytometry analytics software (EQ380).

      Breast coil (EQ388) is crosswalked to Breast biopsy device (coil) (EQ371).

      CAD Workstation (CPU + Color Monitor) (ED056) is crosswalked to Professional PACS workstation (ED053).

      We welcome the submission of invoices with pricing information for these three new equipment items for our consideration to replace the use of these proxies. For the other two equipment items (CAD Server (ED057) and CAD Software--Additional User License (ED059)), we are not proposing to establish a price at this time as we believe both of them would constitute forms of indirect PE under our methodology. We do not believe that the CAD Server or Additional User License would be allocated to the use of an individual patient for an individual service, and can be better understood as forms of indirect costs similar to office rent or administrative expenses. We understand that as the PE data age, these issues involving the use of software and other forms of digital tools become more complex. However, the use of new technology does not change the statutory requirement under which indirect PE is assigned on the basis of direct costs that must be individually allocable to a particular patient for a particular service. We look forward to continuing to seek out new data sources to help in updating the PE methodology.

      We are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (47) Blood Smear Interpretation (CPT Code 85060)

      CPT code 85060 (Blood smear, peripheral, interpretation by physician with written report) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, the RUC recommended a work RVU of 0.45 based on maintaining the current work RVU.

      We disagree with the recommended value and are proposing a work RVU of 0.36 for CPT code 85060 based on the total time ratio between the current time of 15 minutes and the recommended time established by the survey of 12 minutes. This ratio equals 80 percent, and 80 percent of the current work RVU of 0.45 equals a work RVU of 0.36. When we reviewed CPT code 85060, we found that the recommended work RVU was higher than nearly all of the other global XXX codes with similar time values, and we do not believe that this blood smear interpretation procedure would have an anomalously high intensity. 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 reflected in decreases to work RVUs. In the case of CPT code 85060, we believe that it would be more accurate to propose the total time ratio at a work RVU of 0.36 to account for these decreases in the surveyed work time.

      The proposed work RVU is also based on the use of three crosswalk codes. We are directly supporting the proposed valuation through a crosswalk to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash testing, central nervous system except glaucoma, with interpretation and report), which has a work RVU of 0.35 along with 10 minutes of intraservice time and 14 minutes of total time. We also explain the proposed valuation by bracketing it between two other crosswalks, with CPT code 99152 (Moderate sedation services provided by the same physician or other qualified health care professional performing the diagnostic or therapeutic service that the sedation supports; initial 15 minutes of intraservice time, patient age 5 years or older) on the lower end at a work RVU of 0.25 and CPT code 93923 (Complete bilateral noninvasive physiologic studies of upper or lower extremity arteries, 3 or more levels, or single level study with provocative

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      functional maneuvers) on the higher end at a work RVU of 0.45.

      The RUC recommended no direct PE inputs for CPT code 85060 and we are recommending none.

      (48) Bone Marrow Interpretation (CPT Code 85097)

      CPT code 85097 (Bone marrow, smear interpretation) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, the RUC recommended a work RVU of 1.00 based on a direct crosswalk to CPT code 88121 (Cytopathology, in situ hybridization (e.g., FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology).

      We disagree with the RUC-recommended value and we are proposing a work RVU of 0.94 for CPT code 85097 based on maintaining the current work valuation. We noted that the survey indicated that CPT code 85097 typically takes 25 minutes of work time to perform, down from a previous work time of 30 minutes, and, generally speaking, since the two components of work are time and intensity, we believe that significant decreases in time should be reflected in decreases to work RVUs. For the specific case of CPT code 85097, we are supporting our proposed work RVU of 0.94 through a crosswalk to CPT code 88361 (Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, estrogen receptor/progesterone receptor), quantitative or semiquantitative, per specimen, each single antibody stain procedure; using computer-assisted technology), a recently reviewed code from CY 2018 with the identical time values and a work RVU of 0.95.

      We also considered a work RVU of 0.90 based on double the recommended work RVU of 0.45 for CPT code 85060 (Blood smear, peripheral, interpretation by physician with written report). When both of these CPT codes were under review, the explanation was offered that in a peripheral blood smear, typically, the practitioner does not have the approximately 12 precursor cells to review, whereas in an aspirate from the bone marrow, the practitioner is examining all the precursor cells. Additionally, for CPT code 85097, there are more cell types to look at as well as more slides, usually four, whereas with CPT code 85060 the practitioner would typically only look at one slide. While we do not propose to value CPT code 85097 at twice the work RVU of CPT code 85060, we believe this analysis also supports maintaining the current work RVU of 0.94 as opposed to raising it to 1.00.

      For the direct PE inputs, we are proposing to remove the clinical labor time for the ``Accession and enter information'' (PA001) and ``File specimen, supplies, and other materials'' (PA008) activities. As we stated previously, information entry and specimen filing tasks are not individually allocable to a particular patient for a particular service and are considered to be forms of indirect PE. While we agree that these are necessary tasks, under our established methodology we believe that they are more appropriately classified as indirect PE.

      (49) Fibrinolysins Screen (CPT Code 85390)

      CPT code 85390 (Fibrinolysins or coagulopathy screen, interpretation and report) 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. For CY 2019, we are proposing the RUC-recommended work RVU of 0.75 for CPT code 85390.

      Because this is a work only code, the RUC did not recommend, and we are not proposing any direct PE inputs for CPT code 85390.

      (50) Electroretinography (CPT Codes 92X71, 92X73, and 03X0T)

      CPT code 92275 (Electroretinography with interpretation and report) was identified in 2016 on a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. In January 2016, the specialty society noted that they became aware of inappropriate use of CPT code 92275 for a less intensive version of this test for diagnosis and indications that are not clinically proven and for which less expensive and less intensive tests already exist. CPT changes were necessary to ensure that the service for which CPT code 92275 was intended was clearly described, as well as an accurate vignette and work descriptor were developed. In September 2017, the CPT Editorial Panel deleted CPT code 92275 and replaced it with two new codes to describe electroretinography full field and multi focal. A category III code was retained for pattern electroretinography.

      For CPT code 92X71 (Electroretinography (ERG) with interpretation and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we disagree with the recommended work RVU of 0.80 and we are instead proposing a work RVU of 0.69 based on a direct crosswalk to CPT code 88172 (Cytopathology, evaluation of fine needle aspirate; immediate cytohistologic study to determine adequacy for diagnosis, first evaluation episode, each site). CPT code 88172 is another interpretation procedure with the same 20 minutes of intraservice time, which we believe is a more accurate comparison for CPT code 92X71 than the two reference codes chosen by the survey participants due to their significantly higher and lower intraservice times. We note that the recommended intraservice time for CPT code 92X71 as compared to its predecessor CPT code 92275 is decreasing from 45 minutes to 20 minutes (56 percent reduction), and the recommended total time is decreasing from 71 minutes to 22 minutes (69 percent reduction); however, the work RVU is only decreasing from 1.01 to 0.80, which is a reduction of just over 20 percent. Although we do not imply that the decreases 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 reflected in decreases to work RVUs. In the case of CPT code 92X71, we have reason to believe that the significant drops in surveyed work time as compared to CPT code 92275 are a result of improvements in technology since the predecessor code was reviewed. The older machines used for electroretinography were slower and more cumbersome, and now the same work for the service can be performed in significantly less time. Therefore, we are proposing a work RVU of 0.69 based on the direct crosswalk to CPT code 88172, which we believe more accurately accounts for these decreases in surveyed work time.

      For CPT code 92X73 (Electroretinography (ERG) with interpretation and report; multifocal (mfERG)), we disagree with the RUC-recommended work RVU of 0.72 and are proposing a work RVU of 0.61. We concur that the relative difference in work between CPT code 92X71 and 92X73 is equivalent to the recommended interval of 0.08 RVUs. Therefore, we are proposing a work RVU of 0.61 for CPT code 92X73, based on the recommended interval of 0.08 fewer RVUs below our proposed work RVU of 0.69 for CPT code 92X71. The proposed work RVU is also based on the use of two crosswalk codes: CPT code 88387 (Macroscopic examination, dissection, and preparation of tissue for

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      non-microscopic analytical studies; each tissue preparation); and CPT code 92100 (Serial tonometry (separate procedure) with multiple measurements of intraocular pressure over an extended time period with interpretation and report, same day). Both codes share the same 20 minutes of intraservice and 20 minutes of total time, with a work RVU of 0.62 for CPT code 88387 and a work RVU of 0.61 for CPT code 92100.

      The recommendations for this code family also include Category III code 03X0T (Electroretinography (ERG) with interpretation and report, pattern (PERG)). We typically assign contractor pricing for Category III codes since they are temporary codes assigned to emerging technology and services. However, in cases where there is an unusually high volume of services that will be performed under a Category III code, we have sometimes assigned an active status to the procedure and developed RVUs before a formal CPT code is created. In the case of Category III code 03X0T, the recommendations indicate that approximately 80 percent of the services currently reported under CPT code 92275 will be reported under the new Category III code. Since this will involve an estimated 100,000 services for CY 2019, we believe that the interests of relativity would be better served by assigning an active status to Category III code 03X0T and creating RVUs through the use of a proxy crosswalk to a similar existing service. Therefore, we are proposing to assign an active status to Category III code 03X0T for CY 2019, with a work RVU and work time values crosswalked from CPT code 92250 (Fundus photography with interpretation and report). CPT code 92250 is a clinically similar procedure that was recently reviewed during the CY 2017 rule cycle. We are proposing a work RVU of 0.40 and work times of 10 minutes of intraservice and 12 minutes of total time for Category III code 03X0T based on this crosswalk to CPT code 92250.

      For the direct PE inputs, we are proposing to remove the preservice clinical labor in the facility setting for CPT codes 92X71 and 92X73. Both of these codes are diagnostic tests under which the professional (26 modifier) and technical (TC modifier) components will be separately billable, and codes that have these professional and technical components typically will not have direct PE inputs in the facility setting since the technical component is only valued in the nonfacility setting. We also note on this subject that the predecessor code, CPT code 92275, does not currently include any preservice clinical labor, nor any facility direct PE inputs.

      We are proposing to remove the clinical labor time for the ``Greet patient, provide gowning, ensure appropriate medical records are available'' (CA009) and the ``Provide education/obtain consent'' (CA011) activities for CPT codes 92X71 and 92X73. Both of these CPT codes will typically be reported with a same day E/M service, and we believe that these clinical labor tasks will be carried out during the E/M service. We believe that their inclusion in CPT codes 92X71 and 92X73 would be duplicative. We are also 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 for both codes. The predecessor CPT code 92275 did not previously have clinical labor time assigned for the ``Confirm order, protocol exam'' clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed in the new codes, only the way in which this clinical labor time has been presented on the PE worksheets. 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 proposing to refine the clinical labor time for the ``Clean room/equipment by clinical staff'' (CA024) activity from 12 minutes to 8 minutes for CPT codes 92X71 and 92X73. The recommendations for these codes stated that cleaning is carried out in several steps: The patient is first cleaned for 2 minutes, followed by wires and electrodes being scrubbed carefully with detergent, soaked, and then rinsed with sterile water. We agree with the need for 2 minutes of patient cleaning time and for the cleaning of the wires and electrodes to take place in two different steps. However, our standard clinical labor time for room/

      equipment cleaning is 3 minutes, and therefore, we are proposing a total time of 8 minutes for these codes, based on 2 minutes for patient cleaning and then 3 minutes for each of the two steps of wire and electrode cleaning.

      We are proposing to refine the clinical labor time for the ``Technologist QC's images in PACS, checking for all images, reformats, and dose page'' (CA030) activity from 10 minutes to 3 minutes for CPT codes 92X71 and 92X73. We finalized in the CY 2017 PFS final rule (81 FR 80184-80186) a range of appropriate standard minutes for this clinical labor activity, ranging from 2 minutes for simple services up to 5 minutes for highly complex services. We believe that the complexity of the imaging in CPT codes 92X71 and 92X73 is comparable to the CT and magnetic resonance (MR) codes that have been recently reviewed, such as CPT code 76X01 (Magnetic resonance (e.g., vibration) elastography). Therefore, in order to maintain relativity, we are proposing the same clinical labor time of 3 minutes for CPT codes 92X71 and 92X73 that has been recommended for these CT and MR codes. We are also proposing to refine the clinical labor time for the ``Review examination with interpreting MD/DO'' (CA031) activity from 5 minutes to 2 minutes for CPT codes 92X71 and 92X73. We also finalized in the CY 2017 PFS final rule a standard time of 2 minutes for reviewing examinations with the interpreting MD, and we have no reason to believe that these codes would typically require additional clinical labor at more than double the standard time.

      We noted that the new equipment item ``Contact lens electrode for mfERG and ffERG'' (EQ391) was listed twice for CPT code 92X71 but only a single time for CPT code 92X73. We are seeking additional information about whether the recommendations intended this equipment item to be listed twice, with one contact intended for each eye, or whether this was a clerical mistake. We are also interested in additional information as to why the contact lens electrode was listed twice for CPT code 92X71 but only a single time for CPT code 92X73. Finally, we are also proposing to refine the equipment times in accordance with our standard equipment time formulas.

      We are proposing to use the direct PE inputs for CPT code 92X73, including the refinements detailed above, as a proxy for Category III code 03X0T until it can be separately reviewed by the RUC.

      (51) Cardiac Output Measurement (CPT Codes 93561 and 93562)

      CPT codes 93561 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; with cardiac output measurement) and 93562 (Indicator dilution studies such as dye or thermodilution, including arterial and/or venous catheterization; subsequent measurement of cardiac output) were 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

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      Harvard valued and CMS/Other source codes. The specialty societies noted that CPT codes 93561 and 93562 are primarily performed in the pediatric population, thus the Medicare utilization for these Harvard-

      source services is not over 1,000. However, the specialty societies requested and the RUC agreed that these services should be reviewed under this negative IWPUT screen.

      For CPT code 93561, we disagree with the RUC-recommended work RVU of 0.95 and we are proposing a work RVU of 0.60 based on a crosswalk to CPT code 77003 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid)). CPT Code 77003 is another recently-reviewed add-on global code with the same 15 minutes of intraservice time and 2 additional minutes of preservice evaluation time. In our review of CPT code 93561, we found that there was a particularly unusual relationship between the surveyed work times and the RUC-recommended work RVU. We noted that the recommended intraservice time for CPT code 93561 is decreasing from 29 minutes to 15 minutes (48 percent reduction), and the recommended total time for CPT code 93561 is decreasing from 78 minutes to 15 minutes (81 percent reduction); however, the recommended work RVU is instead increasing from 0.25 to 0.95, which is an increase of nearly 300 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 typically be reflected in decreases to work RVUs, not increases in valuation. We recognize that CPT code 93561 is an unusual case, as it is shifting from 0-day global status to add-on code status. However, when the work time for a code is going down and the unit of service is being reduced, we would not expect to see an increased work RVU under these circumstances, and especially not such a large work RVU increase. Therefore, we are proposing instead to crosswalk CPT code 93561 to CPT code 77003 at a work RVU of 0.60, which we believe is a more accurate valuation in relation to other recently-reviewed add-on codes on the PFS. We believe that this proposed work RVU of 0.60 better preserves relativity with other clinically similar codes with similar surveyed work times.

      For CPT code 93562, we disagree with the recommended work RVU of 0.77 and are proposing a work RVU of 0.48 based on the intraservice time ratio with CPT code 93561. We observed a similar pattern taking place with CPT code 93562 as with the first code in the family, noting that the recommended intraservice time is decreasing from 16 minutes to 12 minutes (25 percent reduction), and the recommended total time is decreasing from 44 minutes to 12 minutes (73 percent reduction); however, the RUC-recommended work RVU is instead increasing from 0.01 to 0.77. We recognize that CPT code 93562 is another unusual case, as it is also shifting from 0-day global status to add-on code status, and the current work RVU of 0.01 was a decrease from the code's former valuation of 0.16 following the removal of moderate sedation in the CY 2017 rule cycle. However, when the work time for a code is going down and the unit of service is being reduced, we typically would not expect to see a work RVU increase under these circumstances, and especially not such a large work RVU increase. Therefore, we are proposing instead to apply the intraservice time ratio from CPT code 93561, for a ratio of 0.80 (12 minutes divided by 15 minutes) multiplied by the proposed work RVU of 0.60 for CPT code 93561, which results in the proposed work RVU of 0.48 for CPT code 93562. We note that the RUC-recommended work values also line up according to the same intraservice time ratio, with the recommended work RVU of 0.77 for CPT code 93562 existing in a ratio of 0.81 with the recommended work RVU of 0.95 for CPT code 93561. We believe that this provides further rationale for our proposal to value the work RVU of CPT code 93562 at 80 percent of the work RVU of CPT code 93561.

      There are no recommended direct PE inputs for the codes in this family and we are not proposing any direct PE inputs.

      (52) Coronary Flow Reserve Measurement (CPT Codes 93571 and 93572)

      CPT code 93571 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; initial vessel) was identified on a list of all services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; each additional vessel) was also included for review as part of the same family of CPT codes. The RUC recommended a work RVU of 1.50 for CPT code 93571, which is lower than the current work RVU of 1.80. The total time for this service decreased by 5 minutes from 20 minutes to 15 minutes. The RUC's recommendation is based on a crosswalk to CPT code 15136 (Dermal autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof), which has an identical intraservice and total time as CPT code 93571 of 15 minutes. We disagree with the recommended work RVU of 1.50 for this CPT code because we do not believe that a reduction in work RVU from 1.80 to 1.50 is commensurate with the reduction in time for this service of five minutes. Using the building block methodology, we believe the work RVU for CPT code 93571 should be 1.35. We believe that a crosswalk to CPT code 61517 (Implantation of brain intracavitary chemotherapy agent (List separately in addition to CPT code for primary procedure)) with a work RVU of 1.38 is more appropriate because it has an identical intraservice and total time (15 minutes) as CPT code 93571, describes work that is similar, and is closer to the calculations for intraservice time ratio, total time ratio, and the building block method. Therefore, we are proposing a work RVU of 1.38 for CPT code 93571.

      We are proposing the RUC-recommended work RVU for CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft) during coronary angiography including pharmacologically induced stress; each additional vessel) of 1.00.

      Both of these codes are facility-only procedures with no recommended direct PE inputs.

      (53) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)

      During 2017, we issued a national coverage determination (NCD) for Medicare coverage of supervised exercise therapy (SET) for the treatment of peripheral artery disease (PAD). Previously, the service had been assigned noncovered status under the PFS. CPT code 93668 (Peripheral arterial disease (PAD) rehabilitation, per session) was payable before the end of CY 2017, retroactive to the effective date of the NCD (May 25, 2017), and for CY 2018, CMS made payment for Medicare-

      covered SET for the treatment of PAD,

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      consistent with the NCD, reported with CPT code 93668. We used the most recent RUC-recommended work and direct PE inputs and requested that the RUC review the service, which had not been reviewed since 2001, for direct PE inputs. The RUC is not recommending a work RVU for CPT code 93668 due to the belief that there is no physician work involved in this service. After reviewing this code, we are proposing a work RVU of 0.00 for CPT code 93668 and are proposing to continue valuing the code for PE only.

      (54) Home Sleep Apnea Testing (CPT Codes 95800, 95801, and 95806)

      CPT codes 95800 (Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time), 95801 (Sleep study, unattended, simultaneous recording; minimum of heart rate, oxygen saturation, and respiratory analysis (e.g., by airflow or peripheral arterial tone)), and 95806 (Sleep study, unattended, simultaneous recording of, heart rate, oxygen saturation, respiratory airflow, and respiratory effort (e.g., thoracoabdominal movement)) were flagged by the CPT Editorial Panel and reviewed at the October 2014 Relativity Assessment Workgroup meeting. Due to rapid growth in service volume, the RUC recommended that these services be reviewed after 2 more years of Medicare utilization data (2014 and 2015 data). These three codes were surveyed for the April 2017 RUC meeting and new recommendations for work and direct PE inputs were submitted to CMS.

      For CPT code 95800, the RUC recommended a work RVU of 1.00 based on the survey 25th percentile value. We disagree with the recommended value and are proposing a work RVU of 0.85 based on a pair of crosswalk codes: CPT code 93281 (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 pacemaker system) and CPT code 93260 (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; implantable subcutaneous lead defibrillator system). Both of these codes have a work RVU of 0.85, as well as having the same intraservice time of 15 minutes, similar total times to CPT code 95800, and recent review dates within the last few years.

      In reviewing CPT code 95800, 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 50 minutes to 31 minutes (38 percent reduction); however, the RUC-

      recommended work RVU is only decreasing from 1.05 to 1.00, 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 reflected in decreases to work RVUs. In the case of CPT code 95800, we believe that it would be more accurate to propose a work RVU of 0.85 based on the aforementioned crosswalk codes to account for these decreases in the surveyed work time. We also note that in this case where the surveyed times are decreasing and the utilization of CPT code 95800 is increasingly significantly (quadrupling in the last 5 years), we have reason to believe that practitioners are becoming more efficient at performing the procedure, which, under the resource-based nature of the RVU system, lends further support for a reduction in the work RVU.

      For CPT code 95801, the RUC proposed a work RVU of 1.00 again based on the survey 25th percentile. We disagree with the recommended value and we are again proposing a work RVU of 0.85 based on the same pair of crosswalk codes, CPT codes 93281 and 93260. We noted that CPT codes 95800 and 95801 had identical recommended work RVUs and identical recommended survey work times. Given that these two codes also have extremely similar work descriptors, we interpreted this to mean that the two codes could have the same work RVU, and therefore, we are proposing the same work RVU of 0.85 for both codes.

      For CPT code 95806, the RUC recommended a work RVU of 1.08 based on a crosswalk to CPT code 95819 (Electroencephalogram (EEG); including recording awake and asleep). Although we disagree with the RUC-

      recommended work RVU of 1.08, we concur that the relative difference in work between CPT codes 95800 and 95801 and CPT code 95806 is equivalent to the recommended interval of 0.08 RVUs. Therefore, we are proposing a work RVU of 0.93 for CPT code 95806, based on the recommended interval of 0.08 additional RVUs above our proposed work RVU of 0.85 for CPT codes 95800 and 95801. We also note that CPT code 95806 is experiencing a similar change in the recommended work and time values comparable to CPT code 95800. The recommended intraservice time for CPT code 95806 is decreasing from 25 minutes to 15 minutes (40 percent), and the recommended total time is decreasing from 50 minutes to 31 minutes (38 percent); however, the recommended work RVU is only decreasing from 1.25 to 1.08, which is a reduction of only 14 percent. As we stated for CPT code 95800, we do not believe that decreases in work time must equate to a one-to-one or linear decrease in the valuation of work RVUs, but we do believe that these changes in surveyed work time suggest that practitioners are becoming more efficient at performing the procedure, and that it would be more accurate to maintain the recommended work interval with CPT codes 95800 and 95801 by proposing a work RVU of 0.93 for CPT code 95806.

      We are not proposing any direct PE refinements for this code family.

      (55) Neurostimulator Services (CPT Codes 95970, 95X83, 95X84, 95X85, and 95X86)

      In October 2013, CPT code 95971 (Electronic analysis of implanted neurostimulator pulse generator system; simple spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming) was identified in the second iteration of the High Volume Growth screen. In January 2014, the RUC recommended that CPT codes 95971, 95972 (Electronic analysis of implanted neurostimulator pulse generator system; complex spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming) and 95974 (Electronic analysis of implanted neurostimulator pulse generator system; complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour) be referred to the CPT Editorial Panel to address the entire family regarding the time referenced in the CPT code descriptors. In June 2017, the CPT Editorial Panel revised CPT codes 95970, 95971, and 95972, deleted CPT codes 95974, 95975 (Electronic analysis of implanted neurostimulator pulse

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      generator system; complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour), 95978 (Electronic analysis of implanted neurostimulator pulse generator system, complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; first hour), and 95979 (Electronic analysis of implanted neurostimulator pulse generator system, complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; each additional 30 minutes after first hour) and created four new CPT codes for analysis and programming of implanted cranial nerve neurostimulator pulse generator, analysis, and programming of brain neurostimulator pulse generator systems and analysis of stored neurophysiology recording data.

      The RUC recommended a work RVU of 0.45 for CPT code 95970 (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 brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve neurostimulator pulse generator/transmitter, without programming)), which is identical to the current work RVU for this CPT code. The descriptor for this CPT code has been modified slightly, but the specialty societies affirmed that the work itself has not changed. To justify its recommendation, the RUC provided two references: 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), with intraservice time of 15 minutes, total time of 27 minutes, and a work RVU of 0.67; and CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: An expanded problem focused history; An expanded problem focused examination; or Medical decision making of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 15 minutes are spent face-

      to-face with the patient and/or family), with intraservice time of 15 minutes, total time of 23 minutes, and a work RVU of 0.97. We disagree with the RUC's recommendation because we do not believe that maintaining the work RVU, given a decrease of four minutes in total time, is appropriate. In addition, we note that the reference CPT codes chosen have much higher intraservice and total times than CPT code 95970, and also have higher work RVUs, making them poor comparisons. Instead, we identified a crosswalk to CPT code 95930 (Visual evoked potential (VEP) checkerboard or flash testing, central nervous system except glaucoma, with interpretation and report) with 10 minutes intraservice time, 14 minutes total time, and a work RVU of 0.35. Therefore, we are proposing a work RVU of 0.35 for CPT code 95970.

      CPT code 95X83 (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 simple cranial nerve neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional) is a new CPT code replacing CPT code 95974 (Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour). The description of the work involved in furnishing CPT code 95X83 differs from that of the deleted CPT code in a few important ways, notably that the time parameter has been removed so that the CPT code no longer describes the first hour of programming. In addition, the new CPT code refers to simple rather than complex programming. Accordingly, the intraservice and total times for this CPT code are substantively different from those of the deleted CPT code. CPT code 95X83 has an intraservice time of 11 minutes and a total time of 24 minutes, while CPT code 95974 has an intraservice time of 60 minutes and a total time of 110 minutes. The RUC recommended a work RVU of 0.95 for CPT code 95X83. The RUC's top reference CPT code as chosen by the RUC survey participants was CPT code 95816 (Electroencephalogram (EEG); including recording awake and drowsy), with an intraservice time of 15 minutes, 26 minutes total time, and a work RVU of 1.08. The RUC indicated that the service is similar, but somewhat more complex than CPT code 95X83. We disagree with the RUC's recommended work RVU for this CPT code because we do not believe that the large difference in time between the new CPT code and CPT code 95974 is reflected in the slightly smaller proportional decrease in work RVUs. The reduction in total time, from 110 minutes to 24 minutes is nearly 80 percent. However, the RUC's recommended work RVU reflects a reduction of just under 70 percent. We believe that a more appropriate crosswalk would be CPT code 76641 (Ultrasound, breast, unilateral, real time with image documentation, including axilla when performed; complete) with intraservice time of 12 minutes, total time of 22 minutes, and a work RVU of 0.73. Therefore, we are proposing a work RVU of 0.73 for CPT code 95X83.

      CPT code 95X84 describes the same work as CPT code 95X83, but with complex rather than simple programming. The CPT Editorial Panel refers to simple programming of a neurostimulator pulse generator/transmitter as the adjustment of one to three parameter(s), while complex programming includes adjustment of more than three parameters. For purposes of applying the building block methodology and calculating intraservice and total time ratios, the RUC compared CPT code 94X84 with CPT code 95975 (Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/

      transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour), which is being deleted by the CPT Editorial Panel. We believe that this was an inappropriate comparison since it is time based (first hour of programming) and is an add-on code. Instead we believe that the RUC

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      intended to compare CPT code 95X84 with CPT code 95974 (Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex cranial nerve neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, with or without nerve interface testing, first hour), which has been recommended for deletion by the CPT Editorial Panel and is also the comparison for CPT code 95X83. The RUC recommended a work RVU of 1.19 for CPT code 95X84. The RUC disagreed with the two top reference services CPT code 99215 (Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A comprehensive history; A comprehensive examination; or Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 40 minutes are spent face-

      to-face with the patient and/or family) and CPT code 99202 (Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: An expanded problem focused history; An expanded problem focused examination; or straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 20 minutes are spent face-to-face with the patient and/or family) and instead compared CPT code 95X84 to CPT code 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; An expanded problem focused examination; or Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 15 minutes are spent at the bedside and on the patient's facility floor or unit.) with total time of 31 minutes, intraservice time of 15 minutes, and a work RVU of 1.16; and 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), with total time of 27 minutes, intraservice time of 15 minutes, and a work RVU of 1.22. We disagree with the RUC's recommended work RVU of 1.19 for CPT code 95X84. Once the comparison CPT code is corrected to CPT code 95974, the reverse building block calculation indicates that a lower work RVU (close to 0.82) would be a better reflection of the work involved in furnishing this service. As an alternative to the RUC's recommendation, we added the difference in RUC-recommended work RVUs between CPT code 95X83 and 95X84 (0.24 RVUs) to the proposed work RVU of 0.73 for CPT code 95X83. Therefore, we propose a work RVU of 0.97 for CPT code 95X84.

      CPT code 95X85 (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, doe lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, first 15 minutes face-to-face time with physician or other qualified health care professional) is the base for add-on CPT code 95X86 (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, doe lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, each additional 15 minutes face-to-face time with physician or other qualified health care professional), which is an add-on CPT code and can only be billed with CPT code 95X85. The RUC compared CPT code 95X85 with CPT code 95978 (Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, battery status, electrode selectability and polarity, impedance and patient compliance measurements), complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; first hour), which the CPT Editorial Panel is recommending for deletion. The primary distinction between the new and old CPT codes is that the new CPT code describes the first 15 minutes of programming while the deleted CPT code describes up to one hour of programming. The RUC recommended a work RVU of 1.25 for CPT code 95X85 and a work RVU of 1.00 for CPT code 95X86. For CPT code 95X85, the RUC's recommendation is based on reference CPT codes 12013 (Simple repair of superficial wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 2.6 cm to 5.0 cm), with total time of 27 minutes, intraservice time of 15 minutes, and a work RVU of 1.22; and CPT code 70470 (Computed tomography, head or brain; without contrast material, followed by contrast material(s) and further sections) with 25 minutes of total time, 15 minutes of intraservice time, and a work RVU of 1.27. We disagree with the RUC's recommended work RVU for CPT code 95X85 because we do not believe that the reduction in work RVU reflects the change in time described by the CPT code. Using the reverse building block methodology, we estimate that a work RVU of nearer to 1.11 would be more appropriate. In addition, if we were to sum the RUC-recommended RVUs for a single hour of programming using one of the base CPT codes and three of the 15 minute follow-on CPT codes, 1 hour of programming would be valued at 4.25 work RVUs. This contrasts sharply from the work RVU of 3.50 for 1 hour of programming using the deleted CPT code 95978. We believe that a more appropriate valuation of the work involved in furnishing this service is reflected by a crosswalk to CPT code 93886 (Transcranial Doppler study of the intracranial arteries; complete study), with total time 27 minutes, intraservice time of 17 minutes, and a work RVU of 0.91. Therefore, we are proposing a work RVU of 0.91 for CPT code 95X85.

      The RUC's recommended work RVU of 1.00 for CPT code 95X86 is based on the key reference service CPT code 64645 (Chemodenervation of one extremity; each additional extremity, 5 or more muscles), which has total time of 26 minutes, intraservice time of 25 minutes, and a work RVU 1.39. This new CPT code is replacing CPT code 95978 (Electronic analysis of implanted

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      neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, battery status, electrode selectability and polarity, impedance and patient compliance measurements), complex deep brain neurostimulator pulse generator/transmitter, with initial or subsequent programming; first hour), which is being deleted by the CPT Editorial Panel. If we add the incremental difference between CPT codes 95X85 and 95X86 to the proposed value for the base CPT code (95X85, work RVU = 0.91), we estimate that this add-on CPT code should have a work RVU of 0.75. The building block methodology results in a recommendation of a slightly higher work RVU of 0.82. We are proposing a work RVU of 0.80 for CPT code 95X86, which falls between the calculated value using incremental differences and the calculation from the reverse building block, and is supported by a crosswalk to CPT code 51797 (Voiding pressure studies, intra-abdominal (i.e., rectal, gastric, intraperitoneal)), which is an add-on CPT code with identical total and intraservice times (15 minutes) as CPT code 95X86.

      We are not proposing any direct PE refinements for this code family.

      (56) Psychological and Neuropsychological Testing (CPT Codes 96105, 96110, 96116, 96125, 96127, 963X0, 963X1, 963X2, 963X3, 963X4, 963X5, 963X6, 963X7, 963X8, 963X9, 96X10, 96X11, 96X12)

      In CY 2016, the Psychological and Neuropsychological Testing family of codes were identified as potentially misvalued using a high expenditure services screen across specialties with Medicare allowed charges of $10 million or more. The entire family of codes was referred to the CPT Editorial Panel to be revised, as the testing practices had been significantly altered by the growth and availability of technology, leading to confusion about how to report the codes. In June 2017, the CPT Editorial Panel revised five existing codes, added 13 codes to provide better description of psychological and neuropsychological testing, and deleted CPT codes 96101, 96102, 96103, 96111, 96118, 96119, and 96120. The RUC and HCPAC submitted recommendations for the 13 new codes and for the existing CPT codes 96105, 96110, 96116, 96125, and 96127.

      We are proposing the RUC- and HCPAC-recommend work RVUs for several of the CPT codes in this family: A work RVU of 1.75 for CPT code 96105; a work RVU of 1.86 for CPT code 96116; a work RVU of 1.70 for CPT code 96125; a work RVU of 1.71 for CPT code 963X2; a work RVU of 0.55 for CPT code 963X7; a work RVU of 0.46 for CPT code 963X8; and a work RVU of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 963X9, 96X10, and 96X12 were valued by the RUC for PE only.

      This code family contains a subset of codes that describe psychological and neuropsychological testing administration and evaluation, not including assessment of aphasia, developmental screening, or developmental testing. The CPT Editorial Panel's recommended coding for this subset of services consists of seven new codes: Two that describe either psychological or neuropsychological testing when administered by physicians or other qualified health professionals (CPT codes 963X7 and 963X8), and two for either type of testing when administered by technicians (CPT codes 963X9 and 96X10); and four new codes that describe testing evaluation by physicians or other qualified health care professionals (CPT codes 963X3-963X6). This new coding effectively unbundles codes that currently report the full course of testing into separate codes for testing administration (CPT codes 963X7, 963X8, 963X9, and 96X10) and evaluation (CPT Codes 963X3, 963X4, and 963X5). According to a stakeholder that represents the psychologist and neuropsychologist community, this new coding will result in significant reductions in payment for these services due to the unbundling of the testing codes into codes for physician-

      administered tests and technician-administered tests. The stakeholder asserts that because the new coding includes testing codes with zero work RVUs for the technician administered tests and the work RVUs are lower than they believe to be accurate, this new valuation would ignore the clinical evaluation and decision making performed by the physician or other qualified health professional during the course of testing administration and evaluation. Furthermore, the net result of the code valuations for these new codes is a reduction in the overall work RVUs for this family of codes. In other words, the stakeholder's analysis found that the RUC recommendations result in a reduction in total work RVUs, even though the actual physician work of a testing battery has not changed.

      In the interest of payment stability for these high-volume services, we are proposing to implement work RVUs for this code family, which would eliminate the approximately 2 percent reduction in work spending. We are proposing to achieve work neutrality for this code family by scaling the work RVUs upward from the RUC-recommended values so that the size of the pool of work RVUs would be essentially unchanged for this family of services. Therefore, we are proposing: A work RVU of 2.56 for CPT code 963X0, rather than the RUC recommended work RVU of 2.50; a work RVU of 1.16 for CPT code 963X1, rather than the RUC-recommended work RVU of 1.10; a work RVU of 2.56 for CPT code 963X3, rather than the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code 963X4, rather than the RUC-recommended work RVU of 1.90; a work RVU of 2.56 for CPT code 963X5, rather than the RUC-

      recommended work RVU of 2.50; and a work RVU of 1.96 for CPT code 963X6, rather than the RUC-recommended work RVU of 1.90. We see no evidence that the typical practice for these services has changed to merit a reduction in valuation of professional services.

      The RUC made several revisions to the recommended direct PE inputs for the administration codes from their respective predecessor codes, including revisions to quantities of testing forms. For the supply item, ``psych testing forms, average'' there is a quantity of 0.10 in the predecessor CPT code 96101, and a quantity of 0.33 in the predecessor CPT code 96102. For the supply item ``neurobehavioral status forms, average,'' there is a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 0.30 for predecessor CPT code 96119, and for the supply item ``aphasia assessment forms, average,'' there is a quantity of 1.0 in the predecessor CPT code 96118 and a quantity of 0.30 in predecessor CPT code 96119. The RUC recommendation does not include any forms for CPT codes 963X5 and 963X6. The RUC has replaced the corresponding predecessor supply items with new items ``WAIS-IV Record Form,'' ``WAIS-IV Response Booklet #1,'' and ``WAIS-IV Response Booklet #2,'' and assigned quantities of 0.165 for each of these new supply items for CPT codes 963X7-96X10. In our analysis, we find that the RUC-recommended PE refinements contributes significantly to the reduction in the overall payment for this code family. We see no compelling evidence that the quantities of testing forms used in a typical course of testing would have reduced dramatically and, in the interest of payment stability, we are proposing to refine the direct PE inputs for CPT codes 963X5-96X10 by including 1.0 quantity each of the supply items ``WAIS-IV Record Form,'' ``WAIS-IV Response Booklet #1'', and

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      ``WAIS-IV Response Booklet #2.'' We believe that a typical course of testing would involve use of one booklet for each of the relevant codes. In addition, these proposed refinements would largely mitigate potentially destabilizing payment reductions for these services. We are seeking comment on our proposed work RVUs and proposed PE refinements for this family of services.

      For the direct PE inputs, we are proposing to remove the equipment time for the CANTAB Mobile (ED055) equipment item from CPT code 96X12. This item was listed at different points in the recommendations as a supply item with a cost of $28 per assessment and as an equipment item for a software license with a cost of $2,800 that could be used for up to 100 assessments. We are unclear as to how the CANTAB Mobile would typically be used in this procedure, and we are proposing to remove the equipment time pending the submission of more data about the item. We are seeking additional information about the use of this item and how it should best be included into the PE methodology. We are also interested in information as to whether the submitted invoice refers to the cost of the mobile device itself, or the cost of user licenses for the mobile device, which was unclear from the information submitted with the recommendations.

      (57) Electrocorticography (CPT Code 96X00)

      CPT Code 95829 is used for Electrocorticogram performed at the time of surgery; however, a new code was needed to account for this non-

      face-to-face service for the review of a month's worth or more of stored data. CPT code 96X00 (Electrocorticogram from an implanted brain neurostimulator pulse generator/transmitter, including recording, with interpretation and written report, up to 30 days) is a new code approved at the September 2017 CPT Editorial Panel Meeting to describe this service.

      We disagree with the RUC-recommended work RVU of 2.30 for CPT code 96X00 and are proposing a work RVU of 1.98 based on a direct crosswalk to the top reference, CPT code 95957 (Digital analysis of electroencephalogram (EEG) (e.g., for epileptic spike analysis)). This is a recently-reviewed code with the same intraservice time of 30 minutes and a total time only 2 minutes lower than CPT code 96X00. We agree with the survey respondents that CPT code 95957 is an accurate valuation for this new code, and due to the clinically similar nature of the two procedures and their near-identical time values, we are proposing to value both of them at the same work RVU of 1.98.

      The RUC did not recommend, and we did not propose, any direct PE inputs for CPT code 96X00.

      (58) Chronic Care Remote Physiologic Monitoring (CPT Codes 990X0, 990X1, and 994X9)

      In the CY 2018 PFS final rule, we finalized separate payment for 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) (82 FR 53014). In that rule, we indicated that there would be new coding describing remote monitoring forthcoming from the CPT Editorial Panel and the RUC (82 FR 53014). In September 2017, the CPT Editorial Panel revised one code and created three new codes to describe remote physiologic monitoring and management and the RUC provided valuation recommendations through our standard rulemaking process.

      CPT codes 990X0 (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 990X1 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days) are both PE-only codes. We are proposing the RUC-

      recommended work RVU of 0.61 for CPT code 994X9 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month).

      For the direct PE inputs, we are proposing to accept the RUC-

      recommended direct PE inputs for CPT code 990X0 and to remove the ``Monthly cellular and licensing service fee'' supply from CPT code 990X1. We do not believe that these licensing fees would be allocated to the use of an individual patient for an individual service, and instead believe they can be better understood as forms of indirect costs similar to office rent or administrative expenses. Therefore, we are proposing to remove this supply input as a form of indirect PE. We are proposing the direct PE inputs for CPT code 994X9 without refinement.

      (59) Interprofessional Internet Consultation (CPT Codes 994X6, 994X0, 99446, 99447, 99448, and 99449)

      In September 2017, the CPT Editorial Panel revised four codes and created two codes to describe interprofessional telephone/internet/

      electronic medical record consultation services. CPT codes 99446 (Interprofessional telephone/internet 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; 5-10 minutes of medical consultative discussion and review), 99447 (Interprofessional telephone/internet 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; 11-20 minutes of medical consultative discussion and review), 99448 (Interprofessional telephone/internet 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; 21-30 minutes of medical consultative discussion and review), and 99449 (Interprofessional telephone/internet 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; 31 minutes or more of medical consultative discussion and review) describe assessment and management services in which a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a physician with specific specialty expertise to assist with the diagnosis and/or management of the patient's problem without the need for the face-to-face interaction between the patient and the consultant. These CPT codes are currently assigned a procedure status of B (bundled) and are not separately payable under Medicare. The CPT Editorial Panel revised these codes to include electronic health record consultations, and the RUC reaffirmed the work RVUs it had previously submitted for these codes. We reevaluated the submitted recommendations and, in light of changes in medical practice and technology, we are proposing to change the procedure status for CPT codes 99446, 99447, 99448, and 99449 from B

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      (bundled) to A (active). We are also proposing the RUC re-affirmed work RVUs of 0.35 for CPT code 99446, 0.70 for CPT code 99447, 1.05 for CPT code 99448, and 1.40 for CPT code 99449.

      The CPT Editorial Panel also created two new codes, CPT code 994X0 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and CPT code 994X6 (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 or more minutes of medical consultative time). The RUC-recommended work RVUs are 0.50 for CPT code 994X0 and 0.70 for 994X6. Since the CPT code for the treating/requesting physician or qualified healthcare professional and the CPT code for the consultative physician have similar intraservice times, we believe that these CPT codes should have equal values for work. Therefore, we are proposing a work RVU of 0.50 for both CPT codes 994X0 and 994X6.

      We welcome comments on this proposal. We also direct readers to section II.D. of this proposed rule, which includes additional detail regarding our proposed policies for modernizing Medicare physician payment by recognizing communication technology-based services.

      There are no recommended direct PE inputs for the codes in this family.

      (60) Chronic Care Management Services (CPT Code 994X7)

      In February 2017, the CPT Editorial Panel created a new code to describe at least 30 minutes of chronic care management services performed personally by the physician or qualified health care professional over one calendar month. CMS began making separate payment for 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) in CY 2015 (79 FR 67715). CPT code 99490 describes 20 minutes of clinical staff time spent on care management services for patients with 2 or more chronic conditions. CPT code 99490 also includes 15 minutes of physician time for supervision of clinical staff. For CY 2019, the CPT Editorial Panel created CPT code 994X7 (Chronic care management services, provided personally by a physician or other qualified health care professional, at least 30 minutes of physician or other qualified health care professional time, 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) to describe situations when the billing practitioner is doing the care coordination work that is attributed to clinical staff in CPT code 99490. For CPT code 994X7, the RUC recommended a work RVU of 1.45 for 30 minutes of physician time. We believe this work RVU overvalues the resource costs associated with the physician performing the same care coordination activities that are performed by clinical staff in the service described by CPT code 99490. Additionally, this valuation of the work is higher than that of 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 a physician or other qualified health care professional, per calendar month), which includes 60 minutes of clinical staff time, creating a rank order anomaly within the family of codes if we were to accept the RUC-

      recommended value.

      CPT code 99490 has a work RVU of 0.61 for 15 minutes of physician time. Therefore, as CPT code 994X7 describes 30 minutes of physician time, we are proposing a work RVU of 1.22, which is double the work RVU of CPT code 99490.

      We are not proposing any direct PE refinements for this code family.

      (61) Diabetes Management Training (HCPCS Codes G0108 and G0109)

      HCPCS codes G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes) and G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes) were identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. For CY 2019, we are proposing the HCPAC-recommended work RVU of 0.90 for HCPCS code G0108 and the HCPAC-recommended work RVU of 0.25 for HCPCS code G0109.

      For the direct PE inputs, we note that there is a significant disparity between the specialty recommendation and the final recommendation submitted by the HCPAC. We are concerned about the significant decreases in direct PE inputs in the final recommendation when compared to the current makeup of the two codes. The final HCPAC recommendation removed a series of different syringes and the patient education booklet that currently accompanies the procedure. We believe that injection training is part of these services and that the supplies associated with that training would typically be included in the procedures. Due to these concerns, we are proposing to maintain the current direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we will not add the new supply item ``20x30 inch self-stick easel pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109, as it is not a current supply for HCPCS code G0109; however, we are proposing to accept the submitted invoice price and to add the supply to our direct PE database.

      (62) External Counterpulsation (HCPCS Code G0166)

      HCPCS code G0166 (External counterpulsation, per treatment session) was identified on a screen of CMS or Other source codes with Medicare utilization greater than 100,000 services annually. The RUC is not recommending a work RVU for HCPCS code G0166 due to the belief that there is no physician work involved in this service. After reviewing this code, we are proposing a work RVU of 0.00 for HCPCS code G0166, and are proposing to make the code valued for PE only.

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

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      (63) Wound Closure by Adhesive (HCPCS Code G0168)

      HCPCS code G0168 (Wound closure utilizing tissue adhesive(s) only) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, the RUC recommended a work RVU of 0.45 based on maintaining the current work RVU.

      We disagree with the recommended value and we are proposing a work RVU of 0.31 for HCPCS code G0168 based on a direct crosswalk to CPT code 93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single, dual, or multiple lead pacemaker system, includes recording with and without magnet application with analysis, review and report(s) by a physician or other qualified health care professional, up to 90 days). CPT code 93293 is a recently-reviewed code with the same 5 minutes of intraservice time and 1 fewer minute of total time. In reviewing HCPCS code G0168, the recommendations stated that the work involved in the service had not changed even though the surveyed intraservice time was decreasing by 50 percent, from 10 minutes to 5 minutes. 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 reflected in decreases to work RVUs. In the case of HCPCS code G0168, we believe that it would be more accurate to propose a work RVU of 0.31 based on the aforementioned crosswalk to CPT code 93293 to account for these decreases in the surveyed work time. Maintaining the current work RVU of 0.45 despite a 50 percent decrease in the surveyed intraservice time would result in a significant increase in the intensity of HCPCS code G0168, and we have no reason to believe that the procedure has increased in intensity since the last time that it was valued.

      For the direct PE inputs, we are proposing to refine the equipment times in accordance with our standard equipment time formulas.

      (64) Removal of Impacted Cerumen (HCPCS Code G0268)

      HCPCS code G0268 (Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we are proposing the RUC-

      recommended work RVU of 0.61 for HCPCS code G0268.

      For the direct PE inputs, we are proposing to remove the clinical labor time for the ``Clean surgical instrument package'' (CA026) activity. There is no surgical instrument pack included in the recommended equipment for HCPCS code G0268, and this code already includes the standard 3 minutes allocated for cleaning the room and equipment. In addition, all of the instruments used in the procedure appear to be disposable supplies that would not require cleaning since they would only be used a single time.

      (65) Structured Assessment, Brief Intervention, and Referral to Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and GSBR1)

      In response to the Request for Information in the CY 2018 PFS proposed rule (82 FR 34172), commenters requested that CMS pay separately for assessment and referral related to substance use disorders. In the CY 2008 PFS final rule (72 FR 66371), we created two G-codes to allow for appropriate Medicare reporting and payment for alcohol and substance abuse assessment and intervention services that are not provided as screening services, but that are performed in the context of the diagnosis or treatment of illness or injury. The codes are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse structured assessment (e.g., AUDIT, DAST) and brief intervention, 15 to 30 minutes)) and HCPCS code G0397 (Alcohol and/or substance (other than tobacco) abuse structured assessment (e.g., AUDIT, DAST) and intervention greater than 30 minutes)). In 2008, we instructed Medicare contractors to pay for these codes only when the services were considered reasonable and necessary.

      Given the ongoing opioid epidemic and the current needs of the Medicare population, we expect that these services would often be reasonable and necessary. However, the utilization for these services is relatively low, which we believe is in part due to the service-

      specific documentation requirements for these codes (the current requirements can be found here: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/SBIRT_Factsheet_ICN904084.pdf). We believe that removing the additional documentation requirements will also ease the administrative burden on providers. Therefore, for CY 2019, we are proposing to eliminate the service-specific documentation requirements for HCPCS codes G0397 and G0398. We welcome comments on our proposal to change the documentation requirements for these codes.

      Additionally, we are proposing to create a third HCPCS code, GSBR1, with a lower time threshold in order to accurately account for the resource costs when practitioners furnish these services, but do not meet the requirements of the existing codes. The proposed code descriptor is: Alcohol and/or substance (other than tobacco) abuse structured assessment (e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We are proposing a work RVU of 0.33, based on the intraservice time ratio between HCPCS codes G0396 and G0397. We welcome comments on this code descriptor and proposed valuation for HCPCS code GSBR1.

      (66) Prolonged Services (HCPCS Code GPRO1)

      CPT codes 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)) describe additional time spent face-to-face with a patient. Stakeholders claim that the threshold of 60 minutes for CPT code 99354 is difficult to meet and is an impediment to billing these codes. In response to stakeholder feedback and as part of our proposal as discussed in section II.I. of this proposed rule to implement a single PFS rate for E/M visit levels 2-5 while maintaining payment stability across the specialties, we are proposing HCPCS code GPRO1 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the

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      office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)), which could be billed with any level of E/M code. We note that we do not propose to make any changes to CPT codes 99354 and 99355, which could still be billed, as needed, when their time thresholds and all other requirements are met. We are proposing a work RVU of 1.17, which is equal to half of the work RVU assigned to CPT code 99354. Additionally, we are proposing direct PE inputs for HCPCS code GPRO1 that are equal to one half of the values assigned to CPT code 99354, which can be found in the Direct PE Inputs public use file for this proposed rule.

      (67) Remote Pre-Recorded Services (HCPCS Code GRAS1)

      For CY 2019, we are proposing to make separate payment for remote services when a physician uses pre-recorded video and/or images submitted by a patient in order to evaluate a patient's condition through new HCPCS G-code GRAS1 (Remote evaluation of recorded video and/or images submitted by the patient (e.g., store and forward), including interpretation with verbal 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). We are proposing to value this service by a direct crosswalk to CPT code 93793 (Anticoagulant management for a patient taking warfarin, must include review and interpretation of a new home, office, or lab international normalized ratio (INR) test result, patient instructions, dosage adjustment (as needed), and scheduling of additional test(s), when performed), as we believe the work described is similar in kind and intensity to the work performed as part of HCPCS code GRAS1. Therefore, we are proposing a work RVU of 0.18, preservice time of 3 minutes, intraservice time of 4 minutes, and post service time of 2 minutes. We are also proposing to add 6 minutes of clinical labor (L037D) in the service period. We are seeking comment on the code descriptor and valuation for HCPCS code GRAS1. We direct readers to section II.D. of this proposed rule, which includes additional detail regarding our proposed policies for modernizing Medicare physician payment by recognizing communication technology-based services.

      (68) Brief Communication Technology-Based Service, e.g., Virtual Check-

      in (HCPCS Code GVCI1)

      We are proposing to create a G-code, HCPCS code GVCI1 (Brief communication technology based service, e.g. virtual check-in, by a physician or other qualified health care professional who may 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) to facilitate payment for these brief communication technology-based services. We propose to base the code descriptor and valuation for HCPCS code GVCI1 on existing CPT code 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian 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), which is currently not separately payable under the PFS. As CPT code 99441 only describes telephone calls, we are proposing to create a new HCPCS code GVCI1 to encompass a broader array of communication modalities. We do, however, believe that the resource assumptions for CPT code 99441 would accurately account for the costs associated with providing the proposed virtual check-in service, regardless of the technology. We are proposing a work RVU of 0.25, based on a direct crosswalk to CPT code 99441. For the direct PE inputs for HCPCS code GVCI1, we are also proposing the direct PE inputs assigned to CPT code 99441. Given the breadth of technologies that could be described as telecommunications, we look forward to receiving public comments and working with the CPT Editorial Panel and the RUC to evaluate whether separate coding and payment is needed to account for differentiation between communication modalities. We are seeking comment on the code descriptor, as well as the proposed valuation for HCPCS code GVCI1. We direct readers to section II.D. of this proposed rule, which includes additional detail regarding our proposed policies for modernizing Medicare physician payment by recognizing communication technology-based services.

      (69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code GCG0X)

      We are proposing to create a HCPCS G-code to be reported with an E/

      M service to describe the additional resource costs for specialties for whom E/M visit codes make up a large percentage of their total allowed charges and who we believe primarily bill level 4 and level 5 visits. The treatment approaches for these specialties generally do not have separate coding and are generally reported using the E/M visit codes. We are proposing to create HCPCS code, GCG0X (Visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/

      gynecology, allergy/immunology, otolaryngology, or interventional pain management-centered care (Add-on code, list separately in addition to an evaluation and management visit)). We are proposing a valuation for HCPCS code GCG0X based on a crosswalk to 75 percent of the work RVU and time of CPT code 90785 (Interactive complexity), which would result in a proposed work RVU of 0.25 and a physician time of 8.25 minutes for HCPCS code GCG0X. CPT code 90785 has no direct PE inputs. Interactive complexity is an add-on code that may be billed when a psychotherapy or psychiatric service requires more work due to the complexity of the patient. We believe that this work RVU and physician time would be an accurate representation of the additional work associated with the higher level complex visits. For further discussion of proposals relating to this code, see section II.I of this proposed rule. We are seeking comment on the code descriptor, as well as the proposed valuation for HCPCS code GCG0X.

      (70) Visit Complexity Inherent to Primary Care Services (HCPCS Code GPC1X)

      We are proposing to create a HCPCS G-code for primary care services, GPC1X (Visit complexity inherent to evaluation and management associated with primary medical care services that serve as the continuing focal point for all needed health care services (Add-on code, list separately in addition to an evaluation and management visit)). This code describes furnishing a visit to a new or existing patient, and can include aspects of care management, counseling, or treatment of acute or chronic

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      conditions not accounted for by other coding. HCPCS code GPC1X would be billed in addition to the E/M visit code when the visit involved primary care-focused services. We are proposing a work RVU of 0.07, physician time of 1.75 minutes. This proposed valuation accounts for the additional work resource costs associated with furnishing primary care that distinguishes E/M primary care visits from other types of E/M visits and maintains work budget neutrality across the office/

      outpatient E/M code set. For further discussion of proposals relating to this code, see section II.I of this proposed rule. We are seeking comment on the code descriptor, as well as the proposed valuation for HCPCS code GPC1X.

      (71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X and GPD1X)

      We are proposing to create two HCPCS G-codes, HCPCS codes GPD0X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, new patient) and GPD1X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, established patient), to describe podiatric evaluation and management services. We are proposing a work RVU of 1.36, a physician time of 28.19 minutes, and direct costs summing to $21.29 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.73 minutes, and direct costs summing to $15.87 for HCPCS code GPD1X. These values are based on the average rate for CPT codes 99201-99203 and CPT codes 99211-99212 respectively, weighted by podiatric volume. For further discussion of proposals relating to these codes, see section II.I of this proposed rule.

      (72) Comment Solicitation on Superficial Radiation Treatment Planning and Management

      In the CY 2015 PFS final rule with comment period (79 FR 67666-

      67667), we noted that changes to the CPT prefatory language limited the codes that could be reported when describing services associated with superficial radiation treatment (SRT) delivery, described by CPT code 77401 (radiation treatment delivery, superficial and/or ortho voltage, per day). The changes effectively meant that many other related services were bundled with CPT code 77401, instead of being separately reported. For example, CPT guidance clarified that certain codes used to describe clinical treatment planning, treatment devices, isodose planning, physics consultation, and radiation treatment management cannot be reported when furnished in association with SRT. Stakeholders informed us that these changes to the CPT prefatory language prevented them from billing Medicare for codes that were previously frequently billed with CPT code 77401. We solicited comments as to whether the revised bundled coding for SRT allowed for accurate reporting of the associated services. In the CY 2016 PFS final rule with comment period (80 FR 70955), we noted that the RUC did not review the inputs for SRT procedures, and therefore, did not assess whether changes in valuation were appropriate in light of the bundling of associated services. In addition, we solicited recommendations from stakeholders regarding whether it would be appropriate to add physician work for this service, even though physician work is not included in other radiation treatment services. In the CY 2018 PFS proposed rule (82 FR 34012) and the CY 2018 PFS final rule (82 FR 53082), we noted that the 2016 National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services states that radiation oncology services may not be separately reported with E/M codes. While this NCCI edit is no longer active stakeholders have stated that MACs have denied claims for E/M services associated with SRT based on the NCCI policy manual language. According to stakeholders, the bundling of SRT with associated services, as well as coding confusion regarding the appropriate use of E/M coding to report associated physician work, meant that practitioners were not being paid appropriately for planning and treatment management associated with furnishing SRT. Due to these concerns regarding reporting of services associated with SRT, in the CY 2018 PFS proposed rule (82 FR 34012-

      34013), we proposed to make separate payment for the professional planning and management associated with SRT using HCPCS code GRRR1 (Superficial radiation treatment planning and management related services, including but not limited to, when performed, clinical treatment planning (for example, 77261, 77262, 77263), therapeutic radiology simulation-aided field setting (for example, 77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for example, 77300), treatment devices (for example, 77332, 77333, 77334), isodose planning (for example, 77306, 77307, 77316, 77317, 77318), radiation treatment management (for example, 77427, 77431, 77432, 77435, 77469, 77470, 77499), and associated E/M per course of treatment). We proposed that this code would describe the range of professional services associated with a course of SRT, including services similar to those not otherwise separately reportable under CPT guidance. Furthermore, we proposed that this code would have included several inputs associated with related professional services such as treatment planning, treatment devices, and treatment management. Many commenters did not support our proposal to make separate payment for HCPCS code GRRR1 for CY 2018, stating that our proposed valuation of HCPCS code GRRR1 would represent a significant payment reduction for the associated services as compared with the list of services that they could previously bill in association with SRT. Commenters voiced concern that the proposed coding would inhibit access to care and discourage the use of SRT as a non-surgical alternative to Mohs surgery. We received comments recommending a variety of potential coding solutions and found that there was not general agreement among commenters about a preferred alternative. In the CY 2018 PFS final rule (82 FR 53081-53083), we solicited further comment, and stated that we would continue our dialogue with stakeholders to address appropriate coding and payment for professional services associated with SRT.

      Given stakeholder feedback that we have continued to receive following the publication of the CY 2018 PFS final rule, we continue to believe that there are potential coding gaps for SRT-related professional services. We generally rely on the CPT process to determine coding specificity, and we believe that deferring to this process in addressing potential coding gaps is generally preferable. As our previous attempt at designing a coding solution in the CY 2018 PFS proposed rule did not gain stakeholder consensus, and given that there were various, in some cases diverging, suggestions on a coding solution from stakeholders, we are not proposing changes relating to SRT coding, SRT-related professional codes, or payment policies for CY 2019. However, we are seeking comment on the possibility of creating multiple G-codes specific to services associated with SRT, as was suggested by one stakeholder following the CY 2018 PFS final rule. These codes would be used separately to report services including SRT planning, initial patient simulation visit, treatment device design and construction associated with SRT, SRT management, and medical physics consultation. We are seeking comment

      Page 35776

      on whether we should create such G codes to separately report each of the services described above, mirroring the coding of other types of radiation treatment delivery. For instance, HCPCS code G6003 (Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: Up to 5 mev) is used to report radiation treatment delivery, while associated professional services are billed with codes such as CPT codes 77427 (Radiation treatment management, 5 treatments), 77261 (Therapeutic radiology treatment planning; simple), 77332 (Treatment devices, design and construction; simple (simple block, simple bolus), and 77300 (Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician). We are interested in public comment on whether it would be appropriate to create separate codes for professional services associated with SRT in a coding structure parallel to radiation treatment delivery services such as HCPCS code G6003. We are seeking comment on creating these codes for inclusion in this update of the PFS. We are also interested in whether such codes should be contractor priced for CY 2019. We would consider contractor pricing such codes for CY 2019 because we believe that the preferable method to develop new coding is with multi-specialty input through the CPT and RUC process, and we prefer to defer nationally pricing such codes pending input from the CPT Editorial Panel and the RUC process to assist in determining the appropriate level of coding specificity for SRT-related professional services. Based on stakeholder feedback, we continue to believe there may be a coding gap for these services, and therefore, we are soliciting comment on whether we should create these G codes and allow them to be contractor priced for CY 2019. This would be an interim approach for addressing the potential coding gap until the CPT Editorial Panel and the RUC can address coding for SRT and SRT-related professional services, giving the CPT Editorial Panel and the RUC an opportunity to develop a coding solution that could be addressed in future rulemaking.

      Table 13--CY 2019 Proposed Work RVUs for New, Revised, and Potentially Misvalued Codes

      ----------------------------------------------------------------------------------------------------------------

      CMS time

      HCPCS Descriptor Current work RVU RUC work RVU CMS work RVU refinement

      ----------------------------------------------------------------------------------------------------------------

      03X0T............. Electroretinography NEW............... C 0.40 No.

      (ERG) with

      interpretation and

      report, pattern

      (PERG).

      10021............. Fine needle 1.27.............. 1.20 1.03 No.

      aspiration biopsy;

      without imaging

      guidance; first

      lesion.

      10X11............. Fine needle NEW............... 0.80 0.80 No.

      aspiration biopsy;

      without imaging

      guidance; each

      additional lesion.

      10X12............. Fine needle NEW............... 1.63 1.46 No.

      aspiration biopsy,

      including

      ultrasound

      guidance; first

      lesion.

      10X13............. Fine needle NEW............... 1.00 1.00 No.

      aspiration biopsy,

      including

      ultrasound

      guidance; each

      additional lesion.

      10X14............. Fine needle NEW............... 1.81 1.81 No.

      aspiration biopsy,

      including

      fluoroscopic

      guidance; first

      lesion.

      10X15............. Fine needle NEW............... 1.18 1.18 No.

      aspiration biopsy,

      including

      fluoroscopic

      guidance; each

      additional lesion.

      10X16............. Fine needle NEW............... 2.43 2.26 No.

      aspiration biopsy,

      including CT

      guidance; first

      lesion.

      10X17............. Fine needle NEW............... 1.65 1.65 No.

      aspiration biopsy,

      including CT

      guidance; each

      additional lesion.

      10X18............. Fine needle NEW............... C C No.

      aspiration biopsy,

      including MR

      guidance; first

      lesion.

      10X19............. Fine needle NEW............... C C No.

      aspiration biopsy,

      including MR

      guidance; each

      additional lesion.

      11755............. Biopsy of nail unit 1.31.............. 1.25 1.08 No.

      (e.g., plate, bed,

      matrix,

      hyponychium,

      proximal and

      lateral nail folds).

      11X02............. Tangential biopsy of NEW............... 0.66 0.66 No.

      skin, (e.g., shave,

      scoop, saucerize,

      curette), single

      lesion.

      11X03............. Tangential biopsy of NEW............... 0.38 0.29 No.

      skin, (e.g., shave,

      scoop, saucerize,

      curette), each

      separate/additional

      lesion.

      11X04............. Punch biopsy of NEW............... 0.83 0.83 No.

      skin, (including

      simple closure when

      performed), single

      lesion.

      11X05............. Punch biopsy of NEW............... 0.45 0.45 No.

      skin, (including

      simple closure when

      performed), each

      separate/additional

      lesion.

      11X06............. Incisional biopsy of NEW............... 1.01 1.01 No.

      skin (e.g., wedge),

      (including simple

      closure when

      performed), single

      lesion.

      11X07............. Incisional biopsy of NEW............... 0.54 0.54 No.

      skin (e.g., wedge),

      (including simple

      closure when

      performed), each

      separate/additional

      lesion.

      20551............. Injection(s); single 0.75.............. 0.75 0.75 No.

      tendon origin/

      insertion.

      209X3............. Allograft, includes NEW............... 13.01 13.01 No.

      templating,

      cutting, placement

      and internal

      fixation when

      performed;

      osteoarticular,

      including articular

      surface and

      contiguous bone.

      209X4............. Allograft, includes NEW............... 11.94 11.94 No.

      templating,

      cutting, placement

      and internal

      fixation when

      performed;

      hemicortical

      intercalary,

      partial (i.e.,

      hemicylindrical).

      Page 35777

      209X5............. Allograft, includes NEW............... 13.00 13.00 No.

      templating,

      cutting, placement

      and internal

      fixation when

      performed;

      intercalary,

      complete (i.e.,

      cylindrical).

      27X69............. Injection procedure NEW............... 0.96 0.77 No.

      for contrast knee

      arthrography or

      contrast enhanced

      CT/MRI knee

      arthrography.

      29105............. Application of long 0.87.............. 0.80 0.80 No.

      arm splint

      (shoulder to hand).

      29540............. Strapping; ankle and/ 0.39.............. 0.39 0.39 No.

      or foot.

      29550............. Strapping; toes..... 0.25.............. 0.25 0.25 No.

      31623............. Bronchoscopy, rigid 2.63.............. 2.63 2.63 No.

      or flexible,

      including

      fluoroscopic

      guidance, when

      performed; with

      brushing or

      protected brushings.

      31624............. Bronchoscopy, rigid 2.63.............. 2.63 2.63 No.

      or flexible,

      including

      fluoroscopic

      guidance, when

      performed; with

      bronchial alveolar

      lavage.

      332X0............. Transcatheter NEW............... 6.00 6.00 No.

      implantation of

      wireless pulmonary

      artery pressure

      sensor for long

      term hemodynamic

      monitoring,

      including

      deployment and

      calibration of the

      sensor, right heart

      catheterization,

      selective pulmonary

      catheterization,

      radiological

      supervision and

      interpretation, and

      pulmonary artery

      angiography, when

      performed.

      332X5............. Insertion, NEW............... 1.53 1.53 No.

      subcutaneous

      cardiac rhythm

      monitor, including

      programming.

      332X6............. Removal, NEW............... 1.50 1.50 No.

      subcutaneous

      cardiac rhythm

      monitor.

      335X1............. Replacement, aortic NEW............... 64.00 64.00 No.

      valve; by

      translocation of

      autologous

      pulmonary valve and

      transventricular

      aortic annulus

      enlargement of the

      left ventricular

      outflow tract with

      valved conduit

      replacement of

      pulmonary valve

      (Ross-Konno

      procedure).

      33X01............. Aortic hemiarch NEW............... 19.74 19.74 No.

      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.

      33X05............. Transcatheter NEW............... 8.77 7.80 No.

      insertion or

      replacement of

      permanent leadless

      pacemaker, right

      ventricular,

      including imaging

      guidance (e.g.,

      fluoroscopy, venous

      ultrasound,

      ventriculography,

      femoral venography)

      and device

      evaluation (e.g.,

      interrogation or

      programming), when

      performed.

      33X06............. Transcatheter NEW............... 9.56 8.59 No.

      removal of

      permanent leadless

      pacemaker, right

      ventricular.

      36568............. Insertion of 1.67.............. 2.11 2.11 No.

      peripherally

      inserted central

      venous catheter

      (PICC), without

      subcutaneous port

      or pump, without

      imaging guidance;

      younger than 5

      years of age.

      36569............. Insertion of 1.70.............. 1.90 1.90 No.

      peripherally

      inserted central

      venous catheter

      (PICC), without

      subcutaneous port

      or pump, without

      imaging guidance;

      age 5 years or

      older.

      36584............. Replacement, 1.20.............. 1.47 1.20 No.

      complete, of a

      peripherally

      inserted central

      venous catheter

      (PICC), without

      subcutaneous port

      or pump, through

      same venous access,

      including all

      imaging guidance,

      image

      documentation, and

      all associated

      radiological

      supervision and

      interpretation

      required to perform

      the replacement.

      36X72............. Insertion of NEW............... 2.00 1.82 No.

      peripherally

      inserted central

      venous catheter

      (PICC), without

      subcutaneous port

      or pump, including

      all imaging

      guidance, image

      documentation, and

      all associated

      radiological

      supervision and

      interpretation

      required to perform

      the insertion;

      younger than 5

      years of age.

      36X73............. Insertion of NEW............... 1.90 1.70 No.

      peripherally

      inserted central

      venous catheter

      (PICC), without

      subcutaneous port

      or pump, including

      all imaging

      guidance, image

      documentation, and

      all associated

      radiological

      supervision and

      interpretation

      required to perform

      the insertion; age

      5 years or older.

      3853X............. Biopsy or excision NEW............... 6.74 6.74 No.

      of lymph node(s);

      open,

      inguinofemoral

      node(s).

      38792............. Injection procedure; 0.52.............. 0.65 0.65 No.

      radioactive tracer

      for identification

      of sentinel node.

      Page 35778

      43X63............. Replacement of NEW............... 0.75 0.75 No.

      gastrostomy tube,

      percutaneous,

      includes removal,

      when performed,

      without imaging or

      endoscopic

      guidance; not

      requiring revision

      of gastrostomy

      tract.

      43X64............. Replacement of NEW............... 1.41 1.41 No.

      gastrostomy tube,

      percutaneous,

      includes removal,

      when performed,

      without imaging or

      endoscopic

      guidance; requiring

      revision of

      gastrostomy tract.

      45300............. Proctosigmoidoscopy, 0.80.............. 0.80 0.80 No.

      rigid; diagnostic,

      with or without

      collection of

      specimen(s) by

      brushing or washing

      (separate

      procedure).

      46500............. Injection of 1.42.............. 2.00 1.74 No.

      sclerosing

      solution,

      hemorrhoids.

      49422............. Removal of tunneled 6.29.............. 4.00 4.00 No.

      intraperitoneal

      catheter.

      50X39............. Dilation of existing NEW............... 3.37 2.78 No.

      tract,

      percutaneous, for

      an endourologic

      procedure including

      imaging guidance

      (e.g., ultrasound

      and/or fluoroscopy)

      and all associated

      radiological

      supervision and

      interpretation, as

      well as post

      procedure tube

      placement, when

      performed.

      50X40............. Dilation of existing NEW............... 5.44 4.83 Yes.

      tract,

      percutaneous, for

      an endourologic

      procedure including

      imaging guidance

      (e.g., ultrasound

      and/or fluoroscopy)

      and all associated

      radiological

      supervision and

      interpretation, as

      well as post

      procedure tube

      placement, when

      performed;

      including new

      access into the

      renal collecting

      system.

      52334............. Cystourethroscopy 4.82.............. 3.37 3.37 No.

      with insertion of

      ureteral guide wire

      through kidney to

      establish a

      percutaneous

      nephrostomy,

      retrograde.

      53850............. Transurethral 10.08............. 5.42 5.42 No.

      destruction of

      prostate tissue; by

      microwave

      thermotherapy.

      53852............. Transurethral 10.83............. 5.93 5.93 No.

      destruction of

      prostate tissue; by

      radiofrequency

      thermotherapy.

      538X3............. Transurethral NEW............... 5.93 5.70 No.

      destruction of

      prostate tissue; by

      radiofrequency

      generated water

      vapor thermotherapy.

      57150............. Irrigation of vagina 0.55.............. 0.50 0.50 No.

      and/or application

      of medicament for

      treatment of

      bacterial,

      parasitic, or

      fungoid disease.

      57160............. Fitting and 0.89.............. 0.89 0.89 No.

      insertion of

      pessary or other

      intravaginal

      support device.

      58100............. Endometrial sampling 1.53.............. 1.21 1.21 No.

      (biopsy) with or

      without

      endocervical

      sampling (biopsy),

      without cervical

      dilation, any

      method (separate

      procedure).

      58110............. Endometrial sampling 0.77.............. 0.77 0.77 No.

      (biopsy) performed

      in conjunction with

      colposcopy.

      64405............. Injection, 0.94.............. 0.94 0.94 No.

      anesthetic agent;

      greater occipital

      nerve.

      64455............. Injection(s), 0.75.............. 0.75 0.75 No.

      anesthetic agent

      and/or steroid,

      plantar common

      digital nerve(s)

      (e.g., Morton's

      neuroma).

      65205............. Removal of foreign 0.71.............. 0.49 0.49 No.

      body, external eye;

      conjunctival

      superficial.

      65210............. Removal of foreign 0.84.............. 0.75 0.61 No.

      body, external eye;

      conjunctival

      embedded (includes

      concretions),

      subconjunctival, or

      scleral

      nonperforating.

      67500............. Retrobulbar 1.44.............. 1.18 1.18 No.

      injection;

      medication

      (separate

      procedure, does not

      include supply of

      medication).

      67505............. Retrobulbar 1.27.............. 1.18 0.94 No.

      injection; &

      alcohol.

      67515............. Injection of 1.40.............. 0.84 0.75 No.

      medication or other

      substance into

      Tenon's capsule.

      72020............. Radiologic 0.15.............. 0.15 0.23 No.

      examination, spine,

      single view,

      specify level.

      72040............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine,

      cervical; 2 or 3

      views.

      72050............. Radiologic 0.31.............. 0.31 0.23 No.

      examination, spine,

      cervical; 4 or 5

      views.

      72052............. Radiologic 0.36.............. 0.35 0.23 No.

      examination, spine,

      cervical; 6 or more

      views.

      72070............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine;

      thoracic, 2 views.

      72072............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine;

      thoracic, 3 views.

      72074............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine;

      thoracic, minimum

      of 4 views.

      72080............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine;

      thoracolumbar

      junction, minimum

      of 2 views.

      72100............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine,

      lumbosacral; 2 or 3

      views.

      72110............. Radiologic 0.31.............. 0.31 0.23 No.

      examination, spine,

      lumbosacral;

      minimum of 4 views.

      72114............. Radiologic 0.32.............. 0.31 0.23 No.

      examination, spine,

      lumbosacral;

      complete, including

      bending views,

      minimum of 6 views.

      Page 35779

      72120............. Radiologic 0.22.............. 0.22 0.23 No.

      examination, spine,

      lumbosacral;

      bending views only,

      2 or 3 views.

      72200............. Radiologic 0.17.............. 0.17 0.23 No.

      examination,

      sacroiliac joints;

      less than 3 views.

      72202............. Radiologic 0.19.............. 0.18 0.23 No.

      examination,

      sacroiliac joints;

      3 or more views.

      72220............. Radiologic 0.17.............. 0.17 0.23 No.

      examination, sacrum

      and coccyx, minimum

      of 2 views.

      73070............. Radiologic 0.15.............. 0.15 0.23 No.

      examination, elbow;

      2 views.

      73080............. Radiologic 0.17.............. 0.17 0.23 No.

      examination, elbow;

      complete, minimum

      of 3 views.

      73090............. Radiologic 0.16.............. 0.16 0.23 No.

      examination;

      forearm, 2 views.

      73650............. Radiologic 0.16.............. 0.16 0.23 No.

      examination;

      calcaneus, minimum

      of 2 views.

      73660............. Radiologic 0.13.............. 0.13 0.23 No.

      examination;

      toe(s), minimum of

      2 views.

      74210............. Radiologic 0.36.............. 0.59 0.59 No.

      examination;

      pharynx and/or

      cervical esophagus.

      74220............. Radiologic 0.46.............. 0.67 0.67 No.

      examination;

      esophagus.

      74230............. Swallowing function, 0.53.............. 0.53 0.53 No.

      with

      cineradiography/

      videoradiography.

      74420............. Urography, 0.36.............. 0.52 0.52 No.

      retrograde, with or

      without KUB.

      74485............. Dilation of 0.54.............. 0.83 0.83 No.

      ureter(s) or

      urethra,

      radiological

      supervision and

      interpretation.

      76000............. Fluoroscopy 0.17.............. 0.30 0.30 No.

      (separate

      procedure), up to 1

      hour physician or

      other qualified

      health care

      professional time,

      other than 71023 or

      71034 (e.g.,

      cardiac

      fluoroscopy).

      76514............. Ophthalmic 0.17.............. 0.17 0.14 No.

      ultrasound,

      diagnostic; corneal

      pachymetry,

      unilateral or

      bilateral

      (determination of

      corneal thickness).

      767X1............. Ultrasound, NEW............... 0.59 0.59 No.

      elastography;

      parenchyma (e.g.,

      organ).

      767X2............. Ultrasound, NEW............... 0.59 0.59 No.

      elastography; first

      target lesion.

      767X3............. Ultrasound, NEW............... 0.50 0.50 No.

      elastography; each

      additional target

      lesion.

      76870............. Ultrasound, scrotum 0.64.............. 0.64 0.64 No.

      and contents.

      76942............. Ultrasonic guidance 0.67.............. 0.67 0.67 No.

      for needle

      placement (e.g.,

      biopsy, fine needle

      aspiration biopsy,

      injection,

      localization

      device), imaging

      supervision and

      interpretation.

      76X01............. Magnetic resonance NEW............... 1.29 1.10 No.

      (e.g., vibration)

      elastography.

      76X0X............. Ultrasound, targeted NEW............... 1.62 1.27 No.

      dynamic microbubble

      sonographic

      contrast

      characterization

      (non-cardiac);

      initial lesion.

      76X1X............. Ultrasound, targeted NEW............... 0.85 0.85 No.

      dynamic microbubble

      sonographic

      contrast

      characterization

      (non-cardiac); each

      additional lesion

      with separate

      injection.

      77012............. Computed tomography 1.16.............. 1.50 1.50 No.

      guidance for needle

      placement (e.g.,

      biopsy, aspiration,

      injection,

      localization

      device),

      radiological

      supervision and

      interpretation.

      77021............. Magnetic resonance 1.50.............. 1.50 1.50 No.

      guidance for needle

      placement (e.g.,

      for biopsy, fine

      needle aspiration

      biopsy, injection,

      or placement of

      localization

      device)

      radiological

      supervision and

      interpretation.

      77081............. Dual-energy X-ray 0.22.............. 0.20 0.20 No.

      absorptiometry

      (DXA), bone density

      study, 1 or more

      sites; appendicular

      skeleton

      (peripheral) (e.g.,

      radius, wrist,

      heel).

      77X49............. Magnetic resonance NEW............... 1.45 1.15 No.

      imaging, breast,

      without contrast

      material;

      unilateral.

      77X50............. Magnetic resonance NEW............... 1.60 1.30 No.

      imaging, breast,

      without contrast

      material; bilateral.

      77X51............. Magnetic resonance NEW............... 2.10 1.80 No.

      imaging, breast,

      without and with

      contrast

      material(s),

      including computer-

      aided detection

      (CAD-real time

      lesion detection,

      characterization

      and pharmacokinetic

      analysis) when

      performed;

      unilateral.

      77X52............. Magnetic resonance NEW............... 2.30 2.00 No.

      imaging, breast,

      without and with

      contrast

      material(s),

      including computer-

      aided detection

      (CAD-real time

      lesion detection,

      characterization

      and pharmacokinetic

      analysis) when

      performed;

      bilateral.

      85060............. Blood smear, 0.45.............. 0.45 0.36 No.

      peripheral,

      interpretation by

      physician with

      written report.

      85097............. Bone marrow, smear 0.94.............. 1.00 0.94 No.

      interpretation.

      85390............. Fibrinolysins or 0.37.............. 0.75 0.75 No.

      coagulopathy

      screen,

      interpretation and

      report.

      92X71............. Electroretinography NEW............... 0.80 0.69 No.

      (ERG) with

      interpretation and

      report; full field

      (e.g., ffERG, flash

      ERG, Ganzfeld ERG).

      92X73............. Electroretinography NEW............... 0.72 0.61 No.

      (ERG) with

      interpretation and

      report; multifocal

      (mfERG).

      Page 35780

      93561............. Indicator dilution 0.25.............. 0.95 0.60 No.

      studies such as dye

      or thermodilution,

      including arterial

      and/or venous

      catheterization;

      with cardiac output

      measurement.

      93562............. Indicator dilution 0.01.............. 0.77 0.48 No.

      studies such as dye

      or thermodilution,

      including arterial

      and/or venous

      catheterization;

      subsequent

      measurement of

      cardiac output.

      93571............. Intravascular 1.80.............. 1.50 1.38 No.

      Doppler velocity

      and/or pressure

      derived coronary

      flow reserve

      measurement

      (coronary vessel or

      graft) during

      coronary

      angiography

      including

      pharmacologically

      induced stress;

      initial vessel.

      93572............. Intravascular 1.44.............. 1.00 1.00 No.

      Doppler velocity

      and/or pressure

      derived coronary

      flow reserve

      measurement

      (coronary vessel or

      graft) during

      coronary

      angiography

      including

      pharmacologically

      induced stress;

      each additional

      vessel.

      93668............. Peripheral arterial 0.00.............. 0.00 0.00 No.

      disease (PAD)

      rehabilitation, per

      session.

      93XX1............. Remote monitoring of NEW............... 0.70 0.70 No.

      a wireless

      pulmonary artery

      pressure sensor for

      up to 30 days

      including at least

      weekly downloads of

      pulmonary artery

      pressure

      recordings,

      interpretation(s),

      trend analysis, and

      report(s) by a

      physician or other

      qualified health

      care professional.

      95800............. Sleep study, 1.05.............. 1.00 0.85 No.

      unattended,

      simultaneous

      recording; heart

      rate, oxygen

      saturation,

      respiratory

      analysis (e.g., by

      airflow or

      peripheral arterial

      tone), and sleep

      time.

      95801............. Sleep study, 1.00.............. 1.00 0.85 No.

      unattended,

      simultaneous

      recording; minimum

      of heart rate,

      oxygen saturation,

      and/respiratory

      analysis (e.g., by

      airflow or

      peripheral arterial

      tone).

      95806............. Sleep study, 1.25.............. 1.08 0.93 No.

      unattended,

      simultaneous

      recording of, heart

      rate, oxygen

      saturation,

      respiratory

      airflow, and

      respiratory effort

      (e.g.,

      thoracoabdominal

      movement).

      95970............. Electronic analysis 0.45.............. 0.45 0.35 No.

      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 brain, cranial

      nerve, spinal cord,

      peripheral nerve,

      or sacral nerve

      neurostimulator

      pulse generator/

      transmitter,

      without programming.

      95X83............. Electronic analysis NEW............... 0.95 0.73 No.

      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 simple cranial

      nerve

      neurostimulator

      pulse generator/

      transmitter

      programming by

      physician or other

      qualified health

      care professional.

      95X84............. Electronic analysis NEW............... 1.19 0.97 No.

      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.

      Page 35781

      95X85............. Electronic analysis NEW............... 1.25 0.91 No.

      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 brain

      neurostimulator

      pulse generator/

      transmitter

      programming, first

      15 minutes face-to-

      face time with

      physician or other

      qualified health

      care professional.

      95X86............. Electronic analysis NEW............... 1.00 0.80 No.

      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 brain

      neurostimulator

      pulse generator/

      transmitter

      programming, each

      additional 15

      minutes face-to-

      face time with

      physician or other

      qualified health

      care professional.

      96105............. Assessment of 1.75.............. 1.75 1.75 No.

      aphasia (includes

      assessment of

      expressive and

      receptive speech

      and language

      function, language

      comprehension,

      speech production

      ability, reading,

      spelling, writing,

      e.g., by boston

      diagnostic aphasia

      examination) with

      interpretation and

      report, per hour.

      96110............. Developmental 0.00.............. 0.00 0.00 No.

      screening (e.g.,

      developmental

      milestone survey,

      speech and language

      delay screen) with

      scoring and

      documentation, per

      standardized

      instrument.

      96116............. Neurobehavioral 1.86.............. 1.86 1.86 No.

      status exam

      (clinical

      assessment of

      thinking, reasoning

      and judgment, e.g.,

      acquired knowledge,

      attention,

      language, memory,

      planning and

      problem solving,

      and visual spatial

      abilities), by

      physician or other

      qualified health

      care professional,

      both face-to-face

      time with the

      patient and time

      interpreting test

      results and

      preparing the

      report; first hour.

      96125............. Standardized 1.70.............. 1.70 1.70 No.

      cognitive

      performance testing

      (e.g., ross

      information

      processing

      assessment) per

      hour of a qualified

      health care

      professional's

      time, both face-to-

      face time

      administering tests

      to the patient and

      time interpreting

      these test results

      and preparing the

      report.

      96127............. Brief emotional/ 0.00.............. 0.00 0.00 No.

      behavioral

      assessment (e.g.,

      depression

      inventory,

      attention-deficit/

      hyperactivity

      disorder ADHD

      scale), with

      scoring and

      documentation, per

      standardized

      instrument.

      963X0............. Developmental test NEW............... 2.50 2.56 No.

      administration

      (including

      assessment of fine

      and/or gross motor,

      language, cognitive

      level, social,

      memory and/or

      executive functions

      by standardized

      developmental

      instruments when

      performed), by

      physician or other

      qualified health

      care professional,

      with interpretation

      and report; first

      hour.

      963X1............. Developmental test NEW............... 1.10 1.16 No.

      administration

      (including

      assessment of fine

      and/or gross motor,

      language, cognitive

      level, social,

      memory and/or

      executive functions

      by standardized

      developmental

      instruments when

      performed), by

      physician or other

      qualified health

      care professional,

      with interpretation

      and report; each

      additional 30

      minutes.

      963X2............. Neurobehavioral NEW............... 1.71 1.71 No.

      status exam

      (clinical

      assessment of

      thinking, reasoning

      and judgment, e.g.,

      acquired knowledge,

      attention,

      language, memory,

      planning and

      problem solving,

      and visual spatial

      abilities), by

      physician or other

      qualified health

      care professional,

      both face-to-face

      time with the

      patient and time

      interpreting test

      results and

      preparing the

      report; each

      additional hour.

      Page 35782

      963X3............. Psychological NEW............... 2.50 2.56 No.

      testing evaluation

      services by

      physician or other

      qualified health

      care professional,

      including

      integration of

      patient data,

      interpretation of

      standardized test

      results and

      clinical data,

      clinical decision

      making, treatment

      planning and

      report, and

      interactive

      feedback to the

      patient, family

      member(s) or

      caregiver(s), when

      performed; first

      hour.

      963X4............. Psychological NEW............... 1.90 1.96 No.

      testing evaluation

      services by

      physician or other

      qualified health

      care professional,

      including

      integration of

      patient data,

      interpretation of

      standardized test

      results and

      clinical data,

      clinical decision

      making, treatment

      planning and

      report, and

      interactive

      feedback to the

      patient, family

      member(s) or

      caregiver(s), when

      performed; each

      additional hour.

      963X5............. Neuropsychological NEW............... 2.50 2.56 No.

      testing evaluation

      services by

      physician or other

      qualified health

      care professional,

      including

      integration of

      patient data,

      interpretation of

      standardized test

      results and

      clinical data,

      clinical decision

      making, treatment

      planning and

      report, and

      interactive

      feedback to the

      patient, family

      member(s) or

      caregiver(s), when

      performed; first

      hour.

      963X6............. Neuropsychological NEW............... 1.90 1.96 No.

      testing evaluation

      services by

      physician or other

      qualified health

      care professional,

      including

      integration of

      patient data,

      interpretation of

      standardized test

      results and

      clinical data,

      clinical decision

      making, treatment

      planning and

      report, and

      interactive

      feedback to the

      patient, family

      member(s) or

      caregiver(s), when

      performed; each

      additional hour.

      963X7............. Psychological or NEW............... 0.55 0.55 No.

      neuropsychological

      test administration

      and scoring by

      physician or other

      qualified health

      care professional,

      two or more tests,

      any method, first

      30 minutes.

      963X8............. Psychological or NEW............... 0.46 0.46 No.

      neuropsychological

      test administration

      and scoring by

      physician or other

      qualified health

      care professional,

      two or more tests,

      any method, each

      additional 30

      minutes.

      963X9............. Psychological or NEW............... 0.00 0.00 No.

      neuropsychological

      test administration

      and scoring by

      technician, two or

      more tests, any

      method; first 30

      minutes.

      96X00............. Electrocorticogram NEW............... 2.30 1.98 No.

      from an implanted

      brain

      neurostimulator

      pulse generator/

      transmitter,

      including

      recording, with

      interpretation and

      report, up to 30

      days.

      96X10............. Psychological or NEW............... 0.00 0.00 No.

      neuropsychological

      test administration

      and scoring by

      technician, two or

      more tests, any

      method; each

      additional 30

      minutes.

      96X11............. Psychological or NEW............... 0.51 0.51 No.

      neuropsychological

      test administration

      using single

      instrument, with

      interpretation and

      report by physician

      or other qualified

      health care

      professional and

      interactive

      feedback to the

      patient, family

      member(s), or

      caregivers(s), when

      performed.

      96X12............. Psychological or NEW............... 0.00 0.00 No.

      neuropsychological

      test

      administration,

      with single

      automated

      instrument via

      electronic

      platform, with

      automated result

      only.

      990X0............. Remote monitoring of NEW............... 0.00 0.00 No.

      physiologic

      parameter(s) (e.g.,

      weight, blood

      pressure, pulse

      oximetry,

      respiratory flow

      rate), initial; set-

      up and patient

      education on use of

      equipment.

      990X1............. Remote monitoring of NEW............... 0.00 0.00 No.

      physiologic

      parameter(s) (e.g.,

      weight, blood

      pressure, pulse

      oximetry,

      respiratory flow

      rate), initial;

      device(s) supply

      with daily

      recording(s) or

      programmed alert(s)

      transmission, each

      30 days.

      Page 35783

      99201............. Office or other 0.48.............. 0.48 0.48 No.

      outpatient visit

      for the evaluation

      and management of a

      new patient, which

      requires these 3

      key components: A

      problem focused

      history; A problem

      focused

      examination;

      Straightforward

      medical decision

      making. Counseling

      and/or coordination

      of care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are self

      limited or minor.

      Typically, 10

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99202............. Office or other 0.93.............. 0.93 1.90 Yes.

      outpatient visit

      for the evaluation

      and management of a

      new patient, which

      requires these 3

      key components: An

      expanded problem

      focused history; An

      expanded problem

      focused

      examination;

      Straightforward

      medical decision

      making. Counseling

      and/or coordination

      of care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      low to moderate

      severity.

      Typically, 20

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99203............. Office or other 1.42.............. 1.42 1.90 Yes.

      outpatient visit

      for the evaluation

      and management of a

      new patient, which

      requires these 3

      key components: A

      detailed history; A

      detailed

      examination;

      Medical decision

      making of low

      complexity.

      Counseling and/or

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      moderate severity.

      Typically, 30

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99204............. Office or other 2.43.............. 2.43 1.90 Yes.

      outpatient visit

      for the evaluation

      and management of a

      new patient, which

      requires these 3

      key components: A

      comprehensive

      history; A

      comprehensive

      examination;

      Medical decision

      making of moderate

      complexity.

      Counseling and/or

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      moderate to high

      severity.

      Typically, 45

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99205............. Office or other 3.17.............. 3.17 1.90 Yes.

      outpatient visit

      for the evaluation

      and management of a

      new patient, which

      requires these 3

      key components: A

      comprehensive

      history; A

      comprehensive

      examination;

      Medical decision

      making of high

      complexity.

      Counseling and/or

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      moderate to high

      severity.

      Typically, 60

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99211............. Office or other 0.18.............. 0.18 0.18 No.

      outpatient visit

      for the evaluation

      and management of

      an established

      patient, that may

      not require the

      presence of a

      physician or other

      qualified health

      care professional.

      Usually, the

      presenting

      problem(s) are

      minimal. Typically,

      5 minutes are spent

      performing or

      supervising these

      services.

      Page 35784

      99212............. Office or other 0.48.............. 0.48 1.22 Yes.

      outpatient visit

      for the evaluation

      and management of

      an established

      patient, which

      requires at least 2

      of these 3 key

      components: A

      problem focused

      history; A problem

      focused

      examination;

      Straightforward

      medical decision

      making. Counseling

      and/or coordination

      of care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are self

      limited or minor.

      Typically, 10

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99213............. Office or other 0.97.............. 0.97 1.22 Yes.

      outpatient visit

      for the evaluation

      and management of

      an established

      patient, which

      requires at least 2

      of these 3 key

      components: An

      expanded problem

      focused history; An

      expanded problem

      focused

      examination;

      Medical decision

      making of low

      complexity.

      Counseling and

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      low to moderate

      severity.

      Typically, 15

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99214............. Office or other 1.50.............. 1.50 1.22 Yes.

      outpatient visit

      for the evaluation

      and management of

      an established

      patient, which

      requires at least 2

      of these 3 key

      components: A

      detailed history; A

      detailed

      examination;

      Medical decision

      making of moderate

      complexity.

      Counseling and/or

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      moderate to high

      severity.

      Typically, 25

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99215............. Office or other 2.11.............. 2.11 1.22 Yes.

      outpatient visit

      for the evaluation

      and management of

      an established

      patient, which

      requires at least 2

      of these 3 key

      components: A

      comprehensive

      history; A

      comprehensive

      examination;

      Medical decision

      making of high

      complexity.

      Counseling and/or

      coordination of

      care with other

      physicians, other

      qualified health

      care professionals,

      or agencies are

      provided consistent

      with the nature of

      the problem(s) and

      the patient's and/

      or family's needs.

      Usually, the

      presenting

      problem(s) are of

      moderate to high

      severity.

      Typically, 40

      minutes are spent

      face-to-face with

      the patient and/or

      family.

      99446............. Interprofessional B................. 0.35 0.35 No.

      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

      healthcare

      professional; 5-10

      minutes of medical

      consultative

      discussion and

      review.

      99447............. Interprofessional B................. 0.70 0.70 No.

      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

      healthcare

      professional; 11-20

      minutes of medical

      consultative

      discussion and

      review.

      99448............. Interprofessional B................. 1.05 1.05 No.

      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

      healthcare

      professional; 21-30

      minutes of medical

      consultative

      discussion and

      review.

      Page 35785

      99449............. Interprofessional B................. 1.40 1.40 No.

      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

      healthcare

      professional; 31

      minutes or more of

      medical

      consultative

      discussion and

      review.

      994X0............. Interprofessional NEW............... 0.50 0.50 No.

      telephone/Internet/

      electronic health

      record referral

      service(s) provided

      by a treating/

      requesting

      physician or

      qualified health

      care professional,

      30 minutes.

      994X6............. Interprofessional NEW............... 0.70 0.50 No.

      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 or more minutes

      of medical

      consultative time.

      994X7............. CCM provided NEW............... 1.45 1.22 No.

      personally by a

      physician/QHP.

      994X9............. Remote physiologic NEW............... 0.61 0.61 No.

      monitoring

      treatment

      management

      services, 20

      minutes or more of

      clinical staff/

      physician/other

      qualified

      healthcare

      professional time

      in a calendar month

      requiring

      interactive

      communication with

      the patient/

      caregiver during

      the month.

      G0108............. Diabetes outpatient 0.90.............. 0.90 0.90 No.

      self-management

      training services,

      individual, per 30

      minutes.

      G0109............. Diabetes outpatient 0.25.............. 0.25 0.25 No.

      self-management

      training services,

      group session (2 or

      more), per 30

      minutes.

      G0166............. External 0.07.............. 0.00 0.00 No.

      counterpulsation,

      per treatment

      session.

      G0168............. Wound closure 0.45.............. 0.45 0.31 No.

      utilizing tissue

      adhesive(s) only.

      G0268............. Removal of impacted 0.61.............. 0.61 0.61 No.

      cerumen (one or

      both ears) by

      physician on same

      date of service as

      audiologic function

      testing.

      GCG0X............. Visit complexity NEW............... .............. 0.25 No.

      inherent to

      evaluation and

      management

      associated with

      endocrinology,

      rheumatology,

      hematology/

      oncology, urology,

      neurology,

      obstetrics/

      gynecology, allergy/

      immunology,

      otolaryngology, or

      interventional pain

      management-centered

      care (Add-on code,

      list separately in

      addition to an

      evaluation and

      management visit).

      GPC1X............. Visit complexity NEW............... .............. 0.07 No.

      inherent to

      evaluation and

      management

      associated with

      primary medical

      care services that

      serve as the

      continuing focal

      point for all

      needed health care

      services (Add-on

      code, list

      separately in

      addition to an

      evaluation and

      management visit).

      GPD0X............. Podiatry services, NEW............... .............. 1.35 No.

      medical examination

      and evaluation with

      initiation of

      diagnostic and

      treatment program,

      new patient.

      GPD1X............. Podiatry services, NEW............... .............. 0.85 No.

      medical examination

      and evaluation with

      initiation of

      diagnostic and

      treatment program,

      established patient.

      GPRO1............. Prolonged evaluation NEW............... .............. 1.17 No.

      and management or

      psychotherapy

      service(s) (beyond

      the typical service

      time of the primary

      procedure) in the

      office or other

      outpatient setting

      requiring direct

      patient contact

      beyond the usual

      service; 30 minutes

      (List separately in

      addition to code

      for office or other

      outpatient

      Evaluation and

      Management or

      psychotherapy

      service).

      GRAS1............. Remote pre-recorded NEW............... .............. 0.18 No.

      service via

      recorded video and/

      or images submitted

      by the patient

      (e.g., store and

      forward), including

      interpretation with

      verbal 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.

      GSBR1............. Alcohol and/or NEW............... .............. 0.33 No.

      substance (other

      than tobacco) abuse

      structured

      assessment (e.g.,

      audit, dast), and

      brief intervention,

      5-14 minutes.

      Page 35786

      GVCI1............. Brief communication NEW............... .............. 0.25 No.

      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.

      ----------------------------------------------------------------------------------------------------------------

      BILLING CODE 4120-01-P

      Page 35787

      GRAPHIC TIFF OMITTED TP27JY18.000

      Page 35788

      GRAPHIC TIFF OMITTED TP27JY18.001

      Page 35789

      GRAPHIC TIFF OMITTED TP27JY18.002

      Page 35790

      GRAPHIC TIFF OMITTED TP27JY18.003

      Page 35791

      GRAPHIC TIFF OMITTED TP27JY18.004

      Page 35792

      GRAPHIC TIFF OMITTED TP27JY18.005

      Page 35793

      GRAPHIC TIFF OMITTED TP27JY18.006

      Page 35794

      GRAPHIC TIFF OMITTED TP27JY18.007

      Page 35795

      GRAPHIC TIFF OMITTED TP27JY18.008

      Page 35796

      GRAPHIC TIFF OMITTED TP27JY18.009

      Page 35797

      GRAPHIC TIFF OMITTED TP27JY18.010

      Page 35798

      GRAPHIC TIFF OMITTED TP27JY18.011

      Page 35799

      GRAPHIC TIFF OMITTED TP27JY18.012

      Page 35800

      GRAPHIC TIFF OMITTED TP27JY18.013

      Page 35801

      GRAPHIC TIFF OMITTED TP27JY18.014

      Page 35802

      GRAPHIC TIFF OMITTED TP27JY18.015

      Page 35803

      GRAPHIC TIFF OMITTED TP27JY18.016

      Page 35804

      GRAPHIC TIFF OMITTED TP27JY18.017

      Page 35805

      GRAPHIC TIFF OMITTED TP27JY18.018

      Page 35806

      GRAPHIC TIFF OMITTED TP27JY18.019

      Page 35807

      GRAPHIC TIFF OMITTED TP27JY18.020

      Page 35808

      GRAPHIC TIFF OMITTED TP27JY18.021

      Page 35809

      GRAPHIC TIFF OMITTED TP27JY18.022

      Page 35810

      GRAPHIC TIFF OMITTED TP27JY18.023

      Page 35811

      GRAPHIC TIFF OMITTED TP27JY18.024

      Page 35812

      GRAPHIC TIFF OMITTED TP27JY18.025

      Page 35813

      GRAPHIC TIFF OMITTED TP27JY18.026

      Page 35814

      GRAPHIC TIFF OMITTED TP27JY18.027

      Page 35815

      GRAPHIC TIFF OMITTED TP27JY18.028

      Page 35816

      GRAPHIC TIFF OMITTED TP27JY18.029

      Page 35817

      GRAPHIC TIFF OMITTED TP27JY18.030

      Page 35818

      GRAPHIC TIFF OMITTED TP27JY18.031

      Page 35819

      GRAPHIC TIFF OMITTED TP27JY18.032

      Page 35820

      GRAPHIC TIFF OMITTED TP27JY18.033

      Page 35821

      GRAPHIC TIFF OMITTED TP27JY18.034

      Page 35822

      GRAPHIC TIFF OMITTED TP27JY18.035

      Page 35823

      GRAPHIC TIFF OMITTED TP27JY18.036

      Page 35824

      GRAPHIC TIFF OMITTED TP27JY18.037

      Page 35825

      GRAPHIC TIFF OMITTED TP27JY18.038

      Page 35826

      GRAPHIC TIFF OMITTED TP27JY18.039

      Page 35827

      GRAPHIC TIFF OMITTED TP27JY18.040

      Page 35828

      GRAPHIC TIFF OMITTED TP27JY18.041

      Page 35829

      GRAPHIC TIFF OMITTED TP27JY18.042

      Page 35830

      GRAPHIC TIFF OMITTED TP27JY18.043

      BILLING CODE 4120-01-C

      Page 35831

      Table 15--Proposed CY 2019 Existing Invoices

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Estimated

      non-

      facility

      allowed

      CPT/HCPCS codes Item name CMS code Current Updated Percent Number of services

      price price change invoices for HCPCS

      codes

      using this

      item

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      19085, 19086, 19287, 19288................ Breast MRI computer aided EQ370.................. 0.00 0.00 1 2,466

      detection and biopsy

      guidance software.

      53850..................................... kit, transurethral SA036.................. 1,149.00 1,000.00 -13 1 5,608

      microwave thermotherapy.

      53852..................................... kit, transurethral needle SA037.................. 1,050.00 900.00 -14 2 2,476

      ablation (TUNA).

      85097..................................... stain, Wright's Pack (per SL140.................. 0.05 0.16 235 1 43,183

      slide).

      96116, 96118, 96119, 96125................ neurobehavioral status SK050.................. 5.77 4.00 -31 3 414,139

      forms, average.

      258 codes................................. scope video system ES031.................. 33,391.00 36,306.00 9 2,480,515

      (monitor, processor,

      digital capture, cart,

      printer, LED light).

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Table 16--Proposed CY 2019 New Invoices

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Number of NF allowed

      CPT/HCPCS codes Item name CMS code Average price invoices services

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      10X18, 10X19............................. MREYE CHIBA BIOPSY NEEDLE... SC106.......................... 37.00 1 0

      332X5.................................... subcutaneous cardiac rhythm SA127.......................... 5,032.50 4 280

      monitor system.

      36X72, 36X73, 36584...................... Turbo-Ject PICC Line........ SD331.......................... 170.00 1 24,402

      538X3.................................... kit, Rezum delivery device.. SA128.......................... 1,150.00 1 121

      538X3.................................... generator, water EQ389.......................... 27,538.00 10 121

      thermotherapy procedure.

      58100.................................... Uterine Sound............... SD329.......................... 3.17 1 59,152

      58100.................................... Tenaculum................... SD330.......................... 3.77 1 59,152

      767X1, 767X2, 767X3...................... sheer wave elastography ED060.......................... 9,600.00 1 493

      software.

      76X01.................................... MR Elastography Package..... EL050.......................... 200,684.50 1 350

      76X0X, 76X1X............................. bubble contrast............. SD332.......................... 126.59 1 89

      76X0X, 76X1X............................. Ultrasound Contrast Imaging ER108.......................... 5,760.00 1 89

      Package.

      77X51, 77X52............................. CAD Software................ ED058.......................... 17,200.00 0 36,675

      77X49, 77X50, 77X51, 77X52............... Breast coil................. EQ388.......................... 12,238.00 0 39,785

      77X51, 77X52............................. CAD Workstation (CPU + Color ED056.......................... 14,829.62 0 36,675

      Monitor).

      85097.................................... slide stainer, automated, EP121.......................... 8,649.43 1 34,559

      hematology.

      92X71.................................... Sleep mask.................. SK133.......................... 9.95 1 10,266

      92X71, 92X73............................. mfERG and ffERG EQ390.......................... 102,400.00 1 25,602

      electrodiagnostic unit.

      92X71, 92X73............................. Contact lens electrode for EQ391.......................... 1,440.00 1 25,602

      mfERG and ffERG.

      963X7, 963X8, 963X9, 96X10............... WAIS-IV Record Form......... SK130.......................... 5.25 1 301,452

      963X7, 963X8, 963X9, 96X10............... WAIS-IV Response Booklet #1. SK131.......................... 3.30 1 301,452

      963X7, 963X8, 963X9, 96X10............... WMS-IV Response Booklet #2.. SK132.......................... 2.00 1 301,452

      963X7, 963X8, 963X9, 96X10............... Wechsler Adult Intelligence EQ387.......................... 971.30 1 301,452

      Scale--Fourth Edition (WAIS-

      IV) Kit (less forms).

      96X12.................................... CANTAB Mobile (per single ED055.......................... 2,800.00 1 0

      automated assessment).

      990X1.................................... heart failure patient EQ392.......................... 1,000.00 1 58

      physiologic monitoring

      equipment package.

      G0109.................................... 20x30 inch self-stick easel SK129.......................... 0.00 0 93,576

      pad, white, 30 sheets/pad.

      none..................................... needle holder, Mayo Hegar, SC105.......................... 3.03 1 0

      6''.

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Table 17--Proposed CY 2019 No PE Refinements

      ------------------------------------------------------------------------

      HCPCS Description

      ------------------------------------------------------------------------

      10X11............................. Fna bx w/o img gdn ea addl.

      10X13............................. Fna bx w/us gdn ea addl.

      10X15............................. Fna bx w/fluor gdn ea addl.

      10X17............................. Fna bx w/ct gdn ea addl.

      10X18............................. Fna bx w/mr gdn 1st les.

      10X19............................. Fna bx w/mr gdn ea addl.

      332X0............................. Tcat impl wrls p-art prs snr.

      332X5............................. Insj subq car rhythm mntr.

      332X6............................. Rmvl subq car rhythm mntr.

      Page 35832

      33X05............................. Tcat insj/rpl perm ldls pm.

      33X06............................. Tcat rmvl perm ldls pm.

      36568............................. Insj picc History of Present Illness (History),

      Physical Examination (Exam) and

      Medical Decision Making (MDM).

      These codes are broadly referred to as E/M visit codes. There are three to five E/M visit code levels, depending on site of service and the extent of the three components of history, exam and MDM. For example, there are three to four levels of E/M visit codes in the inpatient hospital and nursing facility settings, based on a relatively narrow degree of complexity in those settings. In contrast, there are five levels of E/M visit codes in the office or other outpatient setting based on a broader range of complexity in those settings.

      Current PFS payment rates for E/M visit codes increase with the level of visit billed. As for all services under the PFS, the rates are based on the resources in terms of work (time and intensity), PE and malpractice expense required to furnish the typical case of the service. The current payment rates reflect typical service times for each code that are based on RUC recommendations.

      In total, E/M visits comprise approximately 40 percent of allowed charges for PFS services, and office/outpatient E/M visits comprise approximately 20 percent of allowed charges for PFS services. Within these percentages, there is significant variation among specialties. According to Medicare claims data, E/M visits are furnished by nearly all specialties, but represent a greater share of total allowed services for physicians and other practitioners who do not routinely furnish procedural interventions or diagnostic tests. Generally, these practitioners include both primary care practitioners and specialists such as neurologists, endocrinologists and rheumatologists. Certain specialties, such as podiatry, tend to furnish lower level E/M visits more often than higher level E/M visits. Some specialties, such as dermatology and otolaryngology, tend to bill more E/M visits on the same day as they bill minor procedures.

      Potential misvaluation of E/M codes is an issue that we have been carefully considering for several years. We have discussed at length in our recent PFS proposed and final rules that the E/M visit code set is outdated and needs to be revised and revalued (for example: 81 FR 46200 and 76 FR 42793). We have noted that this code set represents a high proportion of PFS expenditures, but has not been recently revalued to account for significant changes in the disease burden of the Medicare patient population and changes in health care practice that are underway to meet the Medicare population's health care needs (81 FR 46200). In the CY 2012 PFS proposed rule, we proposed to refer all E/M codes to the RUC for review as potentially misvalued (76 FR 42793). Many commenters to that rule were concerned about the possible inadequacies of the current E/M coding and documentation structure to address evolving chronic care management and to support primary care (76 FR 73060 through 73064). We did not finalize our proposal to refer the E/M codes for RUC review at that time. Instead, we stated that we would allow time for consideration of the findings of certain demonstrations and other initiatives to provide improved information for the valuation of chronic care management, primary care, and care transitions. We stated that we would also continue to consider the numerous policy alternatives that commenters offered, such as separate E/M codes for established visits for patients with chronic disease versus a post-surgical follow-up office visit.

      Many stakeholders continue to similarly express to us through letters, meetings, public comments in past rulemaking cycles, and other avenues, that the E/M code set is outdated and needs to be revised. For example, some stakeholders recommend an extensive research effort to revise and revalue E/M services, especially physician work inputs (CY 2017 PFS final rule, 81 FR 80227-80228). In recent years, we have continued to consider the best ways to recognize the significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients, under the PFS. We have been engaged in an ongoing, incremental effort to identify gaps in appropriate coding and payment.

    3. E/M Documentation Guidelines

      For coding and billing E/M visits to Medicare, practitioners may use one of two versions of the E/M Documentation Guidelines for a patient encounter, commonly referenced based on the year of their release: The ``1995'' or ``1997'' E/M Documentation Guidelines. These guidelines are available on the CMS website.\3\ They specify the medical record information within each of the three key components (such as number of body systems reviewed) that serves as support for billing a given level of E/M

      Page 35833

      visit. The 1995 and 1997 guidelines are very similar to the guidelines that reside within the AMA's CPT codebook for E/M visits. For example, the core structure of what comprises or defines the different levels of history, exam, and medical decision-making are the same. However, the 1995 and 1997 guidelines include extensive examples of clinical work that comprise different levels of medical decision-making and do not appear in the AMA's CPT codebook. Also, the 1995 and 1997 guidelines do not contain references to preventive care that appear in the AMA's CPT codebook. We provide an example of how the 1995 and 1997 guidelines distinguish between level 2 and level 3 E/M visits in Table 18.

      ---------------------------------------------------------------------------

      \3\ See: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf; and the Evaluation and Management Services guide at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf).

      ---------------------------------------------------------------------------

      Table 18--Key Component Documentation Requirements for Level 2 vs. 3 E/M Visit

      ----------------------------------------------------------------------------------------------------------------

      Key component * Level 2 (1995) Level 3 (1995) Level 2 (1997) Level 3 (1997)

      ----------------------------------------------------------------------------------------------------------------

      History (History of Present Review of Systems Problem Pertinent No change from No change from

      Illness or HPI). (ROS) n/a. ROS: Inquires 1995. 1995.

      about the system

      directly related

      to the problem(s)

      identified in the

      HPI.

      Physical Examination (Exam)..... A limited A limited General multi- General multi-

      examination of examination of system exam: system exam:

      the affected body the affected body Performance and Performance and

      area or organ area or organ documentation of documentation of

      system. system and other one to five at least six

      symptomatic or elements in one elements in one

      related organ or more organ or more organ

      system(s). system(s) or body system(s) or body

      area(s). area(s).

      Single organ Single organ

      system exam: system exam:

      Performance and Performance and

      documentation of documentation of

      one to five at least six

      elements. elements.

      ---------------------------------------

      Medical Decision Making (MDM) Straightforward: Low complexity: No change from 1995.

      Measured by: **

      1. Problem--Number of 1. Minimal..... 1. Limited.

      diagnoses/treatment options.

      2. Data--Amount and/or 2. Minimal or 2. Limited data

      complexity of data to be no data review. review.

      reviewed.

      3. Risk--Risk of 3. Minimal risk 3. Low risk.

      complications and/or

      morbidity or mortality.

      ----------------------------------------------------------------------------------------------------------------

      * For certain settings and patient types, each of these three key components must be met or exceeded (for

      example, new patients; initial hospital visits). For others, only two of the three key components must be met

      or exceeded (for example, established patients, subsequent hospital or other visits).

      ** Two of three met or exceeded.

      According to both Medicare claims processing manual instructions and CPT coding rules, when counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter (or, in the case of inpatient E/M services, the floor time) the duration of the visit can be used as an alternative basis to select the appropriate E/M visit level (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1.C available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf; see also 2017 CPT Codebook Evaluation and Management Services Guidelines, page 10). Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1.B states, ``Instruct physicians to select the code for the service based upon the content of the service. The duration of the visit is an ancillary factor and does not control the level of the service to be billed unless more than 50 percent of the face-to-face time (for non-inpatient services) or more than 50 percent of the floor time (for inpatient services) is spent providing counseling or coordination of care as described in subsection C.'' Subsection C states that ``the physician may document time spent with the patient in conjunction with the medical decision-making involved and a description of the coordination of care or counseling provided. Documentation must be in sufficient detail to support the claim.'' The example included in subsection C further states, ``The code selection is based on the total time of the face-to-face encounter or floor time, not just the counseling time. The medical record must be documented in sufficient detail to justify the selection of the specific code if time is the basis for selection of the code.''

      Both the 1995 and 1997 E/M guidelines contain guidelines that address time, which state that ``In the case where counseling and/or coordination of care dominates (more than 50 percent of) the physician/

      patient and/or family encounter (face-to-face time in the office or other outpatient setting or floor/unit time in the hospital or nursing facility), time is considered the key or controlling factor to qualify for a particular level of E/M services.'' The guidelines go on to state that ``If the physician elects to report the level of service based on counseling and/or coordination of care, the total length of time of the encounter (face-to-face or floor time, as appropriate) should be documented and the record should describe the counseling and/or activities to coordinate care.'' \4\

      ---------------------------------------------------------------------------

      \4\ Page 16 of the 1995 E/M guidelines and page 48 of the 1997 guidelines.

      ---------------------------------------------------------------------------

      We note that other manual provisions regarding E/M visits that are cited in this proposed rule are housed separately within Medicare's Internet-Only Manuals, and are not contained within the 1995 or 1997 E/

      M documentation guidelines.

      Page 35834

      In accordance with section 1862(a)(1)(A) of the Act, which requires services paid under Medicare Part B to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, medical necessity is a prerequisite to Medicare payment for E/M visits. The Medicare Claims Processing Manual states, ``Medical necessity of a service is the overarching criterion for payment in addition to the individual requirements of a CPT code. It would not be medically necessary or appropriate to bill a higher level of evaluation and management service when a lower level of service is warranted. The volume of documentation should not be the primary influence upon which a specific level of service is billed. Documentation should support the level of service reported'' (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1A, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).

      Stakeholders have long maintained that all of the E/M documentation guidelines are administratively burdensome and outdated with respect to the practice of medicine. Stakeholders have provided CMS with examples of such outdated material (on history, exam and MDM) that can be found within all versions of the E/M guidelines (the AMA's CPT codebook, the 1995 guidelines and the 1997 guidelines). Stakeholders have told CMS that they believe the guidelines are too complex, ambiguous, fail to meaningfully distinguish differences among code levels, and are not updated for changes in technology, especially electronic health record (EHR) use. Prior attempts to revise the E/M guidelines were unsuccessful or resulted in additional complexity due to lack of stakeholder consensus (with widely varying views among specialties), and differing perspectives on whether code revaluation would be necessary under the PFS as a result of revising the guidelines, which contributed another layer of complexity to the considerations. For example, an early attempt to revise the guidelines resulted in an additional version designed for use by certain specialties (the 1997 version), and in CMS allowing the use of either the 1995 or 1997 versions for purposes of documentation and billing to Medicare. Another complication in revising the guidelines is that they are also used by many other payers, which have their own payment rules and audit protocols. Moreover, stakeholders have suggested that there is sometimes variation in how Medicare's own contractors (Medicare Administrative Contractors (MACs) interpret and apply the guidelines as part of their audit processes.

      As previously mentioned, in recent years, some clinicians and other stakeholders have requested a major CMS research initiative to overhaul not only the E/M documentation guidelines, but also the underlying coding structure and valuation. Stakeholders have reported to CMS that they believe the E/M visit codes themselves need substantial updating and revaluation to reflect changes in the practice of medicine, and that revising the documentation guidelines without addressing the codes themselves simply preserves an antiquated framework for payment of E/M services.

      Last year, CMS sought public comment on potential changes to the E/

      M documentation rules, deferring making any changes to E/M coding itself in order to immediately focus on revision of the E/M guidelines to reduce unnecessary administrative burden (82 FR 34078 through 34080). In the CY 2018 PFS final rule (82 FR 53163 through 53166), we summarized the public comments we received and stated that we would take that feedback into consideration for future rulemaking. In response to commenters' request that we provide additional venues for stakeholder input, we held a listening session this year on March 18, 2018 (transcript and materials are available on the CMS website at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2018-03-21-Documentation-Guidelines-and-Burden-Reduction.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending). We also sought input by participating in several listening sessions recently hosted by the Office of the National Coordinator for Health Information Technology (ONC) in the course of implementing section 4001(a) of the 21st Century Cures Act (Pub. L. 114-255). This provision requires the Department of Health and Human Services to establish a goal, develop a strategy, and make recommendations to reduce regulatory or administrative burdens relating to the use of EHRs. The ONC listening sessions sought public input on the E/M guidelines as one part of broader, related and unrelated burdens associated with EHRs.

      Several themes emerged from this recent stakeholder input. Stakeholders commended CMS for undertaking to revise the E/M guidelines and recommended a multi-year process. Many commenters advised CMS to obtain further input across specialties. They recommended town halls, open door forums or a task force that would come up with replacement guidelines that would work for all specialties over the course of several years. They urged CMS to proceed cautiously given the magnitude of the undertaking; past failed reform attempts by the AMA, CMS, and other payers; and the wide-ranging impact of any changes (for example, how other payers approach the issue).

      We received substantially different recommendations by specialty. Based on this feedback, it is clear that any changes would have substantial specialty-specific impacts, both clinical and financial. Based on this feedback, it also seems that the history and exam portions of the guidelines are most significantly outdated with respect to current clinical practice.

      A few stakeholders seemed to indicate that the documentation guidelines on history and exam should be kept in their current form. Many stakeholders believed they should be simplified or reduced, but not eliminated. Some stakeholders indicated that the documentation guidelines on history and exam could be eliminated altogether, and/or that documentation of these parts of an E/M visit could be left to practitioner discretion. We also heard from stakeholders that the degree to which an extended history and exam enables a given practitioner to reach a certain level of coding (and payment) varies according to their specialty. Many stakeholders advised CMS to increase reliance on medical decision-making (MDM) and time in determining the appropriate level of E/M visit, or to use MDM by itself, but many of these commenters believed that the MDM portions of the guidelines would need to be altered before being used alone. Commenters were divided on the role of time in distinguishing among E/M visit levels, and expressed some concern about potential abuse or inequities among more- or less-efficient practitioners. Some commenters expressed support for simplifying E/M coding generally into three levels such as low, medium and high, and potentially distinguishing those levels on the basis of time.

      2. CY 2019 Proposed Policies

      Having considered the public feedback to the CY 2018 PFS proposed rule (82 FR 53163 through 53166) and our other outreach efforts described above, we are proposing several changes to E/M visit documentation and

      Page 35835

      payment. The proposed changes would only apply to office/outpatient visit codes (CPT codes 99201 through 99215), except where we specify otherwise. We agree with commenters that we should take a step-wise approach to these issues, and therefore, we would limit initial changes to the office/outpatient E/M code set. We understand from commenters that there are more unique issues to consider for the E/M code sets used in other settings such as inpatient hospital or emergency department care, such as unique clinical and legal issues and the potential intersection with hospital Conditions of Participation (CoPs). We may consider expanding our efforts more broadly to address sections of the E/M code set beyond the office/outpatient codes in future years.

      We wish to emphasize that, this year, we are including our proposed E/M documentation changes in a proposed rule due to the longstanding nature of our instruction that practitioners may use either the 1995 or 1997 versions of the E/M guidelines to document E/M visits billed to Medicare, the magnitude of the proposed changes, and the associated payment policy proposals that require notice and comment rulemaking. We believe our proposed documentation changes for E/M visits are intrinsically related to our proposal to alter PFS payment for E/M visits (discussed below), and the PFS payment proposal for E/M visits requires notice and comment rulemaking. We note that we are proposing a relatively broad outline of changes in this proposed rule, and we anticipate that many details related to program integrity and ongoing refinement would need to be developed over time through subregulatory guidance. This would afford flexibility and enable us to more nimbly and quickly make ongoing clarifications, changes and refinements in response to continued practitioner experience moving forward.

    4. Lifting Restrictions Related to E/M Documentation

      (i) Eliminating Extra Documentation Requirements for Home Visits

      Medicare pays for E/M visits furnished in the home (a private residence) under CPT codes 99341 through 99350. The payment rates for these codes are slightly more than for office visits (for example, approximately $30 more for a level 5 established patient, non-

      facility). The beneficiary need not be confined to the home to be eligible for such a visit. However, there is a Medicare Claims Processing Manual provision requiring that the medical record must document the medical necessity of the home visit made in lieu of an office or outpatient visit (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.14.1.B, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf). Stakeholders have suggested that whether a visit occurs in the home or the office is best determined by the practitioner and the patient without applying additional rules. We agree, so we are proposing to remove the requirement that the medical record must document the medical necessity of furnishing the visit in the home rather than in the office. We welcome public comments on this proposal, including any potential, unintended consequences of eliminating this requirement. If we finalize this proposal in the CY 2019 PFS final rule, we would update the manual to reflect the change.

      (ii) Public Comment Solicitation on Eliminating Prohibition on Billing Same-Day Visits by Practitioners of the Same Group and Specialty

      The Medicare Claims Processing Manual states, ``As for all other E/

      M services except where specifically noted, the Medicare Administrative Contractors (MACs) may not pay two E/M office visits billed by a physician (or physician of the same specialty from the same group practice) for the same beneficiary on the same day unless the physician documents that the visits were for unrelated problems in the office, off campus-outpatient hospital, or on campus-outpatient hospital setting which could not be provided during the same encounter'' (Pub. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.7.B, available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf).

      This instruction was intended to reflect the idea that multiple visits with the same practitioner, or by practitioners in the same or very similar specialties within a group practice, on the same day as another E/M service would not be medically necessary. However, stakeholders have provided a few examples where this policy does not make sense with respect to the current practice of medicine as the Medicare enrollment specialty does not always coincide with all areas of medical expertise possessed by a practitioner--for example, a practitioner with the Medicare enrollment specialty of geriatrics may also be an endocrinologist. If such a practitioner was one of many geriatricians in the same group practice, they would not be able to bill separately for an E/M visit focused on a patient's endocrinological issue if that patient had another more generalized E/M visit by another geriatrician on the same day. Stakeholders have pointed out that in these circumstances, practitioners often respond to this instruction by scheduling the E/M visits on two separate days, which could unnecessarily inconvenience the patient. Given that the number and granularity of practitioner specialties recognized for purposes of Medicare enrollment continue to increase over time (consistent with the medical community's requests), the value to the Medicare program of the prohibition on same-day E/M visits billed by physicians in the same group and medical specialty may be diminishing, especially as we believe it is becoming more common for practitioners to have multiple specialty affiliations, but would have only one primary Medicare enrollment specialty. We believe that eliminating this policy may better recognize the changing practice of medicine while reducing administrative burden. The impact of this proposal on program expenditures and beneficiary cost sharing is unclear. To the extent that many of these services are currently merely scheduled and furnished on different days in response to the instruction, eliminating this manual provision may not significantly increase utilization, Medicare spending and beneficiary cost sharing.

      We are soliciting public comment on whether we should eliminate the manual provision given the changes in the practice of medicine or whether there is concern that eliminating it might have unintended consequences for practitioners and beneficiaries. We recognize that this instruction may be appropriate only in certain clinical situations, so we seek public comments on whether and how we should consider creating exceptions to, or modify this manual provision rather than eliminating it entirely. We are also requesting that the public provide additional examples and situations in which the current instruction is not clinically appropriate.

    5. Documentation Changes for Office or Other Outpatient E/M Visits and Home Visits

      (i) Providing Choices in Documentation--Medical Decision-Making, Time or Current Framework

      Informed by comments and examples that we have received asserting that the current E/M documentation guidelines

      Page 35836

      are outdated with respect to the current practice of medicine, and in our efforts to simplify documentation for the purposes of coding E/M visit levels, we propose to allow practitioners to choose, as an alternative to the current framework specified under the 1995 or 1997 guidelines, either MDM or time as a basis to determine the appropriate level of E/M visit. This would allow different practitioners in different specialties to choose to document the factor(s) that matter most given the nature of their clinical practice. It would also reduce the impact Medicare may have on the standardized recording of history, exam and MDM data in medical records, since practitioners could choose to no longer document many aspects of an E/M visit that they currently document under the 1995 or 1997 guidelines for history, physical exam and MDM. While we initially considered reducing the number of key components that practitioners needed to document in choosing the appropriate level of E/M service to bill, feedback from the stakeholder community led us to believe that offering practitioners a choice to either retain the current framework or choose among new options that involve a reduced level of documentation would be less burdensome for practitioners, and would allow more stability for practitioners who may need time to prepare for any potential new documentation framework.

      We wish to be clear that as part of this proposal, practitioners could use MDM, or time, or they could continue to use the current framework to document an E/M visit. In other words, we would be offering the practitioner the choice to continue to use the current framework by applying the 1995 or 1997 documentation guidelines for all three key components. However, our proposals on payment for office-

      based/outpatient E/M visits described later in this section would apply to all practitioners, regardless of their selected documentation approach. All practitioners, even those choosing to retain the current documentation framework, would be paid at the proposed new payment rate described in section II.I.2.c. of this proposed rule (one rate for new patients and another for established patients), and could also report applicable G-codes proposed in that section.

      We also wish to be clear that we are proposing to retain the current CPT coding structure for E/M visits (along with creating new replacement codes for podiatry office/outpatient E/M visits) as described later in this section. Practitioners would report on the professional claim whatever level of visit (1 through 5) they believe they furnished using CPT codes 99201-99215. We considered making an alternative proposal to adopt a single G-code to describe office/

      outpatient E/M visit levels 2 through 5 in conjunction with our proposal to establish a single PFS payment rate for those visits that is described later in this section. Because we believe the adoption of a reduced number of G-codes to describe the visit levels 2 through 5 might result in unnecessary disruption to current billing systems and practices, we are not proposing to modify the existing CPT coding structure for E/M visits. Since we are proposing to create a single rate under the PFS that would be paid for services billed using the current CPT codes for level 2 through 5 E/M visits, it would not be material to Medicare's payment decision which CPT code (of levels 2 through 5) is reported on the claim, except to justify billing a level 2 or higher visit in comparison to a level 1 visit (provided the visit itself was reasonable and necessary). We expect that, for record keeping purposes or to meet requirements of other payers, many practitioners would continue to choose and report the level of E/M visit they believe to be appropriate under the CPT coding structure.

      Even though there would be no payment differential for E/M visits level 2 through 5, we believe we would still need to simplify and change our documentation requirements to better align with the current practice of medicine and eliminate unnecessary aspects of the current documentation framework. As a corollary to our proposal to adopt a single payment amount for office/outpatient E/M visit levels 2 through 5 (see section II.I.2.c. of this proposed rule), we propose to apply a minimum documentation standard where, for the purposes of PFS payment for an office/outpatient E/M visit, practitioners would only need to meet documentation requirements currently associated with a level 2 visit for history, exam and/or MDM (except when using time to document the service, see below). Practitioners could choose to document more information for clinical, legal, operational or other purposes, and we anticipate that for those reasons, they would continue generally to seek to document medical record information that is consistent with the level of care furnished. For purposes of our medical review, however, for practitioners using the current documentation framework or, as we are proposing, MDM, Medicare would only require documentation to support the medical necessity of the visit and the documentation that is associated with the current level 2 CPT visit code.

      For example, for a practitioner choosing to document using the current framework (1995 or 1997 guidelines), our proposed minimum documentation for any billed level of E/M visit from levels 2 through 5 could include: (1) A problem-focused history that does not include a review of systems or a past, family, or social history; (2) a limited examination of the affected body area or organ system; and (3) straightforward medical decision making measured by minimal problems, data review, and risk (two of these three). If the practitioner was choosing to document based on MDM alone, Medicare would only require documentation supporting straightforward medical decision-making measured by minimal problems, data review, and risk (two of these three).

      Some commenters have suggested that the current framework of guidelines for the MDM component of visits would need to be changed before MDM could be relied upon by itself to distinguish visit levels. We propose to allow practitioners to rely on MDM in its current form to document their visit, and are soliciting public comment on whether and how guidelines for MDM might be changed in subsequent years.

      As described earlier, we currently allow time or duration of visit to be used as the governing factor in selecting the appropriate E/M visit level, only when counseling and/or coordination of care accounts for more than 50 percent of the face-to-face physician/patient encounter (or, in the case of inpatient E/M services, the floor time). Our proposal to allow practitioners the choice of using time to document office/outpatient E/M visits would mean that this time-based standard is not limited to E/M visits in which counseling and/or care coordination accounts for more than 50 percent of the face-to-face practitioner/patient encounter. Rather, the amount of time personally spent by the billing practitioner face-to-face with the patient could be used to document the E/M visit regardless of the amount of counseling and/or care coordination furnished as part of the face-to-

      face encounter.

      Some commenters have raised concerns with reliance on time to distinguish visit levels, for example the potential for abuse, inequities among more- or less-efficient practitioners, and specialties for which time is less of a factor in determining visit complexity. Relying on time as the basis for

      Page 35837

      identifying the E/M visit level also raises the issue of what would be required by way of supporting documentation; for example, what amount of time should be documented, and whether the specific activities comprising the time need to be documented and to what degree. However, a number of stakeholders have suggested that, within their specialties, time is a good indicator of the complexity of the visit or patient, and requested that we allow practitioners to use time as the single factor in all E/M visits, not just when counseling or care coordination dominate a visit. We agree that for some practitioners and patients, time may be a good indicator of complexity of the visit, and are proposing to allow practitioners the option to use time as the single factor in selecting visit level and documenting the E/M visit, regardless of whether counseling or care coordination dominate the visit. If finalized, we would monitor the results of this proposed policy for any program integrity issues, administrative burden or other issues.

      For practitioners choosing to support their coding and payment for an E/M visit by documenting the amount of time spent with the patient, we propose to require the practitioner to document the medical necessity of the visit and show the total amount of time spent by the billing practitioner face-to-face with the patient. We are soliciting public comment on what that total time should be for payment of the single, new rate for E/M visits levels 2 through 5. The typical time for our proposed new payment for E/M visit levels 2 through 5 is 31 minutes for an established patient and 38 minutes for a new patient, and we could use these times. These times are weighted averages of the intra-service times across the current E/M visit utilization. Accordingly, these times are higher than the current typical time for a level 2, 3 or 4 visit, but lower than the current typical time for a level 5 visit. We note that currently the PFS does not require the practitioner to spend or document a specified amount of time with a given patient in order to receive payment for an E/M visit, unless the visit is dominated by counseling/care coordination and, on that account, the practitioner is using time as the basis for code selection. The times for E/M visits and most other PFS services in the physician time files, which are used to set PFS rates, are typical times rather than requirements, and were recommended by the AMA RUC and then reviewed and either adopted or adjusted for Medicare through our usual rate setting process as ``typical,'' but not strictly required.

      One alternative is to apply the AMA's CPT codebook provision that, for timed services, a unit of time is attained when the mid-point is passed,\5\ such that we would require documentation that at least 16 minutes for an established patient (more than half of 31 minutes) and at least 20 minutes for a new patient (more than half of 38 minutes) were spent face-to-face by the billing practitioner with the patient, to support making payment at the proposed single rate for visit levels 2 through 5 when the practitioner chooses to document the visit using time.

      ---------------------------------------------------------------------------

      \5\ 2017 CPT Codebook Introduction, p.xv.

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      Another alternative is to require documentation that the typical time for the CPT code that is reported (which is also the typical time listed in the AMA's CPT codebook for that code) was spent face-to-face by the billing practitioner with the patient. For example, a practitioner reporting CPT code 99212 (a level 2 established patient visit) would be required to document having spent a minimum of 10 minutes, and a practitioner reporting CPT code 99214 (a level 4 established patient visit) would be required to document having spent a minimum of 25 minutes. Under this approach, the total amount of time spent by the billing practitioner face-to-face with the patient would inform the level of E/M visit (of levels 2 through 5) coded by the billing practitioner. We note that in contrast to other proposed documentation approaches discussed above, this approach of requiring documentation of the typical time associated with the CPT visit code reported on the claim would introduce unique payment implications for reporting that code, especially when the time associated with the billed E/M code is the basis for reporting prolonged E/M services.

      We are soliciting public comments on the use of time as a framework for documentation of office/outpatient E/M visits, and whether we should adopt any of these approaches or specify other requirements with respect to the proposed option for documentation using time.

      In providing us with feedback, we ask commenters to take into consideration ways in which the time associated with, or required for, the billing of any add-on codes (especially the proposed prolonged E/M visit add-on code(s) described in section II.I.2.d.v. of this proposed rule) would intersect with the time spent for the base E/M visit, when the practitioner is documenting the E/M visit using only time. Currently, when reporting prolonged E/M services, we expect the practitioner to exceed the typical time assigned for the base E/M visit code (also commonly referred to as the companion code). For example, in the CY 2017 PFS final rule (81 FR 80229), we expressed appreciation for the commenters' suggestion to display the typical times associated with relevant services. We also discussed, and in response to those comments, decided to post a file annually that notes the times assumed to be typical for purposes of PFS ratesetting for practitioners to use as a reference in deciding whether time requirements for reporting prolonged E/M services are met. We stated that while these typical times are not required for a practitioner to bill the displayed base codes, we would expect that only time spent in excess of these times would be reported using a non-face-to-face prolonged service code. We are now proposing to formalize this policy in the case where a practitioner uses time to document a visit, since there would be a stricter time requirement associated with the base E/M code. Specifically, we propose that, when a practitioner chooses to document using time and also reports prolonged E/M services, we would require the practitioner to document that the typical time required for the base or ``companion'' visit is exceeded by the amount required to report prolonged services. See section II.I.2.d.v. of this proposed rule for further discussion of our proposal regarding reporting prolonged E/M services.

      As we discuss further in this section of the proposed rule, we believe that allowing practitioners to choose the most appropriate basis for distinguishing among the levels of E/M visits and applying a minimum documentation requirement, together with reducing the payment variation among E/M visit levels, would significantly reduce administrative burden for practitioners, and would avoid the current need to make coding and documentation decisions based on codes and documentation guidelines that are not a good fit with current medical practice. The practitioner could choose to use MDM, time or the current documentation framework, and could also apply the proposed policies below regarding redundancy and who can document information in the medical record.

      We heard from a few commenters on the CY 2018 PFS proposed rule that some practitioners rely on unofficial Marshfield clinic or other criteria to help them document E/M visit levels. These commenters conveyed that the

      Page 35838

      Marshfield ``point system'' is commonly used to supplement the E/M documentation guidelines, because of a lack of concrete criteria for certain elements of medical decision making in the 1995 and 1997 guidelines or in CPT guidance. We are soliciting public comment on whether Medicare should use or adopt any aspects of other E/M documentation systems that may be in use among practitioners, such as the Marshfield tool. We are interested in feedback as to whether the 1995 and 1997 guidelines contain adequate information for practitioners to use in documenting visits under our proposals, or whether these versions of the guidelines would need to be supplemented in any way.

      We are seeking public comment on these proposals to provide practitioners choice in the basis for documenting E/M visits in an effort to allow for documentation alternatives that better reflect the current practice of medicine and to alleviate documentation burden. We are also interested in public comments on practitioners' ability to avail themselves of these choices with respect to how they would impact clinical workflows, EHR templates, and other aspects of practitioner work. Commenters have requested that CMS not merely shift burden by implementing another framework that might avoid issues caused by the current guidelines, but that would be equally complex and burdensome. Our primary goal is to reduce administrative burden so that the practitioner can focus on the patient, and we are interested in commenters' opinions as to whether our E/M visit proposals would, in fact, support and further this goal. We believe these proposals would allow practitioners to exercise greater clinical judgment and discretion in what they document, focusing on what is clinically relevant and medically necessary for the patient. While we propose to no longer apply much of the E/M documentation guidelines involving history, exam and, for those choosing to document based on time, documentation of medical decision-making, our expectation is that practitioners would continue to perform and document E/M visits as medically necessary for the patient to ensure quality and continuity of care. For example, we believe that it remains an important part of care for the practitioner to understand the patient's social history, even though we would no longer require that history to be documented to bill Medicare for the visit.

      (ii) Removing Redundancy in E/M Visit Documentation

      Stakeholders have recently expressed that CMS should not require documentation of information in the billing practitioner's note that is already present in the medical record, particularly with regard to history and exam. Currently, both the 1995 and 1997 guidelines provide such flexibility for certain parts of the history for established patients, stating, ``A Review of Systems ``ROS'' and/or a pertinent past, family, and/or social history ``PFSH'' obtained during an earlier encounter does not need to be re-recorded if there is evidence that the physician reviewed and updated the previous information. This may occur when a physician updates his/her own record or in an institutional setting or group practice where many physicians use a common record. The review and update may be documented by:

      Describing any new ROS and/or PFSH information or noting there has been no change in the information; and

      Noting the date and location of the earlier ROS and/or PFSH.

      Documentation Guidelines ``DG'': The ROS and/or PFSH may be recorded by ancillary staff or on a form completed by the patient. To document that the physician reviewed the information, there must be a notation supplementing or confirming the information recorded by others (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/95Docguidelines.pdf; https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNEdWebGuide/Downloads/97Docguidelines.pdf).

      We propose to expand this policy to further simplify the documentation of history and exam for established patients such that, for both of these key components, practitioners would only be required to focus their documentation on what has changed since the last visit or on pertinent items that have not changed, rather than re-documenting a defined list of required elements such as review of a specified number of systems and family/social history. Since medical decision-

      making can only be accurately formed upon a substantial basis of accurate and timely health information, and the CPT code descriptors for all E/M visits would continue to include the elements of history and exam, we expect that practitioners would still conduct clinically relevant and medically necessary elements of history and physical exam, and conform to the general principles of medical record documentation in the 1995 and 1997 guidelines. However, practitioners would not need to re-record these elements (or parts thereof) if there is evidence that the practitioner reviewed and updated the previous information.

      We are seeking comment on whether there may be ways to implement a similar provision for any aspects of medical decision-making, or for new patients, such as when prior data is available to the billing practitioner through an interoperable EHR or other data exchange. We believe there would be special challenges in realizing documentation efficiencies with new patients, since they may not have received exams or histories that were complete or relevant to the current complaint(s), and the information in the transferred record could be more likely to be incomplete, outdated or inaccurate.

      Also, we propose that for both new and established patients, practitioners would no longer be required to re-enter information in the medical record regarding the chief complaint and history that are already entered by ancillary staff or the beneficiary. The practitioner could simply indicate in the medical record that they reviewed and verified this information. We wish to be clear that these proposed policy changes would be optional, where a practitioner could choose to continue to use the current framework, and the more detailed information could continue to be entered, re-entered or brought forward in documenting a visit, regardless of the documentation approach selected by the practitioner. Our goal is to allow practitioners more flexibility to exercise greater clinical judgment and discretion in what they document, focusing on what is clinically relevant and medically necessary for the patient. Our expectation is that practitioners would continue to periodically review and assess static or baseline historical information at clinically appropriate intervals.

      (iii) Podiatry Visits

      As described in greater detail in section II.I.2.d.iii. of this proposed rule, as part of our proposal to improve payment accuracy by creating a single PFS payment rate for E/M visit levels 2 through 5 (with one proposed rate for new patients and one proposed rate for established patients), we propose to create separate coding for podiatry visits that are currently reported as E/M office/outpatient visits. We propose that, rather than reporting visits under the general E/M office/outpatient visit

      Page 35839

      code set, podiatrists would instead report visits under new G-codes that more specifically identify and value their services. We propose to apply substantially the same documentation standards for these proposed new podiatry-specific codes as we propose above for other office/

      outpatient E/M visits.

      If a practitioner chose to use time to document a podiatry office/

      outpatient E/M visit, we propose to apply substantially the same rules as those we are proposing for documenting on the basis of time for other office/outpatient E/M visits, discussed above. For practitioners choosing to use time to provide supporting documentation for the podiatry visit, we would require documentation supporting the medical necessity of the visit and showing the total amount of time spent by the billing practitioner face-to-face with the patient. We are soliciting public comment on what that total time would be for payment of the proposed new podiatry G-codes. The typical times for these proposed codes are 22 minutes for an established patient and 28 minutes for a new patient, and we could use these times. Alternatively, we could apply the AMA's CPT codebook provision that, for timed services, a unit of time is attained when the mid-point is passed,\6\ such that we would require documentation that at least 12 minutes for an established patient (more than half of 22 minutes) or at least 15 minutes for a new patient (more than half of 28 minutes) were spent face-to-face by the billing practitioner with the patient, to support making payment for these codes when the practitioner chooses to document the visit using time. We are soliciting comment on the use of time as a basis for documentation of our proposed podiatric E/M visit codes, and whether we should adopt any of these approaches or further specify other requirements with respect to this proposed option for podiatric practitioners to document their visits using time.

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      \6\ 2017 CPT Codebook Introduction, p.xv.

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    6. Minimizing Documentation Requirements by Simplifying Payment Amounts

      As we have explained above, including in prior rulemaking, we believe that the coding, payment, and documentation requirements for E/

      M visits are overly burdensome and no longer aligned with the current practice of medicine. We believe the current set of 10 CPT codes for new and established office-based and outpatient E/M visits and their respective payment rates no longer appropriately reflect the complete range of services and resource costs associated with furnishing E/M services to all patients across the different physician specialties, and that documenting these services using the current guidelines has become burdensome and out of step with the current practice of medicine. We have included the proposals described above to mitigate the burden associated with the outdated documentation guidelines for these services. To alleviate the effects and mitigate the burden associated with continued use of the outdated CPT code set, we are proposing to simplify the office-based and outpatient E/M payment rates and documentation requirements, and create new add-on codes to better capture the differential resources involved in furnishing certain types of E/M visits.

      In conjunction with our proposal to reduce the documentation requirements for E/M visit levels 2 through 5, we are proposing to simplify the payment for those services by paying a single rate for the level 2 through 5 E/M visits. The visit level of the E/M service is tied to the documentation requirements in the 1995 and 1997 Documentation Guidelines for E/M Services, which may not be reflective of changes in technology or, in particular, the ways that electronic medical records have changed documentation and the patient's medical record. Additionally, current documentation requirements may not account for changes in care delivery, such as a growing emphasis on team based care, increases in the number of recognized chronic conditions, or increased emphasis on access to behavioral health care. However, based on the feedback we have received from stakeholders, it is clear to us that the burdens associated with documenting the selection of the level of E/M service arise from not only the documentation guidelines, but also from the coding structure itself. Like the documentation guidelines, the distinctions between visit levels reflect a reasonable assessment of variations in care, effort, and resource costs as identified and articulated several decades ago. We believe that the most important distinctions between the kinds of visits furnished to Medicare beneficiaries are not well reflected by the current E/M visit coding. Most significantly, we have understood from stakeholders that current E/M coding does not reflect important distinctions in services and differences in resources. At present, we believe the current payment for E/M visit levels, generally distinguished by common elements of patient history, physical exam, and MDM, that may have been good approximations for important distinctions in resource costs between kinds of visits in the 1990s, when the CPT developed the E/M code set, are increasingly outdated in the context of changing models of care and information technologies.

      As described earlier in this section, we are proposing to change the documentation requirements for E/M levels such that practitioners have the choice to use the 1995 guidelines, 1997 guidelines, time, or MDM to determine the E/M level. We believe that these proposed changes will better reflect the current practice of medicine and represent significant reductions in burdens associated with documenting visits using the current set of E/M codes.

      In alignment with our proposed documentation changes, we are proposing to develop a single set of RVUs under the PFS for E/M office-

      based and outpatient visit levels 2 through 5 for new patients (CPT codes 99202 through 99205) and a single set of RVUs for visit levels 2 through 5 for established patients (CPT codes 99212 through 99215). While we considered creating new HCPCS G-codes that would describe the services associated with these proposed payment rates, given the wide and longstanding use of these visit codes by both Medicare and private payers, we believe it would have created unnecessary administrative burden to propose new coding. Therefore, we are instead proposing to maintain the current code set. Of the five levels of office-based and outpatient E/M visits, the vast majority of visits are reported as levels 3 and 4. In CY 2016, CPT codes 99203 and 99204 (or E/M visit level 3 and level 4 for new patients) made up around 32 percent and 44 percent, respectively, of the total allowed charges for CPT codes 99201-99205. In the same year, CPT codes 99213 and 99214 (or E/M visit level 3 and 4 for established patients) made up around 39 percent and 50 percent, respectively, of the allowed charges for CPT codes 99211-

      99215. If our proposals to simplify the documentation requirements and to pay a single PFS rate for new patient E/M visit levels 2 through 5 and a single rate for established patient E/M visit levels 2 through 5 are finalized, practitioners would still bill the CPT code for whichever level of E/M service they furnished and they would be paid at the single PFS rate. However, we believe that eliminating the distinction in payment between visit levels 2 through 5 will eliminate the need to audit against the visit levels, and therefore,

      Page 35840

      will provide immediate relief from the burden of documentation. A single payment rate will also eliminate the increasingly outdated distinction between the kinds of visits that are reflected in the current CPT code levels in both the coding and the associated documentation rules.

      In order to set RVUs for the proposed single payment rate for new and established patient office/outpatient E/M visit codes, we are proposing to develop resource inputs based on the current inputs for the individual E/M codes, generally weighted by the frequency at which they are currently billed, based on the 5 most recent years of Medicare claims data (CY 2012 through CY 2017). Specifically, we are proposing a work RVU of 1.90 for CPT codes 99202-99205, a physician time of 37.79 minutes, and direct PE inputs that sum to $24.98, each based on an average of the current inputs for the individual codes weighted by 5 years of accumulated utilization data. Similarly, we are proposing a work RVU of 1.22 for CPT codes 99212-99215, with a physician time of 31.31 minutes and direct PE inputs that sum to $20.70. These inputs are based on an average of the inputs for the individual codes, weighted by volume based on utilization data from the past 5 years (CY 2012 through CY 2017). Tables 19 and 20 reflect the payment rates in dollars that would result from the approach described above were it to have been implemented for CY 2018. In other words, the dollar amounts in the charts below reflect how the changes we are proposing for CY 2019 would have impacted payment rates for CY 2018. Proposed RVUs for CY 2019 appear in addendum B of this proposed rule, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

      Table 19--Preliminary Comparison of Payment Rates for Office Visits New

      Patients

      ------------------------------------------------------------------------

      CY 2018 non-

      CY 2018 facility

      non- payment rate

      HCPCS code facility under the

      payment proposed

      rate methodology

      ------------------------------------------------------------------------

      99201......................................... $45 $44

      99202......................................... 76 135

      99203......................................... 110 ............

      99204......................................... 167 ............

      99205......................................... 211 ............

      ------------------------------------------------------------------------

      Table 20--Preliminary Comparison of Payment Rates for Office Visits

      Established Patients

      ------------------------------------------------------------------------

      Current

      non- Proposed non-

      HCPCS code facility facility

      payment payment rate

      rate

      ------------------------------------------------------------------------

      99211......................................... $22 $24

      99212......................................... 45 93

      99213......................................... 74 ............

      99214......................................... 109 ............

      99215......................................... 148 ............

      ------------------------------------------------------------------------

      While we believe that the proposed rates for E/M visit levels 2 through 5 represent the valuation of a typical E/M service, we also recognize that the current E/M code set itself does not appropriately reflect differences in resource costs between certain types of E/M visits. As a result, we believe that the way we currently value the resource costs for E/M services through the existing HCPCS CPT code set for office-based and outpatient E/M visits does not appropriately reflect the resources used in furnishing the range of E/M services that are provided through the current the practice of medicine. Based on stakeholder comments and examples and our review of the literature on E/M services, we have identified three types of E/M visits that differ from the typical E/M visit and are not appropriately reflected in the current office/outpatient E/M code set and valuation. Rather, these three types of E/M visits can be distinguished by the mode of care provided and, as a result, have different resource costs. The three types of E/M visits that differ from the typical E/M service are (1) separately identifiable E/M visits furnished in conjunction with a 0-

      day global procedure, (2) primary care E/M visits for continuous patient care, and (3) certain types of specialist E/M visits, including those with inherent visit complexity. We address each of these distinguishable visit types in the following proposals.

    7. Recognizing the Resource Costs for Different Types of E/M Visits

      Rather than maintain distinctions in services and payment that are based on the current E/M visit codes, we believe we can better capture differential resources costs and minimize reporting and documentation burden by proposing several corollary payment policies and ratesetting adjustments. These additional proposals better reflect the important distinctions between the kinds of visits furnished to Medicare beneficiaries, and would no longer require complex and burdensome billing and documentation rules to effectuate payment.

      In response to the CY 2018 comment solicitation on burden reduction for E/M visits (82 FR 53163 through 53166), we received several comments that highlighted the inadequacy of the E/M code set to accurately pay for the resources associated with furnishing visits, particularly for primary care visits, and visits associated with treating patients with particular conditions for which there is not additional procedural coding. One commenter stated that the current structure and valuation of the E/M code set inadequately describes the range of services provided by different specialties, and in particular primary care services. This commenter noted that although the 10 office/outpatient E/M codes make up the bulk of the services reported by primary care practitioners, the valuation does not reflect their particular resource costs. Another commenter pointed out that for specialties that principally rely on E/M visit codes to bill for their professional services, the complex medical decision making and the intensity of their visits is not reflected in the E/M code set or documentation guidelines. Additionally, we believe that when a separately identifiable visit is furnished in conjunction with a procedure, that there are certain duplicative resource costs that are also not accounted for by current coding and payment.

      Therefore, we are proposing the following adjustments to better capture the variety of resource costs associated with different types of care provided in E/M visits: (1) An E/M multiple procedure payment adjustment to account for duplicative resource costs when E/M visits and procedures with global periods are furnished together; (2) HCPCS G-

      code add-ons to recognize additional relative resources for primary care visits and inherent visit complexity that require additional work beyond that which is accounted for in the single payment rates for new and established patient levels 2 through level 5 visits; (3) HCPCS G-

      codes to describe podiatric E/M visits; (4) an additional prolonged face-to-face services add-on G code; and (5) a technical modification to the PE methodology to stabilize the allocation of indirect PE for visit services (i) Accounting for E/M Resource Overlap between Stand-

      Alone Visits and Global Periods

      Under the PFS, E/M services are generally paid in one of two ways: As standalone visits using E/M visit codes, or included in global procedural codes. In both cases, RVUs are allocated to the services to account for the estimated relative resources involved in furnishing professional E/M services. In the case of procedural codes with global periods,

      Page 35841

      the overall resource inputs reflect the costs of the E/M work considered to be typically furnished with the procedure. Therefore, the standalone E/M visit codes are not billable on the same day as the procedure codes unless the billing professional specifically indicates that the visit is separately identifiable from the procedure.

      In cases where a physician furnishes a separately identifiable E/M visit to a beneficiary on the same day as a procedure, payment for the procedure and the E/M visit is based on rates generally developed under the assumption that these services are typically furnished independently. In CY 2017 PFS rulemaking, we noted that the current valuation for services with global periods may not accurately reflect much of the overlap in resource costs (81 FR 80209). We are particularly concerned that when a standalone E/M visit occurs on the same day as a 0-day global procedure, there are significant overlapping resource costs that are not accounted for. We believe that separately identifiable visits occurring on the same day as 0-day global procedures have resources that are sufficiently distinct from the costs associated with furnishing one of the 10 office/outpatient E/M visits to warrant payment adjustment. There are other existing policies under the PFS where we reduce payments if multiple procedures are furnished on the same day to the same patient. Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same patient by the same physician on the same day, largely based on the presence of efficiencies in PE and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with the same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future. In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy. Finally, in the CY 2011 PFS final rule, CMS finalized the application of the MPPR to always-therapy services on the justification that there was significant overlap in the PE portion of these services (75 FR 73233).

      Using the surgical MPPR as a template, we are proposing that, as part of our proposal to make payment for the E/M levels 2 through 5 at a single PFS rate, we would reduce payment by 50 percent for the least expensive procedure or visit that the same physician (or a physician in the same group practice) furnishes on the same day as a separately identifiable E/M visit, currently identified on the claim by an appended modifier -25. We believe that the efficiencies associated with furnishing an E/M visit in combination with a same-day procedure are similar enough to those accounted for by the surgical MPPR to merit a reduction in the relative resources of 50 percent. We estimate based on CY 2017 Medicare claims data that applying a 50 percent MPPR to E/M visits furnished as separately identifiable services in the same day as a procedure would reduce expenditures under the PFS by approximately 6.7 million RVUs. To accurately reflect resource costs of the different types of E/M visits that we previously identified while maintaining work budget neutrality within this proposal, we are proposing to allocate those RVUs toward the values of the add-on codes that reflect the additional resources associated with E/M visits for primary care and inherent visit complexity, similar to existing policies. As we articulated in the CY 2012 PFS final rule with comment period, where the aggregate work RVUs within a code family change but the overall actual physician work associated with those services does not change, we make work budget neutrality adjustments to hold the aggregate work RVUs constant within the code family, while maintaining the relativity of values for the individual codes within that set (76 FR 73105).

      (ii) Proposed HCPCS G-Code Add-Ons To Recognize Additional Relative Resources for Certain Kinds of Visits

      The distribution of E/M visits is not uniform across medical specialties. We have found that certain specialists, like neurologists and endocrinologists, for example, bill higher level E/M codes more frequently than procedural specialists, such as dermatology. We believe this tendency reflects a significant and important distinction between the kinds of visits furnished by professionals whose treatment approaches are primarily reported using visit codes versus those professionals whose treatment approaches are primarily reported using available procedural or testing codes. However, based on feedback we received from the medical professionals who furnish primary care and have visits with greater complexity, such as the comments cited above, we do not believe the current visit definitions and the associated documentation burdens are the most accurate descriptions of the variation in work. Instead, we believe these professionals have been particularly burdened by the documentation requirements given that so much of their medical treatment is described imperfectly by relatively generic visit codes.

      Similarly stakeholders, such as the commenters responding to the CY 2018 PFS proposed rule, have articulated persuasively that visits furnished for the purpose of primary care also involve distinct resource costs. In developing this proposal, we consulted a variety of resources, including the American Academy of Family Physicians (AAFP) definition of primary care that states that the resource costs associated with furnishing primary care services particularly include time spent coordinating patient care, collaborating with other physicians, and communicating with patients (see https://www.aafp.org/about/policies/all/primary-care.html). Despite our efforts in recent years to pay separately for certain aspects of primary care services, such as through the chronic care management or the transitional care management services, the currently available coding still does not adequately reflect the full range of primary care services, nor does it allow payment to fully capture the resource costs involved in furnishing a face-to-face primary care E/M visit. We recognize that primary care services frequently involve substantial non-face-to-face work, and note that there is currently coding available to account for many of those resources, such as chronic care management (CCM), behavioral health integration (BHI), and prolonged non-face-to-face services. In light of the existing coding, this proposal only addresses the additional resources involved in furnishing the face-to-face portion of a primary care service. As the point of entry for many patients into the healthcare system, primary care visits frequently require additional time for communicating with the patient, patient education, consideration and review of the patient's medical needs. We believe the proposed value for the single payment rate for the E/M levels 2 through 5 new and established patient visit codes does

      Page 35842

      not reflect these additional resources inherent to primary care visits, as evidenced by the fact that primary care visits are generally reported using level 4 E/M codes Therefore, to more accurately account for the type and intensity of E/M work performed in primary care-

      focused visits, we are proposing to create a HCPCS add-on G-code that may be billed with the generic E/M code set to adjust payment to account for additional costs beyond the typical resources accounted for in the single payment rate for the levels 2 through 5 visits.

      We are proposing to create a HCPCS G-code for primary care services, GPC1X (Visit complexity inherent to evaluation and management associated with primary medical care services that serve as the continuing focal point for all needed health care services (Add-on code, list separately in addition to an established patient evaluation and management visit)). As we believe a primary care visit is partially defined by an ongoing relationship with the patient, this code would describe furnishing a visit to an established patient. HCPCS code GPC1X can also be reported for other forms of face-to-face care management, counseling, or treatment of acute or chronic conditions not accounted for by other coding. We note that we believe the additional resources to address inherent complexity in E/M visits associated with primary care services are associated only with stand-alone E/M visits as opposed to separately identifiable visits furnished within the global period of a procedure. Separately identifiable visits furnished within a global period are identified on the claim using modifier -25, and would be subject to the MPPR. We note that we have created separate coding that describes non-face-to-face care management and coordination, such as CCM and BHI; however, these services describe non-face-to-face care and can be provided by any specialty so long as they meet the requirements for those codes. HCPCS code GPC1X is intended to capture the additional resource costs, beyond those involved in the base E/M codes, of providing face-to-face primary care services for established patients. HCPCS code GPC1X would be billed in addition to the E/M visit for an established patient when the visit includes primary care services. For HCPCS code GPC1X, we are proposing a work RVU of 0.07, physician time of 1.75 minutes, a PE RVU of 0.07, and an MP RVU of 0.01. This proposed valuation accounts for the additional resource costs associated with furnishing primary care that distinguishes E/M primary care visits from other types of E/M visits, and maintains work budget neutrality across the office/outpatient E/M code set. Furthermore, the proposed add-on G-code for primary care-

      focused E/M services would help to mitigate potential payment instability that could result from our adoption of single payment rates that apply for E/M code levels 2 through 5. As this add-on G-code would account for the inherent resource costs associated with furnishing primary care E/M services, we anticipate that it would be billed with every primary care-focused E/M visit for an established patient. While we expect that this code will mostly be utilized by the primary care specialties, such as family practice or pediatrics, we are also aware that, in some instances, certain specialists function as primary care practitioners--for example, an OB/GYN or a cardiologist. Although the definition of primary care is widely agreed upon by the medical community and we intend for this G-code to account for the resource costs of performing those types of visits, regardless of Medicare enrollment specialty, we are also seeking comment on how best to identify whether or not a primary care visit was furnished particularly in cases where a specialist is providing those services. For especially complex patients, we also expect that it may be billed alongside the proposed new code for prolonged E/M services described later in this section. We are also seeking comment on whether this policy adequately addresses the deficiencies in CPT coding for E/M services in describing current medical practice, and concerns about the impact on payment for primary care and other services under the PFS. Given the broad scope of our proposals related to E/M services, we are seeking feedback on any unintended consequences of those proposals. We are also seeking comment on any other concerns related to primary care that we might consider for future rulemaking.

      We are also proposing to create a HCPCS G-code to be reported with an E/M service to describe the additional resource costs for specialty professionals for whom E/M visit codes make up a large percentage of their overall allowed charges and whose treatment approaches we believe are generally reported using the level 4 and level 5 E/M visit codes rather than procedural coding. Due to these factors, the proposed single payment rate for E/M levels 2 through 5 visit codes would not necessarily reflect the resource costs of those types of visits. Therefore, we are proposing to create a new HCPCS code GCG0X (Visit complexity inherent to evaluation and management associated with endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, cardiology, or interventional pain management-centered care (Add-on code, list separately in addition to an evaluation and management visit)). Given their billing patterns, we believe that these are specialties that apply predominantly non-procedural approaches to complex conditions that are intrinsically diffuse to multi-organ or neurologic diseases. While some of these specialties are surgical in nature, we believe these surgical specialties are providing increased non-procedural care of high complexity in the Medicare population. The high complexity of these services is reflected in the large proportion of level 4 and level 5 visits that we believe are reported by these specialties, and the extent to which E/M visits are a high proportion of these specialties' total allowed charges. Consequently, these are specialties for which the resource costs of the visits they typically perform are not fully captured in the proposed single payment rate for the levels 2 through level 5 office/outpatient visit codes. When billed in conjunction with standalone office/outpatient E/M visits for new and established patients, the combined valuation more accurately accounts for the intensity associated with higher level E/M visits. To establish a value for this add-on service to be applied with a standalone E/M visit, we are proposing a crosswalk to 75 percent of the work and time of CPT code 90785 (Interactive complexity), which results in a work RVU of 0.25, a PE RVU of 0.07, and an MP RVU of 0.01, as well as 8.25 minutes of physician time based on the CY 2018 valuation for CPT code 90785. Interactive complexity is an add-on code that may be billed when a psychotherapy or psychiatric service requires more resources due to the complexity of the patient. We believe that the proposed valuation for CPT code 90785 would be an accurate representation of the additional work associated with the higher level complex visits. We note that we believe the additional resources to address inherent complexity in E/M visits are associated with stand-alone E/M visits. Additionally, we acknowledge that resource costs for primary care are reflected with the proposed HCPCS code GPC1X, as opposed to the

      Page 35843

      proposed HCPCS code GCG0X. We note that there are additional codes available that include face-to-face and non-face-to-face work, depending on the code, that previously would have been considered part of an E/M visit, such as the codes for CCM, BHI, and CPT code 99483 (Assessment of and care planning for a patient with cognitive impairment, requiring an independent historian, in the office or other outpatient, home or domiciliary or rest home, with all of the following required elements: Cognition-focused evaluation including a pertinent history and examination; Medical decision making of moderate or high complexity; Functional assessment (e.g., basic and instrumental activities of daily living), including decision-making capacity; Use of standardized instruments for staging of dementia (e.g., functional assessment staging test FAST, clinical dementia rating CDR); Medication reconciliation and review for high-risk medications; Evaluation for neuropsychiatric and behavioral symptoms, including depression, including use of standardized screening instrument(s); Evaluation of safety (e.g., home), including motor vehicle operation; Identification of caregiver(s), caregiver knowledge, caregiver needs, social supports, and the willingness of caregiver to take on caregiving tasks; Development, updating or revision, or review of an Advance Care Plan; Creation of a written care plan, including initial plans to address any neuropsychiatric symptoms, neuro-cognitive symptoms, functional limitations, and referral to community resources as needed (e.g., rehabilitation services, adult day programs, support groups) shared with the patient and/or caregiver with initial education and support. Typically, 50 minutes are spent face-to-face with the patient and/or family or caregiver), which were developed to reflect the additional work of those practitioners furnishing primary care visits. Likewise, we are proposing that practitioners in the specialty of psychiatry would not use either add-on code because psychiatrists may utilize CPT code 90785 to describe work that might otherwise be reported with a level 4 or level 5 E/M visit.

      We are seeking comment on both of these proposals.

      (iii) Proposed HCPCS G-Code To Describe Podiatric E/M Visits

      As described earlier, the vast majority of podiatric visits are reported using lower level E/M codes, with most E/M visits billed at a level 2 or 3, reflecting the type of work done by podiatrists as part of an E/M visit. Therefore, while the proposed consolidation of documentation and payment for E/M code levels 2 through 5 is intended to better reflect the universal elements of E/M visits across specialties and patients, we believe that podiatric E/M visits are not accurately represented by the consolidated E/M structure. In order for payment to reflect the resource costs of podiatric visits, we are also proposing to create two HCPCS G-codes, HCPCS codes GPD0X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, new patient) and GPD1X (Podiatry services, medical examination and evaluation with initiation of diagnostic and treatment program, established patient), to describe podiatric E/M services. Under this proposal, podiatric E/M services would be billed using these G-codes instead of the generic office/

      outpatient E/M visit codes (CPT codes 99201 through 99205 and 99211 through 99215). We propose to create these separate G-codes for podiatric E/M services to differentiate the resources associated with podiatric E/M visits rather than proposing a negative add-on adjustment relative to the proposed single payment rates for the generic E/M levels 2 through 5 codes. Therefore, we are proposing to create separate coding to describe these services, taking into account that most podiatric visits are billed as level 2 or 3 E/M codes. We based the coding structure and code descriptor on CPT codes 92004 (Ophthalmological services: Medical examination and evaluation with initiation of diagnostic and treatment program; comprehensive, new patient, 1 or more visits) and 92012 (Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; intermediate, established patient), which describe visits specific to ophthalmology. To accurately reflect payment for the resource costs associated with podiatric E/M visits, we are proposing a work RVU of 1.35, a physician time of 28.11 minutes, and direct PE inputs totaling $22.53 for HCPCS code GPD0X, and a work RVU of 0.85, physician time of 21.60 minutes, and direct PE inputs totaling $17.07 for HCPCS code GPD1X. These values are based on the average rate for the level 2 and 3 E/M codes (CPT codes 99201-99203 and CPT codes 99211-99212, respectively), weighted by podiatric volume.

      (iv) Proposed Adjustment to the PE/HR Calculation

      As we explain in section II.B. Determination of Practice Expense (PE) Relative Value Units (RVUs), of this proposed rule, we generally allocate indirect costs for each code 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. Indirect expenses include administrative labor, office expense, and all other PEs that are not directly attributable to a particular service for a particular patient. Generally, the proportion of indirect PE allocated to a service is determined by calculating a PE/HR based upon the mix of specialties that bill for a service.

      As described earlier, E/M visits comprise a significant portion of allowable charges under the PFS and are used broadly across specialties such that our proposed changes can greatly impact the change in payment at the specialty level and at the practitioner level. Our proposals seek to simplify payment for E/M visit levels 2 through 5, and to additionally take into consideration that there are inherent differences in primary care-focused E/M services and in more complex E/

      M services such that those visits involve greater relative resources, while seeking to maintain overall payment stability across specialties. However, establishing a single PFS rate for new and established patient E/M levels 2 through-5 would have a large and unintended effect on many specialties due to the way that indirect PE is allocated based on the mixture of specialties that furnish a service. The single payment rates proposed for E/M levels 2 through 5 cannot reflect the indirect PE previously allocated differentially across those 8 codes. Historically, a broad blend of specialties and associated PE/HR has been used in the allocation of indirect PE and MP RVUs to E/M services to determine payment rates for these services. As this proposal significantly alters the PE/HR allocation for the office/outpatient E/M codes and any previous opportunities for the public to comment on the data would not have applied to these kinds of E/M services, we do not believe it is in the public interest to allow the allocation of indirect PE to have such an outsized impact on the payment rates for this proposal. Due to the magnitude of the proposed coding and payment changes for E/M visits, it is unclear how the distribution of specialties across E/M services would change. We are concerned that such changes could produce anomalous results for indirect PE allocations since we do not yet know the extent to which specialties would utilize the proposed simplified E/M codes and proposed G-codes. In the past, when utilization data are not

      Page 35844

      available or do not accurately reflect the expected specialty mix of a new service, we have proposed to crosswalk the PE/HR value from another specialty (76 FR 73036). As such, we are proposing to create a single PE/HR value for E/M visits (including all of the proposed HCPCS G-codes discussed above) of approximately $136, based on an average of the PE/

      HR across all specialties that bill these E/M codes, weighted by the volume of those specialties' allowed E/M services. We believe that this is consistent with the methodology used to develop the inputs for the proposed simplified E/M payment for the levels 2 through 5 E/M visit codes, and that, for purposes of consistency, the new PE/HR should be applied across the additional E/M codes. We believe a new PE/HR value would more accurately reflect the mix of specialties billing both the generic E/M code set and the add-on codes. If we finalize this proposal, we will consider revisiting the PE/HR after several years of claims data become available.

      (v) Proposed HCPCS G-Code for Prolonged Services

      Time is often an important determining factor in the level of care, which we consider in our proposal described earlier that physicians and other practitioners can use time as the basis for documenting and billing the appropriate level of E/M visit for purposes of Medicare payment. Currently there is inadequate coding to describe services where the primary resource of a service is physician time. CPT codes 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)) describe additional time spent face-to-face with a patient and may be billed when the applicable amount of time exceeds the typical service time of the primary procedure.

      Stakeholders have informed CMS that the ``first hour'' time threshold in the descriptor for CPT code 99354 is difficult to meet and is an impediment to billing these codes (81 FR 80228). In response to stakeholder feedback and as part of our proposal to implement a single payment rate for E/M visit levels 2 through 5 while maintaining payment accuracy across the specialties, we are proposing to create a new HCPCS code GPRO1 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; 30 minutes (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)). Given that the physician time of HCPCS code GPRO1 is half of the physician time assigned to CPT code 99354, we are proposing a work RVU of 1.17, which is half the work RVU of CPT code 99354.

      In order to estimate the potential impact of these proposed changes, we modeled the results of several options and examined the estimated resulting impacts in overall Medicare allowed charges by physician specialty. In order to isolate the potential impact of these changes from other concurrent proposed changes, we conducted this analysis largely using the code set, policies, and input data that we developed in establishing PFS rates for CY 2018. However, we used the suite of ratesetting programs that included several updates relevant for CY 2019 rulemaking. Consequently, we conducted our analysis regarding potential specialty-level impacts in order to identify the specialties with allowed charges most likely to be impacted by the potential change. We believe these estimates illustrate the magnitude of potential changes for certain physician specialties. However, because our modeling did not account for the full range of technical changes in the input data used in PFS ratesetting, the potential impacts for these isolated policies are relatively imprecise, especially compared to the specialty-level impacts displayed in section VII. of this proposed rule.

      Tables 21, 22, and 23 show the estimated changes, for certain physician specialties, and isolated from other proposed changes, in expenditures for PFS services based on potential changes for E/M coding and payment. We note that we are making additional data available to the public to inform our modeling on our E/M coding and payment proposals, available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

      Table 21--Unadjusted Estimated Specialty Impacts of Proposed Single RVU

      Amounts for Office/Outpatient E/M 2 Through 5 Levels

      ------------------------------------------------------------------------

      Estimated potential

      Allowed impact of valuing

      Specialty charges (in levels 2-5 together,

      millions) without additional

      adjustments

      ------------------------------------------------------------------------

      PODIATRY.......................... $2,022 12%.

      DERMATOLOGY....................... 3,525 7%.

      HAND SURGERY...................... 202 6%.

      OTOLARNGOLOGY..................... 1,220 5%.

      ORTHOPEDIC SURGERY................ 3,815 4%.

      ORAL/MAXILLOFACIAL SURGERY........ 57 4%.

      COLON AND RECTAL SURGERY.......... 168 Less than 3%

      estimated increase

      in overall payment.

      OBSTETRICS/GYNECOLOGY............. 664

      OPTOMETRY......................... 1,276

      PHYSICIAN ASSISTANT............... 2,253

      PLASTIC SURGERY................... 387

      ALLERGY/IMMUNOLOGY................ 240 Minimal change to

      overall payment.

      ANESTHESIOLOGY.................... 1,995

      AUDIOLOGIST....................... 67

      CARDIAC SURGERY................... 313

      Page 35845

      CHIROPRACTOR...................... 789

      CRITICAL CARE..................... 334

      EMERGENCY MEDICINE................ 3,196

      FAMILY PRACTICE................... 6,382

      GASTROENTEROLOGY.................. 1,807

      GENERAL PRACTICE.................. 461

      GENERAL SURGERY................... 2,182

      INFECTIOUS DISEASE................ 663

      INTERVENTIONAL PAIN MGMT.......... 839

      INTERVENTIONAL RADIOLOGY.......... 362

      MULTISPECIALTY CLINIC/OTHER PHYS.. 141

      NEUROSURGERY...................... 812

      NUCLEAR MEDICINE.................. 50

      NURSE PRACTITIONER................ 3,586

      OPHTHALMOLOGY..................... 5,542

      OTHER............................. 30

      PATHOLOGY......................... 1,151

      PHYSICAL MEDICINE................. 1,120

      PSYCHIATRY........................ 1,260

      RADIATION ONCOLOGY AND RADIATION 1,776

      THERAPY CENTERS.

      RADIOLOGY......................... 4,898

      THORACIC SURGERY.................. 360

      UROLOGY........................... 1,772

      VASCULAR SURGERY.................. 1,132

      CARDIOLOGY........................ 6,723 Less than 3%

      estimated decrease

      in overall payment.

      INTERNAL MEDICINE................. 11,173

      NEPHROLOGY........................ 2,285

      PEDIATRICS........................ 64

      PULMONARY DISEASE................. 1,767

      GERIATRICS........................ 214 -4%.

      RHEUMATOLOGY...................... 559 -7%.

      NEUROLOGY......................... 1,565 -7%.

      HEMATOLOGY/ONCOLOGY............... 1,813 -7%.

      ENDOCRINOLOGY..................... 482 -10%.

      -------------------------------------

      TOTAL......................... 93,486 0.

      ------------------------------------------------------------------------

      Table 21 characterizes the estimated overall impact for certain physician specialties, of establishing single payment rates for the new and established patient E/M code levels 2 through 5, without any of the additional coding or proposed payment adjustments, including the estimated percentage change for the specialties with an estimated increase or decrease in payment greater than 3 percent. Those specialties that tend to bill lower level E/M visits would benefit the most from the proposed change to single PFS payment rates, while those specialties that tend to bill more higher level E/M visits would see the largest decreases in payment with the change to a single PFS rate. The single payment rate for E/M code levels 2 through 5 would benefit podiatry the most because, due to the nature of most podiatric E/M visits, they tend to bill only level 2 and 3 E/M visits.

      Table 22--Specialty Specific Impacts Including Payment Accuracy

      Adjustments

      ------------------------------------------------------------------------

      Estimated potential

      Allowed impact of valuing

      Specialty charges (in levels 2-5 together,

      millions) with additional

      adjustments

      ------------------------------------------------------------------------

      OBSTETRICS/GYNECOLOGY............. $664 4%.

      NURSE PRACTITIONER................ 3,586 3%.

      HAND SURGERY...................... 202 Less than 3%

      estimated increase

      in overall payment.

      INTERVENTIONAL PAIN MGMT.......... 839

      OPTOMETRY......................... 1,276

      PHYSICIAN ASSISTANT............... 2,253

      PSYCHIATRY........................ 1,260

      UROLOGY........................... 1,772

      ANESTHESIOLOGY.................... 1,995 Minimal change to

      overall payment.

      CARDIAC SURGERY................... 313

      CARDIOLOGY........................ 6,723

      CHIROPRACTOR...................... 789

      Page 35846

      COLON AND RECTAL SURGERY.......... 168

      CRITICAL CARE..................... 334

      EMERGENCY MEDICINE................ 3,196

      ENDOCRINOLOGY..................... 482

      FAMILY PRACTICE................... 6,382

      GASTROENTEROLOGY.................. 1,807

      GENERAL PRACTICE.................. 461

      GENERAL SURGERY................... 2,182

      GERIATRICS........................ 214

      INFECTIOUS DISEASE................ 663

      INTERNAL MEDICINE................. 11,173

      INTERVENTIONAL RADIOLOGY.......... 362

      MULTISPECIALTY CLINIC/OTHER PHYS.. 141

      NEPHROLOGY........................ 2,285

      NEUROSURGERY...................... 812

      NUCLEAR MEDICINE.................. 50

      OPHTHALMOLOGY..................... 5,542

      ORAL/MAXILLOFACIAL SURGERY........ 57

      ORTHOPEDIC SURGERY................ 3,815

      OTHER............................. 30

      PATHOLOGY......................... 1,151

      PEDIATRICS........................ 64

      PHYSICAL MEDICINE................. 1,120

      PLASTIC SURGERY................... 387

      RADIOLOGY......................... 4,898

      THORACIC SURGERY.................. 360

      VASCULAR SURGERY.................. 1,132

      ALLERGY/IMMUNOLOGY................ 240 Less than 3%

      estimated decrease

      in overall payment.

      AUDIOLOGIST....................... 67

      HEMATOLOGY/ONCOLOGY............... 1,813

      NEUROLOGY......................... 1,565

      OTOLARNGOLOGY..................... 1,220

      PULMONARY DISEASE................. 1,767

      RADIATION ONCOLOGY AND RADIATION 1,776

      THERAPY CENTERS.

      RHEUMATOLOGY...................... 559 -3.

      DERMATOLOGY....................... 3,525 -4.

      PODIATRY.......................... 2,022 -4.

      -------------------------------------

      TOTAL......................... 93,486 0.

      ------------------------------------------------------------------------

      Table 22 characterizes the estimated overall impact for certain physician specialties, including the proposed adjustments have been made to reflect the distinctions in resource costs among certain types of E/M visits. In other words, Table 22 shows the proposed impacts of adopting the proposed single payment rates for new and established patient E/M visit levels 2 through 5, the application of a MPPR to E/M visits when furnished by the same practitioner (or practitioner in the same practice) on the same-day as a global procedure code, the add-on G-codes for primary care-focused services and inherent visit complexity, and the technical adjustments to the PE/HR value. Table 22 includes the estimated percentage change for the specialties with an estimated increase or decrease in payment greater than three percent. In our modeling, we assumed E/M visits for specialties that provide a significant portion of primary care like family practice, internal medicine, pediatrics and geriatrics utilized the G-code for visit complexity inherent to evaluation and management associated with primary medical care services with every office/outpatient visit furnished. Also for the purposes of our modeling, we assumed that specialties including endocrinology, rheumatology, hematology/oncology, urology, neurology, obstetrics/gynecology, allergy/immunology, otolaryngology, or interventional pain management-centered care utilized the G-code for visit complexity inherent to evaluation and management with every office/outpatient E/M visit. Table 22 does not include the impact of the use of the additional prolonged services code. The specialties that we estimate would experience a decrease in payments are those that bill a large portion of E/M visits on the same day as procedures, and would see a reduction based on the application of the MPPR adjustments. Some of these specialties, such as allergy/

      immunology and cardiology are also negatively impacted by the proposed single payment rates themselves, although not to the same degree as they would have been without any adjustments to provide alternate coding to reflect their resource costs, as illustrated in Table 21. The specialties that we estimate will see an increase in payments from these proposals, like psychiatry, nurse practitioner, and endocrinology, are seeing payment increases due to a combination of the single payment rate and the add-on codes for inherent visit complexity.

      As an example, in CY 2018, a physician would bill a level 4 E/M visit and document using the existing documentation framework for a level 4 E/M visit. Their payment rate would be approximately $109 in the office setting.

      Page 35847

      If these proposals are finalized, the physician would bill the same visit code for a level 4 E/M visit, documenting the visit according to the minimum documentation requirements for a level 2 E/M visit and/or based on their choice of using time, MDM, or the 1995 or 1997 guidelines, plus either of the proposed add-on codes (HCPCS codes GPC1X or GCG0X) depending on the type of patient care furnished, and could bill one unit of the proposed prolonged services code (HCPCS code GPRO1) if they meet the time threshold for this code. The combined payment rate for the generic E/M code and HCPCS code GPRO1 would be approximately $165 with HCPCS code GPC1X and approximately $177 with HCPCS code GCG0X.

      We welcome comments on all of these proposals.

      (vi) Alternatives Considered

      We considered a number of other options for simplifying coding and payment for E/M services to align with the proposed reduction in documentation requirements and better account for the resources associated with inherent complexity, visit complexity, and visits furnished on the same day as a 0-day global procedure. For example, we considered establishing single payment rates for new and established patients for combined E/M visit levels 2 through 4, as opposed to combined E/M visit levels 2 through 5. This option would have retained a separately valued payment rate for level 5 visits that would be reserved for the most complex visits or patients. However, maintaining a separately valued payment rate for this higher level visit based on the current CPT code definition has the consequence of preserving some of the current coding distinctions within the billing systems. Ultimately we believe that providing for two levels of payment and documentation (setting aside level 1 visits which are primarily visits by clinical staff) relieves more burden than three levels, and that two levels plus the proposed add-on coding more accurately captures the differential resource costs involved in furnishing E/M services to all patients. If we retained a coding scheme involving three or more levels of E/M visits, it would not be appropriate to apply a minimum documentation requirement as we propose to do. We would need to develop documentation requirements unique to each of the higher level visits. There would be a greater need for program integrity mechanisms to prevent upcoding and ensure that practitioners who chose to report the highest level visit justified their selection of code level. We could still simplify the documentation requirements for E/M visits relative to the current framework, but would need a more extensive, differential documentation framework than what we propose in this rule, in order to distinguish among visit levels. We are interested in stakeholder input on the best number of E/M visit levels and how to best achieve a balance between number of visit levels and simpler, updated documentation rules. We are seeking input as to whether these two aspects of our proposals together can reduce burden and ensure accurate payment across the broad range of E/M visits, including those for complex and high need beneficiaries.

      Table 23--Unadjusted Estimated Specialty Impacts of Single PFS Rate for

      Office/Outpatient E/M Levels 2 Through 4

      ------------------------------------------------------------------------

      Allowed

      Specialty charges Impact

      (millions) (percent)

      ------------------------------------------------------------------------

      Podiatry.................................... $2,022 10

      Dermatology................................. 3,525 6

      Hand Surgery................................ 202 5

      Oral/Maxillofacial Surgery.................. 57 4

      Otolaryngology.............................. 1,220 4

      Cardiology.................................. 6,723 -3

      Hematology/Oncology......................... 1,813 -3

      Neurology................................... 1,565 -3

      Rheumatology................................ 559 -6

      Endocrinology............................... 482 -8

      ------------------------------------------------------------------------

      Note: All other specialty level impacts were within +/- 3%.

      Table 23 shows the specialties that would experience the greatest increase or decrease by establishing single payment rates for E/M visit levels 2 through 4, while maintaining the value of the level 1 and the level 5 E/M visits. The specialty level impacts are similar to those in Table 21 as the specialties that bill more higher level visits do not benefit by maintaining a distinct payment for the level 5 visit as much as they experience a reduction in the rate for a level 4 visit. Similarly, the specialties that bill predominantly lower level visits would still benefit disproportionally to the increase in rate for the level 2 and level 3 visits.

      Section 101(f) of the MACRA, enacted on April 16, 2015, added a new subsection (r) under section 1848 of the Act entitled Collaborating with the Physician, Practitioner, and Other Stakeholder Communities to Improve Resource Use Measurement. Section 1848(r) of the Act requires the establishment and use of classification code sets: Care episode and patient condition groups and codes; and patient relationship categories and codes. As described in the CY 2018 PFS final rule, we finalized use of Level II HCPCS Modifiers as the patient relationship codes and finalized that Medicare claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, should include the applicable patient relationship codes, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). We noted that for CY 2018, reporting of the patient relationship modifiers would be voluntary and the use and selection of the modifiers would not be a condition of payment (82 FR 53234). The patient relationship codes are as follows: X1: Continuous/broad; X2: Continuous/focused; X3: Episodic/focused; X4: Episodic/broad; and X5: Only as ordered by another physician. These codes are to be used to help define and distinguish the relationship and responsibility of a clinician with a patient at the time of furnishing an item or service, facilitate the attribution of patients and episodes to one or more clinicians, and to allow clinicians to self-identify their patient relationships.

      We considered proposing the use of these codes to adjust payment for E/M visits to the extent that these codes are indicative of differentiated resources provided in E/M visits, and we considered using these codes as an alternative to the proposed use of G-codes to reflect visit complexity inherent to evaluation and management in primary care and certain other specialist services, as a way to more accurately reflect the resource costs associated with furnishing different kinds of E/M visits. We are seeking comment on this alternative. We are particularly interested in whether the modifiers would accurately reflect the differences between resources for E/M visits across specialties and would therefore be useful to adjust payment differentially for the different types of E/M visits that we previously identified.

    8. Emergency Department and Other E/M Visit Settings

      As we mentioned above, the E/M visit code set is comprised of individual subsets of codes that are specific to various clinical settings including office/outpatient, observation, hospital inpatient, emergency department, critical care, nursing facility, domiciliary or rest home, and home services. Some of these code subsets have three E/M levels of care, while

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      others have five. Some of these E/M code subsets distinguish among levels based heavily on time, while others do not. Recent public comments have asserted that some E/M code subsets intersect more heavily than others with hospital conditions of participation (CoP). For example, the American Psychiatric Association (APA) submitted a letter to CMS indicating that Medicare requires specific documentation in the medical record as part of the CoPs for inpatient psychiatric facilities. The APA believed that the required initial psychiatric evaluation for inpatients currently closely follows the E/M criteria for CPT codes 99221-99223, which are the codes that would be used to bill for these services. The APA stated that any changes in these E/M codes, without corresponding changes in the CoPs, could lead to the unintended consequence of adding to the burden of documentation by essentially requiring two different sets of data or areas of focus to be included, or two different documentation formats being required.

      Regarding emergency department visits (CPT codes 99281-99285), we received more recent feedback through our coordinated efforts with ONC this year, emphasizing that these codes may benefit from a coding or payment compression into fewer levels of codes, or that documentation rules may need to be reduced or altered. However, in public comments to the CY 2018 PFS proposed rule, commenters noted several issues unique to the emergency department setting that we believe require further consideration. For example, commenters stated that intensity, and not time, is the main determinant of code level in emergency departments. They requested that CMS use caution in changing required elements for documentation so that medical information used for legal purposes (for example, meeting the prudent layperson standard) is not lost. They urged caution and requested that CMS not immediately implement any major changes. They recommended refocusing documentation on presenting conditions and medical decision-making. Some commenters were supportive of leaving it largely to the discretion of individual practitioners to determine the degree to which they should perform and document the history and physical exam in the emergency department setting. Other commenters suggested that CMS encourage use of standardized guidelines and minimum documentation requirements to facilitate post-treatment evaluation, as well as analysis of records for various clinical, legal, operational and other purposes. The commenters discussed the importance of extensive histories and exams in emergency departments, where usually there is no established relationship with the patient and differential diagnosis is critical to rule out many life-threatening conditions. They were cognizant of the need for a clear record of services rendered and the medical necessity for each service, procedure, diagnostic test, and MDM performed for every patient encounter.

      In addition, although the RUC is in the process of revaluing this code set, some commenters stated that the main issue is not that the emergency department visit codes themselves are undervalued. Rather, these commenters believed that a greater percentage of emergency department visits are at a higher acuity level, yet payers often do not pay at a higher level of care and the visit is often inappropriately down-coded based on retrospective review. These commenters believed that the documentation needed to support a higher level of care is too burdensome or subjective. In addition, it seems that policy proposals regarding emergency department visits billed by physicians might best be coordinated with parallel changes to payment policy for facility billing of these codes, which would require more time and analyses.

      Accordingly, we are not proposing any changes to the emergency department E/M code set or to the E/M code sets for settings of care other than office-based and outpatient settings at this time. However, we are seeking public comment on whether we should make any changes to it in future years, whether by way of documentation, coding, and/or payment and, if so, what the changes should be.

      Consistent with public feedback to date, we are taking a step-wise approach and limiting our policy proposals this year to the office/

      outpatient E/M code set (and the limited proposal above regarding documentation of medical necessity for home visits in lieu of office visits). We may consider expanding our efforts more broadly to additional sections of the E/M visit code set in future years, and are seeking public comment broadly on how we might proceed in this regard.

    9. Proposed Implementation Date

      We propose that these proposed E/M visit policies would be effective January 1, 2019. However, we are sensitive to commenters' suggestions that we should consider a multi-year process and proceed cautiously, allowing adequate time to educate practitioners and their staff; and to transition clinical workflows, EHR templates, institutional processes and policies (such as those for provider-based practitioners), and other aspects of practitioner work that would be impacted by these policy changes. Our proposed documentation changes for office/outpatient E/M visits would be optional, and practitioners could choose to continue to document these visits using the current framework and rules, which may reduce the need for a delayed implementation. Nevertheless, practitioners who choose a new documentation framework may need time to deploy it. A delayed implementation date for our documentation proposals would also allow the AMA time to develop changes to the CPT coding definitions and guidance prior to our implementation, such as changes to MDM or code definitions that we could then consider for adoption. It would also allow other payers time to react and potentially adjust their policies. Accordingly, we are seeking comment on whether a delayed implementation date, such as January 1, 2020, would be appropriate for our proposals.

  32. Teaching Physician Documentation Requirements for Evaluation and Management Services

    1. Background

    Per 42 CFR part 415, subpart D, Medicare Part B makes payment under the PFS for teaching physician services when certain conditions are met, including that medical record documentation must reflect the teaching physician's participation in the review and direction of services performed by residents in teaching settings. Under Sec. 415.172(b), for certain procedural services, the participation of the teaching physician may be demonstrated by the notes in the medical records made by a physician, resident, or nurse; and for E/M visits, the teaching physician is required to personally document their participation in the medical record. We received stakeholder feedback suggesting that documentation requirements for E/M services furnished by teaching physicians are burdensome and duplicative of notations that may have previously been included in the medical records by residents or other members of the medical team.

    2. Proposed Implementation

    We are proposing to revise our regulations to eliminate potentially duplicative requirements for notations that may have previously been included in the medical records by residents or

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    other members of the medical team. These proposed changes are intended to align and simplify teaching physician E/M service documentation requirements. We believe these proposed changes will reduce burden and duplication of effort for teaching physicians. We are proposing to amend Sec. 415.172(b) to provide that, except for services furnished as set forth in Sec. Sec. 415.174 (concerning an exception for services furnished in hospital outpatient and certain other ambulatory settings), 415.176 (concerning renal dialysis services), and 415.184 (concerning psychiatric services), the medical records must document that the teaching physician was present at the time the service is furnished. Additionally, the revised paragraph would specify that the presence of the teaching physician during procedures and evaluation and management services may be demonstrated by the notes in the medical records made by a physician, resident, or nurse. We are also proposing to amend Sec. 415.174, by deleting paragraph (a)(3)(v) which currently requires the teaching physician to document the extent of their participation in the review and direction of the services furnished to each beneficiary, and adding new paragraph (a)(6), to provide that the medical record must document the extent of the teaching physician's participation in the review and direction of services furnished to each beneficiary, and that the extent of the teaching physician's participation may be demonstrated by the notes in the medical records made by a physician, resident, or nurse.

  33. Solicitation of Public Comments on the Low Expenditure Threshold Component of the Applicable Laboratory Definition Under the Medicare Clinical Laboratory Fee Schedule (CLFS)

    Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for clinical diagnostic laboratory tests (CDLTs) under the CLFS. The CLFS final rule titled, Medicare Clinical Diagnostic Laboratory Tests Payment System final rule (CLFS final rule), published in the Federal Register on June 23, 2016, implemented section 1834A of the Act. Under the CLFS final rule (81 FR 41036), ``reporting entities'' must report to CMS during a ``data reporting period'' ``applicable information'' (that is, certain private payer data) collected for a ``data collection period'' for their component ``applicable laboratories.'' In general, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected for the 6-month data collection period and reported to us in the 3-month data reporting period, and is equal to the weighted median of the private payor rates for the CDLT.

    An applicable laboratory is defined at Sec. 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at Sec. 493.2) that bills Medicare Part B under its own National Provider Identifier (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the PFS. We refer to this component of the applicable laboratory definition as the ``majority of Medicare revenues threshold.'' The definition of applicable laboratory also includes a ``low expenditure threshold'' component, which requires an entity to receive at least $12,500 of its Medicare revenues from the CLFS in a data collection period for its CDLTs that are not advanced diagnostic laboratory tests (ADLTs).

    We established $12,500 as the low expenditure threshold because we believed it achieved a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for laboratories that receive a relatively small amount of revenues under the CLFS. In the CLFS final rule (81 FR 41051), we estimated that 95 percent of physician office laboratories and 55 percent of independent laboratories would not be required to report applicable information under our low expenditure threshold criterion. Although we substantially reduced the number of laboratories qualifying as applicable laboratories (that is, approximately 5 percent of physician office laboratories and approximately 45 percent of independent laboratories) we estimated that the percentage of Medicare utilization would remain high. That is, approximately 5 percent of physician office laboratories would account for approximately 92 percent of CLFS spending on physician office laboratories and approximately 45 percent of independent laboratories would account for approximately 99 percent of CLFS spending on independent laboratories (81 FR 41051).

    Recently, we have heard from some laboratory stakeholders that the low expenditure threshold excludes most physician office laboratories and many small independent laboratories from reporting applicable information, and that by excluding so many laboratories, the payment rates under the new private payor rate-based CLFS reflects incomplete data, and therefore, inaccurate CLFS pricing. However, it is our understanding that physician offices are generally not prepared to identify, collect, and report each unique private payor rate from each private payor for each laboratory test code on the CLFS and the volume associated with each unique private payor rate. As such, we believe revising the low expenditure threshold so that more physician office laboratories are required to report applicable information would be a very significant administrative burden on physician's offices. We also believe that increasing participation from physician office laboratories would have minimal overall impact on payment rates given that the weighted median of private payor rates is dominated by the laboratories with the largest test volume.

    However, we recognize from stakeholders that some physician office laboratories and small independent laboratories that are not applicable laboratories because they do not meet the current low expenditure threshold may still want to report applicable information, despite the administrative burden associated with qualifying as an applicable laboratory. Therefore, we are seeking public comments on reducing the low expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS revenues during a data collection period. Since more physician office laboratories would meet the low expenditure threshold, we would expect such an approach to increase the level of applicable information reported by physician office laboratories and small independent laboratories. We are seeking public comments regarding the potential administrative burden on physician office laboratories and small independent laboratories that would result from reducing the low expenditure threshold. We are also soliciting public comments on an approach that would increase the low expenditure threshold by 50 percent, from $12,500 to $18,750, in CLFS revenues received in a data collection period. Since fewer physician office laboratories and small independent laboratories would meet the definition of applicable laboratory, we would expect such an approach to result in a decreased level of applicable information reported. For a complete discussion of our solicitation of comments on the low expenditure threshold component of the definition

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    of applicable laboratory under the Medicare CLFS, we refer readers to section III.A. of this proposed rule.

    L. GPCI Comment Solicitation

    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)(D) of the Act requires us to establish the GPCIs using the most recent data available. The last GPCI update was implemented in CY 2017; therefore, we are required to review and make any necessary revisions to the GPCIs for CY 2020. 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). Some stakeholders have continued to express concerns regarding some of the data sources used in developing the indices for PFS geographic adjustment purposes, specifically that we use residential rent data as a proxy for commercial rent in the rent index component of the PE GPCI--that is, the data that are used to develop the office rent component of the PE GPCI. We will continue our efforts to identify a nationally representative commercial rent data source that could be made available to CMS. In support of that effort, we are particularly interested in, and seek comments regarding potential sources of commercial rent data for potential use in the next GPCI update for CY 2020.

  34. Therapy Services

    1. Repeal of the Therapy Caps and Limitation To Ensure Appropriate Therapy

    Section 50202 of the Bipartisan Budget Act of 2018 (BBA of 2018) amended section 1833(g) of the Act, effective January 1, 2018, to repeal the application of the Medicare outpatient therapy caps and the therapy cap exceptions process while retaining and adding limitations to ensure therapy services are furnished when appropriate. Section 50202 also adds section 1833(g)(7)(A) of the Act to require 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 such as the KX modifier on claims for subsequent services in order for Medicare to pay for the services. We implemented this provision by continuing to use the KX modifier. By applying the KX modifier to the claim, the therapist or therapy provider is confirming that the services are medically necessary as justified by appropriate documentation in the medical record. Just 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). For CY 2018, this KX modifier threshold amount is $2,010 for PT and SLP services combined, and $2,010 for OT 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.

    Along with the KX modifier thresholds, section 50202 also adds section 1833(g)(7)(B) of the Act that retains the targeted medical review (MR) process (first established through section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)), but at a lower threshold amount of $3,000. 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. The targeted MR process means that not all claims exceeding the MR threshold amount are subject to review as they once were.

    Section 1833(g)(8) of the Act, as redesignated by section 50202 of the BBA of 2018, retains the provider liability procedures which first became effective January 1, 2013, extending limitation of liability protections to beneficiaries who receive outpatient therapy services, when services are denied for certain reasons, including failure to include a necessary KX modifier.

    2. Proposed Payment for Outpatient PT and OT Services Furnished by Therapy Assistants

    Section 53107 of the Bipartisan Budget Act of 2018 (BBA of 2018) amended the Act to add a new subsection 1834(v) that addresses payment for outpatient therapy services for which payment is made under section 1848 or section 1834(k) of the Act that are furnished on or after January 1, 2022, in whole or in part by a therapy assistant (as defined by the Secretary). The new section 1834(v)(1) of the Act provides for payment of those services at 85 percent of the otherwise applicable Part B payment amount for the service. In accordance with section 1834(v)(1) of the Act, the reduced payment amount for such outpatient therapy services is applicable when payment is made directly under the PFS as specified in section 1848 of the Act, for example when payment is made to therapists in private practice (TPPs); and when payment is made based on the PFS as specified in section 1834(k)(3) of the Act, for example, when payment is made for outpatient therapy services identified in sections 1833(a)(8) and (9) of the Act, including payment to providers that submit institutional claims for therapy services such as outpatient hospitals, rehabilitation agencies, skilled nursing facilities, home health agencies and comprehensive outpatient rehabilitation facilities (CORFs). The reduced payment rate under section 1834(v)(1) of the Act for outpatient therapy services when furnished in whole or in part by a therapy assistant is not applicable to outpatient therapy services furnished by critical access hospitals for which payment is made as specified in section 1834(g) of the Act.

    To implement this payment reduction, section 1834(v)(2)(A) of the Act requires us to establish a new modifier, in a form and manner specified by the Secretary, by January 1, 2019 to indicate, in the case of an outpatient therapy service furnished in whole or in part by a therapy assistant, that the service was furnished by a therapy assistant. Although we generally consider all genres of outpatient therapy services together (PT/OT/SLP), we do not believe there are ``therapy assistants'' in the case of SLP services, so we propose to apply the new modifier only to services furnished in whole or in part by a physical therapist assistant (PTA) or an occupational therapist assistant (OTA). Section 1834(v)(2)(B) of the Act requires that each request for payment or bill submitted for an outpatient PT or OT service furnished in whole or in part by a therapy assistant on or after January 1, 2020, must include the established modifier. As such, the modifier will be required to be reported on claims for outpatient PT and OT services with dates of service on and after January 1, 2020, when the service is furnished in whole or in part by a therapy assistant, regardless of whether the reduced payment under section 1834(v)(1) of the Act is applicable. However, the required payment reductions do not apply for these services until January 1, 2022, as required by section 1834(v)(1) of the Act.

    To implement this provision, we are proposing to establish two new modifiers to separately identify PT and OT services that are furnished in whole or in part by PTAs and OTAs,

    Page 35851

    respectively. We are proposing to establish two modifiers because the incurred expenses for PT and OT services are tracked and accrued separately in order to apply the two different KX modifier threshold amounts as specified by section 1833(g)(2) of the Act; and the use of the two proposed modifiers will facilitate appropriate tracking and accrual of services furnished in whole or in part by PTAs and OTAs. We additionally propose that these two therapy modifiers would be added to the existing three therapy modifiers--GP, GO, and GN--that are currently used to identify all therapy services delivered under a PT, OT or SLP plan of care, respectively. The GP, GO, and GN modifiers have existed since 1998 to track outpatient therapy services that were subject to the therapy caps. Although the therapy caps were repealed through amendments made to section 1833(g) of the Act by section 50202 of the BBA of 2018, as discussed in the above section, the statute continues to require that we track and accrue incurred expenses for all PT, OT, and SLP services, including those above the specified per beneficiary amounts for medically necessary therapy services for each calendar year; one amount for PT and SLP services combined, and another for OT services.

    For purposes of implementing section 1834(v) of the Act through rulemaking as required under section 1834(v)(2)(C) of the Act, we are proposing to define ``therapy assistant'' as an individual who meets the personnel qualifications set forth at Sec. 484.4 of our regulations for a physical therapist assistant and an occupational therapy assistant (PTA and OTA, respectively). We are proposing that the two new therapy modifiers would be used to identify services furnished in whole or in part by a PTA or an OTA; and, that these new therapy modifiers would be used instead of the GP and GO modifiers that are currently used to report PT and OT services delivered under the respective plan of care whenever the service is furnished in whole or in part by a PTA or OTA.

    Effective for dates of service on and after January 1, 2020, the new therapy modifiers that identify services furnished in whole or in part by a PTA or OTA would be required to be used on all therapy claims instead of the existing modifiers GP and GO, respectively. As a result, in order to implement the provisions of the new subsection 1834(v) of the Act and carry out the continuing provisions of section 1833(g) of the Act as amended, we are proposing that, beginning in CY 2020, five therapy modifiers be used to track outpatient therapy services instead of the current three. These five therapy modifiers include two new therapy modifiers to identify PT and OT services furnished by PTAs and OTAs, respectively, and three existing therapy modifiers--GP, GO and GN--that will be used when PT, OT, and SLP services, respectively, are fully furnished by therapists or when fully furnished by or incident to physicians and NPPs.

    The creation of therapy modifiers specific to PT or OT services delivered under a plan of care furnished in whole or in part by a PTA or OTA would necessitate that we make changes to the descriptors of the existing GP and GO modifiers to clarify which qualified professionals, for example, therapist, physician, or NPP, can furnish the PT and OT services identified by these modifiers, and to differentiate them from the therapy modifiers specific to the services of PTAs and OTAs. We also propose to revise the GN modifier descriptor to conform to the changes to the GP and GO modifiers by clarifying the qualified professionals that furnish SLP therapy services.

    We are proposing to define the new therapy modifiers for services furnished in whole or in part by therapy assistants and to revise the existing therapy modifier descriptors as follows:

    New--PT Assistant services modifier (to be used instead of the GP modifier currently reported when a PTA furnishes services in whole or in part): Services furnished in whole or in part by a physical therapist assistant under an outpatient physical therapy plan of care;

    New--OT Assistant services modifier (to be used instead of the GO modifier currently reported when an OTA furnishes services in whole or in part): Services furnished in whole or in part by occupational therapy assistant under an outpatient occupational therapy plan of care;

    We are proposing that the existing GP modifier ``Services delivered under an outpatient physical therapy plan of care'' be revised to read as follows:

    Revised GP modifier: Services fully furnished by a physical therapist or by or incident to the services of another qualified clinician--that is, physician, nurse practitioner, certified clinical nurse specialist, or physician assistant--under an outpatient physical therapy plan of care;

    We are proposing that the existing GO modifier ``Services delivered under an outpatient occupational therapy plan of care'' be revised to read as follows:

    Revised GO modifier: Services fully furnished by an occupational therapist or by or incident to the services of another qualified clinician--that is, physician, nurse practitioner, certified clinical nurse specialist, or physician assistant--under an outpatient occupational therapy plan of care; and

    We are proposing that the existing GN modifier that currently reads ``Services delivered under an outpatient speech-language pathology plan of care'' be revised to be consistent with the revisions to the GP and GO modifiers to read as follows:

    Revised GN modifier: Services fully furnished by a speech-

    language pathologist or by or incident to the services of another qualified clinician--that is, physician, nurse practitioner, certified clinical nurse specialist, or physician assistant--under an outpatient speech-language pathology plan of care.

    As finalized in CY 2005 PFS final rule with comment (69 FR 66351 through 66354), and as required as a condition of payment under our regulations at Sec. Sec. 410.59(a)(3)(iii), 410.60(a)(3)(iii), and 410.62(a)(3)(iii), the person furnishing outpatient therapy services incident to the physician, PA, NP or CNS service must meet the therapist personnel qualification and standards at Sec. 484.4, except for licensure per section 1862(a)(20) of the Act. As such, we note that only a therapist, not a therapy assistant, can furnish outpatient therapy services incident to the services of a physician or a non-

    physician practitioner (NPP), so the new PT- and OT-Assistant therapy modifiers cannot be used on the line of service when the rendering practitioner identified on the claim is a physician or an NPP. For therapy services billed by physicians or NPPs, whether furnished personally or incident to their professional services, the GP or GO modifier is required for those PT or OT services furnished under an outpatient therapy plan.

    We propose that all services that are furnished ``in whole or in part'' by a PTA or OTA are subject to the use of the new therapy modifiers. A new therapy modifier would be required to be used whenever a PTA or OTA furnishes all or part of any covered outpatient therapy service. However, we do not believe the provisions of section 1834(v) of the Act were intended to apply when a PTA or OTA performs portions of the service such as administrative tasks that are not related to their qualifications as a PTA or OTA. Rather, we believe the provisions of section 1834(v) were meant to apply when a PTA or OTA is involved in providing some or all of the therapeutic portions of an outpatient therapy service. We are proposing to define ``in part,'' for purposes of the proposed new modifiers, to mean any

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    minute of the outpatient therapy service that is therapeutic in nature, and that is provided by the PTA or OTA when acting as an extension of the therapist. Therefore, a service furnished ``in part'' by a therapy assistant would not include a service for which the PTA or OTA furnished only non-therapeutic services that others without the PTA's or OTA's training can do, such as scheduling the next appointment, greeting and gowning the patient, preparing or cleaning the room. We remind therapists and therapy providers that we do not recognize PTAs and OTAs to wholly furnish PT and OT evaluations and re-evaluations, that is, CPT codes 97161 through 97164 for PT and CPT codes 97165 through 97168 for OT; but to the extent that they do furnish part of an evaluative service, the appropriate therapy modifier must be used on the claim to signal that the service was furnished in part by the PTA or OTA, and the payment reduction should be applied once it goes into effect. We continue to believe that the clinical judgment and decision making involved in furnishing an evaluation or re-evaluation is similar to that involved with establishing the therapy plan that can only be established by a therapist, physician, or NPP (NP, CNS, or PA) as specified in Sec. 410.61 of our regulations. In addition, PTAs and OTAs are not recognized separately in the statute to enroll as practitioners for purposes of independently billing for their services under the Medicare program. For these reasons, Pub. 100-02, Medicare Benefits Policy Manual, Chapter 15, sections 230.1 and 230.2 state that PTAs and OTAs ``. . . may not provide evaluative or assessment services, make clinical judgments or decisions; develop, manage, or furnish skilled maintenance program services; or take responsibility for the service.'' While we expect that the therapist will continue to furnish the majority of an evaluative procedure service, section 1834(v)(1) of the Act requires that the adjusted payment amount (85 percent of the otherwise applicable Part B payment amount) be applied when a therapy assistant furnishes a therapy service ``in part,'' including part of an evaluative service.

    Additionally, we would like to clarify that the requirements for evaluations, including those for documentation, are separate and distinct from those for plans of care (plans). The plan is a statutory requirement under section 1861(p) of the Act for outpatient PT services (and through sections 1861(g) and 1861(ll)(2) of the Act for outpatient OT and SLP services, respectively) and may only be established by a therapist or physician. Through Sec. 410.61(b)(5), NPs, CNSs, and PAs are also permitted to establish the plan. This means that if the evaluative procedure is furnished in part by an assistant, the new therapy modifiers that distinguish services furnished by PTAs or OTAs must be applied to the claim; however, the plan, which is not separately reported or paid, must be established by the supervising therapist who furnished part of the evaluation services as specified at Sec. 410.61(b). When an evaluative therapy service is billed by a physician or an NPP as the rendering provider, either the physician/NPP or the therapist furnishing the service incident to the services of the physician or NPP, may establish the therapy plan in accordance with Sec. 410.61(b). All regulatory and subregulatory plan requirements continue to apply.

    To implement the new statutory provision at section 1834(v)(2)(A) of the Act, we are proposing to establish two new therapy modifiers to identify the services furnished in whole or in part by PTAs and OTAs. As required under section 1834(v)(2)(B) of the Act, claims from all providers of PT and OT services furnished on and after January 1, 2020, will be required to include these new PT- and OT-Assistant therapy modifiers for services furnished in whole or in part by a PTA or OTA. We propose that these modifiers will be required, when applicable, in place of the GP and GO modifiers currently used to identify PT and OT services furnished under an outpatient plan of care. To test our systems ahead of the required implementation date of January 1, 2020, we anticipate allowing voluntary reporting of the new modifiers at some point during CY 2019, which we will announce to our contractors and therapy providers through a Change Request, as part of our usual change management process.

    We seek comments on these proposals.

    3. Proposed Functional Reporting Modifications

    Since January 1, 2013, all providers of outpatient therapy services, including PT, OT, and SLP services, have been required to include functional status information on claims for therapy services. In response to the Request for Information (RFI) on CMS Flexibilities and Efficiencies that was issued in the CY 2018 PFS proposed rule (82 FR 34172 through 34173), we received comments requesting burden reduction related to the reporting of the functional reporting requirements that were adopted to implement the requirements of section 3005(g) of the Middle Class Tax Relief and Jobs Creation Act (MCTRJCA) of 2012, effective January 1, 2013.

    After considering comments received through the CY 2013 PFS final rule with comment period (77 FR 68598-68978), we finalized the design of the functional reporting system. The MCTRJCA required us to implement a claims-based data collection strategy in order to collect data on patient function over the course of PT, OT, and SLP services in order to better understand patient condition and outcomes. The functional reporting system we implemented collects data using non-

    payable HCPCS G-codes (HCPCS codes G8978 through G8999 and G9158 through G9186) and modifiers (in the range CH through CN) to describe a patient's functional limitation and severity at: (a) The time of the initial service, (b) at periodic intervals in sync with existing progress reporting intervals, (c) at discharge, and (d) when reporting certain evaluative and re-evaluative procedures (often times billed at time of initial service). Claims without the required functional reporting information are returned to therapy services providers, rather than denied, so that they can add the required information and resubmit claims. Therapy services providers must also document functional reporting information in the patient's medical record each time it is reported. The MCTRJCA also specified that data from the functional reporting system were to be used to aid us in recommending changes to, and reforming Medicare payment for outpatient therapy services that were then subject to the therapy caps under section 1833(g) of the Act. We conducted an analysis that focused on the functional reporting data that have been submitted through the claims-

    based system, both by therapy discipline and by episodes of care by discipline using a similar episode definition (for example, clean 60 calendar day period) that was used in our prior utilization reports for CY 2008 through CY 2010 that can be found on the Therapy Services web page in the Studies and Reports page at https://www.cms.gov/Medicare/Billing/TherapyServices/Studies-and-Reports.html). However, we did not find the results compelling enough to use as a basis to recommend or undertake administrative reforms of the current payment mechanism for therapy services. Furthermore, going forward, the functional reporting data we would collect may be even less useful for purposes of recommending or reforming payment for therapy services because, as described earlier, section 50202 of the

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    Bipartisan Budget Act of 2018 (BBA of 2018) amended section 1833(g) of the Act to repeal the application of the Medicare outpatient therapy caps and associated exceptions process, while imposing protections to ensure therapy services are furnished when appropriate.

    The general consensus of the commenters (organizations of physical therapists, occupational therapists, and speech-language pathologists, as well as other organizations of providers of therapy services and individual stakeholders) who responded to our RFI on burden reduction was that the functional reporting requirements for outpatient therapy services are overly complex and burdensome. The majority of commenters urged us to substantially revise and repurpose our functional reporting requirements for other programmatic purposes or to eliminate the functional reporting requirements all together. Most commenters to the RFI on burden reduction criticized us for not having shared with them an analysis of the functional reporting data we had collected to date, even though MCTRJCA does not require that we share any such analysis. A couple of commenters recommended we evolve our functional reporting requirements, at least in the short-term, with the following three changes: (a) Require reporting only at intake and discharge; (b) permit reporting through clinical data registries, electronic health records (EHRs), facility-based submission vehicles, etc., instead of the claims-based reporting required by section 3005(g) of MCTRJCA; and (c) allow functional reporting by therapy providers under MIPS as a clinical practice improvement activity. The short-term recommendation for reduced reporting was based on an independent analysis by one specialty society using a sample of our CY 2014 claims. That analysis noted that over an episode of care: (a) 93 percent reported when an evaluation code was reported; (b) 12 percent to 16 percent reported at the time of progress reporting interval; and (c) 36 percent of the episodes reported discharge data. In the long-term, these same RFI commenters believe our functional reporting system should be eliminated in favor of CMS policies that move therapy providers toward reporting using standardized measures of function. Other commenters suggested that we use standardized measures that reflect global function, or that are condition-specific. Some commenters would like to see CMS develop setting-appropriate quality measures for outpatient therapy that can be used to both (a) measure functionality and (b) meld patient assessment data and functional measures with relevant measures developed in response to the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act of 2014) (Pub. L. 113-185) that is applicable to CMS post-acute care (PAC) settings.

    As part of the requirements of section 3005(g) of MCTRJCA, we established our functional reporting claims-based data collection strategy effective January 1, 2013 in the CY 2013 PFS final rule (77 FR 689580 through 68978) and will have been collecting these functional reporting data for the last 5 years at the close of CY 2018. Because the data from the functional reporting system were to be used to inform our recommendations and reform of Medicare payment for outpatient therapy services that are subject to the therapy caps under section 1833(g) of the Act, we reviewed and analyzed the data internally but did not find them particularly useful in considering how to reform payment for therapy services as an alternative to the therapy caps. In the meantime, section 50202 of BBA of 2018, as discussed previously, amended section 1833(g) of the Act to reform therapy payment. Because section 3005(g) of MCTRJCA was not codified into the Act, and did not specify how long the data collection strategy should last, we do not believe it was intended to last indefinitely. We note that we share commenters' concerns, including those who favor the elimination of functional reporting because it is overly complex and burdensome to report, and that those that questioned the utility of the collected data given the lack of standardized measures used to report the severity of the functional limitation being reported. In response to commenters' concerns that we have not yet shared an analysis of the collected functional reporting data with them, we note that we have not published or shared the results to date because we did not find the results informative when reviewing them for purpose of the section 3005(g) of MCTRJCA requirement. A few commenters requested that we continue to collect functional reporting data in a reduced format--at the outset and at discharge of the therapy episode--as a collective short-term solution, while favoring the elimination of functional reporting in the long-term because, according to our data and the commenters' own data, the discharge data are only infrequently reported. However, we do not believe that collecting additional years of functional reporting data in this reduced format would add utility to our data collection efforts. After consideration of these comments on the RFI along with a review of all of the requirements under section 3005(g) of MCTRJCA, and in light of the recent statutory amendments to section 1833(g) of the Act, we have concluded that continuing to collect more years of these functional reporting data, whether through the same or a reduced format, will not yield additional information that would be useful to inform future analyses, and that allowing the current functional reporting requirements to remain in place could result in unnecessary burden for providers of therapy services without providing further benefit to the Medicare program in the form of additional data.

    As a result, we are proposing to discontinue the functional reporting requirements for services furnished on or after January 1, 2019. Specifically, we are proposing to amend our regulations by removing the following: (1) Conditions of payment at Sec. Sec. 410.59(a)(4), 410.60(a)(4), 410.62(a)(4), and 410.105(d) that require claims for OT, PT, SLP, and Comprehensive Outpatient Rehabilitation Facility (CORF) PT, OT, and SLP services, respectively, to contain prescribed information on patient functional limitations; and, (2) the functional reporting-related phrase that requires the plan's goals to be consistent with functional information on the claim at Sec. 410.61(c) for outpatient PT, OT, and SLP services and at Sec. 410.105(c)(1)(ii) for the PT, OT, and SLP services in CORFs. In addition, we would: (1) Remove the functional reporting subregulatory requirements implemented primarily through Change Request 8005 last issued on December 21, 2012, via Transmittal 2622; (2) eliminate the functional reporting standard systems edits we have applied to claims; and (3) remove the functional reporting requirement provisions in our internet Only Manual (IOM) provisions including the Medicare Claims Processing Manual, Chapter 5; and, the functional reporting requirements in Chapters 12 and 15 of the Medicare Benefits Policy Manual.

    If finalized, our proposal would end the requirements for the reporting and documentation of functional limitation G-codes (HCPCS codes G8978 through G8999 and G9158 through G9186) and severity modifiers (in the range CH through CN) for outpatient therapy claims with dates of service on and after January 1, 2019. Accordingly, with the conclusion of our functional reporting system for dates of service after

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    December 31, 2018, we would delete the applicable non-payable HCPCS G-

    codes specifically developed to implement that system through the CY 2013 PFS final rule with comment period (77 FR 68598 through 68978).

    We are seeking comment on these proposals.

  35. Part B Drugs: Application of an Add-On Percentage for Certain Wholesale Acquisition Cost (WAC)-Based Payments

    Consistent with statutory provisions in section 1847A of the Act, many current Medicare Fee For Service (FFS) payments for separately payable drugs and biologicals furnished by providers and suppliers include an add-on set at 6 percent of the volume-weighted average sales price (ASP) or wholesale acquisition cost (WAC) for the drug or biological (the ``6 percent add-on''). Although section 1847A of the Act does not specifically state what the 6 percent add-on represents, it is widely believed to include services associated with drug acquisition that are not separately paid for, such as handling, and storage, as well as additional mark-ups in drug distribution channels. The 6 percent add-on described in section 1847A of the Act has raised concerns because more revenue can be generated from percentage-based add-on payments for expensive drugs, and an opportunity to generate more revenue may create an incentive for the use of more expensive drugs (MedPAC Report to the Congress: Medicare and the Health Care Delivery System June 2015, http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf, pages 65 through 72). Also, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) March 8, 2016, Issue Briefing pointed out that that administrative complexity and overhead costs are not exactly proportional to the price of a drug (https://aspe.hhs.gov/pdf-report/medicare-part-b-drugs-pricing-and-incentives). Thus, the suitability of using a percentage of the volume-

    weighted average sales price or WAC of the drug or biological for an add-on payment may vary depending on the price of the drug or how the payment rate has been determined.

    While the add-on percentage for drug payments made under section 1847A of the Act is typically applied to the ASP, the same 6 percent add-on is also applied to the WAC to determine the Part B drug payment allowances in the following situations. First, for single source drugs as authorized in section 1847A(b)(4) of the Act, payment is made using the lesser of ASP or WAC; and section 1847A(b)(1) of the Act requires that a 6 percent add-on be applied regardless of whether WAC or ASP is less. Second, for drugs and biologicals where average sales price during first quarter of sales is unavailable, section 1847A(c)(4) of the Act allows the Secretary to determine the payment amount for the drug or biological based on the WAC or payment methodologies in effect on November 1, 2003. We note that this provision does not specify that an add-on percentage be applied if WAC-based payment is used, nor is an add-on percentage specified in the implementing regulations at Sec. 414.904(e)(4). The application of the add-on percentage to WAC-based payments during a period where partial quarter ASP data was available was discussed in the 2011 PFS final rule with comment (75 FR 73465 through 73466). Third, in situations where Medicare Administrative Contractors (MACs) determine pricing for drugs that do not appear on the ASP pricing files and for new drugs, WAC-based payment amounts may also be used, as discussed in Chapter 17, Section 20.1.3 of the Medicare Claims Processing Manual. This section of the Manual describes the use of a 6 percent add-on.

    The incorporation of discounts in the determination of payment amounts made for Part B drug varies. Most Part B drug payments are based on the drug's or biological's ASP; as provided in section 1847A(c)(3) of the Act, the ASP is net of many discounts such as volume discounts, prompt pay discounts, cash discounts, free goods that are contingent on any purchase, chargebacks, rebates (other than rebates under Medicaid drug rebate program), etc. In contrast, the WAC of a drug or biological is defined in section 1847A(c)(6)(B) of the Act as the manufacturer's list price for the drug or biological to wholesalers or direct purchasers in the United States, 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 or biological pricing data. Because the WAC does not include discounts, it typically exceeds ASP, and the use of a WAC-based payment amount for the same drug results in higher dollar payments than the use of an ASP-based payment amount.

    Although discussions about the add-on tend to focus on ASP-based payments (because ASP-based payments are more common than WAC-based payments), the add-on for WAC-based payments has also been raised in the June 2017 MedPAC Report to the Congress (http://www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf, pages 42 through 44). The MedPAC report focused on how the 2 quarter lag in payments determined under section 1847A of the Act led to a situation where undiscounted WAC-based payment amounts determined using information from 2 quarters earlier were used to pay for drugs that providers purchased at a discount. To determine the extent of the discounts, MedPAC sampled new, high-expenditure Part B drugs and found that these drugs' ASPs were generally lower than their WACs. Seven out of the 8 drugs showed pricing declines from initial WAC to ASP one year after being listed in the ASP pricing files with the remaining product showing no change, which suggests purchasers received discounts that WAC did not reflect. MedPAC further cited a 2014 OIG report (OIG, Limitations in Manufacturer Reporting of Average Sales Price Data for Part B Drugs, (OEI-12-13-00040), July 2014) to illustrate that there may be differences between WAC and ASP in other instances in which CMS utilizes WAC instead of ASP and noted that OIG found that ``WACs often do not reflect actual market prices for drugs.'' MedPAC also characterized Part B payments based on undiscounted list prices for products that were available at a discount as excessive. The report suggested that greater parity between ASP-based acquisition costs and WAC-based payments for Part B drugs could be achieved and recommended changing the 6 percent add-on for WAC-based payments to 3 percent. A 3 percent change was recommended based on statements made by industry, MedPAC's analysis of new drug pricing, and OIG data. The report also mentioned that discounts on WAC, such as prompt pay discounts, were available soon after the drug went on the market.

    In the case of a drug or biological during an initial sales period in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer, section 1847A(c)(4) of the Act permits the Secretary to make payments that are based on WAC. In other words, although payments under this section may be based on WAC, unlike section 1847A(b) of the Act (which specifies that certain payments must be made with a 6 percent add-on), section 1847A(c)(4) of the Act does not require that a particular add-on amount be applied to partial quarter WAC-based pricing. Consistent with section 1847A(c)(4) of the Act, we are proposing that effective January 1,

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    2019, WAC based payments for Part B drugs made under section 1847A(c)(4) of the Act, utilize a 3 percent add-on in place of the 6 percent add-on that is currently being used. We are proposing a 3 percent add-on because this percentage is consistent with MedPAC's analysis and recommendations discussed in the paragraph above and cited in their June 2017 Report to the Congress. Although other approaches for modifying the add-on amount, such as a flat fee, or percentages that vary with the cost of a drug, are possible, we are proposing a fixed percentage in order to be consistent with other provisions in section 1847A of the Act which specify fixed add-on percentages of 6 percent (1847A(b)) or 3 percent (section 1847A(d)(3)(C) of the Act). A fixed percentage is also administratively simple to implement and administer, is predictable, and is easy for manufacturers, providers and the public to understand.

    We have also reviewed corresponding regulation text at Sec. 414.904(e)(4). To conform the regulation text more closely to the statutory language at section 1847A(c)(4) of the Act, we are also proposing to strike the word ``applicable'' from paragraph (e)(4). Section 1847A(c)(4) of the Act does not use the term ``applicable'' to describe the payment methodologies in effect on November 1, 2003.

    If we were to finalize these proposals, we would also change the policy articulated in the Claims Processing Manual that describes the application of the 6 percent add-on to payment determinations made by MACs for new drugs and biologicals. Chapter 17 section 20.1.3 of the Claims Processing Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf) states that WAC-based payment limits for drugs and biologicals that are produced or distributed under a new drug application (or other new application) approved by the Food and Drug Administration, and that are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are based on 106 percent of WAC. Invoice-based pricing is used if the WAC is not published. In OPPS, the payment allowance limit is 95 percent of the published Average Wholesale Price (AWP). We would change our policy to permit MACs to use an add-on percentage of up to 3 percent for WAC-based payments for new drugs. MACs have longstanding authority to make payment determinations when we do not publish a payment limit in our national Part B drug pricing files and when new a drug becomes available. This proposal would preserve consistency with our proposed national pricing policy and would apply when MACs perform pricing determinations, for example during the period when ASPs have not been reported. This proposed policy would not alter OPPS payment limits.

    We note that these proposals do not include WAC-based payments for single source drugs under section 1847A(b) of the Act, that is, where the statute specifies that the payment limit is 106 percent of the lesser of ASP or WAC.

    We have stated in previous rulemaking that it is desirable to have fair reimbursement in a healthy marketplace that encourages product development (80 FR 71101). We have also stated that we seek to promote innovation to provide more options to patients and physicians, and competition to drive prices down (82 FR 53183). These positions have not changed. However, since 2011, concern about the impact of drug pricing and spending on Part B drugs has continued to grow. From 2011 to 2016, Medicare Part B drug spending increased from $17.6 billion to $28.0 billion, representing a compound annual growth rate of 9.8 percent, with per capita spending increasing 54 percent, from $532 to $818 (Based on Spending and Enrollment Data from Centers for Medicare and Medicaid Services Office of Enterprise Data and Analytics). These increases affect the spending by Medicare and beneficiary out-of-pocket costs. In the context of these concerns, we believe that implementation of these proposals will improve Medicare payment rates by better aligning payments with drug acquisition costs, especially for the growing number of drugs with high annual spending and high launch prices where single doses can cost tens or even hundreds of thousands of dollars. The proposals will also decrease beneficiary cost sharing. A 3 percentage point reduction in the total payment allowance will reduce a patient's 20 percent Medicare Part B copayment--for a drug that costs many thousands of dollars per dose, this can result in significant savings to an individual. The proposed approach would help Medicare beneficiaries afford to pay for new drugs by reducing out of pocket expenses and would help counteract the effects of increasing launch prices for newly approved drugs and biologicals. Finally, the proposals are consistent with recent MedPAC recommendations.

    III. Other Provisions of the Proposed Rule

  36. Clinical Laboratory Fee Schedule

    1. Background

    Prior to January 1, 2018, Medicare paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) under sections 1832, 1833(a), (b) and (h), and 1861 of the Social Security Act (the Act). Under the previous methodology, CDLTs were paid based on the lesser of: (1) The amount billed; (2) the local fee schedule amount established by the Medicare Administrative Contractor (MAC); or (3) a national limitation amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests were paid at the NLA. Under the previous system, the CLFS amounts were updated for inflation based on the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U), and reduced by a multi-factor productivity adjustment and other statutory adjustments, but were not otherwise updated or changed.

    Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for CDLTs under the CLFS. The CLFS final rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS final rule), published in the Federal Register on June 23, 2016, implemented section 1834A of the Act. Under the CLFS final rule, ``reporting entities'' must report to CMS during a ``data reporting period'' ``applicable information'' collected during a ``data collection period'' for their component ``applicable laboratories.'' Applicable information is defined at Sec. 414.402 as, with respect to each CDLT for a data collection period: Each private payor rate for which final payment has been made during the data collection period; the associated volume of tests performed corresponding to each private payor rate; and the specific Healthcare Common Procedure Coding System (HCPCS) code associated with the test. Applicable information does not include information about a test for which payment is made on a capitated basis. An applicable laboratory is defined at Sec. 414.502, in part, as an entity that is a laboratory (as defined under the Clinical Laboratory Improvement Amendments (CLIA) definition at Sec. 493.2) that bills Medicare Part B under its own National Provider Identifier

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    (NPI). In addition, an applicable laboratory is an entity that receives more than 50 percent of its Medicare revenues during a data collection period from the CLFS and/or the Physician Fee Schedule (PFS). We refer to this component of the applicable laboratory definition as the ``majority of Medicare revenues threshold.'' The definition of applicable laboratory also includes a ``low expenditure threshold'' component which requires an entity to receive at least $12,500 of its Medicare revenues from the CLFS for its CDLTs that are not advanced diagnostic laboratory tests (ADLTs).

    The first data collection period, for which applicable information was collected, occurred from January 1, 2016 through June 30, 2016. The first data reporting period, during which reporting entities reported applicable information to CMS, occurred January 1, 2017 through March 31, 2017. On March 30, 2017, we announced a 60-day enforcement discretion period of the assessment of Civil Monetary Penalties (CMPs) for reporting entities that failed to report applicable information. Additional information about the 60-day enforcement discretion period may be found on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.

    In general, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the data collection period and reported to us during the data reporting period, and is equal to the weighted median of the private payor rates for the test. The weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory. The payment amounts established under the CLFS are not subject to any other adjustment, such as geographic, budget neutrality, or annual update, as required by section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of the Act, implemented at Sec. 414.507(d), provides a phase-in of payment reductions, limiting the amounts the CLFS rates for each CDLT (that is not a new ADLT or new CDLT) can be reduced as compared to the payment rates for the preceding year. For the first 3 years after implementation (CY 2018 through CY 2020), the reduction cannot be more than 10 percent per year, and for the next 3 years (CY 2021 through CY 2023), the reduction cannot be more than 15 percent per year. For most CDLTs, the data collection period, data reporting period, and payment rate update occur every 3 years. As such, the next data collection period for most CDLTs will be January 1, 2019 through June 30, 2019, and the next data reporting period will be January 1, 2020 through March 31, 2020, with the next update to CLFS occurring on January 1, 2021. Additional information on the private payor rate-based CLFS is detailed in the CLFS final rule (81 FR 41036 through 41101).

    2. Recent Stakeholder Feedback

    After the initial data collection and data reporting periods, we received stakeholder feedback on a range of topics related to the private payor rate-based CLFS. Some stakeholders expressed concern that the CY 2018 CLFS payments rates are based on applicable information from only a relatively small number of laboratories. Some stakeholders stated that, because most hospital-based laboratories were not applicable laboratories, and therefore, did not report applicable information during the initial data reporting period, the CY 2018 CLFS payment rates do not reflect their information and are inaccurate. Other stakeholders were concerned that the low expenditure threshold excluded most physician office laboratories and many small independent laboratories from reporting applicable information.

    In determining payment rates under the private payor rate-based CLFS, one of our objectives is to obtain as much applicable information as possible from the broadest possible representation of the national laboratory market on which to base CLFS payment amounts, for example, from independent laboratories, hospital outreach laboratories, and physician office laboratories, without imposing undue burden on those entities. As we noted throughout the CLFS final rule, we believe it is important to achieve a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a CDLT, and minimizing the reporting burden for entities. In response to stakeholder feedback and in the interest of facilitating our goal, we are proposing one change, discussed below, to the Medicare CLFS for CY 2019. We believe this proposal may result in more data being used on which to base CLFS payment rates.

    In addition to this proposal, we are soliciting public comments on other approaches that have been requested by some stakeholders who suggested that such approaches would result in CMS receiving even more applicable information to use in establishing CLFS payment rates. The approaches include revising the definition of applicable laboratory and changing the low expenditure threshold. These topics are discussed below.

    3. Proposed Change to the Majority of Medicare Revenues Threshold in Definition of Applicable Laboratory

    In order for a laboratory to meet the majority of Medicare revenues threshold, section 1834A(a)(2) of the Act requires that, ``with respect to its revenues under this title, a majority of such revenues are from'' the CLFS and the PFS in a data collection period. In the CLFS final rule, we stated that ``revenues under this title'' are payments received from the Medicare program, which includes fee-for-service payments under Medicare Parts A and B, as well as Medicare Advantage (MA) payments under Medicare Part C, and prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance amounts for Medicare services furnished during the data collection period (81 FR 41043). This total Medicare revenues amount (the denominator in the majority of Medicare revenues threshold calculation) is compared to the total of Medicare revenues received from the CLFS and/or PFS (the numerator in the majority of Medicare revenues threshold calculation). If the numerator is greater than 50 percent of the denominator for a data collection period, the entity has met the majority of Medicare revenues threshold criterion. We reflected that requirement in Sec. 414.502 in the third paragraph of the definition of applicable laboratory.

    We have considered that our current interpretation of total Medicare revenues may have the effect of excluding laboratories that furnish Medicare services to a significant number of beneficiaries enrolled in MA plans under Medicare Part C from meeting the majority of Medicare revenues threshold criterion, and therefore, from qualifying as applicable laboratories. For instance, if a laboratory has a significant enough Part C component so that it is receiving greater than 50 percent of its total Medicare revenues from MA payments under Part C, it would not meet the majority of Medicare revenues threshold because its revenues derived from the CLFS and/or PFS would not constitute a majority of its total Medicare revenues. We believe that if we were to exclude MA plan revenues from total Medicare revenues, more laboratories of all types may meet the majority of Medicare revenues threshold, and therefore, the definition

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    of applicable laboratory, because it would have the effect of decreasing the amount of total Medicare revenues and increase the likelihood that a laboratory's CLFS and PFS revenues would constitute a majority of its Medicare revenues.

    We believe section 1834A of the Act permits an interpretation that MA plan payments to laboratories not be included in the total Medicare revenues component of the majority of Medicare revenues threshold calculation. Rather, MA plan payments to laboratories can be considered to only be private payor payments under the CLFS. We emphasize here that this characterization of MA plan payments is limited to only the CLFS for purposes of defining applicable laboratory. Whether MA plan payments to laboratories or other entities are considered Medicare ``revenues'' or ``private payor payments'' in other contexts in the Medicare program is irrelevant here. Nor does our characterization of MA plan payments as private payor payments for purposes of the CLFS have any bearing on any aspect of the Medicare program other than the CLFS. This is because of language included in section 1834A of the Act that is specifically targeted to the CLFS, explained below.

    As noted above, we defined total Medicare revenues for purposes of the majority of Medicare revenues threshold calculation to include fee-

    for-service payments under Medicare Parts A and B, as well as MA payments under Medicare Part C, and prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance amounts for Medicare services furnished during the data collection period. However, section 1834A(a)(8) of the Act, which defines the term ``private payor,'' identifies at section 1834A(a)(8)(B) a ``Medicare Advantage plan under Part C'' as a type of private payor. Under the private payor rate-based CLFS, CLFS payment amounts are based on private payor rates that are reported to CMS. So, an applicable laboratory that receives Medicare Advantage (MA) plan payments is to consider those MA plan payments in identifying its applicable information, which must be reported to CMS. We believe it is more logical to not consider MA plan payments under Part C to be both Medicare revenues for determining applicable laboratory status and private payor rates for purposes of reporting applicable information. Congress contemplated that applicable laboratories would furnish MA services, as reflected in the requirement that private payor rates must be reported for MA services. However, under our current definition of applicable laboratory, laboratories that furnish MA services, particularly those that furnish a significant amount, are less likely to meet the majority of Medicare revenues threshold, which means they would be less likely to qualify as applicable laboratories, and therefore, to report private payor rates for MA services.

    Therefore, after further review and consideration of the new private payor rate-based CLFS, we believe it is appropriate to include MA plan revenues as only private payor payments rather than both Medicare revenues, for the purpose of determining applicable laboratory status, and private payor payments, for the purpose of specifying what is applicable information. Such a change would have the effect of eliminating the laboratory revenue generated from a laboratory's Part C-enrolled patient population as a factor in determining whether a majority of the laboratory's Medicare revenues are comprised of services paid under the CLFS or PFS. We believe this change would permit a laboratory with a significant Medicare Part C revenue component to be more likely to meet the majority of Medicare revenues threshold and qualify as an applicable laboratory. In other words, MA payments are currently included as total Medicare revenues (the denominator). In order to meet the majority of Medicare revenues threshold, the statute requires a laboratory to receive the majority of its Medicare revenues from the CLFS and or PFS. If MA plan payments were excluded from the total Medicare revenues calculation, the denominator amount would decrease. If the denominator amount decreases, the likelihood increases that a laboratory would qualify as an applicable laboratory. Therefore, we believe this proposal responds directly to stakeholders' concerns regarding the number of laboratories for which applicable information must be reported because a broader representation of the laboratory industry may qualify as applicable laboratories, which means we would receive more applicable information to use in setting CLFS payment rates.

    For these reasons, we are proposing that MA plan payments under Part C would not be considered Medicare revenues for purposes of the applicable laboratory definition. We would revise paragraph (3) of the definition of applicable laboratory at Sec. 414.502 accordingly. We reiterate that not characterizing MA plan payments under Medicare Part C as Medicare revenues would be limited to the definition of applicable laboratory under the CLFS, and would not affect, reflect on, or otherwise have any bearing on any other aspect of the Medicare program.

    In an effort to provide stakeholders a better understanding of the potential reporting burden that may result from this proposal, we are providing a summary of the distribution of data reporting that occurred for the first data reporting period. If we were to finalize the proposed change to the majority of Medicare revenues threshold component of the definition of applicable laboratory, additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C could potentially qualify as applicable laboratories, in which case their data would be reported to us. As discussed previously, we received over 4.9 million records from 1,942 applicable laboratories for the initial data reporting period, which we used to set CY 2018 CLFS rates. Additional analysis shows that the average number of records reported for an applicable laboratory was 2,573. The largest number of records reported for an applicable laboratory was 457,585 while the smallest amount was 1 record. A summary of the distribution of reported records from the first data collection period is illustrated in the Table 24.

    Table 24--Summary of Records Reported for First Data Reporting Period

    By applicable laboratory

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Percentile distribution of records

    Total records Average Min records Max records ---------------------------------------------------------------------

    records 10th 25th 50th 75th 90th

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    4,995,877............................... 2,573 1 457,585 23 79 294 1,345 4,884

    --------------------------------------------------------------------------------------------------------------------------------------------------------

    Page 35858

    Assuming a similar distribution of data reporting for the next data reporting period, the mid-point of reported records for an applicable laboratory would be approximately 300 (50th percentile for the first data reporting period was 294). However, as illustrated in Table 24, the number of records reported varies greatly, depending on the volume of services performed by a given laboratory. Laboratories with larger test volumes, for instance at the 90th percentile, should expect to report more records as compared to the midpoint used for this analysis. Likewise, laboratories with smaller test volume, for instance at the 10th percentile, should expect to report less records as compared to the midpoint.

    We welcome comments on our proposal to modify the definition of applicable laboratory to exclude MA plan payments under Part C as Medicare revenues.

    4. Solicitation of Public Comments on Other Approaches to Defining Applicable Laboratory

    As noted previously, we define applicable laboratory at the NPI level, which means the laboratory's own billing NPI is used to identify a laboratory's revenues for purposes of determining whether it meets the majority of Medicare revenues threshold and the low expenditure threshold components of the applicable laboratory definition. For background purposes, the following summarizes some of the considerations we made in establishing this policy.

    In the CLFS proposed rule, entitled Medicare Clinical Diagnostic Laboratory Tests Payment System, published in the October 1, 2015 Federal Register, we proposed to define applicable laboratory at the TIN level so that an applicable laboratory would be an entity that reports tax-related information to the IRS under a TIN with which all of the NPIs in the entity are associated, and was itself a laboratory or had at least one component that was a laboratory, as defined in Sec. 493.2. In the CLFS proposed rule, we discussed that we considered proposing to define applicable laboratory at the NPI level. However, we did not propose that approach because we believed private payor rates for CDLTs are negotiated at the TIN level and not by individual laboratory locations at the NPI level. Numerous stakeholders had indicated that the TIN-level entity is the entity negotiating pricing, and therefore, is the entity in the best position to compile and report applicable information across its multiple NPIs when there are multiple NPIs associated with a TIN-level entity. We stated that we believed defining applicable laboratory by TIN rather than NPI would result in the same applicable information being reported, and would require reporting by fewer entities, and therefore, would be less burdensome to applicable laboratories. In addition, we stated that we did not believe reporting at the TIN level would affect or diminish the quality of the applicable information reported. To the extent the information is accurately reported, we expected reporting at a higher organizational level to produce exactly the same applicable information as reporting at a lower level (80 FR 59391 through 59393).

    Commenters who objected to our proposal to define applicable laboratory at the TIN level stated that our definition would exclude hospital laboratories because, in calculating the applicable laboratory's majority of Medicare revenues amount, which looks at the percentage of Medicare revenues from the PFS and CLFS across the entire TIN-level entity, virtually all hospital laboratories would not be considered an applicable laboratory. Many commenters expressed particular concern that our proposed definition would exclude hospital outreach laboratories, stating that hospital outreach laboratories, which do not provide laboratory services to hospital patients, are direct competitors of the broader independent laboratory market, and therefore, excluding them from the definition of applicable laboratory would result in incomplete and inappropriate applicable information, which would skew CLFS payment rates. Commenters maintained that CMS needed to ensure reporting by a broad scope of the laboratory market to meet what they viewed as Congressional intent that all sectors of the laboratory market be included to establish accurate market-based rates (81 FR 41045).

    In issuing the CLFS final rule, we found particularly compelling the comments that urged us to adopt a policy that would better enable hospital outreach laboratories to be applicable laboratories because we agreed hospital outreach laboratories should be accounted for in the new CLFS payment rates. We noted that hospital outreach laboratories are laboratories that furnish laboratory tests for patients who are not admitted hospital inpatients or registered outpatients of the hospital and who are enrolled in Medicare separately from the hospital of which they are a part as independent laboratories that do not serve hospital patients. We believed it was important to facilitate reporting of private payor rates for hospital outreach laboratories to ensure a broader representation of the national laboratory market to use in setting CLFS payment amounts (81 FR 41045).

    We were clear in the CLFS final rule, however, that we believe Congressional intent was to effectively exclude hospital laboratories as applicable laboratories, which was apparent from the statutory language, in particular, the majority of Medicare revenues threshold criterion in section 1834A(a)(2) of the Act. Section 1834A(a)(2) of the Act provides that, to qualify as an applicable laboratory, an entity's revenues from the CLFS and the PFS needs to constitute a majority of its total Medicare payments received from the Medicare program for a data collection period. What we found significant was that most hospital laboratories would not meet that majority of Medicare revenues threshold because their revenues under the IPPS and OPPS alone would likely far exceed the revenues they received under the CLFS and PFS. Therefore, we believe the statute intended to limit reporting primarily to independent laboratories and physician offices (81 FR 41045 through 41047). For a more complete discussion of the definition of applicable laboratory, see the CLFS final rule (81 FR 41041 through 41051).

    1. Stakeholder Continuing Comments and Stakeholder-Suggested Alternative Approaches

      As noted above, in response to public comments, we finalized that an applicable laboratory is the NPI-level entity so that a hospital outreach laboratory assigned a unique NPI, separate from the hospital of which it is a part, is able to meet the definition of applicable laboratory and its applicable information can be used for CLFS rate-

      setting. We continue to believe that the NPI is the most effective mechanism for identifying Medicare revenues for purposes of determining applicable laboratory status and identifying private payor rates for purposes of reporting applicable information. Once a hospital outreach laboratory obtains its own unique billing NPI and bills for services using its own unique NPI, Medicare and private payor revenues are directly attributable to the hospital outreach laboratory. By defining applicable laboratory using the NPI, Medicare payments (for purposes of determining applicable laboratory status) and private payor rates and the associated volume of CDLTs can be more easily identified and reported to us. We also believe that, if finalized, our proposal to exclude MA plan revenues under Medicare Part C from total Medicare revenues in the

      Page 35859

      definition of applicable laboratory may increase the number of entities meeting the majority of Medicare revenues threshold, and therefore, qualifying for applicable laboratory status. In summary, we believe the proposed change to the total Medicare revenues component of the applicable laboratory definition and our current policy that requires an entity to bill Medicare Part B under its own NPI, may increase the number of hospital outreach laboratories qualifying as applicable laboratories.

      In addition, we are confident that our current policy supports our collecting sufficient applicable information in the next data reporting period, and that we received sufficient and reliable applicable information with which we set CY 2018 CLFS rates, and that those rates are accurate. For instance, we received applicable information from laboratories in every state, the District of Columbia, and Puerto Rico. This data included private payor rates for almost 248 million laboratory tests conducted by 1,942 applicable laboratories, with over 4 million records of applicable information. In addition, as we've noted, the largest laboratories dominate the market, and therefore, most significantly affect the payment weights (81 FR 41049). Given that the largest laboratories reported their applicable information to CMS in the initial data reporting period, along with many smaller laboratories, we believe the data we used to calculate the CY 2018 CLFS rates was sufficient and resulted in accurate weighted medians of private payor rates.

      However, we continue to consider refinements to our policies that could lead to including even more applicable information for the next data reporting period. To that end, the comments and alternative approaches suggested by stakeholders, even though some were first raised prior to the CLFS final rule, are presented and considered for comment now.

      (1) Using Form CMS-1450 Bill Type 14x To Determine Majority of Medicare Revenues and Low Expenditure Thresholds

      Some stakeholders that expressed concern over the CY 2018 CLFS payments rates stated that the NPI-based definition of applicable laboratory reduces the number of hospital outreach laboratories reporting data. These stakeholders suggested we revise the definition specifically for the purpose of including more hospital outreach laboratories. Under a suggested approach, a laboratory could determine whether it meets the majority of Medicare revenues threshold and low expenditure threshold using only the revenues from services reported on the Form CMS-1450 (approved Office of Management and Budget number 0938-0997) 14x bill type, which is used only by hospital outreach laboratories. Therefore, per the stakeholder suggestions, we are seeking public comments on the following approach.

      This approach would revise the definition of applicable laboratory to permit the revenues identified on the Form CMS-1450 14x bill type to be used instead of the revenues associated with the NPI the laboratory uses, to determine whether it meets the majority of Medicare revenues threshold (and the low expenditure threshold). Under this approach, the applicable revenues would be based on the bills used for hospital laboratory services provided to non-patients, which are paid under Medicare Part B (that is, the 14x bill type). If we pursued this approach, we would have to modify the definition of applicable laboratory in Sec. 414.502 by indicating that an applicable laboratory may include an entity that bills Medicare Part B on the Form CMS-1450 14x bill type.

      Although using the 14x bill type could alleviate some initial, albeit limited, administrative burden on hospital outreach laboratories to obtain a unique billing NPI, we would have operational and statutory authority concerns about defining applicable laboratory by the Form CMS-1450 14x bill type.

      First, defining applicable laboratory using the Form CMS-1450 14x bill type does not identify an entity the way an NPI does. Whereas an NPI is associated with a provider or supplier to determine specific Medicare revenues, the 14x bill type is merely a billing mechanism that is currently used only for a limited set of services. Under an approach that permits laboratories to meet the majority of Medicare revenues threshold using the 14x bill type, private payor rates (and the volume of tests paid at those rates) would have to be identified that are associated with only the outreach laboratory services of a hospital's laboratory business. However, some private payors, such as MA plans, may not require hospital laboratories to use the 14x bill type for their outreach laboratory services. To the extent a private payor does not require hospital outreach laboratory services to be billed on a 14x bill type (which specifically identifies outreach services), hospitals may need to develop their own mechanism for identifying and reporting only the applicable information associated with its hospital outreach laboratory services. In light of this possible scenario, we are interested in public comments about the utility of using the 14x bill type in the way we have described and on the level of administrative burden created if we defined applicable laboratory using the Form CMS-

      1450 14x bill type.

      Second, we question whether hospitals would have sufficient time after publication of a new final rule that included using the Form CMS-

      1450 14x bill type, and any related subregulatory guidance, to develop and implement the information systems necessary to collect private payor rate data before the start of the next data collection period, that is, January 1, 2019. To that end, we are interested in public comments as to whether revising the definition of applicable laboratory to use the Form CMS-1450 14x bill type would allow laboratories sufficient time to make the necessary systems changes to identify applicable information before the start of the next data collection period.

      Third, we believe defining applicable laboratory at the NPI level, as we currently do, provides flexibility for hospital outreach laboratories to not obtain a unique billing NPI, which may be significant particularly where a hospital outreach laboratory performs relatively few outreach services under Medicare Part B. For example, under the current definition of applicable laboratory, if a hospital outreach laboratory's CLFS revenues in a data collection period are typically much less than the low expenditure threshold, the hospital of which it is a part could choose not to obtain a separate NPI for its outreach laboratory and could thus avoid determining applicable laboratory status for its outreach laboratory component. In contrast, if laboratories were permitted to use the Form CMS-1450 14x bill type, revenues attributed to the hospital outreach laboratory would have to be calculated in every instance where those services exceeded the low expenditure threshold. This would be true even for a hospital outreach laboratory that performs relatively few outreach services under Medicare Part B. Therefore, we are interested in comments concerning this aspect of using the 14x bill type definition.

      Fourth, and significantly, we believe that if we were to utilize such an approach in defining applicable laboratory, all hospital outreach laboratories would meet the majority of Medicare revenues threshold. At this time, we believe that this approach would be inconsistent with the statute. By virtue of the majority of Medicare revenues threshold, the statute defines applicable laboratory in such a way that

      Page 35860

      not all laboratories qualify as applicable laboratories. However, if we were to use the CMS-1450 14x bill type to define an applicable laboratory, all hospital outreach laboratories that use the 14x bill type would meet the majority of Medicare revenues threshold. Accordingly, we are interested in public comments regarding whether this definition would indeed be inconsistent with the statute, as well as comments that can identify circumstances under this definition whereby a hospital outreach laboratory would not meet the majority of Medicare revenues threshold.

      (2) Using CLIA Certificate To Define Applicable Laboratories

      Some industry stakeholders have requested that we use the CLIA certificate rather than the NPI to identify a laboratory that would be considered an applicable laboratory. We discussed in the CLFS proposed rule (80 FR 59392) why not all entities that meet the CLIA regulatory definition at Sec. 493.2 would be applicable laboratories, and therefore, we did not propose to use CLIA as the mechanism for defining applicable laboratory. However, some commenters to the CLFS proposed rule suggested we use the CLIA certificate to identify the organizational entity that would be considered an applicable laboratory so that each entity that had a CLIA certificate would be an applicable laboratory (81 FR 41045). We considered those comments in the CLFS final rule and discussed why we chose not to adopt that approach.

      Among other reasons, we explained in the CLFS final rule that we believed a CLIA certificate-based definition of applicable laboratory would be overly inclusive by including all hospital laboratories, as opposed to just hospital outreach laboratories. In addition, the CLIA certificate is used to certify that a laboratory meets applicable health and safety regulations in order to furnish laboratory services. It is not associated with Medicare billing so, unlike for example, the NPI, with which revenues for specific services can easily be identified, the CLIA certificate cannot be used to identify revenues for specific services. We also indicated that we did not see how a hospital would determine whether its laboratories would meet the majority of Medicare revenues threshold (and the low expenditure threshold) using the CLIA certificate as the basis for defining an applicable laboratory. In addition, we stated that, given the difficulties many hospitals would likely have in determining whether their laboratories are applicable laboratories, we also believed hospitals may object to using the CLIA certificate (81 FR 41045).

      However, in light of stakeholders' suggestions to use the CLIA certificate to include hospital outreach laboratories in the definition of applicable laboratories, we are soliciting public comments on that approach. Under such approach, the majority of Medicare revenues threshold and low expenditure threshold components of the definition of applicable laboratory would be determined at the CLIA certificate level instead of the NPI level. If we pursued such approach, we would have to modify the definition of applicable laboratory in Sec. 414.502 to indicate that an applicable laboratory is one that holds a CLIA certificate under Sec. 493.2 of the chapter. We would have concerns, however, about defining applicable laboratory by the CLIA certificate.

      First, as we discussed in the CLFS final rule, given that information regarding the CLIA certificate is not required on the Form CMS-1450 14x bill type, which is the billing form used by hospitals for their laboratory outreach services, it is not clear how a hospital would identify and distinguish revenues generated by its separately CLIA-certified laboratories for their outreach services. We are interested in public comments regarding the mechanisms a hospital would need to develop to identify revenues if we used the CLIA certificate for purposes of determining applicable laboratory status, as well as comments about the administrative burden associated with developing such mechanisms.

      In addition, we understand there could be a scenario where one CLIA certificate is assigned to a hospital's entire laboratory business, which would include laboratory tests performed for hospital patients as well as non-patients (that is, patients who are not admitted inpatients or registered outpatients of the hospital). For example, hospital laboratories with an outreach laboratory component would be assigned a single CLIA certificate if the hospital outreach laboratory has the same mailing address or location as the hospital laboratory. In this scenario, the majority of Medicare revenues threshold would be applied to the entire hospital laboratory, not just its outreach laboratory component. If a single CLIA certificate is assigned to the hospital's entire laboratory business, the hospital laboratory would be unlikely to meet the majority of Medicare revenues threshold because its laboratory revenues under the IPPS and OPPS alone would likely far exceed the revenues it receives under the CLFS and PFS. As a result, a hospital outreach laboratory that could otherwise meet the definition of applicable laboratory, as currently defined at the NPI level, would not be an applicable laboratory if we were to require the CLIA certificate to define applicable laboratory. Given that this approach could have the effect of decreasing as opposed to increasing the number of applicable laboratories, we are requesting public comments on this potential drawback of defining applicable laboratory at the CLIA certificate level.

      We believe that feedback on the topics discussed in this section could help inform us regarding potential refinements to the definition of applicable laboratory. We welcome comments on these topics from the public, including, physicians, laboratories, hospitals, and other interested stakeholders. We are especially interested in comments regarding the administrative burden of using the Form CMS-1450 14x bill type or CLIA certificate to identify applicable information attributed only to the hospital outreach laboratory portion of a hospital's total laboratory business. Depending on the comments we receive, it is possible we would consider approaches described in this section.

      Again, we continue to believe that our current regulatory definitions and data collection processes are reasonable pursuant to governing law. The above public comments are solicited as part of the agency's ongoing engagement with stakeholders to receive the most up-

      to-date information and comments from those affected by the CLFS fee schedule.

      5. Solicitation of Public Comments on the Low Expenditure Threshold in the Definition of Applicable Laboratory

    2. Decreasing the Low Expenditure Threshold

      In the CLFS final rule, we established a low expenditure threshold component in the definition of applicable laboratory at Sec. 414.502, which is reflected in paragraph (4). To be an applicable laboratory, at least $12,500 of an entity's Medicare revenues in a data collection period must be CLFS revenues (with the exception that there is no low expenditure threshold for an entity with respect to the ADLTs it furnishes). We established $12,500 as the low expenditure threshold because we believed it achieved a balance between collecting sufficient data to calculate a weighted median that appropriately reflects the private market rate for a test, and minimizing the reporting burden for laboratories that receive a relatively small amount of revenues under the CLFS. We indicated in the CLFS final rule (81 FR 41049) that once we

      Page 35861

      obtained applicable information under the new payment system, we may decide to reevaluate the low expenditure threshold in future years and propose a different threshold amount through notice and comment rulemaking.

      Recently, we have heard from some laboratory stakeholders that the low expenditure threshold excludes most physician office laboratories and many small independent laboratories from reporting applicable information, and that by excluding so many laboratories, the payment rates under the new private payor rate-based CLFS reflect incomplete data, and therefore, inaccurate CLFS pricing.

      As noted above, we discussed in the CLFS final rule that we believed a $12,500 low expenditure threshold would reduce the reporting burden on small laboratories. In the CLFS final rule (81 FR 41051), we estimated that 95 percent of physician office laboratories and 55 percent of independent laboratories would not be required to report applicable information under our low expenditure criterion. Although we substantially reduced the number of laboratories qualifying as applicable laboratories (that is, approximately 5 percent of physician office laboratories and approximately 45 percent of independent laboratories), we estimated that the percentage of Medicare utilization would remain high. That is, approximately 5 percent of physician office laboratories would account for approximately 92 percent of CLFS spending on physician office laboratories and approximately 45 percent of independent laboratories would account for approximately 99 percent of CLFS spending on independent laboratories (81 FR 41051).

      It is our understanding that physician offices are generally not prepared to identify, collect, and report each unique private payor rate from each private payor for each laboratory test code subject to the data collection and reporting requirements, and the volume associated with each unique private payor rate. As such, we believe revising the low expenditure threshold so that more physician office laboratories are required to report applicable information would likely impose significant administrative burdens on physician offices. We also believe that increasing participation from physician office laboratories would have minimal overall impact on payment rates given that the weighted median of private payor rates is dominated by the laboratories with the largest test volume. We note that our participation simulations from the first data reporting period show that increasing the volume of physician office laboratories reporting applicable information has minimal overall impact on the weighted median of private payor rates. For more information on our participation simulations, please visit the CLFS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf.

      We continue to believe the current low expenditure threshold strikes an appropriate balance between collecting enough private payor rate data to accurately represent the weighted median of private payor rates while limiting the administrative burden on small laboratories. In addition, as discussed previously in this section, we are proposing to exclude MA plan revenues under Part C from total Medicare revenues in the definition of applicable laboratory, and if we finalize that proposal, we expect more laboratories of all types, including physician office laboratories, may meet the majority of Medicare revenues threshold.

      However, we recognize from stakeholders that some physician office laboratories and small independent laboratories that are not applicable laboratories because they do not meet the current low expenditure threshold may still want to report applicable information despite the administrative burden associated with qualifying as an applicable laboratory. Therefore, we are seeking public comments on revising the low expenditure threshold to increase the level of participation among physician office laboratories and small independent laboratories. One approach could be for us to decrease the low expenditure threshold by 50 percent, from $12,500 to $6,250, in CLFS revenues during a data collection period. Under such approach, a laboratory would need to receive at least $6,250 in CLFS revenues in a data collection period. If we were to adopt such an approach, we would need to revise paragraph (4) of the definition of applicable laboratory at Sec. 414.502 to replace $12,500 with $6,250. We are seeking public comments on this approach.

      We are particularly interested in comments from the physician community and small independent laboratories as to the administrative burden associated with such a revision to the low expenditure threshold. Specifically, we are requesting comments on the following issues: (1) Whether physician offices and small independent laboratories currently have adequate staff levels to meet the data collection and data reporting requirements; (2) whether data systems are currently in place to identify, collect, and report each unique private payor rate from each private payor for each CLFS test code and the volume of tests associated with each unique private payor rate; (3) if physician offices and small independent laboratories are generally not prepared to conduct the data collection and data reporting requirements, what is the anticipated timeframe needed for physician office and small independent laboratories to be able to meet the data collection and data reporting requirements; and (4) any other administrative concerns that decreasing the low expenditure threshold may impose on offices and small independent laboratories.

    3. Increasing the Low Expenditure Threshold

      We recognize that many small laboratories may not want the additional administrative burden of data collection and reporting and, because their test volume is relatively low, their data is unlikely to have a meaningful impact on the weighted median of private payor rates for CDLTs under the CLFS. Mindful of stakeholder feedback from smaller laboratories that prefer to not be applicable laboratories because of the burden of collecting and reporting applicable information, we could increase the low expenditure threshold in the definition of applicable laboratory by 50 percent, from $12,500 to $18,750, in CLFS revenues during a data collection period. Because physician office laboratories would be less likely to meet a higher threshold, such approach would decrease the number of physician office laboratories and small independent laboratories required to collect and report applicable information. We expect decreasing the number of physician office laboratories and small independent laboratories reporting applicable information will have minimal impact on determining CLFS rates because we believe the largest laboratories with the highest test volumes will continue to dominate the weighted median of private payor rates.

      If we were to adopt such an approach, we would need to revise paragraph (4) of the definition of applicable laboratory at Sec. 414.502 to replace $12,500 with $18,750. We are seeking public comments on this approach. We are particularly interested in comments from the physician community and small independent laboratories on the administrative burden and relief of increasing the low expenditure

      Page 35862

      threshold. We believe that feedback on the topics discussed in this section will help inform us regarding potential refinements to the low expenditure threshold. We welcome comments on these topics from the public including, physicians, laboratories, hospitals, and other interested stakeholders. We are particularly interested in receiving comments from the physician community and small independent laboratories as to the administrative burden and relief associated with revisions to the low expenditure threshold. Depending on the comments we receive, it is possible we would consider approaches described in this section.

  37. Proposed Changes to the Regulations Associated With the Ambulance Fee Schedule

    1. Overview of Ambulance Services

    1. Ambulance Services

      Under the ambulance fee schedule, the Medicare program pays for ambulance transportation services for Medicare beneficiaries under Medicare Part B when other means of transportation are contraindicated by the beneficiary's medical condition and all other coverage requirements are met. Ambulance services are classified into different levels of ground (including water) and air ambulance services based on the medically necessary treatment provided during transport.

      These services include the following levels of service:

      For Ground--

      ++ Basic Life Support (BLS) (emergency and non-emergency)

      ++ Advanced Life Support, Level 1 (ALS1) (emergency and non-emergency)

      ++ Advanced Life Support, Level 2 (ALS2)

      ++ Paramedic ALS Intercept (PI)

      ++ Specialty Care Transport (SCT)

      For Air--

      ++ Fixed Wing Air Ambulance (FW)

      ++ Rotary Wing Air Ambulance (RW)

    2. Statutory Coverage of Ambulance Services

      Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (Supplemental Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary's medical condition.

      The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that--

      The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and

      Only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 89th Cong., 1st Sess. Pt 1, 43 (1965)).

      The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility.

    3. Medicare Regulations for Ambulance Services

      The regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and limitations set forth at Sec. 410.12 and to specific conditions and limitations included at Sec. Sec. 410.40 and 410.41. Part 414, subpart H, describes how payment is made for ambulance services covered by Medicare Part B.

      2. Ambulance Extender Provisions

    4. Amendment to Section 1834(l)(13) of the Act

      Section 146(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), (Pub. L. 110-275) amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008, and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:

      For covered ground ambulance transports that originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent.

      For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.

      The payment add-ons under section 1834(l)(13)(A) of the Act have been extended several times. Most recently, section 50203(a)(1) of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123, enacted on February 9, 2018) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons through December 31, 2022. Thus, these payment add-

      ons apply to covered ground ambulance transports furnished before January 1, 2023. We are proposing to revise Sec. 414.610(c)(1)(ii) to conform the regulations to this statutory requirement. (For further information regarding the implementation of this provision for claims processing, please see CR 10531. For a discussion of past legislation extending section 1834(l)(13) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule with comment period (79 FR 67743) and the CY 2016 PFS final rule with comment period (80 FR 71071 through 71072)).

      This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary.

    5. Amendment to Section 1834(l)(12) of the Act

      Section 414(c) of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108-173, enacted on December 8, 2003) (MMA) added section 1834(l)(12) to the Act, which specified that, in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a ``qualified rural area,'' that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of

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      rural census tract). This rural bonus is sometimes referred to as the ``Super Rural Bonus'' and the qualified rural areas (also known as ``super rural'' areas) are identified during the claims adjudicative process via the use of a data field included in the CMS-supplied ZIP code file.

      The Super Rural Bonus under section 1834(l)(12) of the Act has been extended several times. Most recently, section 50203(a)(2) of the BBA amended section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2022. Therefore, we are continuing to apply the 22.6 percent rural bonus described in this section (in the same manner as in previous years) to ground ambulance services with dates of service before January 1, 2023 where transportation originates in a qualified rural area. Accordingly, we are proposing to revise Sec. 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. (For further information regarding the implementation of this provision for claims processing, please see CR 10531. For a discussion of past legislation extending section 1834(l)(12) of the Act, please see the CY 2014 PFS final rule with comment period (78 FR 74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 67743 through 67744) and the CY 2016 PFS final rule with comment period (80 FR 71072)).

      This statutory provision is self-implementing. It requires an extension of this rural bonus (which was previously established by the Secretary) through December 31, 2022, and does not require any substantive exercise of discretion on the part of the Secretary.

      3. Amendment to Section 1834(l)(15) of the Act

      Section 637 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub.L. 112-240), added section 1834(l)(15) of the Act to specify that the fee schedule amount otherwise applicable under the preceding provisions of section 1834(l) of the Act shall be reduced by 10 percent for ambulance services furnished on or after October 1, 2013, consisting of non-emergency basic life support (BLS) services involving transport of an individual with end-stage renal disease for renal dialysis services (as described in section 1881(b)(14)(B) of the Act) furnished other than on an emergency basis by a provider of services or a renal dialysis facility. In the CY 2014 PFS final rule with comment period (78 FR 74440), we revised Sec. 414.610 by adding paragraph (c)(8) to conform the regulations to this statutory requirement.

      Section 53108 of the BBA amended section 1834(l)(15) of the Act to increase the reduction from 10 percent to 23 percent effective for ambulance services (as described in section 1834(l)(15) of the Act) furnished on or after October 1, 2018. The 10 percent reduction applies for ambulance services (as described in section 1834(l)(15) of the Act) furnished during the period beginning on October 1, 2013 and ending on September 30, 2018. Accordingly, we are proposing to revise Sec. 414.610(c)(8) to conform the regulations to this statutory requirement.

      This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate decrease, and does not require any substantive exercise of discretion on the part of the Secretary. Accordingly, for ambulance services described in section 1834(l)(15) of the Act furnished during the period beginning on October 1, 2013 and ending on September 30, 2018, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 10 percent, and for ambulance services described in section 1834(l)(15) of the Act furnished on or after October 1, 2018, the fee schedule amount otherwise applicable (both base rate and mileage) is reduced by 23 percent. (For further information regarding application of this mandated rate decrease, please see CR 10549.)

  38. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

    1. Payment for Care Management Services

    In the CY 2018 PFS final rule, we revised the payment methodology for Chronic Care Management (CCM) services furnished by RHCs and FQHCs, and established requirements and payment for general Behavioral Health Integration (BHI) and psychiatric Collaborative Care Management (CoCM) services furnished in RHCs and FQHCs, beginning on January 1, 2018.

    For CCM services furnished by RHCs or FQHCs between January 1, 2016, and December 31, 2017, payment is at the PFS national average payment rate for CPT 99490. For CCM, general BHI, and psychiatric CoCM services furnished by RHCs or FQHCs on or after January 1, 2018, we established 2 new HCPCS codes. The first HCPCS code, G0511, is a General Care Management code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI services are furnished to a patient in a calendar month. The second HCPCS code, G0512, is a psychiatric CoCM code for use by RHCs or FQHCs when at least 70 minutes of initial psychiatric CoCM services or 60 minutes of subsequent psychiatric CoCM services are furnished to a patient in a calendar month.

    The payment amount for HCPCS code G0511 is set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS amounts. The 3 codes are CPT 99490 (20 minutes or more of CCM services), CPT 99487 (60 minutes or more of complex CCM services), and CPT 99484 (20 minutes or more of BHI services).

    The payment amount for HCPCS code G0512 is set at the average of the 2 national non-facility PFS payment rates for CoCM codes and updated annually based on the PFS amounts. The 2 codes are CPT 99492 (70 minutes or more of initial psychiatric CoCM services) and CPT 99493 (60 minutes or more of subsequent psychiatric CoCM services).

    For practitioners billing under the PFS, we are proposing for CY 2019 a new CPT code, 994X7, which would correspond to 30 minutes or more of CCM furnished by a physician or other qualified health care professional and is similar to CPT codes 99490 and 99487. For RHCs and FQHCs, we are proposing to add CPT code 994X7 as a general care management service and to include it in the calculation of HCPCS code G0511. That is, we propose that starting on January 1, 2019, RHCs and FQHC would be paid for G0511 based on the average of the national non-

    facility PFS payment rates for CPT codes 99490, 99487, 99484, and 994X7.

    We propose to revise Sec. 405.2464 to reflect the current payment methodology that was finalized in the CY 2018 PFS and incorporate the addition of new CPT codes to HCPCS G0511.

    2. Communication Technology-Based Services and Remote Evaluations

    RHC and FQHC visits are face-to-face (in-person) encounters between a patient and an RHC or FQHC practitioner during which time one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners, physician assistants, certified nurse midwives, clinical psychologists, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient. A Transitional Care Management service can also be an RHC or FQHC visit. A Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT)

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    service furnished by a certified DSMT or MNT provider may also be an FQHC visit.

    RHCs are paid an all-inclusive rate (AIR) for medically-necessary, face-to-face visits with an RHC practitioner. The rate is subject to a payment limit, except for those RHCs that have an exception to the payment limit for being ``provider-based'' (see Sec. 413.65). FQHCs are paid the lesser of their charges or the FQHC Prospective Payment System (PPS) rate for medically-necessary, face-to-face visits with an FQHC practitioner. Only medically-necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner can be RHC or FQHC billable visits.

    The RHC and FQHC payment rates reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day, and are not adjusted for the complexity of the patient health care needs, the length of the visit, or the number or type of practitioners involved in the patient's care.

    Services furnished by auxiliary personnel (such as nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per-visit payment. This may include services furnished prior to or after the billable visit that occur within a medically appropriate time period, which is usually 30 days or less.

    RHCS and FQHCs are also paid for care management services, including chronic care management services, general behavioral health integration services, and psychiatric Collaborative Care Model services. These are typically non-face-to-face services that do not require the skill level of an RHC or FQHC practitioner and are not included in the RHC or FQHC payment methodologies.

    For practitioners billing under the PFS, we are proposing for CY 2019 separate payment for certain communication technology-based services. This includes what is referred to as ``Brief Communication Technology-based Service'' for a ``virtual check-in'' and separate payment for remote evaluation of recorded video and/or images. The ``virtual check-in'' visit would be billable when a physician or non-

    physician practitioner has a brief (5 to 10 minutes), non-face-to-face check in with a patient via communication technology to assess whether the patient's condition necessitates an office visit. This service could be billed only in situations where the medical discussion was for a condition not related to an E/M service provided within the previous 7 days, and does not lead to an E/M service or procedure within the next 24 hours or at the soonest available appointment. We are also proposing payment for practitioners billing under the PFS for remote evaluation services. This payment would be for the remote evaluation of patient-transmitted information conducted via pre-recorded ``store and forward'' video or image technology, including interpretation with verbal 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. Both of these services would be priced under the PFS at a rate that reflects the resource costs of these non-face-to-face services relative to other PFS services, including face-to-face and in-person visits.

    The RHC and FQHC payment models are distinct from the PFS model in that the payment is for a comprehensive set of services and supplies associated with an RHC or FQHC visit. A direct comparison between the payment for a specific service furnished in an RHC or FQHC and the same service furnished in a physician's office is not possible, because the payment for RHCs and FQHCs is a per diem payment that includes the cost for all services and supplies rendered during an encounter, and payment for a service furnished in a physician's office and billed under the PFS is only for that service.

    We recognize that there are occasions when it may be beneficial to both the patient and the RHC or FQHC to utilize communications-based technology to determine the course of action for a health issue. Currently under the RHC and FQHC payment systems, if the communication results in a face-to-face billable visit with an RHC or FQHC practitioner, the cost of the prior communication would be included in the RHC AIR or the FQHC PPS. However, if as a result of the communication it is determined that a visit is not necessary, there would not be a billable visit and there would be no payment.

    RHCs and FQHCs furnish services in rural and urban areas that have been determined to be medically underserved areas or health professional shortage areas. They are an integral component of the Nation's health care safety net, and we want to assure that Medicare patients who are served by RHCs and FQHCs are able to communicate with their RHC or FQHC practitioner in a manner that enhances access to care, consistent with evolving medical care. Particularly in rural areas where transportation is limited and distances may be far, we believe the use of communication technology may help some patients to determine if they need to schedule a visit at the RHC or FQHC. If it is determined that a visit is not necessary, the RHC or FQHC practitioner would be available for other patients who need their care.

    When communication-based technology services are furnished in association with an RHC or FQHC billable visit, the costs of these services are included in the RHC AIR or the FQHC PPS and are not separately billable. However, if there is no RHC or FQHC billable visit, these costs are not paid as part of an RHC AIR or FQHC PPS payment. We are therefore proposing that, effective January 1, 2019, RHCs and FQHCs receive an additional payment for the costs of communication technology-based services or remote evaluation services that are not already captured in the RHC AIR or the FQHC PPS payment when the requirements for these services are met.

    We propose that RHCs and FQHCs receive payment for communication technology-based services or remote evaluation services when at least 5 minutes of communications-based technology or remote evaluation services are furnished by an RHC or FQHC practitioner to a patient that has been seen in the RHC or FQHC within the previous year. These services may only be billed when the medical discussion or remote evaluation is for a condition not related to an RHC or FQHC service provided within the previous 7 days, and does not lead to an RHC or FQHC service within the next 24 hours or at the soonest available appointment, since in those situation the services are already paid as part of the RHC or FQHC per-visit payment.

    We propose to create a new Virtual Communications G code for use by RHCs and FQHCs only, with a payment rate set at the average of the PFS national non-facility payment rates for HCPCS code GVCI1 for communication technology-based services, and HCPCS code GRAS1 for remote evaluation services. RHCs and FQHCs would be able to bill the Virtual Communications G-code either alone or with other payable services. The payment rate for the Virtual Communications G-code would be updated annually based on the PFS amounts.

    We also propose to waive the RHC and FQHC face-to-face requirements when these services are furnished to an

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    RHC or FQHC patient. Coinsurance would be applied to FQHC claims, and coinsurance and deductibles would apply to RHC claims for these services. Services that are currently being furnished and paid under the RHC AIR or FQHC PPS payment methodology will not be affected by the ability of the RHC or FQHC to receive payment for additional services that are not included in the RHC AIR or FQHC PPS.

    3. Other Options Considered

    We considered other options for payment for these services. First, we considered adding communication technology-based and remote evaluation services as an RHC or FQHC stand-alone service. Under this option, payment for RHCs would be at the AIR, and payment for FQHCs would be the lesser of total charges or the PPS rate. We are not proposing this payment option because these services do not meet the requirements for an RHC or FQHC billable visit and payment at the RHC AIR or FQHC PPS would result in a payment rate incongruent with efficiencies inherent in the provision of the technology-based services.

    The second option we considered was to allow RHCs and FQHCs to bill HCPCS codes GVCI1 or GRAS1 separately on an RHC or FQHC claim. We are not proposing this payment option because we believe that a combined G code is less burdensome and will allow expansion of these services without adding additional codes on an RHC or FQHC claim.

    We invite comments on this proposal. In particular, we are interested in comments regarding the appropriateness of payment for communication technology-based and remote evaluation services in the absence of an RHC or FQHC visit, the burden associated with documentation for billing these codes (RHC or FQHC practitioner's time, medical records, etc.), and any potential impact on the per diem nature of RHC and FQHC billing and payment structure as a result of payment for these services. We are also seeking public comment on whether it would be clinically appropriate to apply a frequency limitation on the use of the new Virtual Communications G code by the same RHC or FQHC with the same patient, and on what would be a reasonable frequency limitation to ensure that this code is appropriately utilized.

    4. Other Regulatory Updates

    In addition to the regulatory change described in this section of the rule, we propose the following for accuracy:

    Removal of the extra section mark in the definition of ``Federally qualified health center (FQHC)'' in Sec. 405.2401.

    Replacing the word ``his'' with ``his or her'' in the definition of ``Secretary'' in Sec. 405.2401.

  39. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the Protecting Access to Medicare Act (PAMA) amended Title XVIII of the Act to add section 1834(q) of the Act directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. The CY 2016 PFS final rule with comment period addressed the initial component of the new Medicare AUC program, specifying applicable AUC. In that rule (80 FR 70886), we established an evidence-based process and transparency requirements for the development of AUC, defined provider-

    led entities (PLEs) and established the process by which PLEs may become qualified to develop, modify or endorse AUC. The first list of qualified PLEs was posted on the CMS website at the end of June 2016 at which time their AUC libraries became specified applicable AUC for purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the second component of this program, specification of qualified clinical decision support mechanisms (CDSMs). In the CY 2017 PFS final rule (81 FR 80170), we defined CDSM, identified the requirements CDSMs must meet for qualification, including preliminary qualification for mechanisms documenting how and when each requirement is reasonably expected to be met, and established a process by which CDSMs may become qualified. We also defined applicable payment systems under this program, specified the first list of priority clinical areas, and identified exceptions to the requirement that ordering professionals consult specified applicable AUC when ordering applicable imaging services. The first list of qualified CDSMs was posted on the CMS website in July 2017.

    The CY 2018 PFS final rule addressed the third component of this program, the consultation and reporting requirements. In the CY 2018 PFS final rule (82 FR 53190), we established the start date of January 1, 2020 for the Medicare AUC program for advanced diagnostic imaging services. It is for services ordered on and after this date that ordering professionals must consult specified applicable AUC using a qualified CDSM when ordering applicable imaging services, and furnishing professionals must report AUC consultation information on the Medicare claim. We further specified that the AUC program will begin on January 1, 2020 with a year-long educational and operations testing period during which time claims will not be denied for failure to include proper AUC consultation information. We also established a voluntary period from July 2018 through the end of 2019 during which ordering professionals who are ready to participate in the AUC program may consult specified applicable AUC through qualified CDSMs and communicate the results to furnishing professionals, and furnishing professionals who are ready to do so may report AUC consultation information on the claim (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10481.pdf). Additionally, to incentivize early use of qualified CDSMs to consult AUC, we established in the CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstances Policy for the Transition Year final rule with comment period and interim final rule (hereinafter ``CY 2018 Quality Payment Program final rule'') a high-weight improvement activity for ordering professionals who consult specified AUC using a qualified CDSM for the Merit-based Incentive Payment System (MIPS) performance period that began January 1, 2018 (82 FR 54193).

    This rule proposes additions to the definition of applicable setting, clarification around who may perform the required AUC consultation using a qualified CDSM under this program, clarification that reporting is required across claim types and by both the furnishing professional and furnishing facility, changes to the policy for significant hardship exceptions for ordering professionals under this program, mechanisms for claims-based reporting, and a solicitation of feedback regarding the methodology to identify outlier ordering professionals.

    1. Background

    AUC present information in a manner that links: A specific clinical condition or presentation; one or more services; and an assessment of the appropriateness of the service(s). Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual clinical presentation. For purposes of this program AUC is a set or library of individual appropriate use criteria. Each individual criterion is

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    an evidence-based guideline for a particular clinical scenario based on a patient's presenting symptoms or condition.

    AUC need to be integrated as seamlessly as possible into the clinical workflow. CDSMs are the electronic portals through which clinicians access the AUC during the patient workup. They can be standalone applications that require direct entry of patient information, but may be more effective when they are integrated into Electronic Health Records (EHRs). Ideally, practitioners would interact directly with the CDSM through their primary user interface, thus minimizing interruption to the clinical workflow.

    2. Statutory Authority

    Section 218(b) of the PAMA added a new section 1834(q) of the Act entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging Services,'' which directs the Secretary to establish a new program to promote the use of AUC. Section 1834(q)(4) of the Act requires ordering professionals to consult with specified applicable AUC through a qualified CDSM for applicable imaging services furnished in an applicable setting and paid for under an applicable payment system; and payment for such service may only be made if the claim for the service includes information about the ordering professional's consultation of specified applicable AUC through a qualified CDSM.

    3. Discussion of Statutory Requirements

    There are four major components of the AUC program under section 1834(q) of the Act, and each component has its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of the Act); (2) identification of mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by ordering professionals, and reporting on AUC consultation by January 1, 2017 (section 1834(q)(4) of the Act); and (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5) of the Act). We did not identify mechanisms for consultation by April 1, 2016. Therefore, we did not require ordering professionals to consult CDSMs or furnishing professionals to report information on the consultation by the January 1, 2017 date.

    1. Establishment of AUC

      In the CY 2016 PFS final rule with comment period, we addressed the first component of the Medicare AUC program under section 1834(q)(2) of the Act--the requirements and process for establishment and specification of applicable AUC, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term PLE (provider-led entity) and finalizing requirements for the rigorous, evidence-based process by which a PLE would develop AUC, upon which qualification is based, as provided in section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with comment period. Using this process, once a PLE is qualified by CMS, the AUC that are developed, modified or endorsed by the qualified PLE are considered to be specified applicable AUC under section 1834(q)(2)(A) of the Act. We defined PLE to include national professional medical societies, health systems, hospitals, clinical practices and collaborations of such entities such as the High Value Healthcare Collaborative or the National Comprehensive Cancer Network. Qualified PLEs may collaborate with third parties that they believe add value to their development of AUC, provided such collaboration is transparent. We expect qualified PLEs to have sufficient infrastructure, resources, and the relevant experience to develop and maintain AUC according to the rigorous, transparent, and evidence-based processes detailed in the CY 2016 PFS final rule with comment period.

      In the same rule we established a timeline and process under Sec. 414.94(c)(2) for PLEs to apply to become qualified. Consistent with this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html in June 2016 (OMB Control Number 0938-1288).

    2. Mechanism for AUC Consultation

      In the CY 2017 PFS final rule, we addressed the second major component of the Medicare AUC program--the specification of qualified CDSMs for use by ordering professionals for consultation with specified applicable AUC under section 1834(q)(3) of the Act, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term CDSM and finalizing functionality requirements of mechanisms, upon which qualification is based, as provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS final rule. CDSMs may receive full qualification or preliminary qualification if most, but not all, of the requirements are met at the time of application. The preliminary qualification period began June 30, 2017 and ends when the AUC consulting and reporting requirements become effective on January 1, 2020. The preliminarily qualified CDSMs must meet all requirements by that date. We defined CDSM as an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. Tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or a mechanism established by the Secretary.

      In the CY 2017 PFS final rule, we established a timeline and process in Sec. 414.94(g)(2) for CDSM developers to apply to have their CDSMs qualified. Consistent with this timeline, the first list of qualified CDSMs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in July 2017 (OMB Control Number 0938-1315).

    3. AUC Consultation and Reporting

      In the CY 2018 PFS final rule, we addressed the third major component of the Medicare AUC program--consultation with applicable AUC by the ordering professional and reporting of such consultations under section 1834(q)(4) of the Act. We established a January 1, 2020 effective date for the AUC consultation and reporting requirements for this program. We also established a voluntary period during which early adopters can begin reporting limited consultation information on Medicare claims from July 2018 through December 2019. During the voluntary period there is no requirement for ordering professionals to consult AUC or furnishing professionals to report information related to the consultation. On January 1, 2020, the program will begin with an educational and operations testing period and during this time we will continue to pay claims whether or not they correctly include AUC consultation information. Ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2020; and furnishing professionals must report the AUC consultation information on the Medicare claim for these services ordered on or after January 1, 2020.

      Consistent with section 1834(q)(4)(B) of the Act, we also established that furnishing professionals must report the

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      following information on Medicare claims for advanced diagnostic imaging services as specified in section 1834(q)(1)(C) of the Act and defined in Sec. 414.94(b), furnished in an applicable setting as defined in section 1834(q)(1)(D) of the Act, paid for under an applicable payment system as defined in section 1834(q)(4)(D) of the Act, and ordered on or after January 1, 2020: (1) The qualified CDSM consulted by the ordering professional; (2) whether the service ordered would or would not adhere to specified applicable AUC, or whether the specified applicable AUC consulted was not applicable to the service ordered; and (3) the NPI of the ordering professional (if different from the furnishing professional). Proposed clarifying revisions to the reporting requirement are discussed later in this preamble.

      Section 1834(q)(4)(C) of the Act provides for exceptions to the AUC consultation and reporting requirements in the case of: A service ordered for an individual with an emergency medical condition, a service ordered for an inpatient and for which payment is made under Medicare Part A, and a service ordered by an ordering professional for whom the Secretary determines that consultation with applicable AUC would result in a significant hardship. In the CY 2017 PFS final rule, we adopted a regulation at Sec. 414.94(h)(1)(i) to specify the circumstances under which AUC consultation and reporting requirements are not applicable. These include applicable imaging services ordered: (1) For an individual with an emergency medical condition (as defined in section 1867(e)(1) of the Act); (2) for an inpatient and for which payment is made under Medicare Part A; and (3) by an ordering professional who is granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year under 42 CFR 495.102(d)(4), except for those granted under Sec. 495.102(d)(4)(iv)(C). We are proposing changes to the conditions for significant hardship exceptions, and our proposals are discussed later in this preamble. We remind readers that consistent with section 1834(q)(4)(A) of the Act, ordering professionals must consult AUC for every applicable imaging service furnished in an applicable setting and paid under an applicable payment system unless a statutory exception applies.

      Section 1834(q)(4)(D) of the Act specifies the applicable payment systems for which AUC consultation and reporting requirements apply and, in the CY 2017 PFS final rule, consistent with the statute, we defined applicable payment system in our regulation at Sec. 414.94(b) as: (1) The PFS established under section 1848(b) of the Act; (2) the prospective payment system for hospital outpatient department services under section 1833(t) of the Act; and (3) the ambulatory surgical center payment system under section 1833(i) of the Act.

      Section 1834(q)(1)(D) of the Act specifies the applicable settings in which AUC consultation and reporting requirements apply: A physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other ``provider-led outpatient setting determined appropriate by the Secretary.'' In the CY 2017 PFS final rule, we added this definition to our regulation at Sec. 414.94(b). Proposed additional applicable settings are discussed later in this preamble.

    4. Identification of Outliers

      The fourth component of the Medicare AUC program is specified in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement that applies for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Because we established a start date of January 1, 2020 for AUC consultation and reporting requirements, we will not have identified any outlier ordering professionals by that date. As such, implementation of the prior authorization component is delayed. However, we did finalize in the CY 2017 PFS final rule the first list of priority clinical areas to guide identification of outlier ordering professionals as follows:

      Coronary artery disease (suspected or diagnosed).

      Suspected pulmonary embolism.

      Headache (traumatic and non-traumatic).

      Hip pain.

      Low back pain.

      Shoulder pain (to include suspected rotator cuff injury).

      Cancer of the lung (primary or metastatic, suspected or diagnosed).

      Cervical or neck pain.

      We are not including proposals to expand or modify the list of priority clinical areas in this proposed rule.

      4. Proposals for Continuing Implementation

      We propose to amend Sec. 414.94 of our regulations, ``Appropriate Use Criteria for Certain Imaging Services,'' to reflect the following proposals.

    5. Expanding Applicable Settings

      Section 1834(q)(1)(D) of the Act specifies that the AUC consultation and reporting requirements apply only in an applicable setting, which means a physician's office, a hospital outpatient department (including an emergency department), an ambulatory surgical center, and any other provider-led outpatient setting determined appropriate by the Secretary. In the CY 2017 PFS final rule, we codified this definition in Sec. 414.94(b). We are proposing to revise the definition of applicable setting to add an independent diagnostic testing facility (IDTF).

      We believe the addition of IDTFs to the definition of applicable setting will ensure that the AUC program is in place across outpatient settings in which outpatient advanced diagnostic imaging services are furnished. IDTFs furnish services for a large number of Medicare beneficiaries; nearly $1 billion in claims for 2.4 million beneficiaries in 2010 (OEI-05-09-00560). An IDTF is independent of a hospital or physician's office and diagnostic tests furnished by an IDTF are performed by licensed, certified non-physician personnel under appropriate physician supervision (Sec. 410.33). Like other applicable settings, IDTFs must meet the requirements specified in Sec. 410.33 of our regulations to be enrolled to furnish and bill for advanced diagnostic imaging and other IDTF services. Services that may be provided by an IDTF include, but are not limited to, magnetic resonance imaging (MRI), ultrasound, x-rays, and sleep studies. An IDTF may be a fixed location, a mobile entity, or an individual non-physician practitioner, and diagnostic procedures performed by an IDTF are paid under the PFS. IDTF services must be furnished under the appropriate level of physician supervision as specified in Sec. 410.33(b); and all procedures furnished by the IDTF must be ordered in writing by the patient's treating physician or non-physician practitioner. As such, we believe the IDTF setting is a provider-led outpatient setting appropriate for addition to the list of applicable settings under section 1834(q)(1)(D), and we propose to add IDTF to our definition of applicable setting under Sec. 414.94(b) of the regulations.

      We note that under the PFS, payment for many diagnostic tests including the advanced diagnostic imaging services to which the AUC program applies can be made either ``globally'' when the entire

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      service is furnished and billed by the same entity; or payment can be made separately for the technical component (TC) of the service and the professional component (PC) when those portions of the service are furnished and billed by different entities. In general, the TC for an advanced diagnostic imaging service is the portion of the test during which the patient is present and the image is captured. The PC is the portion of the test that involves a physician's interpretation and report on the captured image. For example, when a CT scan is ordered by a patient's treating physician, the entire test (TC and PC) could be furnished by a radiologist in their office and billed as a ``global'' service. Alternatively, the TC could be furnished and billed by an IDTF, and the PC could be furnished and billed by a radiologist in private practice. By adding IDTFs as an applicable setting, we believe we would appropriately and consistently apply the AUC program across the range of outpatient settings where applicable imaging services are furnished.

      We propose to revise the definition of applicable setting under Sec. 414.94(b) to include an IDTF. We invite comments on this proposal and on the possible inclusion of any other applicable setting. We remind commenters that application of the AUC program is not only limited to applicable settings, but also to services for which payment is made under applicable payment systems (the physician fee schedule, the OPPS, and the ASC payment system).

    6. Consultations by Ordering Professionals

      Section 1834(q)(1)(E) of the Act defines the term ``ordering professional'' as a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who orders an applicable imaging service. The AUC consultation requirement applies to these ordering professionals. We are proposing that the consultation with AUC through a qualified CDSM may be performed by clinical staff working under the direction of the ordering professional, subject to applicable State licensure and scope of practice law, when the consultation is not performed personally by the ordering professional whose NPI will be listed on the order for an advanced imaging service.

      In response to the CY 2018 PFS proposed rule, we received several public comments requesting clarification regarding who is required to perform the consultation of AUC through a qualified CDSM. Commenters not only sought clarification, but also provided recommendations for requirements around this topic. Some commenters recommended that CMS strictly interpret the statutory language and only allow the clinician placing the order to perform the consultation and others recommended that CMS allow others to perform the AUC consultation on behalf of the clinician.

      Section 1834(q)(4)(A)(i) of the Act requires an ordering professional to consult with a qualified CDSM, and this was codified in our regulations at Sec. 414.94(j). The statute does not explicitly provide for consultations under the AUC program to be fulfilled by other professionals, individuals or organizations on behalf of the ordering professional; however, we continue to seek ways to minimize the burden of this new Medicare program and understand that many practices currently use clinical staff, working under the direction of the ordering professional, to interact with the CDSM for AUC consultation and subsequent ordering of advanced diagnostic imaging. Therefore, we propose to modify paragraph Sec. 414.94(j) to specify that additional individuals may perform the required AUC consultation.

      When the AUC consultation is not performed personally by the ordering professional, we propose the consultation may be performed by auxiliary personnel incident to the ordering physician or non-physician practitioner's professional service. We believe this approach is appropriate under this program and still accomplishes the goal of promoting the use of AUC. This proposed policy would allow the ordering professional to exercise their discretion to delegate the performance of this consultation. It is important to note that the ordering professional is ultimately responsible for the consultation as their NPI is reported by the furnishing professional on the claim for the applicable imaging service; and that it is the ordering professional who could be identified as an outlier ordering professional and become subject to prior authorization based on their ordering pattern.

      We propose to revise the AUC consultation requirement specified at Sec. 414.94(j) to specify that the AUC consultation may be performed by auxiliary personnel under the direction of the ordering professional and incident to the ordering professional's services.

    7. Reporting AUC Consultation Information

      Section 1834(q)(4)(B) of the Act requires that payment for an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system may only be made if the claim for the service includes certain information about the AUC consultation. As such, the statute requires that AUC consultation information be included on any claim for an outpatient advanced diagnostic imaging service, including those billed and paid under any applicable payment system (the PFS, OPPS or ASC payment system). When we initially codified the AUC consultation reporting requirement in Sec. 414.94(k) through rulemaking in the CY 2018 PFS final rule, we specified only that ``furnishing professionals'' must report AUC consultation information on claims for applicable imaging services. This led some stakeholders to believe that AUC consultation information would be required only on practitioner claims. To better reflect the statutory requirements of section 1834(q)(4)(B) of the Act, we are proposing to revise our regulations to clarify that AUC consultation information must be reported on all claims for an applicable imaging service furnished in an applicable setting and paid for under an applicable payment system. The revised regulation would more clearly express the scope of advanced diagnostic imaging services that are subject to the AUC program, that is, those furnished in an applicable setting and paid under an applicable payment system.

      The language codified in Sec. 414.94(k) uses the term furnishing professional to describe who must report the information on the Medicare claims. We recognize that section 1834(q)(1)(F) of the Act specifies that a ``furnishing professional'' is a physician (as defined in section 1861(r)) or a practitioner described in section 1842(b)(18)(C) who furnishes an applicable imaging service. However, because section 1834(q)(4)(B) of the Act, as described above, clearly includes all claims paid under applicable payment systems without exclusion, we believe that the claims from both furnishing professionals and facilities must include AUC consultation information. In other words, we would expect this information to be included on the practitioner's claim for the professional component of the applicable advanced diagnostic imaging service and on the provider's or supplier's claim for the facility portion or TC of the imaging service.

      As such, we propose to revise Sec. 414.94(k) to clearly reflect the scope of claims for which AUC consultation information must be reported, and to clarify that the requirement to report AUC consultation information is not limited to the furnishing professional.

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    8. Claims-Based Reporting

      In the CY 2018 PFS proposed rule (82 FR 34094) we discussed using a combination of G-codes and modifiers to report the AUC consultation information on the Medicare claim. We received numerous public comments objecting to this potential solution. In the 2018 PFS final rule, we agreed with many of the commenters that additional approaches to reporting AUC consultation information on Medicare claims should be considered, and we learned from many commenters that reporting a unique consultation identifier (UCI) would be a less burdensome and preferred approach. The UCI would include all the information required under section 1834(q)(4)(B) of the Act including an indication of AUC adherence, non-adherence and not applicable responses. Commenters noted that capturing a truly distinguishing UCI on the claim will allow for direct mapping from a single AUC consultation to embedded information within a CDSM. We indicated that we would work with stakeholders to further explore the concept of using a UCI to satisfy the requirements of section 1834(q)(4)(B) of the Act, which will be used for Medicare claims processing and, ultimately, for the identification of outlier ordering professionals, and consider developing a taxonomy for a UCI.

      We had the opportunity to engage with some stakeholders over the last 6 months and we understand that some commenters from the previous rule continue to be in favor of a UCI, while some may have changed their position upon further consideration.

      We provide the following information to summarize alternatives we considered. CMS had originally considered assigning a G-code for every qualified CDSM with a code descriptor containing the name of the qualified CDSM. The challenge to this approach arises when there is more than one advanced imaging service on a single claim. CMS could attribute a single G-code to all of the applicable imaging services for the patient's clinical condition on the claim, which might be appropriate if each AUC consultation for each service was through the same CDSM. If a different CDSM was used for each service (for example, when services on a single claim were ordered by more than one ordering professional and each ordering professional used a different CDSM) then multiple G-codes could be needed on the claim. Each G-code would appear on the claim individually as its own line item. As a potential solution, we considered the use of modifiers, which are appealing because they would appear on the same line as the CPT code that identifies the specific billed service. Therefore, information entered onto a claim would arrive into the claims processing system paired with the relevant AUC consultation information.

      When reporting the required AUC consultation information based on the response from a CDSM: (1) The imaging service would adhere to the applicable AUC; (2) the imaging service would not adhere to such criteria; or (3) such criteria were not applicable to the imaging service ordered, three modifiers could be developed. These modifiers, when placed on the same line with the CPT code for the advanced imaging service would allow this information to be easily accessed in the Medicare claims data and matched with the imaging service.

      Stakeholders have made various suggestions for a taxonomy that could be used to develop a UCI to report the required information. Stakeholders have also considered where to place the UCI on the claim. We understand the majority of solutions suggested by stakeholders involving a UCI are claim-level solutions and would not allow CMS to attribute the CDSM used or the AUC adherence status (adherent or not adherent, or not applicable) to a specific imaging service. As such, the approach of using a UCI would not identify whether an AUC consultation was performed for each applicable imaging service reported on a claim form, or be useful for purposes of identifying outlier ordering professionals in accordance with section 1834(q)(5) of the Act.

      We have received ideas from stakeholders that are both for and against the two approaches we have identified; and we appreciate the stakeholders that have provided additional information or engaged us in this discussion. Internally, we have explored the possibility of using and feasibility of developing a UCI, and concluded that, although we initiated this approach during the CY 2018 PFS final rule, it is not feasible to create a uniform UCI taxonomy, determine a location of the UCI on the claims forms, obtain the support and permission by national bodies to use claim fields for this purpose, and solve the underlying issue that the UCI seems limited to claim-level reporting. Using coding structures that are already in place (such as G-codes and modifiers) would allow CMS to establish reporting requirements prior to the start of the program (January 1, 2020).

      Since we did not finalize a proposal in the CY 2018 PFS final rule, we propose in this rule to use established coding methods, to include G-codes and modifiers, to report the required AUC information on Medicare claims. This will allow the program to be implemented by January 1, 2020. We will consider future opportunities to use a UCI and look forward to continued engagement with and feedback from stakeholders.

    9. Significant Hardship Exception

      We are proposing to revise Sec. 414.94(i)(3) of our regulations to adjust the significant hardship exception requirements under the AUC program. We are proposing criteria specific to the AUC program and independent of other programs. An ordering professional experiencing any of the following when ordering an advanced diagnostic imaging service would not be required to consult AUC using a qualified CDSM, and the claim for the applicable imaging service would not be required to include AUC consultation information. The proposed criteria include:

      Insufficient internet access;

      EHR or CDSM vendor issues; or

      Extreme and uncontrollable circumstances.

      Insufficient internet access is specific to the location where an advanced diagnostic imaging service is ordered by the ordering professional. EHR or CDSM vendor issues may include situations where ordering professionals experience temporary technical problems, installation or upgrades that temporarily impede access to the CDSM, vendors cease operations, or CMS de-qualifies a CDSM. CMS expects these situations to generally be irregular and unusual. Extreme and uncontrollable circumstances include disasters, natural or man-made, that have a significant negative impact on healthcare operations, area infrastructure or communication systems. These could include areas where events occur that have been designated a Federal Emergency Management Agency (FEMA) major disaster or a public health emergency declared by the Secretary. Based on 2016 data from the Medicare EHR Incentive Program and the 2019 payment year MIPS eligibility and special status file, we estimate that 6,699 eligible clinicians could submit such a request due to extreme and uncontrollable circumstances or as a result of a decertification of an EHR, which represents less than 1-percent of available ordering professionals.

      In the CY 2017 PFS final rule, for purposes of the AUC program significant hardship exceptions, we

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      provided that those who received significant hardship exceptions in the following categories from Sec. 495.102(d)(4) would also qualify for significant hardship exceptions for the AUC program:

      Insufficient Internet Connectivity (as specified in Sec. 495.102(d)(4)(i)).

      Practicing for less than 2 years (as specified in Sec. 495.102(d)(4)(ii)).

      Extreme and Uncontrollable Circumstances (as specified in Sec. 495.102(d)(4)(iii)).

      Lack of Control over the Availability of CEHRT (as specified in Sec. 495.102(d)(4)(iv)(A)).

      Lack of Face-to-Face Patient Interaction (as specified in Sec. 495.102(d)(4)(iv)(B)).

      In the CY 2018 PFS proposed rule, we proposed to amend the AUC significant hardship exception regulation to specify that ordering professionals who are granted reweighting of the Advancing Care Information (ACI) performance category to zero percent of the final score for the year under MIPS per Sec. 414.1380(c)(2) due to circumstances that include the criteria listed in Sec. 495.102(d)(4)(i), (d)(4)(iii), and (d)(4)(iv)(A) and (B) (as outlined in the bulleted list above) would be excepted from the AUC consultation requirement during the same year that the re-weighting applies for purposes of the MIPS payment adjustment. This proposal removed Sec. 495.102(d)(4)(ii), practicing for less than 2 years, as a criterion since these clinicians are not MIPS eligible clinicians and thus would never meet the criteria for reweighting of their MIPS ACI performance category for the year.

      In response to public comments, we did not finalize the proposed changes to the significant hardship exceptions in the CY 2018 PFS final rule and instead decided further evaluation was needed before moving forward with any modifications. As we have continued to evaluate both policy options and operational considerations for the AUC significant hardship exception, we have concluded that the most appropriate approach, which we consider to be more straightforward and less burdensome than the current approach, involves establishing significant hardship criteria and a process that is independent from other Medicare programs. Our original intention was to design the AUC significant hardship exception process in alignment with the process for the Medicare EHR Incentive Program for eligible professionals, and then for the MIPS ACI (now Promoting Interoperability) performance category. Under section 1848(a)(7)(A) of the Act, the downward payment adjustment for eligible professionals under the Medicare EHR Incentive Program will end in 2018, and we are unable to continue making reference to a regulation relating to a program that is no longer in effect. We also note as we have in the past that the AUC program is a real-time program with a need for real-time significant hardship exceptions. This is in contrast to the way significant hardship exceptions are handled under MIPS where the hardship might impact some or all of a performance period, or might impact reporting, both of which occur well before the MIPS payment adjustment is applied in a subsequent year. We recognize that when a significant hardship arises, an application process to qualify for an exception becomes a time consuming hurdle for health care providers to navigate, and we believe that it is important to minimize the burden involved in seeking significant hardship exceptions. As such, we are proposing that ordering professionals would self-attest if they are experiencing a significant hardship at the time of placing an advanced diagnostic imaging order and such attestation be supported with documentation of significant hardship. Ordering professionals attesting to a significant hardship would communicate that information, along with the AUC consultation information, to the furnishing professional with the order and it would be reflected on the furnishing professional's and furnishing facility's claim by appending a HCPCS modifier. The modifier would indicate that the ordering professional has self-attested to experiencing a significant hardship and communicated this to the furnishing professional with the order. Claims for advanced diagnostic imaging services that include a significant hardship exception modifier would not be required to include AUC consultation information.

      In addition to the proposals above, we invite the public to comment on any additional circumstances that would cause the act of consulting AUC to be particularly difficult or challenging for the ordering professional, and for which it may be appropriate for an ordering professional to be granted a significant hardship exception under the AUC program. While we understand the desire by some for significant hardship categories unrelated to difficulty in consulting AUC through a CDSM, we remind readers that circumstances that are not specific to AUC consultation, such as the ordering professional being in clinical practice for a short period of time or having limited numbers of Medicare patients, would not impede clinicians from consulting AUC through a CDSM as required to meet the requirements of this program.

    10. Identification of Outliers

      As previously mentioned, the fourth component of the AUC program specified in section 1834(q)(5) of the Act, is the identification of outlier ordering professionals. In our efforts to start a dialogue with stakeholders, we would like to invite the public to submit their ideas on a possible methodology for the identification of outlier ordering professionals who would eventually be subject to a prior authorization process when ordering advanced diagnostic imaging services. Specifically, we are soliciting comments on the data elements and thresholds that CMS should consider when identifying outliers. We also intend to perform and use analysis to assist us in developing the outlier methodology for the AUC program. Our existing prior authorization programs generally do not specifically focus on outliers. We are interested in hearing ideas from the public on how outliers could be determined for the AUC program. Because we would be concerned about data integrity and reliability, we do not intend to include data from the educational and operations testing period in CY 2020 in the analysis used to develop our outlier methodology. Since we intend to evaluate claims data to inform our methodology we expect to address outlier identification and prior authorization more fully in CY 2022 or 2023 rulemaking. As noted above, we expect to solicit public comment to inform our methodology through rulemaking before finalizing our approach.

      We note that we may not provide comprehensive comment summaries and responses to comments submitted in response to this solicitation. Rather, we will actively consider all input as we develop the methodology for the identification of outliers.

      5. Summary

      Section 1834(q) of the Act includes rapid timelines for establishing a Medicare AUC program for advanced diagnostic imaging services. The impact of this program is extensive as it will apply to every physician or other practitioner who orders or furnishes advanced diagnostic imaging services (for example, MRI, computed tomography (CT) or positron emission tomography (PET)). This crosses almost every medical specialty and could have a particular impact on primary care

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      physicians since their scope of practice can be quite broad.

      We continue to believe the best implementation approach is one that is diligent, maximizes the opportunity for public comment and stakeholder engagement, and allows for adequate advance notice to physicians and practitioners, beneficiaries, AUC developers, and CDSM developers. It is for these reasons we propose to continue a stepwise approach, adopted through notice and comment rulemaking.

      In summary, we are proposing policies to modify existing requirements and criteria and to provide further clarification on implementation of the AUC program. We include a proposal to add IDTFs to the definition of applicable settings under this program. We also include proposals regarding who beyond the ordering professional may consult AUC through a qualified CDSM to meet the statutory requirements for the AUC program, as well as a proposal to more clearly include all entities required to report AUC consultation information on the claim. Finally, we propose to modify the significant hardship exception criteria and process under Sec. 414.94(i)(3) to be specific to the AUC program and independent of other Medicare programs. We are also requesting public comment on other circumstances that could be considered significant hardships, posing particular real-time difficulty or challenge to the ordering professional in consulting AUC. We invite the public to submit comments on these proposals, as well as provide comment on potential methods for, and issues related to, mechanisms for claims-based reporting and identifying outlier ordering professionals.

      We will continue to post information on our website for this program, accessible at www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.

  40. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs)

    1. Background

    Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the incentive payments made to Medicaid EPs and eligible hospitals for the adoption, implementation, upgrade, and meaningful use of CEHRT. We have implemented these statutory provisions in prior rulemakings to establish the Medicaid Promoting Interoperability Programs.

    Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the Act, and the definition of ``meaningful EHR user'' in regulations at Sec. 495.4, one of the requirements of being a meaningful EHR user is to successfully report the clinical quality measures selected by CMS to CMS or a state, as applicable, in the form and manner specified by CMS or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act requires that in selecting electronic clinical quality measures (eCQMs) for EPs to report under the Promoting Interoperability Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required. We have taken steps to align various quality reporting and payment programs that include the submission of eCQMs.

    In the ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices'' final rule (82 FR 37990, 38487) (hereafter referred to as the ``FY 2018 IPPS/LTCH PPS final rule''), we established that, for 2017, Medicaid EPs would be required to report on any six eCQMs that are relevant to the EP's scope of practice. In proposing and finalizing that change, we indicated that it is our intention to align eCQM requirements for Medicaid EPs with the requirements of Medicare quality improvement programs, to the extent practicable.

    2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting Interoperability Program for 2019

    CMS annually reviews and revises the list of eCQMs for each MIPS performance year to reflect updated clinical standards and guidelines. In section III.H.3.h.(2)(b)(i) of this proposed rule, we are proposing to amend the list of available eCQMs for the CY 2019 performance period. To keep eCQM specifications current and minimize complexity, we propose to align the eCQMs available for Medicaid EPs in 2019 with those available for MIPS eligible clinicians for the CY 2019 performance period. Specifically, we propose that the eCQMs available for Medicaid EPs in 2019 would consist of the list of quality measures available under the eCQM collection type on the final list of quality measures established under MIPS for the CY 2019 performance period.

    We believe that this proposal would be responsive to stakeholder feedback supporting quality measure alignment between MIPS and the Medicaid Promoting Interoperability Program for EPs, and that it would encourage EP participation in the Medicaid Promoting Interoperability Program by allowing those that are also MIPS eligible clinicians the ability to report the same eCQMs as they report for MIPS in 2019. In addition, we believe that aligning the eCQMs available in each program would ensure the most uniform application of up-to-date clinical standards and guidelines possible.

    We anticipate that this proposal would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, particularly in light of our belief that many EPs will report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on the available eCQMs for 2019. We expect that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems for 2019 to maintain current eCQM lists and specifications.

    We also request comments on whether in future years of the Medicaid Promoting Interoperability Program beyond 2019, we should include all e-specified measures from the core set of quality measures for Medicaid and the Children's Health Insurance Program (CHIP) (the Child Core Set) and the core set of health care quality measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter together referred to as ``Core Sets'') as additional options for Medicaid EPs. Sections 1139A and 1139B of the Act require the Secretary to identify and publish core sets of health care quality measures for child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries. These measure sets are required by statute to be updated annually and are voluntarily reported by states to CMS. These core sets comprise measures that specifically focus on populations served by the Medicaid and CHIP programs and are of particular importance to their care. Several of these Core Set measures are included in the MIPS eCQM list, but some are not. We believe that including as eCQM reporting options for Medicaid

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    EPs the e-specified measures from the Core Sets that are not also on the MIPS eCQM list would increase EP utilization of these measures and provide states with better data to report. At this time, the only measure within the Core Sets that would not be available as an option for Medicaid EPs in 2019 (because it is not on the MIPS eCQM list) is NQF-1360, ``Audiological Diagnosis No Later Than 3 Months of Age.'' However, as these Core Sets are updated annually, there may be other eCQMs that could be included in future years.

    For 2019, we propose that Medicaid EPs would report on any six eCQMs that are relevant to the EP's scope of practice, regardless of whether they report via attestation or electronically. After we removed the NQS domain requirements for EPs' 2017 eCQM submissions in the FY 2018 IPPS/LTCH PPS final rule, we have found that allowing EPs to report on any six quality measures that are relevant to their practice has increased EPs' flexibility to report pertinent data. In addition, this policy would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established at Sec. 414.1335(a)(1). MIPS eligible clinicians who elect to submit eCQMs must submit data on at least six quality measures, including at least one outcome measure (or, if an applicable outcome measure is not available, one other high priority measure). We refer readers to Sec. 414.1335(a)(2) and (3) for the data submission criteria that apply to individual MIPS eligible clinicians and groups who elect to submit data for other collection types.

    We also propose that for 2019 the Medicaid Promoting Interoperability Program would adopt the MIPS requirement that EPs report on at least one outcome measure (or, if an applicable outcome measure is not available or relevant, one other high priority measure). We also request comments on how high priority measures should be identified for Medicaid EPs. We propose to use all three of the following methods to identify which of the available measures are high priority measures, but invite comments on other possibilities.

    1. We would use the same set of high priority measures for EPs participating in the Medicaid Promoting Interoperability Program that the MIPS program has identified for eligible clinicians. We note that in section III.H., we are proposing to amend Sec. 414.1305 to revise the definition of high priority measure for purposes of MIPS to mean an outcome (including intermediate-outcome and patient-reported outcome), appropriate use, patient safety, efficiency, patient experience, care coordination, or opioid-related quality measure, beginning with the 2021 MIPS payment year.

    2. For 2019, we would also identify as high priority measures the available eCQMs that are included in the previous year's Core Sets and that are also included on the MIPS list of eCQMs. Because the Core Sets are released at the beginning of each year, it would not be possible to update the list of high-priority eCQMs with those added to the current year's Core Sets. CMS has already identified the measures included in the Core Sets as ones that specifically focus on populations served by the Medicaid and CHIP programs and are particularly important to their care. The eCQMs that would be available for EPs to report in 2019, that are both part of the Core Sets and on the MIPS list of eCQMs, and that would be considered high priority measures under our proposal are: CMS2, ``Preventive Care and Screening: Screening for Depression and Follow-Up Plan''; CMS4, ``Initiation and Engagement of Alcohol and Other Drug Dependence Treatment''; CMS122, ``Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%)''; CMS125, ``Breast Cancer Screening''; CMS128, ``Anti-depressant Medication Management''; CMS136, ``Follow-Up Care for Children Prescribed ADHD Medication (ADD)''; CMS153, ``Chlamydia Screening for Women''; CMS155, ``Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents''; and CMS165, ``Controlling High Blood Pressure.''

    3. We would also give each state the flexibility to identify which of the available eCQMs selected by CMS are high priority measures for EPs in that state, with review and approval from CMS, through their State Medicaid HIT Plans (SMHP), similar to the flexibility granted states to modify the definition of Meaningful Use at Sec. 495.332(f). This would give states the ability to identify as high priority those measures that align with their state health goals or other programs within the state. We proposed to amend Sec. 495.332(f) to provide for this state flexibility to identify high priority measures.

    We propose that any eCQMs identified via any of these mechanisms be considered to be high priority measures for EPs participating in the Medicaid Promoting Interoperability Program for 2019. We invite comments on whether all three of these methods should be utilized (as proposed) or whether there are reasons to instead use a subset of these methods, or only one of them.

    We also propose that the eCQM reporting period for EPs in the Medicaid Promoting Interoperability Program would be a full CY in 2019 for EPs who have demonstrated meaningful use in a prior year, in order to align with the corresponding performance period in MIPS for the quality performance category. We continue to align Medicaid Promoting Interoperability Program requirements with requirements for other CMS quality programs, such as MIPS, to the extent practicable, to reduce the burden of reporting different data for separate programs. In addition, we have found that clinical quality data from an entire year reporting period is significantly more useful than partial year data for quality measurement and improvement because it gives states a fuller picture of a health care provider's care and patient outcomes. The eCQM reporting period for EPs demonstrating meaningful use for the first time, which was established in the final rule entitled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program--

    Stage 3 and Modifications to Meaningful Use in 2015 Through 2017'' (80 FR 62762) (hereafter referred to as ``Stage 3 final rule''), would remain any continuous 90-day period (80 FR 62892).

    We will adjust future years' requirements for reporting eCQMs in the Medicaid Promoting Interoperability Program as necessary, through rulemaking, and will continue to align the quality reporting requirements, as logical and feasible, to minimize EP burden.

    We invite public comment on these proposals.

    3. Proposed Revisions to the EHR Reporting Period and eCQM Reporting Period in 2021 for EPs Participating in the Medicaid Promoting Interoperability Program

    In the July 28, 2010 final rule titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive Program'' at 75 FR 44319, we established that, in accordance with section 1903(t)(4)(A)(iii) of the Act, in no case may any Medicaid EP receive an incentive after 2021 (see Sec. 495.310(a)(2)(v)). Therefore, December 31, 2021 is the last date that states could make Medicaid Promoting Interoperability Program payments to Medicaid EPs (other than pursuant to a successful appeal related to 2021 or a prior year).

    For states to make payments by that deadline, there must be sufficient time after EHR and eCQM reporting periods

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    end for EPs to attest to states, for states to conduct their prepayment processes, and for states to issue payments. Therefore, we propose to amend Sec. 495.4 to provide that the EHR reporting period in 2021 for all EPs in the Medicaid Promoting Interoperability Program would be a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. Similarly, we propose to change the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program to a minimum of any continuous 90-

    day period within CY 2021, provided that the end date for this period falls before October 31, 2021, to help ensure that the state can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021.

    We understand that the October 31, 2021 date might not provide some states with sufficient time to process payments by December 31, 2021. We believe that states are best positioned to determine the last possible date in CY 2021 by which the EHR or eCQM reporting periods for Medicaid EPs must end, and the deadline for receiving EP attestations, so that the state is able to issue all payments by December 31, 2021. Therefore, we propose to allow states the flexibility to set alternative, earlier final deadlines for EHR or eCQM reporting periods for Medicaid EPs in CY 2021, with prior approval from us, through their State Medicaid HIT Plan (SMHP). If a state establishes an alternative, earlier date within CY 2021 by which all EHR or eCQM reporting periods in CY 2021 must end, Medicaid EPs in that state would continue to have a reporting period of a minimum of any continuous 90-day period within CY 2021. The end date for the reporting period would have to occur before the day of attestation, which must occur prior to the final deadline for attestations established by their state. We proposed to amend Sec. 495.332(f) to provide for this state flexibility to identify an alternative date by which all EHR reporting periods or eCQM reporting periods for Medicaid EPs in CY 2021 must end.

    We believe there is no reason why a state would need to set a date by which EHR reporting periods and eCQM reporting periods must end for Medicaid EPs that is earlier than the day before that state's attestation deadline for EPs. Doing so would restrict EPs' ability to select EHR and eCQM reporting periods. Therefore, we propose that any alternative deadline for CY 2021 EHR and eCQM reporting periods set by a state may not be any earlier than the day prior to the attestation deadline for Medicaid EPs attesting to that state.

    We invite public comment on this proposal.

    While we are not making any proposals regarding eligible hospitals in this proposed rule, we acknowledge that there will be a similar issue if there are still hospitals eligible to receive Medicaid Promoting Interoperability Program payments in 2021, including Medicaid-only eligible hospitals as well as ``dually-eligible'' eligible hospitals and critical access hospitals (CAHs) (those that are eligible for an incentive payment under Medicare for meaningful use of CEHRT and/or subject to the Medicare payment reduction for failing to demonstrate meaningful use of CEHRT, and are also eligible to earn a Medicaid incentive payment for meaningful use of CEHRT). However, based on attestation data and information from states' SMHPs regarding the number of years states disburse Medicaid Promoting Interoperability Program payments to hospitals, we believe that there will be no hospitals eligible to receive Medicaid Promoting Interoperability Program payments in 2021 due to the requirement that, after 2016, eligible hospitals cannot receive a Medicaid Promoting Interoperability Program payment unless they have received such a payment in the prior fiscal year. At this time, we believe that there are no hospitals that will be able to receive incentive payments in 2020 or 2021. We invite comments and suggestions on whether this belief is accurate, and if not, how we could address the issue in a manner that limits the burden on hospitals and states. We are not proposing any specific policy in this rule, but, if necessary, we expect to address the issue in a future proposed rule that is more specifically related to hospital payment.

    4. Proposed Revisions to Stage 3 Meaningful Use Measures for Medicaid EPs

    1. Proposed Change to Objective 6 (Coordination of Care Through Patient Engagement)

      In the Stage 3 final rule, we adopted a phased approach under Stage 3 for EP Objective 6 (Coordination of care through patient engagement), Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging). This phased approach established a 5 percent threshold for both measures 1 and 2 of this objective for an EHR reporting period in 2017. (80 FR 62848 through 62849) In the same rule, we established that the threshold for Measure 1 would rise to 10 percent, beginning with the EHR reporting period in 2018, and that the threshold for Measure 2 would rise to 25 percent, beginning with the EHR reporting period in 2018 We stated that we would continue to monitor performance on these measures to determine if any further adjustment was needed. In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38493), we established a policy allowing EPs, eligible hospitals, and CAHs to use either 2014 Edition or 2015 Edition CEHRT, or a combination of 2014 Edition and 2015 Edition CEHRT, for an EHR reporting period in CY 2018, and depending on which Edition(s) they use, to attest to the Modified Stage 2 objectives and measures or the Stage 3 objectives and measures. In doing so, we also delayed the rise of the Objective 6 Measure 1 and Measure 2 thresholds until 2019.

      Based on feedback we have received, we understand that these two measures are the largest barrier to successfully demonstrating meaningful use, especially in rural areas and at safety net clinics. Stakeholders have reported a variety of causes that have resulted in lower patient participation than was anticipated when the Stage 3 final rule was issued. The data that we have collected via states for Medicaid EPs and at CMS from Medicare EPs for previous program years supports this feedback. The primary issue is that the view, download, transmit measure requires a positive action by patients, which cannot be controlled by an EP. Medicaid populations that are at the greatest risk have lower levels of internet access, internet literacy and health literacy than the general population. While the Secure Electronic Messaging measure does not require patient action, only that the EP send a secure message, we have received feedback that this functionality is not highly utilized by patients. While we encourage EPs to continue to reach out to patients via secure messaging to engage them in their health care between office visits, it is not productive for EPs to send messages to patients who are unlikely to see them or take action. Retaining the current threshold of 5 percent for both measures would continue to incentivize EPs to engage patients in their own care without raising the requirements to unattainable thresholds for EPs who serve vulnerable Medicaid patients. Therefore, we propose to amend Sec. 495.24(d)(6)(i) such that the thresholds

      Page 35874

      for Measure 1 (View, Download, or Transmit) and Measure 2 (Secure Electronic Messaging) of Meaningful Use Stage 3 EP Objective 6 (Coordination of care through patient engagement) would remain 5 percent for 2019 and subsequent years.

      We invite comments on this proposal.

    2. Proposed Change to the Syndromic Surveillance Reporting Measure

      In the Stage 3 final rule, we established that the syndromic surveillance reporting measure for EPs was limited to those who practice in urgent care settings (80 FR 62866 through 62870). Since then, we have received feedback from states and public health agencies that while many are unable to accept non-emergency or non-urgent care ambulatory syndromic surveillance data electronically, some public health agencies can and do want to receive data from health care providers in non-urgent care settings. We believe that public health agencies that set the requirements for data submission to public health registries are in a better position to judge which health care providers can contribute useful data.

      Therefore, we propose to amend Sec. 495.24(d)(8)(i)(B)(2), EP Objective 8 (Public health and clinical data registry reporting), Measure 2 (Syndromic surveillance reporting measure), to amend the language restricting the use of syndromic surveillance reporting for meaningful use only to EPs practicing in an urgent care setting. We propose to include any EP defined by the state or local public health agency as a provider who can submit syndromic surveillance data. This change would not alter the exclusion for this measure at Sec. 495.25(d)(8)(i)(C)(2)(i), for EPs who are not in a category of health care providers from which ambulatory syndromic surveillance data is collected by their jurisdiction's syndromic surveillance system, as defined by the state or local public health agency. Furthermore, this does not create any requirements for syndromic surveillance registries to include all EPs. Additionally, under the specifications for the 2015 Edition of CEHRT for syndromic surveillance, it is possible that an EP could own CEHRT and submit syndromic surveillance in a format that is not accepted by the local jurisdiction. In this case, the EP may take an exclusion for syndromic surveillance.

      We invite comments on this proposal.

  41. Medicare Shared Savings Program

    As required under section 1899 of the Act, we established the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among health care providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule establishing the Shared Savings Program appeared in the November 2, 2011 Federal Register (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule (76 FR 67802) (hereinafter referred to as the ``November 2011 final rule''). A subsequent major update to the program rules appeared in the June 9, 2015 Federal Register (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule (80 FR 32692) (hereinafter referred to as the ``June 2015 final rule'')). The final rule entitled, ``Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations,'' which addressed changes related to the program's financial benchmark methodology, appeared in the June 10, 2016 Federal Register (81 FR 37950) (hereinafter referred to as the ``June 2016 final rule'').

    We have also made use of the annual calendar year (CY) Physician Fee Schedule (PFS) rules to address quality reporting for the Shared Savings Program and certain other issues. In the CY 2018 PFS final rule (82 FR 53209 through 53226), we finalized revisions to several different policies under the Shared Savings Program, including the assignment methodology, quality measure validation audit process, use of the skilled nursing facility (SNF) 3-day waiver, and handling of demonstration payments for purposes financial reconciliation and establishing historical benchmarks. In addition, in the CY 2017 Quality Payment Program final rule (81 FR 77255 through 77260) and the CY 2018 Quality Payment Program final rule (82 FR 53688 through 53706), we finalized policies related to the Alternative Payment Model (APM) scoring standard under the Merit-Based Incentive Payment System (MIPS), which reduces the reporting burden for MIPS eligible clinicians who participate in MIPS APMs, such as the Shared Savings Program, by: (1) Using the CAHPS for ACOs survey and the ACO reported CMS Web Interface quality data for purposes of assessing quality performance in the Shared Savings Program and to score the MIPS quality performance category for these eligible clinicians; (2) automatically awarding MIPS eligible clinicians participating in Shared Savings Program ACOs a minimum of one-half of the total points in the MIPS improvement activities performance category; (3) requiring ACO participants to report Advancing Care Information (ACI) data at the group practice level or solo practitioner level; and (4) not assessing MIPS eligible clinicians on the MIPS cost performance category because, through their participation in the ACO, they are already being assessed on cost and utilization under the Shared Savings Program.

    As a general summary, we are proposing the following changes to the quality performance measures that will be used to assess quality performance under the Shared Savings Program for performance year 2019 and subsequent years:

    Changes to Patient Experience of Care Survey measures.

    Changes to CMS Web Interface and Claims-Based measures.

    1. Quality Measurement

    1. Background

      Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. In the November 2011 final rule, we established a quality performance standard consisting of 33 measures across four domains, including patient experience of care, care coordination/patient safety, preventive health, and at-risk population (76 FR 67872 through 67891). Since the Shared Savings Program was established, we have updated the measures that comprise the quality performance standard for the Shared Savings Program through the annual rulemaking in the CY 2015, 2016, and 2017 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 71268, and 81 FR 80484 through 80489, respectively).

      As we stated in the November 2011 final rule establishing the Shared Savings Program (76 FR 67872), our principal goal in selecting quality measures for ACOs has been to identify

      Page 35875

      measures of success in the delivery of high-quality health care at the individual and population levels, with a focus on outcomes.

      For performance year 2018, 31 quality measures are used to determine ACO quality performance (81 FR 80488 and 80489). Quality measures are submitted by the ACO through the CMS Web Interface, calculated by CMS from administrative and claims data, and collected via a patient experience of care survey referred to as the Consumer Assessment of Healthcare Provider and Systems (CAHPS) for ACOs Survey. The CAHPS for ACOs survey is based on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) Survey and includes additional, program specific questions that are not part of the CG-CAHPS. The CG-CAHPS survey is maintained, and periodically updated, by the Agency for Healthcare Research and Quality (AHRQ).

      The quality measures collected through the CMS Web Interface in 2015 and 2016 were used to determine whether eligible professionals participating in an ACO would avoid the PQRS and automatic Physician Value-Based Payment Modifier (Value Modifier) downward payment adjustments for 2017 and 2018 and to determine if ACO participants were eligible for upward, neutral or downward adjustments based on quality measure performance under the Value Modifier. Beginning with the 2017 performance period, which impacts payments in 2019, PQRS and the Value Modifier were replaced by the MIPS. Eligible clinicians who are participating in an ACO and subject to MIPS (MIPS eligible clinicians) will be scored under the alternative payment model (APM) scoring standard under MIPS (81 FR 77260). These MIPS eligible clinicians include any eligible clinicians who are participating in an ACO in a track of the Shared Savings Program that is an Advanced APM, but who do not become Qualifying APM Participants (QPs) as specified in Sec. 414.1425, and are not otherwise excluded from MIPS. Beginning with the 2017 reporting period, measures collected through the CMS Web Interface will be used to determine the MIPS quality performance category score for MIPS eligible clinicians participating in a Medicare Shared Savings Program ACO. Starting with the 2018 performance period, the quality performance category under the MIPS APM Scoring Standard for MIPS eligible clinicians participating in a Shared Savings Program ACO will include measures collected through the CMS Web Interface and the CAHPS for ACOs survey measures.

      The CAHPS for ACOs Survey includes the core questions contained in the CG-CAHPS, plus additional questions to measure access to and use of specialist care, experience with care coordination, patient involvement in decision-making, experiences with a health care team, health promotion and patient education, patient functional status, and general health. From 2014 through 2017, ACOs had the option to use a short version of the survey (8 Summary Survey Measures (SSMs) used in assessing quality performance, 1 SSM scored for informational purposes) or a longer version of the survey (8 SSMs used in determining quality performance and 4 SSMs scored for informational purposes). Although not all measures in the longer version of the survey were used in determining the ACO's quality score, the measure performance rate information could be used by the ACO in its quality improvement efforts. For 2018, CMS will only offer one version of the CAHPS for ACOs survey. Eight SSMs will be used in quality determination and two SSMs will be scored for informational purposes. There were no changes to the scored measure set between the 2017 and 2018 surveys: The 2018 survey is a streamlined version of the survey that assesses the same content areas required in 2017, using fewer survey items.

      The 2018 CAHPS for ACOs survey incorporates updates made by AHRQ to the Clinician and Group (CG) CAHPS survey that were based on feedback from survey users and stakeholders as well as analyses of multiple data sets. In the ``Notice of Proposed Changes for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician & Group Survey'' published in the January 21, 2015 Federal Register (80 FR 2938-2939), AHRQ solicited public comment on proposed updates to produce the CAHPS Clinician & Group Survey v. 3.0. Based on analyses of multiple data sets and comments received from the public, AHRQ, released the CAHPS Clinician & Group Survey v. 3.0. The 2018 CAHPS for ACOs survey includes language refinements and core SSM item changes that align with the CAHPS Clinician & Group Survey v. 3.0.

      Additional information on the CG-CAHPS survey update is available on the AHRQ website at https://www.ahrq.gov/sites/default/files/wysiwyg/cahps/surveys-guidance/cg/about/proposed-changes-cahps-c&g-survey2015.pdf.

      In addition to incorporating changes based on the AHRQ survey update, CMS removed all items included in the SSMs, Helping You to Take Medications as Directed and Between Visit Communication. These were optional SSMs that were not part of the scored measures. The update resulted in reducing the number of questions from 80 to 58 questions. Accordingly, the CAHPS for ACOs SSMs that contribute to the ACO performance score for performance year 2018, as finalized in the CY 2017 PFS final rule (81 FR 80488) are: Getting Timely Care, Appointments & Information; How Well Your Providers Communicate; Patients' Rating of Provider; Access to Specialists; Health Promotion and Education; Shared Decision Making; Health Status & Functional Status; and Stewardship of Patient Resources. In addition, the core survey includes SSMs on Care Coordination and Courteous & Helpful Office Staff. However, because these measures are not included in the Shared Savings Program quality measure set for 2018, scores for these measures will be provided to ACOs for informational purposes only and will not be used in determining the ACOs' quality scores.

    2. Proposals for Changes to the CAHPS Measure Set

      To enhance the Patient/Caregiver Experience domain and align with MIPS (82 FR 54163), we are proposing to begin scoring the 2 SSMs that are currently collected with the administration of the CAHPS for ACOs survey and shared with the ACOs for informational purposes only. Under this proposal, we would add the following CAHPS for ACOs SSMs that are already collected and provided to ACOs for informational purposes to the quality measure set for the Shared Savings Program as ACO-45, CAHPS: Courteous and Helpful Office Staff, and ACO-46: CAHPS: Care Coordination. These measures would be scored and included in the ACO quality determination starting in 2019. Both of these SSMs are currently designated by AHRQ as CG CAHPS core measures.

      The Courteous and Helpful Office Staff SSM, which would be added as ACO-45, asks about the helpfulness, courtesy and respectfulness of office staff. This SSM has been a CG-CAHPS core measure in the previous two versions of the CG-CAHPS survey, but was previously provided for informational purposes only and not included in the ACO quality score determination. We are also proposing to add the SSM, CAHPS: Care Coordination to the CAHPS for ACOs

      Page 35876

      measures used in ACO quality score determination as ACO-46. The Care Coordination SSM asks questions about provider access to beneficiary information and provider follow-up. This SSM was designated a core measure in the most recent version of the CG-CAHPS survey.

      Inclusion of these measures in the quality measure set that is used to assess the quality performance of ACOs under the Shared Savings Program would place greater emphasis on outcome measures and the voice of the patient and provide ACOs with an additional incentive to act upon opportunities for improved care coordination and communication, and would align with the MIPS measure set finalized in the CY 2018 Quality Payment Program final rule (82 FR 54163). Care Coordination and patient and caregiver engagement are goals of the Shared Savings Program. The Care Coordination SSM emphasizes the care coordination goal, while the Courteous and Helpful Office Staff SSM supports patient engagement as it addresses a topic that has been identified as important to beneficiaries in testing. For performance year 2016, the mean performance rates across all ACOs for these two measures, which were not included in the ACO quality score determination, were 87.18 for the Care Coordination SSM and 92.12 for Courteous and Helpful Office Staff SSM.

      Consistent with Sec. 425.502(a)(4), regarding the scoring of newly introduced quality measures, we propose that these additional SSMs would be pay-for-reporting for all ACOs for 2 years (performance years 2019 and 2020). The measures would then phase into pay-for-performance for ACOs in their first agreement period in the program according to the schedule in Table 25 beginning in performance year 2021. We seek comment on this proposed change to the quality measure set.

      Additionally, we seek comment on potentially converting the Health and Functional Status SSM (ACO-7) to pay-for-performance in the future. The Health and Functional Status SSM is currently pay-for-reporting for all years. We have not scored this measure because the scores on the Health and Functional Status SSM may reflect the underlying health of beneficiaries seen by ACO providers/suppliers as opposed to the quality of the care provided by the ACO. We are also considering possible options for enhancing collection of Health and Functional Status data. One option would be to change our data collection procedures to collect data from the same ACO assigned beneficiaries over time. This change could allow for measurement of changes that occurred while beneficiaries were receiving care from ACO providers/suppliers. We are seeking stakeholder feedback on this approach or other recommendations regarding the potential inclusion of a functional status measure in the assessment of ACO quality performance in the future.

    3. Proposed Changes to the CMS Web Interface and Claims-Based Quality Measure Sets

      In developing these proposals, we considered the agency's efforts to streamline quality measures, reduce regulatory burden and promote innovation as part of the agency's Meaningful Measures initiative (See CMS Press Release, CMS Administrator Verma Announces New Meaningful Measures Initiative and Addresses Regulatory Reform; Promotes Innovation at LAN Summit, October 30, 2017, available at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2017-Press-releases-items/2017-10-30.html). Under the Meaningful Measures initiative, CMS has committed to assessing only those core issues that are most vital to providing high-quality care and improving patient outcomes, with the aim of focusing on outcome-based measures, reducing unnecessary burden on providers, and putting patients first. In considering the quality reporting requirements under the Shared Savings Program, we have also considered the quality reporting requirements under other initiatives, such as the MIPS and Million Hearts Initiative, and consulted with the measures community to ensure that the specifications for the measures used under the Shared Savings Program are up-to-date with current clinical guidelines, focus on outcomes over process, reflect agency and program priorities, and reduce reporting burden.

      Since the Shared Savings Program was first established in 2012, we have not only updated the quality measure set to reduce reporting burden, but also to focus on more meaningful, outcome-based measures. The most recent updates to the Shared Savings Program quality measure set were made in the CY 2017 PFS final rule (81 FR 80484 through 80489) to adopt the ACO measure recommendations made by the Core Quality Measures Collaborative, a multi-stakeholder group with the goal of aligning quality measures for reporting across public and private initiatives to reduce provider reporting burden. Currently, more than half of the 31 Shared Savings Program quality measures are outcome-

      based, including:

      Patient-reported outcome measures collected through the CAHPS for ACOs Survey that strengthen patient and caregiver experience.

      Outcome measures supporting effective communication and care coordination, such as unplanned admission and readmission measures.

      Intermediate outcome measures that address the effective treatment of chronic disease, such as hemoglobin A1c control for patients with diabetes.

      In this rule, we are proposing to reduce the total number of measures in the Shared Savings Program quality measure set. These proposals are intended to reduce the burden on ACOs and their participating providers and suppliers by lowering the number of measures they are required to report through the CMS Web Interface and on which they are assessed through the use of claims data. Reducing the number of measures on which ACOs are measured would reduce the number of performance metrics that they are required to track and eliminate redundancies between measures that target similar populations. The proposed reduction in the number of measures would enable ACOs to better utilize their resources toward improving patient care. These proposals further reduce burden by aligning with the proposed changes to the CMS Web Interface measures that are reported under MIPS as discussed in Tables A, C, and D of Appendix 1: Proposed MIPS Quality Measures of this proposed rule. We recognize that ACOs and their participating providers and suppliers dedicate resources to performing well on our quality metrics, and we believe that reducing the number of metrics and aligning them across programs would allow them to more effectively target those resources toward improving patient care. We are proposing to reduce the number of measures by minimizing measure overlap and eliminating several process measures. The proposal to remove process measures also aligns with our proposal to reduce the number of process measures within the MIPS measure set as discussed in section III.H.b.iii of this proposed rule and would support the CMS goal of moving toward outcome-based measurement.

      We are proposing to retire the following claims-based quality measures, which have a high degree of overlap with other measures that would remain in the measure set:

      ACO-35--Skilled Nursing Facility 30-Day All-Cause Readmission Measure (SNFRM).

      ACO-36--All-Cause Unplanned Admissions for Patients with Diabetes.

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      ACO-37--All-Cause Unplanned Admission for Patients with Heart Failure.

      Within the claims-based quality measures, overlap exists between measures with respect to the population being measured (the denominator), because a single admission may be counted in the numerator for multiple measures. For example, ACO-35 addresses unplanned readmissions from a SNF, and the vast majority of these SNF readmissions are also captured in the numerator of ACO-8 Risk-

      Standardized All Condition Readmission. Similarly, ACO-36 and ACO-37 address unplanned admissions for patients with diabetes and heart failure and most of these admissions are captured in the numerator of ACO-38 Risk-Standardized Acute Admission Rates for Patients with Multiple Chronic Conditions (please note that the measure name has been updated to align with changes made by the measure steward). Therefore, to reduce redundancies within the Shared Savings Program measure set, we propose to remove ACO-35, ACO-36, and ACO-37 from the measure set. However, because these measures are claims-based measures and therefore do not impose any reporting burden on ACOs, we intend to continue to provide information to ACOs on their performance on these measures for use in their quality improvement activities through a new quarterly claims-based quality outcome report that ACOs will begin receiving in 2018.

      Although we are proposing to retire ACO-35 (SNFRM) from the set of quality measures that are scored for the Shared Savings Program, we recognize the value of measuring the quality of care furnished to Medicare beneficiaries in SNFs. Therefore, we are seeking comment on the possibility of adding the Skilled Nursing Facility Quality Reporting Program (SNFQRP) measure ``Potentially Preventable 30-Day Post-Discharge Readmission Measure for Skilled Nursing Facilities'' to the Shared Savings Program quality measure set through future rulemaking. This measure differs from ACO-35 (Skilled Nursing Facility 30-Day All-Cause Readmission Measure), which we are proposing to remove above, as the SNFQRP measure looks only at unplanned, potentially preventable readmissions for Medicare Fee-For-Service beneficiaries within 30 days of discharge to a lower level of care from a SNF, while ACO-35 assesses readmissions from a SNF, regardless of cause, that occur within 30 days following discharge from a hospital. As a result, the SNFQRP measure would have less overlap with ACO-8 (Risk-

      Standardized All Cause Readmission measure) than does ACO-35 (SNFRM), because the two measures' readmission windows differ. Specifically, the readmission window for the SNFQRP measure is 30 days following discharge from a SNF, while the readmission window for ACO-8 is 30 days following discharge from a hospital.

      We are also proposing to retire claims-based measure ACO-44 (Use of Imaging Studies for Low Back Pain), as this measure is restricted to individuals 18-50 years of age, which results in low denominator rates under the Shared Savings Program, meaning that the measure is not a valuable reflection of the beneficiaries cared for by Shared Savings Program ACOs. As a result, although this measure was originally added to the Shared Savings Program quality measure set in order to align with the Core Quality Measures Collaborative, we no longer believe ACO-

      44 is a meaningful measure that should be retained in the Shared Savings Program quality measure set. The deletion of this measure would also align ACO quality measurement with the MIPS requirements as this measure was removed for purposes of reporting under the MIPS program in the CY 2018 Quality Payment Program final rule (82 FR 54159). However, in recognition of the value in providing feedback to providers on potential overuse of diagnostic procedures, we intend to continue to provide ACOs feedback on performance on this measure as part of the new quarterly claims based quality report.

      We welcome public comment on our proposal to retire these 4 claims-

      based measures from the quality measure set.

      Further, we seek to align with changes made to the CMS Web Interface measures under the Quality Payment Program. In the 2017 PFS final rule, we stated we do not believe it is beneficial to propose CMS Web interface measures for ACO quality reporting separately (81 FR 80499). Therefore, in order to avoid confusion and duplicative rulemaking, we adopted a policy that any future changes to the CMS Web interface measures would be proposed and finalized through rulemaking for the Quality Payment Program, and that such changes would be applicable to ACO quality reporting under the Shared Savings Program. In accordance with the policy adopted in the CY 2017 PFS final rule (81 FR 80501), we are not making any specific proposals related to changes in CMS Web Interface measures reported under the Shared Savings Program. Rather, we refer readers to Tables A, C, and D of Appendix 1: Proposed MIPS Quality Measures of this proposed rule for a complete discussion of the proposed changes to the CMS Web Interface measures. If the proposed changes are finalized, ACOs would no longer be responsible for reporting the following measures for purposes of the Shared Savings Program starting with reporting for performance year 2019:

      ACO-12 (NQF #0097) Medication Reconciliation Post-

      Discharge.

      ACO-13 (NQF #0101) Falls: Screening for Future Fall Risk.

      ACO-15 (NQF #0043) Pneumonia Vaccination Status for Older Adults.

      ACO-16 (NQF #0421) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow Up.

      ACO-41 (NQF #0055) Diabetes: Eye Exam.

      ACO-30 (NQF #0068) Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic.

      We note that ACO-41 is one measure within a two-component diabetes composite that is currently scored as one measure. The proposed removal of ACO-41 means that ACO-27 Diabetes Hemoglobin A1c (HbA1c) Poor Control (>9%) would now be assessed as an individual measure. If the proposed changes are finalized as proposed, Table 26 shows the maximum possible points that may be earned by an ACO in each domain and overall in performance year 2019 and in subsequent performance years.

      Additionally, we note that we are proposing to add the following measure to the CMS Web Interface for purposes of the Quality Payment Program:

      ACO-47 (NQF #0101) Falls: Screening, Risk-Assessment, and Plan of Care to Prevent Future Falls.

      If this proposal is finalized, consistent with our policy of adopting changes to the CMS Web Interface Measures through rulemaking for the Quality Payment Program, Shared Savings Program ACOs would be responsible for reporting this measure starting in performance year 2019.

      Table 25 shows the proposed Shared Savings Program quality measure set for performance year 2019 and subsequent performance years.

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      Table 25--Proposed Measure Set for Use in Establishing the Shared Savings Program Quality Performance Standard, Starting With Performance Year 2019

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Pay for performance phase-

      in R--Reporting P--

      Domain ACO measure Measure title New measure NQF #/measure steward Method of data Performance

      No. submission --------------------------

      PY1 PY2 PY3

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      AIM: Better Care for Individuals

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Patient/Caregiver Experience... ACO-1 CAHPS: Getting ............ NQF N/A AHRQ Survey............ R P P

      Timely Care,

      Appointments, and

      Information.

      ACO-2 CAHPS: How Well ............ NQF N/A AHRQ Survey............ R P P

      Your Providers

      Communicate.

      ACO-3 CAHPS: Patients' ............ NQF N/A AHRQ Survey............ R P P

      Rating of

      Provider.

      ACO-4 CAHPS: Access to ............ NQF #N/A CMS/AHRQ Survey............ R P P

      Specialists.

      ACO-5 CAHPS: Health ............ NQF #N/A AHRQ Survey............ R P P

      Promotion and

      Education.

      ACO-6 CAHPS: Shared ............ NQF #N/A AHRQ Survey............ R P P

      Decision Making.

      ACO-7 CAHPS: Health ............ NQF #N/A AHRQ Survey............ R R R

      Status/Functional

      Status.

      ACO-34 CAHPS: Stewardship ............ NQF #N/A AHRQ Survey............ R P P

      of Patient

      Resources.

      ACO-45 CAHPS: Courteous \1\ X NQF #N/A AHRQ Survey............ R R P

      and Helpful

      Office Staff.

      ACO-46 CAHPS: Care \1\ X NQF #N/A AHRQ Survey............ R R P

      Coordination.

      Care Coordination/Patient ACO-8 Risk-Standardized, ............ Adapted NQF #1789 CMS Claims............ R R P

      Safety. All Condition

      Readmission.

      ACO-38 Risk-Standardized ............ NQF#2888 CMS Claims............ R R P

      Acute Admission

      Rates for

      Patients with

      Multiple Chronic

      Conditions.

      ACO-43 Ambulatory ............ AHRQ Claims............ R P P

      Sensitive

      Condition Acute

      Composite (AHRQ

      Prevention

      Quality Indicator

      (PQI) #91)

      (version with

      additional Risk

      Adjustment) \2\.

      ACO-47 Falls: Screening, ............ NQF #0101 NCQA CMS Web Interface. R R P

      Risk-Assessment,

      and Plan of Care

      to Prevent Future

      Falls.

      ACO-11 Use of certified ............ NQF #N/A CMS Quality Payment R P P

      EHR technology. Program Advancing

      Care Information.

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      AIM: Better Health for Populations

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      Preventive Health.............. ACO-14 Preventive Care ............ NQF #0041 AMA-PCPI CMS Web Interface. R P P

      and Screening:

      Influenza

      Immunization.

      ACO-17 Preventive Care ............ NQF #0028 AMA-PCPI CMS Web Interface. R P P

      and Screening:

      Tobacco Use:

      Screening and

      Cessation

      Intervention.

      ACO-18 Preventive Care ............ NQF #0418 CMS CMS Web Interface. R P P

      and Screening:

      Screening for

      Depression and

      Follow-up Plan.

      ACO-19 Colorectal Cancer ............ NQF #0034 NCQA CMS Web Interface. R R P

      Screening.

      ACO-20 Breast Cancer ............ NQF #2372 NCQA CMS Web Interface. R R P

      Screening.

      ACO-42 Statin Therapy for ............ NQF #N/A CMS CMS Web Interface. R R R

      the Prevention

      and Treatment of

      Cardiovascular

      Disease.

      Clinical Care for At Risk ACO-40 Depression ............ NQF #0710 MNCM CMS Web Interface. R R R

      Population--Depression. Remission at

      Twelve Months.

      Clinical Care for At Risk ACO-27 Diabetes ............ NQF #0059 NCQA CMS Web Interface. R P P

      Population--Diabetes. Hemoglobin A1c

      (HbA1c) Poor

      Control (>9%).

      Clinical Care for At Risk ACO-28 Hypertension : ............ NQF #0018 NCQA CMS Web Interface. R P P

      Population--Hypertension. Controlling High

      Blood Pressure.

      --------------------------------------------------------------------------------------------------------------------------------------------------------

      \1\ Measures that are currently collected as part of the administration of the CAHPS for ACO survey, but will be considered new measures for purposes of

      the pay for performance phase-in.

      \2\ The language in parentheses has been added for clarity and no changes have been made to the measure.

      We are proposing to eliminate 10 measures and to add one measure to the Shared Savings Program quality measure set. This would result in 24 measures for which ACOs would be held accountable. With these proposed measure changes, the 4 domains would include the following numbers of quality measures (See Table 26):

      Patient/Caregiver Experience of Care--10 measures.

      Care Coordination/Patient Safety--5 measures, including the double-weighted EHR measure (ACO-11).

      Preventive Health--6 measures.

      At Risk Populations--3 measures.

      Table 26 provides a summary of the number of measures by domain and the total points and domain weights that would be used for scoring purposes under the changes to the quality measure set proposed in this proposed rule.

      Page 35879

      Table 26--Number of Measures and Total Points for Each Domain Within the Shared Savings Program Quality

      Performance Standard, Starting With Performance Year 2019

      ----------------------------------------------------------------------------------------------------------------

      Number of

      Domain individual Total measures for Total possible Domain weight

      measures scoring purposes points (%)

      ----------------------------------------------------------------------------------------------------------------

      Patient/Caregiver Experience.......... 10 10 individual survey 20 25

      module measures.

      Care Coordination/Patient Safety...... 5 5 measures, including 12 25

      double-weighted EHR

      measure.

      Preventive Health..................... 6 6 measures.............. 12 25

      At-Risk Population.................... 3 3 individual measures... 6 25

      -------------------------------------------------------------------------

      Total in all Domains.............. 24 24...................... 50 100

      ----------------------------------------------------------------------------------------------------------------

  42. Physician Self-Referral Law

    1. Background

    Section 1877 of the Act, also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that pose no risk of program or patient abuse. Additionally, the statute mandates refunding any amount collected under a bill for an item or service furnished under a prohibited referral. Finally, the statute imposes reporting requirements and provides for sanctions, including civil monetary penalty provisions.

    Section 50404 of the Bipartisan Budget Act of 2018 (Pub. L. 115-

    123, enacted February 9, 2018) added provisions to section 1877(h)(1) of the Act pertaining to the writing and signature requirements in certain compensation arrangement exceptions to the statute's referral and billing prohibitions. Although we believe that the newly enacted provisions in section 1877(h)(1) of the Act are principally intended merely to codify in statute existing CMS policy and regulations with respect to compliance with the writing and signature requirements, we are proposing revisions to our regulations to address any actual or perceived difference between the statutory and regulatory language, to codify in regulation our longstanding policy regarding satisfaction of the writing requirement found in many of the exceptions to the physician self-referral law, and to make the Bipartisan Budget Act of 2018 policies applicable to compensation arrangement exceptions issued using the Secretary's authority in section 1877(b)(4) of the Act.

    In the CY 2016 PFS final rule with comment period (80 FR 70885), we revised Sec. 411.357(a)(7), (b)(6), and (d)(1)(vii) to permit a lease arrangement or personal service arrangement to continue indefinitely beyond the stated expiration of the written documentation describing the arrangement under certain circumstances. Section 50404 of the Bipartisan Budget Act of 2018 added substantively identical holdover provisions to section 1877(e) of the Act. Because the new statutory holdover provisions effectively mirror the existing regulatory provisions, we do not believe it is necessary to revise Sec. 411.357(a)(7), (b)(6), and (d)(1)(vii) as a result of these statutory revisions.

    2. Special Rules on Compensation Arrangements (Section 1877(h)(1)(E) of the Act)

    Many of the exceptions for compensation arrangements in Sec. 411.357 require that the arrangements are set out in writing and signed by the parties. (See Sec. 411.357(a)(1), (b)(1), (d)(1)(i), (e)(1)(i), (e)(4)(i), (l)(1), (p)(2), (q) (incorporating the requirement contained in Sec. 1001.952(f)(4)), (r)(2)(ii), (t)(1)(ii) or (t)(2)(iii) (both incorporating the requirements contained in Sec. 411.357(e)(1)(i)), (v)(7), (w)(7), (x)(1)(i), and (y)(1).) \7\ As described above, section 50404 of the Bipartisan Budget Act of 2018 amended section 1877 of the Act with respect to the writing and signature requirements in the statutory compensation arrangement exceptions. As detailed below, we are proposing a new special rule on compensation arrangements at Sec. 411.354(e) and proposing to amend existing Sec. 411.353(g) to codify the statutory provisions in our regulations.

    ---------------------------------------------------------------------------

    \7\ We note that, where the writing requirement appears in the statutory and regulatory exceptions, we interpret it uniformly, regardless of any minor differences in the language of the requirement. See 80 FR 71315. Similarly, we interpret the signature requirement uniformly where it appears, regardless of any minor differences in the language of the statutory and regulatory exceptions.

    ---------------------------------------------------------------------------

    1. Writing Requirement (Sec. 411.354(e))

      In the CY 2016 PFS final rule with comment period, we stated CMS' longstanding policy that the writing requirement in various compensation arrangement exceptions in Sec. 411.357 can be satisfied by ``a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties'' (80 FR 71315). Our guidance on the writing requirement appeared in the preamble of the CY 2016 PFS final rule with comment period but was not codified in regulations. Section 50404 of the Bipartisan Budget Act of 2018 added subparagraph D, ``Written Requirement Clarified,'' to section 1877(h)(1) of the Act. Section 1877(h)(1)(D) of the Act provides that, in the case of any requirement in section 1877 of the Act for a compensation arrangement to be in writing, such requirement shall be satisfied by such means as determined by the Secretary, including by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.

      In light of the recently added statutory provision at section 1877(h)(1)(D) of the Act, we are proposing to add a special rule on compensation arrangements at Sec. 411.354(e). Proposed Sec. 411.354(e) provides that, in the case of any requirement in 42 CFR part 411, subpart J, for a compensation arrangement to be in writing, the writing requirement may be satisfied by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties. The special rule at Sec. 411.357(e) codifies our existing policy on the writing requirement, as previously articulated in the CY 2016 PFS final rule with comment period. (See 80 FR 71314 et seq.)

      Page 35880

    2. Special Rule for Certain Arrangements Involving Temporary Noncompliance With Signature Requirements (Sec. 411.353(g))

      Many of the exceptions for compensation arrangements in Sec. 411.357 require that the arrangement (that is, the written documentation evidencing the arrangement) is signed by the parties to the arrangement. Under our existing special rule for certain arrangements involving temporary noncompliance with signature requirements at Sec. 411.353(g)(1), an entity that has a compensation arrangement with a physician that satisfies all the requirements of an applicable exception in Sec. 411.355, Sec. 411.356 or Sec. 411.357 except the signature requirement may submit a claim and receive payment for a designated health service referred by the physician, provided that: (1) The parties obtain the required signature(s) within 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90-day period); and (2) the compensation arrangement otherwise complies with all criteria of the applicable exception. Existing Sec. 411.353(g)(1) specifies the paragraphs where the applicable signature requirements are found and existing Sec. 411.353(g)(2) limits an entity's use of the special rule at Sec. 411.353(g)(1) to only once every 3 years with respect to the same referring physician.

      Section 50404 of the Bipartisan Budget Act of 2018 added subparagraph E, ``Signature Requirement,'' to section 1877(h)(1) of the Act. Section 1877(h)(1)(E) of the Act provides that, in the case of any requirement in section 1877 of the Act for a compensation arrangement to be in writing and signed by the parties, the signature requirement is satisfied if: (1) Not later than 90 consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant, the parties obtain the required signatures; and (2) the compensation arrangement otherwise complies with all criteria of the applicable exception. Notably, under the newly added section 1877(h)(1)(E) of the Act, an applicable signature requirement is not limited to specific exceptions and entities are not limited in their use of the rule to only once every 3 years with respect to the same referring physician. In addition, section 1877(h)(1)(E) of the Act does not include a reference to the occurrence of referrals or the payment of compensation during the 90-day period when the signature requirement is not met.

      To conform the regulations with the recently added statutory provision at section 1877(h)(1)(E) of the Act, we are proposing to amend existing Sec. 411.353(g) by: (1) Revising the reference at Sec. 411.353(g)(1) to specific exceptions and signature requirements; (2) deleting the reference at Sec. 411.353(g)(1) to the occurrence of referrals or the payment of compensation during the 90-day period when the signature requirement is not met; and (3) deleting the limitation at Sec. 411.353(g)(2). In the alternative, we are proposing to delete Sec. 411.353(g) in its entirety and codify in proposed Sec. 411.354(e) the special rule for signature requirements in section 1877(h)(1)(E). We seek comments regarding the best approach for codifying in regulation this provision of the Bipartisan Budget Act of 2018.

      Finally, we note that the effective date of section 50404 of the Bipartisan Budget Act was February 9, 2018. Thus, beginning February 9, 2018, parties who meet the requirements of section 1877(h)(1)(E) of the Act, including parties who otherwise would have been barred from relying on the special rule for certain arrangements involving temporary noncompliance with signature requirements at Sec. 411.353(g)(1) because of the 3-year limitation at Sec. 411.353(g)(2), may avail themselves of the new statutory provision at section 1877(h)(1)(E) of the Act.

  43. CY 2019 Updates to the Quality Payment Program

    1. Executive Summary

    1. Overview

      This proposed rule would make payment and policy changes to the Quality Payment Program. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) amended title XVIII of the Act to repeal the Medicare sustainable growth rate (SGR) formula, to reauthorize the Children's Health Insurance Program, and to strengthen Medicare access by improving physician and other clinician payments and making other improvements. The MACRA advances a forward-looking, coordinated framework for clinicians to successfully take part in the Quality Payment Program that rewards value in one of two ways:

      The Merit-based Incentive Payment System (MIPS).

      Advanced Alternative Payment Models (Advanced APMs).

      As we move into the third year of the Quality Payment Program, we have taken all stakeholder input into consideration including recommendations made by the Medicare Payment Advisory Commission (MedPAC), an independent congressional agency established by the Balanced Budget Act of 1997 (Pub. L. 105-33) to advise the U.S. Congress on issues affecting the Medicare program, including payment policies under Medicare, the factors affecting expenditures for the efficient provision of services, and the relationship of payment policies to access and quality of care for Medicare beneficiaries. We will continue to implement the Quality Payment Program as required, smoothing the transition where possible and offering targeted educational resources for program participants. A few examples of how we are working to address MedPAC's concerns are evident in our work around burden reduction and reshaping our focus of interoperability. Additionally, we heard the concern about process-based measures, and we are continuing to move towards the development and use of more outcome measures by way of removing process measures that are topped out and funding new quality measure development, as required by section 102 of MACRA. Additionally, we are also developing new episode-based cost measures, with stakeholder feedback, for potential inclusion in the cost performance category beginning in 2019. CMS acknowledges that the Quality Payment Program is a large shift for many clinicians and practices, and thus, we will continue to implement the program gradually with targeted educational resources, public trainings, and technical assistance for those who qualify. With MIPS, eligible clinicians now report under one program, which replaces three separate legacy programs. The Quality Payment Program takes a comprehensive approach to payment. Instead of basing payment only on a series of fee-

      for-service billing codes, the Quality Payment Program adds consideration of quality through a set of evidence-based measures and clinical practice improvement activities that were primarily developed by clinicians.

      As a priority for Quality Payment Program Year 3, we are committed to reducing clinician burden, implementing the Meaningful Measures Initiative, promoting interoperability, continuing our support of small and rural practices, empowering patients through the Patients Over Paperwork initiative, and promoting price transparency.

      Page 35881

      Reducing Clinician Burden

      We are committed to reducing clinician burden by simplifying and reducing burden for participating clinicians. Examples include:

      Implementing the Meaningful Measures Initiative, which is a framework that applies a series of cross-cutting criteria to keep the most meaningful measures with the least amount of burden and greatest impact on patient outcomes;

      Promoting advances in interoperability; and

      Establishing an automatic extreme and uncontrollable circumstances policy for MIPS eligible clinicians.

      Improving Patient Outcomes and Reducing Burden Through Meaningful Measures

      Regulatory reform and reducing regulatory burden are high priorities for us. To reduce the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care, in October 2017, we launched the Meaningful Measures Initiative.\8\ This initiative is one component of our agency-wide Patients Over Paperwork Initiative,\9\ which is aimed at evaluating and streamlining regulations with a goal to reduce unnecessary cost and burden, increase efficiencies, and improve beneficiary experience. The Meaningful Measures Initiative is aimed at identifying the highest priority areas for quality measurement and quality improvement to assess the core quality of care issues that are most vital to advancing our work to improve patient outcomes. The Meaningful Measures Initiative represents a new approach to quality measures that fosters operational efficiencies and will reduce costs, including the collection and reporting burden, while producing quality measurement that is more focused on meaningful outcomes.

      ---------------------------------------------------------------------------

      \8\ Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.

      \9\ See Remarks by Administrator Seema Verma at the Health Care Payment Learning and Action Network (LAN) Fall Summit, as prepared for delivery on October 30, 2017, https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.

      ---------------------------------------------------------------------------

      The Meaningful Measures Framework has the following objectives:

      Address high-impact measure areas that safeguard public health;

      Patient-centered and meaningful to patients;

      Outcome-based where possible;

      Fulfill each program's statutory requirements;

      Minimize the level of burden for health care providers (for example, through a preference for EHR-based measures where possible, such as electronic clinical quality measures);

      Significant opportunity for improvement;

      Address measure needs for population based payment through alternative payment models; and

      Align across programs and/or with other payers.

      To achieve these objectives, we have identified 19 Meaningful Measures areas and mapped them to six overarching quality priorities as shown in Table 27.

      Table 27--Meaningful Measures Framework Domains and Measure Areas

      ------------------------------------------------------------------------

      Quality priority Meaningful measure area

      ------------------------------------------------------------------------

      Making Care Safer by Reducing Harm Healthcare-Associated

      Caused in the Delivery of Care. Infections.

      Preventable Healthcare Harm.

      Strengthen Person and Family Engagement Care is Personalized and

      as Partners in Their Care. Aligned with Patient's Goals.

      End of Life Care according to

      Preferences.

      Patient's Experience of Care.

      Patient Reported Functional

      Outcomes.

      Promote Effective Communication and Medication Management.

      Coordination of Care. Admissions and Readmissions to

      Hospitals.

      Transfer of Health Information

      and Interoperability.

      Promote Effective Prevention and Preventive Care.

      Treatment of Chronic Disease. Management of Chronic

      Conditions.

      Prevention, Treatment, and

      Management of Mental Health.

      Prevention and Treatment of

      Opioid and Substance Use

      Disorders.

      Risk Adjusted Mortality.

      Work with Communities to Promote Best Equity of Care.

      Practices of Healthy Living. Community Engagement.

      Make Care Affordable................... Appropriate Use of Healthcare.

      Patient-focused Episode of

      Care.

      Risk Adjusted Total Cost of

      Care.

      ------------------------------------------------------------------------

      By including Meaningful Measures in our programs, we believe that we can also address the following cross-cutting measure criteria:

      Eliminating disparities;

      Tracking measurable outcomes and impact;

      Safeguarding public health;

      Achieving cost savings;

      Improving access for rural communities; and

      Reducing burden.

      We believe that the Meaningful Measures Initiative will improve outcomes for patients, their families, and health care providers while reducing burden and costs for clinicians and providers and promoting operational efficiencies.

      In the quality performance category, clinicians have the flexibility to select and report the measures that matter most to their practice and patients. However, we have received feedback that some clinicians find the performance requirements confusing, and the program makes it difficult for them to choose measures that are meaningful to their practices and have more direct benefit to beneficiaries. For the 2019 MIPS performance period, we are proposing the following updates: (1) Adding 10 new MIPS quality measures that include 4 patient reported outcome measures, 7 high priority measures, 1 measure that replaces an existing measure, and 2 other measures on important clinical topics in the Meaningful Measures framework; and (2) removing 34 quality measures.

      In addition to having the right measures, we want to ensure that the collection of information is valuable to clinicians and worth the cost and burden of collecting the information. In

      Page 35882

      section III.H.3.h.(2)(b)(iv) of this proposed rule, we are requesting comments on a tiered scoring system for quality measures where measures would be awarded points based on their value. We are also seeking comment on what patient reported outcome measures produce better outcomes and request accompanying supporting evidence that the measures do, in fact, improve outcomes.

      Promoting Interoperability Performance Category

      As required by MACRA, the Quality Payment Program includes a MIPS performance category that focuses on meaningful use of certified EHR technology, referred to in the CY 2017 and CY 2018 Quality Payment Program rules as the ``advancing care information'' performance category. As part of our approach to promoting and prioritizing interoperability of healthcare data, in Quality Payment Program Year 2, we changed the name of the performance category to the Promoting Interoperability performance category.

      We have prioritized interoperability, which we define as health information technology that enables the secure exchange of electronic health information with, and use of electronic health information from, other health information technology without special effort on the part of the user; allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable law; and does not constitute information blocking as defined by the 21st Century Cures Act (Pub. L. 114-255, enacted December 13, 2016). We are committed to working with the Office of the National Coordinator for Health IT (ONC) on implementation of the interoperability provisions of the 21st Century Cures Act to have seamless but secure exchange of health information for clinicians and patients, ultimately enabling Medicare beneficiaries to get their claims information electronically. In addition, we are prioritizing quality measures and improvement activities that lead to interoperability.

      To further CMS' commitment to implementing interoperability, at the 2018 Healthcare Information and Management Systems Society (HIMSS) conference, CMS Administrator Seema Verma announced the launching of the MyHealthEData initiative.\10\ This initiative aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure. The overall government-wide initiative is led by the White House Office of American Innovation with participation from HHS--including its CMS, ONC, and the National Institutes of Health (NIH)--as well as the U.S. Department of Veterans Affairs (VA). MyHealthEData aims to break down the barriers that prevent patients from having electronic access and true control of their own health records from the device or application of their choice. This effort will approach the issue of healthcare data from the patient's perspective.

      ---------------------------------------------------------------------------

      \10\ https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheets-items/2018-03-06.html.

      ---------------------------------------------------------------------------

      For the Promoting Interoperability performance category, we require MIPS eligible clinicians to use 2015 Edition certified EHR technology beginning with the 2019 MIPS performance period to make it easier for:

      Patients to access their data.

      Patient information to be shared between doctors and other health care providers.

      Continuing To Support Small and Rural Practices

      We understand that the Quality Payment Program is a big change for clinicians, especially for those in small and rural practices. We intend to continue to offer tailored flexibilities to help these clinicians to participate in the program. For example, we propose to retain a small practice bonus under MIPS by moving it to the quality performance category. We will also continue to support small and rural practices by offering free and customized resources available within local communities, including direct, one-on-one support from the Small, Underserved, and Rural Support Initiative along with our other no-cost technical assistance.

      Further, we note that we are proposing to amend our regulatory text to allow small practices to continue using the Medicare Part B claims collection type. We are also proposing to revise the regulatory text to allow a small practice to submit quality data for covered professional services through the Medicare Part B claims submission type for the quality performance category, as discussed further in section III.H.3.h. of this proposed rule. Finally, small practices may continue to choose to participate in MIPS as a virtual group, as discussed in section III.H.3. of this proposed rule.

      Empowering Patients Through the Patients Over Paperwork Initiative

      Our Patients Over Paperwork initiative establishes an internal process to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to improve the beneficiary experience.\11\ This administration is dedicated to putting patients first, empowering consumers of healthcare to have the information they need to be engaged and active decision-makers in their care. As a result of this consumer empowerment, clinicians will gain competitive advantage by delivering coordinated, high-value quality care.

      ---------------------------------------------------------------------------

      \11\ Patients Over Paperwork web page available at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.

      ---------------------------------------------------------------------------

      The proposals for the Quality Payment Program in this proposed rule seek to promote competition and to empower patients. We are consistently listening, and we are committed to using data-driven insights, increasingly aligned and meaningful quality measures, and technology that empowers patients and clinicians to make decisions about their healthcare.

      In conjunction with development of the Patients Over Paperwork initiative, we are making progress toward developing a patient-centered portfolio of measures for the Quality Payment Program, including 7 new outcome measures included on the 2017 CMS Measures Under Consideration List,\12\ 5 of which are directly applicable to the prioritized specialties of general medicine/crosscutting and orthopedic surgery. Finally, on March 2, 2018, CMS announced a funding opportunity for $30 million in grants to be awarded for quality measure development. The funding opportunity is aimed at external stakeholders with insight into clinician and patient perspectives on quality measurement and areas for improvement to advance quality measures for the Quality Payment Program.\13\

      ---------------------------------------------------------------------------

      \12\ Centers for Medicare & Medicaid Services. List of Measures Under Consideration for December 1, 2017. Baltimore, MD: US Department of Health and Human Services; 2017. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/Measures-under-Consideration-Listfor2017.pdf. Accessed May 4, 2018.

      \13\ Centers for Medicare & Medicaid Services. Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Funding Opportunity: Measure Development for the Quality Payment Program. Baltimore, MD: US Department of Health and Human Services; 2018. https://blog.cms.gov/2018/03/02/medicare-access-and-chipreauthorization-act-of-2015-macra-funding-opportunity/. Accessed May 4, 2018.

      ---------------------------------------------------------------------------

      Page 35883

      Promoting Price Transparency

      Through the Executive Order Promoting Healthcare Choice and Competition Across the United States (E.O. 13813, 82 FR 48385 (Oct. 12, 2017)), the President prioritized changing the rate of growth of healthcare spending to foster competition in healthcare markets, resulting in the American people receiving better value for their investment in healthcare. To support these goals, we are helping patients control their health data and make it easier to take their data with them as they move in and out of the healthcare system. This will let patients make informed choices about their care, leading to more competition and lower costs.

    2. Summary of the Major Provisions

      (1) Quality Payment Program Year 3

      We believe the third year of the Quality Payment Program should build upon the foundation that has been established in the first 2 years, which provides a trajectory for clinicians moving to a performance-based payment system. This trajectory provides clinicians the ability to participate in the program through two pathways: MIPS and Advanced APMs.

      (2) Payment Adjustments

      As discussed in section VII.F.8. of this proposed rule, for the 2021 MIPS payment year and based on Advanced APM participation during the 2019 MIPS performance period, we estimate that between 160,000 and 215,000 clinicians will become Qualifying APM Participants (QP). As a QP, an eligible clinician is exempt from the MIPS reporting requirements and payment adjustment, and qualifies for a lump sum incentive payment based on 5 percent of their aggregate payment amounts for covered professional services for the prior year. We estimate that the total lump sum APM incentive payments will be approximately $600-

      800 million for the 2021 Quality Payment Program payment year.

      For MIPS, we have posted a blog that provides preliminary participation information for the first year of MIPS.\14\ However, due to time constraints, we are unable to incorporate and analyze the performance and participation data from the first year of MIPS for the estimates in this proposed rule. Therefore, under the policies proposed in this proposed rule, we based our estimates for the 2019 MIPS performance period/2021 MIPS payment year on historical 2016 PQRS and Medicare and Medicaid EHR Incentive Program data. We estimate that approximately 650,000 clinicians would be MIPS eligible clinicians in the 2019 MIPS performance period. This number will depend on a number of factors, including the number of eligible clinicians excluded from MIPS based on their status as QPs or Partial QPs, the number that report as groups, and the number that elect to opt-in to MIPS. In the 2021 MIPS payment year, MIPS payment adjustments, which only apply to covered professional services, will be applied based on MIPS eligible clinicians' performance on specified measures and activities within four integrated performance categories. We estimate that MIPS payment adjustments will be approximately equally distributed between negative MIPS payment adjustments ($372 million) and positive MIPS payment adjustments ($372 million) to MIPS eligible clinicians, as required by the statute to ensure budget neutrality. Positive MIPS payment adjustments will also include up to an additional $500 million for exceptional performance to MIPS eligible clinicians whose final score meets or exceeds the proposed additional performance threshold of 80 points. However, the distribution will change based on the final population of MIPS eligible clinicians for the 2021 MIPS payment year and the distribution of final scores under the program. We anticipate that we will be able to update these estimates with the data from the first year of MIPS in the CY 2019 Quality Payment Program final rule.

      ---------------------------------------------------------------------------

      \14\ https://blog.cms.gov/2018/05/31/quality-payment-program-exceeds-year-1-participation-goal/.

      ---------------------------------------------------------------------------

      2. Definitions

      At Sec. 414.1305, subpart O--

      We define the following terms:

      ++ Ambulatory Surgical Center (ASC)-based MIPS eligible clinician.

      ++ Collection type.

      ++ Health IT vendor.

      ++ MIPS determination period.

      ++ Submission type.

      ++ Submitter type.

      ++ Third party intermediary.

      We revise the definitions of the following terms:

      ++ High priority measure.

      ++ Hospital-based MIPS eligible clinician

      ++ Low-volume threshold.

      ++ MIPS eligible clinician.

      ++ Non-patient facing MIPS eligible clinician.

      ++ Qualified Clinical Data Registry (QCDR).

      ++ Qualifying APM Participant (QP).

      ++ Small practices.

      These terms and definitions are discussed in detail in relevant sections of this proposed rule.

      3. MIPS Program Details

    3. MIPS Eligible Clinicians

      Under Sec. 414.1305, a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, is defined as any of the following (excluding those identified at Sec. 414.1310(b)): A physician (as defined in section 1861(r) of the Act); a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act); and a group that includes such clinicians. Section 1848(q)(1)(C)(II) of the Act provides the Secretary with discretion, beginning with the 2021 MIPS payment year, to specify additional eligible clinicians (as defined in section 1848(k)(3)(B) of the Act) as MIPS eligible clinicians. Such clinicians may include physical therapists, occupational therapists, or qualified speech-

      language pathologists; qualified audiologists (as defined in section 1861(ll)(3)(B) of the Act); certified nurse-midwives (as defined in section 1861(gg)(2) of the Act); clinical social workers (as defined in section 1861(hh)(1) of the Act); clinical psychologists (as defined by the Secretary for purposes of section 1861(ii) of the Act); and registered dietitians or nutrition professionals.

      We received feedback from non-physician associations representing each type of additional eligible clinician through listening sessions and meetings with various stakeholder entities and through public comments discussed in the CY 2017 Quality Payment Program final rule (81 FR 77038). Commenters generally supported the specification of such clinicians as MIPS eligible clinicians beginning with the 2021 MIPS payment year.

      To assess whether these additional eligible clinicians could successfully participate in MIPS, we evaluated whether there would be sufficient measures and activities applicable and available for each of the additional eligible clinician types. We focused our analysis on the quality and improvement activities performance categories because these performance categories require submission of data. We did not focus on the Promoting Interoperability performance category because there is extensive analysis regarding who can participate under the current exclusion criteria. In addition,

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      in section III.H.3.i.(2)(b) of this proposed rule, we are proposing to automatically assign a zero percent weighting for the Promoting Interoperability performance category for these new types of MIPS eligible clinicians. In addition, we did not focus on the cost performance category because we are only able to assess cost performance for a subset of eligible clinicians--those who are currently eligible as a result of not meeting any of the current exclusion criteria. So the impact of the cost performance category for these additional eligible clinicians will continue to be considered but is currently not a decisive factor. From our analysis, we found that improvement activities would generally be applicable and available for each of the additional eligible clinician types. However, for the quality performance category, we found that not all of the additional eligible clinician types would have sufficient MIPS quality measures applicable and available. As discussed in section III.H.3.h.(2)(b)(iii) of this proposed rule, for the quality performance category, we are proposing to remove several MIPS quality measures. If those measures are finalized for removal, we anticipate that qualified speech-language pathologists, qualified audiologists, certified nurse-midwives, and registered dietitians or nutrition professionals would each have less than 6 MIPS quality measures applicable and available to them. However, if the quality measures are not finalized for removal, we will reassess whether these eligible clinicians would have an adequate amount of MIPS quality measures available to them. If we find that these additional clinicians do have at least 6 MIPS quality measures available to them, then we propose to include them in the MIPS eligible clinician definition. We are focusing on the quality performance category because as discussed above, the quality and improvement activities performance categories require submission of data. We believe there would generally be applicable and available improvement activities for each of the additional eligible clinician types, but that not all of the additional eligible clinician types would have sufficient MIPS quality measures applicable and available if the proposed MIPS quality measures are removed from the program. We did find QCDR measures approved for the CY 2018 performance period that are either high priority and/or outcome measures that, if approved for the CY 2019 performance period, may be applicable to these additional eligible clinicians. However, this would necessitate that they utilize a QCDR in order to be successful in MIPS.

      Further, we have heard some concerns from the non-physician associations, through written correspondence, that since their clinicians would be joining the program 2 years after its inception, we should consider several ramp-up policies in order to facilitate an efficient integration of these clinicians into MIPS. We note that the MIPS program is still ramping up, and we will continue to increase the performance threshold to ensure a gradual and incremental transition to the performance threshold until Quality Payment Program Year 6. Therefore, if specified as MIPS eligible clinicians beginning with the 2021 MIPS payment year, the additional eligible clinicians would have 4 years in the program in order to ramp up. Conversely, if specified as MIPS eligible clinicians beginning in a future year, they would be afforded less time to ramp up the closer the program gets to Quality Payment Program Year 6.

      Therefore, we request comments on our proposal to amend Sec. 414.1305 to modify the definition of a MIPS eligible clinician, as identified by a unique billing TIN and NPI combination used to assess performance, to mean any of the following (excluding those identified at Sec. 414.1310(b)): A physician (as defined in section 1861(r) of the Act); a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act); beginning with the 2021 MIPS payment year, a physical therapist, occupational therapist, clinical social worker (as defined in section 1861(hh)(1) of the Act), and clinical psychologist (as defined by the Secretary for purposes of section 1861(ii) of the Act); and a group that includes such clinicians. Alternatively, we propose that if the quality measures proposed for removal are not finalized, then we would include additional eligible clinician types in the definition of a MIPS eligible clinician beginning with the 2021 MIPS payment year (specifically, qualified speech-language pathologists, qualified audiologists, certified nurse-midwives, and registered dietitians or nutrition professionals), provided that we determine that each applicable eligible clinician type would have at least 6 MIPS quality measures available to them. In addition, we are requesting comments on: (1) Specifying qualified speech-language pathologists, qualified audiologists, certified nurse-midwives, and registered dietitians or nutrition professionals as MIPS eligible clinicians beginning with the 2021 MIPS payment year; and (2) delaying the specification of one or more additional eligible clinician types as MIPS eligible clinicians until a future MIPS payment year.

    4. MIPS Determination Period

      Currently, MIPS uses various determination periods to identify certain MIPS eligible clinicians for consideration for certain applicable policies. For example, the low-volume threshold, non-patient facing, small practice, hospital-based, and ambulatory surgical center (ASC)-based determinations are on the same timeline with slight differences in the claims run-out policies, whereas the facility-based determinations has a slightly different determination period. The virtual group eligibility determination requires a separate election process. We are proposing in this rule to add a virtual group eligibility determination period beginning in CY 2020 as discussed in section III.H.3.f.(2)(a) of this proposed rule. In addition, the rural and health professional shortage area (HPSA) determinations do not utilize a determination period.

      Under Sec. 414.1305, the low-volume threshold determination period is described as a 24-month assessment period consisting of an initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period, and a second 12-

      month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the initial 12-month segment will continue to be excluded under Sec. 414.1310(b)(1)(iii) for the applicable year regardless of the results of the second 12-month segment analysis. For the 2020 MIPS payment year and future years, each segment of the low-volume threshold determination period includes a 30-day claims run out.

      Under Sec. 414.1305, the non-patient facing determination period is described as a 24-month assessment period consisting of an initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period and a second 12-

      month segment that spans from the last 4 months of the calendar year 1 year prior to the performance

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      period through the first 8 months of the calendar year performance period. An individual eligible MIPS clinician, group, or virtual group that is identified as non-patient facing during the initial 12-month segment will continue to be considered non-patient facing for the applicable year regardless of the results of the second 12-month segment analysis. For the 2020 MIPS payment year and future years, each segment of the non-patient facing determination period includes a 30-

      day claims run out.

      In the CY 2018 Quality Payment Program final rule (82 FR 53581), we finalized that for the small practice size determination period, we would utilize a 12-month assessment period, which consists of an analysis of claims data that spans from the last 4 months of a calendar year 2 years prior to the performance period followed by the first 8 months of the next calendar year and includes a 30-day claims run out.

      In the CY 2017 Quality Payment Program final rule (81 FR 77238 through 77240), we finalized that to identify a MIPS eligible clinician as hospital-based we would use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we would use a 12-month period as close as practicable to this time period.

      In the CY 2018 Quality Payment Program final rule (82 FR 53684 through 53685), we finalized that to identify a MIPS eligible clinician as ASC-based, we would use claims with dates of service between September 1 of the calendar year 2 years preceding the performance period through August 31 of the calendar year preceding the performance period, but in the event it is not operationally feasible to use claims from this time period, we would use a 12-month period as close as practicable to this time period.

      In the CY 2018 Quality Payment Program final rule (82 FR 53760), we discussed, but did not finalize, our proposal or the alternative option for how an individual clinician or group would elect to use and be identified as using facility-based measurement for the MIPS program. Because we were not offering facility-based measurement until the 2019 MIPS performance period, we did not need to finalize either of these for the 2018 MIPS performance period. However, in section III.H.3.i.(1)(d) of this proposed rule, we are proposing to amend Sec. 414.1380(e)(2)(i)(A) to specify a criterion for a clinician to be eligible for facility-based measurement. Specifically, that is, the clinician furnishes 75 percent or more of his or her covered professional services in sites of service identified by the place of service codes used in the HIPAA standard transaction as an inpatient hospital, on-campus outpatient hospital, or emergency room setting based on claims for a 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period with a 30-days claims run out. We are not proposing to utilize the MIPS determination period for purposes of the facility-

      based determination because for the facility-based determination, we are only using the first segment of the MIPS determination period. We are using the first segment because the performance period for measures in the hospital value-based purchasing program overlapped in part with that determination period. If we were to use the second segment, we could not be assured that the clinician actually worked in the hospital on which their MIPS score would be based during that time. We believe this approach provides clarity and is a cleaner than providing a special exception for the facility-based determination in the MIPS determination period for the second segment. We refer readers to section III.H.3.i.(1)(d) for further details on the facility-based determinations and the time periods that are applicable to those determinations.

      In the CY 2018 Quality Payment Program final rule (82 FR 53602 through 53604), we finalized that for the virtual group eligibility determination period, we would utilize an analysis of claims data during an assessment period of up to 5 months that would begin on July 1 and end as late as November 30 of the calendar year prior to the applicable performance period and include a 30-day claims run out. To capture a real-time representation of TIN size, we finalized that we would analyze up to 5 months of claims data on a rolling basis, in which virtual group eligibility determinations for each TIN would be updated and made available monthly. We noted that an eligibility determination regarding TIN size is based on a relative point in time within the 5-month virtual group eligibility determination period, and not made at the end of such 5-month determination period. Beginning with the 2019 performance period, we are proposing to amend Sec. 414.1315(c)(1) to establish a virtual group eligibility determination period to align with the first segment of the MIPS determination period, which includes an analysis of claims data during a 12-month assessment period (fiscal year) that would begin on October 1 of the calendar year 2 years prior to the applicable performance period and end on September 30 of the calendar year preceding the applicable performance period and include a 30-day claims run out. We refer readers to section III.H.3.f.(2)(a) for further details on this proposal.

      In addition, we have established other special status determinations, including rural area and HPSA. Rural area is defined at Sec. 414.1305 as a ZIP code designated as rural, using the most recent Health Resources and Services Administration (HRSA) Area Health Resource File data set available. HPSAs are defined at Sec. 414.1305 as areas designated under section 332(a)(1)(A) of the Public Health Service Act.

      We understand that the current use of various MIPS determination periods is complex and causes confusion. Therefore, beginning with the 2021 MIPS payment year, we propose to consolidate several of these policies into a single MIPS determination period that would be used for purposes of the low-volume threshold and to identify MIPS eligible clinicians as non-patient facing, a small practice, hospital-based, and ASC-based, as applicable. We are not proposing to include the facility-

      based or virtual group eligibility determination periods or the rural and HPSA determinations in the MIPS determination period, as they each require a different process or timeline that does not align with the other determination periods, or do not utilize determination periods. We invite public comments on the possibility of incorporating these determinations into the MIPS determination period in the future.

      There are several reasons we believe a single MIPS determination period for most of the eligibility criteria is the most appropriate. First, it would simplify the program by aligning most of the MIPS eligibility determination periods. Second, it would continue to allow us to provide eligibility determinations as close to the beginning of the performance period as feasible. Third, we believe a timeframe that aligns with the fiscal year is easier to communicate and more straightforward to understand compared to the current determination periods. Finally, it would allow us to extend our data analysis an additional 30 days.

      It is important to note that during the final 3 months of the calendar year in

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      which the performance period occurs, in general, we do not believe it would be feasible for many MIPS eligible clinicians who join an existing practice (existing TIN) or join a newly formed practice (new TIN) to participate in MIPS as individuals. We refer readers to section III.H.3.i.(2)(b) of this proposed rule for more information on the proposed reweighting policies for MIPS eligible clinicians who join an existing practice or who join a newly formed practice during this timeframe.

      We request comments on our proposal that beginning with the 2021 MIPS payment year, the MIPS determination period would be a 24-month assessment period including a two-segment analysis of claims data consisting of: (1) An initial 12-month segment beginning on October 1 of the calendar year 2 years prior to the applicable performance period and ending on September 30 of the calendar year preceding the applicable performance period; and (2) a second 12-month segment beginning on October 1 of the calendar year preceding the applicable performance period and ending on September 30 of the calendar year in which the applicable performance period occurs. The first segment would include a 30-day claims run out. The second segment would not include a claims run out, but would include quarterly snapshots for informational use only, if technically feasible. For example, a clinician could use the quarterly snapshots to understand their eligibility status between segments. Specifically, we believe the quarterly snapshots would be helpful for new TIN/NPIs and TINs created between the first segment and the second segment allowing them to see their preliminary eligibility status sooner. Without the quarterly snapshots, these clinicians would not have any indication of their eligibility status until just before the submission period. An individual eligible clinician or group that is identified as not exceeding the low-volume threshold, or a MIPS eligible clinician that is identified as non-patient facing, a small practice, hospital-based, or ASC-based, as applicable, during the first segment would continue to be identified as such for the applicable MIPS payment year regardless of the second segment. For example, for the 2021 MIPS payment year, the first segment would be October 1, 2017 through September 30, 2018, and the second segment would be October 1, 2018 through September 30, 2019. However, based on our experience with the Quality Payment Program, we believe that some eligible clinicians, whose TIN or TIN/NPIs are identified as eligible during the first segment and do not exist in the second segment, are no longer utilizing these same TIN or TIN/NPI combinations. Therefore, because those TIN or TIN/NPIs would not exceed the low-volume threshold in the second segment, they would no longer be eligible for MIPS. For example, in the 2019 performance period a clinician exceeded the low-volume threshold during the first segment of the determination period (data from the end of CY 2017 to early 2018) under one TIN; then in CY 2019 the clinician switches practices under a new TIN and during segment two of the determination period. Therefore, it is determined that the clinician is not eligible (based on CY 2019 data) under either TIN. This clinician would not be eligible to participate in MIPS based on either segment of the determination period because the TIN that was assessed for the first segment of the determination period no longer exists. So there are no charges or services that would be available to assess in the second segment for that TIN and the new TIN assessed during the second segment was not eligible. In this scenario, though the clinician exceeded the low-volume threshold criteria initially, the clinician is not required to submit any data based on TIN eligibility determinations. However, it is important to note that if a TIN or TIN/

      NPI did not exist in the first segment but does exist in the second segment, these eligible clinicians could be eligible for MIPS. For example, the eligible clinician may not find their TIN or TIN/NPI in the Quality Payment Program lookup tool but may still be eligible if they exceed the low-volume threshold in the second segment. We proposed to incorporate this policy into our proposed definition of MIPS determination period at Sec. 414.1305. We also request comments on our proposals to define MIPS determination period at Sec. 414.1305 and modify the definitions of low-volume threshold, non-patient facing, a small practice, hospital-based, and ASC-based at Sec. 414.1305 to incorporate references to the MIPS determination period.

    5. Low-Volume Threshold

      (1) Overview

      Section 1848(q)(1)(C)(iv) of the Act, as amended by section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018, provides that, for performance periods beginning on or after January 1, 2018, the low-

      volume threshold selected by the Secretary may include one or more or a combination of the following (as determined by the Secretary): (1) The minimum number of part B-enrolled individuals who are furnished covered professional services (as defined in section 1848(k)(3)(A) of the Act) by the eligible clinician for the performance period involved; (2) the minimum number of covered professional services furnished to part B-

      enrolled individuals by such clinician for such performance period; and (3) the minimum amount of allowed charges for covered professional services billed by such clinician for such performance period.

      Under Sec. 414.1310(b)(1)(iii), for a year, eligible clinicians who do not exceed the low-volume threshold for the performance period with respect to a year are excluded from MIPS. Under Sec. 414.1305, the low-volume threshold is defined as, for the 2019 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician or group that, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Part B-enrolled Medicare beneficiaries. In addition, for the 2020 MIPS payment year and future years, the low-volume threshold is defined as the low-volume threshold that applies to an individual eligible clinician or group that, during the low-volume threshold determination period, has Medicare Part B allowed charges less than or equal to $90,000 or provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. The low-volume threshold determination period is a 24-month assessment period consisting of: (1) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding the performance period; and (2) a second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible clinician or group that is identified as not exceeding the low-volume threshold during the initial 12-month segment will continue to be excluded under Sec. 414.1310(b)(1)(iii) for the applicable year regardless of the results of the second 12-

      month segment analysis. For the 2019 MIPS payment year, each segment of the low-volume threshold determination period includes a 60-day claims run out. For the 2020 MIPS payment year, each segment of the low-volume threshold determination period includes a 30-day claims run out.

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      (2) Proposed Amendments To Comply With the Bipartisan Budget Act of 2018

      In this proposed rule, we are proposing to amend Sec. 414.1305 to modify the definition of low-volume threshold in accordance with section 1848(q)(1)(C)(iv) of the Act, as amended by section 51003(a)(1)(A)(ii) of the Bipartisan Budget Act of 2018. Specifically, we request comments on our proposals that for the 2020 MIPS payment year, we will utilize the minimum number (200 patients) of Part B-

      enrolled individuals who are furnished covered professional services by the eligible clinician or group during the low-volume threshold determination period or the minimum amount ($90,000) of allowed charges for covered professional services to Part B-enrolled individuals by the eligible clinician or group during the low-volume threshold determination period.

      (3) MIPS Program Details

      We request comments on our proposal to modify Sec. 414.1310 to specify in paragraph (a), Program Implementation, that except as specified in paragraph (b), MIPS applies to payments for covered professional services furnished by MIPS eligible clinicians on or after January 1, 2019. We also request comments on our proposal to revise Sec. 414.1310(b)(1)(ii) to specify that for a year, a MIPS eligible clinician does not include an eligible clinician that is a Partial Qualifying APM Participant (as defined in Sec. 414.1305) and does not elect, as discussed in section III.H.4.e. of this proposed rule, to report on applicable measures and activities under MIPS. Finally, we request comments on our proposal to revise Sec. 414.1310(d) to specify that, in no case will a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) apply to payments for covered professional services furnished during a year by eligible clinicians (including those described in paragraphs (b) and (c) of this section) who are not MIPS eligible clinicians, including those who voluntarily report on applicable measures and activities under MIPS.

      (4) Proposed Addition of Low-Volume Threshold Criterion Based on Number of Covered Professional Services

      In the CY 2018 Quality Payment Program final rule (82 FR 53591), we received several comments in response to the proposed rule regarding adding a third criterion of ``items and services'' for defining the low-volume threshold. We refer readers to that rule for further details.

      For the 2021 MIPS payment year and future years, we are proposing to add one additional criterion to the low-volume threshold determination--the minimum number of covered professional services furnished to Part B-enrolled individuals by the clinician. Specifically, we request comments on our proposal, for the 2021 MIPS payment year and future years, that eligible clinicians or groups who meet at least one of the following three criteria during the MIPS determination period would not exceed the low-volume threshold: (1) Those who have allowed charges for covered professional services less than or equal to $90,000; (2) those who provide covered professional services to 200 or fewer Part B-enrolled individuals; or (3) those who provide 200 or fewer covered professional services to Part B-enrolled individuals.

      For the third criterion, we are proposing to set the threshold at 200 or fewer covered professional services furnished to Part B-enrolled individuals for several reasons. First, in the CY 2018 Quality Payment Program final rule (82 FR 53589 through 53590), while we received positive feedback from stakeholders on the increased low-volume threshold, we also heard from some stakeholders that they would like to participate in the program. Second, setting the third criterion at 200 or fewer covered professional services allows us to ensure that a significant number of eligible clinicians have the ability to opt-in if they wish to participate in MIPS. Finally, when we were considering where to set the low-volume threshold for covered professional services, we examined two options: 100 or 200 covered professional services. For 100 covered professional services, there is some historical precedent. In the CY 2017 Quality Payment Program final rule (81 FR 77062), we finalized a low-volume threshold that excluded individual eligible clinicians or groups that have Medicare Part B allowed charges less than $30,000 or that provide care for 100 or fewer Part B-enrolled Medicare beneficiaries; we believe the latter criterion is comparable to 100 covered professional services. Conversely for 200 covered professional services, in the CY 2018 Quality Payment Program final rule comment period (82 FR 53588), we discussed that based on our data analysis, excluding individual eligible clinicians or groups that have Medicare Part B allowed charges less than or equal to $90,000 or that provide care for 200 or fewer Part B-enrolled Medicare beneficiaries decreased the percentage of MIPS eligible clinicians that come from small practices. In addition, in the CY 2018 Quality Payment final rule (82 FR 53955), we codified at Sec. 414.1380(b)(1)(iv) a minimum case requirements for quality measures are 20 cases which both services threshold considerations (100 or 200) exceed and at Sec. 414.1380(b)(1)(v) a minimum case requirements for the all-cause hospital readmission measure is 200 cases, which only the 200 services threshold consideration exceeds. We believe that setting a threshold of 200 services for the third criterion strikes the appropriate balance between allowing a significant number of eligible clinicians the ability to opt-in (as described below) to MIPS and consistency with the previously established low-volume threshold criteria. In section VII.F.8.b. of this proposed rule, we estimate no additional clinicians would be excluded if we add the third criterion because a clinician that cares for at least 200 beneficiaries would have at least 100 or 200 services; however, we estimate 42,025 clinicians would opt-in with the low-volume threshold at 200 services, as compared to 19,621 clinicians if we did not add the third criterion. If we set the third criterion at 100 services, then we estimate 50,260 clinicians would opt-in.

      (5) Low-Volume Threshold Opt-In

      In the CY 2018 Quality Payment Program final rule (82 FR 53589), we proposed the option to opt-in to MIPS participation if clinicians might otherwise be excluded under the low-volume threshold. We received general support from comments received in the CY 2018 Quality Payment Program final rule (82 FR 53589). However, we did not finalize the proposal for the 2019 MIPS performance period. We were concerned that we would not be able to operationalize this policy in a low-burden manner to MIPS eligible clinicians as it was proposed.

      After consideration of operational and user experience implications of an opt-in policy, we are proposing an approach we believe can be implemented in a way that provides the least burden to clinicians. We are proposing to modify Sec. 414.1310(b)(1)(iii) to provide that beginning with the 2021 MIPS payment year, if an eligible clinician or group meets or exceeds at least one, but not all, of the low-volume threshold determinations, including as defined by dollar amount (less than or equal to $90,000) or number of beneficiaries (200 or fewer), or number of covered professional services (200 or fewer), then such eligible individual or group may choose to opt-in to MIPS.

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      This policy would apply to individual eligible clinicians and groups who exceed at least one, but not all, of the low-volume threshold criteria and would otherwise be excluded from MIPS participation as a result of the low-volume threshold. We believe that it would be beneficial to provide, to the extent feasible, such individual eligible clinicians and groups with the ability to opt-in to MIPS. Conversely, this policy would not apply to individual eligible clinicians and groups who exceed all of the low-volume threshold criteria, who unless otherwise excluded, are required to participate in MIPS. In addition, this policy would not apply to individual eligible clinicians and groups who do not exceed any of the low-volume threshold criteria, who would be excluded from MIPS participation without the ability to opt-in to MIPS. While we believe we are proposing the appropriate balance for the low-volume threshold elements, we request comments on other low-volume threshold criteria and supporting justification for the recommended criteria.

      Under the proposed policies, we estimate clinician eligibility based on the following (we refer readers to the regulatory impact analysis in section VII.F.8.b. of this proposed rule for further details on our assumptions): (1) Eligible because they exceed all three criteria of the low-volume threshold and are not otherwise excluded (estimated 608,000 based on our assumptions of who did individual and group reporting); (2) eligible because they exceed at least one, but not all, of the low-volume threshold criteria and elect to opt-in (estimated 42,000 for a total MIPS eligible clinician population of approximately 650,000); (3) potentially eligible if they either did group reporting or elected to opt-in \15\ (estimated 483,000); (4) excluded because they do not exceed any of the low-volume threshold criteria (estimated 88,000); and (5) excluded due to non-eligible specialty, newly enrolled, or QP status (estimated 302,000).

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      \15\ A clinician may be in a group that we estimated would not elect group reporting, however, the group would exceed the low-

      volume threshold on all three criteria if the group elected group reporting. Similarly, an individual or group may exceed at least one but not all of the low-volume threshold criteria, but we estimated the clinician or group would not elect to opt-in to MIPS. In both cases, these clinicians could be eligible for MIPS if the group or individual makes choices that differ from our assumptions.

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      We are proposing that applicable eligible clinicians who meet one or two, but not all, of the criteria to opt-in and are interested in participating in MIPS would be required to make a definitive choice to either opt-in to participate in MIPS or choose to voluntarily report before data submission. If they did not want to participate in MIPS, they would not be required to do anything and would be excluded from MIPS under the low-volume threshold. For those who did want to participate in MIPS, we considered the option of allowing the submission of data to signal that the clinician is choosing to participate in MIPS. However, we anticipated that some clinicians who utilize the quality data code (QDC) claims submission type may have their systems coded to automatically append QDCs on claims for eligible patients. We were concerned that they could submit a QDC code and inadvertently opt-in when that was not their intention.

      For individual eligible clinicians and groups to make an election to opt-in or voluntarily report to MIPS, they would make an election via the Quality Payment Program portal by logging into their account and simply selecting either the option to opt-in (positive, neutral, or negative MIPS adjustment) or to remain excluded and voluntarily report (no MIPS adjustment). Once the eligible clinician has elected to participate in MIPS, the decision to opt-in to MIPS would be irrevocable and could not be changed for the applicable performance period. Clinicians who opt-in would be subject to the MIPS payment adjustment during the applicable MIPS payment year. Clinicians who do not decide to opt-in to MIPS would remain excluded and may choose to voluntarily report. Such clinicians would not receive a MIPS payment adjustment factor. To assist commenters in providing pertinent comments, we have developed a website that provides design examples of the different approaches to MIPS participation in CY 2019. The website uses wi