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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 409, 410, 411, 414, 415, 416, 418, 424, 425, 489, and 498

[CMS-1715-F and IFC]

RIN 0938-AT72

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

AGENCY:

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

ACTION:

Final rule and interim final rule.

SUMMARY:

This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. In addition, we are issuing an interim final rule with comment period (IFC) to establish coding and payment for evaluation and management, observation and the provision of self-administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible.

DATES:

Effective date:

These regulations are effective on January 1, 2020.

Comment date:

Comments will be accepted/considered ONLY on the Interim Rule “Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine” contained in section V. of the preamble of this document. To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 31, 2019.

ADDRESSES:

In commenting, please refer to file code CMS-1715-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-1715-IFC, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1715-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 issues not identified below.

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

Geri Mondowney, (410) 786-1172, or Tourette Jackson, (410) 786-4735, for issues related to malpractice RVUs and geographic practice cost indices (GPCIs).

Larry Chan, (410) 786-6864, or Geri Mondowney, (410) 786-1172, for issues related to potentially misvalued services under the PFS.

Lindsey Baldwin, (410) 786-1694, Emily Yoder, (410) 786-1804, or Patrick Sartini, (410) 786-9252, for issues related to telehealth services.

Pierre Yong, (410) 786-8896, or Lindsey Baldwin, (410) 786-1694, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs (OTPs).

Lindsey Baldwin, (410) 786-1694, for issues related to bundled payments under the PFS for substance use disorders.

Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, for issues related to the comment solicitation on opportunities for bundled payments under the PFS.

Regina Walker-Wren, (410) 786-9160, for issues related to physician supervision for physician assistant (PA) services and review and verification of medical record documentation.

Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, Liane Grayson, (410) 786-6583, or Christiane LaBonte (410) 786-7237, for issues related to care management services.

Terry Simananda, (410) 786-8144, for issues related to interim final rule with comment period (payment for self-administered esketamine).

Kathy Bryant, (410) 786-3448, for issues related to coinsurance for colorectal cancer screening tests and global surgery data collection.

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

Ann Marshall, (410) 786-3059, Emily Yoder, (410) 786-1804, or Christiane LaBonte, (410) 786-7237, for issues related to payment for evaluation and management services.

Thomas Kessler, (410) 786-1991, for issues related to ambulance physician certification statement.

Felicia Eggleston, (410) 786-9287, or Amy Gruber, (410) 786-1542, for issues related to the ambulance fee schedule and the requirements related to the Medicare ground ambulance data collection system.

Linda Gousis, (410) 786-8616, for issues related to intensive cardiac rehabilitation.

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

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

Katie Mucklow, (410) 786-0537, or Diana Behrendt (410) 786-6192, for issues related to open payments.

Cheryl Gilbreath, (410) 786-5919, for issues related to home infusion therapy benefit.

Joseph Schultz, (410) 786-2656, for issues related to Medicare enrollment of opioid treatment programs, and enhancements to provider enrollment regulations concerning improper prescribing and patient harm.

Jacqueline Leach, (410) 786-4282, for issues related to Deferring to State Scope of Practice Requirements: Ambulatory Surgical Centers (ASC).

Mary Rossi-Coajou, (410) 786-6051, for issues related to Deferring to State Scope of Practice Requirements: Hospice.

1877AdvisoryOpinion@cms.hhs.gov,

for issues related to Advisory Opinions on Application of the Physician Self-referral law.

Molly MacHarris, (410) 786-4461, for inquiries related to Merit-based Incentive Payment System (MIPS).

Brittany LaCouture, (410) 786-0481, for inquiries related to Alternative Payment Models (APMs).

Patricia Taft, (410) 786-4561, for issues related to Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes Annual Update.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://regulations.gov.

Follow the search instructions on that website to view public comments.

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

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.

Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS

Federal Register

and other related documents. For the CY 2020 PFS final rule, refer to item CMS-1715-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 2019 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

This major final rule revises payment polices under the Medicare PFS and makes other policy changes, including provisions to implement certain provisions of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L. 115-271, October 24, 2018), related to Medicare Part B payment, applicable to services furnished in CY 2020 and thereafter. In addition, this final rule includes provisions related to other payment policy changes that are addressed in section III. of this final rule.

To facilitate beneficiary access to treatment for treatment-resistant depression (TRD) as using esketamine, we are creating two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim final basis. For 2020, we are establishing RVUs for these services that reflect the relative resource costs associated with the evaluation and management (E/M), observation and provision of the self-administered esketamine product.

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 final rule, we are establishing RVUs for CY 2020 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes discussions and provisions regarding several other Medicare Part B payment policies, Medicare Shared Savings Program quality reporting requirements, Medicaid Promoting Interoperability Program requirements for eligible professionals, the establishment of a ground ambulance data collection system, updates to the Quality Payment Program, Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. Specifically, this final rule addresses:

• Practice Expense RVUs (section II.B.)

• Malpractice RVUs (section II.C.)

• Geographic Practice Cost Indices (GPCIs) (section II.D.)

• Potentially Misvalued Services under the PFS (section II.E.)

• Telehealth Services (section II.F.)

• Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs (section II.G.)

• Bundled Payments Under the PFS for Substance Use Disorders (section II.H.)

• Physician Supervision for Physician Assistant (PA) Services (section II.I.)

• Review and Verification of Medical Record Documentation (section II.J.)

• Care Management Services (section II.K.)

• Coinsurance for Colorectal Cancer Screening Tests (section II.L.)

• Therapy Services (section II.M.)

• Valuation of Specific Codes (section II.N.)

• Comment Solicitation on Opportunities for Bundled Payments under the PFS (section II.O.)

• Payment for Evaluation and Management (E/M) Services (section II.P.)

• Ambulance Coverage Services—Physician Certification Statement (section III.A.)

• Ambulance Fee Schedule—Medicare Ground Ambulance Data Collection System (section III.B.)

• Intensive Cardiac Rehabilitation (section III.C.)

• Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) (section III.D.)

• Medicare Shared Savings Program Quality Measures (section III.E.)

• Open Payments (section III.F.)

• Home Infusion Therapy Benefit (section III.G.)

• Medicare Enrollment of Opioid Treatment Programs and Enhancements to Existing General Enrollment Policies Related to Improper Prescribing and Patient Harm (section III.H.)

• Deferring to State Scope of Practice Requirements (section III.I.)

• Advisory Opinions on the Application of the Physician Self-Referral Law (section III.J.)

• Updates to the Quality Payment Program (section III.K.)

• Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes (section IV.)

• Interim Final Rule with Comment Period: Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine (HCPCS codes G2082 and G2083) (section V.)

• Collection of Information Requirements (section VI.)

• Regulatory Impact Analysis (section VII.)

2. Summary of Costs and Benefits

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

see

section VII. of this final rule.

II. Provisions of the Final Rule for the PFS

A. Background

Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published in the November 25, 1991

Federal Register

(56 FR 59502) set forth the first fee schedule used for payment for physicians' services.

We note that throughout this major final rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

1. Development of the RVUs

a. Work RVUs

The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.

As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule.

b. Practice Expense RVUs

Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding MP expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.

Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA of 1997) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA of 1997 provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.

We established the resource-based PE RVUs for each physicians' service in the November 2, 1998 final rule (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 PFS final rule with comment period (76 FR 73033).

Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some resource costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those specific facility resource costs is not made under the PFS.

Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and

published in the

Federal Register

(65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.

In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.

c. Malpractice RVUs

Section 4505(f) of the BBA of 1997 amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' MP insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs,

see

section II.C. of this final rule, Determination of Malpractice Relative Value Units.

d. Refinements to the RVUs

Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed 5-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.

Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.

In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.

In addition to the 5-year reviews, beginning for CY 2009, CMS and the RUC identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically identify, review and adjust values for potentially misvalued codes.

e. Application of Budget Neutrality to Adjustments of RVUs

As described in section VII. of this final rule, the Regulatory Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.

2. Calculation of Payments Based on RVUs

To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP in an area compared to the national average costs for each component. Please refer to the CY 2017 PFS final rule with comment period for a discussion of the last GPCI update (81 FR 80261 through 80270), and to the GPCI section of this current rule for the CY 2020 update.

RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS' Office of the Actuary (OACT). The formula for calculating the Medicare PFS payment amount for a given service and fee schedule area can be expressed as:

Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU MP × GPCI MP)] × CF

3. Separate Fee Schedule Methodology for Anesthesia Services

Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia CF, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate CF for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.

B. Determination of PE RVUs

1. Overview

Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.

2. Practice Expense Methodology

a. Direct Practice Expense

We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work relative value units under the PFS and proposed changes to the PE

methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

b. Indirect Practice Expense per Hour Data

We use survey data on indirect PEs incurred per hour worked, in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.

We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file called “CY 2020 PFS Proposed Rule PE/HR” on the CMS website under downloads for the CY 2020 PFS proposed rule at

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

For CY 2020, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2018. These specialties are Medical Toxicology and Hematopoietic Cell Transplantation and Cellular Therapy. We 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:

• Medical Toxicology from Emergency Medicine; and

• Hematopoietic Cell Transplantation and Cellular Therapy from Hematology/Oncology.

These updates are reflected in the “CY 2020 PFS Final Rule PE/HR” file available on the CMS website under the supporting data files for the CY 2020 PFS final rule at

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

We did not receive any public comments on the use of the proposed PE/HR proxy values for Medical Toxicology and Hematopoietic Cell Transplantation and Cellular Therapy. Therefore, we are finalizing our PE/HR crosswalks as proposed.

c. Allocation of PE to Services

To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

(1) Direct Costs

The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

(2) Indirect Costs

We allocate the indirect costs at the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00

(2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).

• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.

• Then, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs

For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

(4) Services With Technical Components and Professional Components

Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2020 PFS proposed rule at

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

This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes.

(a) Setup File

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

(b) Calculate the Direct Cost PE RVUs

Sum the costs of each direct input.

Step 1:

Sum the direct costs of the inputs for each service.

Step 2:

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

Step 3:

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

Step 4:

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

Step 5:

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

(c) Create the Indirect Cost PE RVUs

Create indirect allocators.

Step 6:

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

Step 7:

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

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

For CY 2020, we proposed to clarify the expected specialty assignment for a series of cardiothoracic services. Prior to the creation of the expected specialty list for low volume services in CY 2018, we previously finalized through rulemaking a crosswalk to the thoracic surgery specialty for a series of cardiothoracic services that typically had fewer than 100 services reported each year (

see,

for example, the CY 2012 PFS final rule (76 FR 73188-73189)). However, we noted that for many of the affected codes, the expected specialty list for low volume services incorrectly listed a crosswalk to the cardiac surgery specialty instead of the thoracic surgery specialty. We proposed to update the expected specialty list to accurately reflect the previously finalized crosswalk to thoracic surgery for these services. The affected codes are shown in Table 1.

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We note that the cardiac surgery and thoracic surgery specialties are similar to one another, sharing the same PE/HR data for PE valuation and nearly

identical MP risk factors for MP valuation. As a result, we noted that we did not anticipate the proposal having a discernible effect on the valuation of the codes listed above. The complete list of expected specialty assignments for individual low volume services, including the assignments for the codes identified in Table 1, is available on our website under downloads for the CY 2020 PFS final rule at

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

We received public comments on the proposed updates to the expected specialty list. The following is a summary of the comments we received and our responses.

Comment:

Several commenters stated that CMS had indicated that the expected specialty would be updated to include a column specifying if a service was identified as a low volume service for CY 2020, indicating if the service-level override was being applied for CY 2020. However, commenters noted that this additional column did not appear in the download version and asked for additional information.

Response:

We thank the commenters for identifying this missing information and we apologize for the technical oversight that caused this information not to be displayed for the proposed rule. We will include this additional column in the public use files released with the final rule.

Comment:

Several commenters disagreed with the CMS proposal to update the expected specialty list to accurately reflect the previously finalized crosswalk to thoracic surgery for these services. Commenters stated that when the expected specialty list was developed, the affected specialties specifically selected the cardiac surgery specialty for these codes. Commenters also stated that, for nearly all of the applicable codes, cardiac surgery was the dominant provider in the 2018 Medicare claims data. Commenters acknowledged that the MP risk factor for both cardiac surgery and thoracic surgery is naturally very similar, but still asked that CMS assign the codes listed in Table 1 to the cardiac surgery specialty.

Response:

As we stated in the proposed rule, we did not propose to assign the codes listed in Table 1 to the cardiac surgery specialty. Instead, we proposed to update the incorrect documentation in our expected specialty list to accurately reflect the previously finalized crosswalk to thoracic surgery for these services. The previously finalized assignment of the cardiac specialty to these services has been in place since the CY 2012 rule cycle, and we believe that the expected specialty list should be updated to reflect the correct specialty assignment.

Comment:

Several commenters disagreed with the CMS methodology used to determine low volume service status; that is, codes that have fewer than 100 allowed services in the non-modified 3-year average of Medicare claims data. Commenters stated that utilization frequencies are adjusted in the RUC database for certain codes based on the CPT modifiers that were appended to the code to ensure that certain services are not over- or underweighted, such as changes made for bilateral modifier 50, post-op only modifier 55 and anesthesia modifiers QK, QX and QY. Commenters stated that CMS does not discount the utilization when determining what constitutes a low volume service and instead uses the non-modified 3-year service count for this criterion. Commenters stated that this could lead to double-counting and overestimating utilization for the purposes of determining low volume status, and requested that CMS use discounted utilization for this purpose.

Response:

We disagree that it would be more accurate to use a discounted form of utilization to determine low volume status. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use claims data to determine which codes are low volume for the coming year, defining “low volume” as those that had fewer than 100 allowed services in the Medicare claims data. We did not finalize a policy to discount this utilization and we do not believe that it would be more accurate to do so, as a service is still performed even if a payment discount is applied to its billing. More importantly, we did not make any proposals concerning the methodology to determine what constitute a low volume service in the proposed rule, and therefore, we are not finalizing any changes to this methodology.

Comment:

One commenter provided a list of 112 additional codes that the commenter stated were low volume procedures, with an expected specialty for each code. The commenter recommended that CMS append this list to the anticipated specialty assignment for low volume services. Another commenter stated that gastroenterologists do not perform CPT code 96571 on a current basis, and recommended that CMS remove gastroenterology as the expected specialty for this code.

Response:

We appreciate the list of additional services identified by the commenter. As we have stated in previous rulemaking (82 FR 52982), we consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis. In reviewing the submitted list of 112 additional codes, we noted that they generally fell into two categories—codes with a restricted coverage status code (“R”) or codes that exceed 100 services in the claims data, and therefore, did not meet our criteria for low volume status. We are finalizing the addition of these 112 codes to the low volume services list with the recommended expected specialty; however, we caution that many of these codes will continue to have utilization too high to meet the criteria for expected specialty assignment. We are adding these codes to the list in the interest of maintaining payment stability, such that, if they were to fall below 100 annual services at a future date, then an expected specialty would be assigned. We do not have indirect PE data for two of the specialties on the recommended list, and as a result we are substituting the established PE/HR crosswalk for these specialties. (The full list of all established PE/HR crosswalks is available on our website under downloads for the CY 2020 PFS final rule at

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

) The two affected specialties are Interventional Cardiology (crosswalked to Cardiology) and Surgical Oncology (crosswalked to General Surgery). We are also finalizing a change to the expected specialty for CPT code 96571 in response to the information supplied by the commenter, which we are changing to Pulmonary Disease to match the dominant specialty in the claims data. The complete list of additional updates to the low volume services list is detailed in Table 2.

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Comment:

Several commenters stated that the non-facility PE RVUs for CPT code 55874 (

Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed

) are projected to decrease 13 percent for CY 2020, which the commenter believed to be attributed to the current specialty mix utilizing the code. The commenters stated that the projected decrease for CY 2020 was due to CMS using the first year of actual claims data, which had a different ratio of the urology and radiation oncology specialties than in the previously projected utilization crosswalk. The commenters requested that CMS address the proposed decreases for CPT code 55874 in the final rule.

Response:

We agree with the commenters that the proposed decreases for CPT code 55874 were due to changes in the specialty mix, as the code shifted from projected utilization to reported claims data. However, we do not agree with the commenters that there is a need to address the valuation of this code, as we believe that it is important to use actual claims data as opposed to utilization projections once the data for new codes has become available. The specialty mix on reported claims will necessarily be more accurate than the utilization projections created in advance before claims data exists. We also note that the specialty mix associated with CPT code 55874 in the claims data is unrelated to the low volume list or the assignment of an expected specialty.

Comment:

A commenter stated that CPT codes 33271 (

Insertion of subcutaneous implantable defibrillator electrode

) and 33273 (

Repositioning of previously implanted subcutaneous implantable defibrillator electrode

) are low volume service codes that are proposed to have a service-level override to the anticipated specialty of cardiology. The commenter supported this expected specialty assignment.

Response:

We appreciate the support for our proposals from the commenter.

After consideration of the public comments, we are finalizing our proposal to update the expected specialty list to accurately reflect the previously finalized crosswalk to thoracic surgery for these services. We are also finalizing the updates to the expected specialty list detailed above in Table 2; we reiterate again that we do not anticipate this finalized proposal having a discernible effect on the valuation of the codes in the table due to the similarity between the cardiac surgery and thoracic surgery specialties.

Step 8:

Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: The direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.

For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified:

• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.

• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.

(

Note:

For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)

For presentation purposes, in the examples in the download file called “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.

• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).

• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9:

Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.

Step 10:

Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.

Step 11:

Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.

Calculate the indirect practice cost index.

Step 12:

Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators

for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13:

Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

Step 14:

Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.

Step 15:

Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16:

Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (

Note:

For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)

Step 17:

Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

(d) Calculate the Final PE RVUs

Step 18:

Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this final rule.)

Step 19:

Apply the phase-in of significant RVU reductions and its associated adjustment. Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year one reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931).

(e) Setup File Information

•

Specialties excluded from ratesetting calculation:

For the purposes of calculating the PE and MP RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 2.

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• 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 4 details the manner in which the modifiers are applied.

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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:

(1/(minutes per year * usage)) * price * ((interest rate/(1−(1/((1 + interest rate) ‸ life of equipment)))) + maintenance)

Where:

minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); generally 150,000 minutes.

usage = variable,

see

discussion below in this 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 below 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.

Comment:

A commenter stated that they disagreed with the 90 percent utilization metric for CT and MRI equipment, as the commenter did not believe it to be realistic in a typical outpatient imaging setting, but the commenter recognized that the percentage is dictated by statute. The commenter stated that the 90 percent equipment usage assumption for CT and MRI is inconsistent with actual imaging center practice and ignores scheduling in the “real world,” such as lunch and other mandated breaks, complicated patients, and downtime for maintenance and quality control. The commenter stated that to achieve a 90 percent utilization rate under ideal conditions would require two employees per unit; one doing pre-service tasks while the other is setting up the machine as opposed to assumptions of one CT or MRI technologist per scanner.

Response:

We disagree with the commenters regarding the equipment time assigned to highly technical equipment such as CT or MRI machines. 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).

Comment:

One commenter stated that most ophthalmology diagnostic equipment is in use far less than 50 percent of the time. The commenter indicated that they had developed a survey instrument that asked ophthalmic technicians to provide time usage estimates for the 16 most-utilized pieces of diagnostic testing equipment. The commenter stated that their preliminary survey results produced a utilization rate of 22 percent, much lower than the 50 percent assumption currently used by CMS. The commenter suggested that CMS should work with the RUC to do a robust survey to help determine a more valid utilization rate, including the possibility of specialty-specific equipment utilization rates. The commenter also requested a meeting to discuss what options CMS would find acceptable in undertaking their own survey for ophthalmology services.

Response:

We are always looking for more accurate information to improve our PE methodology. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items, and we will review any information that the RUC's PE subcommittee or other stakeholders are willing to submit through the public comment process. We concur with the commenter that a wide-ranging survey or similar study designed to address the subject of equipment utilization rates would be an appropriate tool to investigate this subject in further detail. At the moment, 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 further submission of data that illustrates an alternative rate.

Maintenance:

This factor for maintenance was finalized in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. We do not believe that voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we did not propose a variable maintenance factor for equipment cost per minute pricing as we noted that we did not believe that we have sufficient information at present to do so. 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 the maintenance costs for an MRI unit include servicing the scanner itself plus replacing cryogens for a cost well in excess of 5 percent even using CMS' low assumptions of MRI and CT room cost.

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. We remind readers that 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.

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 2020. The Interest rates are listed in Table 5.

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Comment:

A commenter stated that they did not support the continued use of the 2012 SBA maximum interest rates, which the commenter stated are significantly lower than the 2019 rates. The commenter stated that CMS should also update the interest rates used to calculate PE RVUs for such items based on current SBA data.

Response:

We appreciate the additional information regarding SBA

maximum interest rates from the commenter. However, we did not propose any changes to these interest rates for CY 2020; we will consider potential changes to the interest rates used in the equipment cost per minute calculation for possible future rulemaking.

3. Changes to Direct PE Inputs for Specific Services

This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2020 direct PE input public use files, which are available on the CMS website under downloads for the CY 2020 PFS final rule at

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

a. Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

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

We also finalized standard times for clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902) at 4 minutes for “Accession specimen/prepare for examination”, 0.5 minutes for “Assemble and deliver slides with paperwork to pathologists”, 0.5 minutes for “Assemble other light microscopy slides, open nerve biopsy slides, and clinical history, and present to pathologist to prepare clinical pathologic interpretation”, 1 minute for “Clean room/equipment following procedure”, 1 minute for “Dispose of remaining specimens, spent chemicals/other consumables, and hazardous waste”, and 1 minute for “Prepare, pack and transport specimens and records for in-house storage and external storage (where applicable).” We do not believe these activities would be dependent on number of blocks or batch size, and we believe that these values accurately reflect the typical time it takes to perform these clinical labor tasks.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes: CA007 (“Review patient clinical extant information and questionnaire”) in the preservice period, and CA014 (“Confirm order, protocol exam”) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. We agreed with commenters that we would finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did not contain any clinical labor for the CA007 activity. In these situations, we continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. For additional details, we direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).

Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties

developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did in previous calendar years, to facilitate rulemaking for CY 2020, we are continuing to display two versions of the Labor Task Detail public use file: One version with the old listing of clinical labor tasks, and one with the same tasks crosswalked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2020 PFS final rule at

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

Comment:

A commenter wrote to express their concerns with the manner in which data was displayed in the Proposed CY 2020 Direct PE Refinements table in the proposed rule (84 FR 40623-40666), specifically the common refinements to equipment time. The commenter stated that nearly 64 percent of the total PE refinements were related to equipment, and 59 percent of these refinements were listed as “E15: Refined equipment time to conform to changes in clinical labor time.” The commenter stated that they did not agree that these are separate refinements; rather, they are the formulaic result of the applying refinements to the clinical labor time. The commenter stated that including these instances as refinements adds a large quantity of rows to the PE refinement table and gives the impression that there are major inaccuracies in the RUC PE recommendations. The commenter provided an example of a single clinical labor refinement to a code family creating 32 rows of subsequent equipment refinements, and contended that articulating these edits was not necessary as they do not reflect either an error or a policy discrepancy with the RUC. The commenter requested that CMS no longer include refinements based on “E15: Refined equipment time to conform to changes in clinical labor time” in the refinement table of the proposed rule.

Response:

We agree with the commenter that these equipment time refinements generated in response to clinical labor time refinements are indeed the result of applying standard equipment time formulas, and they do not reflect errors in the equipment recommendations or policy discrepancies with the RUC. We also agree that these refinements add a significant number of rows to the table of direct PE refinements. However, we disagree with the commenter on the subject of whether these constitute separate refinements, and we believe that it is important to publish the specific equipment times that we are proposing (or finalizing in the case of the final rule) when they differ from the recommended values. We include the direct cost change in dollars resulting from our PE refinements on the aforementioned table, and if we were to avoid including these equipment refinements, it would not always be clear what effect they were having on the direct costs for the procedure. For example, a modest reduction of a few minutes in clinical labor time can result in a substantial decrease in direct costs for procedures that employ highly expensive equipment. We believe that it is more important to provide additional transparency regarding the changes in direct costs resulting from our equipment time refinements so that the public can better comment on our proposals, as opposed to limiting the total number of printed equipment refinements.

However, we agree with the commenter that the information displayed in the table of direct PE refinements can be confusing and overwhelming, and we believe that it could potentially be provided to the public in a more useful fashion. For this CY PFS 2020 final rule, we will separate out the “E15: Refined equipment time to conform to changes in clinical labor time” direct PE refinements and print them in a separate table of refinements. We believe that this will help to address the issues raised by the commenter while also retaining all of the data included in previous rules. We refer readers to Table 28 in section II.N. of this final rule, the Valuation of Specific Codes section, for additional details.

b. Equipment Recommendations for Scope Systems

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

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

(1) Scope Equipment

Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.

We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies

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

We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We considered creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We stated our belief that the variation between these scopes was not significant enough to warrant maintaining these distinctions, and we believed that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.

After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal was to create an administratively simple scheme that would be easier to maintain and help to reduce administrative burden. In 2018, the RUC convened a Scope Equipment Reorganization Workgroup to incorporate feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we delayed proposals for any further changes to scope equipment until CY 2020 in order to incorporate the feedback from the aforementioned workgroup.

(2) Scope Video System

We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306.

We did not finalize this updated pricing to the scope video system in CY 2018, but we did propose and finalize the updated pricing for CY 2019 to $36,306 along with changing the name of the ES031 equipment item to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.

(3) Scope Accessories

We understand that there may be other accessories associated with the use of scopes. We finalized a proposal in the CY 2017 PFS final rule (81 FR 80188) to separately price any scope accessories outside the use of the scope video system, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.

(4) Scope Proposals for CY 2020

The Scope Equipment Reorganization Workgroup organized by the RUC submitted detailed recommendations to CMS for consideration in the CY 2020 rule cycle, describing 23 different types of scope equipment, the HCPCS codes associated with each scope type, and a series of invoices for scope pricing. We appreciate the information provided by the workgroup and continue to welcome additional comments and feedback from stakeholders. Based on the recommendations from the workgroup, we proposed to establish 23 new scope equipment codes as detailed in Table 6.

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We note that we did not receive invoices for many of the new scope equipment items. There also was some inconsistency in the workgroup recommendations regarding the non-channeled flexible digital scope, laryngoscopy (ES080) equipment item and the non-video flexible scope, laryngoscopy (ES092) equipment item. These scopes were listed as a single equipment item in some of the workgroup materials and listed as separate equipment items in other materials. We proposed to establish them as separate equipment items based on the submitted invoices, which demonstrated that these were two different types of scopes with distinct price points of approximately $17,000 and $5,000 respectively.

We noted a similar issue with the submitted invoices for the rigid scope, laryngoscopy (ES075) equipment item. Among the eight total invoices, five of them were clustered around a price point of approximately $4,000 while the other three invoices had prices of roughly $15,000 apiece. The invoices indicated that these prices came from two distinct types of equipment, and as a result we proposed to consider these items separately. We proposed to use the initial five invoices to establish a proposed price of $3,966.08 for the rigid scope, laryngoscopy (ES075) equipment item. We noted that this is a close match for the current price of $3,178.08 used by the endoscope, rigid, laryngoscopy (ES010) equipment, which is the closest equivalent scope equipment. We also noted that the other three invoices appear to describe a type of stroboscopy system rather than a scope, and they have an average price of $14,737. This is a reasonably close match for the price of our current stroboscoby system (ES065) equipment, which has a CY 2020 price of $17,950.28 as it transitions to a final CY 2022 destination price of $16,843.87 (see the 4-year pricing transition of the market-based supply and equipment pricing update discussed later in this section for more information). We stated that we believe that these invoices reinforce the value established by the market-based pricing update for the stroboscoby system carried out last year, and we did not propose to update the price of the ES065 equipment. We also noted that we were open to feedback from stakeholders if they believe it would be more accurate to assign a price of $14,737 to the stroboscoby system based on these invoice submissions, as opposed to maintaining the current pricing transition to a CY 2022 price of $16,843.87.

For the eight new scope equipment items where we received submitted invoices for pricing, we proposed to replace the existing scopes with the new scope equipment. We noted that we received recommendations from the RUC's scope workgroup regarding which HCPCS codes make use of the new scope equipment items, and we proposed to make this scope replacement for approximately 100 HCPCS codes in total (see Table 7).

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In all but three cases (as identified with an asterisk (*) in Table 7), we proposed for the new scope equipment item to replace the existing scope with the identical amount of equipment time. For CPT codes 92612 (

Flexible endoscopic evaluation of swallowing by cine or video recording

), 92614 (

Flexible endoscopic evaluation, laryngeal sensory testing by cine or video recording

), and 92616 (

Flexible endoscopic evaluation of swallowing and laryngeal sensory testing by cine or video recording

), we noted the current scopes in use are the FEES video system

(ES027) and the FEESST video system (ES028). Since we proposed the use of a non-channeled flexible digital scope that requires a corresponding scope video system, we also proposed to add the ES080 equipment at the same equipment time to these three procedures rather than replacing the ES027 and ES028 equipment. In all other cases, we proposed to replace the current scope equipment listed in Table 7 with the new scope equipment, while maintaining the same amount of equipment time.

We identified inconsistencies with the workgroup recommendations for a small number of HCPCS codes. CPT code 45350 (

Sigmoidoscopy, flexible; with band ligation(s) (e.g., hemorrhoids)

) was recommended to include a multi-channeled flexible digital scope, flexible sigmoidoscopy (ES085); however, we noted that this CPT code does not include any scopes among its current direct PE inputs. CPT code 31595 was recommended to include a non-channeled flexible digital scope, laryngoscopy (ES080) but it no longer exists as a CPT code after having been deleted for CY 2019. CPT code 43232 (

Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s)

) was recommended to include a multi-channeled flexible digital scope, esophagoscopy (ES088), but it does not include a scope amongst its direct PE inputs any longer following clarification from the same workgroup recommendations that CPT code 43232 is never performed in the nonfacility setting. In all three of these cases, we did not propose to add one of the new scope equipment items to these procedures.

We noted that we did not receive pricing information along with the workgroup recommendations for the other 15 new scope equipment items. Therefore, we proposed to establish new equipment codes for these scopes as detailed in Table 6. However, we noted that due to a lack of pricing information, we did not propose to replace existing scope equipment with the new equipment items as we did for the other eight new scope equipment items for CY 2020. We welcomed additional feedback from stakeholders regarding the pricing of these scope equipment items, especially the submission of detailed invoices with pricing data. We proposed to transition the scopes for which we did have pricing information over to the new equipment items for CY 2020, and we noted that we looked forward to engaging with stakeholders to assist in pricing and then transitioning the remaining scopes in future rulemaking.

We received public comments on our scope equipment proposals. The following is a summary of the comments we received and our responses.

Comment:

Several commenters stated that they appreciated the proposal of the recommended 23 new scope equipment codes and the proposed pricing of 8 of those new scope equipment codes. Commenters also stated that they appreciated the proposal of scope replacements for 100 CPT codes as recommended by the RUC utilizing the 8 scopes that CMS was able to price. One commenter encouraged CMS to continue to work with the RUC workgroup and other stakeholders to obtain detailed invoices for the scopes for which it did not have pricing data to assist in the correct pricing and transition of these equipment items.

Response:

We appreciate the support for our proposals from the commenters. We welcome the submission of additional pricing data from the RUC scope workgroup and other stakeholders regarding the pricing of the remaining scope equipment items.

Comment:

One commenter stated that they appreciated the recognition of the existing specialized equipment that is required in addition to the proposed scope equipment, and they supported the proposal to add ES080 and retain ES027 or ES028 at the same equipment time for CPT codes 92612, 92614, and 92616.

Response:

We appreciate the support for our proposals from the commenter.

Comment:

Several commenters stated it was their understanding that additional scope pricing information submitted now would be considered for the CY 2021 PFS proposed rule. These commenters asked for clarification that the CPT codes impacted by any scope proposals for CY 2021 will be outlined in a table just as the impacted codes for CY 2020 were outlined in Table 7, so that they will be subject to stakeholder review and comment prior to implementation.

Response:

As we stated in the proposed rule, we welcome additional feedback from stakeholders regarding the pricing of these remaining scope equipment items, especially the submission of detailed invoices with pricing data. Any future proposals that we make regarding scope equipment will be subject to notice and comment rulemaking, including displaying information in a table similar Table 7, if it would be appropriate to do so.

Comment:

A commenter stated that they had identified inconsistencies with the scope workgroup recommendations for a small number of HCPCS codes. The commenter stated that CPT code 45350 (

Sigmoidoscopy, flexible; with band ligation(s) (e.g., hemorrhoids)

) was recommended by the workgroup to include a multi-channeled flexible digital scope, flexible sigmoidoscopy (ES085); however, CMS noted in the proposed rule that this CPT code does not include any scopes among its current direct PE inputs. The commenter stated that all codes in the flexible sigmoidoscopy family require a flexible sigmoidoscope in order to perform the procedure, and therefore, the commenter requested that CMS add the ES085 scope equipment to CPT code 45350.

Response:

We appreciate the feedback from the commenter in pointing out this inconsistency in the direct PE inputs for CPT code 45350. Based on the information supplied by the commenter, we are finalizing the addition of the ES085 scope equipment to CPT code 45350. We are finalizing an equipment time of 59 minutes based on the use of our standard equipment time formula for scopes.

Comment:

A commenter requested that the “rigid scope, hysteroscopy” (ES071) equipment be updated to read “rigid scope, channeled, hysteroscopy” and that the hysteroscopy codes (that is, CPT codes 58555, 58562, 58565) be valued with ES071. The commenter submitted an invoice with pricing information associated with the ES071 scope equipment.

Response:

We appreciate the submission of an invoice from the commenter for use in pricing the ES071 scope. Based on the information provided by the commenter, we are finalizing a change in the name of the ES071 scope from “rigid scope, hysteroscopy” to “rigid scope, channeled, hysteroscopy.” We are also finalizing a price of $6,795 for the ES071 scope based on the pricing data supplied by the commenter, and we are finalizing the replacement of the existing “endoscope, rigid, hysteroscopy” (ES009) scope with the new ES071 scope equipment. The CPT codes affected by this replacement are CPT codes 58555, 58562, and 58565 as identified by the commenter, as well as CPT code 58563 which is the only other code that previously employed the ES009 scope. These scope replacements are summarized below in Table 9.

Comment:

One commenter provided a series of invoices for different types of rigid scopes in response to the comment solicitation.

Response:

We appreciate the submission of additional invoices from the commenter. Based on the

information included in these invoices, we are finalizing prices for three scopes that did not previously have pricing data. We are finalizing a price of $2,333.98 for the “rigid scope, otoscopy” (ES072) equipment, a price of $3,004.75 for the “rigid scope, nasal/sinus endoscopy” (ES073) equipment, and a price of $21,923.425 for the “non-channeled flexible digital scope, nasopharyngoscopy” (ES078) equipment. We are not finalizing the replacement of any of the old scope equipment codes with these three new scope equipment items for CY 2020, as the commenter did not identify the HCPCS codes in which this replacement would take place. We will consider additional scope pricing information for these three scope equipment codes, including the HCPCS codes in which they would typically be employed, as part of the CY 2021 PFS proposed rule.

The commenter also provided five new invoices for the pricing of the “non-video flexible scope, laryngoscopy” (ES092) equipment. These five invoices had an average price of $5,105.97, which was nearly identical to our proposed price of $5,078.04 for the ES092 scope. We believe that these invoices reinforce the accuracy of the proposed pricing. We are finalizing an increase in the price of the ES092 scope to $5,105.97, which will slightly increase the direct costs for the 14 HCPCS codes containing this scope listed above in Table 7.

Comment:

Several commenters sent a series of additional invoices, and recommended crosswalks from existing equipment codes to the proposed equipment codes to ensure that the equipment currently listed for GI endoscopy procedures was appropriately attributed to the correct new scopes. Although the commenters did not provide information to update any of the proposed scope equipment prices, the commenters did clarify that several of the new scope equipment items which lacked proposed prices in fact shared the same current scope equipment codes as other new scope equipment items that did have proposed pricing. For example, CMS proposed to replace the “videoscope, gastroscopy” (ES034) scope equipment with the new “multi-channeled flexible digital scope, esophagoscopy” (ES088) scope equipment. The commenters clarified that this same ES034 equipment, when used in additional CPT codes, would be replaced by either the “multi-channeled flexible digital scope, esophagoscopy gastroscopy duodenoscopy” (ES087) or the “multi-channeled flexible digital scope, ileoscopy” (ES089) equipment items, all of which should share the same proposed price of $34,585.35. The commenter also explained that the same “Video Sigmoidoscope” (ES043) equipment which CMS proposed to replace with the “multi-channeled flexible digital scope, pouchoscopy” (ES090) new scope equipment would, in additional CPT codes, be replaced by the new “multi-channeled flexible digital scope, flexible sigmoidoscopy” (ES085) scope equipment, and that both ES085 and ES090 should share the same proposed price of $19,308.56. Finally, the commenter also stated that the new “ultrasound digital scope, endoscopic ultrasound” (ES091) equipment item would only be used in the facility setting, and that none of the HCPCS codes that included this scope contained direct PE inputs.

Response:

We appreciate the submission of additional invoices and the clarification of the relationship between the former scope equipment codes and the newly created scope equipment codes. After considering this additional information supplied by the commenters, we are updating Table 8 of CY 2020 new scope equipment codes.

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We note again that we are not finalizing changes to the pricing of the group of new scope equipment codes with previously proposed prices, aside from the minor increase in the price of the ES092 equipment, only newly pricing several scopes that previously lacked pricing, and extending proposed pricing such that the ES087 and ES089 scopes share the same price with the ES088 scope, and the ES090 scope shares the same price with the ES085 scope. The new scope equipment codes ES087, ES088, and ES089 all share the same price because they are replacing the same current scope equipment code (ES034), and similarly the new ES085 and ES090 scope equipment codes share the same price because they are both replacing the same current scope equipment code (ES043). There are 21 HCPCS codes which are affected by the new scope replacements; these codes are detailed in Table 9.

BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

Although we are updating the scope equipment pricing for CY 2020 such that the ES087 and ES089 scopes share the same price with the ES088 scope, and the ES090 scope shares the same price with the ES085 scope, we do not mean to suggest that these scopes that share pricing are identical with one another. We are assigning the same price to these scopes because they are replacing the same current scope equipment codes, and because we do not have individual pricing information for them at the moment. We are open to the submission of additional invoices in future rule cycles to establish individual pricing for these scopes, and we continue to welcome more data to help identify pricing for the remaining 7 scope equipment codes that still lack invoices.

After consideration of the public comments, we are finalizing pricing for the new scope equipment as detailed above in Table 8. We are also finalizing the scope equipment replacements as detailed in Tables 7 and 9.

c. Technical Corrections To Direct PE Input Database and Supporting Files

Subsequent to the publication of the CY 2019 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We proposed to correct these inconsistencies as described below and reflected in the CY 2020 proposed direct PE input database displayed on the CMS website under downloads for the CY 2020 PFS proposed rule at

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

For CY 2020, we proposed to address the following inconsistencies:

• The RUC's Scope Equipment Reorganization Workgroup recommended deletion of the non-facility inputs for CPT codes 43231 (

Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination

) and 43232 (

Esophagoscopy, flexible, transoral; with transendoscopic ultrasound-guided intramural or transmural fine needle aspiration/biopsy(s)

). The gastroenterology specialty societies stated that these services are never performed in the non-facility setting. After our own review of these services, we agreed with the workgroup's recommendation, and we proposed to remove the non-facility direct PE inputs for these two CPT codes.

• In rulemaking for CY 2018, we reviewed a series of CPT codes describing nasal sinus endoscopy surgeries. At that time, we sought comments on whether the broader family of nasal sinus endoscopy surgery services should be subject to the special rules for multiple endoscopic procedures instead of the standard multiple procedure payment reduction. We received very few comments in response to our solicitation. In the CY 2018 PFS final rule (82 FR 53043), we indicated that we would continue to explore this option for future rulemaking. We proposed to apply the special rule for multiple endoscopic procedures to this family of codes beginning in CY 2020. We noted this proposal would treat this group of CPT codes consistently with other similar endoscopic procedures when codes within the CPT code family are billed together with another endoscopy service in the same family. Similar to other similar endoscopic procedure code families, we proposed that CPT code 31231 (

Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)

) would be the base procedure for the remainder of nasal sinus endoscopies. The codes affected by the proposal are detailed in Table 10.

ER15NO19.014

Special rules for multiple endoscopic procedures would apply if any of the procedures listed in Table 10 are billed together for the same patient on the same day. We apply the multiple endoscopy payment rules to a code family before ranking the family with other procedures performed on the same day (for example, if multiple endoscopies in the same family are reported on the same day as endoscopies in another family, or on the same day as a non-endoscopic procedure). If an endoscopic procedure is reported together with its base procedure, we do not pay separately for the base procedure. Payment for the base procedure is included in the payment for the other endoscopy. For additional information about the payment adjustment under the special rule for multiple endoscopic services, we refer readers to the CY 1992 PFS final rule where this policy was established (56 FR 59515) and to Public Law 100-04, Medicare Claims Processing Manual, Chapter 23 (available on the CMS website at

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf

).

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

Comment:

One commenter agreed with the RUC workgroup's recommendation and the CMS proposal to remove the non-facility direct PE inputs from CPT code 43231 and 43232.

Response:

We appreciate the support for our proposals from the commenter.

Comment:

One commenter stated that the proposed approach for nasal sinus endoscopy procedure better reflects the work RVU associated with the different levels of sinus endoscopy procedures and stated their support for this payment change. The commenter requested clarification regarding the application of the bilateral adjustment in conjunction with the special rules for multiple endoscopic procedures. The commenter stated that it was their understanding that if the CPT code is reported as a bilateral procedure and is reported with other procedure codes on the same day, the guidance is to apply the bilateral adjustment before applying any form of multiple procedure rules.

Response:

The special rule for multiple endoscopic procedures has been described correctly in general terms by the commenter, although we encourage readers once again to refer to the CY 1992 PFS final rule where this policy was established (56 FR 59515) and to Public Law 100-04, Medicare Claims Processing Manual, Chapter 23. This manual text states that special rules for multiple endoscopic procedures apply if the procedure is billed with another endoscopy in the same family (

i.e.,

another endoscopy that has the same base procedure). The base procedure for each code with this indicator is identified in the endoscopic base code field. In these situations, we apply the multiple endoscopy rules to a family before ranking the family with other procedures performed on the same day (for example, if multiple endoscopies in the same family are reported on the same day as endoscopies in another family or on the same day as a non-endoscopic procedure). If an endoscopic procedure is reported with only its base procedure, we do not pay separately for the base procedure. Payment for the base procedure is included in the payment for the other endoscopy.

Comment:

A commenter requested clarification regarding the proposal to apply the special rule for multiple endoscopic procedures to the family of codes listed in Table 10. The commenter stated that it was their understanding that that the diagnostic endoscopy described by CPT code 31231 is included in the valuation of all of the surgical procedure codes on the list (for example, CPT codes 31254, 31256, 31276, etc.), and therefore, CPT Code 31231 would not be billed on the same side that any nasal endoscopic surgical code(s) are performed. However, the commenter stated that it was their understanding that CPT code 31231 could be billed for one side of the nose if it was the only procedure performed and there was no surgical intervention on that side. Assuming that this interpretation was correct, the commenter stated that they supported the application of the special rules for endoscopy to the nasal endoscopy family.

Response:

We reiterate that the special rule for multiple endoscopic procedures has been described correctly in general terms by the commenter, although we encourage readers once again to refer to the CY 1992 PFS final rule where this policy was established (56 FR 59515) and to Public Law 100-

04, Medicare Claims Processing Manual, Chapter 23. We encourage stakeholders to contact their local Medicare Administrative Contractor (MAC) for information regarding proper billing instructions for CPT code 31231.

Comment:

One commenter stated that they were troubled by the proposal to apply the multiple endoscopy payment methodology to the CPT codes included in Table 10 without further clarification in the regulatory language or the Medicare Carriers Manual about the number of multiple procedure modifiers CMS can append to one claim. The commenter questioned whether these 27 codes will be assigned a multiple procedure indicator of “3” and if that would override the prior multiple procedure indicator of “4”. The commenter stated that they did not support the application of multiple endoscopy payment rules if CMS intended to assign reductions for both multiple endoscopy and multiple procedures, as application of both payment rules would result in inappropriate reductions to this set of services.

Response:

In response to the commenter's question, only one multiple procedure indicator can be applied to each HCPCS code. We also clarify that our proposal would assign a multiple procedure indicator of “3” to all of the codes listed in Table 10 aside from CPT code 31231, which would be the endoscopic “base code” and would be assigned a multiple procedure indicator of “2”. We also note that none of these codes previously contained a multiple procedure indicator of “4”, which is associated with certain diagnostic imaging services. We encourage readers once again to refer to the CY 1992 PFS final rule where this policy was established (56 FR 59515) and to Pub. 100-04, Medicare Claims Processing Manual, Chapter 23.

Comment:

One commenter stated that although they recognized that by including the nasal endoscopy family among the codes using the special rule for multiple endoscopies, CMS may be trying to harmonize endoscopic procedures, and they stated that the unique situation surrounding the nasal endoscopy code family should prohibit the application of this special rule. The commenter stated that the nasal endoscopy code family differed significantly from colonoscopy procedures in that there is not uniformity across the sites of service where these sinus procedures are performed, since these services could be performed in both the facility and non-facility settings. The commenter stated that applying the special rules for multiple endoscopic procedures to this group would result in a significant inappropriate reduction in the value of the secondary and subsequent nasal surgical codes performed on the same patient on the same day when performed in the office setting, and the commenter stated that they opposed the application of the special rules for multiple endoscopies to the nasal endoscopy family in the non-facility setting.

Response:

We disagree that this nasal endoscopy code family differs significantly from other colonoscopy families where the special rule for multiple endoscopic procedures has long been in place. Although the commenter stated that the nasal endoscopy codes were unique in the sense that they could be performed in both the facility and non-facility settings, and that the base code for the family, CPT code 31231, is typically an office-based procedure with significant PE built into the code, we note in response that there are many other groups of codes which utilize the special rule for multiple endoscopic procedures and are also performed in both the facility and non-facility settings. These include CPT codes 31573-31579 (base CPT code 31575), CPT codes 43220-43229 (base CPT code 43220), CPT codes 44389-44394 (base CPT code 44388), and CPT codes 45303-45320 (base CPT code 45300). There are dozens of these codes which can be performed in both the facility and non-facility settings, many of them with significant PE inputs built into their non-facility valuation. In light of this evidence, we disagree with the commenter that there is a unique situation regarding the nasal endoscopy family of codes.

Comment:

Several commenters requested that CMS utilize the RUC-recommended direct PE inputs to publish PE relative value units for CPT code 90460, which was reviewed by the RUC in October 2009. Rather than finalize the RUC recommendations, CMS crosswalked CPT code 90460 from CPT code 90471, which is crosswalked from CPT code 96372 (formerly CPT code 90772 and then 90782). Commenters stated that the recent measles crisis spotlights the importance of immunization administration being appropriately valued, and that the crosswalk from CPT code 96372 to codes CPT codes 90471/90460 has brought about a 60 percent reduction in PE RVUs. Commenters stated that CMS typically only uses a crosswalk for work values, not PE values, and requested that CMS disconnect the codes after the initial crosswalk so that changes to the source code no longer affect the crosswalked code. One commenter stated that CMS was proposing to reduce the non-facility PE RVUs for CPT code 90471 from 0.29 in 2019 to 0.22 in 2020, and while this may appear to be a relatively small change in RVUs, if finalized it would reduce the national unadjusted payment for CPT code 90471 (and consequently the payment rates for HCPCS codes G0008 and G0009) by 15 percent.

Response:

We appreciate the feedback from the commenters and note that we finalized the crosswalks associated with CPT code 90460 in the CY 2011 final rule (75 FR 73306). However, we note that we are separately addressing the valuation of HCPCS codes G0008, G0009, and G0010 in the codes valuation section of this rule.

We also received comments regarding a variety of subjects about which we did not make proposals for CY 2020. These included comments regarding the proper specialty employed to determine indirect cost factors for home PT/INR monitoring services and the application of the multiple procedure payment reduction to physical therapist services. We will take the feedback from the commenters on these subjects into consideration for future rulemaking.

After consideration of the public comments, we are finalizing the proposal to remove the non-facility direct PE inputs from CPT code 43231 and 43232. We are also finalizing the proposal to apply the special rule for multiple endoscopic procedures to the family of codes listed in Table 10 without refinement.

d. Updates to Prices for Existing Direct PE Inputs

In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2020, we proposed the following price updates for existing direct PE inputs.

We proposed to update the price of one supply and one equipment item in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we proposed that the new pricing take effect for CY 2020 for these items instead of being phased in over 4 years.

We also proposed to update the name of the EP001 equipment item from “DNA/digital image analyzer (ACIS)” to “DNA/Digital Image Analyzer” due to

clarification from stakeholders regarding the typical use of this equipment.

(1) Market-Based Supply and Equipment Pricing Update

Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.

As part of our authority under section 1848(c)(2)(M) of the Act, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005. StrategyGen submitted a report with updated pricing recommendations for approximately 1,300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at

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

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

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

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

• The General Services Administration system (GSA).

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

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

•

Federal Register

, current DPEI data, historical proposed and final rules prior to CY 2018, and other resources; that is, AMA RUC reports (References).

StrategyGen prioritized the equipment and supply research based on current share of PE RVUs attributable by item provided by CMS. StrategyGen developed the preliminary Recommended Price (RP) methodology based on the following rules in hierarchical order considering both data representativeness and reliability.

(1) If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of equipment and a more precise reference for the RP.

(2) If no data were available for commercial products, the current CMS prices were used as the RP.

GSA prices were not used to calculate the StrategyGen recommended prices, due to our concern that the GSA system curtails the number and type of suppliers whose products may be accessed on the GSA Advantage website, and that the GSA prices may often be lower than prices that are available to non-governmental purchasers. After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen.

StrategyGen found that despite technological advancements, the average commercial price for medical equipment and supplies has remained relatively consistent with the current CMS price. Specifically, preliminary data indicated that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties would experience increases or decreases in their Medicare payments if CMS were to adopt the pricing updates recommended by StrategyGen. At the service level, there may be large shifts in PE RVUs for individual codes that happened to contain supplies and/or equipment with major changes in pricing, although we note that codes with a sizable PE RVU decrease would be limited by the requirement to phase in significant reductions in RVUs, as required by section 1848(c)(7) of the Act. The phase-in requirement limits the maximum RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year.

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

We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased-in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices

fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 11.

ER15NO19.015

For new supply and equipment codes for which we establish prices during the transition years (CYs 2019, 2020 and 2021) based on the public submission of invoices, we proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values. We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation.

For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price. We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes).

We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer timeframe will allow more opportunities for public comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

We received many comments regarding the market-based supply and equipment pricing proposal following the publication of the CY 2019 PFS proposed rule. For a full discussion of these comments, we direct readers to the CY 2019 PFS final rule (83 FR 59475-59480). In each instance in which a commenter raised questions about the accuracy of a supply or equipment code's recommended price, the StrategyGen contractor conducted further research on the item and its price with special attention to ensuring that the recommended price was based on the correct item in question and the clarified unit of measure. Based on the commenters' requests, the StrategyGen contractor conducted an extensive examination of the pricing of any supply or equipment items that any commenter identified as requiring additional review. Invoices submitted by multiple commenters were greatly appreciated and ensured that medical equipment and supplies were re-examined and clarified. Multiple researchers reviewed these specified supply and equipment codes for accuracy and proper pricing. In most cases, the contractor also reached out to a team of nurses and their physician panel to further validate the accuracy of the data and pricing information. In some cases, the pricing for individual items needed further clarification due to a lack of information or due to significant variation in packaged items. After consideration of the comments and this additional price research, we updated the recommended prices for approximately 70 supply and equipment codes identified by the commenters. Table 9 in the CY 2019 PFS final rule lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing (83 FR 59479-59480).

After consideration of the public comments, we finalized our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.

For CY 2020, we received invoice submissions for approximately 30 supply and equipment codes from stakeholders as part of the second year of the market-based supply and

equipment pricing update. These invoices were reviewed by the StrategyGen contractor and the submitted invoices were used in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. The contractor reviewed the invoices, as well as prior data for the relevant supply/equipment codes to make sure the item in the invoice was representative of the supply/equipment item in question and aligned with past research. Based on this research, we proposed to update the prices of the supply and equipment items listed in Table 9 of the CY 2020 PFS proposed rule.

For most supply and equipment items, there was an alignment between the research carried out by the StrategyGen contractor and the submitted invoice. The updated CY 2020 pricing was calculated using an average between the previous market research and the newly submitted invoices in these cases. In some cases the submitted invoices were not representative of market prices, such as for the centrifuge with rotor (EP007) equipment item where the invoice price of $8,563 appeared to be an outlier. We did not use the invoices to calculate our pricing recommendation in these situations and instead continued to rely on our prior pricing data. In other instances, such as for the kit, probe, cryoablation, prostate (Galil-Endocare) (SA099) supply item, our research indicated that the submitted invoice price was more representative of the commercial price than our CY 2019 research and pricing. We proposed the new invoice prices for these supply and equipment items due to our belief in their greater accuracy.

For some of the remaining supply and equipment items, such as the five-gallon paraffin (EP031) equipment and the Olympus DP21 camera (EP089) equipment, we maintained the extant pricing for CY 2019 due to a lack of sufficient data to update the pricing. In these situations where we did not have an updated price for CY 2019, we believe that the newly submitted invoices are more representative of the current commercial prices that are being paid on the market. We proposed the new invoice prices for these supply and equipment items due to our belief in their greater accuracy.

In addition, we were alerted by stakeholders that the price of the EM visit pack (SA047) supply did not match the sum of the component prices of the supplies included in the pack. After reviewing the prices of the individual component supplies, we agree with the stakeholders that there was a discrepancy in the previous pricing of this supply pack. We proposed to update the price of the EM visit pack to $5.47 to match the sum of the prices of the component supplies, and proposed to continue to transition towards this price over the remaining years of the phase-in period.

We finalized a policy last year to phase in the new supply and equipment pricing over 4 years so that supply and equipment values transition smoothly from their current prices to the final updated prices in CY 2022. We finalized our proposal to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price was implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 11. For CY 2020, one third of the difference between the CY 2019 price and the final price will be implemented as per the previously finalized policy. Table 12 contains the list of proposed CY 2020 market-based supply and equipment pricing updates:

BILLING CODE 4120-01-P

ER15NO19.016

ER15NO19.017

BILLING CODE 4120-01-C

(2) Invoice Submission

The full list of updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2020 PFS proposed rule at

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

We received public comments on updates to prices for existing direct PE inputs. The following is a summary of the comments we received and our responses.

Comment:

Many commenters were supportive of the proposed update to supply and equipment pricing based on the submission of additional invoices as detailed in Table 12. One commenter thanked CMS for gathering additional pertinent information and proposing a more accurate price for the balloon sinus surgery kit (SA106) supply for CY 2020. Several commenters urged CMS to finalize the proposed updates to the direct PE supplies and equipment prices as listed in the table. One commenter encouraged CMS to continue to carefully consider all pricing data including invoices and other supporting evidence that they receive from the specialty societies throughout this comment period and the entirety of the 4-year transition period.

Response:

We will continue to carefully consider all pricing data submitted from commenters throughout the 4-year transition period.

Comment:

Several commenters stated that they were concerned that supply and equipment pricing will quickly become outdated once the transition to updated prices is complete in CY 2022. The commenters encouraged CMS to move to an ongoing update process for supplies and equipment, as well as for clinical labor staff costs, one that is open for public comment through the rulemaking process.

Response:

We share the concerns from the commenters that the supply and equipment pricing will eventually become outdated again after the pricing transition is complete. We welcome additional feedback from stakeholders on potential solutions to this issue, and we will consider the possibility of different approaches to supply and equipment pricing for use in future rulemaking.

Comment:

One commenter stated that they appreciated and supported recognition by CMS that the supplies and equipment associated with physician services were past due for review, but noted that there remains large numbers of supplies and equipment that are overdue for updates. The commenter stated that they supported a gradual transition of the pricing given the widespread impact on the PE values; however, doing so creates a situation in which items that have seen dramatic increases over a short time are not being adequately compensated for several years. The commenter asked CMS to consider shortening the transition period from 4 years to 3 years for the supply and equipment pricing.

Response:

Although we appreciate the feedback from the commenter, we finalized a policy last year to phase in the new supply and equipment pricing over 4 years so that supply and equipment values transition smoothly from their current prices to the final updated prices in CY 2022 (83 FR 59479-59480). We did not propose any changes to this transition period, and therefore, we decline to adopt a different approach.

Comment:

One commenter stated that they supported the CMS proposal to update the price of the EM visit pack (SA047) supply to $5.47 to match the sum of the prices of the component supplies. The commenter also stated that they had concerns over the pricing of the other bundled supply items (such as kits, trays, and packs) that may have been similarly mispriced by StrategyGen. The commenter stated that they could not assist CMS in correcting supply codes that may have been incorrectly priced without details about the pricing for individual component supplies.

Response:

We appreciate the support for our proposed pricing of the EM visit pack (SA047) supply by the commenter. We encourage stakeholders to comment

upon and submit pricing information for any supply items that they believe may have been mispriced by StrategyGen. In the absence of alternative pricing information, we continue to believe that our proposed prices are the most accurate source of data.

Comment:

One commenter recommended CMS consider only the best available evidence and market research data in proposing any changes to the pricing approach of the balloon sinus surgery kit (SA106). The commenter stated that the use of navigation instruments has increased for this supply kit, particularly in the lower cost office setting, which enhances the ability to navigate the complex sinus anatomy, resulting in improved safety and reliability of the procedure, which benefits the patient.

Response:

We note that the commenter did not make any specific recommendations regarding the pricing of this supply or submit invoices with additional pricing information. In the absence of alternative pricing information, we continue to believe that our proposed prices are the most accurate source of data.

Comment:

Several commenters stated that they supported and urged CMS to finalize the proposed prices for the general ultrasound room (EL015) and vascular ultrasound room (EL016) equipment. Commenters stated that the proposed prices more accurately reflected the costs faced by vascular ultrasound practitioners and would reduce health care costs by ensuring ultrasound services are readily available to the most vulnerable Medicare beneficiaries.

Response:

We appreciate the support for our proposed pricing by the commenters.

Comment:

One commenter disagreed with the proposed pricing of the general ultrasound room (EL015) equipment. The commenter stated that the proposed pricing would drastically reduce the general ultrasound room price by 65 percent, which would have a downstream impact on the vascular ultrasound room, resulting in a 57 percent reduction. The commenter stated that a 40 percent reduction in payment as a result of this pricing would significantly reduce patient access to ultrasound services across the board.

Response:

We clarify for the commenter that we did not propose a reduction in the price of the general ultrasound room (EL015) equipment. We proposed to update the price of the general ultrasound room to $410,303.32 and proposed to continue to transition towards this price over the remaining years of the phase-in period, with a CY 2020 price of $383,397.77. We note that this is a slight increase over the finalized CY 2019 price of $369,945.00; we encourage readers to consult the full list of supply and equipment pricing as detailed in the public use files.

Comment:

Several commenters disagreed with the proposed pricing of the “HDR Afterload System, Nucletron—Oldelft” (ER003) equipment, the “treatment planning system, IMRT (Corvus w-Peregrine 3D Monte Carlo)” (ED033) equipment, and the “SRS system, SBRT, six systems, average” (ER083) equipment. The commenters stated that all of these equipment items have proposed prices that are below industry standards, and that given the high cost of these items and their substantial utilization in certain radiation oncology delivery codes, it was imperative that the CMS inputs accurately reflect the marketplace pricing. The commenters recommended that CMS conduct additional research regarding fair and accurate market pricing for equipment items ER003, ED033 and ER083. Another commenter also disagreed with the proposed pricing of the ER003 equipment, and stated that StrategyGen may have included updated pricing for a less costly electronic brachytherapy system used to treat non-melanoma skin cancer, or alternatively the proposed price for ER003 may represent an equipment upgrade or refurbished equipment.

Response:

We share the concerns of the commenters on the importance to ensure fair and accurate market-based pricing for supplies and equipment. However, the commenters did not submit invoices or other pricing data for the ER003, ED033, and ER083 equipment items, and, as previously stated, in the absence of alternative pricing information, we continue to believe that our proposed prices are the most accurate source of data. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing over the ongoing 4-year transition period, including the submission of additional invoices for consideration.

Comment:

Several commenters stated that they supported the efforts by CMS to ensure accurate pricing for direct PE inputs and supported the updated valuation of the ultrasound room and vascular ultrasound room. However, the commenters stated that there was an inconsistency with the pricing for the CT room (EL007), PET room (EL009), and PET-CT room (EL010) equipment. The commenters stated that it did not follow logically that the EL009 equipment is increasing from $1,328,996 to $2,410,677 and the EL007 equipment is increasing from $1,284,000 to $1,429,967 while a room that is a combination of these two, EL010, is decreasing from $2,136,283 to $206,326. The commenters asked that CMS investigate this issue further while delaying any price change for this one item.

Response:

With regards to the pricing of the PET-CT room (EL010) equipment, we share the desire of the commenters to ensure fair and accurate market-based pricing for this equipment item. However, as we noted in the previous comment response, the commenters did not submit invoices or other pricing data for the EL010 equipment, and, as previously stated, in the absence of alternative pricing information, we continue to believe that our proposed prices are the most accurate source of data. We remind stakeholders that the proposed pricing was based on market research carried out by the StrategyGen contractor during the prior rule cycle. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing over the ongoing 4-year transition period, and we are willing to revisit the subject of pricing for this equipment if provided with market-based pricing data.

Comment:

Several commenters disagreed with the proposed price of the “stent, vascular, deployment system, Cordis SMART” (SA103) and “stent, balloon, implantable” (SD299) supplies. Commenters stated that the Cordis SMART stent (SA103) supply is not FDA approved to stent iliac veins in CPT codes 37238-37239 due to the markedly undersized diameters of the available stents, and that this supply is essentially never used in iliac veins due to its much smaller size. The commenter stated that they believe the proposed pricing of the SA103 supply to be inaccurate, and stated that they were submitting 10 invoices in the hopes of pricing a new supply code at $2,537 which would replace the SA103 supply in these CPT codes. The commenters also stated a desire to work with CMS to reconsider pricing of the SD299 supply given the likely non-viability by CY 2022 of the services represented by CPT codes 37236 and 37237 in the office setting, and to resolve the lack of clarity surrounding the implantable stent balloon.

Response:

We appreciate the desire on the part of the commenters to submit invoices with additional pricing data. However, despite an exhaustive search of the comments, we were unable to find the 10 invoices mentioned in the letters from the commenters, which

were not included along with the rest of the submitted text. Although we are willing to consider these invoices if they were to be submitted, as previously stated, in the absence of alternative pricing information, we continue to believe that our proposed prices are the most accurate source of data. We urge commenters submitting invoices to include them as part of their comment letter to avoid any potential for miscommunication. We also note for the commenters that we did not make any proposals regarding CPT codes 37238-37239 or CPT codes 37236-37237, and therefore, we decline to make changes to the supplies for these codes at this time.

Comment:

Several commenters disagreed with the proposed price of the percutaneous neuro test stimulation kit (SA022) supply. The commenters stated that the proposed price of $114.52 was insufficient to reflect the cost associated with the SA022 supply, and that there may have been some misunderstanding about what items comprise the sacral nerve test kit. The commenters stated that it appears that the line item reflecting the device that generates the neurostimulation, which is the most expensive component of the test kit, was not included in the proposed pricing for this supply, which instead reflects the costs of the test kit leads only. The commenters stated that they reviewed all of the paid invoices for kits sold during January and February 2019, which resulted in pricing that was more in line with the CY 2018 pricing of $420 for the kit. One commenter submitted a random sample of 120 paid invoices (out of the 481 paid invoices that the commenter accumulated in total) for consideration by CMS.

Response:

We appreciate the submission of a large quantity of additional invoices with pricing data from the commenter. After further review, we agree with the commenters that the proposed price failed to incorporate all of the components of the test kit. Based on the data submitted by the commenters, we are finalizing an update in the price of the percutaneous neuro test stimulation kit (SA022) supply to $413.24, and we will continue to transition towards this price over the remaining years of the phase-in period.

Comment:

One commenter stated that the proposed price of $752.40 for the “plasma LDL adsorption column (Liposorber)” (SD186) supply did not accurately reflect the actual average prices paid by their provider customers. The commenter submitted copies of all U.S. customer invoices for purchases of the SD186 supply for the most recent three-month period from June 1 through August 30, 2019 and requested that the price should be updated to reflect the average market pricing.

Response:

We appreciate the submission of a large quantity of additional invoices with pricing data from the commenter. Based on the data submitted by the commenter, we are finalizing an update in the price of the “plasma LDL adsorption column (Liposorber)” (SD186) supply to $1118.06, and we will continue to transition towards this price over the remaining years of the phase-in period.

Comment:

The same commenter stated that the “plasma antibody adsorption column (Prosorba)” (SD185) supply was withdrawn from the market by its manufacturer more than 10 years ago, and the associated procedure code (CPT code 36515) has been deleted. The commenter also stated that the blood warmer tubing set (SC084) supply is not utilized to perform LDL apheresis with a Liposorber System, and therefore, recommended that this supply should be delisted as a direct PE input for CPT code 36516.

Response:

We appreciate the additional information provided by the commenter regarding these supply items. After conducting our own review, we agree with the commenter that there is no longer any need for the “plasma antibody adsorption column (Prosorba)” (SD185) supply, which is not utilized by any HCPCS codes and has been withdrawn from the market. Therefore, we are finalizing the deletion of the SD185 supply code. We are not finalizing the removal of the blood warmer tubing set (SC084) supply at this time, as it is currently utilized in two codes (CPT codes 36514 and 36516), and we did not make any proposals on this issue. We welcome additional feedback from stakeholders regarding the use of the SC084 supply for potential future rulemaking.

Comment:

One commenter stated that they appreciated recent efforts by CMS to update the price of supply and equipment inputs to better reflect current market rates. The commenter requested that CMS update the price inputs for three inputs: The Biodegradable Material Kit—PeriProstatic (SA126) supply, the Rezum delivery device kit (SA128) supply, and the water thermotherapy procedure generator (EQ389) equipment. The commenter submitted invoices with updated pricing data for consideration by CMS.

Response:

Based on the data submitted by the commenters, we are finalizing an update in the price of all three of these direct PE inputs. We are finalizing an increase in the price of the Biodegradable Material Kit—PeriProstatic (SA126) supply from $2,850 to $2,965 based on averaging the submission of eight invoices. We are finalizing an increase in the price of the Rezum delivery device kit (SA128) supply from $1,150 to $1,220 based on averaging the submission of ten invoices. Finally, we are finalizing an increase in the price of the water thermotherapy procedure generator (EQ389) equipment from $27,538 to $33,950 based on averaging the submission of two invoices.

Comment:

One commenter disagreed with the proposed pricing for the “fluorescein inj (5ml uou)” (SH033) supply. The commenter stated that the proposed price for injectable fluorescein was concerning as it did not reflect the most recent price increase of nearly 60 percent. The commenter stated that for several months practices have been paying $38.02 per vial and submitted four invoices to this effect.

Response:

After reviewing the submitted invoices, we are finalizing an increase of the price of the SH033 supply to $38.02 to match the information detailed by the commenter.

Comment:

One commenter disagreed with the proposed pricing for HCPCS code G0166 (

External counterpulsation, per treatment session

) and stated that the reductions in the proposed pricing would decrease the availability of this service and have already impacted their ability to provide external counterpulsation (ECP) therapy. The commenter stated that the prior review of HCPCS code G0166 in the CY 2019 rule cycle contained major errors, including omissions that artificially deflated the cost of the equipment associated with ECP therapy, inappropriate valuation of the ECP therapy equipment, and a failure to reflect the clinical guidelines and requirements for delivering ECP therapy. The commenter requested that CMS reverse the CY 2019 RVU reductions such that ECP therapy would return to the CY 2018 payment rates, or alternately pause any future reductions until CMS considered and acted upon forthcoming RUC recommendations for HCPCS code G0166. The commenter also submitted a series of invoices for the EECP external counterpulsation system (EQ012) equipment and a number of additional equipment items that previously lacked pricing.

Response:

We remind commenters that we nominated HCPCS code G0166 as potentially misvalued in the CY 2020 PFS proposed rule (84 FR 40516) due to concerns that the RVUs for this code did not fully reflect the total resources required to deliver the service. Aside from nominating HCPCS code G0166 as

potentially misvalued, we did not make any other proposals concerning this code. We are aware that the RUC plans to review HCPCS code G0166 for the CY 2021 PFS rule cycle, and we look forward to considering their recommendations for next year's rulemaking.

However, although we are not reviewing the work RVU or direct PE inputs for HCPCS code G0166 for CY 2020, we were able to consider the submission of invoices from the commenter as part of our market-based supply and equipment pricing transition. Based on the information provided by the commenters, we are finalizing an increase in the price of the EECP external counterpulsation system (EQ012) equipment from $61,490.75 to $117,495.00. For the additional equipment items submitted by the commenter, which are not currently in

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