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; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

 
CONTENT

Federal Register, Volume 83 Issue 226 (Friday, November 23, 2018)

Federal Register Volume 83, Number 226 (Friday, November 23, 2018)

Rules and Regulations

Pages 59836-60303

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

FR Doc No: 2018-24170

Page 59451

Vol. 83

Friday,

No. 226

November 23, 2018

Part II

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; Medicaid Promoting Interoperability Program; Quality Payment Program--Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program--Accountable Care Organizations--Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; Final Rules and Interim Final Rule

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, 425, and 495

CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F

RIN 0938-AT31, 0938-AT13, & 0938-AT45

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; Medicaid Promoting Interoperability Program; Quality Payment Program--

Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program--

Accountable Care Organizations--Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

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

ACTION: Final rules and interim final rule.

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SUMMARY: This major final 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. This final rule also finalizes policies included in the interim final rule with comment period in ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule ``Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Pathways to Success''. This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program.

The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.

DATES: Effective Dates: These regulations are effective on January 1, 2019, except for the following:

Revisions to Sec. Sec. 414.1415(b)(2) and (3), and 414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and

Amendments to Part 425, which are effective on December 31, 2018.

Applicability Date: The following provisions related to Section II.I. of this final rule, Evaluation and Management Services, are applicable beginning January 1, 2021: Implementation of a blended payment rate for E/M visits levels 2-4; Payment to adjust the base E/M visit rate(s) upward to account for visit complexity associated with non-procedural specialty care and primary care; Payment to adjust the base visit rate(s) upward to account for the additional resource costs when practitioners need to spend significantly more time with particular patients; and Flexible documentation requirements related to Medical Decision Making, Time or Current E/M visit documentation framework. The amendment to the definition of ``low-volume criteria'' at Sec. 414.1305 is applicable at the start of the first Merit-based Incentive Payment System (MIPS) determination period for CY 2018 MIPS performance period.

Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 31, 2018.

ADDRESSES: In commenting, please refer to file code CMS-1693-IFC. 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-IFC, P.O. Box 8010, 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-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

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.

Lindsey Baldwin, (410) 786-1694, for issues related to sections 2001(a) and 2005 of the SUPPORT for Patients and Communities Act.

Kathy Bryant, (410) 786-3448, for issues related to global surgery data collection.

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, for issues related to potentially misvalued services, geographic price cost indices (GPCIs), and malpractice RVUs.

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

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.

Marcie O'Reilly, (410) 786-9764, for issues related to the Potential Model for Radiation Therapy.

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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.

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

David Koppel, (303) 844-2883, or Elizabeth LeBreton (202) 615-3816 for issues related to the Medicaid Promoting Interoperability Program.

Elizabeth November, (410) 786-8084, for inquiries related to the Medicare Shared Savings Program Pathways to Success.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Provisions of the Final 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 and Interim Final Rule Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

  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. GPCI Comment Solicitation

    L. Therapy Services

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

  12. Potential Model for Radiation Therapy

    III. Other Provisions of the Final Rule

  13. Clinical Laboratory Fee Schedule

  14. 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

  18. Medicare Shared Savings Program Quality Measures

  19. Physician Self-Referral Law

  20. Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes

    I. CY 2019 Updates to the Quality Payment Program (Includes the Extreme and Uncontrollable Circumstances MIPS Eligible Clinicians Faced as a Result of Widespread Catastrophic Events Affecting a Region or Locale in CY 2017 IFC Policies)

    IV. Requests for Information

    V. Medicare Shared Savings Program; Accountable Care Organizations--

    Pathways to Success

    VI. Collection of Information Requirements

    VII. Regulatory Impact Analysis

    Regulations Text

    Appendix 1: Finalized 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 final rule are available on the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-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 final rule, refer to item CMS-

    1693-F. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this final 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 final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2018 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

  21. Purpose

    This major final rule makes payment and policy changes under the Medicare PFS and implements certain provisions of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 9, 2018) and the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018) related to Medicare Part B payment, and except as specified otherwise, applicable to services furnished in CY 2019. This final rule also revises certain policies under the Medicare Shared Savings Program.

    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 final rule, we 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 final rule includes discussions regarding:

    Potentially Misvalued Codes.

    Communication Technology-Based Services.

    Provisions Expanding Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders under the SUPPORT Act.

    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.

    Evaluation & Management (E/M) Visits.

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    Therapy Services.

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

    Potential Model for Radiation Therapy.

    Clinical Laboratory Fee Schedule.

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

    Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

    Appropriate Use Criteria for Advanced Diagnostic Imaging Services.

    Medicaid Promoting Interoperability Program Requirements for Eligible Professionals.

    Medicare Shared Savings Program Quality Measures.

    Physician Self-Referral Law.

    Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.

    CY 2019 Updates to the Quality Payment Program (including the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017).

    Comments in response to the 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.

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

    This rule also finalizes certain provisions from the ``Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Pathways to Success'' proposed rule that appeared in the August 17, 2018 Federal Register (83 FR 41786). Under the Medicare Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee-for-

    service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs participating under a two-sided shared savings and shared losses model of the program may also be responsible for repaying shared losses if the Parts A and B FFS expenditures for their assigned beneficiaries exceed the ACO's historical benchmark. The revised policies for ACOs participating in the Medicare Shared Savings Program will ensure continuity of program participation for ACOs whose agreement periods expire on December 31, 2018 by allowing these ACOs the opportunity to elect a voluntary 6-month extension of their current agreement periods; supporting coordination of care across settings and strengthening beneficiary engagement; providing relief for ACOs impacted by extreme and uncontrollable circumstance in performance year 2018 and subsequent years; and promoting interoperable electronic health record technology among ACO providers/suppliers. We plan to address the remaining proposals from the August 2018 proposed rule (83 FR 41786) in a forthcoming second final rule.

    2. Summary of Costs and Benefits

    We have determined that this major final rule is economically significant. For a detailed discussion of the economic impacts, see section VII. of this final rule.

  22. 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).

      Comment: Several commenters requested that CMS include pharmacists as active qualified health care providers for purposes of calculating physician PE direct costs. The commenters stated that pharmacists need to be included in the calculation of direct PE expenses as an element of the clinical labor variable relating to physicians' services. The commenter stated that pharmacists are key members of the healthcare team supporting the advent of digital medicine and telehealth services and suggested that pharmacists should be recognized as staff included in practice expense inputs.

      Response: The direct PE input database contains the service-level costs in clinical labor based on the typical service furnished to Medicare beneficiaries. When these resource costs are typically incurred in furnishing services, we do not have any standing policies that would prohibit the inclusion of the costs in the direct PE input database used to develop PE RVUs for individual services, to the extent that inclusion of such costs would not lead to duplicative payments. Therefore, we welcome more detailed information regarding the typical clinical labor costs involving pharmacists for particular PFS services. We note, however, that in the case of many PFS services, especially care management services, certain elements of the services could be provided by clinicians other than the billing professionals, which could include services provided by pharmacists. As such, we encourage interested stakeholders to provide information through the RUC process or directly to us by February 10th prior to annual rulemaking about the inclusion of additional clinical labor costs for specific services described by HCPCS codes for which payment is made under the PFS, as opposed to clinical labor costs that may be typical only under certain circumstances.

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    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 Final Rule PE/HR'' on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      Comment: Several commenters recommended that it was time to consider a new nationwide all specialty PE/HR survey, given the amount of time that has passed since the last survey was conducted. The commenters stated that the practice of medicine has significantly and substantially evolved in the past decade and that many specialties have had extensive changes in physician employment models during that time. The commenters stated that continued use of the outdated PPIS survey leads to an inappropriate and inaccurate distortion of the PE RVUs for current practice.

      Response: We have previously identified several concerns regarding the underlying data used in determining PE RVUs in the CY 2014 PFS final rule with comment period (78 FR 74246 through 74247). While we continue to believe that the PPIS survey data are the best data currently available, we continue to seek the best broad based, auditable, routinely updated source of information regarding PE costs. To that end, we have engaged a contractor, the RAND Corporation, to explore the feasibility of updating the data used in the development of PE RVUs.

      Comment: One commenter requested that CMS consider studying indirect PE associated with emergency departments including Emergency Medical Treatment & Labor Act (EMTALA)-mandated uncompensated care. The commenter stated that emergency physicians are not able to schedule their patients and therefore cannot maximize the use of staff and resources, and that there are costs associated with being open and having to pay shift differentials over nights, weekends, and holidays.

      Response: We will take the information under consideration for future rulemaking.

      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 proposed 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, and

      Advanced Heart Failure and Transplant Cardiology from Cardiology.

      These updates are reflected in the ``CY 2019 PFS Final Rule PE/HR'' file available on the CMS website under the supporting data files for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-

      Notices.html.

      The following is a summary of the public comments we received on our proposal to use proxy PE/HR values for these two new specialties.

      Comment: One commenter stated that they supported the CMS proposal to crosswalk the Advanced Heart Failure and Transplant specialty to the cardiology PPIS data.

      Response: We appreciate the support from the commenter for our proposal.

      Comment: A few commenters wrote to detail their concerns with the current PE/HR assigned to home PT/INR monitoring services. Commenters stated that these services are provided by entities that are enrolled in Medicare as independent testing facilities because there is no other specialty category that currently describes these suppliers; however, home PT/INR monitoring services are fundamentally different in nature. Commenters stated that home PT/INR monitoring services tend to be

      Page 59456

      more therapeutic than diagnostic in nature, typically utilize different staffing types, and have a different ratio of direct to indirect costs. The commenters encouraged CMS to consider home PT/INR monitoring as a distinct specialty from independent testing facilities and to survey suppliers to determine accurate indirect cost factors for these services, while using either the Pathology or All Physicians specialty as a proxy for PE/HR in the meantime. One commenter suggested that CMS should consider holding payments harmless for home PT/INR monitoring services while additional analysis is completed.

      Response: We welcome suggestions from interested parties regarding new indirect PE surveys and the use of PE/HR proxies that could be considered for future rulemaking. Interested parties may wish to submit a physician specialty designation request per the instructions found in Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section 10.8 (available on the CMS website at https://www.cms.gov/Regulations-

      and-Guidance/Guidance/Manuals/Downloads/clm104c26.pdf). This section of the Medicare Claims Processing Manual includes the criteria that CMS uses to evaluate physician specialty designation requests.

      After consideration of the public comments, we are finalizing our proposal to use proxy PE/HR values for Hospitalists and Advanced Heart Failure and Transplant Cardiology as described above.

    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 at the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion (see section II.B.2.b of this final 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.

      Comment: One commenter stated that it was not clear why the PE change would differ so greatly between the office and facility settings for CPT code 37227 (Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed). The commenter stated that the facility PE RVU for this CPT code was proposed to decrease by 4.8 percent while the non-facility PE RVU was proposed to decrease by 10.6 percent, and the commenter could not understand how these payment rates were determined.

      Response: As detailed above, 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. It is not unusual for facility and nonfacility RVUs for a CPT code to change at different rates from year to year, as the direct costs associated with the facility and nonfacility settings are typically distinct from one another. For a more detailed description of the PE RVU methodology, we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69630 through 69643) and the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).

      (4) Services With Technical Components and Professional Components

      Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be

      Page 59457

      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 final 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 final rule for individual codes.

      (

    4. Setup File

      First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.

      (b) Calculate the Direct Cost PE RVUs

      Sum the costs of each direct input.

      Step 1: Sum the direct costs of the inputs for each service.

      Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs.

      Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service.

      Step 4: Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1).

      Step 5: Convert the results of Step 4 to a RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling adjustments offset one another.

      (c) Create the Indirect Cost PE RVUs

      Create indirect allocators.

      Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.

      Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

      We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we instead use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, ``always therapy'' services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.

      For CY 2019, we proposed to add 28 additional codes that we 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 proposed 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 proposed to add is displayed in Table 1.

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

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

      2017

      CPT code Modifier 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 Gastroenterology.......... 10

      obstruction.

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

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

      tube.

      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/ Diagnostic Radiology...... 41

      leg.

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

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

      Page 59458

      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 Pathology................. 24

      assay.

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

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

      tissue.

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

      congenital.

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

      congenital.

      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

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

      The complete list of expected specialty assignments for individual low volume services, including the assignments for the codes identified in Table 1, is available on our website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      The following is a summary of the public comments we received on our proposal to update the list of expected specialty assignments for low volume services.

      Comment: Several commenters supported the continued use of service-

      level overrides for low volume codes, and stated that they agreed with the addition of the proposed 28 codes to the list of expected specialties.

      Response: We appreciate the support from the commenters.

      Comment: Several commenters stated that CPT code 22857 (Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar) was missing from the proposed list. These commenters requested that CMS include CPT code 22857 in the low utilization category and permanently assign it to the orthopaedic surgery specialty to maintain payment stability and minimize annual fluctuations.

      Response: We agree with the commenters that CPT code 22857 qualifies as a low volume code, with an annual Medicare utilization of roughly 20 services. We agree with the commenters that assigning this code to the orthopaedic surgery specialty will help to maintain payment stability, and we are finalizing the addition of CPT code 22857 to the low volume services list.

      Comment: One commenter stated that several of the proposed low volume services would be more accurately assigned to different expected specialties based on their practice patterns. The commenter stated that CPT codes 70557 and 70558 are intraoperative exams and are most often performed by neurosurgeons and that CPT code 74235 is a diagnostic radiology code rather than a gastroenterology code. The commenter stated that CPT code 75810 should be assigned to interventional radiology rather than diagnostic radiology, and that CPT codes 78282 and 79300 should be assigned to nuclear medicine rather than diagnostic radiology.

      Response: We agree that these codes would be more accurately assigned to the expected specialties described by the commenter based on an examination of the claims data. We are finalizing changes in expected specialty to these six codes as described by the commenter.

      Comment: One commenter stated that there are four codes that are still not included in the proposed CY 2019 low volume override list and recommended that the following low volume procedures be added to the override list with the indicated specialty assignment:

      Cardiac Surgery: CPT code 35812, and

      Thoracic Surgery: CPT codes 32654, 33025 and 33251

      Response: We agree with the inclusion of CPT codes 32654 and 33251. These are services with very low annual utilization, and we are finalizing their addition to the low volume services list with the expected specialty as described by the commenter. We note that CPT code 33251 is already on the low volume services list with an expected specialty of Cardiac Surgery; we are finalizing a change to the Thoracic Surgery specialty as requested by the commenter. We are not finalizing the addition of CPT code 35812 to the list, as it does not appear to be a current CPT code. We are also not finalizing the addition of CPT code 33025 to the list, as the code had a utilization of more than 5,000 services in the most recent year of claims data, and this would not qualify as a low volume service under the criteria that we have previously finalized through rulemaking.

      Comment: One commenter stated that the appropriate low volume overrides were not applied to a series of congenital/pediatric cardiac surgery codes. The commenter stated that each of these operations can only be performed by congenital heart surgeons classified as either cardiac or thoracic surgeons, and that they believe the malpractice RVUs had been improperly decreased as a result of the low volume service overrides not being applied.

      Response: Each of the CPT codes identified by the commenter was already present on the low volume services list with an expected specialty assignment of either Cardiac Surgery or Thoracic Surgery. The shifts in malpractice RVUs identified by the commenter were a result of proposed policies associated with E/M visits. We refer readers to section II.I. of this final rule for additional details on these policies.

      After consideration of the public comments, we are finalizing the addition of the proposed 28 codes to the low volume services list, with the expected specialty as proposed except where modified in response to comments. We are also finalizing the addition of CPT codes 32654 and 33251 to the list with an expected specialty of Thoracic Surgery as detailed previously.

      Page 59459

      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.

      The following is a summary of the public comments we received on the indirect practice cost indices.

      Comment: Many commenters stated that they were opposed to the proposed significant shifts in the indirect practice cost indices at the specialty level. Commenters stated that the creation of a separate PE/HR rate for the E/M visits resulted in large unintended effects on specialties given the way that indirect PE is allocated, and that this was inconsistent with CMS' intent to maintain stability in payment. One commenter stated that the proposal to create a separate PE/HR rate for the E/M visits was based on statistically unsound methodology, had opaque analytics, and was not resource-based. Many commenters stated that the effects of the proposed changes to the indirect practice cost indices had not been sufficiently detailed in the proposed rule to allow for proper feedback from commenters. Commenters expressed concern that a reduction in payment due to shifts in the indirect PE allocation could affect patient access to critical services, such as but not limited to CPT codes 96360 (intravenous infusion, hydration; initial, 31 minutes to 1 hour), 96372 (therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular), 96374 (therapeutic, prophylactic or diagnostic injection IV push, single or initial substance/drug), 96375 (therapeutic, prophylactic or diagnostic injection; each additional sequential IV push of a new substance/drug), and HCPCS code G0416 (Surgical pathology, gross and microscopic examinations, for prostate needle biopsy, any method). A few commenters stated that the proposed indirect practice cost indices ignored statutory requirements that payments under the PFS must be resource based and failed to meet the transparency requirements of the Protecting Access to Medicare Act of 2014 (PAMA). Commenters urged CMS not to finalize the proposed changes to the indirect practice cost indices.

      Response: The proposed changes in the indirect practice cost indices identified by the commenters were a result of proposed policies associated with E/M visits, and specifically the proposal to establish a separate specialty for E/M visits. We refer readers to section II.I. of this final rule for additional discussion of these policies.

      Comment: One commenter stated that the level of detail in the CY 2019 PFS proposed rule was insufficient to comment on several aspects of the proposed changes in coding and payment related to office/

      outpatient E/M visits, which was a departure from past rules. The commenter specifically stated that there was insufficient information to model how the proposed changes in the office/outpatient E/M visit codes affected the indirect practice cost indices for all other services. Similarly, the commenter suggested that not enough information was provided to simulate the PFS ratesetting in a way that would isolate the impact of the proposed multiple procedure payment reduction (MPPR), in the proposed rates and associated estimates of specialty-level impact. The commenter requested that CMS provide additional technical information and files going forward to enable the commenter to better model proposed and future policies.

      Response: We agree with commenters regarding the importance of transparency and the need for detailed

      Page 59460

      information about proposed policies so that public commenters can provide a full and informed response. We also understand that there is merit to providing as much information as possible that would allow for complete reproduction of our proposed and final ratesetting methodologies. We also understand that the proposals related to office/

      outpatient E/M visits are of great importance to the medical community and represent a significant portion of spending under the PFS. We do not agree with the commenter that the level of detail provided in the proposed rule, including the data provided as publicly available download files, was insufficient for public comment due to the extensive documentation associated with the E/M policy proposals, or that it represented a departure from past practice. Over several years, we have invested significant resources in improving the transparency of the data we use in developing proposed and final PFS rates. We intend to maintain a focus on increasing transparency, and believe the commenters' concerns will help us understand the kind of information that can be most helpful to stakeholders interested in the underlying data sets. While we are not finalizing the MPPR element of the E/M proposal, we appreciate the commenter's interest in the use of code-

      level assumptions regarding proposed payment adjustments that are reflected in the discounts in the setup file, as discussed in section II.B.2.(5)(e) of this final rule.

      (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).

      Comment: We received many comments regarding the ongoing decrease in the technical component of CPT code 76881 (Ultrasound, complete joint (i.e., joint space and peri-articular soft tissue structures) real-time with image documentation). Commenters stated that this procedure is essential for making appropriate diagnosis and managing patients with various rheumatologic conditions and musculoskeletal disorders. Commenters stated that cutting the reimbursement for the code would not only result in poor patient care but also increase total costs through the use of more expensive MRI procedures. Commenters also disagreed with the RUC's recommended direct PE inputs for CPT code 76881 from the CY 2018 rule cycle, citing concerns with the RUC's use of workforce data, and urged CMS not to make further reductions in payment.

      Response: The comments regarding CPT code 76881 are out of scope, as we did not make any proposals involving this code for CY 2019. The reductions in payment described by the commenters for CPT code 76881 were finalized as part of the CY 2018 PFS final rule (82 FR 53058-

      53059), and are continuing to be phased in over time as part of the transition policy described above. 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.

      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.

      Page 59461

      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 Preoperative + Preoperative +

      only. Intraoperative Percentages Intraoperative

      on the payment files used portion.

      by Medicare contractors to

      process Medicare claims.

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

      the payment files used by

      Medicare contractors to

      process Medicare claims.

      62.............................. Co-surgeons............ 62.5%....................... 50%.

      66.............................. Team Surgeons.......... 33%......................... 33%.

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

      We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

      For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.

      Work RVUs: The setup file contains the work RVUs from this final rule.

      (6) Equipment Cost per Minute

      The equipment cost per minute is calculated as:

      Page 59462

      (1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate) supcaret 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 final 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 final rule.

      Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.

      Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that would support an alternative rate.

      Comment: A few commenters stated that equipment time associated with payment for diagnostic imaging services is not aligned with practice. The commenters disagreed with the CMS statement that certain highly technical equipment is less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff, and stated that the CMS analysis of equipment time is not accurate based on their experience with imaging centers. Commenters stated that there are non-imaging functions that are required by CMS for payment, such as documentation requirements and the need for enrollment in Medicare by professionals, which add to their administrative burden and increase costs yet are underrepresented in the PE methodology. Commenters stated that they disagreed with how CMS defined room time as inconsistent with how imaging centers actually function, and indicated a preference for assigning equipment time based on the total technologist time.

      Response: We disagree with the commenters regarding the equipment time assigned to highly technical equipment. We continue to 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 and are typically available for other patients even when one member of clinical staff may be occupied with a preservice or postservice task related to the procedure. For a more detailed description of this topic, we refer readers to the CY 2015 PFS final rule with comment period (79 FR 67639 through 67640).

      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 a different maintenance factor, we do not believe that we have sufficient information at present to propose a variable maintenance factor for equipment cost per minute pricing. We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.

      Comment: A commenter stated that they continue to believe that maintenance costs for imaging equipment are much higher than the current 5 percent assumption. The commenter stated that they were hopeful that the market-based research into equipment and supply pricing would result in a broad range, systematic data collection methodology that could be applied to collecting information on equipment maintenance costs.

      Response: As detailed above, we continue to believe that the current 5 percent maintenance factor likely understates the true cost of maintaining some equipment and overstates the maintenance costs for other equipment. We continue at this time to lack publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining maintenance factor. With regards to the market-based study, the StrategyGen contractors were tasked with updating the commercial pricing of supplies and equipment, and did not include an investigation of equipment maintenance rates as part of their research.

      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 did not propose any changes to these interest rates for CY 2019. The interest rates are listed in Table 4.

      Table 4--SBA Maximum Interest Rates

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

      Useful

      Price life Interest

      (years) rate (%)

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

      $50K............................................. $50K............................................. 7+ 6.00

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

      3. Changes to Direct PE Inputs for Specific Services

      This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2019 direct PE input database, which is available on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    5. 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

      Page 59463

      instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

      In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for ``Availability of prior images confirmed'', 2 minutes for ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'', 2 minutes for ``Review examination with interpreting MD'', and 1 minute for ``Exam documents scanned into PACS.'' Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, ``Technologist QCs images in PACS, checking for all images, reformats, and dose page.'' These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values.

      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 final 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 proposed to maintain the 3 minutes of clinical labor time for the ``Prepare room, equipment and supplies'' activity and remove the clinical labor time for the ``Confirm order, protocol exam'' activity wherever we observed this pattern in the RUC-

      recommended direct PE inputs. 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 RUC-

      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.

      The following is a summary of the public comments we received on our proposal 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 the aforementioned pattern in the RUC-recommended direct PE inputs.

      Comment: Several commenters supported CMS' proposal and requested that these clinical labor refinements should be finalized wherever the refinement had been proposed. These commenters noted that there was no change in the total clinical labor direct costs in these situations and urged CMS to finalize the proposal.

      Page 59464

      Response: We appreciate the support for the proposal from the commenters.

      Comment: Other commenters disagreed with the proposal. Commenters stated that the standard clinical labor time for the CA013 ``Prepare room, equipment and supplies'' activity has always been 2 minutes, and that the occasional assignment of additional clinical labor time in individual procedures has not changed this standard.

      Response: We agree with the commenters that the standard clinical labor time for the CA013 activity code is 2 minutes. We noted in the proposed rule that 3 minutes has often traditionally been assigned for this clinical labor activity, and our proposal was intended to reflect this common practice pattern. In our table of direct PE refinements, we listed many of these clinical labor refinements using the refinement code ``L1: Refined time to standard for this clinical labor task.'' This was the incorrect refinement code to use in these situations, and we acknowledge that this was a technical error. The direct PE refinements would have more accurately employed the general refinement code ``G1: See preamble text'' instead. We wish to clarify that although we agree that the standard clinical labor time for the CA013 activity is 2 minutes, we continue to believe that 2 minutes would not be typical for many of the codes currently under discussion.

      Comment: Commenters explained that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes. In the old version of the PE worksheet, there was a clinical labor task named ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist.'' Commenters stated that this clinical labor task was split into two of the new clinical labor activity codes: CA007 (``Review patient clinical extant information and questionnaire'') in the preservice period, and CA014 (``Confirm order, protocol exam'') in the service period. Commenters stated that the same clinical labor from the old PE worksheet is now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. The commenters stated that they recognized that the proposal had no effect on the total clinical labor direct costs, but urged CMS not to finalize anyway due to concerns over inaccuracy and long term effects on the direct practice expense inputs across the PFS.

      Response: We agree with the commenters that in situations where a CPT code under review had the old clinical labor task ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'' on a prior version of the PE worksheet, and where that old clinical labor task was divided into the new CA007 and CA014 activity codes as described by the commenters, we will not finalize our proposed refinements to maintain 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, as we agree that the old clinical labor task is adequately accounted for by being divided into the new activity codes. In these cases, we will finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code.

      However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include the old clinical labor task ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'' on a prior version of the PE worksheet. We also noted that several of the reviewed codes that contained the CA014 clinical labor activity code for ``Confirm order, protocol exam'' did not contain any clinical labor for the CA007 activity (``Review patient clinical extant information and questionnaire''). In these situations, we believe that it is more accurate to finalize our direct PE refinements 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 as proposed, since the rationale provided by the commenters does not appear to be the case. These codes do not appear to be an instance where the old clinical labor task was split into two new clinical labor activities. We do not understand how time assigned to an old clinical labor task could be divided between the CA007 and CA014 activity codes, as the commenters suggested, in situations where the code under review does not contain any clinical labor for the CA007 activity. We continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 ``Prepare room, equipment and supplies'' activity code, as these codes do not currently have clinical labor time assigned for the CA014 ``Confirm order, protocol exam'' clinical labor activity.

      After consideration of the public comments, we are finalizing our proposal for the reviewed codes that did not include the old clinical labor task described above and do not contain any clinical labor for the CA007 clinical labor activity. We are therefore finalizing our proposal for CPT codes 27369, 38792, 76870, 77012, 77021, 92273, and 92274. We are not finalizing our proposal for the reviewed codes where we were able to determine that the old clinical labor task had been divided into the CA007 and CA014 activity codes as described by the commenters. We are therefore finalizing the RUC-recommended CA013 and CA014 clinical labor for CPT codes 76978, 76981, and 76982.

    6. Equipment Recommendations for Scope Systems

      During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.

      To promote appropriate relativity among the services and facilitate the transparency of our review process, during the review of the recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope, the associated video system, and any scope accessories that might be typical as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems and accessories that are used with scopes.

      (1) Scope Equipment

      Beginning in the CY 2017 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

      Page 59465

      scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-

      rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-

      channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.

      We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking. We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.

      We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in 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 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal 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 proposed 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, we proposed 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 also proposed to update the name of the ES031

      Page 59466

      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.

      The following is a summary of the public comments we received on our proposals involving scopes and scope systems.

      Comment: Several commenters supported the decision to delay proposals for any further changes to scope equipment until CY 2020 in order to incorporate the feedback from the RUC's Scope Equipment Reorganization Workgroup. One commenter thanked CMS for adding a scope category for multi-channeled flexible video scopes. A different commenter supported the proposal to increase the price of the scope video system (ES03l) from its current price of $33,391 to a price of $36,306 and also supported the proposed update to the name of the ES03l equipment item since the use of the scope video system is not limited to endoscopy procedures.

      Response: We appreciate the support for our proposals from the commenters.

      Comment: One commenter stated that they were concerned that the proposed pricing for both the scope video system (ES03l) and the stroboscopy system (ES065) are less than the true cost of the equipment items, and therefore do not accurately reimburse physicians for their direct overhead costs. The commenter stated that they had supplied more recent invoices for these equipment items, which should be taken into consideration for pricing, and reiterated their disagreement with the CMS proposal from the previous calendar year to create single scope equipment categories for all specialties, as scope equipment is not always comparable across specialties. A different commenter supplied invoices for several other scope equipment items and requested that CMS update the prices for these equipment codes and that the new pricing take effect for CY 2019.

      Response: We continue to believe that any further changes to scope equipment, including invoice submissions to update scope pricing, should be delayed until CY 2020 so that we can incorporate the feedback from the RUC's Scope Equipment Reorganization Workgroup.

      After consideration of the public comments, we are finalizing our scope proposals for CY 2019 without refinement.

    7. 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.

      When CPT codes 31295 through 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 solicited comments on two aspects of the use of the balloon sinus surgery kit (SA106) supply. First, we solicited 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 solicited 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, frontal, .............. kit......................... $2,599.86

      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

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

      Page 59467

      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. The following is a summary of the public comments we received on our comment solicitation regarding the balloon sinus surgery kit supply.

      Comment: Several commenters stated that the variability inherent in the underlying patient anatomy makes it extremely difficult to reliably assign a fixed number of sinuses that can be dilated per balloon or establish a supply quantity that would constitute the typical case. These commenters urged CMS to create a separate HCPCS code for the balloon sinus surgery kit that would be billable based on the number of balloons used per patient.

      Response: As we stated in the proposed rule, 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 maintain appropriate relativity while pricing 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).

      Comment: One commenter provided extensive information regarding the pricing and composition of the balloon sinus surgery kit. This commenter stated that the components of the supply kit have changed from those listed in Table 5, and that there are multiple different types of this kit available for purchase. The commenter stated that the total cost of the balloon sinus surgery kit varies by sinus dilated, whether navigation is used, and by manufacturer, with the average price of a basic kit costing $2,204 and the average price of the kit used for navigation costing $2,850, not including the navigation device itself. The commenter stated that the kit components should not be individually priced and that invoices could be made available upon request.

      With regards to the number of sinus dilation procedures that typically can be performed per balloon, the commenter repeated that the variability inherent in the underlying patient anatomy makes it extremely difficult to assign a fixed number of sinuses that can be dilated per balloon. The commenter also urged CMS to consider a shift away from the current supply methodology and instead create a separate HCPCS code for the balloon sinus surgery kit which would be billable based on the number of balloons used per patient. The commenter stated that should CMS elect to preserve the current policy of assigning a fixed number of sinus dilations per kit, they recommended maintaining the current supply quantity that allows one kit for every two sinuses, as they were unable to find compelling evidence to support a more appropriate supply amount.

      Response: We are particularly interested in the feedback suggesting that there may be multiple types of balloon sinus surgery kits that have different prices, and we would be interested in further information, including invoice submissions, on this subject for future rulemaking.

      After consideration of the public comments, we are not finalizing any changes to the balloon sinus surgery kit (SA106) supply for CY 2019, outside of the market-based supply and equipment pricing update to the supply cost. We do not believe that we have sufficient information to finalize any other changes to the supply cost or supply quantity in the associated CPT codes at this point in time.

    8. 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 proposed to correct these inconsistencies as described below and reflected in the CY 2019 final direct PE input database displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      For CY 2019, we proposed 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 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 proposed 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 post- nonfacility nonfacility

      CPT code 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

      Page 59468

      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

      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

      Page 59469

      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

      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

      Page 59470

      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 proposed to align the number of minimum multi-

      specialty visit packs with the number of post-operative office visits included in these codes. We did not propose any supply pack quantity refinements for CPT codes 11100, 95974, or 95978 since they are being deleted for CY 2019. We also did not propose 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.

      Comment: One commenter stated that they supported this effort as it serves to remedy any discrepancies/errors that may be in the PFS related to postoperative visits and the required multi-specialty packs needed to render those visits.

      Response: We appreciate the support for our proposal from the commenter.

      Comment: One commenter stated that removal of the SA048 supply pack was inappropriate for CPT code 43200 (Esophagoscopy, flexible, transoral; diagnostic, including collection of specimen(s) by brushing or washing, when performed (separate procedure)) as it is required for the esophagoscopy procedure and the supply is included in the other codes in the family (CPT codes 43201-43233) as well as for the other GI endoscopy code families. The commenter requested that CMS not remove the SA048 supply from CPT code 43200.

      Response: After reviewing the supply inputs for the group of codes identified by the commenter, we agree that it would not be consistent to remove the SA048 multi-specialty pack from CPT code 43200 while retaining the supply pack in CPT codes 43201-43233. As a result, we are not finalizing the removal of the SA048 multi-specialty pack from CPT code 43200. However, we note that many of the CPT codes in this range also contain SA048 supply packs without having any postoperative office visits included in their global periods. We believe that it may be more accurate to achieve consistency within this range of CPT codes by removing the SA048 supply pack from all of these codes, as opposed to adding the SA048 supply pack to CPT code 43200. In regard to this topic, stakeholders can always provide data to us if they believe the code is not bundled/valued/etc. correctly.

      After consideration of the public comments, we are finalizing our proposal to align the number of minimum multi-specialty visit packs with the number of post-operative office visits included in these CPT codes listed in Table 6, with the exception of CPT code 43200 as detailed above.

      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 proposed to revise the direct PE inputs to reflect the ones previously finalized through rulemaking for CPT code 11311.

      Comment: One commenter agreed that a significant clerical error occurred after the RUC recommended its valuation of CPT code 11311 and its final acceptance by CMS. The commenter recommended that the direct PE inputs of CPT code 11310 be replicated for CPT code 11311 and submitted a table with recommended values.

      Response: After reviewing this information, we found that the direct PE inputs requested by the commenter mostly, but do not entirely, match the direct PE inputs that CMS finalized through rulemaking for CY 2013. The commenter requested the inclusion of an additional SB007 (drape, sterile barrier 16in x 29in) supply and a SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022 (sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and 4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise the direct PE inputs to match the ones previously finalized through rulemaking for CPT code 11311, we are not finalizing these five changes to the direct PE inputs requested by the commenter. In all other respects, the direct PE inputs recommended by the commenter matched the direct PE inputs previously finalized through

      Page 59471

      rulemaking. We are therefore finalizing our proposal to revise the direct PE inputs to reflect the ones previously finalized in CY 2013 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 proposed 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 also proposed 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.

      Comment: Several commenters agreed with the CMS rationale for refining the clinical labor task times for each of these codes.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: One commenter opposed the CMS proposal 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.

      Response: We continue to believe that changes in clinical labor time should be matched with corresponding changes in equipment time. Since the commenter did not supply a rationale as to why the EF028 equipment time should not match the change in clinical labor time, we are finalizing our proposal 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 received a letter from a commenter alerting us to an anomaly in the direct PE inputs for CPT code 52000 (Cystourethroscopy (separate procedure)). The commenter 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 commenter requested that this 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 agreed with the commenter and we proposed 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.

      Comment: One commenter supported the CMS proposal to add an endoscope disinfector to CPT code 52000 and to add 22 minutes of equipment time to match the equipment time of the other non-scope items included in the code. This commenter requested that this addition apply to all endoscopic urologic procedures that do not already include the endoscope disinfector.

      Response: We do not agree that the endoscope disinfector should be added to all endoscopic urologic procedures that lacked the equipment, as the addition of this equipment to CPT code 52000 is a technical correction to address a specific anomaly with the recommendations for CPT code 52000 and not the implementation of a new policy. After consideration of the public comments, we are finalizing the addition of 22 minutes of equipment time for the endoscope disinfector (ES005) to CPT code 52000 as proposed.

      The following is a summary of the public comments we received on additional technical corrections to the direct PE input database and supporting files.

      Comment: A commenter stated that they had reviewed the CY 2019 Proposed Rule physician work time file and discovered an issue with 13 CPT codes that had incorrect work times. The commenter stated that these were technical errors in which the current work time values did not match what CMS had finalized through rulemaking, and the commenter requested that these services be corrected in the CY 2019 CMS work time file for the CY 2019 Final Rule.

      Response: We agree with the commenter that some of these CPT codes are subject to technical corrections, while disagreeing with the commenter with regards to other CPT codes, as described in more detail below.

      Listed in order, the commenter identified these issues:

      Comment: For CPT code 15220 (Full thickness graft, free, including direct closure of donor site, scalp, arms, and/or legs; 20 sq cm or less), the commenter stated that their records showed CMS missing 15 min of positioning time from the Harvard study.

      Response: We are not finalizing a change in the work time of this code at this time, as we were unable to verify the positioning time of CPT code 15220 as originally measured by the Harvard study.

      Comment: For CPT code 22558 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar), the commenter stated that the CMS work time file accidentally double counted postoperative visit time in the immediate postoperative time field.

      Response: We agree with the commenter that this is subject to a technical correction, and we are finalizing an immediate postservice work time of 25 minutes for CPT code 22558.

      Comment: For CPT code 43760 (Change of gastrostomy tube, percutaneous, without imaging or endoscopic guidance), the commenter stated that the code is being deleted for CY 2019 and should not appear in the work time file.

      Response: We agree with the commenter, and we are finalizing the removal of this code from the work time file.

      Comment: For CPT codes 61645 (Percutaneous arterial transluminal mechanical thrombectomy and/or infusion for thrombolysis, intracranial, any method, including diagnostic angiography, fluoroscopic guidance, catheter placement, and intraprocedural pharmacological thrombolytic injection(s)) and 61650 (Endovascular intracranial prolonged administration of pharmacologic agent(s) other than for thrombolysis, arterial, including catheter placement, diagnostic angiography, and imaging guidance; initial vascular territory), the commenter stated that CMS incorrectly applied 23 hour stay rule for these codes even though the RUC recommended these services as typically inpatient. The commenter stated that there are now available data to see that these CPT codes are done on an inpatient basis 98 percent and 86 percent of the time respectively.

      Response: We do not believe that the work times of these codes are subject to

      Page 59472

      a technical correction, as the work times finalized for these codes in the CY 2017 PFS final rule (81 FR 80307-08) were based on a disagreement in policy with the commenter and not a technical error.

      Comment: For CPT code 91200 (Liver elastography, mechanically induced shear wave (e.g., vibration), without imaging, with interpretation and report), the commenter stated that the RUC recommended 5 minutes of immediate postservice work time, not 3 minutes, and that CMS had finalized the code without a time refinement. The commenter stated that the immediate postservice work time for CPT code 91200 should be 5 minutes in accordance with the RUC recommendations.

      Response: We investigated the RUC recommendations from the April 2015 RUC meeting when CPT code 91200 was reviewed, and we found that the RUC recommended an immediate postservice work time of 3 minutes on the code family's cover sheet and the accompanying summary spreadsheet. Although the RUC may have intended to recommend an immediate postservice work time of 5 minutes for this code, we proposed and finalized an immediate postservice work time of 3 minutes for CPT code 91200 without receiving any comments on the issue. Therefore we are not finalizing any changes to the work time of CPT code 91200 at this time, which will remain 3 minutes.

      Comment: For CPT codes 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), 93284 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead transvenous implantable defibrillator system), and 93286 (Peri-

      procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead pacemaker system), the commenter stated that CMS has the wrong intraservice work times, despite the CY 2018 final rule indicating no time refinement for these codes.

      Response: After reviewing the work times for these codes, we agree with the commenter and we are finalizing a technical correction to the intraservice work times as recommended.

      Comment: For CPT code 97166 (Occupational therapy evaluation, moderate complexity), the commenter stated that the HCPAC recommended 15 min of immediate postservice work time, not 10 minutes, and that CMS had finalized the code without a time refinement.

      Response: We investigated the RUC recommendations from the October 2015 RUC meeting when CPT code 97166 was reviewed, and we found that the HCPAC recommendations contained two different values for the immediately postservice work time. The written recommendations stated that the immediate postservice work time was recommended at 15 minutes, while the data on the summary spreadsheet stated that the immediate postservice work time was recommended at 10 minutes. Although there were two conflicting HCPAC recommendations for this code, we finalized in the CY 2017 PFS final rule (81 FR 80331) an immediate postservice work time of 10 minutes for CPT code 97166 without receiving any comments on the issue. Therefore we are not finalizing any changes to the work time of CPT code 97166 at this time.

      Comment: For CPT code 33866 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion (List separately in addition to code for primary procedure)), the commenter stated that the RUC recommendation was rescinded and that the code should be removed from the work time file.

      Response: We disagree with the commenter, and we are not finalizing the removal of CPT code 33866 from the work time file; we refer readers to the code valuation section of this final rule for additional details regarding CPT code 33866.

      Comment: For CPT code 96X11 (Psychological or 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), the commenter stated that the code is not being created for CY 2019 by the CPT Editorial Panel and should be removed from the work time file.

      Response: We agree with the commenter and we are finalizing the removal of this code from the work time file.

      Comment: For HCPCS code G0281 (Electrical stimulation, (unattended), to one or more areas, for chronic stage iii and stage iv pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care), the commenter stated that their records show an intraservice time for this code of 11 minutes and not 7 minutes as currently listed in the work time file.

      Response: We disagree with the commenter. As we stated in the CY 2003 PFS final rule with comment period (67 FR 80014), the work, practice expense, and malpractice values G0281 are based on a crosswalk to CPT code 97014 (Application of a modality to 1 or more areas; electrical stimulation (unattended)), and the intraservice work time of CPT code 97014 remains 7 minutes.

      Comment: Many commenters raised concerns about the use of the portable X-ray machine (EF041) equipment in CPT code 71045 (Radiologic examination, chest; single view). Commenters stated that the use of the portable X-ray machine in CPT code 71045 understated the price of the equipment typically used in the service, and that the default equipment utilization rate of 50 percent did not reflect the experience of portable X-ray suppliers. Commenters supplied an invoice for a Digital Radiography portable X-ray machine, which they stated would be typical for use in this procedure, along with data on the equipment utilization rate that suggested a utilization rate significantly lower than 50 percent would be typical. Commenters requested modifying the direct PE inputs for CPT code 71045 to include the use of the Digital Radiography portable X-ray machine at a distinctive utilization rate of approximately 22 percent, or alternatively, to use the same equipment as the other three codes in the Chest X-Ray code family (CPT codes 71046-71048) as direct PE inputs for CPT code 71045.

      Response: We agree with the commenters and we are finalizing the replacement of the 9 minutes of equipment time for the portable X-ray machine (EF041) with 9 minutes of equipment time for a basic radiology room (EL012) for CPT code 71045. The equipment cost per minute of the basic radiology room (48.4 cents) is nearly identical to the equipment cost per

      Page 59473

      minute of the proposed Digital Radiography portable X-ray machine (46.0 cents), and we believe that it would better serve the interests of relativity for CPT code 71045 to match the same equipment inputs as the rest of the Chest X-Ray code family. We previously updated the PE RVU of this code in the July 2018 Quarterly Update (CMS Change Request 10644) based on the same information previously supplied by the commenters, and due to a technical error, this update to the direct PE inputs of CPT code 71045 was not included in the CY 2019 PFS proposed rule. We are finalizing this technical correction to the direct PE inputs of CPT code 71045 for CY 2019.

      Comment: One commenter stated that there was a typographical error in Attachment B of the proposed rule, which resulted in the misstatement of the total RVUs for CPT code 48554 (Transplantation of pancreatic allograft). The commenter recommended that we include 74.81 total RVUs for CPT code 48554 to correct the error of 73.70 total RVUs.

      Response: We do not agree with the commenter that there was a typographical error in Addendum B for CPT code 48554, which appears to sum its component parts of the work RVU (37.80), PE RVU (27.72), and malpractice RVU (9.29) to the correct total RVU of 74.81.

      We also received comments regarding a variety of subjects about which we did not make proposals for CY 2019. These included comments regarding: The level of physician supervision for CPT code 99091, the 7 percent reduction to the technical component of computed radiography services not performed using digital radiography, a request to migrate the RUC recommended RVU assignment of CPT code 77387 to HCPCS code G6017, a request that CMS not finalize the proposed changes in payment for the revascularization codes (CPT codes 37225-37231) that were a byproduct of the E/M proposals and the supply/equipment pricing update, a request that CMS should assign direct cost inputs and PE RVUs to several disposable negative pressure wound therapy codes (CPT codes 97607-97608), a disagreement with previous reductions in the payment rate for HCPCS code G0416 from past calendar years, a request for clarification regarding the facility PE RVUs for CPT code 99153, a request for CMS to provide additional reimbursement stability for vascular access services by increasing the work RVUs and direct PE inputs for these codes (CPT codes 36901-36909), and a request for CMS to study the possible effect of tariffs on the cost of imaging equipment manufactured overseas. These comments are considered out of scope for the CY 2019 PFS final rule, as we did not make any proposals on these issues in the CY 2019 PFS Proposed Rule. We will take the feedback from the commenters under consideration for future rulemaking.

      After consideration of the public comments, we are finalizing technical corrections to the direct PE input database and supporting files as described above.

    9. 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 proposed the following price updates for existing direct PE inputs.

      We proposed 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 proposed 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 final rule, Table 15: 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) (Pub. L. 113-93) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.

      As part of our authority under section 1848(c)(2)(M) of the Act, as added by 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 final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-

      Federal-Regulation-Notices.html.

      The StrategyGen team of researchers, attorneys, physicians, and health policy experts conducted a market research study of the supply and equipment items currently used in the PFS direct PE input database. Resources and methodologies included field surveys, aggregate databases, vendor resources, market scans, market analysis, physician substantiation, and statistical analysis to estimate and validate current prices for medical equipment and medical supplies. StrategyGen conducted secondary market research on each of the 2,072 DPEI medical equipment and supply items that CMS identified from the current DPEI. The primary and secondary resources StrategyGen used to gather price data and other information were:

      Telephone surveys with vendors for top priority items (Vendor Survey).

      Physician panel validation of market research results, prioritized by total spending (Physician Panel).

      The General Services Administration system (GSA).

      An aggregate health system buyers database with discounted prices (Buyers).

      Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors).

      Federal Register, current DPEI data, historical proposed and final rules prior to 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

      Page 59474

      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.

      After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen. For the reasons subsequently discussed, the GSA price was not incorporated into the calculation for the StrategyGen recommended prices printed in the proposed rule. The proposed recommended price was developed as follows:

      Recommended CMS Price: The StrategyGen proposed recommended price was the researched-commercial price, when available. If not, the StrategyGen proposed recommended price was the current CMS price.

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

      We believe that it is important to make use of the most current information available for supply and equipment pricing instead of continuing to rely on pricing information that is more than a decade old. Given the potentially significant changes in payment that would occur, both for specific services and more broadly at the specialty level, we proposed to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. This approach is consistent with how we have previously incorporated significant new data into the calculation of PE RVUs, such as the 4-year transition period finalized in CY 2007 PFS final rule with comment period when changing to the ``bottom-up'' PE methodology (71 FR 69641). This transition period will not only ease the shift to the updated supply and equipment pricing, but will also allow interested parties an opportunity to review and respond to the new pricing information associated with their services.

      We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the 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 proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values. We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation.

      For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and

      Page 59475

      equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price. We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes).

      We believed that implementing the proposed updated prices with a 4-

      year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer time frame will allow more opportunities for public comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. We were 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 that we 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 under downloads for the CY 2019 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

      The following is a summary of the public comments we received on our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing.

      Comment: Many commenters were concerned with the transparency of the data used to calculate medical equipment and supply prices. The commenters were particularly concerned about the use of a subscription-

      based benchmark database as a source for pricing data. The commenters stated that without identification of the database and access to the precise data used in determining the pricing update, they would have no systematic way to evaluate pricing accuracy. In addition, these commenters were concerned that small physician practices are not well represented in benchmark databases, with the consequence that the proposed repricing did not reflect the typical price paid by smaller stakeholders. Commenters stated a general concern that any methodology that more heavily weighs larger physician groups, group purchasing organizations (GPOs), or even hospital contract pricing would result in pricing that is significantly depressed compared to the pricing that can be obtained by an individual practitioner. The commenters asserted that this has the potential to pressure the financial viability of smaller physician practices and to force lower cost non-facility procedures into hospital outpatient or inpatient sites of service.

      Response: As to whether there is sufficient transparency to enable others to replicate and validate the proposed pricing, the StrategyGen contractors carried out a market research plan designed to estimate the typical discounted prices that physicians and other providers normally pay. The proprietary database of buyer reported pricing is one of the few sources of typical discounted price data available. Other potential sources of typical discounted pricing were other proprietary databases and the publicly available GSA pricing. For each item priced, the analysis from the contractors included research on as many as five current sources of prices: (1) A proprietary database of buyer reported pricing, (2) Prices reported by GSA, (3) Amazon Business, (4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs.

      The proprietary database of buyer reported pricing offers three advantages: (1) It represents discounted prices as opposed to retail pricing, (2) It has the largest sample sizes to represent a wider range of pricing as opposed to single invoices, and (3) The database provides variety with respect to the purchaser's geographic location, purchasing method, procedure volume and other purchasing arrangements. We initially assumed that GSA also represents typical discounted pricing across regions with smaller sample sizes, but subsequently rejected GSA data because we did not believe that its prices were typically representative of commercially available pricing. As a result, GSA data were not used to calculate the StrategyGen recommended prices included in the proposed rule. Amazon Business and Cardinal Healthcare represent typical retail pricing, with smaller sample sizes. In addition, the StrategyGen contractors utilized vendors' and manufacturers' catalogs to identify publicly available pricing. Table 8 summarizes sources of online pricing and characteristics of each source:

      Table 8--Market-Based Supply and Equipment Pricing Update Data Sources

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

      Variety (that is,

      Source of pricing data Discounted pricing Sample size geography, purchasing

      arrangement, etc.)

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

      Buyers database..................... Actual discounts....... Largest.................. National footprint.

      GSA................................. Wholesale price........ 3-5...................... Government purchasers

      only.

      Amazon Business (on-line)........... Retail price........... 3-5...................... National footprint.

      Cardinal Healthcare (on-line)....... Retail price........... 3-5...................... National footprint.

      Catalogs (on-line).................. Retail price........... 3-5...................... National footprint.

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

      Page 59476

      The Buyers database provides the most accurate market pricing estimates that include market discounts for a range of buyer organizations. Its larger sample sizes provide more confidence that the proposed pricing is not skewed toward higher or lower pricing but toward the actual market price paid by purchasers.

      The StrategyGen contractors chose not to include invoice research in the market research plan as there is already an existing process to modify Direct Practice Expense Input (DPEI) prices based on invoices. Additionally, the contractors determined that providing specific models and other identifying data with the researched prices would offer a broader and more consistent source of pricing data. We do not agree with the commenters that the updated supply and equipment prices will pressure the financial viability of smaller physician practices, as we believe that the larger sample sizes obtained by StrategyGen's research provide more accurate and more consistent pricing of actual market conditions than the single invoices that we have traditionally been reliant upon for pricing.

      As to whether the proposed pricing is representative of prices available to small physician practices and non-facility practitioners generally, one of the objectives of the primary market research was to understand what kind of discounts are available to small physician practices similar to discounted pricing available to large health systems under GPOs. The market research plan included a series of questions to vendors designed to illuminate typical discounts they offer to large and small providers other than GPOs. This market research indicates that there are a variety of discount purchasing options available. Vendors indicated that both volume and timing can influence pricing discounts. Approximately 80 percent of respondents indicated that timing has some impact on the price of equipment, and about half of respondents indicated that timing had some impact on the price of supplies. Discussions with other subject matter experts also indicated that timing of purchase is an important factor in pricing. For example, the end of the sales cycle can drive discounts. Less than 10 percent of vendors indicated that these timing discounts may not be available to smaller practices outside of a GPO. The vendor research also indicated that other factors beyond ``size and timing'' influence discounted pricing, such as service agreements and bundled purchases.

      Research indicates that service agreements often include discounts for equipment and supplies. For example, longer term service agreements generally result in larger discounts. However, some vendors indicated that the effect of service agreements was to reduce the size of the discounts, negatively impacting providers. This may be a difference in service agreement strategies across different vendors. Regardless, only 3 percent of respondents indicated that the availability of service agreement discounts was dependent on a GPO.

      The vendors identified other factors that impact pricing decisions including:

      Market demand and competitive pricing;

      Contract renewal;

      Customer history and contract history; and

      Vendor considerations independent of the purchaser such as manufacturer and sales incentives, revenue goals, and new product releases.

      In conclusion, while volume purchasing and GPOs can drive down prices for many large providers, these are not the only drivers of discounts for providers. A number of additional factors applicable to large, small, and non-facility practices may result in discounts for the buying organizations. We believe that the pricing update required looking at a broad range of data that was collected from different sources, which included pricing data from both large and small organizations. We note that not all private practices are small in nature, and we do not agree that it would be more accurate to obtain prices only from small practices as opposed to the broader data collection undertaken by the StrategyGen contractor.

      Comment: Some commenters were concerned that the researched GSA price was incorporated into the recommended commercial price. These commenters expressed concern as to how the GSA price fit into the calculation of new recommended prices.

      Response: We want to clarify how the GSA price was used in developing the new recommended DPEI prices for equipment and supplies. We regret the confusion on this issue, which was due to a technical error in the drafting of the language in the proposed rule. We wish to clarify that the GSA price was not used to calculate the StrategyGen recommended prices printed in the proposed rule. Our use of the GSA website to research supply and equipment pricing was found to have a number of limitations. Only suppliers that meet stringent qualifications and that complete a lengthy and detailed application process are eligible to participate in GSA Advantage, GSA's online shopping and ordering system. These requirements sharply curtail the number and type of suppliers whose products may be accessed on the GSA Advantage website. In addition, only products that are purchased by federal agencies or other qualified government entities are listed on the GSA Advantage website, which has the effect of eliminating a number of medical supplies and equipment that are reflected in the CMS DPEI codes. This limitation was especially acute when researching bundled codes for equipment rooms and lanes, and supply packs, kits, and trays. The GSA website does not record comparable bundled purchasing of medical equipment or supplies, so no GSA pricing could be recovered for products included in the bundled codes organized as rooms, lanes, packs, kits or trays. Finally, the prices listed on the GSA Advantage website are required to be the supplier's best offer, which may often be lower than prices that are available to non-governmental purchasers.

      For these reasons, the GSA price was not incorporated into the calculation for the StrategyGen recommended prices printed in the proposed rule. The final recommended price for CY 2019 was the commercially researched price, if available. Otherwise the current CY 2018 CMS price remained in place as the CY 2019 CMS price.

      Comment: Several commenters were concerned with the methodology used by StrategyGen to conduct market research to determine an updated price for medical equipment and supplies. There were significant concerns with the use of market research to supplement the current AMA/

      Specialty Society RVS Update Committee (RUC) process. A number of commenters stated that CMS should only use invoices supplied by the specialty society via the RUC process, and should not finalize the updated prices researched by the StrategyGen contractor.

      Response: We determined that the most effective way to update the DPEI for CY 2019 was through comprehensive market research. The current RUC process has resulted in updates to many of the equipment and supply codes, but many of the prices in the CY 2018 DPEI are over a decade old, and a significant number date back to research conducted 15 years ago. Therefore, we requested a market research plan from the StrategyGen contractor designed to research current pricing to estimate the typical discounted prices that physicians and other providers normally pay.

      Page 59477

      The comprehensive market research plan to update DPEI equipment and supplies was designed to supplement the AMA RUC process, not replace it. The current RUC process, while indispensable, does not provide for comprehensive pricing updates. Under the current process, physicians and other providers voluntarily submit invoices for items to RUC for consideration, and after review, the RUC submits these invoices to us. This process results in inherent biases due to the limited number of items represented by submitted invoices and due to the voluntary selection of reported invoices.

      The StrategyGen market research plan examined up to five online sources of current prices for each item of equipment or supply researched, including: (1) A proprietary database of buyer reported pricing, (2) Prices offered on GSA (Note: This data was subsequently excluded from the recommended 2019 CMS prices), (3) Amazon Business, (4) Cardinal Healthcare, and (5) Vendors' and manufacturers' catalogs. Each of these sources contains nationally reported vendor and buyer pricing data. The research plan also included vendor interviews to clarify the variety of discount programs available to physicians and other providers.

      The comprehensive research plan for the 2019 DPEI required researching approximately 2,000 supply and equipment codes. Qualitative and potentially quantitative research to include all the specialty societies impacted by the DPEI updates was beyond the resources and time allocated to this update. The market research plan did include a physician panel with specialists and a general practitioner to review the reasonableness of the researched data. In addition, the regulatory process remains available to all specialty societies to comment on the recommended prices. We encouraged interested stakeholders to continue to provide feedback on supply and equipment pricing, including the submission of invoices, throughout the 4-year pricing transition.

      Comment: Several commenters stated that there is an inherent bias to prioritizing the medical equipment and supplies based on spending and code utilization. These commenters stated that any attempt to accurately price items in the supply and equipment list should devote equal effort to each item of equipment or supply and should not devote additional attention to the most utilized codes. These commenters stated that using utilization data as the primary driver for identifying supply and equipment items to review suggests that there may have been specific intent to lower the cost of high utilization items, perhaps to the detriment of pricing accuracy. In addition, there was concern that some underutilized codes were not researched.

      Response: To control for potential research bias, the StrategyGen market research team used an identical online methodology to research commercial pricing data for each of the supply and equipment codes, regardless of the code's prioritization. The prioritization of high-

      utilization supply and equipment codes was not designed to reduce prices for these codes.

      The prioritization of supply and equipment codes was designed to facilitate understanding and validation of the researched commercial prices for these items. Surveying other market entities, including vendors, as opposed to buyers, was used to more precisely identify the range of commercial pricing and factors impacting those prices. For example, additional priority research included a physician panel that reviewed the researched commercial prices for reasonableness. The prioritization of research for certain codes did not change the recommended commercial prices.

      In addition, limited time and resources required prioritizing the codes based on use. We recognize that a few medical supply and equipment codes do not have updated recommended prices, and we continue to welcome the submission of updated pricing information from stakeholders for these and other codes.

      Comment: Many commenters were supportive of the proposal to use a 4-year pricing transition. Commenters agreed with using the transition period as an opportunity for specialty societies and other stakeholders to continue to evaluate the new pricing and submit invoices and other pricing data as needed. Commenters who disagreed with the use of the 4-

      year pricing transition also requested that CMS not finalize the proposal. One commenter stated that CMS should phase in the new prices for equipment and supplies during a shorter transition period than the proposed 4-year transition, and suggested a 2-year transition instead.

      Response: Our proposal was intended to minimize any potential disruptive effects during the proposed transition period, and we continue to 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.

      Comment: Several commenters stated that CMS should consider delaying implementation of this proposal until there could be a more thorough and adequate review of the inputs and give medical societies and/or practices more time to gather invoices in order to determine if the proposed pricing is accurate. Some commenters similarly requested that the 4-year pricing transition should begin in CY 2020 to provide stakeholders with additional time to evaluate the approach used by StrategyGen. A few commenters stated that they would prefer a delay of more than 1 year before implementation began.

      Response: We disagree with the commenters that delaying the implementation of the pricing updates for a year or longer would lead to more accurate pricing. We believe that our proposal to update the pricing of direct PE inputs for supplies and equipment over a 4 year-

      transition already allows many opportunities for public comment and the submission of additional, applicable data. We welcomed feedback from commenters on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration, and many commenters provided detailed feedback regarding the pricing of individual supply and equipment items. We note that we received feedback from commenters on approximately 65 individual supply and equipment codes, which is roughly 3 percent of the total number of items we proposed to update. We also note that commenters did not identify an alternative source for pricing information outside of the sources employed by the StrategyGen contractors, with commenters largely suggesting that we should continue to rely on invoice submissions included along with the review of individual codes via the RUC process.

      We continue to believe that a delay in implementation would be unlikely to result in more accurate pricing information. Therefore, we are finalizing the 4-year pricing transition, beginning in CY 2019. We look forward to working with commenters over the 4-year transition for assistance in identifying individual supply and equipment codes that may require additional research into their pricing. As a reminder, to be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th

      Page 59478

      deadline used for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices for the following year.

      Comment: Many commenters addressed the proper pricing of some multi-component items, including supply kits, packs, and trays as well as some items of equipment. Several commenters noted some of the proposed prices for supply and equipment items that contain multiple components may not accurately reflect all the components, while other commenters noted that some of the components could be improperly priced. Commenters expressed concerns that some equipment may not possess precise components that are necessary for a specific procedure.

      Response: Using the information provided by these commenters, the StrategyGen contractors re-examined the pricing of the multi-component supply and equipment items that had been identified. In some instances, the additional research confirmed some commenters' concerns, as the contractors found that a limited set of these multi-item supply and equipment kits required further clarification of components. For example, an item within a kit, pack, or tray may have had an updated component, resulting in a mispriced item within that kit. To further clarify the prices of these kits, the kits were broken into their most basic components and priced individually. The total price of the kit was determined by adding the specific item prices together. If one of the items within a kit was misidentified, it resulted in an incorrect price of the entire kit.

      For example, a review of the recommended price for the ``Antigens, multi'' (SH007) supply code identified the need to add pricing data for additional antigens and to refine the unit of measurement used in calculating the price. For SH007, additional antigens were added and data analyzed for 1 milliliter vials of two allergy antigens. The first antigen is an allergy antigen for pollen and mites and contains antigens for Timothy, Birch, Ragweed, Cocklebur, MarshElde, and the mites Dermatophagoides pteronyssinus and Dermatophagoides farina. The second antigen is an allergy antigen for mold and cats and contains antigens for Alternaria, Helminth, Hormoden, Penicillium, and Fel d1. To determine the price of the allergy antigen, the StrategyGen contractor researched each component of the antigen separately and averaged the price of the separate vials as the recommended price to arrive at an updated recommended price of $8.96.

      In instances related to equipment, an item may have been improperly priced because a specific component was omitted but the items priced could perform the requisite task. An example of this occurred in the pricing of the ``SRS System, SBRT'' (ER083) equipment item where the equipment priced would retrofit a system to perform SBRT procedures, but pricing did not include the linear accelerator. When re-examining this specific medical equipment, we ensured it was a linear accelerator with SBRT capabilities and arrived at an updated recommended price of $2,973,721.83.

      We reexamined the recommended price of each multi-component item cited by a commenter. Table 9 at the conclusion of this section lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing.

      Comment: Several commenters questioned the prices of certain supply codes based on their conclusion that the quantity of the items priced was inaccurate. Depending on the type of supply, a number of different units of measurement are used to set prices for DPEI supply codes. Commenters stated that StrategyGen had used the incorrect unit of measurement in their recommended prices, and identified specific supply codes where they believed these errors had taken place.

      Response: In each instance in which a commenter questioned the accuracy of a DPEI code's recommended price based on a concern about the unit quantity of the item priced, the StrategyGen contractor conducted further research of the item and its price with special attention to ensuring that the recommended price was based on the clarified unit of measure. The price assigned to a given code may be for a single item, a kit, a tray, or it may be based on a per test or per ml basis. For example, the price for the SG055 supply is for a single sterile 4in x 4in gauze sponge; whereas the price for SG056 is for a tray/pack of 10 sterile 4in x 4in gauze sponges. In other situations, such as the ``Embedding Mold'' (SL060) supply, the price for a package of multiple molds was reported instead of the price of a single embedding mold. After consideration of comments received and additional price research, we have updated the recommended prices for a number of relevant supply codes identified by the commenters. Table 9 at the conclusion of this section lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing.

      Comment: Several commenters addressed the subject of the proper pricing for certain items of medical supply and equipment. These commenters requested these specific CMS codes be reviewed again to ensure the correct items were being researched and priced accordingly.

      Response: Based on the commenters' requests, the StrategyGen contractor conducted an extensive examination of the pricing of any supply or equipment items that any commenter identified as requiring additional review. Invoices submitted by multiple commenters were greatly appreciated and ensured that medical equipment and supplies were re-examined and clarified. Multiple researchers reviewed these specified supply and equipment codes for accuracy and proper pricing. In most cases, the contractor also reached out to a team of nurses and their physician panel to further validate the accuracy of the data and pricing information. In some cases, the pricing for individual items needed further clarification due to a lack of information or due to significant variation in packaged items. An example of such clarification occurred with the ``Covered Stent (Viabahn, Gore)'' (SD254) supply, which encompasses a wide range of stents, with varying sizes and other qualities. In other cases, such as the ``Patient Worn Telemetry System'' (EQ340) equipment, an inpatient unit was originally priced as opposed to an outpatient unit. After an extensive review and validation process, we updated our recommended prices for a number of supply and equipment codes. Table 9 at the conclusion of this section lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing.

      Comment: Several commenters expressed concerns with the proposed prices for individual supply and equipment codes, and recommended that the price of these codes remain unchanged until additional research can be conducted.

      Response: The StrategyGen contractor investigated the accuracy of components or features included in an item by researching the identity of the item based on the description contained in the item's supply or equipment code, as well as the identity of any item's prices

      Page 59479

      in submitted invoices. Additional research into approximately half a dozen supply/equipment codes failed to produce reliable product data sufficient to calculate a recommended price. To price these equipment and supply items accurately, we believe additional information is required. Therefore, we will continue to use the current CMS price for these supply and equipment items pending additional research and analysis. We welcome the submission of updated pricing information regarding these supply and equipment items through submission of valid invoices from commenters and other stakeholders. These supply and equipment codes are also listed in Table 9 at the conclusion of this section.

      Comment: A few commenters stated that CMS should ensure that the direct practice expenses for HCPCS codes G6001-G6015 are applied consistent with the directives of the Patient Access and Medicare Protection Act (PAMPA) (Pub. L. 114-115) and the Bipartisan Budget Act (BBA) of 2018 (Pub. L. 115-123). Commenters stated that Congress established via statute that the direct PE inputs for these radiation treatment delivery services furnished in CY 2017, CY 2018, and CY 2019 shall be the same as such inputs as established for these services in CY 2016. These commenters stated that the proposed changes to the PE RVUs for HCPCS codes G6001-G6015 were directly opposed to current law, and that CMS should revisit its analysis to ensure that the direct PE inputs are consistent with those used in 2016 as required by Congress.

      Response: We disagree with the commenters that the proposed direct PE inputs for HCPCS codes G6001-G6015 were not applied consistent with the directives established in the PAMPA and the BBA. The statute at section 1848(b)(11) of the Act (as added by the PAMPA and amended) specifies that the code definitions, work RVUs, and direct inputs for the practice expense RVUs for these services shall be the same as such definitions, units, and inputs for such services for the fee schedule established for services furnished in CY 2016. We did not propose to change the code definitions, work relative value units, or direct practice expense inputs from those established for CY 2016. We proposed to update the pricing of those same supply and equipment inputs as part of the market-based study of commercial pricing undertaken by the contractor, which was not a subject addressed by the statutory provisions concerning HCPCS codes G6001-G6015. We did not propose changes to the direct practice expense inputs for these services. We simply proposed to update pricing for these inputs; and to adopt the same prices for these supplies and equipment across the PFS for all codes that include them. We note that we estimate that the overall effect of incorporating the new prices in calculating the payment rates for these services results in higher overall RVUs for these services, on the whole, than the potential alternative of relying exclusively on pricing from prior years.

      After consideration of the public comments, we are finalizing our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. However, while we are adopting most of the prices for supplies and equipment as recommended by StrategyGen and included in the proposed rule, in response to the initial feedback provided by the commenters, we are finalizing changes to the proposed pricing of approximately 60 supply and equipment codes as detailed in Table 9:

      Table 9--Supply and Equipment Prices Updated in Response to Comments

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

      Proposed CY Final CY 2019

      Supply/ equipment code Description CY 2018 price 2019 price price

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

      ED033.......................... treatment planning system, IMRT $350,545.000 $157,392.835 $197,247.000

      (Corvus w-Peregrine 3D Monte

      Carlo).

      EF031.......................... table, power................... 6,153.630 5,438.120 5,906.760

      EL015.......................... room, ultrasound, general...... 369,945.000 130,252.571 369,945.000

      EL016.......................... Room--Ultrasound, vascular/ 466,492.000 199,449.308 466,492.000

      Original submission.

      EP014.......................... flow cytometer................. 119,850.000 147,210.980 192,000.000

      EP088.......................... ThermoBrite.................... 6,120.000 3,467.000 4,795.000

      EP116.......................... VP-2000 Processor.............. 30,800.000 81,775.462 37,993.000

      EQ031.......................... INR monitor, home.............. 2,000.000 6,014.819 635.000

      EQ125.......................... glucose continuous monitoring 1,170.540 835.527 850.000

      system.

      EQ288.......................... ultrasonic cleaning unit....... 895.000 76,725.556 895.000

      EQ312.......................... INR analysis and reporting 21,085.000 6,014.819 19,325.000

      system w-software.

      EQ340.......................... Patient Worn Telemetry System.. 23,537.000 18,565.719 23,494.000

      EQ343.......................... Radioaerosol Administration 2,560.250 30.000 623.000

      System.

      ER003.......................... HDR Afterload System, 375,000.000 111,425.876 132,574.780

      Nucletron--Oldelft.

      ER083.......................... SRS system, SBRT, six systems, 4,000,000.000 931,965.479 2,973,721.836

      average.

      ES052.......................... brachytherapy treatment vault.. 175,000.000 134,998.000 193,114.250

      SA026.......................... kit, radiofrequency introducer. 50.000 658.700 24.160

      SA074.......................... kit, endovascular laser 519.000 313.460 323.330

      treatment.

      SA081.......................... pack, drapes, ortho, small..... 1.128 1.000 2.250

      SA099.......................... Kit, probe, cryoablation, 4,700.000 1,539.560 1,539.560

      prostate (Galil-Endocare).

      SA100.......................... kit, probe, radiofrequency, XIi- 2,695.000 753.420 1,966.670

      enhanced RF probe.

      SA105.......................... UroVysion test kit............. 176.800 132.130 129.280

      SA106.......................... Balloon Sinus Surgery Kit...... 2,599.860 2,876.220 2,374.330

      SA117.......................... Universal Detection Kit........ 4.000 6.510 4.000

      SA122.......................... Claravein Kit.................. 890.000 575.000 883.330

      SB019.......................... drape-towel, sterile 18in x 0.282 0.920 0.470

      26in.

      SB026.......................... gown, patient.................. 0.533 3.540 0.590

      SD109.......................... probe, radiofrequency, 3 array 2,233.000 871.660 2,289.000

      (StarBurstSDE).

      SD114.......................... sensor, glucose monitoring 53.080 43.950 59.310

      (interstitial).

      Page 59480

      SD134.......................... tubing, suction, non-latex 2.961 0.290 2.670

      (6ft) with Yankauer tip (1).

      SD155.......................... catheter, RF endovenous 725.000 1,010.550 550.000

      occlusion.

      SD250.......................... introducer sheath, Ansel 45 cm 90.000 64.450 72.640

      6 Fr Ansel.

      SD251.......................... Sheath Shuttle (Cook).......... 0.000 0.000 109.690

      SD253.......................... atherectomy device 4,979.670 2,293.100 3,048.330

      (Spectronetics laser or Fox

      Hollow).

      SD254.......................... covered stent (VIABAHN, Gore).. 3,768.000 2,573.000 3,129.000

      SD255.......................... Reentry device (Frontier, 0.000 0.000 2,343.120

      Outback, Pioneer).

      SD304.......................... IVUS catheter.................. 1,025.000 727.750 858.330

      SF040.......................... suture, vicryl, 3-0 to 6-0, p, 7.852 4.310 8.520

      ps.

      SG055.......................... gauze, sterile 4in x 4in....... 0.159 0.030 0.190

      SG056.......................... gauze, sterile 4in x 4in (10 0.798 0.030 1.200

      pack uou).

      SH007.......................... antigen, multi (pollen, mite, 6.700 4.780 8.960

      mold, cat).

      SH009.......................... antigen, venom................. 20.140 27.360 30.930

      SH010.......................... antigen, venom, tri-vespid..... 44.050 51.320 60.240

      SH033.......................... fluorescein inj (5ml uou)...... 5.442 10.310 24.390

      SJ055.......................... test strip, INR................ 5.660 3.750 4.710

      SL012.......................... antibody IgA FITC.............. 41.180 274.090 30.025

      SL060.......................... embedding mold................. 0.149 5.140 0.123

      SL182.......................... mounting media (DAPI II 67.000 14.420 54.000

      counterstain).

      SL184.......................... slide, negative control, Her-2. 29.400 21.240 29.400

      SL185.......................... slide, positive control, Her-2. 29.400 25.000 26.200

      SL191.......................... ethanol, 85%................... 0.003 0.170 0.021

      SL195.......................... kit, FISH paraffin pretreatment 20.850 23.290 20.850

      SL196.......................... kit, HER-2/neu DNA Probe....... 105.000 80.450 79.050

      SL258.......................... Control slides................. 228.000 279.000 203.730

      SL261.......................... FISH pre-treatment kit......... 549.000 454.480 579.210

      SL474.......................... Confirm anti-CD15 Mouse 3.610 3.880 3.820

      Monoclonal Antibody (Ventana

      760-2504).

      SL483.......................... Hematoxylin II (Ventana 790- 0.023 0.023 0.780

      2208).

      SL484.......................... Bluing reagent (Ventana 760- 4.522 0.290 0.450

      2037).

      SL488.......................... UltraView Universal DAB 10.485 15.390 9.700

      Detection Kit.

      SL493.......................... Antibody Estrogen Receptor 14.470 322.400 16.117

      monoclonal.

      SL497.......................... (EBER) DNA Probe Cocktail...... 8.570 420.060 8.189

      SL498.......................... Kappa Probe Cocktail........... 0.095 0.070 0.910

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

      The updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final 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 solicited 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.

      The following is a summary of the public comments we received on our comment solicitation regarding whether to update of the rates for the clinical labor staff types during the 4-year pricing transition for supplies and equipment.

      Comment: Most commenters were supportive of the idea of updating the clinical labor wages during the 4-year pricing transition for supplies and equipment. Several commenters requested that the updated pricing for clinical labor should continue to be based on Bureau of Labor Statistics wage data and remain open for public comment from interested commenters through the rulemaking process. One commenter supported updating the prices for the clinical labor staff types and stated that they had convened an expert physician panel that suggested that the clinical labor costs for radiation therapists and nurses are up to 33 percent higher than what is currently included in the CMS database. A few commenters did not support updating clinical labor wages during the 4-year pricing transition for supplies and equipment, in one case stating that the clinical labor pricing should be updated after the pricing transition for supplies and equipment was complete, and in another case stating that CMS should not make any changes to clinical labor costs for the foreseeable future.

      Response: We will take this information into account for future rulemaking on the subject of whether or not to update the clinical labor wages used in future calendar years alongside the 4-year pricing transition for supplies and equipment.

      (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 CY 2014 PFS rulemaking, 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

      Page 59481

      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 77048 (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 77049 (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 did not propose 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 77048 and 77049 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.

      The following is a summary of the public comments we received on our proposal not to update the price of the Breast Biopsy software or add the software to the listed procedures.

      Comment: Several commenters stated that CAD or biopsy software is not part of any standard MRI room package available for purchase, and that these are different equipment items sold by different vendors. One commenter requested that CMS clarify the equipment items that make up the MR room (EL008) in order to verify whether or not legitimate duplication exists with the Breast Biopsy software. Another commenter stated that the new CAD Software equipment (ED058) in CPT codes 77048 and 77049 is actually synonymous with the ``breast biopsy software'' (EQ370). This commenter stated that there had been a lack of consistency in identifying the equipment item between the breast biopsy codes and the MR breast codes, and requested updating the price of the equipment item consistent with the submitted invoices.

      Response: In response to the comment requesting that CMS clarify the equipment items that make up the MR room (EL008), we can state that the MR room contains a 1.5T MR Scanner as well as coils, NV array, torso array, shoulder, wrist, extremity, dual array, power injector, and a computer workstation.

      After consideration of the public comments, we are finalizing our proposal not to update the price of the Breast Biopsy software (EQ370). However, we note that in light of the information supplied by the commenter that the new CAD Software equipment (ED058) is actually synonymous with the Breast Biopsy software (EQ370), we had already proposed to include this equipment in CPT codes 77048 and 77049. We are finalizing the inclusion of the new CAD Software equipment (ED058) in these procedures, and we are finalizing an update in the price of the CAD Software to $43,308.12. This is based on a submitted invoice from the commenters which contained a price of $52,725 as averaged together with additional invoices for the same CAD Software equipment researched by the StrategyGen contractor. We are also finalizing the replacement of the time assigned to the EQ370 Breast Biopsy software in CPT codes 19085, 19086, 19287, and 19288 with an equal amount of time assigned to the new ED058 CAD Software equipment. Finally, due to the continued confusion and lack of price for the EQ370 equipment item, and due to its redundancy with the new ED058 equipment code, we are deleting EQ370.

      (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 noted that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.

      (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

      Page 59482

      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 proposed to continue with the second year of the transition of this adjustment to the standard process for allocating indirect PE.

      We received no comments specific to our proposal to continue with the 2nd year of the transition to the standard process for allocating indirect PE. Therefore, we are finalizing our proposal to proceed with the second year of implementing an alternative methodology for the allocation of indirect PE for some office-based services.

  23. 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 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 PFS 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 paid 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.

    In the CY 2019 PFS proposed rule, we solicited additional comment regarding the next MP RVU update which must occur by CY 2020. Specifically, we solicited 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.

    We received a few comments in response to the comment solicitation, and we appreciate the commenters' feedback and input. We will consider the suggestions and information received for future rulemaking, and in particular for the CY 2020 statutorily required update to MP RVUs.

  24. 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, we have also established several PFS policies to explicitly pay for non-face-to-face services included as part of ongoing care management.

    Although 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

    Page 59483

    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) (Pub. L. 115-

    123) 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 (82 FR 53012), we solicited 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 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 recognized 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 aimed 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 made several proposals for modernizing Medicare physician payment for communication technology-based services, described below. These services will 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 will be paid under the PFS like other physicians' services. Additionally, we note that in furnishing these services, practitioners 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 G2012)

    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

    Page 59484

    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 proposed to pay separately, beginning January 1, 2019, for a newly defined type of physicians' service furnished using communication technology. We stated 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 kind 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 solicited comment on what types of communication technology are utilized by physicians or other qualified health care professionals in furnishing these services, including whether audio-only telephone interactions are sufficient compared to interactions that are enhanced with video or other kinds of data transmission.

    The following discussion summarizes particular definitions and billing rules for these services, as proposed, and more detailed comments we received regarding these aspects of the proposal. Our responses below include information regarding the service definitions and billing requirements applicable for CY 2019.

    Comment: Many commenters supported the proposal to pay for these kinds of services. Many commenters offered specific suggestions regarding the service definitions and associated billing rules, which we describe in detail below. Several commenters urged CMS to take a cautious approach in paying for these services, given concerns these commenters stated regarding potential overutilization, while some noted that potential overutilization would be mitigated by Medicare's requirements for the visit to be reasonable and medically necessary/

    appropriate. Specific aspects of these comments are detailed below.

    Response: Based on the broad support for the proposal, we are creating coding and finalizing our proposal to make separate payment for this service. We note that in the proposed rule we referred to this service as HCPCS code GVCI1, which was a placeholder code. The code will be described as HCPCS code G2012 (Brief communication technology-

    based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).

    We appreciate commenters' concerns regarding the potential for overutilization of these services. We plan to monitor utilization with the intention of determining whether changes, such as a frequency limitation on the use of this code, are warranted. We would consider proposing such changes in future rulemaking. We note that, like all other physicians' services billed under the PFS, each of these services must be medically reasonable and necessary to be paid by Medicare.

    Comment: Many commenters suggested that we not be overly prescriptive regarding the types of communication technology that are utilized by physicians or other qualified health care professionals in furnishing these services. The commenters noted that technology is evolving at a rapid pace and would require us to have to update our policies frequently. Several commenters suggested that we permit the use of email and Electronic Health Record (EHR) patient portals to qualify. A few commenters stated that audio-visual communication is ideal. Others acknowledged that not all patients have the same level of connectivity and therefore recommended allowing audio-only communication.

    Response: We are persuaded by the comments advising us not to be overly prescriptive about the technology that is used, and are finalizing allowing audio-only real-time telephone interactions in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission. We note that telephone calls that involve only clinical staff could not be billed using HCPCS code G2012 since the code explicitly describes (and requires) direct interaction between the patient and the billing practitioner.

    We further proposed 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 proposed that in instances when the brief communication technology-based service leads to an E/M 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 noted that this service could be used as part of a treatment regimen for opioid use disorders and other substance use disorders to assess whether the patient's condition requires an office visit.

    We proposed pricing this distinct service at a rate lower than current 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 will 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. Therefore, we specifically solicited comment on whether we should require, for example, verbal consent that will be noted in the medical record for each service.

    Comment: Many commenters stated that it would be burdensome to obtain consent from the patient prior to each occurrence of this service. Some commenters suggested that the patient be informed through the use of a service agreement which could be signed once and kept on file. Several commenters

    Page 59485

    expressed concern about the cost to beneficiaries, especially since they may have previously received this service without financial liability, and therefore recommended requiring verbal consent that is documented in the medical record.

    Response: We understand the potential burden regarding obtaining consent for each occurrence of this service. However, we are persuaded by those commenters who suggest that unexpected cost to beneficiaries would be particularly problematic. We note that under our current policy for several types of care management services, verbal consent is required to be obtained and documented in the medical record. The consent policy was implemented, in part, based on feedback we received from practitioners reporting the care management services, to alleviate burdens of alternative approaches, such as requirements for written consent or completion of particular forms. Consequently, we believe the same requirement could be applied here, without imposition of significant burden. We are finalizing requiring verbal consent that is noted in the medical record for each billed service.

    We also proposed 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.

    Comment: Many commenters were supportive of our proposal to limit this service to established patients, while several commenters noted that there would be instances when it would be appropriate to bill this service for new patients. MedPAC noted particular concern regarding potential increases in volume that are not related to ongoing, informed patient care. A few commenters requested that CMS clarify that established patients include those patients who have been seen by a practitioner within the same group practice.

    Response: After considering the comments, we are finalizing our proposal to limit this service to established patients, given the concern expressed by commenters regarding the degree to which these services can be furnished without familiarity and experience with individual patients, and in light of MedPAC's concerns regarding increases in utilization that are not related to ongoing, informed patient care. In response to the request for clarification about what constitutes an established patient, we defer to CPT's definition of this term. CPT defines an established patient as one who has received professional services from the physician or qualified health care professional or another physician or qualified health care professional of the exact same specialty and subspecialty who belongs to the same group practice, within the past 3 years. We also emphasize that payment for this service would not preclude a physician or other qualified health care professional from having communication via phone or other modalities with any patient, new or existing, for a variety of reasons. We believe that much of the pre- and post- work associated with, and included in the valuation of existing in-person services that are paid under the PFS can include some types of interactions with patients that are not in-person.

    We did not propose 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 solicited 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.

    Comment: Many commenters were opposed to creating a frequency limitation, suggesting we wait and monitor utilization. Others noted that it could be clinically appropriate to utilize this service multiple times in a week. A few commenters stated that this service could be utilized in behavioral health treatment, and cited an example of assessing suicidal risk, in which case they suggested the frequency should not be limited since routine virtual check-ins would be clinically warranted in some cases. Some commenters suggested a frequency limit of three times per week whereas others suggested a limit of once per week.

    Response: After considering these comments, we are not implementing a frequency limitation for CY 2019. However, we plan to monitor utilization with the intention of determining whether such a limitation is warranted. In that case, we would consider proposing a limitation in future rulemaking. We note that, like all other physicians' services billed under the PFS, each of these services must be medically reasonable and necessary to be paid by Medicare.

    We also solicited 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 solicited 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 noted that these services, like any other physicians' service, must be medically reasonable and necessary in order to be paid by Medicare.

    Comment: Several commenters suggested that we remove the language in the code descriptor that states ``or soonest available appointment.'' A few commenters suggested we extend the timeframe to 48 hours following the virtual check-in, while others suggested it would be reasonable to expand the limit to 14 days before and 72 hours after the service. Several commenters stated concerns that it might be difficult to document that a subsequent visit was not the ``soonest available appointment.'' Several commenters expressed concern about the potential for overutilization of this code.

    Response: We agree with commenters that urged caution regarding overutilization of this service and believe that the language stating, `or soonest available appointment' in the code description may serve to reduce potential perverse payment incentives to delay seeing patients to ensure payment for this code. We appreciate the concerns regarding potential difficulty in proving that a particular visit was not the ``soonest available.'' We agree that in each individual case, it might be challenging to prove whether or not other appointments were available prior to the visit, especially since beneficiary convenience is also presumably a factor for when appointments are scheduled. However, we believe that, as written, the code description could help to guard against the potential for abuse that would be present if we instead adopted a purely time-based window for bundling of this service. We also believe that ``soonest available appointment'' might allow for clinically appropriate flexibility. Therefore, after consideration of the public comments, we are finalizing the code descriptor for HCPCS code G2012 as proposed. However, we plan to monitor this service with the intention of determining whether changes are

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    necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.

    We solicited 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.

    Comment: A few commenters stated that documentation for this service should be consistent with the requirements for an in-person encounter and requested appropriate documentation requirements to ensure that the check-in is fully incorporated into the individual's medical history. Other commenters urged us not to be overly prescriptive.

    Response: We appreciate the commenters' input. We do not want to impose undue administrative burden likely to discourage appropriate provision of these services, and are therefore not requiring any service-specific documentation requirements for this service. We note again that these services, like any other physicians' service, must be medically reasonable and necessary in order to be paid by Medicare.

    Comment: Several commenters stated that the proposed payment rate would be inadequate for modalities that are both audio- and visual-

    capable, whereas others stated that the proposed valuation was appropriate. One commenter suggested we create a second code for a virtual check-in that only utilizes synchronous audio/video technology, with a higher reimbursement rate associated with the increased complexity of technology.

    Response: As discussed in section II.H of this final rule, we are finalizing the valuation for HCPCS code G2012 as proposed. We believe this valuation reflects the work time and intensity of the service relative to other PFS services and accounts for the resource costs and efficiencies associated with the use of communication technology. We recognize that the valuation of this service is relatively modest, especially compared to in-person services, however, we believe that the proposed valuation accurately reflects the resources involved in furnishing this service. We plan to monitor the utilization of this code and note that we routinely address recommended changes in values for codes paid under the PFS.

    Comment: A few commenters requested that CMS allow licensed physical therapists to furnish these services. Additionally, a few commenters requested that we allow other clinical staff, such as registered nurses, to furnish this service.

    Response: We are finalizing maintaining this code as part of the set of codes that is only reportable by those that can furnish E/M services. We believe this is appropriate since the service describes a check-in directly with the billing practitioner to assess whether an office visit is needed. We agree that similar check-ins provided by nurses and other clinical staff can be important aspects of coordinated patient care. We note that these kinds of non-face-to-face services by other medical professionals and clinical staff continue to be included in the RVUs for other codes, including those that describe E/M visits, and for procedures with global periods. We also note that non-face-to-

    face services provided by clinical staff can be explicitly and separately paid for as part of several care management services, many of which we have introduced over the past several years. However, this service is meant to describe, and account for the resources involved, when the billing practitioner directly furnishes the virtual check-in.

    Comment: Several commenters requested that CMS waive the beneficiary co-payment for this service.

    Response: We appreciate the commenters' request; however, we do not have the statutory authority to make specific changes to the requirements regarding beneficiary cost sharing for this service.

    In summary, we are creating coding and finalizing our proposal to make separate payment for brief communication technology-based services. The code will be described as G2012 (Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion). We are finalizing allowing real-time audio-only telephone interactions in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission. We are finalizing our proposal to limit this service to established patients.

    We are finalizing that if the 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. In instances when the service leads to an E/M service with the same physician or other qualified health care professional, we are finalizing that 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 plan to monitor this service with the intention of determining whether changes are necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.

    We are finalizing requiring verbal consent from beneficiaries that is noted in the medical record for each service. We are not implementing a frequency limitation for CY 2019, however, we plan to monitor utilization with the intention of determining whether such a limitation is warranted. In that case, we would consider that for future rulemaking.

    We are finalizing the valuation for HCPCS code G2012 as proposed. We will monitor the utilization of this code and consider any potential adjustments to billing rules or valuation for this service through future rulemaking. We note that cost sharing for these services will apply.

    For details related to developing utilization estimates for this service, see section VII. of this final rule, Regulatory Impact Analysis. For additional details related to valuation of this service, see section II.H. of this final rule, Valuation of Specific Codes.

    2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code G2010)

    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 noted in the proposed rule 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 (83 FR 35724). Under section 1834(m) of

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    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. However, much like the brief communication technology-based service (``virtual check-in service'') that we are finalizing in this rule as described previously, this remote evaluation service would not be a substitute for an in-person service currently separately payable under the PFS. As such, this remote evaluation service is distinct from the telehealth services described under section 1834(m) of the Act. Effective January 1, 2019, we proposed 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. Because this service would not be considered a Medicare telehealth service, it would not be subject to the geographic and other restrictions on telehealth services under section 1834(m) of the Act; and the proposed valuation reflects the resource costs associated with furnishing services utilizing communication technology.

    Also like the virtual check-in service we are finalizing as described previously, this service would be used to determine whether or not an office visit or other service is warranted. When the remote evaluation of pre-recorded patient-submitted images and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we proposed that this remote service will be considered bundled into that office visit and therefore not be separately billable. We further proposed 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 will be considered bundled into that previous E/M service and not be separately billable. In summary, we proposed 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. We believe the 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. We note that in the proposed rule we referred to this service as HCPCS code GRAS1, which was a placeholder code. The code for this service is G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). We solicited 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 noted that this service is distinct from the virtual check-in service described previously in that this service involves the practitioner's evaluation of a patient-generated still or video image transmitted by the patient, and the subsequent communication of the practitioner's response to the patient; while the virtual check-in service describes a service that occurs in real time and does not involve the asynchronous transmission of any recorded image.

    The following discussion summarizes particular definitions and billing rules we proposed for this service and the more detailed comments we received regarding these aspects of the proposal. Our responses below include information regarding the service definitions and billing requirements applicable for 2019. We additionally address comments we received regarding 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.

    Comment: Several commenters were supportive of the proposal to pay for these kinds of services. Several commenters urged CMS to take a cautious approach in paying for these services, given concerns these commenters expressed regarding potential overutilization.

    Response: We appreciate the many thoughtful comments regarding this proposal. Based on our review of the comments received, especially the broad support for the proposal, we are creating coding and finalizing our proposal to make separate payment for this service. The code will be described as G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment).

    We appreciate commenters' concerns regarding the potential for overutilization of these services. We plan to monitor utilization. We note that, like all other physicians' services billed under the PFS, each of these services must be medically reasonable and necessary to be paid by Medicare.

    Comment: Many commenters supported allowing this service to be furnished to new patients, noting that an established relationship is not required for the practitioner to remotely evaluate an image or video to consider whether an office visit or other service is warranted, particularly in dermatology and ophthalmology. One commenter stated that allowing new patients to receive this service would also be of value in urology, as it would provide a way to assess patients with conditions such as hematuria (that is, blood in the urine) in a timely manner. The AMA and other commenters urged CMS to limit these services to established patients. The AMA also suggested that, at some point before a physician or practitioner furnishes a virtual service, the clinician (or another clinician with whom the furnishing clinician has a cross-coverage agreement in place) should conduct a face-to-face examination (either in-person or via telehealth) with the patient, noting that the existence of a valid patient-physician relationship ensures that the treating physician or qualified health professional meets a threshold standard of care, enhances care coordination/

    continuity of care, and ensures that patients are afforded advance notice of when the relationship is being established and that such a patient-initiated service may result in out-of-pocket expenses including deductibles and co-insurance, and additionally serves to minimize the potential for program integrity concerns.

    Response: We are persuaded by comments urging us to permit separate

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    payment for these services only for established patients. Since this service is furnished directly by the billing practitioner, we believe it should be furnished in the context of an existing patient-clinician relationship. Therefore, we are finalizing the reporting and billing of HCPCS code G2010 only for established patients.

    Comment: Many commenters stated that it would be burdensome to obtain consent from the patient prior to each occurrence of this service. Some commenters suggested that the patient could be informed through the use of a service agreement which could be signed once and kept on file. Several commenters expressed concern about the cost to beneficiaries and therefore recommended requiring verbal consent that is documented in the medical record.

    Response: As noted previously regarding HCPCS code G2012, we believe it is important for patients to consent to receive these services, especially since many beneficiaries would be financially liable for sharing in the cost of these services. We understand the potential burden regarding obtaining consent for each occurrence of this service. However, we are persuaded by those commenters who suggest that unexpected cost to beneficiaries would be particularly problematic. We are finalizing requiring beneficiary consent that could be verbal or written, including electronic confirmation that is noted in the medical record for each billed service for HCPCS code G2010.

    We acknowledge that verbal consent could be obtained using more than one communication modality, especially since this service is initiated by the patient and involves submission of an image or video. Therefore, we do not intend to include the word ``verbal'' in the descriptor for the code that describes this services, since ``verbal'' could imply written or electronic consent.

    Comment: Several commenters stated that the proposed payment rate is too low, citing that it is below market compared to the rate many asynchronous telemedicine companies pay their contracted/employed physician staff, and noted that new patients in particular require more resources, whereas others stated that the proposed valuation was appropriate. One commenter suggested that CMS should encourage clinicians to recommend that patients have virtual or in-person visits if the clinician has concerns about the quality of the pre-recorded patient information, such as still or video images.

    Response: As discussed in section II.H. of this final rule, we are finalizing the valuation for HCPCS code G2010 as proposed. As stated previously regarding the valuation of the brief communication technology-based service code, HCPCS code G2012, we believe that the proposed valuation accurately reflects the resources involved in furnishing this service. We will monitor the utilization of this code and consider any potential adjustments to billing rules or valuation for this service through future rulemaking.

    Comment: A few commenters requested that CMS clarify that the ``verbal follow-up'' that occurs after the billing practitioner evaluates the images or video submitted by the patient may take place via any mode of communication, including secure text messaging, phone call, or live/asynchronous video chat, so as not to restrict a clinician's interaction with patients. One commenter suggested that CMS should encourage clinicians to recommend that patients have a face-to-

    face visit (in-person or via telehealth) if the clinician has concerns about the quality of the pre-recorded patient information, such as still or video images.

    Response: We are finalizing that the follow-up could take place via phone call, audio/video communication, secure text messaging, email, or patient portal communication and note that accordingly, we do not intend to include the word ``verbal'' in the code descriptor. We note that any such communications must be compliant with HIPAA and other relevant laws. Additionally, we agree that in instances in which the quality of the pre-recorded information submitted by a patient is insufficient for the clinician to assess whether an office visit or other medical service is warranted, the clinician could not fully furnish a remote evaluation service and, therefore, could not bill for the service. We anticipate that in such a circumstance, the clinician would attempt other methods of communication with the patient to either obtain sufficient images to enable a remote evaluation service or suggest other appropriate alternatives.

    Comment: Several commenters suggested that we remove the language in the code descriptor for this service that states ``or soonest available appointment,'' and stated that it might be difficult to document that a subsequent visit was not the ``soonest available appointment.''

    Response: As noted previously regarding similar comments on HCPCS code G2012, we appreciate the concerns regarding potential difficulty in proving that a particular visit was not the ``soonest available.'' We agree that in each individual case, it might be challenging to prove whether or not other appointments were available prior to the visit, especially since beneficiary convenience is also presumably a factor in when appointments are scheduled. However, we believe that, as written, the code description would guard against the potential for abuse that would be present if we instead adopted a purely time-based window for bundling of this service. Therefore, in response to the comments, we are finalizing retaining this language in the code descriptor for HCPCS code G2010 as proposed. However, we plan to monitor this service with the intention of determining if changes are necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.

    Comment: A few commenters suggested that CMS consider inclusion of email/messaging or questionnaires/assessments that do not include an image or other visual item in the scope of this code.

    Response: The scope of this service is limited to the evaluation of pre-recorded video and/or images. We note that there is separate coding under the PFS for several types of formal assessments, such as CPT code 96160 (Administration of patient-focused health risk assessment instrument (e.g., health hazard appraisal) with scoring and documentation, per standardized instrument), many of which can be reported when the form is completed by the patient and submitted using remote communication technology for subsequent evaluation by the clinician. Additionally, behavioral health assessments are included in coding and payment for the behavioral health integration services that were finalized for separate payment beginning in CY 2017.

    In summary, we are creating coding and finalizing our proposal to make separate payment for remote evaluation of recorded video and/or images submitted by the patient. The code will be described as G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). We are finalizing that

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    HCPCS code G2010 may be billed only for established patients. We are finalizing that the follow-up with the patient could take place via phone call, audio/video communication, secure text messaging, email, or patient portal communication.

    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 are finalizing that this remote service will be considered bundled into that office visit and therefore will not be separately billable. We are further finalizing 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 will be considered bundled into that previous E/M service and also will not be separately billable.

    We are finalizing requiring beneficiary consent that could be verbal or written, including electronic confirmation that is noted in the medical record for each billed service for HCPCS code G2010.

    We are finalizing the valuation for HCPCS code G2010 as proposed. We will monitor utilization of this code and consider any potential adjustments to billing rules or valuation of this service through future rulemaking. We note that cost sharing for these services will apply.

    For details related to our utilization estimates for this service, see section VII. of this final rule, Regulatory Impact Analysis. For further discussion related to valuation of this service, please see the section II.H. of this final rule, Valuation of Specific Codes.

    3. Interprofessional Internet Consultation (CPT Codes 99451, 99452, 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 adopt these codes for 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 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 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) 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 proposed

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    separate payment for these services, discussed in section II.H. of this final rule, Valuation of Specific Codes.

    Although we proposed 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 will 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 therefore solicited 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 noted that there are program integrity concerns around making separate payment for these interprofessional consultation services, including around CMS's or its contractors' ability to evaluate whether an interprofessional consultation is reasonable and necessary under the particular circumstances. As the beneficiary would be liable for any cost sharing associated with these services, we also sought comment on the necessity of requiring patient consent for these, and whether than consent should be written or verbal. We solicited comment on how best to minimize potential program integrity issues, and noted we were 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.

    The following is a summary of the comments we received regarding how best to minimize potential program integrity issues.

    Comment: Almost all commenters were very supportive of CMS proposing separate payment for these services. Commenters pointed out that these are discrete physician services undertaken for the benefit of the patient, and easily distinguished from consultations undertaken for the edification of the practitioner. One commenter stated as medical care moves toward more comprehensive patient-centered care management, frequent consultation with multiple specialists is necessary. Under the current model this means separate visits for the patients that are costly and inconvenient. Internet-based consultations between the treating practitioner and the consulting specialists provide appropriate, convenient and cost effective alternatives. Commenters were clear that, by not making separate payment for these services, CMS would not be accurately paying for the work of both the treating and consulting physicians in a consultative scenario.

    Many commenters provided helpful responses to CMS' request for information on how to minimize program integrity concerns for these services. A few commenters provided suggestions as to how CMS could verify the medical necessity of the consultation, including verifying that the treating and consulting physician were of different medical specialties, requiring patient identifiers and documentation of how the interaction improved patient care, defining a time period under which an E/M visit and an Interprofessional Consultation cannot both be billed for the same diagnosis, and creating frequency limitations on billing. Others suggested that the treating physician must document that they acted on the recommendation of the consulting physician prior to billing for CPT code 99452. Commenters had a number of suggestions for items that CMS should require, including that Interprofessional Consultations should consist of focused questions that are answerable solely from information in the EMR; that they be answered in 3 business days; and that the consulting physician should restate the question in their response, provide recommendations for evaluation, management, and/or ongoing monitoring, provide a rationale for recommendations, and provide recommendations for contingencies. Other commenters suggested that CMS could make separate payment contingent upon whether the underlying condition was urgent or related to critical care and that the consultation helped avoid transfer or interruption of care or that internal expertise was sought and was not available. Many commenters also encouraged CMS to avoid imposing overly restrictive documentation requirements. One commenter stated that, due to potential program integrity concerns, these services should be subject to the Medicare telehealth restrictions on beneficiary location and site of service. Another commenter recommended that CMS delay implementation until the program integrity concerns have been addressed. Other commenters encouraged CMS to monitor utilization for abuse.

    Response: We thank commenters for their support and additional information on the ways in which these services are distinct physician services. We note that because these services are inherently non face-

    to-face (the patient need not be present in order for the service to be furnished in its entirety), they would not be considered as potential Medicare telehealth services under section 1834(m) of the Act. We appreciate the wealth of information and suggestions from commenters; however, we also agree with the many commenters who pointed out that adding many additional billing requirements may inhibit uptake for these services. As we note below, we are requiring documentation of verbal patient consent to receive these services, and are adopting existing CPT prefatory language. We plan to monitor utilization of these services and will consider making refinements to billing rules, documentation requirements or claims edits, including those suggested by commenters, through future rulemaking as necessary.

    Comment: Many commenters suggested that CMS limit or eliminate beneficiary cost sharing for these services to obviate the question of patient consent entirely.

    Response: Under current statute, we do not have the authority to change the requirements for the beneficiary cost sharing for these services.

    Additionally, since these codes describe services that are furnished without the beneficiary being present, we proposed 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 patient's medical record, similar to the conditions of payment associated with separately billable care management services under the PFS. Obtaining advance beneficiary consent includes ensuring that the patient is aware of applicable cost sharing.

    The following is a summary of the comments we received regarding whether 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, as well as comments on other aspects of this proposal.

    Comment: Many commenters stated that verbal patient consent was an appropriate safeguard against unnecessary utilization, while others disagreed, stating that the requirement

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    to obtain consent may cause unnecessary burden in cases where the patient is unresponsive or the need for the interprofessional consultation is urgent such as in a critical care or emergency setting. Other commenters stated that a single blanket patient consent to receive interprofessional consultation services would be preferable to minimize the need to obtain consent for each of what may be multiple consultations. One commenter questioned whether the consulting physician would need to verify that the beneficiary had consented, given that only the treating physician is in contact with the beneficiary.

    Response: We understand the potential burden regarding obtaining consent. However, we believe that it is important for beneficiaries to consent to the service and thus be notified of their cost-sharing obligations. We note that under our current policy for several care management services, consent is required to be documented in the medical record. That policy was implemented, in part, based on feedback we received from practitioners reporting the care management services, to alleviate burdens of alternative approaches. Consequently, we believe the same requirement could be applied here, without imposition of significant burden.

    We are finalizing that the patient's verbal consent is required, and that consent must be noted in the medical record for each service, consistent with the policy we are finalizing for the brief communication technology-based services (HCPCS code G2012) as noted above, as well as with the patient consent policies in place for care management services, under the PFS.

    Comment: Commenters requested that CMS clarify whether billing for these services is limited to physicians or if other healthcare practitioners, such as nurses or physical therapists, may bill for these services as well.

    Response: We appreciate commenters' request for clarification. We believe that billing of these services should be limited to those practitioners that can independently bill Medicare for E/M visits, as interprofessional consultations are primarily for the ongoing evaluation and management of the patient, including collaborative medical decision making among practitioners. We are therefore not finalizing any expansion of these services beyond their current scope.

    Comment: A few commenters requested that CMS adopt CPT prefatory language for these services as is CMS' longstanding practice when adopting most new CPT coding.

    Response: We agree with the commenters and confirm that we will be adopting existing CPT prefatory language regarding these services.

    In summary, we are finalizing separate payment for CPT codes 99451, 99452, 99446, 99447, 99448, and 99449 describing Interprofessional consultations. We are finalizing a policy to require the patient's verbal consent that is noted in the medical record for each interprofessional consultation service. We note that cost sharing will apply for these services. These interprofessional services may be billed only by practitioners that can bill Medicare independently for E/M services.

    For further discussion related to the valuation of these services, please see section II.H. of this final rule, Valuation of Specific Codes.

    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 this rule and in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. For further details, see the full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006).

    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 later in this section, 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

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      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 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 proposed 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 will 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 did not propose 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 99453, 99454, and 99457)

      CPT code 99453 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment).

      CPT code 99454 (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 99457 (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 99453, 99454, and 99457 describe services that are inherently non face-to-face. As discussed in section II.H. of this final rule, Valuation of Specific Codes, we instead proposed to adopt CPT codes 99453, 99454, and 99457 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 did not propose to add them to the list of Medicare telehealth services.

      (2) Interprofessional Internet Consultation (CPT Codes 99451and 99452)

      CPT code 99452 (Interprofessional telephone/internet/

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

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

      CPT code 99451 (Interprofessional telephone/internet/

      electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time).

      As discussed in section II.H. of this final rule, Valuation of Specific Codes, we proposed to adopt CPT codes 99452 and 99451 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 did not propose to add them to the list of Medicare telehealth services for CY 2019.

      (3) Initial Hospital Care Services (CPT Codes 99221-99223)

      CPT code 99221 (Initial hospital care, per day, for the evaluation and

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      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 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 did 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 did not propose adding initial hospital care services to the Medicare telehealth services list on a Category 2 basis.

      We noted 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 did not propose to add the initial hospital care services to the list of Medicare telehealth services for CY 2019.

      (4) Subsequent Hospital Care Services (CPT Codes 99231-99233)

      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 requested that we remove the frequency limitation. We stated in the CY 2011 PFS final rule with comment period (75 FR 73316) that, although 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 did not propose to remove the frequency limitation on these codes.

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      (5) Subsequent Nursing Facility Care Services (CPT Codes 99307-99310)

      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 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 requested 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 did not propose to remove the frequency limitation for subsequent nursing facility care services in CY 2019.

      In summary, we proposed 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).

      Comment: Commenters were unanimously supportive of our proposal to add HCPCS codes G0513 and G0514 to the Medicare telehealth list. A few commenters noted they were disappointed that we did not propose to add the initial hospital care codes to the telehealth list and that we did not propose to lift the frequency limitation on the subsequent hospital care and subsequent nursing facility care codes.

      Response: We are finalizing adding HCPCS codes G0513 and G0514 to the Medicare telehealth list. We are not adding the initial hospital care codes to the telehealth list and we are not removing the frequency limitations on the subsequent hospital care and subsequent nursing facility care codes for the reasons noted above.

      Comment: Several commenters suggested that CMS conduct a pilot or demonstration program to evaluate the clinical benefit of physical therapists, occupational therapists, and speech-language pathologists furnishing telehealth services to Medicare beneficiaries in states that permit such services, noting that this would improve beneficiary access to therapy services, and help to inform policymakers as they consider whether to recognize such healthcare professionals as authorized providers of telehealth under the Social Security Act.

      Response: While we did not include any proposals on this topic in the proposed rule, we reiterate our commitment to expanding access to telehealth services consistent with statutory authority, and paying appropriately for services that maximize telecommunications technology. Regarding the possibility of a model or demonstration, we will consider the comments as we develop new models through the Center for Medicare and Medicaid Innovation. We note that we would need to determine whether such a model or demonstration would meet the statutory requirements, which generally require that the test be expected to reduce Medicare expenditures and preserve or enhance the quality of care for beneficiaries.

      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.

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      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) of the BBA of 2018, 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 proposed 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 proposed 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 proposed 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 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.

      Commenters supported our proposals to revise the regulation text at Sec. Sec. 410.78 and 414.65 to implement the requirements of section 50302 of the BBA of 2018 for expanding access to home dialysis therapy through telehealth. We are finalizing these regulation text changes as proposed.

    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 proposed 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 also proposed to revise Sec. 410.78(b)(3) to add mobile stroke unit as a permissible originating site for acute stroke telehealth services. We proposed 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 solicited comment on this definition, as well as additional information on how these units are used in current medical practice. We therefore proposed 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 solicited 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 proposed 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.

      Comment: Commenters supported the expansions to Medicare telehealth. The majority of commenters agreed with our proposed definition of a mobile stroke unit. However, the AMA suggested that CMS specify in the definition that a mobile stroke unit must include a computed tomographic (CT) scanner and a telehealth (audio and video) connection or an in-person physician who is able to interpret the CT scan and prescribe an intravenous thrombolysis and also have a qualified health

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      professional who is able to administer an intravenous thrombolysis if the physician interpreting the CT scan and prescribing the treatment does so via telehealth. The AMA also suggested that CMS add as an originating site Emergency Medical Service (EMS) transports equipped with a telehealth connection to stroke specialists in order to provide faster national access to patients who require an accurate stroke diagnosis and decision about eligibility for intravenous or endovascular therapy, and to determine where to take them (such as a primary stroke or comprehensive stroke center). One commenter urged CMS to distinguish between a mobile stroke unit and a standard ambulance that is equipped with telemedicine capability and to establish separate payment for each, noting that a telemedicine consult on a mobile stroke unit may involve much greater complexity and critical care treatment than on a standard ambulance that is equipped with telemedicine capability. Another commenter recommended that CMS require specially trained paramedics who can evaluate an acute ischemic stroke patient based on national standards.

      Response: We are finalizing the changes to the regulation text and the definition of a mobile stroke unit as proposed without modification. We believe that clinicians are in the best position to make decisions about what equipment and professional support are required in furnishing these services. We plan to monitor utilization of these services and will consider making refinements, including those suggested by commenters, through future rulemaking as necessary. We would welcome additional information to help us understand the merits of the commenters' suggestions, including those regarding specific equipment and staffing requirements for mobile stroke units.

      In summary, we are finalizing a new modifier that will be used to identify acute stroke telehealth services. The practitioner and, as appropriate, the originating site, will append this modifier to the HCPCS code as clinically appropriate when billing for an acute stroke telehealth service or an originating site facility fee, respectively. We are finalizing the regulation text changes at Sec. Sec. 410.78 and 414.65 as proposed to implement the requirements of section 50325 of the BBA of 2018 for acute stroke telehealth services. Mobile stroke units, with the definition as proposed, and the current eligible telehealth originating sites, which include hospitals and critical access hospitals, but exclude renal dialysis facilities and patient homes because they are originating sites only for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act, will be permissible originating sites for acute stroke telehealth services.

      6. Requirements of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

    6. Expanding Medicare Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders--Interim Final Rule With Comment Period

      Section 2001(a) of the SUPPORT for Patients and Communities Act (Pub. L. 115-271, October 24, 2018) (the SUPPORT Act) makes several revisions to section 1834(m) of the Act. First, it removes the originating site geographic requirements under section 1834(m)(4)(C)(i) for telehealth services furnished on or after July 1, 2019 for the purpose of treating individuals diagnosed with a substance use disorder or a co-occurring mental health disorder, as determined by the Secretary, at an originating site described in section 1834(m)(4)(C)(ii) of the Act, other than an originating site described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act. The site described in subclause (IX) of section 1834(m)(4)(C)(ii) of the Act is a renal dialysis facility, which is only an allowable originating site for purposes of home dialysis monthly ESRD-related clinical assessments in section 1881(b)(3)(B) of the Act. It also adds the home of an individual as a permissible originating site for these telehealth services. Section 2001(a) of the SUPPORT Act for Patients and Communities Act additionally amends section 1834(m) of the Act to require that no originating site facility fee will be paid in instances when the individual's home is the originating site. Section 2001(b) of the SUPPORT for Patients and Communities Act grants the Secretary specific authority to implement the amendments made by section 2001(a) through an interim final rule.

      Under the authority of section 2001(b) of the SUPPORT for Patients and Communities Act, we are issuing an interim final rule with comment period to implement the requirements of section 2001(a) of the SUPPORT for Patients and Communities Act. In accordance with section 1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the SUPPORT for Patients and Communities Act, we are revising Sec. 410.78(b)(3) on an interim final basis, by adding Sec. 410.78(b)(3)(xii), which adds the home of an individual as a permissible originating site for telehealth services furnished on or after July 1, 2019 to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder. We are amending Sec. 414.65(b)(3) on an interim final basis 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 individual's home. Additionally, we are adding Sec. 410.78(b)(4)(iv)(C) on an interim final basis to specify that the geographic requirements in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth services furnished on or after July 1, 2019, to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder at an originating site other than a renal dialysis facility.

      We note that section 2001 of the SUPPORT for Patients and Communities Act 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 individuals have a substance use disorder diagnosis and whether it would be clinically appropriate to furnish telehealth services for the treatment of the individual's substance use disorder or a co-

      occurring mental health disorder. By billing codes on the Medicare telehealth list with the telehealth place of service code, practitioners would be indicating that the codes billed were used to furnish telehealth services to individuals with a substance use disorder diagnosis for the purpose of treating the substance use disorder or a co-occurring mental health disorder. We note that we may issue additional subregulatory guidance in the future for billing these telehealth services.

      We note that there is a 60-day period following publication of this interim final rule for the public to comment on these interim final amendments to our regulations. We invite public comment on our policies to implement section 2001 of the SUPPORT for Patients and Communities Act.

      Page 59497

    7. Medicare Payment for Certain Services Furnished by Opioid Treatment Programs (OTPs)--Request for Information

      Section 2005 of the SUPPORT Act establishes a new Medicare benefit category for opioid use disorder treatment services furnished by OTPs under Medicare Part B, beginning on or after January 1, 2020. This provision requires that opioid use disorder treatment services would include FDA-approved opioid agonist and antagonist treatment medications, the dispensing and administration of such medications (if applicable), substance use disorder counseling, individual and group therapy, toxicology testing, and other services determined appropriate (but in no event to include meals and transportation). The provision defines OTPs as those that enroll in Medicare and are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), accredited by a SAMHSA-approved entity, and meeting additional conditions as the Secretary finds necessary to ensure the health and safety of individuals being furnished services under these programs and the effective and efficient furnishing of such services.

      We note that there is a 60-day period for the public to comment on the provisions of the interim final rule described previously to implement section 2001 of the SUPPORT for Patients and Communities Act. During that same comment period, we are requesting information regarding services furnished by OTPs, payments for these services, and additional conditions for Medicare participation for OTPs that stakeholders believe may be useful for us to consider for future rulemaking to implement this new Medicare benefit category.

      7. 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 proposed 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).

      Comment: Commenters were supportive of CMS making a technical revision to delete the description of individual services and exceptions for Medicare payment for telehealth services in Sec. 414.65.

      Response: We are finalizing the technical revision to Sec. 414.65 as proposed.

      8. 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.

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

      \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.

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

      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 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.

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

      \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.

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

      As indicated earlier, we considered whether it would be appropriate to develop a separate bundled payment for an episode of care for treatment of SUDs. We solicited public comment on whether such a bundled episode-based payment would be beneficial to improve access, quality and efficiency for SUD treatment. Further, we solicited 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 solicited 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 were interested in stakeholder feedback regarding how to define and value this bundle and what conditions of payment should be attached. Additionally, we solicited 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 solicited 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 will 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

      Page 59498

      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 welcomed comments on potentially creating a bundled episode of care for management and counseling treatment for SUDs, which we will consider for future rulemaking.

      Comment: We received several comments with detailed information on this topic. Some commenters expressed concern that the format of a bundled episode of care may fail to take into account the wide variability in patient needs for treatment of SUDs, especially given the chronic nature of SUDs, which like other chronic diseases, typically involves ongoing treatment without a definitive end point. Some commenters additionally noted that a global period would not lend itself to treatment of SUDs, because the treatment is not an acute intervention like surgery; rather, patients with SUDs may require increasing and decreasing access to care, depending on their progress in treatment.

      Response: We thank the commenters for all of the information submitted and will consider this feedback for future rulemaking. We agree with commenters and understand that there is wide variability in patient needs for treatment of SUDs, and that unlike surgical global periods, ongoing treatment is often necessary in the treatment of SUDs. While we do not necessarily believe these characteristics preclude payment bundles and/or global periods, we do understand they would need to be taken into account. We reiterate that our intention as we consider these issues for future rulemaking is to increase access to necessary care, and that any potential bundled payment would be developed in consideration of these comments.

      We note that there is a 60-day period for the public to comment on the interim final telehealth policies and revisions to our regulations we are adopting to implement statutory amendments to section 1834(m) of the Act that expand access to telehealth services used to treat substance use disorders. During that same comment period, we are requesting additional information from stakeholders and the public that we might consider for future rulemaking regarding payment structure and amounts for SUD treatment that account for ongoing treatment and wide variability in patient needs for treatment of SUDs while improving access to necessary care.

      Additionally, we invited 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 solicited 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 were interested in suggestions to improve existing requirements to more effectively address the opioid epidemic.

      Comment: We received several comments with detailed information on this topic.

      Response: We thank the commenters for all of the information submitted and will consider this for future rulemaking.

      9. Telehealth Originating Site Facility Fee Payment Amount Update

      Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002, at $20.00. For telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The originating site facility fee for telehealth services furnished in CY 2018 is $25.76. The MEI increase for 2019 is 1.5 percent and is based on the most recent historical update of the MEI through 2018Q2 (2.0 percent), and the most recent historical multifactor productivity adjustment (MFP) through calendar year 2017 (0.5 percent). Therefore, for CY 2019, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $26.15. The Medicare telehealth originating site facility fee and the MEI increase by the applicable time period is shown in Table 10.

      Table 10--The Medicare Telehealth Originating Site Facility Fee

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

      MEI Facility

      Time period increase fee

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

      10/01/2001-12/31/2002............................... N/A $20.00

      01/01/2003-12/31/2003............................... 3.0 20.60

      01/01/2004-12/31/2004............................... 2.9 21.20

      01/01/2005-12/31/2005............................... 3.1 21.86

      01/01/2006-12/31/2006............................... 2.8 22.47

      01/01/2007-12/31/2007............................... 2.1 22.94

      01/01/2008-12/31/2008............................... 1.8 23.35

      01/01/2009-12/31/2009............................... 1.6 23.72

      01/01/2010-12/31/2010............................... 1.2 24.00

      01/01/2011-12/31/2011............................... 0.4 24.10

      01/01/2012-12/31/2012............................... 0.6 24.24

      01/01/2013-12/31/2013............................... 0.8 24.43

      01/01/2014-12/31/2014............................... 0.8 24.63

      01/01/2015-12/31/2015............................... 0.8 24.83

      01/01/2016-12/31/2016............................... 1.1 25.10

      01/01/2017-12/31/2017............................... 1.2 25.40

      01/01/2018-12/31/2018............................... 1.4 25.76

      01/01/2019-12/31/2019............................... 1.5 26.15

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

  25. 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 final rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the RUC, MedPAC, and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section

    Page 59499

    1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

    In its March 2006 Report to the Congress (http://www.medpac.gov/

    docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, ``When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.'' We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

    As MedPAC noted in its March 2009 Report to Congress (http://

    www.medpac.gov/docs/default-source/reports/march-2009-report-to-

    congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

    Codes that have experienced the fastest growth.

    Codes that have experienced substantial changes in PE.

    Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.

    Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.

    Codes with low relative values, particularly those that are often billed multiple times for a single treatment.

    Codes that have not been subject to review since implementation of the fee schedule.

    Codes that account for the majority of spending under the PFS.

    Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.

    Codes for which there may be a change in the typical site of service since the code was last valued.

    Codes for which there is a significant difference in payment for the 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

    Page 59500

    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. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

    Documentation in peer reviewed medical literature or other reliable data that 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 MIPS data).

    National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

    We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.

    1. Public Nominations

      We received one submission that nominated several high-volume codes for review under the potentially misvalued code initiative. In its 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 11 be prioritized for review under the potentially misvalued code initiative.

      Table 11--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 submitter 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).

      We received several comments with regard to the nomination of several high-volume codes for review under the potentially misvalued code initiative.

      Comment: One commenter stated that specific details of the nomination of the seven high-volume codes were not provided in the CY 2019 PFS proposed rule. Several other commenters, including the RUC, expressed concern that the source of the nomination of the seven high-

      volume codes and its entire nomination letter was not made available. These commenters requested that CMS provide greater transparency and publicly provide all nomination requests identifying potentially misvalued codes.

      Response: We believe that we summarized the contents of the public nomination letter and provided the rationale in the CY 2019 PFS proposed rule with enough detail for commenters to comment substantively and provide supporting documentation or data to rebut the suggestion that these codes are potentially misvalued. We recognize the importance of transparency and note that under the public nomination process that was established in CY 2012 rulemaking, the first opportunity for the public to nominate codes was during the 60-day comment period for the CY

      Page 59501

      2012 final rule with comment period; therefore, public nominations were received via submission to www.regulations.gov. In the CY 2015 final rule with comment period (79 FR 67606 through 67608), we finalized a modified process for identifying potentially misvalued codes (fully effective in CY 2017), where we established a new deadline of February 10th for receipt of public nominations for potentially misvalued codes to be considered for inclusion in the proposed rule. Although stakeholders often include public nominations of misvalued codes for consideration in a subsequent year's rulemaking as part of their comments on a current year's proposed rule, the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation to CMS by February 10th of each year. In the future, public nominations that CMS receives by the February 10th deadline will be made available in the form of a public use file with the proposed rule, in the downloads section on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-

      Payment/PhysicianFeeSched/. We remind submitters that any information that might be considered proprietary or confidential should not be included. Additionally, we have included the submission that nominated these high-volume codes for review as potentially misvalued as a public use file for the CY 2019 PFS final rule.

      Comment: One commenter stated that because CMS did not include these publicly nominated codes in Table 13 of the proposed rule, it does not appear that CMS has agreed with the commenter on the need to revisit these codes. Another commenter stated that CMS did not provide guidance on whether these nominated codes would be considered for revaluation or retained at their current value.

      Response: We clarify that the codes for which we received public nominations as potentially misvalued were not included in Table 13 of the proposed rule because that table contains a list of codes for which we proposed work RVUs for CY 2019 (the list does not include codes for which we received nominations discussed in the proposed rule for consideration as potentially misvalued). As previously indicated, in the proposed rule we publish the list of codes nominated as potentially misvalued, which allows the public the opportunity to comment on these codes; then, in the final rule, we finalize our list of potentially misvalued codes. No new valuations were proposed for these codes in the CY 2019 PFS proposed rule. Any revaluation of these codes would be proposed in future rulemaking.

      Comment: One commenter stated that the codes in Table 8 in the proposed rule and their respective code families should be prioritized for review as potentially misvalued. The commenter suggested revisiting two recent efforts funded by CMS, reports by Urban Institute and RAND Corporation (https://www.urban.org/sites/default/files/publication/

      87771/2001123-collecting-empirical-physician-time-data-piloting-

      approach-for-validating-work-relative-value-units_1.pdf, and, https://

      www.rand.org/content/dam/rand/pubs/research_reports/RR600/RR662/

      RAND_RR662.pdf), for prioritization of codes for review to expand the misvalued codes initiative list. The commenter referenced a June 2018 MedPAC report that stated that CMS' review of potentially misvalued codes has not addressed services that account for a substantial share of fee schedule spending and is hampered by the lack of current, accurate, and objective data on clinician work time and practice expenses. Consequently, according to the MedPAC report, work RVUs for procedures, imaging, and tests are systemically overvalued relative to other services, such as ambulatory evaluation and management (E/M) services.

      Response: We appreciate the commenters' recommendations for expanding the misvalued codes list. We will consider whether to address these suggestions in future rulemaking.

      Comment: One commenter recommended that additional research be conducted on the analytic products available that could be used to create transparency into the RUC process and allow for greater external participation in misvalued cost evaluation. The commenter also stated that CMS should reconsider reliance on the RUC altogether given the inherent conflicts of interest in the RUC-based process.

      Response: We acknowledge that the RUC provides critically important information that factors into our review process. However, our review of recommended work RVUs and time inputs is also informed by review of various alternate sources of information, in addition to the RUC. Examples of these alternate sources of information include information provided by other public commenters, Medicare claims data, comparative databases, medical literature, as well as consultation with other physicians and healthcare professionals within CMS and the federal government. We also reiterate that we continue to be open to reviewing additional and supplemental sources of data furnished by stakeholders, and providing such information to CMS is not limited to the public nomination process for potentially misvalued codes. We encourage stakeholders to continue to provide such information for our consideration in establishing work RVUs.

      Comment: One commenter stated concerns with CMS' use of a non-

      relative measuring approach for the seven codes nominated for review when generally the RUC-valued and CMS-approved codes are based on the concept of relativity. The commenter stated that using such an inconsistent approach on select codes will potentially cause disruption and instability in code valuations. The commenter also stated that determining reimbursement in value-based care delivery models must rely on the carefully cultivated RUC process for fairness and accountability.

      Response: We are unclear about the commenter's claim that CMS is using a non-relative measuring approach for the seven high volume codes that have been nominated as potentially misvalued. We did not propose a valuation for the nominated codes, nor did we propose to use a non-

      relative measuring approach. Rather, as part of our statutory obligation to identify and review potentially misvalued codes, we implemented an annual process whereby the public can nominate potentially misvalued codes with supporting documentation; we then publish the list of nominated codes and the public has the opportunity to comment on these nominations. We continue to maintain that adjustments to work RVUs should be based on the resources involved with each procedure or service, and reiterate that our review of work RVUs and time inputs utilizes information from various resources, including the RUC. We continue to seek information on the best sources of objective, routinely-updated, auditable, and robust data regarding the resource costs of furnishing PFS services.

      Comment: Several commenters stated that CPT codes 27130 and 27447 should not be considered potentially misvalued and do not warrant any further action because the current valuation for the codes was established after review by the RUC and CMS in 2013, and since that time there are no new data to indicate a change in the work of performing the procedure or the number of post-operative follow up visits. Another commenter stated that CMS should not subject professions to code

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      valuations and analysis so frequently, and that doing so calls into question the validity of the RUC process in the first place.

      Response: We do not agree that recent review of a code should preclude it from being considered as potentially misvalued, nor that it calls into question the validity of the RUC process. We have a responsibility to identify and review potentially misvalued codes, and believe there is value in consistent and routine review of high-volume services, particularly considering that a minor adjustment to the work RVU of a high-volume code may have a significant dollar impact. We also note that review of high-volume services does not need to be predicated on the suspicion of overvaluation.

      Comment: One commenter stated that if CMS decides to reexamine these nominated codes in the future, then the agency should provide ample opportunity for public comments, and in the event of such review, CMS should consider supplemental sources of information, including hospital anesthesia time in addition to any RUC recommendations in order to support accurate valuations of these procedures.

      Response: Any revaluations of these codes would be undertaken through notice and comment rulemaking. Notice and comment rulemaking provides for an open process whereby we welcome input from all interested parties, and we encourage commenters to provide feedback including supplemental sources of information regarding potentially misvalued codes, as well as input on our annual proposed valuations.

      Comment: One commenter disagreed that CPT codes 43239 and 45385 are misvalued and stated that while the Urban Institute report provides insights into potential flaws in the RUC survey process, it should not be considered proof that these codes are overvalued. The commenter stated that these code valuations were recently revised, and the RUC survey responses from gastroenterologists informed revisions to the work RVUs for both services. The commenter stated that for CPT code 43239, CMS finalized work RVUs that were less than the RUC's recommended work RVUs, and for CPT code 45385, CMS finalized the RUC-

      recommended work RVUs, which were lower than the work RVUs prior to reevaluation. Therefore, the commenter stated that CMS should reject the nominations of these codes as potentially misvalued.

      Response: We note that the nomination referenced the Urban Institute report as only one of the sources regarding the issue of time inflation of specific services. Additionally, as previously indicated, we do not agree that recent review of a code should preclude it from being considered as potentially misvalued. We believe there is value in consistent and routine review of high-volume services, particularly considering that a minor adjustment to the work RVU of a high-volume code may have a significant dollar impact. Therefore, we do not agree that we should reject nominations of these codes as potentially misvalued because they were previously reviewed and refinements were made.

      Comment: A few commenters stated that the current work RVU valuation of 0.85 for CPT code 70450 is inadequate. The commenters stated that the level of effort associated with CPT code 70450 increased between the time the code was originally valued and the 2012 survey, and this increase continued through 2016. The commenters stated that over time, advances in technology led to many more images being created than existed historically. The commenters also stated that volume acquisitions, a CT scan technique that allows for multiple two-

      dimensional images, has resulted in thinner reconstructions and effortless multiplanar reformats, and other technological advancements have increased the amount of professional work associated with interpreting a non-contrast head CT and should be considered in the work RVU. The commenters expressed concern that the nomination by a single entity threatens the integrity of how physician services are valued generally.

      Response: We disagree with the commenter that a nomination by a single entity threatens the integrity of how physician services are valued generally, and reiterate that a public nomination process was established through rulemaking as a way for the public and stakeholders to nominate potentially misvalued codes for consideration. Any future proposed valuations of specific codes are open for public comment, and we encourage stakeholders to submit data that would indicate that the current valuation is insufficient.

      Comment: One commenter stated that with regard to CPT code 70450, the times prior to survey were CMS/other times and were not subdivided into pre-service, intra-service, and post-service categories. Therefore, the commenter stated that drawing comparisons between prior RUC database times and the surveyed times is invalid because the source of the prior RUC database times are unknown and completely different from the surveyed times. The commenter also stated that selecting as potentially misvalued only certain CPT codes that have undergone the RUC process with validated surveys is not a rational approach because if the times assumed based on the RUC approved survey data are invalid for these codes, they should be invalid for the entire fee schedule so that consistent methodology is applied to all CPT codes.

      Response: We typically rely on RUC survey values because we believe they are the closest to accurate values, as they are the best data available in some cases. Although we do not agree that we should not consider comparisons of RUC database times to the newly surveyed times as described by the commenter, on a case-by-case basis we can consider the existence of previous inaccuracies. However, we also note that previous valuations established based on those inaccuracies would also indicate that the payments would have been inaccurate as well. The goal of the identification and review of potentially misvalued services is to facilitate accurate payment for PFS services. We also disagree with the commenter's characterization that selecting codes that have undergone the RUC process with validated surveys is not rational, and note that just because a code has been reviewed by the RUC does not preclude it from being identified and/or publically nominated as potentially misvalued.

      Comment: With regard to CPT codes 93000 and 93306, one commenter stated that while the Urban Institute report concludes that the intraservice time to interpret an electrocardiogram is 6 seconds, practitioners who furnish the service do not believe it is possible to completely interpret a study so quickly. The commenter expressed concern about the large emphasis placed on service time by CMS and some stakeholders when it comes to valuation. The commenter suggested that frequent reviews of long-established mature services like electrocardiography and echocardiography will produce two outcomes--the inputs will remain the same or circumstances at some point will align such that it appears they take less time, which will open the window for payers to try to reduce payment for services that have not actually changed, and eventually these reductive re-valuations produce underpayment. A few commenters stated that CPT code 93306 was recently reviewed and valued in CY 2018. One commenter stated that the current valuation is reflective of numerous accreditation body requirements that were implemented since the service was last valued in 2007, which increased the

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      work required per study. The commenter stated that the Urban Institute report should not be considered proof that the CPT code is overvalued, and given the recent RUC review of this service, CMS' acceptance of the RUC recommendation, and no change in the physician work of performing the service in the past year, this code should not be included in the potentially misvalued codes list.

      Response: We reiterate that it is our practice to consider all elements of the relative work when we are reviewing and determining work RVU valuations. Additionally, our review of recommended work RVUs and time inputs generally includes review of various sources such as information provided by the RUC, and other public commenters, medical literature, and comparative databases. As previously stated, we believe there is great value in consistent and routine review of high-volume services. Additionally, as previously indicated, we do not agree that recent review of a code should preclude it from being considered as potentially misvalued, and therefore, do not agree that CMS should not include a code in the list of potentially misvalued services because it was previously reviewed.

      Comment: One commenter disagreed that the time allocated to CPT code 93306 is overstated. The commenter stated that the Intersocietal Accreditation Commission for Echocardiography Guidelines regarding time standards indicated that more time is necessary from patient encounter to departure than is stipulated in the CMS time file. The commenter also stated there is more and more information being gathered with the introduction of technology that is labor and time intensive. The commenter suggested that if anything is revised, CMS times should be increased, not decreased.

      Response: We reiterate that we are interested in receiving resource-based data from stakeholders and not just the RUC and we encourage stakeholders to submit data that would indicate that the current valuations are insufficient.

      Although we appreciate the comments that were received regarding the seven high-volume codes, we believe that the nominator presented some concerns that have merit, such as the observation that in many cases time is reduced substantially but the work RVU only minimally, which results in an implied increase in the intensity of work that does not appear to be valid, and ultimately creates work intensity anomalies that are difficult to defend, and further review of these high-volume codes is the best way to determine the validity of the concerns articulated by the submitter. Therefore, we are adding CPT codes 27130, 27447, 43239, 45385, 70450, 93000, and 93306 to the list of potentially misvalued codes and anticipate reviewing recommendations from the RUC and other stakeholders. We reiterate that we do not believe that the inclusion of a code on a potentially misvalued code list necessarily means that a particular code is misvalued. Instead, the list is intended to prioritize codes to be reviewed under the misvalued code initiative.

      In addition to comments on the nomination of the seven high-volume codes, we also received comments on the nomination of two contractor-

      priced codes for review under the potentially misvalued code initiative.

      Comment: We received a few comments with regard to CPT codes 92992 and 92993, which were requested for review under the potentially misvalued code initiative in order to establish national RVU values for these services under the PFS. One of the commenters, the RUC, stated that these contractor-priced services, which are typically performed on children, would be discussed at the October 2018 Relativity Assessment Workgroup meeting.

      Response: We appreciate the information from the RUC on their plans to discuss these codes. Given the plans by the RUC to consider CPT codes 92992 and 92993 we will wait for the RUC's review and will not add these codes to the list of potentially misvalued codes.

    2. Update on the Global Surgery Data Collection

      Payment for postoperative care is currently bundled 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, we 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 groups 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.

      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. 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 visits reported using CPT code 99024.

      In the CY 2019 PFS proposed rule, we suggested one potential explanation for

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

      We sought comment on several other issues. Given the very small number of postoperative visits reported using CPT code 99024 during 10-

      day global periods, we sought 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. Alternatively, we sought comment 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 sought comment on whether we should consider requiring use of modifiers -54 and -55 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 also sought 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 and whether we should consider changing the global period and reviewing the code valuation.

      The following is a summary of the comments we received on collecting data on global surgery and reporting.

      Comment: The majority of commenters, including the RUC, noted that more time was needed for physicians to become aware of reporting and prepare for reporting. Moreover, they opposed implementing an enforcement mechanism, but supported more efforts by CMS to make physicians aware of the requirement. A few commenters objected to reporting and noted that CMS had complied with the statute. MedPAC, which supported converting all 10- and 90-day global codes to 0-day global codes and revaluing these codes as 0-day codes, suggested that these findings are consistent with the OIG's three studies that showed post-operative visits were not occurring at the rate that we estimated. MedPAC noted support for converting all codes with 10- and 90-day global periods to 0-day global codes and revaluing these codes as 0-day codes, most other commenters were opposed to creating 0-day global services out of 10-day global services. Of those who commented on reporting of post-operative visits, most suggested that improving reporting of these visits is essential if the data is to be used to improve the accuracy of the existing codes.

      Response: We will evaluate the public comments received and consider whether to propose action at a future date. For the comment calling for additional efforts to make physicians aware of the requirement, we sent a letter describing the requirement to practitioners who are required to report in the 9 affected states and we plan to send another such letter to these practitioners. We will also consider other actions to make sure affected practitioners are aware of the requirement.

  26. 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 PFS must be furnished under at least a general level of physician supervision as defined in paragraph (b)(3)(i) of that regulation. In addition, some of these tests require either direct or personal supervision as defined in paragraphs (b)(3)(ii) or (iii) of Sec. 410.32, 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 (RA) under the supervision of a physician. Specifically, the commenters stated that all diagnostic tests, when performed by 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 proposed 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 proposed 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 noted 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 that included specific recommendations on how to implement the change. Representatives of the practitioner community submitted information on the education and clinical experience of RAs, which we took into consideration in determining whether the 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 indicated that 28 states have statutes or regulations that recognize RAs, and these states have general or direct supervision requirements for RAs.

    Comment: Many commenters supported our proposed changes to the regulations and stated that they agreed that diagnostic tests performed by RAs be performed under at most direct supervision rather than personal

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    supervision where permitted by state law and state scope of practice regulations. According to these commenters, the change would allow for greater efficiency, improved patient access, more dedicated time with patients, increased quality of care, and increased patient satisfaction.

    Response: We appreciate the comments received in support of this proposal. As discussed in the proposed rule, for diagnostic imaging tests requiring a general level of physician supervision, we are not changing the level of physician supervision to direct supervision. Otherwise, the diagnostic imaging tests must be performed as specified elsewhere under Sec. 410.32(b). In order to provide further clarity, we are modifying the regulation to clarify that diagnostic tests performed by an RRA who is certified and registered by the American Registry of Radiologic Technologists or an RPA who is certified by the Certification Board for Radiology Practitioner Assistants, and that would otherwise require a personal level of supervision as specified in Sec. 410.32(b)(3), may be furnished under a direct level of physician supervision to the extent permitted by state law and state scope of practice regulations.

    Comment: Many commenters requested that CMS ensure that the proposed policy be effective January 1, 2019 by providing any necessary administrative guidance. Many commenters requested that CMS clarify in its final regulation that all services within the RA scope of practice, including procedures, may be performed under direct supervision.

    Response: In implementing these changes to the regulation, we will be updating guidance contained in Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available on the CMS website at https://

    www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-

    Manuals-IOMs-Items/Pub100_23.html). Medicare supervision rules are only directly applicable to diagnostic tests, not procedures. We note that for procedures provided by auxiliary personnel (such as a radiologist assistant) incident to the services of the billing physician or practitioner, Medicare generally requires direct supervision in accordance with the regulation at Sec. 410.26(b)(5).

    Comment: One commenter suggested that CMS require verbal assurances to patients as to the credentials of the health care professional conducting the procedure, when the procedure is performed by an RA. The commenter stated that requiring this verbal assurance will minimize confusion about who the physician is when there are multiple individuals furnishing the procedure.

    Response: We believe such a requirement would be unwarranted and overly restrictive. We do not generally require practitioners to provide such assurances to Medicare beneficiaries, nor did we propose such a requirement in the proposed rule.

    Comment: Several commenters suggested that CMS should operationalize the proposal starting January 1, 2019 by using a radiologist supervision indicator to recognize the RA under direct supervision rather than personal supervision when they provide Medicare services under their state scope of practice. These commenters requested the creation of a new supervision indicator that would be applied to specific codes and would indicate that the procedure may be performed under the direct supervision of a radiologist when performed by an RRA who is certified by The American Registry of Radiologic Technologists, and an RPA who is certified by the Certification Board for Radiology Practitioner Assistants.

    Response: Our approach to effectuating this policy change was based on recommendations we received from the practitioner community. Under this approach, we allow for direct supervision for tests performed in part by an RA, which avoids the need to identify which CPT codes would be appropriate for inclusion under a new indicator. We believe our approach offers the most flexibility, ease of implementation, and subsequently reduces burden for billing practitioners and radiologist assistants.

    After consideration of the public comments received, we are finalizing, with refinements for further clarity, our proposed revisions to Sec. 410.32, by adding a new paragraph (b)(4) that states that diagnostic tests that are performed by a registered radiologist assistant (RRA) who is certified and registered by the American Registry of Radiologic Technologists or a radiology practitioner assistant (RPA) who is certified by the Certification Board for Radiology Practitioner Assistants, and that would otherwise require a personal level of supervision as specified in paragraph (3), may be furnished under a direct level of physician supervision to the extent permitted by state law and state scope of practice regulations.

  27. 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 (OPD) 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, enacted November 2, 2015).

    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. We also summarize proposals for CY 2019, respond to public comments, and finalize 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 final 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,

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    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 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 TC, 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 Ambulatory Payment Classifications (C-

    APCs), conditionally and unconditionally packaged items and services, and major procedures. As we noted in the CY 2017 PFS 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 in this section.

    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 10 CPT codes describing different levels of office visits for new and established payments. We compared the payment rate under OPPS for HCPCS code 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 PFS 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

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    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 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. 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 TC 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 believed that this overall approach is still appropriate, and we are finalizing our proposal 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 to 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/OPPS status indicator (SI) code 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. Approximately half 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 over 30 percent of total Medicare payments for separately payable or conditionally packaged services. The top 30 HCPCS/SI code combinations accounted for over 80 percent of all claim lines and approximately 70 percent of Medicare payments for services that are separately billable or conditionally packaged. In contrast with prior analyses, we also looked at claims units, which reflect HCPCS/SI code combinations that are billed more than once on a claim line. Certain HCPCS codes are much more frequently billed in multiple units than others. 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 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 (PEs) not associated with the professional component (PC) of the service. As discussed in prior rulemaking (81 FR 79720 through 79729), we believe the most appropriate code-level comparison would reflect the 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 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 (status indicator = ``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

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    rates under the PFS across all nonexcepted items and services, weighted by the number of HCPCS code claims units 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 code claims units. 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 proposed to continue applying a PFS Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to maintain this PFS Relativity Adjuster for future years until updated data or other considerations indicate that an alternative adjuster or a change to our approach is warranted, which we will 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 in this section.

    Comment: Several commenters were disappointed that CMS did not provide the same level of detail regarding the data and methodology used in calculating the PFS Relativity Adjuster for CY 2019 as we had in prior rulemaking (CY 2017 and CY 2018). In particular, these commenters noted that we had previously included specific HCPCS codes that comprised the top 25 reported, the number of claims lines for each HCPCS code, and the associated PFS payment rates we used to estimate the appropriate adjuster. Some commenters maintained that the lack of specific HCPCS codes and associated PFS payment rates prevented them from replicating our analysis and commenting on the merits of maintaining the 40 percent PFS Relativity Adjuster.

    Response: We understand and appreciate commenters' interest in replicating our analysis using the full set of claims data and PFS payment rates we used to conduct our analysis. However, we do not agree that commenters were not able to conduct their own analysis for purposes of evaluating our proposal. The principal data sources in the analysis are the OPPS CY 2017 rates, the CY 2017 PFS rates, and institutional claims data for items and services furnished in CY 2017 that included the ``PN'' modifier, which are publicly available resources. We did not receive specific inquiries indicating that commenters tried to reproduce our results using these data sources (or other data sources), nor did we receive any specific alternatives for consideration. As we noted in the proposed rule, the methodological aspects of our proposed PFS Relativity Adjuster calculation for CY 2019 differ from the calculation for CY 2017 and CY 2018 by the following two adjustments: (1) Development of site specific technical-equivalent rates under the PFS for all HCPCS codes reported on a claim with the ``PN'' modifier in CY 2017; and (2) the addition of OPPS SI ``N'' claims data to the PFS component of the PFS Relativity Adjuster equation to reflect items and services that are packaged under OPPS but paid separately under the PFS. We imputed certain PFS rates, such as for codes that are contractor priced under the PFS, because those would be paid at the contractor price if the claim had been submitted in a freestanding office. We remind commenters that adding PFS rates to the analysis, where such rates would not have otherwise been included, has the effect of increasing the PFS Relativity Adjuster since the aggregate PFS payment amount increases relative to the aggregate OPPS payment amount. Nonetheless, we appreciate the commenters' interest in validating the results of our analysis. For the convenience of commenters wishing to conduct analysis of differences in payment rates between off-campus PBDs and freestanding offices for similar services, we are providing a public use file (PUF), available on the CMS website under the ``downloads'' section for this final rule containing the CY 2017 PFS technical-equivalent payment rates for all HCPCS codes reported on an institutional claim with the ``PN'' modifier, as well as the OPPS payment rate and the number of claims units by OPPS SI (see https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/

    PhysicianFeeSched).

    Comment: Commenters posed specific questions about our PFS Relativity Adjuster calculations and requested that CMS provide additional detail about the calendar year we used for OPPS and PFS rates, the specific HCPCS codes for which we imputed PFS rates, our rationale for weighting the data using claims units instead of claims lines, and if our analysis accounted for the more extensive packaging that occurs under the OPPS compared with the PFS.

    Response: Although we addressed much, if not all, of the information requested by these commenters in the discussion of our methodology in the proposed rule, we provide the following summary, along with additional detail on specific aspects of our analysis to respond explicitly to commenters' questions. We began our analysis to identify the proposed CY 2019 PFS Relativity Adjuster by examining a full year of claims data for services furnished in CY 2017 that were reported on an institutional claim form and appended with the ``PN'' modifier. Because claims processed through the institutional setting are adjudicated based on the OPPS SI, our unit of analysis was the number of claims units at the HCPCS/SI code level. We used claim units instead of claim lines because this metric accounts for instances when a HCPCS code is reported multiple times on the same claim line. We made this methodological change in formulating our proposal for CY 2019 in large part to address commenters' concerns from prior years that our calculations may underrepresent PFS payment for HCPCS codes that would have been paid multiple times under the PFS if they were reported separately. For the majority of HCPCS/SI code combinations that were reported with the ``PN'' modifier, there is little difference between the number of claim lines and claim units. However, because more units are separately paid under the PFS than under the OPPS, using claims units rather than claims lines yielded a slightly higher PFS Relativity Adjuster.

    For CY 2019, our proposed PFS Relativity Adjuster was based on all HCPCS codes that were submitted on an institutional claim form in CY 2017, appended with the ``PN'' modifier in order to improve the accuracy of the overall payment comparison using the best data available regarding the actual mix of services furnished in nonexcepted off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a subset of claims from CY 2016 because of known limitations regarding the data available at the time. In particular, the data from CY 2016 were based on claims that were appended with the ``PO'' modifier, which was a new reporting requirement for CY 2016. Although the ``PO'' modifier allowed us to distinguish items and services furnished in off-

    campus PBDs in CY 2016, it did not allow us to distinguish between excepted and nonexcepted off-campus PBDs. The ``PN'' modifier, which was a new reporting requirement for CY 2017, allows us to make the distinction between excepted and nonexcepted off-campus PBDs.

    In updating our analysis for calculating the proposed PFS Relativity Adjuster for CY 2019 to include all HCPCS codes that were reported on an institutional claim with the ``PN'' modifier, we also extended to all HCPCS

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    codes our earlier logic with regard to calculating the site specific rates that represent the technical-equivalent of the resource costs of furnishing a service under the PFS. This amount, as we discussed in the proposed rule, generally reflected: (1) The difference between the PFS nonfacility payment rate and the PFS facility rate; (2) the TC; or (3) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. Applying the same logic to the fuller range of HCPCS codes, we developed site specific rates for all HCPCS codes that are nationally priced under the PFS and we referred to them as the technical-equivalent rates.

    To continue with our analysis, we combined the CY 2017 OPPS rates at the HCPCS code level with the CY 2017 claims data representing nonexcepted items and services furnished in nonexcepted off-campus PBDs. Next, we added the technical-equivalent PFS rates for each HCPCS code, calculated using the approach described above. For both the OPPS and the PFS portions of the PFS Relativity Adjuster calculations, we weighted our analysis of HCPCS/SI code combinations by the number of claims units. For the OPPS component of the calculation, we restricted our analysis to HCPCS/SI code combinations that had OPPS SI indicators ``J1'', ``J2'', ``Q1'', ``Q2'', ``Q3'', ``S'', ``T'', or ``V'', which are separately payable or conditionally packaged codes under the OPPS. We multiplied the number of claims units for each HCPCS/SI code combination by the OPPS rate for each HCPCS/SI code combination and summed across the weighted rates. To calculate the PFS component of the PFS Relativity Adjuster, we used the same OPPS/SI code combinations, but we also included claims for HCPCS codes with OPPS SI ``N'', which indicates that, under the OPPS, payment for these services is packaged into payment for other services. We multiplied the number of claims units for each HCPCS/SI code combination by the technical-equivalent PFS rate for each HCPCS code and summed across the HCPCS/SI code combinations. We believe that adding weighted rates for HCPCS codes with OPPS SI ``N'' to the PFS allows us to better adjust, although imprecisely, for the packaging under the OPPS of nonexcepted items and services for which separate payment would typically be made under the PFS in the office setting. Although we did not conduct code-level analysis to estimate packaging under the OPPS, we believe that the combination of using the full range of claims data for nonexcepted items and services furnished in nonexcepted off-campus PBDs, using claim units rather than claim lines to weight rates on both the OPPS and PFS, and adding PFS rates for HCPCS codes with OPPS status indicator ``N'' is an improved approach to the PFS Relativity Adjuster that better accounts for OPPS packaging policies.

    To increase the precision of our analysis, we imputed payment rates under the PFS for certain HCPCS codes for which payment is based on rates other than national PFS pricing. For services that are contractor-priced under the PFS, as indicated by a PFS status indicator of ``C'', we applied the national median allowed charge for these services in CY 2017. For a limited number of other services, where appropriate, we incorporated rates from the applicable fee schedule under which the service may have been paid if furnished in a freestanding office. For instance, HCPCS codes with a PFS status indicator of either ``X'' (service is statutorily excluded for payment under PFS) or ``E'' (service is excluded from payment under PFS by regulation), may be paid under the CLFS or the National Limitation Amount (NLA). The imputed values that we used, both from contractor priced codes and other fee schedules, are included in the data file that will be posted with this final rule, available at https://

    www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/

    PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

    Although there remains a certain level of imprecision inherent in our analysis, we believe the margin of error is relatively small and would likely affect the PFS and OPPS amounts similarly. For instance, we did not take into account the several MPPRs that would reduce payment on the PFS side when multiple codes are billed together. In many cases, these codes are packaged under the OPPS, so not including the PFS MPPRs in our analysis has the effect of increasing the PFS component of the calculation by a marginal amount. Likewise, we recognize that because of existing packaging rules under the OPPS, there is likely to be underreporting of codes on institutional claims for which the hospital does not receive separate payment, but for which the practitioner might receive separate payment if furnished in a freestanding office and reported on a professional claim form. This would effectively reduce the PFS Relativity Adjuster, but only to the extent hospitals are not appropriately reporting furnished items and services.

    Comment: Many commenters expressed that the appropriate point of comparison for PFS technical-equivalent rates is the full nonfacility rate rather than the difference between the nonfacility rate and the facility rate. The commenters stated that since hospitals, like freestanding offices, incur both direct and indirect costs when services are furnished in nonexcepted off-campus PBDs, the difference between the nonfacility rate and the facility rate does not appropriately account for indirect costs incurred by the facility.

    Response: We believe the commenters misunderstood the methodology for allocating direct and indirect costs as part of the PFS ratesetting process. Under the PFS algorithm for allocating indirect costs, nonfacility PFS rates include indirect PE that is directly related to the resources associated with the professional portion of the service alone. In other words, this is the indirect PE that is also paid by Medicare to professionals like physicians when they report services in the hospital setting. In addition to these indirect PE RVUs, nonfacility PFS rates include indirect PE RVUs allocated based on the direct PE inputs. We believe these indirect costs, those associated with provision of the technical aspects of the service alone, are analogous to those incurred by facilities when professionals furnish services there. To be clear, even when the total nonfacility rates are reduced by the facility rates, there are remaining PE RVUs that result from both direct inputs and indirect allocations under the established PFS methodology. We agree with the commenters that nonexcepted off-

    campus PBDs incur indirect costs, but we believe our calculation for the technical-equivalent PFS rates includes the relative resource costs of indirect expenses involved in furnishing the services. We also note that CMS makes corresponding payments under the PFS at the facility rate for nonexcepted items and services furnished in nonexcepted off-

    campus PBD settings, meaning that CMS is already paying for some of the indirect expenses associated with the PCs of the service. If CMS were to use the full nonfacility PE RVUs as the basis for comparing PFS rates to OPPS rates, we would effectively be paying twice for a portion of indirect costs, once under the PFS for the PC of services and again through the PFS Relativity Adjusted payment under the OPPS to off-

    campus PBDs for the facility part of the same service.

    We recognize that the process of allocating indirect costs under the PFS is built on assumptions about

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    organizational practices and healthcare payment structures that may not fully reflect the current health care delivery environment, especially where physicians and other professionals are paid under salaried arrangements by institutions such as hospitals. Under the current PFS payment methodology, we assume that indirect costs associated with professional services furnished in institutions like hospital PBDs are incurred by the individual practitioners and not by the institutions. We may consider this issue for future rulemaking.

    Comment: A commenter requested that CMS clarify how, in calculating the PFS Relativity Adjuster, CMS treated codes that are valued under the PFS only in a facility setting. Because these HCPCS codes do not have PE inputs reflecting the specific costs of furnishing a service in a freestanding office, the commenter stated concern that these codes may have been incorrectly incorporated in the analysis at a PFS payment rate of zero.

    Response: We appreciate the commenter's concern and the opportunity to clarify the way we treated services not priced in the nonfacility setting in calculating the PFS Relativity Adjuster. Because there are no PFS payment rates for these services in the nonfacility setting, we incorporated the OPPS rate as the technical equivalent rate under the PFS.

    Comment: Several commenters were opposed to our proposal to maintain the PFS Relativity Adjuster at 40 percent, citing both the lack of transparency in our methodology and prior analyses provided by the American Hospital Association (AHA) in earlier notice and comment rulemaking, suggesting that a 65 percent PFS Relativity Adjuster would appropriately incorporate into the Adjuster the additional packaging that occurs under the OPPS. Two commenters urged CMS to implement a 75 percent PFS Relativity Adjuster for CY 2019, although no specific rationale was given.

    Response: We accounted for packaging under the OPPS by including PFS payment rates for HCPCS codes that were reported with OPPS SI ``N''. Our analysis does not support a PFS Relativity Adjuster of 65 or 75 percent, but rather indicates that a PFS Relativity Adjuster of 40 percent appropriately accounts for packaging of services under the OPPS. For additional discussion of the challenges related to incorporating the effect of packaging into the PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule (82 FR 53024 through 53022).

    Comment: A commenter stated that CMS has not provided sufficient justification for continuation of a reduction in payment of 60 percent for nonexcepted items and services furnished in nonexcepted off campus PBDs. Commenters noted that the first 2017 claims from the initial period of implementation of this policy are only now being incorporated into CMS claims files. The commenter indicated that there is an insufficient volume of claims to determine the impact this policy is having on beneficiary access to services in the PBD setting, particularly at the 40 percent Relativity Adjuster. The commenter stated that CMS should, at minimum, restore the 50 percent PFS Relativity Adjuster that was in place for CY 2017.

    Response: We appreciate the commenter's suggestions, but we do not agree that there is insufficient data to support the PFS Relativity Adjuster of 40 percent. We have no reason to believe that the CY 2017 claims data are not as robust as any other claims based analysis and, to the extent that we recognize, acknowledge, and try to account for difference in payment policies between the PFS and OPPS, we believe our analysis demonstrates that a PFS Relativity Adjuster of 40 percent is appropriate.

    Comment: Several commenters supported the 40 percent PFS Relativity Adjuster for CY 2019 and future years because this will provide stability for clinicians practicing in these settings and not disrupt patient access to care. One commenter cited the importance of making gradual changes to site neutrality policies to ensure alignment with other rapid changes in Medicare and the private sector regarding provider payment, including the movement to value-based purchasing and alternative payment systems.

    Response: We agree with the commenter that there is value in the stability of maintaining the PFS Relativity Adjuster at 40 percent, particularly to the extent that this enables continuity of care for beneficiaries. We appreciate the support from commenters.

    Comment: Some commenters, rather than opposing any particular PFS Relativity Adjuster, expressed disappointment that CMS did not propose to make broader changes to implement site-neutrality under section 603 of the Bipartisan Budget Act of 2015. Commenters were displeased that CMS is continuing to implement the requirements of the legislation using a single scaling factor applied to payment rates under the OPPS. Instead, they stated CMS should revise the applicable payment rates to appropriately reimburse for services provided by off-campus PBDs. Commenters did not provide specific suggestions for implementing alternative policies, but several commenters noted that a single overall scaling factor was intended by CMS to be an interim, not a long term policy solution. A few commenters suggested that the PFS Relativity Adjuster as a mechanism for implementing section 603 of the Bipartisan Budget Act of 2015 is not consistent with the requirement under that section to pay for nonexcepted items and services under the applicable payment system because this approach is still fundamentally based on OPPS payment rates. Other commenters stated that nonexcepted off-campus PBDs differ from one another in the mix of services furnished and the beneficiary population and that CMS payment policies should reflect those variances.

    Despite concerns about the appropriateness of the PFS Relativity Adjuster for implementing requirements under section 603 of the Bipartisan Budget Act of 2015, several of the same commenters pointed out that there are significant advantages of continuing to allow hospitals to bill for items and services furnished in nonexcepted PBDs using the institutional claim form. In particular, they stated, this allows PBDs to properly use cost reporting procedures and to accurately reconcile the cost report to hospital ledgers for all services and departments and to correctly allow revenue for nonexcepted PBDs to flow through the Provider Statistical and Reimbursement (PS&R) report.

    Response: We previously expressed interest in exploring how hospitals might report and receive payment for nonexcepted items and services furnished in nonexcepted off-campus PBDs using the standard PFS payment rates based on HCPCS-specific RVUs. However, CMS does not currently develop as part of the PFS ratesetting process separate payment rates for the technical aspects of the full range of nonexcepted items and services furnished in nonexcepted off-campus PBDs specifically for services for which there are not separately valued PCs and TCs. As such, we do not have a consistent way for nonexcepted off-

    campus PBDs and the professionals who furnish services in those settings to bill for the respective portions of the services for which they incurred costs. Additionally, while the statute was amended to change the nature and payment of nonexcepted items and services furnished in nonexcepted off-campus PBDs, the amendments did not

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    alter the status of non-excepted off-campus PBDs as parts of hospitals. Nonexcepted off-campus PBDs are still required to follow all reporting and regulatory policies consistent with hospital settings.

    We continue to explore options that would allow hospitals to report nonexcepted items and services on an institutional claim form but receive payments that more directly reflect the technical aspect of services under the PFS. In general, we believe there may be additional utility, especially in the context of improving price transparency for Medicare beneficiaries, in establishing and displaying a set of payment rates, recalculated annually as part of the annual PFS rulemaking cycle, that reflect the relative resource costs of the technical aspects of furnishing PFS services.

    Along with this final rule, we are including the technical-

    equivalent rates that we developed specifically for calculating the PFS Relativity Adjuster for CY 2019, which is the current mechanism for implementing the PFS as the applicable payment system for nonexcepted items and services furnished in nonexcepted off-campus PBDs. This information is being made available under the downloads section for this final rule on the CMS website at https://www.cms.gov/Medicare/

    Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-

    Regulation-Notices.html.

    Comment: Several commenters supported our ongoing efforts to implement site neutral payments in the context of section 603 of the Bipartisan Budget Act of 2015. Several commenters indicated their support for additional policies that would equalize payment across freestanding offices and hospital PBDs, both on-campus and off-campus.

    Response: We recognize that this is a topic of great interest to many commenters and we welcome the range of perspectives and ideas posed by commenters.

    Comment: Some commenters disagreed with our view that the amendments under section 603 of the Bipartisan Budget Act of 2015 were intended to produce site neutral payments between freestanding offices and off-campus PBDs with the goal of removing incentives for hospitals to purchase physician offices. These commenters noted that hospital PBDs face higher costs than freestanding offices, such as those associated with regulatory requirements, and reducing payment to nonexcepted off-campus PBDs threatens the viability of hospitals that serve a vital role in providing services to rural and underserved communities in these off-campus settings. We received several comment letters from Medicare beneficiaries expressing concern about reduced payments to their community's major medical hospital offsite locations. The commenters stated that without the hospital's offsite locations community members would be forced to drive unreasonable distances to seek basic and immediate care.

    Response: We understand the commenters' concerns, especially with regard to maintaining access to appropriate care. CMS continues to evaluate data regarding beneficiary access to care to identify possible issues. We also agree that hospitals face additional regulatory and operational costs not generally incurred by physician offices, and that OPDs of a hospital function as an important and integral part of the Medicare care delivery infrastructure. However, many off-campus PBDs are similar to physician's offices and do not necessarily have the same operational costs as the main hospital. We believe that the amendments made to the statute by section 603 of the Bipartisan Budget Act of 2015 were intended to reduce Medicare payment incentives for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill under the OPPS for items and services furnished there.

    Comment: Several commenters opposed our inclusion of the proposal related to payment for nonexcepted off-campus PBDs under the CY 2019 PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that proposals related to the payment rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs are inseparable from proposals and comment solicitations in the OPPS/ASC rule related to service line expansions and other payment policies related to implementation of the amendments under section 603 of the Bipartisan Budget Act of 2015. Some commenters suggested that, for purposes of administrative simplification, the discussion of any changes to site-

    of-service payments regarding PBDs of a hospital should be fully maintained within a single rule and recommended this be included in the OPPS rule. Some commenters expressed concern that the PFS and OPPS proposed rules were not released at the same time and that this presents challenges for them in reconciling and preparing their comments on each rule.

    Response: We appreciate commenters' concerns about responding to two separate rules for policies associated with payment for nonexcepted items and services furnished in nonexcepted off-campus PBDs. However, we note that in finalizing the PFS as the applicable payment system for most nonexcepted items and services, proposals related to the implementation of payment rates under the PFS fall reasonably under the purview of PFS rulemaking, while proposals related to the applicability of those rates are more appropriately addressed in OPPS/ASC rulemaking. We will consider these concerns for future rulemaking.

    We believe that our proposal to maintain the PFS Relativity Adjuster at 40 percent for CY 2019 and for future years reflects an analysis that accounts for many of the concerns expressed by commenters regarding the PFS Relativity Adjuster in prior rules. Therefore, we are finalizing the proposal to maintain the PFS Relativity Adjuster at 40 percent for CY 2019 and beyond until there is an appropriate reason and process for implementing an alternative to our current policy, at which time we will make a proposal through notice and comment rulemaking.

    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 are maintaining these policies for CY 2019, as finalized in the 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

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    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.

    In response to that rule, 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 noted 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. The 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.

    We agreed with the commenters' concerns and adopted payment for partial hospitalization items and services furnished by nonexcepted off-campus PBDs under the PFS in the CY 2017 OPPS/ASC final rule with comment period and interim final rule with comment period (81 FR 79715, 79717, and 79727). When billed in accordance with the CY 2017 PFS 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), and the CY 2017 OPPS/ASC final rule with comment period/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 TC 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 (82 FR 53025 to 53026), 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.

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

    We received no comments on our PHP proposals for CY 2019 and future years, and are finalizing our policies as proposed.

    7. Future Years

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

    In developing our proposal for CY 2019 as described previously, we incorporated all HCPCS codes that appeared in CY 2017 claims data from nonexcepted off-campus PBDs. We also expanded the number of site specific, technical-equivalent 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 PBDs, 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 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-

    equivalent rates under the PFS compared with APC rates

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    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, 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 TC of items and services furnished in nonexcepted off-campus PBDs. Although we believe that our site-specific HCPCS code-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 PC 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 a PFS Relativity Adjuster for CY 2019 of 40 percent advances efforts 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.

  28. 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 final rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.

    In the CY 2015 PFS final rule with comment period, 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 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

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    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. Although 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 a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

    Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we 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

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    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 make 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.

    Following the publication of the CY 2019 PFS proposed rule, we received several comments noting that there was some confusion in the terminology between ``reference services'' and ``crosswalks.'' Commenters stated that ``reference services'' are services indicated by the specialty society or the RUC as a good comparator that demonstrates relativity using magnitude estimation as requiring similar physician work, time, intensity and complexity. ``Key reference services'' are the top two services selected by the survey respondents as most similar to the code being surveyed. By contrast, ``crosswalks'' are services that have similar or exact intraservice time and require the same physician work (that is, have the same work RVU), and the term ``crosswalk'' should only be used when making a comparison to a CPT code with the identical work RVU. The commenters noted that these terms were used interchangeably in the proposed rule when they have distinct and separate meanings.

    In response to the commenters, we would like to clarify that the terms ``reference services'', ``key reference services'', and ``crosswalks'' as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate stakeholder feedback, we will seek to limit the use of the term, ``crosswalk,'' to those cases where we are making a comparison to a CPT code with the identical work RVU.

    We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the final valuation considered for specific codes. Table 13 contains a list of codes for which we are finalizing work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2018. The finalized work RVUs, work time and other payment information for all CY 2019 payable codes are available on the CMS website under downloads for the CY 2019 PFS final rule at https://www.cms.gov/Medicare/Medicare-

    Fee-for-Service-Payment/PhysicianFeeSched/index.html). Table 13 also contains the CPT code descriptors for all new, revised, and potentially misvalued codes discussed in this section.

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    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 final 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 finalized 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 final 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 final 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 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 final rule, Determination of Practice

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      Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.

      (4) Recommended Items That Are Not Direct PE Inputs

      In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.

      (5) New Supply and Equipment Items

      The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. 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 14 and 15 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this final rule, we encouraged stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encouraged stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.

      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 14 and 15 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.

      In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.

      (6) Service Period Clinical Labor Time in the Facility Setting

      Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address proposed code-specific refinements to clinical labor in the individual code sections.

      (7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap

      We note that the public use files for the PFS proposed and final rules for each year display the services subject to the MPPR 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 final 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. Valuation of Specific Codes for CY 2019

      (1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 10007, 10008, 10009, 10010, 10011, 10012, 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 proposed the RUC-recommended work RVU for seven of the ten codes in this family. Specifically, we proposed a work RVU of 0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging guidance; each additional lesion), a work RVU of 1.00 for CPT code 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine needle aspiration biopsy, including fluoroscopic guidance; first lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration biopsy, including fluoroscopic guidance; each additional lesion), and a work RVU of

      Page 59518

      1.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT guidance; each additional lesion). We also proposed to assign the recommended contractor-priced status to CPT codes 10011 (Fine needle aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine needle aspiration biopsy, including MR guidance; each additional lesion) due to low utilization until these services are more widely utilized. In addition, we proposed 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 proposed 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 disagreed with the RUC-recommended work RVU of 1.20 for CPT code 10021 (Fine needle aspiration biopsy; without imaging guidance; first lesion) and proposed 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 did 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 believed that it was 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 disagreed with the RUC-recommended work RVU of 1.63 for CPT code 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and proposed a work RVU of 1.46. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10005 is equivalent to the recommended interval of 0.43 RVUs. Therefore, we proposed a work RVU of 1.46 for CPT code 10005, 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 was 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 10005, and both crosswalk codes share a work RVU of 1.39.

      We disagreed with the RUC-recommended work RVU of 2.43 for CPT code 10009 (Fine needle aspiration biopsy, including CT guidance; first lesion) and we proposed a work RVU of 2.26. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10009 is equivalent to the recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of 2.26 for CPT code 10009, 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 was 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 noted 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 believed that this indicated 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 noted 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 will 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 proposed 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 noted 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Fine Needle Aspiration family of codes.

      Comment: Several commenters disagreed with the CMS statement in the proposed rule that the RUC-recommended work pool was increasing by approximately 20 percent for this family of codes. Commenters stated that the work pool based on the RUC-recommended values would actually decrease by 15 percent and that the CMS work valuations were based on a flawed methodology that did not account for the associated savings with bundling the image guidance codes. One of the commenters supplied a table with data to support the claim that the work

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      pool based on the RUC-recommended values would decrease by 15 percent rather than increasing by 20 percent.

      Response: We disagree with the commenters that the work pool would decrease by 15 percent if we were to finalize the RUC recommendations. We investigated the data in the table submitted by the commenters, and we believe that there are several methodological flaws in the analysis it contains. First, there are a number of 0.00 work RVUs listed in the ``RUC Recommended RVUs'' column for the new codes, which results in an incorrect amount of ``New/Rev Total RVUs'' when multiplied by the utilization for the new codes. As an example, CPT code 10005 has approximately 135,000 services that are counted as having a work RVU of 0.00 in this table instead of the RUC-recommended work RVU of 1.63, which undercounts the total number of RVUs by a wide margin. Second, the values in the ``Total Source RVUs'' include the ratios from the utilization crosswalk (listed on the table as ``Percent''). We do not understand why these ratios would be used to calculate the total source RVUs, as this side of the work pool comparison is calculated from the utilization of the source codes times the work RVUs of the source codes. Third, the imaging guidance codes are not fully included in both sides of the comparison on this table, with their work RVUs included in the source RVU total but not in the new/revised RVU total. This uneven comparison results in an inaccurate tally of the work pools from before and after the coding revisions take place.

      In the interest of providing transparency, we are including Table 12 with our work pool comparison for the Fine Needle Aspiration code family.

      Table 12--Fine Needle Aspiration Work Pool Comparison

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

      Utilization Utilization Work RVU Work pool Work RVU Work pool Work pool Work pool %

      HCPCS code source destination source source destination destination RVU change change

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

      10021................................... 23,755 21,380 1.27 30,169 1.20 25,655 -4,513 -15

      10004................................... 0 2,376 0.00 0 0.80 1,900 1,900 ............

      10005................................... 0 270,753 0.00 0 1.63 441,327 441,327 ............

      10006................................... 0 30,621 0.00 0 1.00 30,621 30,621 ............

      10007................................... 0 6,857 0.00 0 1.81 12,411 12,411 ............

      10008................................... 0 873 0.00 0 1.18 1,030 1,030 ............

      10009................................... 0 60,665 0.00 0 2.43 147,416 147,416 ............

      10010................................... 0 6,831 0.00 0 1.65 11,271 11,271 ............

      10011................................... 0 83 0.00 0 C 0 0 ............

      10012................................... 0 3 0.00 0 C 0 0 ............

      10022................................... 186,455 0 1.27 236,798 0.00 0 -236,798 -100

      76942................................... 558,081 488,321 0.67 373,914 0.67 327,175 -46,739 -13

      7694226................................. 641,346 561,178 0.67 429,702 0.67 375,989 -53,713 -13

      76942TC................................. 8,588 7,515 0.00 0 0.00 0 0 ............

      77002................................... 311,280 308,790 0.54 168,091 0.54 166,746 -1,345 -1

      7700226................................. 180,964 179,516 0.54 97,721 0.54 96,939 -782 -1

      77002TC................................. 7,936 7,873 0.00 0 0.00 0 0 ............

      77012................................... 9,343 7,792 1.16 10,838 1.50 11,688 850 8

      7701226................................. 194,611 162,306 1.16 225,749 1.50 243,458 17,710 8

      77012TC................................. 469 391 0.00 0 0.00 0 0 ............

      77021................................... 1,481 1,432 1.50 2,222 1.50 2,148 -73 -3

      7702126................................. 1,038 1,004 1.50 1,557 1.50 1,506 -51 -3

      77021TC................................. 67 65 0.00 0 0.00 0 0 ............

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

      Totals.............................. 2,125,414 2,126,622 ............ 1,576,760 ............ 1,897,282 320,523 20

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

      We continue to believe that the RUC-recommended work pool is increasing by approximately 20 percent for the Fine Needle Aspiration family as a whole, and that this percentage increase suggests that CPT codes 10021, 10005, and 10009 are more accurately valued at the CMS proposed work RVUs.

      Comment: Several commenters disagreed that this code family will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular services. Commenters stated that there is no overlap between the current descriptions of work for the bundled codes, and that CPT code 10022 is never performed on the same patient without an image guidance code and the image guidance codes are never performed on the same patient without a corresponding procedure code. The commenters stated that any associated reduction in payment would be due to other factors, not due to the code bundling.

      Response: We disagree with the commenters that there would be no savings achieved via elimination of duplicative assumptions of the resources involved in furnishing particular services. As we stated in the proposed rule, a practitioner will 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. In similar fashion, these codes both separately include immediate postservice work time for dictating a report in their clinical vignettes. This is an example of how savings are achieved via elimination of duplicative assumptions of resources, as the practitioner will only dictate a single report in the newly created CPT code 10005 that bundles these two services together. We continue to believe that 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.

      Comment: One commenter stated that while it may be true mathematically that the work pool for this family of codes was increasing by 20 percent, using this observation as the sole basis to implement work value relies on incorrect assumptions which do not adhere to current relativity-based RUC methodologies. The commenter stated that the rationale proposed by CMS incorrectly implies 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 fails to recognize changes in intensity that have taken place over time.

      Response: We disagree with the commenter that our analysis of changes in the work pool for this family of codes was the sole basis for the proposed refinements to the work RVUs. While

      Page 59520

      this was an important factor in our analysis of the work valuation of individual codes, we also detailed in the proposed rule our use of time ratios, increments, and crosswalk codes as part of our larger methodology to determine work RVUs. We specifically stated that we did 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, but rather that 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. We do consider changes in intensity that have taken place over time as part of our analysis of work valuation, as demonstrated by the fact that we proposed the RUC-recommended work RVUs for seven of the ten codes in this family.

      Comment: One commenter disagreed that the work pool for a family of revised codes should be similar before and after the valuation of the new codes. The commenter stated that by separating different modalities into their own codes, the appropriate time and intensity differences for these services were more accurately reflected in the recommended RVUs, and the work pool appropriately expanded to reflect these differences. The commenter cited the example of CPT code 10022 being unable to account for different patients receiving a biopsy using ultrasound or CT technology.

      Response: We agree with the commenter that the work pool for a revised code family does not always need to be similar before and after the valuation of the new codes. However, the commenter did not address our rationale for why we believe that an increase in the work pool would be inaccurate for this particular family of codes, which was based on the observation that the RUC-recommended work pool was increasing by approximately 20 percent while the RUC-recommended work time pool for the same codes was only increasing by about 2 percent. In a situation where prior coding was unable to account for newer and more complex forms of treatment, we would expect the work time pool to expand alongside the work pool, since these more complex and intensive procedures would take more time to furnish.

      Comment: A few commenters stated that since CMS changed the multiple procedure indicator from ``0'' to ``2'' for all Fine Needle Aspiration biopsy initial lesion codes for CY 2019, the commenter believes that using XXX global codes as references was incorrect. The commenter instead recommended that CMS review similar minor procedures that have a 0-day global designation, which suggested that a higher work RVU could have been supported.

      Response: We continue to believe that codes should generally be compared to codes with the same global period. Codes with a 0-day global period bundle other services that take place on the same day as the procedure into the valuation of the code, whereas such bundling is not included in codes with an XXX global period. We do not agree that it would have been more accurate to use codes with a 0-day global period as references for the codes in this family.

      Comment: Many commenters disagreed with the proposed work RVU of 1.03 for CPT code 10021 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.20. Commenters stated that this service has a new coding structure as compared to the past, and that the prior review was last carried out in 1995 when physician work time was evaluated with much less rigor. Commenters stated that the old time values were also based on a crosswalk and not a survey, and that therefore the drop in work time did not warrant a proportional change in work RVU as the previous times were inaccurate.

      Response: We agree that it is important to use the most recent data available regarding time, and we note that when many years have passed between when time is measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The times currently associated with codes play a very important role in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had routinely been overestimated, this would undermine the relativity of the work RVUs on the PFS in general, given the process under which codes are often valued by comparisons to codes with similar times, and it also would undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS. Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times used in the PFS ratesetting processes are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we want to reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of prior work time values in our methodology, we refer readers to our discussion of the subject in the CY 2017 PFS final rule (81 FR 80273 through 80274).

      Comment: Several commenters stated the CMS rationale for the proposed work RVU for CPT code 10021 incorrectly implies that the decreased time reflected in survey values should have a one-to-one decrease in value, or a linear decrease in the valuation of work RVUs. Commenters stated that CMS incorrectly assumed that there are no differences in how work was valued in 1995 and how it is valued now.

      Response: We do not agree with the commenters' characterization of our statements, and believe it misinterprets our view on this matter. We specifically stated in the CY 2019 PFS proposed rule that we were not implying that the decrease in time as reflected in survey values must necessarily equate to a one-to-one or linear decrease in the valuation of work RVUs, both generally speaking and with regards to this particular CPT code (83 FR 35747). We recognize that intensity for any given procedure may change over several years or within the intraservice period. Nevertheless, since the two components of work are time and intensity, we believe that absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has specifically increased or the reduction in time occurs disproportionally in the less-intensive portions of the procedure, significant decreases in time should generally be reflected as decreases to work RVUs.

      Comment: Several commenters disagreed with the use of CPT code 36440 as a crosswalk for the work RVU of CPT code 10021. Commenters stated that there were differences in site of service, patient population, and utilization between these two codes, which made CPT code 36440 a poor choice to use for work valuation. One commenter stated that CPT code 36440 is used to report a push transfusion of blood through an already established

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      access in a vessel, and does not carry the same risk and intensity as CPT code 10021, which involves accessing a lesion in the neck multiple times to aspirate biopsy specimens. Commenters supplied a chart depicting several comparator codes for 10021 that they stated were more appropriate choices for a crosswalk.

      Response: We disagree with the commenters that CPT code 36440 is an inappropriate choice for a crosswalk code. While it is true that this code is typically performed on an inpatient basis and the patient population comprises neonates instead of adults, we note that these factors suggest that the patient population for CPT code 36440 is likely sicker and more complex than the patient population for CPT code 10021. These differences would, if anything, be grounds for a lower work RVU for CPT code 10021, not a higher work RVU. We continue to believe that CPT code 36440 is an appropriate choice for a crosswalk due to the highly similar work times and intensity as compared to CPT code 10021. As for the other comparator codes provided by the commenters, we do not agree that they would be more appropriate choices for a crosswalk as we believe that they have a higher intensity than the service described by CPT code 10021. In more general terms, we continue to believe that the nature of the PFS relative value system necessarily involves comparisons of all services to one another. Although codes that describe clinically similar services are sometimes stronger comparator codes, we do not agree that codes must share the same site of service, patient population, or utilization level to serve as an appropriate crosswalk.

      Comment: Many commenters disagreed with the proposed work RVU of 1.46 for CPT code 10005 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.63. Commenters stated that CMS should use valid methods of evaluating services, such as survey data and magnitude estimation, instead of relying on an incremental difference in work RVUs between CPT codes 10021 and 10005.

      Response: We believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Historically, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code or another family of codes. We note that the RUC has also used the same incremental methodology on occasion when it was unable to produce valid survey data for a service. We further note that we did not rely solely on an increment for our proposed work RVU for CPT code 10005, supporting our proposed valuation with the use of two reference codes: CPT codes 99225 and 99232. Both of these codes have the same intraservice time and 1 additional minute of total time as compared with CPT code 10005, and both reference codes share a work RVU of 1.39.

      Comment: One commenter stated that they did not object to the CMS designation of 0.43 RVUs as the increment over CPT code 10021 for adding ultrasound guidance; however, the commenter objected to the assumption that the work value for CPT code 36440 offers an acceptable baseline.

      Response: We continue to believe that a crosswalk to the work RVU of CPT code 36440 produces the most accurate valuation for baseline CPT code 10021.

      Comment: Commenters disagreed with the proposed work RVU of 2.26 for CPT code 10009 and stated that CMS should finalize the RUC-

      recommended work RVU of 2.43. Commenters provided similar comments for CPT code 10009 as they provided for CPT code 10005, suggesting that the use of an incremental methodology was inaccurate and that CMS should use more valid methods of evaluating services, such as survey data and magnitude estimation.

      Response: We continue to disagree with the commenters that the use of an increment is a less valid methodology for valuing services. As detailed in the response to the comment summary above for CPT code 10005, we believe the use of an incremental difference is appropriate, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We further note that we did not rely solely on an increment for our proposed work RVU for CPT code 10009, supporting our proposed valuation with the use of a reference to CPT code 74263.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT codes 77012 and 77021, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-recommended direct PE inputs for clinical labor.

      Response: We address this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT codes 77012 and 77021, we are finalizing these clinical labor refinements as proposed.

      After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for all of the codes in the Fine Needle Aspiration family as proposed.

      (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 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 disagreed with the recommended value and proposed a work RVU of 1.08 for CPT code 11755 based on the survey 25th percentile value. We noted 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 did 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 believed 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 noted 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

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      this further supports our proposal of a work RVU of 1.08 for CPT code 11755.

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

      The following is a summary of the public comments we received on our proposals involving CPT code 11755.

      Comment: A few commenters stated that section 1848(c)(7) of the Act, as amended by section 220(e) of the Protecting Access to Medicare Act of 2014 (PAMA), specifies that for services that are not described by new and revised codes, if the total RVU for a service would be decreased by 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments must be phased in over a 2-

      year period. These commenters stated that, according to this requirement, CPT code 11755 should be subject to the phase-in for CY 2019.

      Response: We agree that CPT code 11755 should be subject to the phase-in for CY 2019. Due to a technical error, we inadvertently neglected to apply the phase-in to the total RVU of this code in the facility setting for the proposed rule, and we are correcting this for the final rule.

      Comment: Many commenters disagreed with the proposed work RVU of 1.08 for CPT code 11755 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.25. Commenters urged CMS to view the survey and the HCPAC's recommendation for the survey median work value of 1.25 apart from the current work time and work RVU because the primary specialty that currently performs the service was not included in the prior survey conducted in 1993.

      Response: We disagree with the commenters that the current work time and work RVU for CPT code 11755 should be viewed separately from the new recommended values. We do not pay differentially for services on the basis of specialty, and a change in the dominant specialty since the time of the last survey is not a reason to disregard the current work time and work RVUs in developing proposed work RVUs.

      Comment: Commenters compared the proposed work RVU of CPT code 11755 to the work valuation of the top key reference service, CPT code 11730 (Avulsion of nail plate, partial or complete, simple; single). Commenters stated that the increment of work between CPT code 11730 of 1.05 and the CMS proposed value for CPT code 11755 of 1.08 was only 0.03 RVUs, which was not enough to account for the additional work involved in CPT code 11755 given that the latter code also had 50 percent more intraservice time. Commenters also expressed concerns with the CMS reference to CPT code 11042 at a work RVU of 1.01, stating that it required less physician work time and a less refined technique. Commenters stated that the service described by CPT code 11755 was more intense to perform because the physician has to be extremely careful not to accidentally hit the patient's bone while taking the biopsy. Commenters stated that the nail plate is typically difficult to remove during the process of the biopsy performed in the service described by CPT code 11755, and that the biopsy must be performed with extreme care to avoid injury to the surgeon or extension of the incision to the underlying bone, which carries the potential for an osteomyelitis and significant post-operative pain. Commenters again urged CMS to finalize the RUC-recommended values for this code.

      Response: After reviewing the additional information about the risks inherent in the service provided by the commenters, we agree that it would be more accurate to finalize the RUC-recommended work RVU of 1.25 for CPT code 11755 to reflect the intensity of the procedure.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the basic instrument pack (EQ137) equipment, we removed the clinical labor for the CA024, CA027, CA029, and CA035 clinical labor activities in accordance with our standard equipment time formula for surgical instrument packs. For the other three equipment items, we removed the clinical labor for the CA027 and CA035 clinical labor activity codes in accordance with our standard equipment time formula for non-highly technical equipment.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVU of 1.25 for CPT code 11755. We are finalizing the direct PE inputs for this code as proposed.

      (3) Skin Biopsy (CPT Codes 11102, 11103, 11104, 11105, 11106, and 11107)

      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 proposed the RUC-recommended work RVUs for five of the six codes in the family. We proposed a work RVU of 0.66 for CPT code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch biopsy of skin, (including simple closure when performed), single lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin, (including simple closure when performed), each separate/additional lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), single lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), each separate/additional lesion).

      For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), each separate/additional lesion), we disagreed with the RUC-recommended work RVU of 0.38 and proposed 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 11103 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 was 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

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      CPT code 11103. We also noted that the intraservice time ratio between CPT code 11103 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 also supported 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 believed that our proposed work RVU of 0.29 for CPT code 11103 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 proposed to remove the 2 minutes of clinical labor time for the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) activity for CPT codes 11102, 11104, and 11106. 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      We proposed 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 11102, 11104, and 11106. We proposed 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 also proposed to remove all of the supplies in the three add-on procedures (CPT codes 11103, 11105, and 11107) 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 noted 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.

      The following is a summary of the public comments we received on our proposals involving the Skin Biopsy family of codes.

      Comment: Many commenters disagreed with the proposed work RVU of 0.29 for CPT code 11103 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.38. Commenters disagreed that CPT code 11103 would have the second-highest work RVU for any code with 7 minutes or less of total time, stating that the total number of add-on codes with RUC total time of 7 minutes or less is 18. Commenters stated that only five of these services have total time of 6 or 7 minutes and the rest were lower, thus the majority of the work RVUs among these services were lower and not comparable. Commenters stressed that the RUC-

      recommended work RVU of 0.38 for CPT code 11103 was appropriate since the service is performed on a separate site than the base code and there is additional physician work to transition to a different site. Commenters stated that the RUC's direct crosswalk to CPT code 11732 (Avulsion of nail plate, partial or complete, simple; each additional nail plate), which describes procedures with significant physician effort in removing a nail plate with its anesthesia and hemostasis challenges, was a much better comparator to CPT code 11103 which involves the biopsy of a vascular tumor, typically on the face. Commenters stated that the proposed crosswalk to CPT code 11201 at a work RVU of 0.29 was too low to maintain relativity within the family of codes. One commenter stated that the type of skin biopsies performed in CPT code 11103 can result in the detection of carcinoma, melanoma, sarcoma/lymphoma, and other dangerous pathologies, and that making these diagnoses can save lives and ultimately decrease Medicare spending.

      Response: After reviewing the additional information provided by the commenters, we agree that it would be more accurate to finalize the RUC-recommended work RVU of 0.38 for CPT code 11103 as the proposed work RVU was too low to maintain relativity within the family of codes.

      Comment: Commenters disagreed with many of the refinements made by CMS to the direct PE inputs for this family of codes. Commenters stated that it was not appropriate to only include equipment and supply items in the new biopsy add-on codes that were included in the old add-on code (CPT code 11101) because the old codes were not specific enough to accurately distinguish between the three types of biopsies. Commenters cited as an example the fact that the predecessor CPT code 11101 did not include supply items that are necessary for the performance of the incisional biopsy.

      Response: We appreciate the feedback from the commenters clarifying some of the differences between the predecessor code and the newly created add-on codes. We evaluated these differences on an individual case-by-case basis when determining whether or not to finalize the proposed refinements to the direct PE inputs.

      Comment: Several commenters disagreed with the proposed refinements to the ``Review home care instructions, coordinate visits/

      prescriptions'' (CA035) clinical labor time. Commenters stated that home care instructions furnished in an E/M visit do not typically include wound care instructions, and that this instruction would be above and beyond instructions proved during an E/M visit in which no procedure is performed.

      Response: We disagree with the commenters that wound care instructions would not be provided during the same day E/M visit. We continue to believe that it would be duplicative to assign clinical labor time for this task given the fact that a same day E/M visit is typical for these services. We believe that these instructions would be provided during the same day E/M visit.

      Comment: Several commenters disagreed with the CMS proposal 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 11102, 11104, and 11106 since these supplies are also included within the surgical instrument cleaning pack (SA043). Commenters stated that the SA043 instrument cleaning pack is used in the dirty instrument room as part of the instrument cleaning and sterilization process and therefore cannot be used during a patient procedure as the instrument cleaning occurs after the procedure has been completed. Commenters stated that the personal protective equipment used during the patient procedure is considered contaminated after the procedure is concluded, and that personal protective equipment must be removed and disposed of prior to leaving the procedure room. As a result, these supplies were not duplicative and should not be removed.

      Response: We disagree with the commenter and we continue to believe that the impervious staff gown and the surgical mask with face shield would be duplicative supplies given that they are also contained within the instrument cleaning pack. We do not believe that it

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      would be typical to remove the staff gown and face shield used during a procedure and put on new items afterwards for the purposes of cleaning instruments.

      Comment: Commenters also disagreed with the CMS proposal to remove all of the supplies in the three add-on procedures (CPT codes 11103, 11105, and 11107) that were not contained in the previous add-on procedure for this family, CPT code 11101. For the ``drape, sterile, fenestrated 16in x 29in'' (SB011) supply, commenters stated that draping the new body site with a new sterile disposable drape was clinically indicated and would be typically done rather than take a drape used on one body site and then reposition it to a new body site for a new procedure. Commenters made the same claim for the sterile gloves (SB024) supply. For the ``needle, OSHA compliant (SafetyGlide)'' (SC080) and the ``scalpel, safety, surgical, with blade (#10-20)'' (SF047) supplies, commenters stated that the add-on represented a completely new body site and completely new skin lesion which would not allow the needle or scalpel to be un-sheathed and then reused at a separate body site out of fear of contamination. For the ``dressing, 12-7mm (Gelfoam)'' (SG033), ``dressing, 3in x 4in (Telfa, Release)'' (SG035), and ``gauze, sterile 4in x 4in (10 pack uou)'' (SG056) supplies, commenters stated that the add-on procedure is a second biopsy of a completely different body location and that these dressings/gauze pads would not be retained and then used on the second procedure out of fear of contamination. For the ``tape, surgical paper 1in (Micropore)'' (SG079) supply, commenters stated that the quantity of this supply in the base code was sufficient for one lesion, but not more than one lesion due to the simple fact that two lesions required more surgical tape than one lesion. Finally, for the ``swab, patient prep, 1.5 ml (chloraprep)'' (SJ081) supply, commenters stated that the process of skin prep starts with the center of the lesion and moves outward in concentric circles to avoid bringing pathogens back into the field. Commenters stated that the prep sponge cannot be reused on a separate area of skin as it will contaminate that area by transporting pathogens from the last concentric circle of the prior area, and that the supply quantity in the base code contained an amount insufficient to prep more than one area. Commenters requested CMS not to finalize the proposal to remove these supplies from the add-on codes.

      Response: After considering the new information provided by the commenters regarding the clinical use of these supplies, we will not finalize our proposal to remove these supplies from the three add-on procedures (CPT codes 11103, 11105, and 11107). We will restore the RUC-recommended supplies for these three codes.

      Comment: Several commenters disagreed with the refinements to the equipment time in CPT codes 11102, 11104, and 11106. The commenters stated that the removal of 2 minutes of equipment time was not appropriate and that equipment time needs to match clinical staff time.

      Response: We agree with the commenter that changes in clinical labor time should be matched with corresponding changes in equipment time. However, since we continue to believe that the clinical labor to the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) clinical labor time should be removed as duplicative with the same day E/M visit, we also continue to believe that the equipment times are accurate as proposed.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for all of the codes in the Skin Biopsy family. We are finalizing the direct PE inputs as proposed, with the exception of the supplies from the three add-on procedures (CPT codes 11103, 11105, and 11107) as detailed above.

      (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 proposed the RUC-

      recommended work RVU of 0.75 for CPT code 20551.

      We proposed 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 noted 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 proposed 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 will be duplicative to assign clinical labor time for obtaining consent or reviewing home care instructions given that these tasks will typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 20551.

      Comment: A few commenters supported our proposal to maintain the current work RVU for this code, as recommended by the RUC.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: Several commenters disagreed with the proposed direct PE refinements to CPT code 20551. Commenters stated that they did not agree that the clinical labor taking place in activity codes CA011 and CA035 were duplicative and that the RUC is careful to remove any duplication with E/M visits. Commenters stated that the home care instructions in activity code CA035 refer directly to the tendon injection and may include discussion of care for the affected area and home restrictions. Commenters stated that this injection is more involved and invasive than a vaccination such as the ones taking place in CPT codes 90470 and 90471, which were allowed 3 minutes for ``F/u on physician's discussion w/patient/parent & obtain actual consent signature'' and an additional 3 minutes for home care instructions and recording vaccine information.

      Response: For the CA011 clinical labor activity, we agree with the commenters that there would be a need for some additional time to obtain consent for the injection, but we do not agree that it would be typical to require the full 3 minutes because we believe there would be some overlap with the same day E/M visit. In similar fashion, we believe that there would also be some overlap with the same-day E/M

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      visit for the home care instructions described in activity code CA035. We also note that there is 1 minute of clinical labor time assigned to the ``Check dressings & wound/home care instructions/coordinate office visits/prescriptions'' clinical labor task for CPT code 90471 referenced by the commenters. As a result, we are finalizing the assignment of 1 minute of clinical labor time to both of the CA011 and CA035 activities for CPT code 20551. We are also finalizing an increase of 1 minute in the equipment time for the exam table (EF023) to a total of 15 minutes, in accordance with our standard time formula for non-

      highly technical equipment.

      After consideration of the public comments, we are finalizing our proposal to maintain the current work RVU for CPT code 20551. We are finalizing the direct PE inputs with the refinements detailed above.

      (5) Structural Allograft (CPT Codes 20932, 20933, and 20934)

      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 proposed the RUC-recommended work RVUs for all three codes. We proposed a work RVU of 13.01 for CPT code 20932 (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 20933 (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 20934 (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.

      We did not receive any comments on our proposals involving the Structural Allograft family of codes. Therefore we are finalizing the work RVUs for the codes in this family as proposed.

      (6) Knee Arthrography Injection (CPT Code 27369)

      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, 27369, to report injection procedure for knee arthrography or enhanced CT/MRI knee arthrography.

      The RUC recommended a work RVU of 0.96 for CPT code 27369, 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 disagreed with the RUC's recommended work RVU for CPT code 27369. 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 proposed a work RVU of 0.77 for CPT code 27369.

      For the direct PE inputs, we proposed 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 27369, CPT code 27370, did not 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 noted 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 proposed 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 27369 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 27369.

      Comment: We received one comment regarding our proposed work RVU for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's reference to CPT code 27370, which is being deleted, as a basis for evaluating whether the RUC's proposed work RVU for this CPT code (0.96) adequately accounts for the large reduction in time between the deleted code, CPT code 27370 and the new code, CPT code 27369. The commenter noted that it is particularly inappropriate for CMS to value codes on the basis of time differences when the comparison code had not been previously surveyed by the RUC. The commenter urged CMS to finalize the RUC-recommended work RVU for CPT code 27369 of 0.96.

      Response: We use several parameters to review the work RVU for codes including, where applicable, refining the work RVUs in direct proportion to either total time or intraservice time based on the best available information regarding the time resources involved in furnishing particular services. We note that the reason the CPT Editorial Panel was asked to review the code was to prevent incorrect reporting of the code, not to reflect a fundamentally different service. The work involved in furnishing the service described by CPT code 27369 is not fundamentally different from the work involved in furnishing the service described by the deleted code. In such cases we do not believe it is inappropriate to compare the survey times for the new code to the existing time for the code that it is intended to replace as one of several parameters we consider in our review. We are finalizing a work RVU for CPT code 27369 of 0.77 as proposed.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-

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      recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 27369, we are finalizing these clinical labor refinements as proposed.

      Comment: One commenter agreed with the proposed CMS refinement to the CA032 clinical labor activity.

      Response: We appreciate the support for our proposal from the commenter.

      After consideration of the public comments, we are finalizing the direct PE inputs for CPT code 27369 as proposed.

      (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 proposed the RUC-

      recommended work RVU of 0.80 for CPT code 29105. For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 29105.

      Comment: Some commenters expressed support for our proposal to accept the RUC-recommended work RVU for this code.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the five equipment items utilized in CPT code 29105, we removed the clinical labor for the CA035 clinical labor activity code in accordance with our standard equipment time formula for non-

      highly technical equipment.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 29105 as proposed.

      (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 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 proposed 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 proposed 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 also proposed 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Strapping Lower Extremity family of codes.

      Comment: A few commenters supported our proposal to accept the HCPAC-recommended work RVUs.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: Several commenters disagreed with the proposed direct PE refinements to CPT codes 29540 and 29550. Commenters stated that CMS mistakenly cited a standard for this activity of 2 minutes, however there is no set standard for CA011, and that 3 minutes is needed for clinical staff to perform this clinical activity.

      Response: We disagree with the commenters that 3 minutes would be typically needed for the clinical staff to provide education and obtain consent in these procedures. We have typically assigned 2 minutes for this clinical labor activity unless we had a specific rationale for a higher amount of clinical labor time, and we continue to believe that this standard amount of clinical labor time would be the most accurate value for CPT codes 29540 and 29550.

      Comment: Several commenters disagreed that the clinical labor for home care instructions and coordinating visits/prescriptions would be duplicative with the same day E/M office visit in these services. Commenters stated that these home care instructions directly pertain to the strapping procedure and would not be provided during an evaluation of the patient. Commenters stated that the strappings do not work unless left alone and taken care of in a specific manner, and that this important information is included in the home care instructions that the patient receives from clinical staff.

      Response: We disagree with the commenters and we continue to believe that this clinical labor would be duplicative with the same day E/M visit. We believe that this clinical labor would take place during the same day E/M visit. Due to the way patients typically present in these procedures, we do not believe that the patients would typically need additional home care instructions above and beyond the E/M visit. We also note that these strapping procedures are frequently repeated for the same patient multiple times, and there would not be a need for repeated home care instructions for subsequent strapping procedures for the same patient. Any home care instructions taking place outside of the same day E/M visit would only be needed the first time that these procedures are performed on a patient, and as a result they would not be typical. As a result, we continue to believe that this clinical labor would not be typical.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the two equipment items utilized in these CPT codes, we removed the clinical labor for the CA035 clinical labor activity code in accordance with our standard equipment time formula for non-

      highly technical equipment.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 29540 and 29550 as proposed.

      (9) Bronchoscopy (CPT Codes 31623 and 31624)

      CPT code 31623 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with

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      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 proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623 and 31624.

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

      The following is a summary of the public comments we received on our proposals involving the Bronchoscopy family of codes.

      Comment: Several commenters disagreed with the proposal 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. Commenters stated that there is no standard for the CA027 clinical labor activity and that the CMS logic to conform to such a standard lacks merit. Commenters also stated that these services require verification of samples, and completion of several lab forms and clearly requires more than the standard time for completing forms.

      Response: We disagree with the commenters. While it is true that we have not formalized 2 minutes as a standard through rulemaking for this clinical labor activity code, we have typically assigned 2 minutes for the CA027 activity across a wide variety of codes. Out of the 168 HCPCS codes that have clinical labor time for the CA027 clinical labor activity in our database, 64 codes have 2 minutes of assigned clinical labor time while only 9 codes have 4 minutes of assigned clinical labor time, which indicates that 2 minutes is far more typical for this activity. More importantly, commenters did not address our statement that 2 minutes is the current time for this clinical labor activity, and we had no reason to believe that the time to perform this task has increased since the codes were last reviewed. As a result, we are finalizing our refinement to 2 minutes of clinical labor time for the CA027 activity.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 31623 and 31624 as proposed.

      (10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and 93264)

      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 proposed the RUC-recommended work RVU of 6.00 for CPT code 33289 (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 93264 (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 did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Pulmonary Wireless Pressure Sensor Services family of codes.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs.

      Response: We thank commenters for their support.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.

      (11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)

      In February 2017, the CPT Editorial Panel created two new codes replacing cardiac event recorder codes to reflect new technology. For CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code 33285 (Insertion, subcutaneous cardiac rhythm monitor, including programming) and the RUC-recommended work RVU of 1.50 for CPT code 33286 (Removal, subcutaneous cardiac rhythm monitor).

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Cardiac Event Recorder Procedures family of codes.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs.

      Response: We thank commenters for their support.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and 33286 as proposed.

      (12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)

      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 proposed the RUC-recommended work RVU of 64.00 for CPT code 33440 (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 33440.

      For the direct PE inputs, we proposed to refine the preservice clinical labor times to match our standards for 90-day global procedures. We proposed 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 also proposed to add 15 minutes of clinical labor time for the ``Perform regulatory mandated quality assurance activity (pre-service)'' (CA008) activity. We agreed with the recommendation that the total preservice clinical labor

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      time for CPT code 33440 is unchanged from the two reference codes at 75 minutes. However, we believed 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 33440. We also noted 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.

      The following is a summary of the public comments we received on our proposals involving CPT code 33440.

      Comment: A few commenters stated that they had no objections to the CMS proposal to refine the preservice clinical labor times for the direct PE inputs for code 33440 to match the 90-day global procedure standards and to add 15 minutes of clinical labor time to clinical labor activity code CA008. The commenters stated that they believed the RUC-recommended allocation of the preservice activities was appropriate, whereas activity code CA008 was not an accurate description of the additional work being done, and hoped that CMS would not use the allocation of time to CA008 as a way to reduce the preservice time in future rulemaking.

      Response: We appreciate the feedback on our proposed direct PE refinements from the commenters.

      After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for CPT code 33440 as proposed.

      (13) Hemi-Aortic Arch Replacement (CPT Code 33866)

      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 proposed the RUC-recommended work RVU of 19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion). CPT code 33866 is a facility-

      only procedure with no recommended direct PE inputs.

      The following is a summary of the public comments we received on our proposals involving CPT code 33866.

      Comment: We received several comments, including comments from the RUC. The RUC noted in its comment letter that at the April 2018 RUC meeting, the specialty societies determined that the family of services encompassing CPT code 33866 should be submitted to the CPT Editorial Panel for the following revisions: (1) To develop distinct codes for ascending aortic report for dissection and ascending aortic repair for other ascending aortic disease such as aneurysms and congenital anomalies. The specialties noted that there is a difference in the work associated with these procedures and now there is sufficient volume to allow for more accurate capture of the work and outcomes data for these distinct patient populations, which was not the case when the code was first developed, (2) Revise the descriptor for transverse arch code, CPT code 33870, to further clarify the difference in work between the new add on code, CPT code 33866, and (3) Revise the guidelines to provide additional instructions on the appropriate use of these codes. The RUC further noted that the specialty societies had already submitted a new coding proposal for consideration at the May 2018 CPT Editorial Panel for CPT 2020, which the RUC supported. Following the April 2018 RUC meeting, the RUC rescinded its interim value recommendation (work RVU of 19.74) to us for CPT code 33866 for CY 2019. One commenter noted, that although the RUC rescinded the interim work RVU of 19.74 due to a specialty societies' recommendation to submit the family of services to the CPT Editorial Panel, they encouraged CMS to consider using the work RVU of 19.74 as an interim value until the code can be re-surveyed and reviewed by the RUC. The commenter further noted that using the RUC-recommended value would allow physicians to be paid for the service in CY 2019, decreasing the burden of reporting a carrier-priced service to both the carriers and providers.

      Response: While we recognize that the RUC rescinded its work RVU recommendation, we note that we proposed the RUC-recommended work RVU for valuation in CY 2019. We also want to remind commenters that we no longer establish interim valuations on a routine basis, and we are not convinced that establishing an interim valuation for CPT code 33866 is necessary. We will review any new coding that the CPT Editorial Panel provides for 2020, and will review any recommendations we receive timely from the RUC or other stakeholders for valuation through CY 2020 rulemaking.

      After consideration of the public comments received, we are finalizing the RUC-recommended work RVUs for CPT code 33866 as proposed.

      (14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)

      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 33274 (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 disagreed with the recommended work RVU of 8.77 and we proposed 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 33274 and an additional 61 minutes of total time at a work RVU of 7.80. In our review of CPT code 33274, 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 33274 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 33274 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 proposed to crosswalk CPT code 33274 to CPT code 33207 at the same work RVU of 7.80. The proposed work RVU was 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

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      7.80 is a more accurate valuation for CPT code 33274, while still recognizing the greater intensity of this procedure in comparison to its reference code.

      For CPT code 33275 (Transcatheter removal of permanent leadless pacemaker, right ventricular), we disagreed with the RUC-recommended work RVU of 9.56 and we proposed a work RVU of 8.59. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 33274 and 33275 is equivalent to the recommended interval of 0.79 RVUs. Therefore, we proposed a work RVU of 8.59 for CPT code 33275, based on the recommended interval of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT code 33274. We also noted that our proposed work RVU for CPT code 33275 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 33275 has a surveyed intraservice time of 75 minutes and nearly splits the difference between them at our proposed work RVU of 8.59.

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Leadless Pacemaker Procedures family of codes.

      Comment: One commenter recommended that CMS adopt the RUC-

      recommended RVUs for both codes due to the newness of the procedures. The commenter stated that there might not be sufficient evidence or rationale for CMS to disagree with the RUC-recommended values, and again cited the newness of these procedures.

      Response: We disagree with the commenter that the newness of a procedure would provide a sufficient rationale for finalizing the RUC-

      recommended work RVU for a new CPT code without any further consideration. Establishing valuations for newly created CPT codes is a routine part of maintaining the PFS, and we have historically valued new services since the inception of the resource-based relative value system. We also believe that RUC surveys are less likely to be representative of practitioners when evaluating new services, due to the fact that practitioners are not yet sufficiently experienced with the services to provide accurate evaluations, which is why we have been supportive of the RUC's policy to resurvey new services a few years after their creation when typical practice patterns have been more firmly established.

      Comment: Many commenters disagreed with the proposed work RVUs for CPT codes 33274 and 33275 and stated that CMS should instead finalize the RUC-recommended work RVUs for these services. Commenters stated that CMS provided no qualitative or quantitative rationale to support their assumption that the difference in time between CPT codes 33274 and the top key reference from the survey (CPT code 33207) completely reflects the difference in intensity. Commenters stated that patients receiving leadless pacemakers are more complex and have more comorbidities and contraindications than transvenous patients, with more significant groin complications and more commonly present tamponade. Commenters stated that there were other issues that make CPT code 33274 more challenging, including: (1) Capture thresholds tend to change more than with transvenous devices; (2) There is a higher risk for complications including embolization and groin complications, which are not associated with tranvenous implants; and (3) Patients undergoing leadless pacemaker procedures are more likely to have chronic atrial fibrillation and poor venous access. Commenters emphasized that they believed the leadless pacemaker procedure described by CPT code 33274 was more intensive than the CMS crosswalk to CPT code 33207.

      Response: We disagree with the commenters' assertion that we provided no qualitative or quantitative rationale to support our choice of a crosswalk to CPT code 33207. We stated in the proposed rule that in our review of CPT code 33274, we noted that this reference code had an additional inpatient hospital visit of CPT code 99232 and a full, instead of a half, discharge visit of CPT code 99238 included in its 90-day global period. We acknowledged that CPT code 33274 is a more intense procedure than CPT code 33207; however, we did not believe that it should be valued almost a full RVU higher than the reference code. We also supported the proposed work RVU through the use of a reference code, CPT code 38542, which was not addressed by the commenters.

      We also disagree with the commenters that CPT code 33274 has so much additional intensity and complexity as compared to key reference CPT code 33207 that they should be valued at the same work RVU of 8.77. We note that the RUC's research panel selected preservice package 3, ``a straightforward patient and a difficult procedure'' for CPT code 33274. We believe this indicates that the patient population for CPT code 33274 would not be unusually difficult or complex as suggested by the commenters. We further note that the summary of recommendations for CPT code 33274 states that these patients are typically sent home from the facility the next day. In contrast, reference CPT code 33207 includes a full hospital inpatient day of post procedure care associated with CPT code 99322, as well as a full discharge visit instead of half of a discharge visit. We believe that this further suggests that the patient population for CPT code 33274 would not be more difficult or complex than the patient population for CPT code 33207. As we stated in the proposed rule, we continue to acknowledge that CPT code 33274 is a more intense procedure than CPT code 33207, but 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.

      Comment: Commenters stated that CMS should use valid methods of evaluating services, such as survey data and magnitude estimation, instead of relying on an incremental difference in work RVUs between CPT codes 33274 and 33275.

      Response: We believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Historically, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code or another family of codes. We note that the RUC has also used the same incremental methodology on occasion when it was unable to produce valid survey data for a service. We further note that we did not rely solely on an increment for our proposed work RVU for CPT code 33275, supporting our proposed valuation by noting that the CMS work RVU of 8.59 situated the code approximately halfway between the two reference codes from the survey, with CPT code 33270 having an intraservice time of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an intraservice

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      time of 60 minutes and a work RVU of 7.80.

      Comment: Several commenters stated that while these procedures described in CPT code 33275 will be rare, these patients will still have the elevated risk factors mentioned in discussion of CPT code 33274 and warranted the additional work indicated by survey respondents at the 25th percentile of the survey.

      Response: We continue to believe that the patients in CPT code 33274 would not be more difficult or complex than the patients in CPT code 33207 for the reasons detailed above. We continue to believe that the relative difference in work between CPT codes 33274 and 33275 is equivalent to the recommended interval of 0.79 RVUs.

      After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Leadless Pacemaker Procedures family as proposed.

      (15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, 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 real-time 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 proposed the RUC-recommended work RVU for two of the CPT codes in the family. We proposed 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 36572 (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 disagreed with the RUC-

      recommended work RVU of 2.00 and proposed 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 36572, 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 36572 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 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 36572 has a lower recommended intraservice time and total time as compared to CPT code 36569, yet has a higher recommended work RVU. Although we did 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 36572, we believed 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 was 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 share a work RVU of 1.82.

      For CPT code 36573 (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 disagreed with the RUC-recommended work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. In our review of CPT code 36573, 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 36573 as compared to CPT code 36569, the most similar code in the family, was decreasing from 27 minutes to 15 minutes (45 percent), and the recommended total time was decreasing from 60 minutes to 40 minutes (33 percent); however, the RUC-recommended work RVU was exactly the same for these two codes at 1.90. Although we did 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 36573, we believed 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 36573) and without (CPT code 35659) imaging guidance and radiological supervision and interpretation. Because the inclusion of the imaging described by CPT code 36573 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

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      increasing the work RVU to 1.90, especially considering that the new surveyed work time for CPT code 36573 is lower than the current work time for CPT code 36569. The proposed work RVU of 1.70 was 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 disagreed with the RUC-recommended work RVU of 1.47 and proposed a work RVU of 1.20 based on maintaining the current work RVU. We noted that the recommended intraservice time for CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent reduction), and the recommended total time was decreasing from 45 minutes to 34 minutes (25 percent reduction); however, the recommended work RVU was increasing from 1.20 to 1.47, an increase of approximately 23 percent. Although we did 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 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 were 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 believed 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 believed that it was 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 was decreasing from the current work time. The proposed work RVU of 1.20 was 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 noted that the RUC-recommended work pool was 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 was only increasing by about 22 percent. Since time is defined as one of the two components of work, we believe that this indicated 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 did 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 noted 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 believed 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 proposed 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 36572 and 36573. We noted 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 did not agree that the patient positioning would take twice as long for CPT codes 36572 and 36573 as compared to the rest of the family, and therefore proposed to refine both of them to the same 2 minutes of clinical labor time. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the PICC Line Procedures family of codes.

      Comment: One commenter stated that CMS believes it is not accurate to ``increase'' work RVUs when survey results indicate that work time is ``decreasing'' due to improving technology and greater efficiencies in practice patterns. The commenter disagreed that the difference between the current codes (without imaging guidance) and the new bundled codes (with imaging guidance) could be characterized as an ``increase'' or a ``decrease,'' as it was inappropriate simply to compare the RVUs of the bundled codes to the existing codes, because the bundled codes include imaging services that involve significantly more intense physician work than PICC line insertion without imaging guidance.

      Response: We disagree with the commenter that it is methodologically inappropriate to characterize changes in surveyed work time as ``increases'' or ``decreases''. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36572 is a new code resulting from the bundling together of CPT code 36568 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36568 and 76397 will now be reported under CPT code 36572. We believe that it is highly relevant to note how the recommended work times for CPT code 36572 compare to the recommended work times for CPT code 36568, which includes noting that the intraservice time is decreasing from 38 minutes to 22 minutes (42 percent), and the recommended total time is decreasing from 71 minutes to 51 minutes (38 percent). We also do not agree that it is inappropriate to compare the RVUs of the bundled codes to the existing codes, as all of these procedures describe clinically similar procedures that together comprise a family of codes. In more general terms, we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes with clinically similar services are sometimes stronger comparator codes, we do not agree that codes must both include imaging guidance or not include imaging guidance to be used as a crosswalk.

      Comment: Several commenters disagreed that the recoding of the services in the PICC line code family had only resulted in a change in the way that services will be reported, and stated that that the imaging-related services now bundled into CPT codes 36572, 36573, and 36584 are significantly more intense than PICC line insertion standing alone. One commenter stated that valuing a code using imaging guidance the same or less than the same code without imaging guidance is

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      specious and treats the use of imaging guidance as a negative work component when in fact there is additional work required in using imaging guidance. Commenters stated that the RUC-recommended values already reflect efficiencies in radiology work, and that the efficiency of radiologists should not diminish the RUC's recognition that their work is significantly more intense in these procedures.

      Response: We disagree with the commenters that the addition of imaging guidance has made CPT codes 36572, 36573, and 36584 significantly more intense than the non-imaging guidance version of these procedures. While the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We believe that if these procedures were significantly more intensive to perform, this would be reflected in the surveyed work times associated with these codes. However, the surveyed work times are instead decreasing in all three cases in comparison to the current non-imaging guidance version of the same services. As we stated in the proposed rule, we believe that the work times for these services are decreasing due to a combination of improving technology and greater efficiencies in practice patterns. Based on the RUC-

      recommended utilization crosswalk for these services, which has 90 to 95 percent of the utilization expected to be reported under the new codes that include imaging guidance, we believe that the use of imaging guidance has become typical for these services and does not represent a dramatic increase in intensity.

      Comment: Many commenters disagreed with the proposed work RVU of 1.82 for CPT code 36572 and stated that CMS should finalize the RUC-

      recommended work RVU of 2.00. Commenters stated that the CMS use of a crosswalk to CPT code 50435 was unsupported on a clinical basis, with significant differences in work intensity and patient population. Commenters stated that CPT code 36572 involves establishing new deep venous access on a pediatric patient while ensuring maximum sterile barrier technique so as to prevent a hospital acquired infection, whereas CPT code 50435 involves the exchange of an existing catheter in an adult who understands the procedure involved and has had previous catheter exchanges to maintain patency. One commenter stated that the RUC crosswalk to CPT code 19283 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds)) was a more accurate choice because this service also uses imaging guidance to obtain de novo percutaneous access to a target and perform an intervention. Commenters stated that the crosswalk code would frequently be less intense than CPT code 36572.

      Response: We disagree with the commenters that the work involved in CPT code 50435 would be less clinically intense than the work in CPT code 36572. We believe that the exchange of a nephrostomy catheter taking place in CPT code 50435 is more difficult than the placement of a breast localization device as in the RUC crosswalk to CPT code 19283, percutaneous; first lesion, including stereotactic guidance). We also disagree with the commenters that the crosswalk we identified lacks clinical similarity to CPT code 36572. Both the reviewed code and the crosswalk to CPT code 50435 involve the percutaneous placement of a catheter in a deep structure; we believe that this crosswalk code is more clinically similar than the RUC's choice of a crosswalk to CPT code 19283, which does not involve catheter placement at all.

      Commenter: Several commenters disagreed that the RUC-recommended work RVU of 2.00 for CPT code 36572 would create a rank order anomaly within the family of codes. Commenters stated that since CPT code 36568 requires more physician time to complete than CPT code 36572 (38 versus 22 minutes intra-service time), the recommended work RVU of 2.00 for CPT code 36572 maintains the proper rank order within this family of services considering differences in patient population and differences in clinical intensity of work.

      Response: The commenters did not address the concerns we expressed regarding a potential rank order anomaly within the family. We noted in the proposed rule that CPT code 36572 had a lower recommended intraservice time and total time as compared to CPT code 36569 (not CPT code 36568), yet had a higher recommended work RVU. We continue to believe that this creates the potential for a rank order anomaly within the family, and we do not believe that this discrepancy can be justified by differences in patient population and differences in clinical intensity of work.

      Comment: Several commenters disagreed with the CMS statement that the reduced intraservice and total times in CPT code 36572 as compared to CPT code 36568 should result in a lower work value. Commenters stated that this was a simplistic comparison based on time, and that these were two technically different procedures, involving different patient populations and different service intensity. Commenters stated that each step in the non-image guided CPT code 36568 takes longer, though involves more periods of low intensity intraservice work as compared to CPT code 36572, where each procedural step is performed sequentially without the less intense intraservice work of the non-

      image guided CPT code 36568.

      Response: We disagree with the commenters that the reductions in intraservice and total work time in CPT code 36572 as compared to CPT code 36568 should not result in a lower work value. 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 continue to 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. We disagree that this is a simplistic comparison, and chose a crosswalk to CPT code 50435 to better fit with the recommended work RVUs for CPT codes 36568 and 36569.

      We also do not agree that CPT codes 36568 and 36572 have significantly different patient populations and different service intensity. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36572 is a new code resulting from the bundling together of CPT code 36568 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36568 and 76397 will now be reported under CPT code 36572. Given that 90 percent of the services that were formerly reported using CPT code 36568 will now be reported using CPT code 36572, we do not agree that these codes represent significantly different patient populations.

      Comment: Many commenters disagreed with the proposed work RVU of 1.70 for CPT code 36573 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.90. Commenters stated that CMS should not use a code value that is no longer in existence as the service (CPT code 36569) itself has been revised and is currently under review in this family. Commenters stated that the reference was therefore not valid to the old work RVU.

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      Response: We disagree with the commenters that it is somehow invalid to use a crosswalk to the current work RVU for CPT code 36569. It is not accurate to state that this code is no longer in existence, as it is being revised for CY 2019, not deleted. The RUC frequently recommends maintaining the current work RVU for reviewed codes rather than using a new work RVU from survey results when it believes that there is appropriate rationale to do so. Given that CPT code 36573 is a new code resulting from the bundling together of CPT code 36569 with imaging guidance, and that the use of imaging guidance has become typical in the performance of this service, we believe that it is appropriate to maintain the same work RVU for these services when they are reported under the new coding, especially in light of the fact that the surveyed intraservice work time for CPT code 36573 remains the same 15 minutes as the current intraservice work time for CPT code 36569.

      Comment: Several commenters stated that CPT code 36573 involves a different patient population than CPT code 36569, as the patient population for CPT code 36573 does not have peripheral venous access present that can be used to obtain central venous access. Commenters stated that there is no evidence for a rank order anomaly within the codes in the family considering the differences in intensity and patient population.

      Response: As we stated previously with regard to CPT codes 36568 and 36572, we also do not agree that CPT codes 36569 and 36573 have significantly different patient populations and different service intensity. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36573 is a new code resulting from the bundling together of CPT code 36569 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36569 and 76397 will now be reported under CPT code 36573. Given that 95 percent of the services that were formerly reported using CPT code 36569 are expected to be reported using CPT code 36573, we do not agree that these codes represent noticeably different patient populations.

      Comment: Several commenters disagreed with our use of CPT code 36556 as a reference code. Commenters stated that CPT code 36556 describes line placement in a larger and more central vein such as the internal jugular vein with known anatomical landmarks and a shorter distance between access and where the tip terminates centrally while CPT code 36573 describes access into a smaller vein without anatomic landmarks. Commenters stated that although imaging is inherent to CPT code 36573, the catheter is longer and there is a need to navigate the catheter through these peripheral and central veins for adequate placement, all of which would require more work.

      Response: We disagree with the commenters that CPT code 36556 would not be an accurate reference code for CPT code 36573. CPT code 36556 describes the insertion of non-tunneled centrally inserted central venous catheter whereas CPT code 36573 describes the insertion of a peripherally inserted central venous catheter (PICC). We believe that these two codes, which both describe the insertion of central venous catheters, are highly similar to one another on a clinical basis and also from the perspective of work time, as they share the identical intraservice work time and total work time. Moreover, after further consideration, we are not able to identify any other more appropriate reference code for CPT code 36573 than CPT code 36556.

      Comment: Many commenters disagreed with the proposed work RVU of 1.20 for CPT code 36584 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.47. Commenters stated that CMS was completely dismissing the additional work that was bundled in with CPT code 36584 as part of the imaging guidance. Commenters stated that the RUC agreed that the recommended work RVU of 1.47 involves less time but involves a significant increase in intensity, and that the work RVU should not remain at the current work RVU of 1.20 as CPT code 36584 is now a bundled service.

      Response: We disagree with the commenters that the bundling of a service or the addition of imaging guidance must necessarily increase the intensity of the service or the work RVU. As we stated above, while the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We believe that if CPT code 36584 had become significantly more intensive to perform, this would be reflected in the surveyed work times associated with the code. However, the surveyed intraservice work time and total work time for CPT code 36584 are both decreasing from their current values. As we stated in the proposed rule, we believe that these work times are decreasing due to a combination of improving technology and greater efficiencies in practice patterns, and we believe that the use of imaging guidance has become now typical for CPT code 36584 and does not represent a dramatic increase in intensity.

      Comment: Several commenters disagreed with the proposal 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 36572 and 36573. Commenters stated that this additional clinical labor time would be typical since it included positioning of the patient as well as positioning the two forms of imaging equipment which are being bundled into the code (fluoroscopy and ultrasound). Commenters stated that the equipment needs to be positioned in a manner that is specific to the procedure and the chosen extremity, and that it takes approximately 2 additional minutes to position the patient and the equipment for those codes which are imaging-guided as opposed to those procedures which are not. Commenters stated that this difference applies to the two new placement codes (CPT code 36572 and 36573) but not to the replacement code (CPT code 36584) as the equipment is limited to fluoroscopy and the positioning is slightly simpler as the site already contains a PICC line.

      Response: After consideration of the new information provided by the commenters regarding the need for additional positioning time, we are not finalizing our proposed refinement to the CA016 clinical labor time. Due to this change in clinical labor time, we are also not finalizing any changes to the RUC-recommended equipment times.

      After consideration of the public comments, we are finalizing the work RVUs for the codes in the PICC Line Procedures family as proposed. After considering public comments, we are not finalizing our proposed direct PE refinements, and we are instead finalizing the RUC-

      recommended direct PE inputs for all five codes.

      (16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)

      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 CPT code 38531 with radical

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      vulvectomy. This service was previously reported with unlisted codes.

      CPT code 38531 (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 38531, with 223 minutes of total time and 65 minutes of intraservice time. We proposed the RUC-recommended work RVU of 6.74 for CPT code 38531. However, we were 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 codes 56630 and 56633, are both 90-day global codes. In addition, CPT code 38531 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 proposed to assign a 90-day global indicator for CPT code 38531 rather than the 10-day global time period reflected in the RUC recommendation.

      We did not propose any direct PE refinements for this code family.

      Comment: Several commenters thanked us for proposing the RUC-

      recommended work RVU of 6.74 for CPT code 38531.

      Response: We appreciate the support from commenters.

      Comment: Several stakeholders disagreed with CMS's proposal to change the global status of this code from a 10-day global code to a 90-day global code. They maintained that there are no claims data available to assess how often CPT code 38531 will be billed together with CPT codes 56630 or 56633. Commenters also noted that there is no necessary direct correlation between the two codes (CPT code 56630 and CPT code 56633) having a 90-day global period and the new code having a 90-day global period.

      Response: We agree with commenters that when two or more closely related CPT codes are billed together, there is no requirement for them to share the same global period. However, the amount of post service time and the number of visits in CPT code 38531 are consistent with other 90-day global codes. We continue to believe that CPT code 38531 should have a 90-day global period and we are finalizing that change as proposed.

      Comment: A few commenters pointed out that CMS has the opportunity to review the global periods for new codes directly after CPT Editorial Panel meetings, and that CMS should have provided input regarding the code's global period at that time.

      Response: While some of our staff have the opportunity to review global periods for new or modified CPT codes immediately after the CPT Editorial Panel meeting, the Agency does not systematically review or provide feedback on components of a CPT code, including global period, until we fully consider and address the code as part of the annual PFS notice-and-comment rulemaking process.

      After consideration of the public comments, we are finalizing a work RVU of 6.74 for CPT code 38531 as proposed.

      (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 proposed the RUC-recommended work RVU of 0.65 for CPT code 38792.

      For the direct PE inputs, we proposed 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, CPT code 78300 (Bone and/or joint imaging; limited area), 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 38792.

      Comment: A commenter stated that they appreciated and supported our proposal to adopt the RUC-recommended work RVU of 0.65. The commenter also stated that they agreed with and supported the changes CMS proposed in clinical labor time and the standardized equipment time formulas.

      Response: We appreciate the support for our proposals from the commenter.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 38792 as proposed.

      (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 CPT codes, CPT codes 43762 and 43763, which describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. (See discussion of these codes below.) Therefore, we did not propose work or direct PE values for CPT code 43760.

      Due to the impending deletion of CPT code 43760, we received no comments on this code.

      (19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)

      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 proposed a work RVU of 0.75 for CPT code 43762 (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 43763 (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.

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

      The following is a summary of the public comments we received on our proposals involving the codes in the Gastrostomy Tube Replacement code family.

      Comment: Several commenters stated that they appreciated CMS proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.

      Response: We appreciate the support for our proposals from the commenters.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was added to the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the four equipment items where we made time refinements, we added the clinical labor for the CA029 clinical labor activity in accordance with our standard equipment time formula for non-highly technical equipment.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for the codes in the as Gastrostomy Tube Replacement code family as proposed.

      (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 proposed the RUC-recommended work RVU of 0.80 for CPT code 45300.

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

      The following is a summary of the public comments we received on our proposals involving CPT code 45300.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs.

      Response: We thank commenters for their support.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the four equipment items where we made time refinements, we removed the clinical labor for the CA035 clinical labor activity in accordance with our standard equipment time formula for non-highly technical equipment.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 45300 as proposed.

      (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 disagreed with the RUC-recommended work RVU of 2.00 and we proposed 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 crosswalk code 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 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 did 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 noted 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 proposed a work RVU of 1.74 for CPT code 46500 based on the aforementioned crosswalk.

      For the direct PE inputs, we proposed 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 appreciated this notification in the recommendations, and therefore, we requested more information about why the clinical labor associated with this additional staff member was left out for previous reviews. We were particularly interested in knowing what activities the additional staff member would be undertaking during the procedure. We proposed to remove the clinical labor associated with this additional clinical staff member pending the receipt of additional information. We also proposed 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 proposed 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 46500.

      Comment: Many commenters disagreed with the proposed work RVU

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      of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-

      recommended work RVU of 2.00. Commenters stated that they disagreed with CMS calculating intraservice time ratios to account for changes in work time, and that CPT code 46500 possesses a negative IWPUT, which makes the use of time ratios particularly inappropriate.

      Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several reasonable methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values do not account for information that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology, we direct readers to the CY 2017 PFS final rule (81 FR 80272 through 80277). We also note that in the case of CPT code 46500, we derived our proposed work RVU of 1.74 by using a direct crosswalk to CPT code 68811 and not a time ratio.

      Comment: Several commenters stated that the RUC compared CPT code 46500 to the two key reference services: CPT code 46221 (Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code 46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g., infrared coagulation, cautery, radiofrequency)). Commenters stated that the RUC-recommended work RVU of 2.00 places the value correctly between the key reference services and results in similar procedure intensity, whereas the CMS crosswalk to CPT code 68811 was not well aligned with the top two key reference services due to having a lower intensity.

      Response: We disagree with the commenters that our crosswalk to CPT code 68811 would be less accurate for work valuation than the two key references chosen by the survey respondents. We note, for example, that CPT code 46221 has 50 percent more intraservice time than CPT code 46500, and CPT code 46930 has 50 percent less intraservice time than CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the same 10 minutes of intraservice time as CPT code 46500. We believe that this closer match in the work time values makes CPT code 68811 a more appropriate choice for a crosswalk code. We also note that at the RUC meeting when CPT code 46500 was under review, the specialty presenters stated that the work RVU had not changed from the historical value of 1.69 before the recommendation was changed to the final value of 2.00. As we stated in the proposed rule, 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. We continue to believe that this is the most accurate value to finalize for CPT code 46500.

      Comment: Several commenters compared CPT code 46500 to CPT code 68810 (Probing of nasolacrimal duct, with or without irrigation) and noted that these codes have the same intraservice work time but the comparison code includes a lower level follow-up visit and therefore correctly has a lower work RVU. Commenters stated that CPT code 46500 includes a follow-up office visit with an anoscopy to determine the effectiveness of the treatment and to monitor for infection or sepsis which adds work to the visit. Commenters stated that the proposed CMS crosswalk to CPT code 68811 includes an even lower level office visit (CPT code 99211) than the office visit in CPT code 68810, which indicated that it was an inappropriate choice for a crosswalk.

      Response: We continue to disagree with the commenters that the CMS crosswalk to CPT code 68811 would provide an inappropriate work valuation for CPT code 46500 based on the differences in postoperative work and work time. We would like to clarify again that we used CPT code 68811 as our crosswalk, not CPT code 68810, and we do not understand the comparisons to CPT code 68810 suggested by the commenters. Regarding our crosswalk code, while it is true that CPT code 68811 does not contain a level three (CPT code 99213) office visit in its global period like CPT code 46500, the code does include half of a discharge visit (CPT code 99238) in its global period, which is missing from the reviewed code. Under the building block methodology, the combined work RVU and the work time of a half discharge visit (CPT code 99238) and a level 1 office visit (CPT code 99211) would equal 0.82 RVUs and 26 minutes. This is approximately equal to the level 3 office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work time) in the global period of CPT code 46500. As a result, we do not agree with the commenters that CPT code 46500 has a significantly greater amount of postservice work and postservice work time than our crosswalk code.

      Comment: Several commenters responded to our request for more information about why the clinical labor associated with the additional staff member was left out of previous reviews and what activities the additional staff member would be undertaking during the procedure. Commenters stated that two clinical staff are needed to assist the physician during the intraservice portion of the service: one staff person is handling suction and holding the retractor while the surgeon identifies and injects anesthetic and sclerosant into the poles of the hemorrhoids, and the second staff person is handing supplies (syringes, gauze) and taking soiled supplies away. The commenters stated that one staff person will assist with tasks such as irrigation, suction, etc. and one circulating staff person will hand syringes, sponges, etc. to the physician.

      Response: We appreciate the additional feedback from the commenters regarding what activities the additional staff member would be undertaking during the procedure, although we note that we did not receive a response regarding why the clinical labor associated with this additional staff member was left out of previous reviews. After reviewing the

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      additional information supplied by the commenters, we are not finalizing our proposal to remove the clinical labor time for the ``Assist physician or other qualified healthcare professional'' (CA018) activity or the proposal to remove 1 impervious staff gown (SB027), 1 surgical mask with face shield (SB034), and 1 pair of shoe covers (SB039). We are finalizing the RUC-recommended values for these direct PE inputs.

      Comment: Several commenters disagreed with the proposal to remove the clinical labor time for the ``Review home care instructions, coordinate visits/prescriptions'' (CA035) activity. Commenters stated that this clinical activity was not duplicative with the same day E/M office visit, as the home care instructions directly pertain to the procedure and would not be provided during an evaluation of the patient.

      Response: We disagree with the commenters that home care instructions would not be provided during the same day E/M visit. The commenters did not provide a rationale to explain why home care instructions would not be provided during the same day E/M visit, which also directly pertains to the procedure. We continue to believe that it would be duplicative to assign clinical labor time for this task, as we believe that the home care instructions would be furnished during the same day E/M visit.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the anoscope with light source (ES002) equipment, we removed the clinical labor for the CA029 and CA035 clinical labor activities in accordance with our standard equipment time formula for scopes.

      After consideration of the public comments, we are finalizing the work RVU for CPT code 46500 as proposed. We are finalizing the RUC-

      recommended direct PE inputs for this code, with the exception of our refinement to the CA035 clinical labor activity and standard equipment time refinements as detailed above.

      (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 it 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 proposed the RUC-recommended work RVU of 4.00 for CPT code 49422.

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving CPT code 49422.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs. Commenters also supported the change in global period to a 0-day global.

      Response: We thank commenters for their support.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVU and direct PE inputs for CPT code 49422 as proposed.

      (23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and 74485)

      In October 2014, the CPT Editorial Panel deleted 6 codes and created 12 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 2 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 50436 (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 disagreed 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 noted that the reference CPT codes both have substantially higher total and intraservice times than CPT code 50436. We considered a number of parameters to arrive at our proposed work RVU of 2.78, supported by a 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

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      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 proposed a work RVU of 2.78 for CPT code 50436.

      The specialty society also surveyed the new CPT code 50437 (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 50436. 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 did not agree with the RUC's recommended work RVU because we believed 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 proposed to reduce the intraservice time for CPT code 50437 from the RUC- recommended 60 minutes to the survey median time of 45 minutes. We noted that this is still 15 minutes more than the intraservice time for CPT code 50436, primarily for the provider to introduce the guidewire into the renal pelvis and/or ureter. We welcomed 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 believed that the RUC-recommended work RVU for this CPT code is overstated. When we applied the increment between the RUC-

      recommended values for between CPT codes 50436 and 50437 (2.07 work RVUs) in addition to our proposed work RVU for CPT code 50436, we estimated that this CPT code was 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 an intraservice time of 40 minutes and a total time of 86 minutes. We believed that CPT code 36902 describes a service that is similar to the new CPT code 50437) and therefore provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT code 50437.

      We proposed 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 proposed 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 50436 and 50437), CPT code 52334 does not include imaging guidance in its code descriptor. When CPT code 52334 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 believed that it would be duplicative to include this clinical labor time in CPT code 52334.

      The following is a summary of the public comments we received on our proposals involving the Dilation of Urinary Tract family of codes.

      Comment: Several commenters responded to our proposals regarding work RVUs for this family of codes. In general, commenters expressed support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83 for CPT code 74485.

      Response: We are finalizing the work RVUs for each of these codes as proposed.

      Comment: Several commenters did not support our proposals regarding the work RVU for CPT codes 50436 and 50437. The RUC and other commenters stated that CMS misunderstood the RUC's summary of results (SOR) and the purpose of the reference codes and the code comparisons as part of their review process. They suggested that our rejection of the RUC recommendation for CPT code 50436 was based on a mistake about the codes that the RUC cited as reference codes.

      Response: We consider a variety of documents and data during our review of the RUC's recommended work RVU for a code. The two reference codes cited in the excel summary work RVU spreadsheet for CPT code 50436 were CPT codes 50694 and 50695, while the two reference codes cited in the SOR were CPT codes 52287 52214. In other words, there was an inconsistency in the documentation. We believe that any of the four reference codes cited in the documentation and/or data are valid points of comparison for evaluating whether the RUC's recommended work RVUs are appropriate.

      Comment: Some commenters did not agree with CMS's use of intraservice time ratios as a factor in determining whether a CPT code is appropriately valued. The commenters maintained that CMS's use of these parameters is inappropriate and demonstrates our prioritization of time-related factors above the intensity and complexity of the service.

      Response: We routinely use intraservice time ratios to determine whether a recommended work RVU for a new CPT code adequately reflects efficiencies gained when codes are bundled and/or providers become more efficient at furnishing services and we disagree with commenters that time

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      ratios are an inappropriate metric. We identify a crosswalk for the purpose of establishing the work RVU by comparing the survey code to other codes in the PFS with similar intraservice and total times and also by considering the intensity among codes with similar times. We disagree that this means we are prioritizing time parameters over other factors that are relevant in considering a code's value.

      Comment: Commenters disagreed with CMS's proposed work RVU of 2.78 for CPT code 50436, citing CMS's inappropriate use of time parameters in comparing this code with the deleted CPT code 50395.

      Response: Even after taking into consideration the bundling of the deleted code, CPT 50395, with CPT code 74485, we believe that there are efficiencies in the work that are not adequately reflected in the RUC-

      recommended work RVU for this new code, CPT 50436. We examined a number of parameters in seeking an appropriate crosswalk code for CPT 50436, including the intraservice time ratio for this new code in relation to the combination of CPT codes that the service represents and the intraservice time ratio for the new code in relation to each of the RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the work RVU (2.78) corresponding to the most appropriate, and the highest, work RVU (2.72) associated with these calculations. Our identification of a crosswalk code is not dictated by the time parameter calculations alone, but rather is based on a combination of the time parameters and our understanding of the intensity involved in furnishing the service. If we had been looking only at time parameters, we might have chosen a CPT code with a work RVU closest to the lowest of the time parameter calculations (2.54). We continue to believe that the most appropriate crosswalk is CPT code 31646, and we are finalizing our proposed work RVU of 2.78 for CPT code 50436.

      Comment: As with CPT code 50436, commenters suggested that CMS mistook the codes included in the SOR as the codes that the RUC cited as reference codes.

      Response: As we indicated in our response to this comment for CPT code 50436, we consider all documentation and data provided by the RUC in our assessment of the work RVU for a code. The reference and comparison CPT codes cited in the SOR did not match those in the summary work RVU spreadsheet.

      Comment: Several commenters disagreed with our method of proposing a work RVU based on the incremental differences in the RUC-recommended work RVU between codes. Commenters stated that this erroneously considers all time components as having equal intensity.

      Response: We generally apply this methodology where we agree with, and seek to maintain the relativity between two codes reflected in the RUC recommendations, but we disagree with the RUC-recommended work RVU for one or both of the codes. We also considered, as an alternative, whether it would be more appropriate to use proportional increments rather than absolute differences between two RUC-recommended work RVUs. Under that scenario, we would have proposed a work RVU of 4.49 for CPT code 50437 (2.78 * 5.44)/3.37 = 4.49. However, since our general approach involves applying the absolute difference in work RVUs, our proposed value for CPT code 50437 was 4.83 work RVUs. We thank the commenter for pointing out our calculation error, due to which our proposed work RVU should have been 4.85 instead of 4.83. We continue to believe that relative difference in the RUC's recommendations for work RVUs between codes is a useful and appropriate tool for determining work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for CPT code 50437 based on a comparison with CPT code 36902, which has a work RVU of 4.83.

      Comment: Several commenters disagreed with the proposal to remove the clinical labor time for the ``Confirm availability of prior images/

      studies'' (CA006) activity for CPT code 52334. Commenters stated that the equivalent of the CA006 clinical labor activity did not exist when this service was last reviewed by the Practice Expense subcommittee in 2002, and that many surgical procedures and other types of services that do not have imaging bundled involve the physician reviewing images and studies before performing the service. Commenters stated that this review is not duplicative with image-guidance codes as it instead involves reviewing distinct previous studies.

      Response: We continue to believe that this clinical labor time should be removed because it is duplicative, as CPT code 52334 would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images when it is performed with imaging guidance. We believe that the commenters may be conflating the absence of the CA006 clinical labor activity when CPT code 52334 was previously reviewed with the lack of any clinical labor for reviewing images that did not exist previously in this specific code. There were hundreds of procedures that included clinical labor for reviewing images prior to the creation of the CA006 clinical labor code, and CPT code 52334 was not one of them. Similarly, while we agree that there are many services that do not have bundled imaging and nonetheless include the physician reviewing images and studies before performing the service, this does not explain why CPT code 52334 would require clinical labor time for confirming the availability of prior images and studies when the service did not include this clinical labor time previously. We continue to believe that the inclusion of this clinical labor time would be duplicative for this service.

      Comment: One commenter requested that CPT code 52334 be added to the phase-in list for codes with significant PE RVU reductions.

      Response: Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, 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. We proposed to exempt CPT code 52334 from the phase-in due to the fact that it is part of the same family of codes that included new CPT codes 50436 and 50437. We have previously finalized this policy through rulemaking, stating that significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Excluding codes from the phase-in when there are significant revisions to the code family also helps to maintain the appropriate rank order among codes in the family, avoiding years for which RVU changes for some codes in a family are in transition while others were fully implemented. For additional information regarding the phase-in of significant RVU reductions, we direct readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70929).

      (24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 53852, and 53854)

      In September 2017, the CPT Editorial Panel created a new code (CPT code

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      53854) 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 proposed 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 53854 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for CPT code 53852.

      CPT code 53854 is a service reflecting 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 did 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 believed that this would be a better reflection of the work involved in furnishing CPT code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT code. We welcomed 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 proposed to add a new supply (SA128: ``kit, Rezum delivery device''), a new equipment item (EQ389: ``generator, water thermotherapy procedure''), and proposed to update the price of two supplies (SA036: ``kit, transurethral microwave thermotherapy'' and SA037: ``kit, transurethral needle ablation (TUNA)'') after reviewing invoices that we received. We noted that these invoices were submitted along with additional information listing the vendor discount for these supplies and equipment. We appreciated the inclusion of the discounted prices on these invoices, and we encouraged other invoice submissions to provide the discounted price as well, where available. Based on market research on supply and equipment pricing carried out by our contractors, we 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 encouraged the submission of additional invoices that include the discounted price of supplies and equipment to more accurately assess the market cost of these resources.

      The following is a summary of the public comments we received on our proposals involving the Transurethral Destruction of Prostate Tissue family of codes.

      Comment: Several commenters expressed support for our proposed work RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which reflect the RUC's recommendations for these two codes.

      Response: We appreciate the commenters' support and we are finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93 for CPT code 53852.

      Comment: A commenter pointed out that there is an error in our description of the RUC's time components for this code. We stated that there was less post service time for CPT code 53854 than for CPT code 53852 when, in fact, both codes have a post service time of 15 minutes. The intraservice time between the two codes differs by 5 minutes, with CPT code 53854 having 5 fewer minutes than CPT code 53852.

      Response: We thank the commenter for informing us of the error. We note, however, that this does not affect our proposal which is based on a comparison of both intraservice and total time ratios.

      Comment: Several commenters, ranging from device manufacturers and professional associations, disagreed with our proposed value of 5.70 for CPT code 53854 instead of the RUC-recommended work RVU of 5.93. Commenters stated that the work involved in furnishing the service described by CPT code 53854 is the most intense of the three CPT codes in this family because of the added risk of bleeding, urinary retention and damage to the external urinary sphincter with resultant incontinence of urine if not performed properly. Commenters also urged CMS to approach the time results from the survey for this code with caution, as few practitioners are likely to have had much experience with the new technology described by this service.

      Response: In our proposal, we requested additional information from stakeholders about the time and intensity required to furnish this service because we were not convinced that the work involved in furnishing the service described by CPT code 53854 is more intense than the work involved in furnishing CPT code 53852, which the RUC used as a reference code in developing their recommendation. We were convinced by commenters, however, that the additional risk in furnishing this service supports a higher work RVU than what we proposed. Therefore, we are finalizing a work RVU of 5.93 for this CPT code, as recommended by the RUC.

      Comment: One commenter stated that both CPT codes should be subject to the phase-in for CY 2019 because they will decrease more than 20 percent and are not new or revised codes. The commenter urged CMS to add CPT codes 52380 and 52382 to the list of codes subject to the phase-in.

      Response: Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, specifies that for services that

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      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. We proposed to exempt CPT codes 52380 and 52382 from the phase-

      in of significant RVU reductions required by section 1848(b)(11) of the Act because these codes are part of the same family of codes that included new CPT code 53854. We have previously finalized this policy through rulemaking, stating that significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Excluding codes from the phase-in when there are significant revisions to the code family also helps to maintain the appropriate rank order among codes in the family, avoiding years for which RVU changes for some codes in a family are in transition while others were fully implemented. For additional information regarding the phase-in of significant RVU reductions, we direct readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70929).

      Comment: One commenter stated that they were concerned about substantial reductions in billable staff time and supply costs associated with CPT codes 53850 and 53852. The commenter stated that reductions in billable staff time will require treating physicians to minimize non-procedural time which may include: Comfort control protocols; patient expectation management; patient post-procedure instructions; and recommended best practices for follow-up care. The commenter stated that they were concerned that the proposed supply costs are not in line with actual pricing or with actual cost increases for manufacturing of the product, and indicated that significant reductions in reimbursement will limit patient access to a therapy with demonstrated safety, effectiveness, and cost efficacy.

      Response: We appreciate the feedback from the commenter, and we are sensitive to the need for accurate payment under the PFS to ensure that beneficiaries maintain access to care. However, we note that we proposed the RUC-recommended direct PE inputs for this family of codes without refinement, and the decreases in clinical staff time for these procedures were almost entirely due to shorter surveyed intraservice work times and the removal of office visits in the postoperative portion of the global period as identified by the RUC. We agree with the RUC that fewer follow-up office visits and shorter intraservice times are now typical for these procedures, and we do not believe that the resulting decreases in clinical labor time will create barriers to accessing care. With regard to changes in the proposed supply costs, we direct readers to our discussion of the market-based supply and equipment pricing update in section II.B. of this final rule. We encourage stakeholders to continue to provide feedback concerning accurate supply and equipment pricing.

      After consideration of the comments, we are finalizing the RUC-

      recommended work RVUs and direct PE inputs for the three codes in the Transurethral Destruction of Prostate Tissue family of codes.

      (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 proposed 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 did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Vaginal Treatments family of codes.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs.

      Response: We thank commenters for their support.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT codes 57150 and 57160 as proposed.

      (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 proposed 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 proposed 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Biopsy of Uterus Lining family of codes.

      Comment: Several commenters stated that they appreciated that CMS proposed 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.

      Response: We appreciate the support for our proposals from the commenters.

      Comment: Several commenters disagreed with the CMS proposal to remove the clinical labor time for the ``Review/read post-procedure x-

      ray, lab and pathology reports'' (CA028) activity for CPT code 58100. Commenters stated that this clinical labor activity was not duplicative, as CA028 is designed specifically for post-procedure activity during the postservice of the service period which would not overlap with activities in the E/M office visit, which typically occur prior to the procedure and are listed as a preservice clinical labor activity. Commenters stated that the clinical description of the service for CPT code 58100 clearly notes that the E/M service is done the day before the service and that the patient returns for the biopsy.

      Response: We disagree with the commenters' statements about the timing of the E/M office visit. The same day billing data indicates that CPT code 58100 is typically billed with an E/M office visit on the same day (59 percent of the time), and it therefore seems clear that the E/M office visit typically takes place during the day of the procedure,

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      not the day before. We do not understand how the claims analysis fits with the statement from the commenters that the E/M service happens the day before the procedure, especially since CPT code 58100 has a 0-day global period that does not include preoperative care that takes place the day before the procedure. We continue to 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 believe that this clinical labor would be carried out during the same day E/M visit.

      After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Biopsy of Uterus Lining family of codes as proposed.

      (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 proposed the RUC-recommended work RVU of 0.94 for CPT code 64405.

      For the direct PE inputs, we proposed to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 64405.

      Comment: Some commenters expressed support for our proposal to accept the RUC-recommended work RVU for this code.

      Response: We appreciate the support from the commenters for our proposals.

      After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 64405 as proposed.

      (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 proposed the RUC-

      recommended work RVU of 0.75 for CPT code 64455.

      For the direct PE inputs, we proposed to refine the equipment time for the exam table (EF023) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 64455.

      Comment: Several commenters supported the CMS proposal of the RUC-

      recommended work RVU of 0.75.

      Response: We appreciate the support for our proposals from the commenters.

      After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 64455 as proposed.

      (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 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 proposed the RUC-recommended work RVU of 0.49 for CPT code 65205. We noted 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 noted 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 did 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 disagreed with the RUC-recommended work RVU of 0.75 and we proposed 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 noted 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 did not propose 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 noted 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 proposed 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)

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      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 disagreed 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 did not currently propose to refine the equipment time for the screening lane in these two codes, we solicited 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.

      The following is a summary of the public comments we received on our proposals involving the Removal of Foreign Body--Eye family of codes.

      Comment: Commenters agreed with the CMS proposal of the RUC-

      recommended work RVU for CPT code 65205.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: Several commenters disagreed with our statement that the RUC-recommended work RVU for CPT code 65205 appeared to have been developed under a methodology similar to the use of time ratios. Commenters stated that time ratios were not used in arriving at the value of 0.49 for CPT code 65205, and that the recommended work RVU was based instead on a crosswalk to the second key reference code from the survey, CPT code 68200, which requires the same total time to perform and shares identical intensity and complexity.

      Response: We appreciate the additional information provided by the commenters regarding the methodology behind the recommended work RVU for CPT code 65205. As we noted in the proposed rule, this recommendation appeared to have been developed under a methodology similar to our ongoing use of time ratios; we did not state that the recommendation was explicitly based on the use of a time ratio.

      Comment: Many commenters disagreed with the proposed work RVU of 0.61 for CPT code 65210 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.75. Commenters stated that CMS should not use intraservice time ratios for work valuation as this methodology ignored the work estimates present in the survey data and the RUC review of those work estimates. Commenters stated that the RUC-recommended work values consider intensity and complexity of the work, while CMS substituted an arbitrary determination of work values based on time and a subjective estimate of intensity and complexity based on an unknown and clinically uninformed opinion.

      Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values recommended by the RUC and other commenters do not account for information provided by surveys that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology for developing work RVUs, we direct readers to the discussion in the CY 2017 PFS final rule (81 FR 80272 through 80277). We also note that in the case of CPT code 65210, we derived our proposed work RVU of 0.61 by using a direct crosswalk to CPT code 92511 and not a time ratio.

      Comment: Several commenters noted that CPT code 65210 had never been surveyed and was based on Harvard time which contributed to the median survey intraservice time of 5 minutes being less than half of the current value of 13 minutes. Commenters stated that Harvard times should be not be used for any sort of time comparison, especially when the code was not originally surveyed by Harvard, and any comparisons with these work times were inappropriate.

      Response: We agree that it is important to use the most recent data available regarding time, and we note that when many years have passed between when time is measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The times currently associated with codes play a very important role in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had routinely been overestimated, this would undermine the relativity of the work RVUs on the PFS in general, given the process under which codes are often valued by comparisons to codes with similar times, and it also would undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS. Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times used in the PFS ratesetting processes are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we want to reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of current work time values in our methodology, we refer readers to our discussion of the subject in the CY 2017 final rule (81 FR 80273 through 80274).

      Comment: Several commenters stated that the procedure described by CPT code 65210 has not fundamentally changed, and therefore the RUC had recommended a work RVU at the 25th percentile in accordance with the recent survey. One commenter stated that the

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      intensity of the procedure was also unchanged. Commenters stated that the crosswalk and reference codes chosen by CMS were clearly not as intense as the removal of an embedded foreign body described by CPT code 65210, in which an incision into ocular tissue is required.

      Response: We disagree with the commenters that CPT code 65210 has not fundamentally changed. We note for example that the surveyed work times have decreased drastically from the prior valuation, and similarly, the intensity of the service as measured by the survey more than doubled. These factors do not comport with the statement from the commenters that intensity of this service is unchanged. We also note that the RUC-recommended work RVU of 0.75 was a decrease from the current work RVU of 0.84, which also does not appear to reflect the idea that the intensity of the service has not changed. We similarly disagree with the commenters that our crosswalk and reference codes are not as intense as CPT code 65210. CPT code 92511 in particular describes a nasopharyngoscopy with endoscope that requires removing secretions and dried mucus blocking passage to the nasopharynx with suction and/or forceps. We disagree with the commenters that this procedure would be less intensive than the removal of a foreign body as described in CPT code 65210.

      Comment: Several commenters disagreed with the CMS comparison of CPT code 65210 to two injection codes (CPT codes 20551 and 64455) which were reviewed at the same RUC meeting as CPT code 65210. Commenters stated that the two referenced codes both have a lower intensity than CPT code 65210 and therefore they were not appropriate references for work valuation. Commenters stated that CPT code 65210 has a lower total time and a higher intensity than both of these injection procedures, justifying the recommended work RVU of 0.75.

      Response: We disagree with the commenters that CPT code 65210 would typically have a higher intensity than CPT codes 20551 and 64455. These codes both describe injection procedures, with CPT code 20551 describing an injection into the tendon and CPT code 64455 describing an injection into the plantar common digital nerve. We do not agree that the removal of a foreign body from the eye as described in CPT code 65210 would have such greater intensity that it warrants a work RVU of 0.75 (to match CPT codes 20551 and 64455) despite having approximately 40 percent less total work time.

      Comment: Several commenters stated in response to the CMS comment solicitation that the screening lane (EL006) equipment would typically be in use for the total work time of CPT codes 65205 and 65210. Commenters stated that the screening lane is the ophthalmic equivalent of an exam room in the non-facility setting which would be needed for the total time of the procedure. Commenters stated that this equipment time represented the total time taken by the physician to perform the service in the screening lane (which would be not be available for use by another patient during the time of the procedure), plus the time inputs for the technician work as listed above.

      Response: We appreciate the additional information provided by the commenters regarding the use of the screening lane (EL006) equipment.

      After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Removal of Foreign Body--Eye family of codes as proposed.

      (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 proposed the RUC-recommended work RVU of 1.18 for CPT code 67500.

      For CPT code 67505, we disagreed with the RUC-recommended work RVU of 1.18 and we proposed 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 proposed a work RVU of 0.94 for CPT code 67505.

      For CPT code 67515, we disagreed with the RUC-recommended work RVU of 0.84 and we proposed 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; 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 did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Injection--Eye family of codes.

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      Comment: Commenters were supportive of the CMS proposal of the RUC-

      recommended work RVU of 1.18 for CPT code 67500.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: Many commenters disagreed with the proposed work RVU of 0.94 for CPT code 67505 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.18. Commenters were confused by the CMS statement that, at the recommended identical work RVUs, CPT code 67500 has almost triple the intensity of CPT code 67505. Commenters stated that the RUC recommendation for CPT code 67505 has less total time and slightly higher intensity than CPT code 67500.

      Response: We agree with the commenters that this was an inaccurate statement; we intended to state that the current intensity of CPT code 67500 prior to review is almost triple the current intensity of CPT code 67505. We regret any resulting confusion on this subject.

      Comment: Several commenters disagreed with the use of a time ratio analysis to support the CMS proposed work value. Commenters stated that time ratios do not adequately account for intensity and complexity of work, which can only be addressed through the survey and the RUC process.

      Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values recommended by the RUC and other commenters do not account for information provided by surveys that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology for developing work RVUs, we direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277). We also note that in the case of CPT code 65210, we derived our proposed work RVU of 0.61 by using a direct crosswalk to CPT code 31575 and not a time ratio.

      Comment: Several commenters stated that while it was true that the current work value for CPT code 67500 is higher than that of CPT code 67505, the survey 25th percentiles indicated that the physician work of CPT code 67505 (work RVU = 1.30) is higher than that of CPT code 67500 (work RVU = 1.18). Commenters stated that the reason for performing surveys is to adjust for changes in physician work that have occurred since the prior survey, and that it was inappropriate to put more weight on old data than on the most recent data. Commenters also disagreed with the proposed work RVU on clinical grounds, stating that CPT code 67505 has a higher intensity than CPT code 67500, not because of potential vision loss, but because of the risk of death if the absolute alcohol is injected accidentally into the optic nerve sheath. Commenters stated that the alcohol injection involved in CPT code 67505 is typically very painful, even after a local anesthetic injection, and carries with it the risk of death which therefore makes it a high-

      intensity procedure for both patient and physician.

      Response: We appreciate the additional clinical details involving CPT code 67505 from the commenters. After reviewing the information provided by the commenters, we are not finalizing our proposed work RVU of 0.94 for CPT code 67505, and we are finalizing the RUC-recommended work RVU of 1.18 instead due to the additional risks carried by the procedure.

      Comment: Many commenters disagreed with the proposed work RVU of 0.75 for CPT code 67515 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.84. Commenters disagreed with the CMS crosswalk to CPT code 64450 and stated that the intensity of an injection adjacent to the eye in which the physician is unable to see the needle tip is clearly greater than that of an injection into a peripheral nerve as in the code for the CMS proposed crosswalk. Commenters stated that the use of a time ratio methodology for CPT code 67515 was particularly inappropriate due to changes in the RUC survey methodology since the last survey for this service was performed, and that increases in the intensity of CPT code 67515 should not be of concern due to the 0-day global period and short intraservice work time.

      Response: We continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs, as described in more detail in our response to the comments for CPT code 67505 above. We also disagree with the commenters on their objections on clinical grounds concerning our crosswalk to CPT code 64450. CPT code 64450 describes the injection of an anesthetic agent into a peripheral nerve or branch, and the practitioner performing this service also cannot see a needle tip when injecting into a peripheral nerve. In other words, this is the same situation as that described in CPT code 67515: The practitioner performing the service is unable to see the needle tip in both cases. We continue to note that the RUC-

      recommended crosswalk code (CPT code 65222) has more than double the intraservice time of CPT code 67515 at 7 minutes, and we continue to believe that it would be more accurate to use a crosswalk to a code with a similar intraservice time such as CPT code 64450.

      After consideration of the public comments, we are finalizing the work RVUs for CPT codes 67500 and 67515 as proposed. We are finalizing the RUC-recommended work RVU of 1.18 for CPT code 67505. We are also finalizing the direct PE inputs for all three codes as proposed.

      (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

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      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 had 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. Without the benefit of a survey or other external source of data about these CPT codes, there is no information 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 the RUC process or methodology that might reduce the burden of conducting surveys, but without the benefit of any additional data, through surveys or otherwise, we were not convinced that there was 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 proposed 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 was a work RVU of 0.23, which we proposed 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 recognized that the proposed work RVU for some of these CPT codes might be somewhat lower at the code level than the RUC's recommendation, while the proposed work RVU for other CPT codes might 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 implied a level of precision about the time and intensity of the CPT codes that we had no way to validate.

      For the direct PE inputs, we proposed 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 proposed to add the patient gown to match the other codes in the family. We believed that the exclusion of the patient gown for CPT code 72120 was most likely due to a clerical error in the recommendations. We also proposed 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 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 did not propose to refine the clinical labor times for this task as we did not have data available to know how many views would be typical for these CPT codes. However, we noted 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 believed 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 welcomed any comments that may be able to provide additional details for the 12 codes under review in this family.

      The following is a summary of the public comments we received on our proposals involving the X-Ray Spine family of codes.

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      Comment: A number of commenters disagreed with our proposal to apply an identical work RVU, calculated as the utilization-weighted average RUC-recommended work RVU for each of the 20 CPT codes, to each of the CPT codes in this group. Commenters defended the crosswalk methodology, stating that it is the best approach for valuing work RVUs for codes in which the service times are very low and therefore difficult to survey. The commenters noted that the specialty societies have tried to survey codes such as this in the past with results that yielded substantial inconsistencies.

      Response: We share the commenters' concerns about the validity of surveying services with very low intraservice and total time, but we have even more substantial concerns about a methodology that introduces no new information about the work involved in furnishing these CPT codes and then states their accuracy to the hundredth of a work RVU. Survey data from the specialty societies is often the only data source available to us that reflects the experiences of a cross-section of providers. We remind stakeholders that we welcome additional information or data from all sources to assist us in making proposals and finalizing values.

      Comment: In response to our proposal, the RUC offered to survey each code in the expanded family of X-ray codes to which CMS applied the weighted average methodology and provide survey based recommendations for CY 2020.

      Response: We appreciate the recognition on the part of the RUC of our serious concerns about the crosswalk methodology and the integrity of the resulting RUC recommended work RVUs. We welcome the submission of any additional data or information that would allow us to consider these codes for review at a future time. Commenters raised concerns that assigning a single weighted average work RVU across this broad family of x-ray codes inadequately reflects meaningful differences among the codes, including the number of views and the complexity of positioning for some x-ray services. In response to commenters' concerns, we are instead maintaining the CY 2018 work RVUs for each CPT code as follows: Work RVU of 0.15 for CPT code 72020, 0.22 for CPT 72040, 0.31 for CPT code 72050, 0.36 for CPT code 72052, 0.22 for CPT code 72070, 0.22 for CPT code 72072, 0.22 for CPT code 72074, 0.22 for CPT code 72080, 0.22 for CPT code 72100, 0.31 for CPT code 72110, 0.32 for CPT code 72114, and 0.22 for CPT code 72120.

      Comment: Several commenters indicated that it was inappropriate for CMS to value the practice expense portion of the 20 CPT codes identically because the resources required to furnish each of the services differ in accordance with the number of X-rays or views and other factors.

      Response: We did not propose to value the practice expense portion of these codes identically. The proposal regarding the weighted average for these codes refers to the work component of RVUs only.

      Comment: One commenter stated that they appreciated and agreed with adding a patient gown (SB026) supply to CPT code 72120.

      Response: We appreciate the support for our proposal from the commenter.

      Comment: Several commenters stated that they would like to provide clarity on the typical number of films obtained for the X-ray spine codes and the rationale for the number of minutes and assumed number of views that would be typical. Commenters stated that a minimum of 3 views would be needed in order to adequately assess the cervical spine as described by CPT code 72040. Commenters stated that the open mouth odontoid view helps in the assessment of the atlanto-occipital joint, and that the AP and lateral views of the vertebral bodies are required to assess the alignment of the vertebral bodies in two planes, the disc spaces, the spinal canal, fractures, and widening of different joints. Commenters provided a similar level of clinical detail regarding the typical number of views required for CPT codes 72050 and 72052.

      Response: We appreciate the detailed information provided by the commenters in response to our request for data sources regarding the intraservice clinical labor times in those services that do not match the physician intraservice time.

      After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Spine family of codes. We are finalizing the direct PE inputs for these codes as proposed.

      (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 proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the X-Ray Sacrum family of codes.

      Comment: Comments regarding our proposed work RVU for this family of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120).

      Response: As discussed above, we are maintaining the CY 2018 work RVUs for each code in this family as follows: Work RVU of 0.17 for CPT code 72200, 0.19 for CPT Code 72202, and 0.17 for CPT code 72220.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the basic radiology room (EQ137) equipment, we removed the clinical labor for the CA030 clinical labor activity in accordance with our standard equipment time formula for highly technical equipment.

      After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Sacrum family of codes. We are finalizing the direct PE inputs for these codes as proposed.

      (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 proposed to refine the equipment time for the

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      basic radiology room (EL012) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the X-Ray Elbow-Forearm family of codes.

      Comment: Comments regarding our proposed work RVU for this family of codes were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120).

      Response: As discussed above, we are maintaining the CY 2018 work RVUs for each code in this family as follows: Work RVU of 0.15 for CPT code 73070, 0.17 for CPT code 73080, 0.17 for CPT code 73090.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the basic radiology room (EQ137) equipment, we removed the clinical labor for the CA030 clinical labor activity in accordance with our standard equipment time formula for highly technical equipment.

      After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Elbow-Forearm family of codes. We are finalizing the direct PE inputs for these codes as proposed.

      (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 proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 73650.

      Comment: Comments regarding our proposed work RVU for this code were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120).

      Response: As discussed above, we are maintaining the CY 2018 work RVU of 0.16 for CPT code 73650.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the basic radiology room (EQ137) equipment, we removed the clinical labor for the CA030 clinical labor activity in accordance with our standard equipment time formula for highly technical equipment.

      After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Heel family of codes. We are finalizing the direct PE inputs for these codes as proposed.

      (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 proposed 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 proposed to add the patient gown to match the other codes in these families. We also proposed to refine the equipment time for the basic radiology room (EL012) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 73660.

      Comment: Comments regarding our proposed work RVU for this code were similar to those discussed in (31) X-Ray Spine (CPT codes 72020, 72040, 72050, 72052, 72070, 72072, 72074, 72080, 72100, 72110, 72114, and 72120).

      Response: As discussed above, we are maintaining the CY 2018 work RVU of 0.13 for CPT code 73660.

      Comment: Several commenters stated that the typical patient for this service would not require a patient gown. Commenters stated that this was different than other codes in the family where the patient may need to be rotated lateral and prone for different views.

      Response: We appreciate the feedback from the commenters. In light of the information supplied by commenters, we will not finalize our proposal to add a patient gown (SB026) supply to CPT code 73660.

      Comment: One commenter stated that CMS did not indicate what amount of service period time was removed from the calculation of the equipment time, and that this made it difficult to determine the accuracy of the refinements. The commenter requested more information about this change.

      Response: For the basic radiology room (EQ137) equipment, we removed the clinical labor for the CA030 clinical labor activity in accordance with our standard equipment time formula for highly technical equipment.

      After consideration of the public comments, we are maintaining the CY 2018 work RVUs for the codes in the X-Ray Toe family of codes. We are finalizing the direct PE inputs as proposed with the exception of the patient gown (SB026) supply as detailed above.

      (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 proposed 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 did not propose to refine the quantity of the Polibar barium suspension at this time, we solicited additional comment about the typical use of the supply in these procedures. We also proposed to refine the equipment times for all three codes in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our

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      proposals involving the X-Ray Esophagus family of codes.

      Comment: We received no specific comments regarding our proposals for work RVUs in this family.

      Response: As a result, we are finalizing a work RVU of 0.59 for CPT code 74210, a work RVU of 0.67 for CPT code 74220, and a work RVU of 0.53 for CPT code 74230 as proposed.

      Comment: Several commenters responded to the comment solicitation about the typical use of the Polibar barium suspension (SH016) supply in these procedures. Commenters stated that the barium suspension quantity listed for CPT code 74210 prior to review was only 1 ml which appeared to be a technical error in mistaking number of milliliters for number of items, as this was an insufficient quantity of barium for the procedure. Commenters stated that CPT code 74220 did not have barium suspension listed as a supply item, which appeared to be an oversight. The commenters described how the patient swallows a small quantity of high density barium to outline the esophagus, followed by multiple subsequent swallows of normal density barium that are assessed under fluoroscopy from different angles to evaluate the esophageal anatomy and mucosa.

      Response: We appreciate the additional details provided by the commenters regarding the use of the Polibar barium suspension (SH016) supply, and the clarification that the previous supply quantities in these procedures appear to have been in error.

      After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for the codes in the X-Ray Esophagus family of codes as proposed.

      (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 proposed the RUC-recommended work RVU of 0.52 for CPT code 74420 (Urography, retrograde, with or without KUB).

      For the direct PE inputs, we proposed 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 proposed to remove it to match the rest of the X-ray codes. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 74420.

      Comment: We received no specific comments regarding our proposal for the work RVU for CPT code 74420.

      Response: We are finalizing a work RVU of 0.52 for CPT code 74420.

      Comment: Several commenters disagreed with the proposal to remove the 1 minute of clinical labor time for the ``Confirm order, protocol exam'' (CA014) activity. The commenters stated that this service was distinct from the other X-ray services reviewed during this cycle and encouraged CMS to modify this proposal by finalizing the RUC-

      recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 74420, we are finalizing these clinical labor refinements as proposed as there is no clinical labor assigned to the ``Review patient clinical extant information and questionnaire'' (CA007) activity. We also note that commenters did not provide a rationale as to what made CPT code 74420 distinct from the other X-ray services reviewed during this cycle and would justify this additional clinical labor time.

      After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 74420 as proposed.

      (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 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 proposed 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 proposed to refine the equipment times in accordance with our standard equipment time formulas.

      We did not receive specific comments regarding our proposals for CPT code 76000. We are finalizing a work RVU of 0.30 and the direct PE inputs for CPT code 76000 as proposed.

      (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 disagreed with the RUC-recommended work RVU of 0.17 and we proposed a work RVU of 0.14. We noted 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 did 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 noted 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

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      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 proposed 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 recognized 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 did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving CPT code 76514.

      Comment: Many commenters disagreed with the proposed work RVU of 0.14 for CPT code 76514 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.17. Commenters stated that using an approach that takes a fraction of the intraservice time ratio in lieu of strong crosswalks and input from the RUC and physicians providing these services is unfounded. Commenters restated the key reference codes chosen by the survey participants and urged CMS to use survey data and supportive relative reference services when valuing services.

      Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values recommended by the RUC and other commenters do not account for information provided by surveys that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology for developing work RVUs, we direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277). We also note that in the case of CPT code 76514, we recognized that the minutes shifted to the clinical staff were less intense than the minutes that remained in CPT code 76514, and therefore, we applied only half of the intraservice time ratio instead of the full ratio.

      Comment: Several commenters stated that while it is true that changes in workflow as a result of smaller, portable, easier to use pachymeters now mean that the technician typically takes the measurements that used to be taken by the physician, the remaining 3 minutes of intraservice work time reflect the more intense cognitive work performed by the physician after the measurements are taken. Commenters agreed that the procedure has not fundamentally changed and that maintaining a work RVU of 0.17 was warranted.

      Response: We disagree with the commenters and continue to believe that CPT code 76514 does not require 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. While the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique, and we believe that for CPT code 76514 the latter case is true since the same work previously carried out by the practitioner is now being carried out by the technician.

      After consideration of the public comments, we are finalizing the work RVU and the direct PE inputs for CPT code 76514 as proposed.

      (40) Ultrasound Elastography (CPT Codes 76981, 76982, and 76983)

      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 76981 (Ultrasound, elastography; parenchyma), 76982 (Ultrasound, elastography; first target lesion) and 76983 (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 76981 (Ultrasound, elastography; parenchyma (e.g., organ)), a work RVU of 0.59 for CPT code 76982 (Ultrasound, elastography; first target lesion), and a work RVU of 0.50 for add-on CPT code 76983 (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 proposed 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 76981 and 76982. 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

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      worksheets. We also noted 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 76981 and 76982. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Ultrasound Elastography family of codes.

      Comment: Several commenters expressed support for our proposed work RVUs for each of the three CPT codes in this family.

      Response: We appreciate the support of commenters.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT codes 76981 and 76982, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT codes 76981 and 76982, we are not finalizing these clinical labor refinements as proposed, as these codes have the ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'' task in predecessor CPT code 76700 on the old PE worksheet as well as 1 minutes of CA007 clinical labor time. We are instead finalizing the RUC-recommended clinical labor times for CA013 and CA014 for CPT codes 76981 and 76982. We are also not finalizing our refinements to the corresponding equipment times as a result.

      After consideration of the public comments, we are finalizing the work RVUs for the codes in the Ultrasound Elastography family of codes as proposed: 0.59 work RVUs for CPT code 76981, 0.59 work RVUs for CPT code 76982, and 0.50 work RVUs for CPT code 76983. We are not finalizing our proposed direct PE inputs and are instead finalizing the RUC-recommended direct PE inputs for these three codes.

      (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 proposed 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 proposed 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 did 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 noted that there was 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 76870.

      Comment: We received general support from commenters for our proposed work RVU of 0.64 for CPT code 76870, as recommended by the RUC.

      Response: We thank commenters for their support.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT code 76870, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-

      recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 76870, we are finalizing these clinical labor refinements as proposed.

      After consideration of the public comments, we are finalizing the work RVU of 0.64 and direct PE inputs for CPT code 76870 as proposed.

      (42) Contrast-Enhanced Ultrasound (CPT Codes 76978 and 76979)

      In September 2017, the CPT Editorial Panel created two new CPT codes describing the use of intravenous microbubble agents to evaluate suspicious lesions by ultrasound. CPT code 76978 (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 76979 (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 76978 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); initial lesion), is the base code for the new add-on CPT code 76979 (Ultrasound, targeted dynamic microbubble sonographic contrast characterization (non-cardiac); each additional lesion with separate injection). The RUC reviewed the survey results for CPT code 76978 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 76979, 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.

      Although 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 76978. When we considered the range of existing CPT codes with 30 minutes total time and 20 minutes intraservice time, we noted that a work RVU of 1.62 is among the highest potential crosswalks. We also noted that the RUC agreed with the 25th percentile of survey results for the new add-on CPT code, 76979, and we did not see

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      why the 25th percentile would not also be appropriate for the base CPT code, 76978. Therefore, we proposed a work RVU of 1.27 for CPT code 76978. 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 proposed the RUC-recommended work RVU of 0.85 for add-on CPT code 76979.

      For the direct PE inputs, we proposed 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 76978. 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 did 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 noted 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 76978.

      We proposed to remove the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978 and 76979. 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 proposed to remove the supply and solicited comments on the phosphate buffered saline or a replacement saline solution. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Contrast-Enhanced Ultrasound family of codes.

      Comment: Commenters were supportive of our proposed work RVU of 0.85 for CPT code 76979, as recommended by the RUC.

      Response: We thank the commenters for their support of our proposal regarding the work RVU for this CPT code.

      Comment: A few commenters expressed opposition to our proposed work RVU of 1.27 for new CPT code 76978. Commenters acknowledged that the code is valued at the high end of the range of values for a given intraservice time. However, they stated, being on the high end of a range of comparison codes is not necessarily in itself a reason to reduce the work RVU. They cite this as an illustration of CMS's discounting the importance of intensity in valuing physician services in favor of considering only time. The same commenters also noted that the new technology used in furnishing the service, Contrast Enhanced Ultrasound (CEUS), requires more technical skill and time than other established ultrasound services.

      Response: Our observation that a survey code is on the high end of codes on the PFS with similar intraservice and total times is only one among several factors we consider when we perceive that the code is not properly valued in relation to other similar codes. We agree that there are instances in which valuing a code at the high range of work RVUs for codes with similar times is appropriate. However, on the whole, if a recommended work RVU places the code on the very high end of work RVUs with similar time parameters, we expect that the code would be of notably higher intensity than most other codes with those time parameters. We were not convinced that this was the case with CPT code 76978.

      We were, however, persuaded by commenters that the higher technical skill and time involved in using the new technology, CEUS, compared with other established ultrasound services, is better reflected by the RUC's recommended work RVU than our proposed value. Consequently we are finalizing the RUC-recommended work RVU of 1.62 for CPT code 76978.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT code 76978, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-

      recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 76978, we are not finalizing these clinical labor refinements as proposed, as this code has the ``Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist'' task in predecessor CPT code 76700 on the old PE worksheet as well as 1 minutes of CA007 clinical labor time. We are therefore finalizing the RUC-recommended clinical labor times for CA013 and CA014 for CPT code 76978. We are also not finalizing our refinements to the corresponding equipment times as a result.

      Comment: Several commenters disagreed with the proposal to remove the 50 ml of the phosphate buffered saline (SL180) for CPT codes 76978 and 76979. Commenters stated that the SL180 supply can be replaced with ``normal saline'', however the change was not made because an appropriate replacement could not be identified. Commenters stated that the SL180 phosphate buffered saline (PBS) had been removed but ``normal saline'' has not replaced it. Commenters agreed that this change was appropriate and urged CMS to add the correct supply item for the appropriate type of saline.

      Response: We disagree with the commenters that the ``normal saline'' was not added to these procedures. Both of these CPT codes include the ``sodium chloride 0.9% inj bacteriostatic (30ml uou)'' (SH068) supply which would function as a form of normal saline. We do not believe that it would be typical for these procedures to contain 50 ml of the phosphate buffered saline (SL180) in addition to the ``normal saline'' described by the SH068 supply.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for both codes in this family as follows: Work RVU of 0.85 for CPT code 76979 and a work RVU of 1.62 for CPT code 76978. We are also finalizing the RUC-recommended direct PE inputs for these codes, with the exception of the refinement to the phosphate buffered saline (SL180) supply as detailed above.

      (43) Magnetic Resonance Elastography (CPT Code 76391)

      The CPT Editorial Panel created new stand-alone CPT code 76391 describing the use of magnetic resonance elastography for the evaluation of organ parenchymal pathology. This code will most often be used to evaluate patients

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      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 76391 (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 noted that, despite shorter intraservice and total time, CPT code 76391 is slightly more intense to perform due to the evaluation of wave propagation images and quantitative stiffness measures. We did 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 76391, we proposed 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 76391, and we believe that the work involved in furnishing both services is similar. We note that CPT code 76391 describes a new technology and will be reviewed again by the RUC in 3 years.

      For the direct PE inputs, we proposed 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 disagreed 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 proposed 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 76391.

      Comment: A commenter stated that CMS misunderstood the role of reference CPT codes in the RUC's valuation process, and therefore our proposed work RVU for CPT code 76391 is premised on a false time comparison and a methodology that is invalid.

      Response: In the materials provided to us, the RUC explicitly compared the two key reference services to CPT 76391 and stated that the higher work values for these codes are justified by higher intraservice times. The RUC did not provide a crosswalk code for CPT 76391. Because of the RUC's justification of the higher work RVUs in the reference services in relation to the higher intraservice times for these codes, and because the RUC did not provide a crosswalk CPT code for us to review, we believe it is an entirely appropriate methodology to calculate the intraservice time ratios using those reference codes. We acknowledged that the survey code is slightly more intense to perform than the reference codes, according to the RUC's SOR, which is why our calculation of intraservice time ratios is only a starting point in our review of the code's recommended work RVU. We considered the intraservice time ratios for both reference codes, which were not identical, and compared these values to other CPT codes in the PFS with similar intraservice and total times. For this particular CPT code 76391, we identified a crosswalk to CPT code 71250, which, as we stated, achieved an overall balance of similar times and similar intensity as the survey code and has a work RVU of 1.10.

      Comment: Some commenters stated that our proposed value of 1.10 work RVUs for CPT code 76391 creates a rank order anomaly between an MRI code and CPT code, CPT code 74160.

      Response: We do not agree that our proposed work RVU of 1.10 for this code creates a rank order anomaly between an MRI code and CT code because this service is described as being unlike a routine magnetic resonance imaging. This service also involves use of a new technology, which makes it difficult to compare directly to services involving magnetic resonance imaging. We are finalizing a work RVU of 1.10 for CPT code 76391.

      Comment: One commenter agreed with the refinements to the direct PE inputs.

      Response: We appreciate the support for our proposals from the commenter.

      After consideration of the public comments, we are finalizing the work RVU of 1.10 and the direct PE inputs for CPT code 76391 as proposed.

      (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 proposed 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 proposed 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 did 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 noted 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 proposed 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

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      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 proposed to maintain the current equipment room time of 9 minutes until this group of procedures can be subject to a more comprehensive review. We also proposed to refine the equipment time for the Technologist PACS workstation (ED050) in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving CPT code 77012.

      Comment: We received support from a few commenters for our proposed work RVU for CPT code 77012, as recommended by the RUC.

      Response: We appreciate commenters' support. We are finalizing a work RVU of 1.50 for CPT code 77012.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT code 77012 CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-

      recommended direct PE inputs for clinical labor.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 77012, we are finalizing these clinical labor refinements as proposed.

      Comment: Several commenters disagreed with the proposal to refine the equipment time for the CT room (EL007) to maintain the current time of 9 minutes. Commenters stated that the room time is included in CT guidance, as it is in US guidance (such as in CPT code 76942) because that is the room the procedure is performed in. Commenters stated that they agreed with CMS that other RS&I codes use the 9 minutes for room time as a precedent, but this was specific to angiographic rooms and referred to language from 2013 regarding angiographic rooms.

      Response: We disagree with the commenters regarding the equipment time for the CT room (EL007) due to the 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 radiological supervision and interpretation procedure. We agree with the commenters that at least some portion of the procedure is performed in the CT room, but we continue to believe that it would not 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 in a more comprehensive fashion. We also disagree with the commenters that this policy is specific to angiography rooms, as CPT codes 75989 and 77012 both employ CT rooms and currently utilize the standardized 9 minutes of equipment time for radiological supervision and interpretation procedures.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 77012 as proposed.

      (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 proposed the RUC-recommended work RVU of 0.20 for CPT code 77081.

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving CPT code 77081.

      Comment: Commenters were supportive of our proposal regarding the work RVU for CPT code 77081.

      Response: We appreciate the support for our proposals from the commenters.

      After consideration of the public comments, we are finalizing the work RVU of 0.20 and direct PE inputs for CPT code 77081 as proposed.

      (46) Breast MRI With Computer-Aided Detection (CPT Codes 77046, 77047, 77048, and 77049)

      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 77046 (Magnetic resonance imaging, breast, without contrast material; unilateral). This recommendation was 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 77046. We disagreed with the RUC's recommended work RVU because we did not believe that the reduction in total time of 15 minutes between the new CPT code 77046 and the deleted CPT code 77058 was adequately reflected in its recommendation. Although 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 proposed a work RVU of 1.15 for CPT code 77046, 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 77047 (Magnetic resonance imaging, breast, without contrast material; bilateral) describes the same work as CPT code 77046, but reflects a bilateral rather than the unilateral procedure. The RUC recommended a work RVU of 1.60 for CPT code 77047. Since we proposed 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 77047 relative to the RUC's recommended difference in work between the two CPT codes. The RUC's recommendation for

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      the bilateral procedure is 0.15 work RVUs larger than for the unilateral procedure. Therefore, we proposed a work RVU of 1.30 for CPT code 77047.

      The RUC recommended a work RVU of 2.10 for CPT code 77048 (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 77048 is a new CPT code that bundles the deleted CPT code for unilateral breast 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 77046) should be a work RVU of 1.15, we are proposing a work RVU for CPT code 77048 that adds the RUC-

      recommended difference in RUC-recommended work RVUs between CPT codes 77046 and 77048 (0.65 work RVUs) to the proposed work RVU for CPT code 77046. Therefore, we proposed a work RVU of 1.80 for CPT code 77048.

      The last new CPT code in this series, CPT code 77049 (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 77048, 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 77047 and CPT code 77048, we believe that a more appropriate work RVU is calculated by adding the difference in the RUC recommended work RVU for CPT codes 77046 and 77049, to the proposed value for CPT code 77046. Therefore, we proposed a work RVU of 2.00 for CPT code 77049.

      For the direct PE inputs, we proposed 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 77046 and 77047, and from 9 minutes to 5 minutes for CPT codes 77048 and 77049. We noted 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 noted 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 had 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 refined the clinical labor time for the CA016 activity as detailed earlier 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 proposed 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 welcomed 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 did not propose 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 also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving the Breast MRI with Computer-Aided Detection (CAD) family of codes.

      Comment: A commenter disagreed with our use of deleted CPT code 77058 as a point of reference for considering whether the reduction in work RVU in the new code, CPT code 77046, is commensurate with the reduction in work time between the two codes. The commenter stated that CMS should not compare these new services with the old deleted services, as indicated by the specialty society having demonstrated compelling evidence that the work involved in the breast MRI code family has fundamentally changed.

      Response: We disagree that it is inappropriate to use time comparisons with a code that is being deleted as a guide for assessing whether the reduction in work RVU recommended by the RUC is commensurate with the reduction in time based on survey results. The description of the work involved in furnishing CPT code 77046 has not changed substantively from the code being deleted. The compelling evidence that the commenter cites is related to the two new codes, CPT code 77048 and 77049, which are newly bundled with CAD. The main distinction in the description of physician work for this CPT code is that the new code specifies `without contrast', while the deleted code described the service `without and/or with contrast.' The change in patient population, also cited by the commenter, actually suggests that the more complex patients will be screened using the advanced technologies, such as is described by CPT code 77048. We recognize that changes in technology and work flow for the work described by CPT code 77046 have affected the work involved in furnishing these services. This is why we use the time ratios as a starting point for code comparisons rather than the end point.

      Comment: One commenter stated that our proposed crosswalk code for CPT 77046, CPT code 77334, is inappropriate because of different preservice and intraservice times between the two codes, and because there is more low-

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      intensity time in CPT code 77334 compared with CPT code 77046. The commenter also indicated that our proposed work RVU for CPT code 77046 would create a rank order anomaly with other MRI codes.

      Response: As a matter of principle, we do not agree that a chosen crosswalk for a CPT code is required to be clinically similar or to have identical intraservice and/or total time as the code being valued. However, in this instance, after further consideration, we agree with the commenter that our crosswalk code, CPT 77334, is not a particularly good comparison, in terms of intensity, to CPT 77046. We also agree with the commenter that our proposed work RVU for CPT code 77046 would create an anomaly among other CPT codes involving MRI. We are finalizing a work RVU for CPT code 77046 of 1.45, as recommended by the RUC.

      Comment: A commenter disagreed with our use of increments in recalibrating work RVUs for codes that precede or follow a new or revalued CPT code, as was the process underlying our proposed work RVUs for CPT codes 77047, 77048, and 77049.

      Response: The recalibration of CPT codes based on incremental difference in the work RVUs recommended by the RUC is an established methodology used by CMS to value the work involved in furnishing a service. There are certain types of code groups, particularly those with clear stepwise changes in intensity, as described by the RUC, for which we believe this is entirely appropriate. We continue to believe that this is an appropriate approach. However, having agreed with the commenter that our proposed work RVU for CPT code 77046 should be finalized at the RUC recommended work RVU of 1.45, we also believe that it is unnecessary to recalibrate the RUC's recommended work RVUs for the remainder of the three codes in the series. Therefore, we are finalizing a work RVU of 1.60 for CPT code 77047, 2.10 for CPT code 77048, and 2.30 for CPT code 77049.

      Comment: Several commenters disagreed with the CMS proposal 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 77046 and 77047, and from 9 minutes to 5 minutes for CPT codes 77048 and 77049. Commenters stated that the rationale for this change was likely derived from reference to the lower clinical labor times for this activity associated with lower extremity MRI codes, and that it was an error to treat the clinical labor time for this activity as akin to that for lower extremity MRI. Commenters requested that CMS consider the experience of an 80-year-old patient who needs assistance on and off the table, along with reassurance, added explanation, IV insertion into delicate skin, and other anxiety needs. Commenters stated that another major distinction between breast MRI and extremity MRI is that the patient lies prone on the coil, which requires an awkward process of positioning and causes the need for additional clinical labor time.

      Response: We continue to disagree with the commenters that the RUC-

      recommended clinical labor time would be typical for these procedures. As part of our review, we compared the clinical labor times for the CA016 activity not only to the codes in the MRI of Lower Extremity family, but also to 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, and we do not agree that the clinical labor times would be increasing to 7 and 9 minutes in the newly created CPT codes, especially given that commenters did not provide a rationale as to why time would be increasing. We also note that while some patients will have conditions that are more difficult than the typical case, such as the 80-year-old patient described by the commenters, other patients would have conditions that are less difficult than the typical case. We remind the reader that valuation of services under the PFS is based on the typical case and not the most difficult cases that may arise. We further note that the clinical vignette for CPT code 77047 describes a 53-year old female patient, not an 80-year old patient, and was stated to be typical by 96 percent of the survey respondents.

      Comment: A commenter stated that in the CMS refinements to the direct PE inputs for these four CPT codes, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-recommended direct PE inputs for clinical labor.

      Response: We believe that the commenter may have been confused with several of the other code families that included these clinical labor refinements, which we described in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). We did not propose any refinements to the CA014 clinical labor for the codes in this family.

      Comment: Several commenters requested that CMS add 5 minutes to CPT codes 77048 and 77049 to account for the time required to obtain vital signs. Commenters stated that to maintain consistency within the codes for MRI with contrast, they requested that new codes for breast MRI with contrast receive an additional two minutes of time for MRI technologist (L047A) bringing the total time for obtain vital signs to 5 minutes.

      Response: We proposed in CY 2018 to assign 5 minutes of clinical labor time for all codes that include the ``Obtain vital signs'' task, that included at least 1 minute previously assigned to this task regardless of the date of last review. After considering the comments, we did not finalize our proposal to establish 5 minutes as the new standard for the ``Obtain vital signs'' clinical labor task. As a result, we do not agree with the commenters that the clinical labor time for the CA010 activity should be increased to 5 minutes for CPT codes 77048 and 77049, especially given that we did not make a proposal to do so. We refer readers to the CY 2018 PFS final rule (82 FR 52990-

      52991) for additional details about last year's proposal on this issue.

      Comment: One commenter requested that CMS assign additional clinical labor time for MRI procedures with contrast in order to account for time spent counseling patients. Commenters stated that because of the increased public awareness of the risk relating to gadolinium, additional time is required to explain the benefits and risks of the procedure.

      Response: We note that the MRI procedures in this family that are done with contrast (CPT codes 77048 and 77049) already contain more clinical labor than the MRI procedures that are done without contrast (CPT codes 77046 and 77047). Specifically, these procedures already contain two additional minutes for ``Provide education/obtain consent'' (CA011) clinical labor than the non-contrast versions of the procedures, which we believe indicates that the concerns of the commenters have been taken into account.

      Comment: Several commenters stated that the lack of invoices for the new equipment items may have been an oversight and enclosed new invoices with their comment letter. Commenters also stated that the CAD Software equipment (ED058) is actually synonymous with the ``breast biopsy software'' (EQ370) equipment, and recognized that in hindsight they should

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      have been consistent in identifying the equipment item between the breast biopsy codes and the MR breast codes. One commenter disagreed that the CAD Server or Additional User License equipment constituted forms of direct PE, and requested that CMS consider the cost of CAD service contracts and ``C-view'' costs in order to accurately access the calculation of indirect practice expenses.

      Response: We appreciate the submission of additional invoices from the commenters to assist in pricing these new equipment items. As we detailed in the Practice Expense portion of this final rule (section II.B. of this final rule), we are finalizing an update in the price of the CAD Software (ED058) equipment to $43,308.12 based on the new invoice submission and additional review by the StrategyGen contractor. We are also finalizing a price of $83,200 for the Breast coil (EQ388) equipment and a price of $12,031.52 for the CAD Workstation (CPU + Color Monitor) (ED056) based on the invoices submitted by the commenters. For the other two equipment items (CAD Server (ED057) and CAD Software--Additional User License (ED059)), we continue to believe that both of them would constitute forms of indirect PE under our methodology. The submitted invoices indicated that the CAD Server was a server type used in a data center while the user license was for a third license above and beyond the two licenses included in the price of the CAD software. As we stated in the proposed rule, we do not believe that these types of equipment 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.

      Comment: Several commenters stated that CMS had overstated the useful life of a breast coil. The commenters stated that a coil will start to display signs of wear, such as cracking of its case, flex spots, exposed wiring, or a degradation of its attenuated field causing a loss in image quality after about three to four years. Commenters stated that a useful life of 5 years would be more appropriate and consistent with the experience of their members.

      Response: We appreciate the additional information regarding the useful life of the breast coil equipment from the commenters. Our proposal to use 10 years as the useful life for this new equipment was based on our use of the breast biopsy device (EQ371) equipment as a proxy. We agree with the commenters that it would be more accurate to update the useful life to 5 years in light of this new information.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for the codes in the Breast MRI with Computer-Aided Detection family of codes. We are finalizing the direct PE inputs as proposed, with the updates to the pricing of the new equipment as detailed above.

      (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 disagreed with the recommended value and proposed 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 did 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 was also based on the use of three crosswalk codes. We directly supported 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 explained 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 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 proposed none.

      The following is a summary of the public comments we received on our proposals involving CPT code 85060.

      Comment: Many commenters disagreed with the proposed work RVU of 0.36 for CPT code 85060 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.45. Commenters stated that a time ratio should not be used because any decrease will result in a large ratio and a corresponding but inappropriate decrease to the physician work RVU. Commenters stated that rather than using time ratios CMS should examine the magnitude estimation between the physician work, time, and intensity. Commenters also stated that the current time was not based on a survey and it was unclear how the time was determined.

      Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several appropriate methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values recommended by the RUC and other commenters do not account for information provided by surveys that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual

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      procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology for developing work RVUs, we direct readers to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277).

      Comment: Several commenters disagreed with our statement that the recommended work value of 0.45 is higher than nearly all of the other global XXX codes with similar time values. Commenters stated that a search of the RUC database contradicted this finding, showing that eleven XXX codes with 12 minutes of intraservice time have values lower than 0.45 and thirteen XXX codes with 12 minutes of intraservice time have values the same or higher than 0.45 RVUs. Commenters stated that none of these services are pathology services and were not comparable, except for CPT code 88388 (Macroscopic examination, dissection, and preparation of tissue for non-microscopic analytical studies (e.g., nucleic acid-based molecular studies)) which has identical work value and intra-service time and was the reference code cited in the RUC recommendation. Commenters also disagreed with the CMS crosswalk to CPT code 95930 due to the fact that it is not a pathology service.

      Response: We disagree with the commenters' statement that pathology services are only comparable to other pathology services. Although we agree that the unique nature of pathology and laboratory services can make comparisons across codes more difficult than in other services, we believe the comparison of codes with similar work RVUs across different specialties is important to maintaining the relativity of the PFS. We disagree with the commenters that the crosswalk to CPT code 95930 would be methodologically inappropriate solely on the grounds that it is not a pathology service.

      Comment: Several commenters stated that there are a number of variables that must be considered in the evaluation of a blood smear when compared to others, including red blood cell count, size and morphology, platelet morphology and number, white blood cell morphology and the presence of white blood cell precursors. Commenters stated that other services with identical physician work include CPT code 88314 (Special stain including interpretation and report; histochemical stain on frozen tissue block) and CPT code 93923 (Complete bilateral noninvasive physiologic studies of upper or lower extremity arteries, 3 or more levels). Commenters stated the proposed work value would create significant rank order anomalies within the array of pathology services, as CPT code 85060 has nearly identical work time to CPT code 88314 but would be valued lower at the proposed work RVU.

      Response: We appreciate the detailed information about CPT code 85060 provided by the commenters regarding the clinical comparisons to CPT codes 88314 and 93923.

      After consideration of the public comments, we are not finalizing our proposed work RVU of 0.36 for CPT code 85060. We are finalizing the RUC-recommended work RVU of 0.45 instead.

      (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 disagreed with the RUC-recommended value and we proposed 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 supported 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. Although we did 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 proposed 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. Although we agree that these are necessary tasks, under our established methodology we believe that they are more appropriately classified as indirect PE.

      The following is a summary of the public comments we received on our proposals involving CPT code 85097.

      Comment: Many commenters disagreed with the proposed work RVU of 0.94 for CPT code 85097 and stated that CMS should finalize the RUC-

      recommended work RVU of 1.00. Commenters stated that the CMS rationale about changes in work time was out of place in this context because the survey respondents indicate that the service requires 25 minutes to perform rather than the current time of 30 minutes, yet CMS proposed to maintain the current work value. The commenters suggested that maintaining the current work RVU of 0.94 was therefore inappropriate. Commenters also stated that the current work time for CPT code 85097 was not based on a survey and that it was unknown how this time was

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      determined and what it actually represents.

      Response: We agree that it is important to use the most recent data available regarding time, and we note that when many years have passed between when time is measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The times currently associated with codes play a very important role in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had routinely been overestimated, this would undermine the relativity of the work RVUs on the PFS in general, given the process under which codes are often valued by comparisons to codes with similar times, and it also would undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS. Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times used in the PFS ratesetting processes are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we want to reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of old work time values in our methodology, we refer readers to our discussion of the subject in the CY 2017 final rule (81 FR 80273 through 80274). With regard to the specific case of CPT code 85097, we proposed to maintain the current work RVU rather than decreasing the work RVU due to some of the same concerns about the historical work times for this code raised by the commenters. We believe that the logic provided by the commenters suggests that the decreases in the work time of CPT code 85097 should have been reflected in decreases to the work RVU (as opposed to maintaining the current value), which we do not believe was their intention.

      Comment: Several commenters stated that given the total work, time, intensity, and complexity of the patient case, the current work RVU of 0.94 was too low for CPT code 85097. Commenters stated that the RUC chose a 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) specifically because it is a similar pathology code with a value between the current work value of 0.94 and the survey 25th percentile of 1.15. Commenters stated that the CMS reference code (CPT code 88361) was less intense and complex to perform as it involves evaluating a single antibody and determining the percentage of tumor cells that are positive for that antibody, as opposed to the work of CPT code 85097 which involves evaluating all blood cell precursors for quantitative and morphologic abnormalities, as well as evaluating for metastatic tumor cells, evidence of infection, or evidence of lymphoid neoplasms.

      Response: We disagree with the commenters that the current work RVU of 0.94 or the work RVU of our reference code of 88361 are too low in comparison to CPT code 85097. All three of the codes under discussion (CPT codes 85097, 88121, and 88361) are clinically similar procedures that involve the practitioner using their eyes to look at staining patterns. We do not agree with the commenters that the RUC's use of CPT code 88121 as a crosswalk would be any more accurate on clinical grounds that the reference code of 88361 that we chose in the proposed rule. Overall, we do not believe that there is a significant difference between these three procedures given their nearly identical work RVUs, intensities, and work times. However, given the decrease in surveyed work time, we continue to believe that it is more appropriate to maintain the current work RVU of 0.94 than to increase it to 1.00 due to our longstanding belief that decreases in work time should typically be not be reflected in increases to the work RVU. We note that we are not proposing to decrease the work RVU for CPT code 85097 despite this decrease in the surveyed work time, only to maintain the current valuation.

      Comment: Several commenters responded to the CMS consideration of a work RVU of 0.90 based on double the recommended work RVU of 0.45 for CPT code 85060. Commenters stated that they wished to clarify that this explanation was put forward to a RUC member whom was simply questioning why this service requires twice the time of CPT code 85060. Commenters stated that simply doubling the RUC-recommended work RVU of 0.45 for CPT code 85060 based on the amount of time does not account for the considerably greater intensity and complexity of CPT code 85097 over CPT code 85060 as described elsewhere in their comments.

      Response: We appreciate the clarification on this issue from the commenters.

      Comment: Several commenters disagreed with the CMS proposal remove the clinical labor time for the ``Accession and enter information'' (PA001) and ``File specimen, supplies, and other materials'' (PA008) activities. Commenters stated that although the descriptions for the PA001 and PA008 clinical labor activities appeared to describe data entry and filing activities, these tasks are very different in the pathology lab. Commenters stated that it is crucial for the performance of these tasks be executed accurately according to rigid patient laboratory protocols, standards, and legal processes associated with specimen/patient care and they should not be considered a form of indirect expense.

      Response: Although we agree that the unique nature of pathology and laboratory services can make comparisons across codes more difficult than for other services, we believe the comparison of similar clinical labor activities across different services is important to maintaining the relativity of the direct PE inputs. As we stated in the CY 2017 PFS final rule (81 FR 80324), we agree with the commenters that entering patient data into information systems and filing specimens are important tasks, and we agree that these would take more than zero minutes to perform. However, we continue to believe that these activities are correctly categorized as indirect PE as administrative functions, and therefore, we do not recognize the entry of patient data or the filing of specimens as direct PE inputs, and we do not consider this task as typically performed by clinical labor on a per-service basis.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 85097 as proposed.

      (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

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      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 did not propose any direct PE inputs for CPT code 85390.

      The following is a summary of the public comments we received on our proposals involving CPT code 85390.

      Comment: A commenter expressed support for our proposal to accept the RUC-recommended work RVU for this code.

      Response: We appreciate the support for our proposals from the commenter.

      After consideration of the public comments, we are finalizing our proposal to accept the RUC-recommended work RVU for this code.

      (50) Electroretinography (CPT Codes 92273, 92274, and 0509T)

      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 92273 (Electroretinography (ERG) with interpretation and report; full field (e.g., ffERG, flash ERG, Ganzfeld ERG)), we disagreed with the recommended work RVU of 0.80 and we instead proposed 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 92273 than the two reference codes chosen by the survey participants due to their significantly higher and lower intraservice times. We noted that the recommended intraservice time for CPT code 92273 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 did 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 92273, 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 proposed 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 92274 (Electroretinography (ERG) with interpretation and report; multifocal (mfERG)), we disagreed with the RUC-recommended work RVU of 0.72 and proposed a work RVU of 0.61. We concurred that the relative difference in work between CPT code 92273 and 92274 is equivalent to the recommended interval of 0.08 RVUs. Therefore, we proposed a work RVU of 0.61 for CPT code 92274, based on the recommended interval of 0.08 fewer RVUs below our proposed work RVU of 0.69 for CPT code 92273. 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 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 CPT Category III code 0509T (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 CPT code 0509T, 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 CPT code 0509T and creating RVUs through the use of a proxy crosswalk to a similar existing service. Therefore, we proposed to assign an active status to CPT Category III code 0509T 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 proposed a work RVU of 0.40 and work times of 10 minutes of intraservice and 12 minutes of total time for CPT code 0509T based on this crosswalk to CPT code 92250.

      For the direct PE inputs, we proposed to remove the preservice clinical labor in the facility setting for CPT codes 92273 and 92274. 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 noted 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 proposed 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 92273 and 92274. 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 92273 and 92274 would be duplicative. We also proposed to refine the clinical labor time for the

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      ``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 did not have any reason to believe that the services being furnished by the clinical staff had changed in the new codes, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted 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 proposed 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 92273 and 92274. 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 proposed 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 proposed 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 92273 and 92274. 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 92273 and 92274 is comparable to the CT and magnetic resonance (MR) codes that have been recently reviewed, such as CPT code 76391 (Magnetic resonance (e.g., vibration) elastography). Therefore, in order to maintain relativity, we proposed the same clinical labor time of 3 minutes for CPT codes 92273 and 92274 that has been recommended for these CT and MR codes. We also proposed 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 92273 and 92274. 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 92273 but only a single time for CPT code 92274. We solicited 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 92273 but only a single time for CPT code 92274. Finally, we also proposed to refine the equipment times in accordance with our standard equipment time formulas.

      We proposed to use the direct PE inputs for CPT code 92274, including the refinements detailed above, as a proxy for CPT Category III code 0509T until it can be separately reviewed by the RUC.

      The following is a summary of the public comments we received on our proposals involving the Electroretinography family of codes.

      Comment: Many commenters disagreed with the proposed work RVU of 0.69 for CPT code 92273 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.80. Commenters stated that the RUC-

      recommended work RVU was based on the survey 25th percentile and CMS should use survey data in establishing the work RVU. Commenters stated that the decrease in intraservice work time of deleted CPT code 92275 from when it was last surveyed in 1995 was due to the fact that the physician no longer participates in the acquisition of the data or performing the test on the patient, which has become the technician's work. Commenters stated that the RUC determined that the physician work is not the same as it was with CPT code 92275 and the recommended decrease in work RVUs appropriately addresses the decrease in physician time to perform this service.

      Response: We disagree with the commenters that the RUC-recommended decrease in work RVUs appropriately addresses the decrease in physician time to perform this service. As we stated in the proposed rule, the recommended intraservice time for CPT code 92273 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 RUC-

      recommended work RVU is only decreasing from 1.01 to 0.80, which is a reduction of just over 20 percent. Although we did 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. As a result, we believe that our proposed work RVU of 0.69 more accurately captures the changes in work that have taken place since the previous survey.

      Comment: Several commenters stated that while the time required for CPT code 92273 is less than the time required for CPT code 92275, the code it replaced, the intensity and complexity of the work involved in interpreting the test has increased significantly. Commenters stated that the newer machines are easily programmed to produce more images and numbers for interpretation (double or more) than the machines in use in 1995 when the procedure was last valued and that advances in medical knowledge have identified more specific retinal dystrophy diagnoses with specific genotypes that the clinician must consider when interpreting the test. Commenters emphasized that while the machine may be more efficient as stated by CMS, the cognitive work required by the physician interpreting the test has increased significantly.

      Response: We disagree with the commenters that all of the efficiencies gained in work time via improved technology would be offset via higher intensity (that is, greater cognitive work on the part of the practitioner). While the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. At the RUC-recommended work RVU of 0.80, the intensity of CPT code 92273 would increase by nearly 300 percent, and we do not agree that the cognitive intensity of the procedure would have increased by this amount. We continue to believe that our proposed work RVU of 0.69 more accurately captures the changes in work taking place as a result of greater technological efficiencies in the service.

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      Comment: Many commenters disagreed with the proposed work RVU of 0.61 for CPT code 92274 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.72. Commenters stated that CMS should use valid methods of evaluating services, such as survey data and magnitude estimation, instead of relying on an incremental difference in work RVUs between codes 92273 and 92274.

      Response: We believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Historically, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code or another family of codes. We note that the RUC has also used the same incremental methodology on occasion when it was unable to produce valid survey data for a service. We further note that we did not rely solely on an increment for our proposed work RVU for CPT code 92274, as the proposed work RVU was also based on the use of a reference code (CPT code 88387) and a crosswalk code (CPT code 92100). 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.

      Comment: Several commenters stated that while there was no predecessor code for direct comparison, the intensity and complexity of the work involved in interpreting the test has increased significantly compared to 1995, when CPT code 92275 was last valued. Commenters restated the same arguments they expressed for CPT code 92273: The new machines used in CPT code 92274 have become more efficient but the cognitive work required by the physician interpreting the test has increased significantly.

      Response: As we stated with regard to CPT code 92273, we continue to disagree with the commenters that all of the efficiencies gained in work time via improved technology would be offset via higher intensity (that is, greater cognitive work on the part of the practitioner). At the RUC-recommended work RVU of 0.72, the intensity of CPT code 92274 would also increase by nearly 300 percent, and we do not agree that the cognitive intensity of the procedure would have increased by this amount. We continue to believe that our proposed work RVU of 0.61 more accurately captures the changes in work taking place as a result of greater technological efficiencies in the service.

      Comment: Several commenters stated that CPT code 92274 requires more physician work than the crosswalks we identified. Commenters stated that CPT code 88387 is a straightforward manual dissection that does not require interpretation of multiple images and numeric values to arrive at a diagnosis. Commenters stated that CPT code 92100 also requires less physician work, as CPT code 92274 requires interpretation of significantly more data and consideration of many more diagnostic possibilities.

      Response: We disagree with the commenters that our reference and crosswalk codes require less work than CPT code 92274. While it is true that CPT code 88387 does not require interpretation of multiple images and numeric values, this is because it is not an imaging service, and it is inappropriate to state that the work of CPT code 88387 is lower than CPT code 92274 based on this criteria. We do not agree that the macroscopic examination, dissection, and preparation of tissue taking place in CPT code 88387 would inherently constitute less work than CPT code 92274. Similarly, we do not agree that the serial tonometry with multiple measurements of intraocular pressure taking place in CPT code 92100 would involve less work than CPT code 92274, especially due to the nearly identical intraservice and total work times shared by these procedures.

      Comment: One commenter disagreed with our proposal to assign active pricing to Category III code 0509T. The commenter stated that this code should go through the regular vetting process that other new technology typically follows, including development of appropriate clinical literature that would qualify it for elevation to a full Category I CPT code, and then a RUC survey in order to develop accurate valuation for work and practice expense. The commenter was concerned that CMS would single out and put forward a value for a technology that has not gone through the same scrutiny as other new technologies.

      Response: We understand the concerns expressed by the commenter. As we stated in the proposed rule, 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 in the case of Category III code 0509T the recommendations indicated 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 continue to believe that the interests of relativity would be better served by assigning an active status to Category III code 0509T and creating RVUs through the use of a proxy crosswalk to a similar existing service. We agree with the commenter that this code should still go through the regular vetting process that other new technology typically follows, and we look forward to receiving recommendations for work and practice expense inputs in the future.

      Comment: One commenter stated that many of the proposed changes to the direct PE inputs were made with the intent to standardize inputs. The commenter stated that although the RUC has created many standards, they have always acknowledged that there are and will be exceptions to those standards. The commenter stated that these important diagnostic tests are unusual services that require significant amounts of preservice clinical labor time in whichever setting they are performed, and that the recommended direct PE inputs were carefully prepared based upon documented personal observation and time motion studies. The commenter stated that the predecessor CPT code 92275 had an over-

      simplified PE spreadsheet with very few data inputs, each comprising substantial amounts of time that are now broken out into separate inputs, and as a result the work required had not changed substantially but there had been additional granularity in the direct PE inputs.

      Response: As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 through 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. We have stated that we believe this additional level of detail helps to facilitate transparency, allows us to more easily compare clinical labor times across the PFS to maintain relativity, and helps in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years. However, we have always recognized that standards for clinical labor cannot be applied universally due to the differences between individual services, and we have frequently finalized

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      clinical labor times above the standard values where we believed that there was sufficient reason to establish these values as the typical case. In the case of CPT code 92273 and 92274, we detailed our rationale in the proposed rule for why we believed that some of the RUC-recommended direct PE inputs should be refined to a standard clinical labor time. We also note that we did not propose the standard clinical labor time for all activities, such as the ``Clean room/

      equipment by clinical staff'' (CA024) activity.

      Comment: Several commenters disagreed with the proposal to remove the preservice clinical labor in the facility setting for CPT codes 92273 and 92274. Commenters stated that these procedures, when done in a facility, must be scheduled in the operating room. Commenters stated that these procedures would typically be done in the facility only when it is not clinically appropriate for them to be performed in the clinic, such as for children or the cognitively impaired; and it takes substantial amounts of time for the staff to accomplish this coordination of care for these higher-needs patients.

      Response: We recognize that these procedures are rarely performed in the facility setting, with approximately 1 percent of the utilization of predecessor CPT code 92275 taking place in this setting. However, we disagree that these procedures would typically be performed in the operating room when furnished in the facility, and therefore, we do not agree that these procedures would typically require preservice clinical labor for coordination of care. We also noted on this subject that the predecessor code, CPT code 92275, does not currently include any preservice clinical labor, nor any facility direct PE inputs, and we did not receive an explanation from the commenters as to why this was the case. Furthermore, 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.

      Comment: Several commenters disagreed with the proposal 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 92273 and 92274. Commenters stated that although slightly more than 50 percent of these services are done on the same day as an office visit, the clinical staff time involved is completely divorced from the office visit and the staff performing the test are different from the staff assisting in the office visit. Commenters stated that the machine used for these procedures is housed in a different room, the patient needs to be transported from the ophthalmic exam lane to the ERG room and back, additional instructions are required that are never done during a typical office visit, and the nature of this test requires extra supplies and work in addition to those used for the office visit. Commenters emphasized that these clinical tasks are not duplicative with an E/M, as they represent separate actions by a different technician in a different room.

      Response: We disagree with the commenters and continue to believe that this clinical labor would be duplicative with the same day E/M office visit. While it is true that there is a different clinical labor staff type used by CPT codes 92273 and 92274, we are not suggesting that all clinical labor is duplicative with the same day E/M visit, only that clinical labor activities such as greeting and gowning the patient would only be done a single time. We also note that we do not include patient transportation as a form of direct PE, as it is not individually allocable to a single service and would instead be classified as an administrative task under indirect PE. However, we do agree with the commenters that additional instructions would be required for these electroretinography services, and as a result we will restore the 1 minute of clinical labor time for the ``Provide education/obtain consent'' (CA011) activity. We agree that this would not be duplicative with the same day E/M office visit.

      Comment: Several commenters stated that in our refinements to the direct PE inputs for CPT codes 92273 and 92274, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-recommended direct PE inputs for clinical labor. One commenter stated that this work is done by a different technician in a different room typically in a busy clinical setting and this work was separate from that being done during the office visit.

      Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT codes 92273 and 92274, we are finalizing these clinical labor refinements as proposed. We also note in response to the one commenter that our refinements to the CA013 and CA014 clinical labor activities were not based on the premise on being duplicative with the same day E/M visit.

      Comment: Several commenters disagreed with the proposal 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 92273 and 92274. Commenters stated that this was the time that the specialty society found when directly shadowing the process to clean the patient and the equipment. Commenters stated that the technician needs to clean the patient's skin, rinse their eyes, and clean around the patient and escort them out. Commenters stated that the expensive and delicate eye electrodes require a significant amount of time to remove and clean the conductive paste and Goniosol without damaging the electrodes, which needs to be performed after each procedure so that the electrodes can be re-used for the next procedure. Commenters emphasized that the equipment cleaning process requires meticulous care and a significant amount of technician time.

      Response: We agree with the commenters that these procedures require more time for cleaning the room and equipment than the standard for the CA024 activity. This is the reason we proposed 8 minutes of clinical labor time instead of 3 minutes, almost triple the standard value for this activity code. As we stated in the proposed rule, we agreed 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. Since our standard clinical labor time for room/equipment cleaning is 3 minutes, we therefore proposed 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 continue to believe that 8 minutes would be the typical amount of clinical labor used for these procedures.

      Comment: Several commenters disagreed with the proposal 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 92273 and 92274. Commenters stated that the machine used for the ERG codes is not typically integrated into the clinic's electronic medical record. Commenters stated that this machine requires printing all images created by the testing

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      machine and uploading them into the EMR for subsequent review by the physician and that it is not unusual for re-printing using a different scale or limits to be necessary. Commenters stated that this clinical labor differed from a typical radiology scenario because the procedure is in fact different from a typical imaging study.

      Response: We disagree with the commenters that the full recommended time of 10 minutes would be typical for this clinical labor activity. We do not agree that it would be typical to physically print out all of the images produced by the machine, and note that we do not include additional direct PE inputs for inefficiencies in practice operations. We continue to believe that the complexity of the imaging in CPT codes 92273 and 92274 is comparable to the CT and magnetic resonance (MR) codes, and that in order to maintain relativity, we proposed the same clinical labor time of 3 minutes.

      Comment: Several commenters disagreed with the proposal 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 92273 and 92274. Commenters stated that this input was calculated by direct observation of typical procedures with a stopwatch. Commenters stated that this test is performed in a different room than the office visit, and the technician needs to take time to find the ordering/

      interpreting physician and review the quality of the gain and results.

      Response: We disagree with the commenters that the full recommended time of 5 minutes would be typical for this clinical labor activity. We note again that we do not include additional direct PE inputs for inefficiencies in practice operations, and that we would not increase the clinical labor to include time that the technician needs to find the ordering/interpreting physician. We 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.

      Comment: Several commenters responded to the comment solicitation regarding additional information about whether the recommendations for the ``Contact lens electrode for mfERG and ffERG'' (EQ391) equipment intended this equipment item to be listed twice, with one contact intended for each eye, or whether this was a clerical mistake. Commenters stated that this was not an error but was intentional and reflects typical practice. Commenters stated that the test carried out in CPT code 92273 is performed with two contact lenses in place (one in each eye at the same time) in a simultaneous testing fashion. Commenters stated that the test carried out in CPT code 92274 is typically performed sequentially one eye at a time, re-using the same contact lens for each eye. Commenters stated that this discrepancy is primarily due to the dark and light-adaptation needs for the ffERG, which if done sequentially would double the amount of clinical time.

      Response: We appreciate the additional information supplied by the commenters in response to our comment solicitation.

      Comment: One commenter stated that the highly technical equipment formula should be used for the mfERG and ffERG electrodiagnostic unit (EQ390) equipment item.

      Response: We did not propose to classify the EQ390 equipment as highly technical. We note that if we were to use the highly technical equipment formula for the EQ390 equipment, the total equipment time for this item would decrease, and we do not believe that this was what the commenter intended.

      After consideration of the public comments, we are finalizing the work RVUs for the codes in the Electroretinography family of codes as proposed. We are also finalizing the direct PE inputs as proposed, with the exception of the CA011 clinical labor activity as described above.

      (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 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 disagreed with the RUC-recommended work RVU of 0.95 and we proposed 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 was decreasing from 29 minutes to 15 minutes (48 percent reduction), and the recommended total time for CPT code 93561 was decreasing from 78 minutes to 15 minutes (81 percent reduction); however, the recommended work RVU was instead increasing from 0.25 to 0.95, which is an increase of nearly 300 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear 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 recognized 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 proposed 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 disagreed with the recommended work RVU of 0.77 and proposed 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 was decreasing from 16 minutes to 12 minutes (25 percent reduction), and the recommended total time was decreasing from 44 minutes to

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      12 minutes (73 percent reduction); however, the RUC-recommended work RVU was instead increasing from 0.01 to 0.77. We recognized 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 is 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 proposed 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 noted 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 did not propose any direct PE inputs.

      The following is a summary of the public comments we received on our proposals involving the Cardiac Output Measurement family of codes.

      Comment: Commenters stated that there were three intertwined flawed assumptions that CMS considered when proposing values for CPT codes 93561 and 93562, which if finalized would lead to continued misvaluation of these services. Commenters stated that the first of these flawed assumptions was a comparison of the survey data to Harvard data: The current time data for these codes came from the Harvard studies, has zero validity and should not be used to compare to current valid survey data. Commenters stated that the second of these flawed assumptions was a comparison of the recommended physician work RVUs to old work RVUs: The negative intensity of these codes confirmed that this previous methodology in which the current work RVU was derived from is flawed. Commenters stated that the third of these flawed assumptions was the use of an intraservice time ratio: This inaccurately treated all components of the physician time as having identical intensity and is incorrect. Other commenters identified changes in the global period from 0-day to add-on status and changes in the patient population from adult patients to pediatric patients as a rationale for why the increases in valuation were appropriate.

      Many commenters disagreed with the proposed work RVU of 0.60 for CPT code 93561 and stated that CMS should finalize the RUC-recommended work RVU of 0.95. Commenters disagreed with the CMS crosswalk to CPT code 77003, stating that it was not a good crosswalk despite having the same intraservice work time. Commenters stated that CPT code 77003 is the imaging guidance code for needle placement for the epidural injection, and that placing a catheter in the heart and lungs of a child is not merely an imaging procedure. Commenters stated that a more appropriate injection procedure comparison would be the actual epidural injection procedure code, CPT code 62320 (Injection(s), of diagnostic or therapeutic substance(s) (e.g., anesthetic, antispasmodic, opioid, steroid, other solution), not including neurolytic substances, including needle or catheter placement, interlaminar epidural or subarachnoid, cervical or thoracic; without imaging guidance) at a work RVU of 1.80 or to the top key reference CPT code 93567 (Injection procedure during cardiac catheterization including imaging supervision, interpretation, and report; for supravalvular aortography) at a work RVU of 0.97.

      Many commenters also disagreed with the proposed work RVU of 0.48 for CPT code 93562 and stated that CMS should finalize the RUC-

      recommended work RVU of 0.77. Commenters stated that using an incremental approach in lieu of strong crosswalks and input from the RUC and physicians providing these services was an unfounded methodology. Commenters stated that CMS should rely on the survey data instead of the use of an increment, and commenters listed the reference codes chosen by the RUC which they stated were more appropriate for valuation.

      Response: We appreciate the detailed feedback from the commenters regarding CPT Codes 93561 and 93562. We agree with the commenters that the proposed crosswalk to CPT code 77003 would result in an inappropriately low intensity for CPT code 93561.

      After consideration of the public comments, we are finalizing the RUC-recommended work RVU of 0.95 for CPT code 93561 and the RUC-

      recommended work RVU of 0.77 for CPT code 93562. We are also finalizing our proposal to have no direct PE inputs for these codes.

      (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 disagreed with the recommended work RVU of 1.50 for this CPT code because we did not believe that a reduction in work RVU from 1.80 to 1.50 was commensurate with the reduction in time for this service of 5 minutes. Using the building block methodology, we believed 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 was more appropriate because it has an identical intraservice and total time (15 minutes) as CPT code 93571, described work that is similar, and was closer to the calculations for intraservice time ratio, total time ratio, and the building block method. Therefore, we proposed a work RVU of 1.38 for CPT code 93571.

      We proposed the RUC-recommended work RVU for CPT code 93572 (Intravascular Doppler velocity and/or pressure derived coronary flow reserve measurement (coronary vessel or graft)

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      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.

      The following is a summary of the public comments we received on our proposals involving the Coronary Flow Reserve Measurement family of codes.

      Comment: We received several comments regarding our proposed work RVU of 1.38 for CPT 93571. Commenters generally did not agree with the use of time based metrics in our assessment of the work RVU for this code. In particular, they opposed CMS's reduction of work RVUs in proportion to the total reduction in time for furnishing this service. This methodology, they maintain, ignores the fact that the time reduction of 5 minutes in furnishing this service is associated with the low intensity portion of the work.

      Response: We do not agree that a reduction in work RVU proportional to the total time decrease for this code, which has essentially only one time parameter since the intraservice time and total time are the same, is not appropriate. We continue to believe that this calculated value of 1.35 (a 75 percent reduction in both time and work RVU) accounts more appropriately for the reduction in time for a service in which the work to perform the service has not changed. We therefore continue to believe that our crosswalk to CPT code 61517 is similar in both work and time to CPT code 93571, and we are finalizing our proposed work RVU for CPT code 93571 of 1.38.

      Comment: We received support from commenters regarding our proposed work RVU of 1.00 for CPT code 93572.

      Response: We appreciate the support and are finalizing a work RVU of 1.00 for CPT code 93572 as proposed.

      After consideration of the public comments, we are finalizing the work RVUs for the codes in the Coronary Flow Reserve Measurement family of codes as proposed.

      (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, 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 did not recommend 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 proposed a work RVU of 0.00 for CPT code 93668 and proposed to continue valuing the code for PE only.

      The following is a summary of the public comments we received on our proposals involving CPT code 93688.

      Comment: Commenters were supportive of our proposal of the RUC-

      recommended work RVUs and PE inputs.

      Response: We thank commenters for their support.

      Comment: Several commenters noted that the proposed reductions in payment would impact their ability to perform the service in an office setting and that this would force them to perform the service in a hospital setting. They further noted that this would ultimately increase costs and impact patient satisfaction as well as impact their ability to provide the service to rural and under insured patients.

      Response: We appreciate the feedback these commenters provided. We note that we accepted the RUC-recommended work RVU of 0.00 and the RUC-

      recommended direct PE inputs without refinements for CPT code 93668. We further note that the RUC has generally provided recommendations on work, work time, and direct PE inputs. We do not believe that the work or direct PE inputs assigned to these services are inaccurate. We further note that if commenters believe an additional RUC review would serve to address the issues they identified in our proposal, we would consider this information or recommendations from other interested stakeholders for future rulemaking.

      After consideration of the public comments received, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT code 93668 as proposed.

      (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 disagreed with the recommended value and proposed 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 did 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

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      based on the aforementioned crosswalk codes to account for these decreases in the surveyed work time. We also noted 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 had 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 disagreed with the recommended value and we proposed 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 proposed 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 disagreed with the RUC-

      recommended work RVU of 1.08, we concurred that the relative difference in work between CPT codes 95800 and 95801 and CPT code 95806 was equivalent to the recommended interval of 0.08 RVUs. Therefore, we proposed 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 noted 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 did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Home Sleep Apnea Testing family of codes.

      Comment: One commenter stated that the obesity epidemic has contributed to the rising prevalence of obstructive sleep apnea, and sleep centers have already worked to reduce costs in diagnosis of obstructive sleep apnea by utilizing out-of-center, or home, sleep apnea testing. The commenter stated that further reduction in work RVUs, and hence payments for home sleep apnea testing services, may endanger the sustainability of sleep centers to provide this service to Medicare beneficiaries and may thus deny beneficiaries access to testing for obstructive sleep apnea. A different commenter stated that a reduction in work RVUs for home sleep apnea testing services will discourage vendors from producing technically better home sleep apnea testing devices and software.

      Response: We agree with the commenter regarding the importance of sleep centers in helping to diagnose and treat the occurrence of obstructive sleep apnea. However, we remind the commenter that we are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2017 PFS final rule (81 FR 80272 through 80277), 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. 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. For the codes in the Home Sleep Apnea Testing family, we believe that the decreases in the surveyed work times should be reflected in decreases to the work RVUs.

      Comment: Many commenters disagreed with the proposed work RVU of 0.85 for CPT codes 95800 and 95801, and stated that CMS should finalize the RUC-recommended work RVU of 1.00 for these services. Commenters stated that it was unclear why CMS chose to employ the crosswalk to CPT codes 93281 and 93260, which the commenters stated were not at all similar to the home sleep apnea test codes and are cardiovascular implantable recording device codes, not diagnostic studies.

      Response: We continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes with clinically similar services are sometimes stronger comparator codes, we do not agree that codes must both constitute diagnostic studies to be used as a crosswalk. In the case of our specific crosswalk to CPT codes 93281 and 93260, we noted in the proposed rule that both of these codes have a work RVU of 0.85, as well as having the same intraservice time of 15 minutes and similar total times to CPT codes 95800 and 95801, and recent review dates within the last few years.

      Comment: Several commenters stated that the existing times for CPT codes 95800 and 95801 were likely an overestimate due to the lack of experience providing these services when they were first valued as new codes in April 2010. Commenters stated that physicians are now more familiar with home sleep apnea testing and the new survey times were more reflective of this family of services.

      Response: This information from the commenters appears to suggest that the current work RVUs for CPT codes 95800 and 95801 are also overestimates. If practitioners have become more familiar and efficient in the practice of home sleep apnea testing, we believe that the work RVUs should also be decreased to reflect the fact that the procedures can now be performed faster. We remind the commenters that we are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services, and we have no reason to believe that the intensity of these procedures has increased to the point of offsetting these gains in time efficiency.

      Comment: Several commenters stated that, despite the fact that we indicated we did not intend to imply that the decrease in time should equate to a linear decrease in the valuation of work RVUs, this seems to be the approach taken in the proposed rule. Commenters stated that modifications to work RVUs should be based on empirical evidence, gathered through the survey process, which takes into consideration the amount of time required to provide a service as well as the complexity and intensity of each service.

      Response: We disagree with the commenters, and we note that the proposed work RVUs for both CPT codes 95800 and 95801 were not based on pure time ratios on a one-to-one or linear basis. For CPT code 95800, use of

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      the intraservice time ratio alone would have yielded a work RVU of 0.79 and the total time ratio would have yielded a work RVU of 0.65. For CPT code 95801, use of the intraservice time ratio would have yielded a work RVU of 1.00 and the total time ratio would have yielded a work RVU of 0.78. We did not propose these values and instead proposed a work RVU of 0.85 for both codes specifically because the consideration of time ratios is only one component of our review process. We believe that our proposed work RVU of 0.85 for these services based on a pair of crosswalk codes, CPT codes 93281 and 93260 is appropriate, and note that we recognized that the use of pure time ratios at a one-to-one or linear basis would not accurately capture the changes in work taking place in these codes since their last valuation.

      Comment: Many commenters disagreed with the proposed work RVU of 0.93 for CPT code 95806, and stated that CMS should finalize the RUC-

      recommended work RVU of 1.08. Commenters stated that the survey process values a service compared to other similar services, and that using an incremental approach in lieu of strong crosswalks and input from the RUC and physicians providing these services was unfounded.

      Response: We believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Historically, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code or another family of codes. We note that the RUC has also used the same incremental methodology on occasion when it was unable to produce valid survey data for a service. We continue to believe that the proposed work RVU of 0.93 would be the most accurate valuation for CPT code 95806.

      Comment: Several commenters stated that CPT code 95806 has become a more complex study and requires more time as well as greater levels of skill and training to perform the interpretation for this study. Commenters stated that more complex patients with a wider variety of sleep problems and more severe conditions are being studied with this modality, which means that the skills and continuing updates to education required to interpret these studies have dramatically increased.

      Response: We agree with the commenters that due to the decreasing surveyed work times and rapidly increasing utilization for these codes, we had reason to believe that practitioners are becoming more efficient at performing the procedure. While the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We do not agree with the commenter that the need for additional training to use the equipment would necessarily be grounds for an increase in the work RVU, as improvements in technology are commonplace across many different services and are not specific to this procedure. As detailed above, we also have reason to believe that the improved technology has led to greater efficiencies in the procedure which, under the resource-based nature of the RVU system, lends further support for a reduction in the work RVU.

      After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Home Sleep Apnea Testing family of codes as proposed.

      (55) Neurostimulator Services (CPT Codes 95970, 95976, 95977, 95983, and 95984)

      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 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

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      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 disagreed with the RUC's recommendation because we did not believe that maintaining the work RVU, given a decrease of four minutes in total time, was appropriate. In addition, we noted 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 proposed a work RVU of 0.35 for CPT code 95970.

      CPT code 95976 (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 95976 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 95976 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 95976. 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 95976.

      We disagreed with the RUC's recommended work RVU for this CPT code because we did not believe that the large difference in time between the new CPT code and CPT code 95974 was 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 proposed a work RVU of 0.73 for CPT code 95976.

      CPT code 95977 describes the same work as CPT code 95976, 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 intended to compare CPT code 95977 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 95976. The RUC recommended a work RVU of 1.19 for CPT code 95977. 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 95977 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.

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      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 disagreed with the RUC's recommended work RVU of 1.19 for CPT code 95977. 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 codes 95976 and 95977 (0.24 RVUs) to the proposed work RVU of 0.73 for CPT code 95976. Therefore, we proposed a work RVU of 0.97 for CPT code 95977.

      CPT code 95983 (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 code for add-on CPT code 95984 (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 95983. The RUC compared CPT code 95983 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 95983 and a work RVU of 1.00 for CPT code 95984. For CPT code 95983, 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 disagreed with the RUC's recommended work RVU for CPT code 95983 because we did not believe that the reduction in work RVU reflected the change in time described by the CPT code. Using the reverse building block methodology, we estimated 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 proposed a work RVU of 0.91 for CPT code 95983.

      The RUC's recommended work RVU of 1.00 for CPT code 95984 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 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 were to add the incremental difference between CPT codes 95983 and 95984 to the proposed value for the base CPT code (95983, work RVU = 0.91), we estimated that this add-on CPT code would 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 proposed a work RVU of 0.80 for CPT code 95984, 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 (ie, rectal, gastric, intraperitoneal)), which is an add-on CPT code with identical total and intraservice times (15 minutes) as CPT code 95984.

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving the Neurostimulator Services family of codes.

      Comment: We received a number of comments regarding our proposed work RVUs for CPT codes 95970, 95976, 95977, 95983, and 95984. Commenters suggested that CMS misunderstood the role of reference codes in the RUC's process, and that CMS should not be comparing the times for the surveyed code to the reference codes because they are not specifically intended to match in time.

      Response: We appreciate the opportunity to clarify that we do not believe the reference codes provided by the RUC in the summary documents are being provided as a crosswalk. We did not state that we thought the two top reference codes, CPT code 62368 (total time of 27 minutes) and CPT code 99213 (total time of 23 minutes) were being used by the RUC as crosswalk codes (as that term is used in the RUC process). Instead, we pointed out that the two reference codes are generally not a particularly good comparison for a survey code with 15 minutes of total time. We understand that survey respondents, not the RUC, chose the reference codes, and that survey respondents do not have the physician times readily available when choosing from among services that they are familiar with. Nonetheless, we expect reference codes to generally have physician work times that are more similar to the survey code than an 80 percent difference (in the case of CPT

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      code 62368). When we make such an observation with regard to the times for reference codes in relation to a survey code, we are not disregarding parameters other than time. We also note that the RUC compares reference codes in terms of time or intensity relative to the survey code as a matter of common practice. We understand those comparisons to be intended by the RUC as one of several dimensions of a code's work RVU valuation.

      As we have stated in the past, we believe that practitioners become more efficient at furnishing some services over time, shortening the amount of clinical time required. We still believe this is the case with regard to CPT code 95970, which has decreased in time without a significant change in intensity. We maintain that our crosswalk to CPT code 95930 with a work RVU of 0.35 for this CPT code is appropriate.

      Comment: A commenter stated that, since CMS acknowledges that CPT code 95976 is different from CPT code 95974, which is being deleted, CMS should not compare the two codes for purpose of evaluating whether the decreased work time in the new code is appropriate in relation to the work involved in furnishing CPT code 95930. The commenter urged CMS to finalize the work RVU proposed by the RUC, which is 0.95.

      Response: The major difference in the description of work involved in furnishing CPT code 95974 and CPT code 95976 involves a change from `complex' to `simple' programming. We do not believe that this change, which indicates a lower level of intensity for new CPT code 95976 than for deleted CPT code 95974, precludes us from using the deleted CPT code as the basis for evaluating whether the comparatively lower time involved in furnishing CPT code 95976 is adequately reflected by the RUC-recommended work RVU for this new CPT code. We continue to believe that the lower time in furnishing the work described by CPT code 95976, compared with the time in furnishing the service described by deleted CPT code 95974, should result in a lower work RVU than the value recommended by the RUC. Therefore, we are finalizing the work RVU for CPT code 95976 of 0.73 based on a crosswalk to CPT code 76641.

      Comment: A commenter clarified that we incorrectly stated that the RUC compared the new CPT code 95977 with deleted CPT code 95975, which is an add-on code and would therefore not be an acceptable point of comparison.

      Response: We appreciate the commenter informing us of the error and we agree that the RUC did not compare CPT code 95977 with the deleted code, CPT code 95975. Instead, the RUC compared the new code with several other codes: CPT code 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient) with a work RVU of 1.16, 15 minutes of intra-service time and 31 minutes total time 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 a work RVU of 1.22, 15 minutes of intra-service time and 27 minutes total time. The RUC also cited the following two CPT codes for support: CPT code 93975 (Duplex scan of arterial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; complete study) with a work RVU of 1.16, 20 minutes of intra-service time and 30 minutes total time, and 67810 (Incisional biopsy of eyelid skin including lid margin), with a work RVU of 1.18, 13 minutes of intra-service time and 27 minutes total time. Despite having cited these numerous CPT codes as support for their recommended work RVU for CPT code 95977, we do not see why CPT code 95974 is not an entirely appropriate point of comparison for CPT code 95977 as we explained in making our proposal. The only difference between new CPT code 95977 and new CPT code 95976 is complex vs. simple programming and, since as we explained in response to comments above, we believe it is appropriate to use the deleted CPT code 95974 for a time comparison with CPT code 95976, we believe that code is equally valid as the basis for comparison to CPT code 95977. The building block methodology between CPT code 95977 and CPT code 95974 suggests that a work RVU in the area of 0.82 would better reflect both the time and intensity of furnishing this service. In identifying a more appropriate work RVU, we looked at the difference in the RUC-recommended work RVU between CPT codes 95976 and 95977, which differ by simple vs. complex programming, and added the increment to our proposed value for CPT code 95976. We continue to believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Given that we are finalizing our proposed work RVU for CPT code 95976 of 0.73, we believe a work RVU of 0.97 for CPT code 95977 is appropriate. We are finalizing a work RVU of 0.97 for CPT code 95977 as proposed.

      Comment: A commenter expressed opposition to our use of the reverse building block methodology to evaluate the RUC-recommended work RVU for CPT code 95983 and to identify possible alternative crosswalk CPT codes. Consequently, the commenter stated that our crosswalk of CPT code 93886 is based on invalid reasoning about how the time parameter factors into the code valuation. The work involved in furnishing the service described by the crosswalk code, according to the commenter, is less intense than the work described by the survey code.

      Response: We disagree with the commenter that the reverse building block methodology not an appropriate approach to assessing whether the RUC-recommended work RVU for a code is appropriate. We employed a reverse building block methodology to assess the reasonableness of the RUC's recommendation, not to value the code in the first instance. As the commenter noted, the work described by new CPT code 95983 is difficult to value in relation to both the deleted code and other codes on the fee schedule because of the 15 minute time parameter. However, having looked carefully at the work involved in furnishing the service described by our crosswalk code, CPT code 93886, we do not believe it is less intense than the survey code. The service described by CPT code 93886 is performed on patients with recent brain hemorrhage, which we believe is as complex to study as the work involved in programming adjustments to multiple parameters in real time. We continue to believe that CPT code 93886 is an appropriate crosswalk for CPT code 95983, and we are finalizing a work RVU for this code of 0.91.

      Comment: A commenter stated that our approach for valuing CPT code 95984 ignored physician work intensity and complexity in favor of a random calculation involving code increments, which is a flawed methodology. CMS's choice of crosswalk code, according to the commenter, is invalid because it is based on this incorrect approach.

      Response: We disagree that the use of incremental differences in work RVU between codes that have an established pattern of intensity or time, is inappropriate. We remind the commenter that our calculation of increments is based on the RUC's recommended work RVUs for the relevant CPT codes. We continue to believe that this approach is necessary to maintain intra-family relativity of the PFS, and we maintain that CPT code 51797 is an appropriate crosswalk to the

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      add-on CPT code 95984. We are finalizing a work RVU for CPT 95984 of 0.80.

      Comment: One commenter stated that CMS reduced the nonfacility service cost for clinical labor for CPT code 95970 to zero. The commenter stated that this may be a potential oversight, given that the RUC recommended nonfacility clinical labor time be reduced from 44 to 15 minutes. The commenter stated that it was not consistent for CMS to recommend a nonfacility service cost of zero in light of the nonfacility exam table (EF023) equipment time of 15 minutes, and that this clinical labor should still be reflected in this service.

      Response: We disagree with the commenter and note that the RUC did not recommend any clinical labor time for CPT code 95970, as we proposed the RUC-recommended direct PE inputs without refinement. We believe that the equipment time assigned for the exam table (EF023) and the neurostimulator programmer (EQ209) indicate that these equipment items are in use by the practitioner and not the clinical staff.

      After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Neurostimulator Services family of codes as proposed.

      (56) Psychological and Neuropsychological Testing (CPT Codes 96105, 96110, 96116, 96125, 96127, 96112, 96113, 96121, 96130, 96131, 96132, 96133, 96136, 96137, 9613896138, 96139, 96X11, and 96146)

      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 proposed 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 96121; a work RVU of 0.55 for CPT code 96136; a work RVU of 0.46 for CPT code 96137; and a work RVU of 0.51 for CPT code 96X11. CPT codes 96110, 96127, 96138, 96139, and 96146 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 96136 and 96137), and two for either type of testing when administered by technicians (CPT codes 96138 and 96139); and four new codes that describe testing evaluation by physicians or other qualified health care professionals (CPT codes 96130 through 96133). This new coding effectively unbundles codes that currently report the full course of testing into separate codes for testing administration (CPT codes 96136, 96137, 96138, and 96139) and evaluation (CPT codes 96130, 96131, and 96132). 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 noted 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 proposed to implement work RVUs for this code family, which would eliminate the approximately 2 percent reduction in work spending. We proposed 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 proposed: A work RVU of 2.56 for CPT code 96112, rather than the RUC-recommended work RVU of 2.50; a work RVU of 1.16 for CPT code 96113, rather than the RUC-recommended work RVU of 1.10; a work RVU of 2.56 for CPT code 96130, rather than the RUC-recommended work RVU of 2.50; a work RVU of 1.96 for CPT code 96131, rather than the RUC-recommended work RVU of 1.90; a work RVU of 2.56 for CPT code 96132, rather than the RUC-recommended work RVU of 2.50; and a work RVU of 1.96 for CPT code 96133, rather than the RUC-

      recommended work RVU of 1.90. We saw 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 96132 and 96133. 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 96136 through 96139. In our analysis, we found that the RUC-recommended direct PE refinements contributed significantly to the reduction in the overall payment for this code family. We saw no compelling evidence that the quantities of testing forms used in a typical course of testing would have been reduced dramatically and, in the interest of payment stability, we proposed to refine the direct PE inputs for CPT codes 96132 through 96139 by including 1.0 quantity each of the supply items ``WAIS-IV Record

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      Form,'' ``WAIS-IV Response Booklet #1'', and ``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 solicited comments on our proposed work RVUs and proposed PE refinements for this family of services.

      We also proposed to remove the equipment time for the CANTAB Mobile (ED055) equipment item from CPT code 96146. 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 were unclear as to how the CANTAB Mobile would typically be used in this procedure, and we proposed to remove the equipment time pending the submission of more data about the item. We solicited additional information about the use of this item and how it should best be included into the PE methodology. We were 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.

      The following is a summary of the comments we received regarding our proposed work RVUs and proposed direct PE refinements for this family of services.

      Comment: Many commenters supported our proposal to increase payment from the RUC recommendations in the interest of payment stability. These commenters stated this proposal will help mitigate reductions in reimbursement rates for psychologists.

      According to some commenters, some psychologists will see slight decreases for neuropsychological testing services due to the new coding structure, which they say aligns psychological and neuropsychological testing services with other testing services in the program. Some commenters said that, due to the new coding structure, reimbursement will be lower for neuropsychological evaluation services that are provided by physicians than those provided by technicians. These commenters stated that physicians should not be reimbursed at a lesser rate than EEG or MRI technicians or other physician extenders.

      Response: We note that our proposed values for the evaluation CPT codes 96130 through 96133 and the administration and scoring CPT codes 96136 through 96139 are generally higher for the physician-administered codes than for the analogous technician-administered codes. According to our proposed rates, however, the valuation of the add-on code for each additional 30 minutes of administration and scoring when performed by a technician reported with CPT code 96139 is, however, slightly higher than the valuation of the add-on code for each additional 30 minutes of administration and scoring when performed by a physician or other qualified health care professional, reported with CPT code 96137. We thank commenters for bringing this potential rank-order anomaly to our attention. We believe that clinical staff will typically be providing some support when the physician or other qualified health care professional is performing testing administration as described by CPT codes 96136 and 96137. We are therefore refining the direct PE inputs for these services by adding 10 minutes of clinical labor time for the CA021 clinical labor activity, ``Perform procedure/service--NOT directly related to physician work time'' for these codes. We believe this will more accurately reflect the clinical staff support that is typical when a physician is performing test administration, and it will preserve appropriate rank-order among this subset of services, while mitigating reductions to payment rates for testing administration services.

      Comment: The RUC noted that in the February 5, 2018 RUC submission to CMS, the RUC rescinded its interim recommendation from October 2017, and stated that CPT code 96X11 is deleted and will not be a CPT code for CPT 2019. The RUC recommended that CMS delete this service and work RVU recommendation for the 2019 PFS.

      Response: As CPT code 96X11 will not be a CPT code for CY 2019, we are deleting this code. Based on the RUC-recommended utilization crosswalk, our proposed rates included utilization assumptions that for all services currently reported with CPT codes 96103 and 96120, half of these services will be reported with the new CPT code 96X11 and half will be reported with CPT code 96146. As we are not finalizing 96X11, for the purposes of ratesetting, our utilization for these service will include the assumption that half of the services currently reported with 96103 and 96120 will be reported with CPT code 96136 and half with CPT code 96146.

      Comment: A commenter requested clarification on how much time is considered typical for the neuropsychologist to perform record review and test selection in newly created CPT codes 96132 and 96133.

      Response: For CPT code 96132, we proposed the RUC-recommended 5 minutes of pre-service work time which reflects activities such as preliminary selection of tests and record review. As CPT code 96133 is an add-on code for reporting each additional hour, it does not include additional pre-service work time, as the latter would be considered to be included in the corresponding base code.

      Comment: Several commenters disagreed with the proposal to remove the equipment time for the CANTAB Mobile (ED055) equipment item from CPT code 96146. Commenters stated that the PE Subcommittee determined that this was a software license and it would be more appropriately classified as equipment than as a supply. Commenters stated that they had submitted paid invoices for two additional software license-based automated instruments typically used when furnishing CPT code 96146, and that they were resubmitting these same invoices with their comment letter.

      Response: We appreciate the feedback from the commenter that the CANTAB Mobile (ED055) equipment item referred to a software license. We continue to believe that software licenses would typically be classified as a form of indirect PE under our methodology, and as a result we are finalizing our proposal to remove this equipment time from CPT code 96146.

      Comment: A commenter requested clarification on why new CPT codes 96138, 96139, and 96146 do not include a facility fee, despite the fact that their respective source CPT codes 96102, 96119, 96103, and 96120 do have RVUs in the facility setting.

      Response: The source codes mentioned by the commenter have associated work RVUs, while the new CPT codes do not, and they do not include physician work time. The new CPT coding effectively unbundles professional and technical services for some of these codes. Codes that do not have a physician work component would typically not be valued in the facility setting.

      After consideration of the public comments, we are finalizing the work RVUs for the codes in the Psychological and Neuropsychological Testing family of codes as proposed. We are also finalizing the direct PE inputs as proposed, with the exception of the refinement to the CA021 clinical labor for CPT codes 96136 and 96137 as detailed above.

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      (57) Electrocorticography (CPT Code 95836)

      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 95836 (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 disagreed with the RUC-recommended work RVU of 2.30 for CPT code 95836 and proposed 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 95836. We agreed with the survey respondents that CPT code 95957 was 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 proposed 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 95836.

      The following is a summary of the public comments we received on our proposals involving CPT code 95836.

      Comment: Many commenters disagreed with the proposed work RVU of 1.98 for CPT code 95836 and stated that CMS should finalize the RUC-

      recommended work RVU of 2.30. Commenters stated that the survey respondents chose CPT code 95957 as a reference service and not as a direct crosswalk. Commenters stated that the survey respondents pick from a list of 10-20 services to use as a comparison and then recommend a work RVU based on the intensity, complexity and physician time required to perform the surveyed code. Commenters stated that the median survey work RVU was actually 2.97, much higher than the key reference service, and that the respondents specifically indicated that CPT code 95836 is more intense and complex than CPT code 95957 on all measures.

      Response: We disagree with the commenters that the key reference service of CPT code 95957 would be an inappropriate choice for a direct crosswalk, not least because the RUC commonly uses one of the key reference services in exactly this fashion. While it is true that the median survey work RVU was 2.97, we note that the RUC did not recommend this work valuation either, instead choosing to recommend a work RVU of 2.30 in recognition that the survey median would be a value that is too high to maintain relativity. Similarly, while the survey respondents specifically indicated that CPT code 95836 is more intense and complex than CPT code 95957 on all measures, we note that the survey respondents also indicated that CPT code 95836 is more intense and complex than the second key reference code, CPT code 95810 (Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist) which has a work RVU of 2.50. We proposed to use a crosswalk to CPT code 95957 not only because it was selected by the survey participants as the top key reference, but also because it is a recently-reviewed code with the same intraservice time of 30 minutes and a total time only 2 minutes lower than CPT code 95836. We continue to believe that this is the most accurate choice for work valuation.

      Comment: Several commenters stated that although the specialty society did not submit any direct PE inputs, it is not a facility only code. Commenters stated that CPT code 95836 can be performed in both the nonfacility and the facility setting, and that the nonfacility is actually the typical setting for this service. Commenters stated that they understood that there would be no direct staffing, equipment or supply costs associated with this service and that indirect costs would be similar regardless of the setting in which the service is performed, but there would still be indirect practice expense associated with providing the service in the nonfacility. Commenters apologized for the misunderstanding and requested that CPT code 95836 should be valued in the nonfacility setting.

      Response: We appreciate the additional information supplied by the commenters on this issue. We will remove the ``NA'' designation from the nonfacility setting for CPT code 95836. Due to the fact that there are no direct PE inputs for CPT code 95836, the PE RVU will be the same in both the nonfacility and facility settings because it is based solely on the indirect PE methodology.

      After consideration of the public comments, we are finalizing the work RVU for CPT code 95836 as proposed. We are not finalizing any direct PE inputs for this code, but we will value it in both the facility and nonfacility settings as noted above.

      (58) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454, and 99457)

      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 99453 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment) and 99454 (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 proposed the RUC-recommended work RVU of 0.61 for CPT code 99457 (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 proposed to accept the RUC-recommended direct PE inputs for CPT code 99453 and to remove the ``Monthly cellular and licensing service fee'' supply from CPT code 99454. We do not believe that these licensing fees will 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 proposed to remove this supply input as a form of indirect PE. We proposed the direct PE inputs for CPT code 99457 without refinement.

      The following is a summary of the public comments we received on our

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      proposals involving the Chronic Care Remote Physiologic Monitoring family of codes.

      Comment: Commenters were very supportive of CMS making separate payment for these services. Several commenters supported the proposal of the RUC-recommended work RVU of 0.61 for CPT code 99457. A few commenters stated that the proposed rates for these services were too low, and that given industry standards, reimbursement should be increased.

      Response: We appreciate the support for our proposal from the commenters.

      Comment: Several commenters disagreed with the proposal to remove the ``Monthly cellular and licensing service fee'' supply from CPT code 99454. Commenters stated that the monthly cellular and licensing service fee was a direct practice expense input as it is allocable to the patient for this service. Commenters stated that this fee is not a license for the entire practice; rather it is an individually allocable fee for the period that the patients is monitored and the physician would not incur such fees if the patient did have the wireless monitor. Commenters clarified that the fee is comprised of the monthly cost associated with encryption of data for safe HIPAA compliant transfer, programmed alerts, and the monthly cost of pre-loaded connectivity used to transmit patient generated physiological data from a specific patient to the provider's software. Commenters stated that reliance upon a patient's cellular connectivity or WIFI, which may or may not be operating based on patient technology capabilities, was not reliable for medical delivery purposes.

      Response: We disagree with the commenters and we continue to believe that the monthly cellular and licensing service fee constitutes a form of indirect PE. We believe that licensing and data costs are administrative costs that are not unique to individual procedures, in the same fashion that we do not assign separate direct PE for higher electricity costs to diagnostic imaging procedures as compared to cognitive evaluation procedures. We continue to believe that these data costs are appropriately captured via the indirect PE methodology as opposed to being included as a separate direct PE input. We also note that other services that require around-the-clock monitoring, such as the home PT/INR monitoring described in HCPCS code G0249 (Provision of test materials and equipment for home inr monitoring of patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; includes: Provision of materials for use in the home and reporting of test results to physician; testing not occurring more frequently than once a week; testing materials, billing units of service include 4 tests), do not include additional direct PE inputs for data costs, and we do not believe it would be appropriate to include them for CPT code 99454.

      Comment: One commenter stated that CMS should add the cost of equipment sanitation and reprocessing as a one-time cost that is directly attributable to a patient. The commenter stated that FDA device guidelines require that a reusable medical device be reprocessed, which includes sanitation or sterilization and ensuring that all personal data is `wiped' or removed from the device. The commenter stated that this cost was not considered by the RUC, however, it is routinely part of the `set up' costs that are onetime costs directly attributable to a patient.

      Response: We disagree with the commenter that these expenses would constitute a separate form of direct PE. We agree with the RUC, which discussed the specialty society's recommended supply items, shipping costs and a device reprocessing fee, and determined that these expenses are not specifically allocable to the patient for this service, and would be considered indirect practice expenses.

      Comment: One commenter stated that there was direct time spent by pharmacists for each patient, and the commenter requested that CMS factor pharmacist time into the PE valuation for CPT codes 99453, 99454, 99091, and 99457.

      Response: We typically do not consider time spent by a pharmacist to be a part of the clinical labor time for purposes of direct PE. For additional information, we direct readers to the Practice Expense portion of this final rule (section II.B. of this final rule).

      Comment: Many commenters pointed out that beneficiary cost sharing is a significant barrier to the use of non-face-to-face services, like remote patient monitoring. Commenters requested that CMS waive the cost sharing requirements for these codes.

      Response: We do not have the authority to make changes to the applicable beneficiary cost sharing for most physicians' services, including these.

      Comment: Many commenters requested that CMS clarify the kinds of technology covered under CPT codes 99453, 99454, and 99457. Commenters provided examples of the kinds of technology these codes should cover including software applications that could be integrated into a beneficiary's smart phone, Holter-Monitors, Fit-Bits, or artificial intelligence messaging. One commenter suggested that behavioral health data and data from wellness applications be included as well. Another commenter stated that the descriptor should include results of patients' self-care tasks. Many commenters stated that CMS should clarify certain elements in the scope of service and code descriptors and issue appropriate sub-regulatory guidance. Commenters inquired as to whether CPT code 99453 can be furnished via telecommunication technology, if it can be billed again if the number of parameters changed in the future. Commenters requested that CMS clarify the meaning of ``programmed alerts transmission'' in the descriptor for CPT code 99454, and whether it included transmissions that occurred other than daily. Commenters also encouraged CMS to allow flexibility in the time frame covered by these services.

      Response: We plan to issue guidance to help inform practitioners and stakeholders on these issues.

      Comment: Commenters requested that CMS clarify whether CPT code 99457 can be billed incident to a practitioner's professional services and asked that CMS make an exception to the direct supervision requirements, stating that general supervision is sufficient for these services.

      Response: We note that CPT code 99457 describes professional time and therefore cannot be furnished by auxiliary personnel incident to a practitioner's professional services.

      Comment: A few commenters suggested that additional medical professionals, including pharmacists, paramedics, chiropractors, physical therapists, occupational therapists and dentists should be allowed to bill Medicare for these services. Other commenters requested that CMS clarify the practitioners referred to as ``other qualified healthcare professionals'' in the code descriptor.

      Response: We note that all practitioners must practice in accordance with applicable state law and scope of practice laws, and that some of the practitioners identified by the commenters are not authorized to bill Medicare independently for their services. We note that the term, ``other qualified healthcare professionals,'' used in the code descriptor is a defined by CPT, and that definition can be found in the CPT Codebook.

      Comment: A few commenters provided specific suggestions for revising the code descriptors, including

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      the addition of secure messaging platforms, revision of the time thresholds, specifying that the follow-up should be written in all instances, including ``for medical consultative discussion and review'' in the descriptor for CPT codes 99446 through 99449, and striking ``referral services'' and rather, including language similar to the other codes regarding ``assessment and management'' services. Other commenters requested CMS clarify the definition of ``health record assessment'' in the descriptors for CPT codes 99451 and 99452. One commenter suggested that CMS add language about use of EHR to the existing CPT codes, rather than finalize separate payment for CPT codes 99451 and 99452.

      Response: While we appreciate all of the specific suggestions regarding the code descriptions, we defer to the CPT to maintain code descriptors for CPT codes. Where additional clarification is needed, we may provide guidance in the future.

      Comment: A few commenters urged CMS not to be prescriptive regarding the technology that could be used to perform consultations, including real-time video, a store-and-forward visit, or simply a patient-provider message via a patient portal.

      Response: While we are sympathetic to the commenters' desire not to be overly prescriptive about the technology used to furnish these services, especially given the speed at which technology evolves, we note that we refer to the CPT code descriptors and guidance to ascertain the scope of technology that is used to furnish these services.

      Comment: One commenter asked whether there were geographic restrictions on these services.

      Response: There are no geographic restrictions, as these services are not Medicare telehealth services.

      After considering the public comments, we are finalizing the RUC-

      recommended work RVU of 0.61 for CPT code 99457 and the direct PE inputs for all three codes as proposed.

      (59) Interprofessional Internet Consultation (CPT Codes 99451, 99452, 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 proposed to change the procedure status for CPT codes 99446, 99447, 99448, and 99449 from B (bundled) to A (active). We also proposed 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 99452 (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 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time). The RUC-recommended work RVUs are 0.50 for CPT code 99452 and 0.70 for 99451. 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 proposed a work RVU of 0.50 for both CPT codes 99452 and 99451.

      We welcomed comments on this proposal. We also direct readers to section II.D. of this final rule, Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services, which includes additional detail regarding our 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.

      The following is a summary of the public comments we received on our proposals involving the Interprofessional Internet Consultation family of codes.

      Comment: Almost all commenters were supportive of CMS' proposal to unbundle CPT codes 99446 through 99449 and make separate payment for CPT codes 99452 and 99451. Almost all commenters did not support lowering the RVU of CPT code 99451 to 0.50 as the work of the consulting physician in CPT code 99451 is more intense than the work of the treating physician in CPT code 99452. Commenters stated that the consulting practitioner exercises greater effort, both in judgment and technical skill to make a recommendation for the treatment of a previously unknown patient than the treating physician does in conveying the relevant information. A few commenters expressed concern that the proposed work RVU for CPT code 99452 is too low, and does not accurately reflect the resources associated with the work of the treating physician.

      Response: We agree with commenters that the work of the consulting physician is significant, and we are persuaded by the additional descriptions of that work provided by commenters. We also agree with the commenters who suggested that the proposed work RVU of 0.50 for CPT code 99452 undervalues the work associated with aggregating patient information, communicating with the consulting practitioner, and

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      implementing the results of the consultation. We continue, however, to have concerns regarding the valuation of these services. We note that there are instances where the patient would not be new to the consulting practitioner, and therefore the intensity of the work would be reduced. We are also concerned that, given the similarity of intraservice times, CPT code 99452 is undervalued relative to CPT code 99451, especially since the code descriptor for CPT code 99452 specifies that the consulting practitioner can spend a minimum of 5 minutes providing the consultation. We believe that a work RVU of 0.50 more accurately describes the work associated with both services. Given the similarity of intraservice times and the information indicating that both codes may be undervalued at 0.50 RVUs, we are finalizing a work RVU of 0.70 for CPT codes 99451 and 99452.

      Comment: A few commenters expressed concern that these codes were only payable in the facility setting.

      Response: These codes are payable in both facility and non-facility settings.

      Comment: One commenter requested that CMS include pharmacists as clinical staff in the direct PE.

      Response: We direct readers to the discussion of this issue in the PE section of the rule (Section II.B. of this final rule). We also note that these codes do not have direct PE inputs.

      (60) Chronic Care Management Services (CPT Code 99491)

      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 99491 (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 99491, 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 99491 describes 30 minutes of physician time, we proposed a work RVU of 1.22, which is double the work RVU of CPT code 99490.

      We did not propose any direct PE refinements for this code family.

      The following is a summary of the public comments we received on our proposals involving CPT code 99491.

      Comment: Almost all commenters recommended that CMS finalize the RUC-recommended work value of 1.45 for 99491. The RUC stated that CPT code 99491 is different from the existing chronic care management (CCM) services codes because those codes are performed by clinical staff under the supervision of a physician, while CPT code 99491 is performed by the physicians themselves. Commenters also stated that the typical patient requiring that the physician personally perform the care management services is of greater acuity than the typical patient for whom CCM may be performed by clinical staff. Additionally, CPT code 99491 cannot be reported with CPT code 99490 or CPT code 99487, and must therefore account for all of the care management work in the month. Commenters also pointed out that there are multiple examples of CMS valuing the work of a physician more highly than clinical staff when they perform the same services, for example CPT codes 96101 (Psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, e.g., MMPI, Rorschach, WAIS), per hour of the psychologist's or physician's time, both face-to-face time administering tests to the patient and time interpreting these test results and preparing the report) and 96102 (Psychological testing (includes psychodiagnostic assessment of emotionality, intellectual abilities, personality and psychopathology, e.g., MMPI and WAIS), with qualified health care professional interpretation and report, administered by technician, per hour of technician time, face-to-face.)

      Response: We agree with commenters that a work RVU of 1.45 accurately captures the resources associated when a physician furnishes CCM. We agree that in most cases, the physician would perform CCM on patients with higher acuity and therefore the care planning and medical decision making would be of greater intensity. We also agree with commenters that the work associated with personally performing CCM as opposed to supervising clinical staff is also of greater intensity. Therefore, we are finalizing that value based on our review of comments received.

      Comment: A few commenters requested that CMS clarify that CPT code 99491 can be performed incident to a practitioner's professional services.

      Response: CPT code 99491 is specifically for use when the billing practitioner personally performs care management services, so this code cannot be furnished incident to a practitioner's professional services.

      (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-

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      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 proposed 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 noted that there was a significant disparity between the specialty recommendation and the final recommendation submitted by the HCPAC. We were 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 proposed to maintain the current direct PE inputs for HCPCS codes G0108 and G0109. Therefore, we proposed not to add the new supply item ``20x30 inch self-stick easel pad, white, 30 sheets/pad'' (SK129) to HCPCS code G0109 that was included in the final HCPAC recommendation, as it was not a current supply for HCPCS code G0109; however, we proposed to accept the submitted invoice price and to add the supply to our direct PE database.

      The following is a summary of the public comments we received on our proposals involving the Diabetes Management Training family of codes.

      Comment: Several commenters supported the proposal of the HCPAC-

      recommended work RVUs. Commenters also stated that they applauded CMS for recognizing and addressing the significant disparity in direct PE inputs between the specialty recommendations and the final recommendations submitted to CMS by the HCPAC.

      Response: We appreciate the support for our proposals from the commenters.

      Comment: One commenter expressed disappointment that CMS did not address barriers in Medicare that impact beneficiary utilization of the diabetes self-management training (DSMT) benefit. The commenter stated that CMS solicited comments from stakeholders in the CY 2017 PFS proposed rule on this subject, and the commenter has been part of ongoing conversations with CMS about this issue, through in-person meetings and written communications, over the past two years. The commenter stated that they were hopeful CMS would use this opportunity to address barriers to DSMT given that utilization of the DSMT benefit stands at only 5 percent of eligible Medicare beneficiaries.

      Response: We appreciate the feedback from the commenter, and we will consider these issues for future rulemaking. However, we note that we did not specifically make any proposals associated with these subjects in the CY 2019 proposed rule.

      Comment: One commenter stated that the final HCPAC recommendations removed a series of different syringes and the patient education booklet that currently accompany these procedures. The commenter stated that several anti-glycemic medications other than insulin require injection with a syringe and a significant number of persons with both type 1 and type 2 diabetes are prescribed these medications, however the list of supplies in the current direct PE inputs does not include syringes. The commenter therefore recommended that CMS add a series of different syringes to the direct PE inputs for HCPCS codes G0108 and G0109.

      Response: We proposed to maintain the current direct PE inputs for HCPCS codes G0108 and G0109, which do not currently include the syringe supplies described by the commenter (supply codes SC051, SC052, and SC055). Although we are sensitive to the concerns raised by the commenter, we do not believe that adding these syringe supplies to the procedures would be consistent with our policy of maintaining the current direct PE inputs.

      After consideration of the public comments, we are finalizing the work RVUs and the direct PE inputs for the codes in the Diabetes Management Training family of codes as proposed.

      (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 because they found that there is no physician work involved in this service. After reviewing this code, we proposed a work RVU of 0.00 for HCPCS code G0166, and proposed to make the code valued for PE only. For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving HCPCS code G0166.

      Comment: A commenter agreed with the proposal that an individual treatment session would have no physician work and supported the proposed direct PE inputs. However, the commenter stated that future coding solutions may be necessary to recognize management of these services that is additional to that captured by E/M coding.

      Response: We appreciate the feedback from the commenter, and we will consider this information for future rulemaking.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0166 as proposed.

      (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 disagreed with the recommended value and we proposed 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 did 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

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      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 proposed to refine the equipment times in accordance with our standard equipment time formulas.

      The following is a summary of the public comments we received on our proposals involving HCPCS code G0168.

      Comment: Many commenters disagreed with the proposed work RVU of 0.31 for HCPCS code G0168 and stated that CMS should finalize the HCPAC-recommended work RVU of 0.45. Commenters stated that CMS should not compare the valid survey time to the current work time because the initial CMS/Other source data is flawed and maintains zero validity for comparison. Commenters stated that surveyed time was never obtained from physicians who perform this service and should not be used as a comparison.

      Response: We agree that it is important to use the most recent data available regarding time, and we note that when many years have passed between when time is measured, significant discrepancies can occur. However, we also believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The times currently associated with codes play a very important element in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had routinely been overestimated, this would undermine the relativity of the work RVUs on the PFS in general, given the process under which codes are often valued by comparisons to codes with similar times and it undermine the validity of the allocation of indirect PE RVUs to physician specialties across the PFS. Instead, we believe that it is crucial that the code valuation process take place with the understanding that the existing work times, used in the PFS ratesetting processes, are accurate. We recognize that adjusting work RVUs for changes in time is not always a straightforward process and that the intensity associated with changes in time is not necessarily always linear, which is why we apply various methodologies to identify several potential work values for individual codes. However, we want to reiterate that we believe it would be irresponsible to ignore changes in time based on the best data available and that we are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. For additional information regarding the use of old work time values in our methodology, we refer readers to our discussion of the subject in the CY 2017 final rule (81 FR 80273 through 80274).

      Comment: Several commenters stated that HCPCS code G0168 should not be crosswalked to CPT code 93293, as this is an evaluation of pacemaker strips over a 90 day period. Commenters stated that the skill of closing a facial laceration, typically near the eye, using a surgical tissue adhesive for HCPCS code G0168 is more intense and complex to perform than CPT code 93293 and thus should be valued higher. Commenters stated that CPT code 51702 (Insertion of temporary indwelling bladder catheter; simple (e.g., Foley)) would be a better reference service.

      Response: We disagree with the commenters that CPT code 93293 would be an inappropriate choice for a crosswalk. CPT code 93293 describes a transtelephonic rhythm strip pacemaker evaluation(s) for a single, dual, or multiple lead pacemaker system. We do not agree that this crosswalk code has lower intensity or complexity due to the cognitive work involved in evaluating the patient correctly. Both CPT code 93293 and HCPCS code G0168 require skill on the part of the practitioner, only of different types. We also believe that our crosswalk to CPT code 92393 is a more accurate choice because it has the same intraservice work time (5 minutes) closely matches the total work time (13 minutes as opposed to 14 minutes) of HCPCS code G0168. By contrast, CPT code 51702 has nearly double the total work time at 25 minutes, which accounts for its higher work RVU of 0.50.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0168 as proposed.

      (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 proposed the RUC-

      recommended work RVU of 0.61 for HCPCS code G0268.

      For the direct PE inputs, we proposed 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.

      The following is a summary of the public comments we received on our proposals involving HCPCS code G0268.

      Comment: Several commenters supported our proposal of the HCPAC-

      recommended work RVU as well as the refinement to the direct PE inputs.

      Response: We appreciate the support for our proposals from the commenters.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G0268 as proposed.

      (65) Structured Assessment, Brief Intervention, and Referral to Treatment for Substance Use Disorders (HCPCS Codes G0396, G0397, and G2011)

      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.

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      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 are available at 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 proposed to eliminate the service-specific documentation requirements for HCPCS codes G0397 and G0398. We welcomed comments on our proposal to change the documentation requirements for these codes.

      The following is a summary of the comments we received regarding our proposal to change the documentation requirements for these codes.

      Comment: The majority of commenters were supportive of this proposal, some noting that this will ease administrative burden and some noting that this will incentivize providers to deliver SBIRT services, thereby increasing access to this service. One commenter stated they believe that practitioners are not utilizing SBIRT for illicit drug use due to the absence of conclusive evidence to support use of this service for illicit drug use and therefore, support removing the service documentation requirements for SBIRT when used to screen for unhealthy alcohol use, but not when used to screen for illicit drug use.

      Response: We thank the commenters for their feedback. We note that the services described by HCPCS codes G0397 and G0398 describe services for alcohol and/or substance abuse; we believe it would be administratively burdensome for practitioners were we to create varying rules for different diagnoses. Additionally, it is our intention to increase access to care for services that may be of use in addressing all substance use disorders, especially in light of the ongoing opioid epidemic. Therefore, we are finalizing our proposal to eliminate the service-specific documentation requirements for HCPCS codes G0397 and G0398.

      Additionally, we proposed to create a third HCPCS code G2011with a lower time threshold in order to accurately account for the resource costs when practitioners furnish these services, but do not meet the minimum time requirements of the existing codes. We note that in the proposed rule we referred to this service as HCPCS code GSBR1, which was a placeholder code. The code will be described as G2011: Alcohol and/or substance (other than tobacco) abuse structured assessment (e.g., AUDIT, DAST), and brief intervention, 5-14 minutes. We proposed a work RVU of 0.33, based on the intraservice time ratio between HCPCS codes G0396 and G0397. We welcomed comments on this code descriptor and proposed valuation for HCPCS code G2011.

      The following is a summary of the comments we received on this code descriptor and proposed valuation for HCPCS code G2011.

      Comment: Commenters were supportive of creating this code and the valuation proposed, and noted the lower time threshold will allow physicians the opportunity to provide brief counseling rather than 15 or more minutes of discussion, which requires extended interest from a patient who may not yet be ready for prolonged discussion and/or is receptive to being referred to another health care provider for treatment. One commenter recommended finalizing guidance that allows the newly proposed SBIRT HCPCS code to be used for alcohol, but not illicit drug use.

      Response: We thank the commenters for their feedback. After considering these comments, we are finalizing the code descriptor and valuation for HCPCS code G2011 as proposed. We believe the code descriptor and guidance for this new SBIRT HCPCS code should be consistent with the existing SBIRT HCPCS codes. For future rulemaking we would consider recommendations on how to refine this family of codes under our standard process of reviewing codes.

      (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 have shared with us 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 final rule, Evaluation and Management Services, to implement a single PFS rate for E/M visit levels 2-5 while maintaining payment stability across the specialties, we proposed 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)), which could be billed with any level of E/M code. We noted that we did not propose to make any changes to CPT codes 99354 and 99355, which can still be billed, as needed, when their time thresholds and all other requirements are met. We proposed a work RVU of 1.17, which is equal to half of the work RVU assigned to CPT code 99354. Additionally, we proposed 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 final rule.

      Comment: As almost all commenters did not support the overall E/M coding and payment proposals, we did not receive many comments with specific suggestions on valuation for HCPCS code GPRO1. Of the commenters that supported creation of the code, most supported the proposed valuation while others, while supporting the creation of a 30-

      minute prolonged services code in principle, encouraged CMS to wait for recommendations from the CPT Editorial Panel and the RUC.

      Response: For CY 2021, we are finalizing the proposed add-on code for HCPCS code GPRO1 using the input values, as proposed. We note that prior to implementation for 2021, we could consider, through rulemaking, the code and its valuation in the context of any potential changes to CPT codes and/or recommendations offered by stakeholders, including the RUC, as part of our annual process for valuing PFS services. See section II.I. of this final rule for further discussion of the E/M policy.

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      (67) Remote Pre-Recorded Services (HCPCS Code G2010)

      For CY 2019, we proposed to make separate payment for remote evaluation 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 G2010 (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 proposed 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 G2010. Therefore, we proposed a work RVU of 0.18, preservice time of 3 minutes, intraservice time of 4 minutes, and post service time of 2 minutes. We also proposed to add 6 minutes of clinical labor (L037D) in the service period. We solicited comment on the code descriptor and valuation for HCPCS code G2010. We direct readers to section II.D. of this final rule, which includes additional detail regarding our proposed policies for modernizing Medicare physician payment by recognizing communication technology-based services.

      The following is a summary of the comments we received on the code descriptor and valuation for HCPCS code G2010.

      Comment: Several commenters stated that the proposed payment rate is too low, citing that it is below market compared to the rate many asynchronous telemedicine companies pay their contracted/employed physician staff, and noted that new patients in particular require more resources, whereas others stated that the proposed valuation was appropriate.

      Response: We believe that the proposed valuation accurately reflects the resources involved in furnishing this service and note that we are finalizing limiting this service to established patients. We also note that we plan to monitor the utilization of this code and routinely address recommended changes in values for codes paid under the PFS.

      After considering the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G2010 as proposed.

      (68) Brief Communication Technology-Based Service, e.g. Virtual Check-

      In (HCPCS Code G2012)

      We proposed to create a G-code, HCPCS code G2012 (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 proposed to base the code descriptor and valuation for HCPCS code G2012 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 G2012 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 proposed a work RVU of 0.25, based on a direct crosswalk to CPT code 99441. For the direct PE inputs for HCPCS code G2012, we also proposed the direct PE inputs assigned to CPT code 99441. Given the breadth of technologies that could be described as telecommunications, we anticipated 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 solicited comment on the code descriptor, as well as the proposed valuation for HCPCS code G2012. We direct readers to section II.D. of this final rule, which includes additional detail regarding our proposed policies for modernizing Medicare physician payment by recognizing communication technology-

      based services.

      The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code G2012.

      Comment: Several commenters stated that the proposed payment rate would be inadequate for modalities that are both audio and visual capable, whereas other commenters stated that the proposed valuation was appropriate.

      Response: We appreciate the input provided by the commenters. As noted in section II.D. of this final rule, we are finalizing the valuation for this service as proposed. We note that we are finalizing allowing audio-only real-time telephone interactions in addition to synchronous, two-way audio interactions that are enhanced with video or other kinds of data transmission. We believe the proposed valuation reflects the low work time and intensity and accounts for the resource costs and efficiencies associated with the use of communication technology. We recognize that the valuation of this service is relatively modest, especially compared to in-person services, however, we believe that the proposed valuation accurately reflects the resources involved in furnishing this service.

      We plan to monitor the utilization of this code and note that we routinely address recommended changes in values for codes paid under the PFS and would expect to do this in future rulemaking.

      After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for HCPCS code G2012 as proposed.

      (69) Visit Complexity Inherent to Certain Specialist Visits (HCPCS Code GCG0X)

      We proposed 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 proposed 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

      Page 59582

      interventional pain management-centered care (Add-on code, list separately in addition to an evaluation and management visit)). We proposed 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 final rule. We solicited comment on the code descriptor, as well as the proposed valuation for HCPCS code GCG0X.

      The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code GCG0X.

      Comment: As almost all commenters did not support the overall E/M coding and payment proposals, we did not receive comments with specific suggestions on valuation for HCPCS code GCG0X.

      Response: For CY 2021, we are finalizing the proposed add-on code for visit complexity inherent to non-procedural specialty care using the input values, as proposed. We note that prior to implementation for CY 2021, we could consider, through rulemaking, the code and its valuation in the context of any potential changes to CPT codes and/or recommendations offered by stakeholders, including the RUC, as part of our annual process for valuing PFS services. See section II.I. of this final rule for further discussion of the E/M policy.

      (70) Visit Complexity Inherent to Primary Care Services (HCPCS Code GPC1X)

      We proposed 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 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 proposed 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 final rule. We solicited comment on the code descriptor, as well as the proposed valuation for HCPCS code GPC1X.

      The following is a summary of the comments we received on the code descriptor, as well as the proposed valuation for HCPCS code GPC1X.

      Comment: We received a few comments suggesting that the primary care add-on was undervalued, particularly in comparison to the add-on code for specialty visit complexity. A few commenters suggested that, at the very least, we should equalize the value for these codes.

      Response: We agree that the proposed inputs do not reflect the resources associated with furnishing primary care visits. For CY 2021, we are finalizing the proposed add-on code for visit complexity inherent to primary care using the inputs associated with HCPCS code GCG1X: A work RVU of 0.25 and a physician time of 8.25 minutes. We note that prior to implementation for 2021, we could consider, through rulemaking, the code and its valuation in the context of any potential changes to CPT codes and/or recommendations offered by stakeholders, including the RUC, as part of our annual process for valuing PFS services. See section II.I. of this final rule for further discussion of the E/M policy.

      (71) Podiatric Evaluation and Management Services (HCPCS Codes GPD0X and GPD1X)

      We proposed 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 proposed 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 final rule.

      Comment: As almost all commenters did not support the overall E/M coding and payment proposals and these codes specifically, we did not receive comments with specific suggestions on valuation.

      Response: In response to comments, we are not finalizing HCPCS codes GPD0X and GPD1X for CY 2019. See section X of this final rule for further discussion of the E/M policy.

      (72) Comment Solicitation on Superficial Radiation Treatment Planning and Management

      In the CY 2015 PFS final rule with comment period (79 FR 67666 through 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

      Page 59583

      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 through 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 but without a consistent 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 did not propose changes relating to SRT coding, SRT-related professional codes, or payment policies for CY 2019. However, we solicited 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 solicited comment on whether we should create such G-codes to separately report each of the services described previously, 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 stated that we 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 solicited 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.

      The following is a summary of the comments we received on the possibility of creating multiple G-codes specific to services associated with SRT, which could 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, which would be contractor priced for CY 2019.

      Comment: Many commenters urged CMS to make appropriate payment for SRT-related services, stating that it is a vital non-surgical alternative treatment for skin cancer. Many commenters also said that coding should recognize newer generation, Image Guided Superficial Radiation (IGSRT), stating that IGSRT is the most advanced form of this technology, and has far better outcomes compared to those achieved with SRT.

      Some commenters recommended implementation of G-codes for SRT-

      related professional services, and they submitted alternative G-code scenarios that they believe would be preferable to adopting contractor-

      priced G-codes. These scenarios include one in which there would be one code for SRT-related treatment planning, with a value based on a crosswalk to CPT code 77261 (Therapeutic radiology treatment planning; simple), a code for SRT treatment device construction, with a value based on a crosswalk to CPT code 77332 (Treatment devices, design and construction; simple (simple block, simple bolus), and a code for SRT treatment management billed once per treatment, valued with a crosswalk to CPT code 99213 (Office or other outpatient visit for the evaluation and management of an established patient,

      Page 59584

      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.). According to this commenter, image guidance and tracking should not be billed with superficial treatments. Another commenter suggested a single code bundling SRT-related treatment management with SRT-related device construction as well as a code for SRT-related radiation treatment management, and a code representing treatment for multiple lesions. This commenter also urged us to either revalue CPT code 77401 or to create an additional G-code billable with CPT code 77401 to represent professional services associated with SRT. Another commenter suggested a code for SRT-related radiology treatment planning, and an SRT management code including five treatments. A commenter suggested a coding structure that recognizes Image-Guided Superficial Radiation Therapy as a newer generation of SRT, and would consist of CPT code 77401 for practitioners that utilize the SRT technologies; relying on human visualization for lesion(s) simulation, treatment and tracking, and a new G-code for providers who provide the newer generation technology relying on image-guided lesion simulation, treatment and tracking per fraction with Record and Verify precision tracking of treatment progress.

      A commenter stated that any codes utilized as part of superficial radiation treatment delivery that include medical physics time should require that a qualified medical physicist perform the physics work.

      A commenter stated that adopting contractor-priced G codes would be appropriate. Some other commenters, however, did not support our suggested adoption of contractor-priced codes. According to these commenters, we are correct in our belief that there are coding gaps in the current reimbursement structure, however a fuller evaluation that does not defer to Medicare contractors in determining reimbursement rates is appropriate. According to a commenter, contractor pricing creates unnecessary work for the Medicare Administrative Contractors and can also lead to wide variances in the valuing of codes across jurisdictions. Commenters expressed preference that coding for these services be developed through the CPT and RUC processes. Many commenters urged us not to change coding for CY 2019 for these services.

      Response: We expect to take these comments into consideration for future rulemaking and we hope to continue a dialogue with stakeholders on these important services. We reiterate that we believe multi-

      specialty input through the CPT and RUC processes is the ideal way to develop coding specificity and evaluation, and we are not making any changes to payment policy based on this comment solicitation. In the interim, we refer readers to CPT guidance that states that CPT code 77401, when performed, may be reported with appropriate E/M codes, and this is the appropriate way to currently report professional work associated with SRT. Going forward, we will attempt to determine whether MACs are inappropriately denying billing of E/M codes with CPT code 77401, and we will instruct MACs accordingly.

      (73) Adaptive Behavior Analysis Services

      We note that we intended to assign a contractor price status in the Addendum B file of the proposed rule for the following CPT codes that describe adaptive behavior analysis services: CPT codes 97151, 97152, 97153, 97154, 97155, 97156, 97157, and 97158. These codes are formerly contractor priced Category III CPT codes that were converted to Category I for CY 2019. We inadvertently excluded these codes in the Addendum B file of the proposed rule, and have updated the Addendum B file for this final rule.

      BILLING CODE 4120-01-P

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      Table 15--CY 2019 Invoices Received for Existing Direct PE Inputs

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

      Estimated

      non-

      facility

      Current Updated Percent Number of allowed

      CPT/HCPCS codes Item name CMS code price price change invoices services

      for HCPCS

      codes using

      this item

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

      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--CY 2019 New Invoices

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

      Number of NF Allowed

      CPT/HCPCS codes Item name CMS code Average price invoices services

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

      10011, 10012............................. MREYE Chiba Biopsy Needle... SC106 37.00 1 0

      33285.................................... subcutaneous cardiac rhythm SA127 5,032.50 4 280

      monitor system.

      36572, 36573, 36584...................... Turbo-Ject PICC Line........ SD331 170.00 1 24,402

      53854.................................... kit, Rezum delivery device.. SA128 1,150.00 1 121

      53854.................................... 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

      76391.................................... MR Elastography Package..... EL050 200,684.50 1 350

      76978, 76979............................. bubble contrast............. SD332 126.59 1 89

      76978, 76979............................. Ultrasound Contrast Imaging ER108 5,760.00 1 89

      Package.

      76981, 76982, 76983...................... sheer wave elastography ED060 9,600.00 1 493

      software.

      77048, 77049............................. CAD Software................ ED058 43,308.12 1 36,675

      77046, 77047, 77048, 77049............... Breast coil................. EQ388 83,200.00 1 39,785

      77048, 77049............................. CAD Workstation (CPU + Color ED056 12,031.52 1 36,675

      Monitor).

      85097.................................... slide stainer, automated, EP121 8,649.43 1 34,559

      hematology.

      92273.................................... Sleep mask.................. SK133 9.95 1 10,266

      92273, 92274............................. mfERG and ffERG EQ390 102,400.00 1 25,602

      electrodiagnostic unit.

      92273, 92274............................. Contact lens electrode for EQ391 1,440.00 1 25,602

      mfERG and ffERG.

      96136, 96137, 96138, 96139............... WAIS-IV Record Form......... SK130 5.25 1 301,452

      96136, 96137, 96138, 96139............... WAIS-IV Response Booklet #1. SK131 3.30 1 301,452

      96136, 96137, 96138, 96139............... WMS-IV Response Booklet #2.. SK132 2.00 1 301,452

      96136, 96137, 96138, 96139............... Wechsler Adult Intelligence EQ387 971.30 1 301,452

      Scale--Fourth Edition (WAIS-

      IV) Kit (less forms).

      99454.................................... 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--CY 2019 No PE Refinements

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

      HCPCS Description

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

      10004............................. Fna bx w/o img gdn ea addl.

      10006............................. Fna bx w/us gdn ea addl.

      10008............................. Fna bx w/fluor gdn ea addl.

      10010............................. Fna bx w/ct gdn ea addl.

      10011............................. Fna bx w/mr gdn 1st les.

      10012............................. Fna bx w/mr gdn ea addl.

      11103............................. Tangntl bx skin ea sep/addl.

      11105............................. Punch bx skin ea sep/addl.

      11107............................. Incal bx skn ea sep/addl.

      33274............................. Tcat insj/rpl perm ldls pm.

      33275............................. Tcat rmvl perm ldls pm.

      33285............................. Insj subq car rhythm mntr.

      33286............................. Rmvl subq car rhythm mntr.

      33289............................. Tcat impl wrls p-art prs snr.

      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 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.

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

      BILLING CODE 4120-01-P

      Page 59626

      GRAPHIC TIFF OMITTED TR23NO18.287

      BILLING CODE 4120-01-C

      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. L. 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). Public Law 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

      Page 59627

      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\

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      \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 final rule are housed separately within Medicare's Internet-Only Manuals, and are not contained within the 1995 or 1997 E/

      M documentation guidelines.

      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. L. 100-04, Medicare Claims Processing Manual, Chapter 12, Section 30.6.1.A., 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 efforts 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 meaningful 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

      Page 59628

      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 commenters 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 noted 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 Final Policies

    4. Overview

      Having considered the public feedback to the CY 2018 PFS proposed rule (82 FR 53163 through 53166) and our other outreach efforts described above, in our CY 2019 proposed rule, we proposed several changes to E/M visit documentation and payment. We proposed that the changes would only apply to office/outpatient visit codes (CPT codes 99201 through 99215), except where we specify otherwise. We agreed with commenters that we should take a step-wise approach to these issues, and therefore, we limited proposed changes to the office/outpatient E/M code set. We understood 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 emphasized that, this year, we included 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 believed our proposed documentation changes for E/M visits were intrinsically related to our proposal to alter PFS payment for E/M visits, and the PFS payment proposal for E/M visits required notice and comment rulemaking. We noted that we were proposing a relatively broad outline of changes, and anticipated 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