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Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations-Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

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AGENCY:

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

ACTION:

Final rules and interim final rule.

SUMMARY:

This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in “Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year” that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success”. This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program.

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

DATES:

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

  • Revisions to §§ 414.1415(b)(2) and (3), and 414.1420(b), (c)(2), and (3), which are effective January 1, 2020; and
  • Amendments to Part 425, which are effective on December 31, 2018.

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

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

ADDRESSES:

In commenting, please refer to file code CMS-1693-IFC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1693-IFC, P.O. Box 8010, Baltimore, MD 21244-8016.

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

3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1693-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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

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FOR FURTHER INFORMATION CONTACT:

Jamie Hermansen, (410) 786-2064, for any physician payment issues not identified below.

Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, for issues related to evaluation and management (E/M) payment, communication technology-based services and telehealth services.

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

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

Isadora Gil, (410) 786-4532, for issues related to payment rates for nonexcepted items and services furnished by nonexcepted off-campus provider-based departments of a hospital, and work relative value units (RVUs).

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

Geri Mondowney, (410) 786-1172, for issues related to potentially misvalued services, geographic price cost indices (GPCIs), and malpractice RVUs.

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

Tourette Jackson, (410) 786-4735, for issues related to malpractice RVUs.

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

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

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

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

Marcie O'Reilly, (410) 786-9764, for issues related to the Potential Model for Radiation Therapy.Start Printed Page 59453

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

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

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

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

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

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

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

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

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

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

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SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Provisions of the Final Rule for PFS

A. Background

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

C. Determination of Malpractice Relative Value Units (RVUs)

D. Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services and Interim Final Rule Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

E. Potentially Misvalued Services Under the PFS

F. Radiologist Assistants

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

H. Valuation of Specific Codes

I. Evaluation & Management (E/M) Visits

J. Teaching Physician Documentation Requirements for Evaluation and Management Services

K. GPCI Comment Solicitation

L. Therapy Services

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

N. Potential Model for Radiation Therapy

III. Other Provisions of the Final Rule

A. Clinical Laboratory Fee Schedule

B. Changes to the Regulations Associated With the Ambulance Fee Schedule

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

D. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

E. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals

F. Medicare Shared Savings Program Quality Measures

G. Physician Self-Referral Law

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

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

IV. Requests for Information

V. Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success

VI. Collection of Information Requirements

VII. Regulatory Impact Analysis

Regulations Text

Appendix 1: Finalized MIPS Quality Measures

Appendix 2: Improvement Activities

Addenda Available Only Through the Internet on the CMS Website

The PFS Addenda along with other supporting documents and tables referenced in this final rule are available on the CMS website at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2019 PFS final rule, refer to item CMS-1693-F. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this final rule and posted on the CMS website identified above should contact Jamie Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

Throughout this final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2018 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

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

1. Summary of the Major Provisions

The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work; practice expense (PE); and malpractice (MP) expense. In addition, the statute requires that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule, we establish RVUs for CY 2019 for the PFS, and other Medicare Part B payment policies, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule includes discussions regarding:

  • Potentially Misvalued Codes.
  • Communication Technology-Based Services.
  • Provisions Expanding Telehealth Services for the Treatment of Opioid Use Disorder and Other Substance Use Disorders under the SUPPORT Act.
  • Valuation of New, Revised, and Misvalued Codes.
  • Payment Rates under the PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital.
  • Evaluation & Management (E/M) Visits.Start Printed Page 59454
  • Therapy Services.
  • Part B Drugs: Application of an Add-on Percentage for Certain Wholesale Acquisition Cost (WAC)-based Payments.
  • Potential Model for Radiation Therapy.
  • Clinical Laboratory Fee Schedule.
  • Ambulance Fee Schedule—Provisions in the Bipartisan Budget Act of 2018.
  • Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
  • Appropriate Use Criteria for Advanced Diagnostic Imaging Services.
  • Medicaid Promoting Interoperability Program Requirements for Eligible Professionals.
  • Medicare Shared Savings Program Quality Measures.
  • Physician Self-Referral Law.
  • Physician Self-Referral Law: Annual Update to the List of CPT/HCPCS Codes.
  • CY 2019 Updates to the Quality Payment Program (including the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017).
  • Comments in response to the Request for Information on Promoting Interoperability and Electronic Healthcare Information Exchange through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare- and Medicaid-Participating Providers and Suppliers.
  • Comments in response to the Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information.

This rule also finalizes certain provisions from the “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Pathways to Success” proposed rule that appeared in the August 17, 2018 Federal Register (83 FR 41786). Under the Medicare Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs participating under a two-sided shared savings and shared losses model of the program may also be responsible for repaying shared losses if the Parts A and B FFS expenditures for their assigned beneficiaries exceed the ACO's historical benchmark. The revised policies for ACOs participating in the Medicare Shared Savings Program will ensure continuity of program participation for ACOs whose agreement periods expire on December 31, 2018 by allowing these ACOs the opportunity to elect a voluntary 6-month extension of their current agreement periods; supporting coordination of care across settings and strengthening beneficiary engagement; providing relief for ACOs impacted by extreme and uncontrollable circumstance in performance year 2018 and subsequent years; and promoting interoperable electronic health record technology among ACO providers/suppliers. We plan to address the remaining proposals from the August 2018 proposed rule (83 FR 41786) in a forthcoming second final rule.

2. Summary of Costs and Benefits

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

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

1. Overview

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

2. Practice Expense Methodology

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 Five-Year Review of Work Relative Value Units under the PFS and Proposed Changes to the Practice Expense Methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).

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

Response: The direct PE input database contains the service-level costs in clinical labor based on the typical service furnished to Medicare beneficiaries. When these resource costs are typically incurred in furnishing services, we do not have any standing policies that would prohibit the inclusion of the costs in the direct PE input database used to develop PE RVUs for individual services, to the extent that inclusion of such costs would not lead to duplicative payments. Therefore, we welcome more detailed information regarding the typical clinical labor costs involving pharmacists for particular PFS services. We note, however, that in the case of many PFS services, especially care management services, certain elements of the services could be provided by clinicians other than the billing professionals, which could include services provided by pharmacists. As such, we encourage interested stakeholders to provide information through the RUC process or directly to us by February 10th prior to annual rulemaking about the inclusion of additional clinical labor costs for specific services described by HCPCS codes for which payment is made under the PFS, as opposed to clinical labor costs that may be typical only under certain circumstances.Start Printed Page 59455

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

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

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

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

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

For CY 2019, we have incorporated the available utilization data for two new specialties, each of which became a recognized Medicare specialty during 2017. These specialties are Hospitalists and Advanced Heart Failure and Transplant Cardiology. We proposed to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data:

  • Hospitalists from Emergency Medicine, and
  • Advanced Heart Failure and Transplant Cardiology from Cardiology.

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

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

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

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

Comment: A few commenters wrote to detail their concerns with the current PE/HR assigned to home PT/INR monitoring services. Commenters stated that these services are provided by entities that are enrolled in Medicare as independent testing facilities because there is no other specialty category that currently describes these suppliers; however, home PT/INR monitoring services are fundamentally different in nature. Commenters stated that home PT/INR monitoring services tend to be Start Printed Page 59456more therapeutic than diagnostic in nature, typically utilize different staffing types, and have a different ratio of direct to indirect costs. The commenters encouraged CMS to consider home PT/INR monitoring as a distinct specialty from independent testing facilities and to survey suppliers to determine accurate indirect cost factors for these services, while using either the Pathology or All Physicians specialty as a proxy for PE/HR in the meantime. One commenter suggested that CMS should consider holding payments harmless for home PT/INR monitoring services while additional analysis is completed.

Response: We welcome suggestions from interested parties regarding new indirect PE surveys and the use of PE/HR proxies that could be considered for future rulemaking. Interested parties may wish to submit a physician specialty designation request per the instructions found in Pub. 100-04, Medicare Claims Processing Manual, Chapter 26, Section 10.8 (available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​Downloads/​clm104c26.pdf). This section of the Medicare Claims Processing Manual includes the criteria that CMS uses to evaluate physician specialty designation requests.

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

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 (see section II.B.2.b of this final rule). The general approach to developing the indirect portion of the PE RVUs is as follows:

  • For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
  • Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
  • Next, we incorporated the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

(3) Facility and Nonfacility Costs

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

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

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

(4) Services With Technical Components and Professional Components

Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be Start Printed Page 59457furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. This file contains a table that illustrates the calculation of PE RVUs as described in this final rule for individual codes.

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

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

CPT codeModifierShort descriptorExpected specialty2017 utilization
7055726Mri brain w/o dyeDiagnostic Radiology126
7055826Mri brain w/dyeDiagnostic Radiology32
7423526Remove esophagus obstructionGastroenterology10
7430126X-rays at surgery add-onDiagnostic Radiology73
7435526X-ray guide intestinal tubeDiagnostic Radiology11
7444526X-ray exam of penisUrology26
7474226X-ray fallopian tubeDiagnostic Radiology5
7477526X-ray exam of perineumDiagnostic Radiology80
7580126Lymph vessel x-ray arm/legDiagnostic Radiology114
7580326Lymph vessel x-ray arms/legDiagnostic Radiology41
7580526Lymph vessel x-ray trunkDiagnostic Radiology50
7581026Vein x-ray spleen/liverDiagnostic Radiology46
Start Printed Page 59458
7694126Echo guide for transfusionObstetrics/Gynecology15
7694526Echo guide villus samplingObstetrics/Gynecology31
7697526Gi endoscopic ultrasoundGastroenterology49
7828226Gi protein loss examDiagnostic Radiology8
7930026Nuclr rx interstit colloidDiagnostic Radiology2
8632726Immunoelectrophoresis assayPathology24
8716426Dark field examinationPathology30
8837126Protein western blot tissuePathology2
9353226R & l heart cath congenitalCardiology28
9353326R & l heart cath congenitalCardiology36
9356126Cardiac output measurementCardiology28
9356226Card output measure subsqCardiology38
9361626Esophageal recordingCardiology38
9362426Electrophysiologic studyCardiology51
9596626Meg evoked singleNeurology72
9596726Meg evoked each addlNeurology61

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

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

Comment: Several commenters supported the continued use of service-level overrides for low volume codes, and stated that they agreed with the addition of the proposed 28 codes to the list of expected specialties.

Response: We appreciate the support from the commenters.

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

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

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

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

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

  • Cardiac Surgery: CPT code 35812, and
  • Thoracic Surgery: CPT codes 32654, 33025 and 33251

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

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

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

After consideration of the public comments, we are finalizing the addition of the proposed 28 codes to the low volume services list, with the expected specialty as proposed except where modified in response to comments. We are also finalizing the addition of CPT codes 32654 and 33251 to the list with an expected specialty of Thoracic Surgery as detailed previously.Start Printed Page 59459

Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: The direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.

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

There are two situations where this formula is modified:

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

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

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

  • The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
  • The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.

Calculate the indirect practice cost index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

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

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

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

Comment: One commenter stated that the level of detail in the CY 2019 PFS proposed rule was insufficient to comment on several aspects of the proposed changes in coding and payment related to office/outpatient E/M visits, which was a departure from past rules. The commenter specifically stated that there was insufficient information to model how the proposed changes in the office/outpatient E/M visit codes affected the indirect practice cost indices for all other services. Similarly, the commenter suggested that not enough information was provided to simulate the PFS ratesetting in a way that would isolate the impact of the proposed multiple procedure payment reduction (MPPR), in the proposed rates and associated estimates of specialty-level impact. The commenter requested that CMS provide additional technical information and files going forward to enable the commenter to better model proposed and future policies.

Response: We agree with commenters regarding the importance of transparency and the need for detailed Start Printed Page 59460information about proposed policies so that public commenters can provide a full and informed response. We also understand that there is merit to providing as much information as possible that would allow for complete reproduction of our proposed and final ratesetting methodologies. We also understand that the proposals related to office/outpatient E/M visits are of great importance to the medical community and represent a significant portion of spending under the PFS. We do not agree with the commenter that the level of detail provided in the proposed rule, including the data provided as publicly available download files, was insufficient for public comment due to the extensive documentation associated with the E/M policy proposals, or that it represented a departure from past practice. Over several years, we have invested significant resources in improving the transparency of the data we use in developing proposed and final PFS rates. We intend to maintain a focus on increasing transparency, and believe the commenters' concerns will help us understand the kind of information that can be most helpful to stakeholders interested in the underlying data sets. While we are not finalizing the MPPR element of the E/M proposal, we appreciate the commenter's interest in the use of code-level assumptions regarding proposed payment adjustments that are reflected in the discounts in the setup file, as discussed in section II.B.2.(5)(e) of this final rule.

(d) Calculate the Final PE RVUs

Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this final rule.)

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

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

Response: The comments regarding CPT code 76881 are out of scope, as we did not make any proposals involving this code for CY 2019. The reductions in payment described by the commenters for CPT code 76881 were finalized as part of the CY 2018 PFS final rule (82 FR 53058-53059), and are continuing to be phased in over time as part of the transition policy described above. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931).

(e) Setup File Information

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

Table 2—Specialties Excluded From Ratesetting Calculation

Specialty codeSpecialty description
49Ambulatory surgical center.
50Nurse practitioner.
51Medical supply company with certified orthotist.
52Medical supply company with certified prosthetist.
53Medical supply company with certified prosthetist-orthotist.
54Medical supply company not included in 51, 52, or 53.
55Individual certified orthotist.
56Individual certified prosthetist.
57Individual certified prosthetist-orthotist.
58Medical supply company with registered pharmacist.
59Ambulance service supplier, e.g., private ambulance companies, funeral homes, etc.
60Public health or welfare agencies.
61Voluntary health or charitable agencies.
73Mass immunization roster biller.
74Radiation therapy centers.
87All other suppliers (e.g., drug and department stores).
88Unknown supplier/provider specialty.
Start Printed Page 59461
89Certified clinical nurse specialist.
96Optician.
97Physician assistant.
A0Hospital.
A1SNF.
A2Intermediate care nursing facility.
A3Nursing facility, other.
A4HHA.
A5Pharmacy.
A6Medical supply company with respiratory therapist.
A7Department store.
B2Pedorthic personnel.
B3Medical supply company with pedorthic personnel.
  • Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
  • Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
  • Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
  • Payment modifiers: Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 3 details the manner in which the modifiers are applied.

Table 3—Application of Payment Modifiers to Utilization Files

ModifierDescriptionVolume adjustmentTime adjustment
80, 81, 82Assistant at Surgery16%Intraoperative portion.
ASAssistant at Surgery—Physician Assistant14% (85% * 16%)Intraoperative portion.
50 or LT and RTBilateral Surgery150%150% of work time.
51Multiple Procedure50%Intraoperative portion.
52Reduced Services50%50%.
53Discontinued Procedure50%50%.
54Intraoperative Care onlyPreoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claimsPreoperative + Intraoperative portion.
55Postoperative Care onlyPostoperative Percentage on the payment files used by Medicare contractors to process Medicare claimsPostoperative portion.
62Co-surgeons62.5%50%.
66Team Surgeons33%33%.

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

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

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

(6) Equipment Cost per Minute

The equipment cost per minute is calculated as:

Start Printed Page 59462

(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 in this final rule.

price = price of the particular piece of equipment.

life of equipment = useful life of the particular piece of equipment.

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion in this final rule.

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

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

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

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

Maintenance: This factor for maintenance was finalized in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. We do not believe that voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we do not believe that we have sufficient information at present to propose a variable maintenance factor for equipment cost per minute pricing. We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.

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

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

Interest Rate: In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation (see 77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). We did not propose any changes to these interest rates for CY 2019. The interest rates are listed in Table 4.

Table 4—SBA Maximum Interest Rates

PriceUseful life (years)Interest rate (%)
<$25K<77.50
$25K to $50K<76.50
>$50K<75.50
<$25K7+8.00
$25K to $50K7+7.00
>$50K7+6.00

3. Changes to Direct PE Inputs for Specific Services

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

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 Start Printed Page 59463instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.

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

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

Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did for CY 2018, to facilitate rulemaking for CY 2019, we are continuing to display two versions of the Labor Task Detail public use file: one version with the old listing of clinical labor tasks, and one with the same tasks cross-walked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. These RUC-reviewed codes do not currently have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets.

As a result, we proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. If we had received RUC recommendations for codes that currently include clinical labor time for the “Confirm order, protocol exam” clinical labor task, we would have left the RUC-recommended clinical labor times unchanged, but there were no such codes reviewed for CY 2019. We note that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being used in the calculation of PE RVUs.

The following is a summary of the public comments we received on our proposal to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed the aforementioned pattern in the RUC-recommended direct PE inputs.

Comment: Several commenters supported CMS' proposal and requested that these clinical labor refinements should be finalized wherever the refinement had been proposed. These commenters noted that there was no change in the total clinical labor direct costs in these situations and urged CMS to finalize the proposal.Start Printed Page 59464

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

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

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

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

Response: We agree with the commenters that in situations where a CPT code under review had the old clinical labor task “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist” on a prior version of the PE worksheet, and where that old clinical labor task was divided into the new CA007 and CA014 activity codes as described by the commenters, we will not finalize our proposed refinements to maintain 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity, as we agree that the old clinical labor task is adequately accounted for by being divided into the new activity codes. In these cases, we will finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code.

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

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

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 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 Start Printed Page 59465scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.

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

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

After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal is to create an administratively simple scheme that will be easier to maintain and help to reduce administrative burden. We look forward to receiving detailed recommendations from expert stakeholders regarding the scope equipment items that would be typically required for each scope category, as well as the proper pricing for each scope.

(2) Scope Video System

We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306. We did not finalize this updated pricing to the scope video system in CY 2018, and indicated our intention to address these changes in CY 2019 to incorporate feedback from expert stakeholders.

(3) Scope Accessories

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

(4) Scope Proposals for CY 2019

We understand that the RUC has convened a Scope Equipment Reorganization Workgroup that will be incorporating feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we proposed to delay proposals for any further changes to scope equipment until CY 2020 so that we can incorporate the feedback from the aforementioned workgroup. However, we proposed to update the price of the scope video system (ES031) from its current price of $33,391 to a price of $36,306 to reflect the addition of the LED light and miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories, as we explained in detail in the CY 2018 PFS final rule (82 FR 52992 through 52993). We also proposed to update the name of the ES031 Start Printed Page 59466equipment item from “video system, endoscopy (processor, digital capture, monitor, printer, cart)” to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.

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

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

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

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

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

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

c. Balloon Sinus Surgery Kit (SA106) Comment Solicitation

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

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

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

Table 5—Balloon Sinus Surgery Kit (SA106) Price

Supply componentsQuantityUnitPrice
kit, sinus surgery, balloon (maxillary, frontal, or sphenoid)kit$2,599.86
Sinus Guide Catheter1item444.00
Sinus Balloon Catheter1item820.80
Sinus Illumination System (100 cm lighted guidewire)1item454.80
Light Guide Cable (8 ft)1item514.80
ACMI/Stryker Adaptor1item42.00
Sinus Guide Catheter Handle1item66.00
Sinus Irrigation Catheter (22 cm)1item150.00
Sinus Balloon Catheter Inflation Device1item89.46
Extension Tubing (High Pressure) (20 in)1item18.00
Start Printed Page 59467

We are interested in any information regarding possible changes in the pricing for this kit or its individual components since the initial pricing we adopted in CY 2011. The following is a summary of the public comments we received on our comment solicitation regarding the balloon sinus surgery kit supply.

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

Response: As we stated in the proposed rule, we continue to believe that this option presents a series of potential problems that we have addressed previously in the context of the broader challenges regarding our ability to maintain appropriate relativity while pricing high cost disposable supply items. For a discussion of this issue, we direct the reader to our discussion in the CY 2011 PFS final rule with comment period (75 FR 73251).

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

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

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

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

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

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

For CY 2019, we proposed to address the following inconsistencies:

  • The RUC alerted us that there are 165 CPT codes billed with an office E/M code more than 50 percent of the time in the nonfacility setting that have more minimum multi-specialty visit supply packs (SA048) than post-operative visits included in the code's global period. This indicates that either the inclusion of office E/M services was not accounted for in the code's global period when these codes were initially reviewed by the PE Subcommittee, or that the PE Subcommittee initially approved a minimum multi-specialty visit supply pack for these codes without considering the resulting overlap of supplies between SA048 and the E/M supply pack (SA047). The RUC regarded these overlapping supply packs as a duplication, due to the fact that the quantity of the SA048 supply exceeded the number of postoperative visits, and requested that CMS remove the appropriate number of supply item SA048 from 165 codes. After reviewing the quantity of the SA048 supply pack included for the codes in question, we proposed to refine the quantity of minimum multi-specialty visit packs as displayed in Table 6.

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

CPT codeNumber of post-op office visitsCY 2018 nonfacility quantity of minimum visit pack (SA048)Proposed CY 2019 nonfacility quantity of minimum visit pack (SA048)
10040121
10060121
10061232
10080121
10120121
10121121
10180121
11200121
11300010
11301010
11302010
Start Printed Page 59468
11303010
11306010
11307010
11310010
11311010
11312010
11400121
11750121
11900010
11901010
12001010
12002010
12004010
12011010
12013010
16020010
17000121
17004121
17110121
17111121
17260121
17270121
17280121
19100010
20005121
20520121
21215676
21550121
21920121
223101.52.51.5
235002.53.52.5
235702.53.52.5
23620343
24500454
24530454
24650343
24670343
25530343
25600565
25605565
256223.54.53.5
25630343
26600454
26720232
267402.53.52.5
26750232
27508454
275203.54.53.5
27530454
27613121
277503.54.53.5
27760454
277803.54.53.5
277863.54.53.5
27808454
28190121
28400343
284502.53.52.5
284901.52.51.5
285101.52.51.5
30901010
30903010
30905010
31000121
31231010
31233010
31235010
Start Printed Page 59469
31238010
31525010
31622010
32554010
36600010
38220010
40490010
42800121
43200010
45330010
46040343
46050121
46083121
463200.51.50.5
46600010
46604010
46900121
51102020
51701010
51702010
51703010
51710010
51725010
51736010
51741010
51792010
51798010
52000010
52001010
52214010
52265010
52281010
52285010
53601010
53621010
53660010
53661010
54050121
54056121
54100010
54235010
54450010
55000010
56405121
56605010
56820010
57061121
57100010
57420010
57500010
57505121
62252010
62367010
62368010
62370010
64413010
64420010
64450010
64611121
69000121
69100010
691451.52.51.5
69210010
69420121
69433121
69610121
93292010
Start Printed Page 59470
93303010
94667010
9504400.0280
95870010
95921010
95922010
95924010
95972011
96904011

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

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

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

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

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

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

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

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

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

Response: After reviewing this information, we found that the direct PE inputs requested by the commenter mostly, but do not entirely, match the direct PE inputs that CMS finalized through rulemaking for CY 2013. The commenter requested the inclusion of an additional SB007 (drape, sterile barrier 16in x 29in) supply and a SB011 (drape, sterile, fenestrated 16in x 29in) supply while leaving out a SK075 (skin marking pen, sterile (Skin Skribe)) supply, 3 SM022 (sanitizing cloth-wipe (surface, instruments, equipment)) supplies, and 4 SL463 (Aluminum Chloride 70%) supplies. Since we proposed to revise the direct PE inputs to match the ones previously finalized through rulemaking for CPT code 11311, we are not finalizing these five changes to the direct PE inputs requested by the commenter. In all other respects, the direct PE inputs recommended by the commenter matched the direct PE inputs previously finalized through Start Printed Page 59471rulemaking. We are therefore finalizing our proposal to revise the direct PE inputs to reflect the ones previously finalized in CY 2013 for CPT code 11311.

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

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

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

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

Comment: One commenter opposed the CMS proposal to refine the equipment time for the table, mat, hi-lo, 6 x 8 platform (EF028) for CPT code 97124 to reflect the change in the clinical labor time.

Response: We continue to believe that changes in clinical labor time should be matched with corresponding changes in equipment time. Since the commenter did not supply a rationale as to why the EF028 equipment time should not match the change in clinical labor time, we are finalizing our proposal to refine the “Obtain vital signs” clinical labor task for these three codes back to their previous times of 1 minute for CPT codes 97124 and 97750 and to 3 minutes for CPT code 97755.

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

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

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

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

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

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

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

Listed in order, the commenter identified these issues:

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

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

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

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

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

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

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

Response: We do not believe that the work times of these codes are subject to Start Printed Page 59472a technical correction, as the work times finalized for these codes in the CY 2017 PFS final rule (81 FR 80307-08) were based on a disagreement in policy with the commenter and not a technical error.

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

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

Comment: For CPT codes 93281 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead pacemaker system), 93284 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead transvenous implantable defibrillator system), and 93286 (Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or other qualified health care professional; single, dual, or multiple lead pacemaker system), the commenter stated that CMS has the wrong intraservice work times, despite the CY 2018 final rule indicating no time refinement for these codes.

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

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

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

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

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

Comment: For CPT code 96X11 (Psychological or neuropsychological test administration using single instrument, with interpretation and report by physician or other qualified health care professional and interactive feedback to the patient, family member(s), or caregivers(s), when performed), the commenter stated that the code is not being created for CY 2019 by the CPT Editorial Panel and should be removed from the work time file.

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

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

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

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

Response: We agree with the commenters and we are finalizing the replacement of the 9 minutes of equipment time for the portable X-ray machine (EF041) with 9 minutes of equipment time for a basic radiology room (EL012) for CPT code 71045. The equipment cost per minute of the basic radiology room (48.4 cents) is nearly identical to the equipment cost per Start Printed Page 59473minute of the proposed Digital Radiography portable X-ray machine (46.0 cents), and we believe that it would better serve the interests of relativity for CPT code 71045 to match the same equipment inputs as the rest of the Chest X-Ray code family. We previously updated the PE RVU of this code in the July 2018 Quarterly Update (CMS Change Request 10644) based on the same information previously supplied by the commenters, and due to a technical error, this update to the direct PE inputs of CPT code 71045 was not included in the CY 2019 PFS proposed rule. We are finalizing this technical correction to the direct PE inputs of CPT code 71045 for CY 2019.

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

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

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

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

e. Updates to Prices for Existing Direct PE Inputs

In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2019, we proposed the following price updates for existing direct PE inputs.

We proposed to update the price of four supplies and one equipment item in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we proposed that the new pricing take effect for CY 2019 for these items instead of being phased in over 4 years. For the details of these proposed price updates, please refer to section II.H. of this final rule, Table 15: Invoices Received for Existing Direct PE Inputs.

(1) Market-Based Supply and Equipment Pricing Update

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

As part of our authority under section 1848(c)(2)(M) of the Act, as added by PAMA, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005. StrategyGen has submitted a report with updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

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

  • Telephone surveys with vendors for top priority items (Vendor Survey).
  • Physician panel validation of market research results, prioritized by total spending (Physician Panel).
  • The General Services Administration system (GSA).
  • An aggregate health system buyers database with discounted prices (Buyers).
  • Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors).
  • Federal Register, current DPEI data, historical proposed and final rules prior to FY 2018, and other resources; that is, AMA RUC reports (References).

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

1. If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of Start Printed Page 59474equipment and a more precise reference for the RP.

2. If StrategyGen did not have market share for commercial products, then they used a weighted average (weighted by sample size) of the commercial price and GSA price for the RP. The impact of the GSA price may be nominal in some of these cases since it is proportionate to the commercial samples sizes.

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

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

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

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

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

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

We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the proposed transition from the current to the fully-implemented new pricing is provided in Table 7.

Table 7—Example of Direct PE Pricing Transition

Current Price$100
Final Price200
Year 1 (CY 2019) Price1251/4 difference between $100 and $200.
Year 2 (CY 2020) Price1501/3 difference between $125 and $200.
Year 3 (CY 2021) Price1751/2 difference between $150 and $200.
Final (CY 2022) Price200

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 Start Printed Page 59475equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price. We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes).

We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer time frame will allow more opportunities for public comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration. We were particularly interested in comments regarding the supply and equipment pricing for CPT codes 95165 and 95004 that are frequently used by the Allergy/Immunology specialty. The Allergy/Immunology specialty was disproportionately affected by the updated pricing, even with a 4-year phase-in. The direct PE costs for CPT code 95165 would go down from $8.43 to $8.17 as a result of the updated supply and equipment pricing information. This would result in the PE RVU for CPT code 96165 to decrease from 0.30 to 0.26. We are seeking feedback on the supply and equipment pricing for the affected codes typically performed by this specialty and whether the direct PE inputs should be reviewed along with the pricing. The full report from the contractor, including the updated supply and equipment pricing that we proposed to be implemented over the proposed 4-year transition period, will be made available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

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

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

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

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

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

Source of pricing dataDiscounted pricingSample sizeVariety (that is, geography, purchasing arrangement, etc.)
Buyers databaseActual discountsLargestNational footprint.
GSAWholesale price3-5Government purchasers only.
Amazon Business (on-line)Retail price3-5National footprint.
Cardinal Healthcare (on-line)Retail price3-5National footprint.
Catalogs (on-line)Retail price3-5National footprint.
Start Printed Page 59476

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

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

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

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

The vendors identified other factors that impact pricing decisions including:

  • Market demand and competitive pricing;
  • Contract renewal;
  • Customer history and contract history; and
  • Vendor considerations independent of the purchaser such as manufacturer and sales incentives, revenue goals, and new product releases.

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

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

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

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

Comment: Several commenters were concerned with the methodology used by StrategyGen to conduct market research to determine an updated price for medical equipment and supplies. There were significant concerns with the use of market research to supplement the current AMA/Specialty Society RVS Update Committee (RUC) process. A number of commenters stated that CMS should only use invoices supplied by the specialty society via the RUC process, and should not finalize the updated prices researched by the StrategyGen contractor.

Response: We determined that the most effective way to update the DPEI for CY 2019 was through comprehensive market research. The current RUC process has resulted in updates to many of the equipment and supply codes, but many of the prices in the CY 2018 DPEI are over a decade old, and a significant number date back to research conducted 15 years ago. Therefore, we requested a market research plan from the StrategyGen contractor designed to research current pricing to estimate the typical discounted prices that physicians and other providers normally pay.Start Printed Page 59477

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

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

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

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

Response: To control for potential research bias, the StrategyGen market research team used an identical online methodology to research commercial pricing data for each of the supply and equipment codes, regardless of the code's prioritization. The prioritization of high-utilization supply and equipment codes was not designed to reduce prices for these codes.

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

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

Comment: Many commenters were supportive of the proposal to use a 4-year pricing transition. Commenters agreed with using the transition period as an opportunity for specialty societies and other stakeholders to continue to evaluate the new pricing and submit invoices and other pricing data as needed. Commenters who disagreed with the use of the 4-year pricing transition also requested that CMS not finalize the proposal. One commenter stated that CMS should phase in the new prices for equipment and supplies during a shorter transition period than the proposed 4-year transition, and suggested a 2-year transition instead.

Response: Our proposal was intended to minimize any potential disruptive effects during the proposed transition period, and we continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer time frame will allow more opportunities for public comment and submission of additional, applicable data.

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

Response: We disagree with the commenters that delaying the implementation of the pricing updates for a year or longer would lead to more accurate pricing. We believe that our proposal to update the pricing of direct PE inputs for supplies and equipment over a 4 year-transition already allows many opportunities for public comment and the submission of additional, applicable data. We welcomed feedback from commenters on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration, and many commenters provided detailed feedback regarding the pricing of individual supply and equipment items. We note that we received feedback from commenters on approximately 65 individual supply and equipment codes, which is roughly 3 percent of the total number of items we proposed to update. We also note that commenters did not identify an alternative source for pricing information outside of the sources employed by the StrategyGen contractors, with commenters largely suggesting that we should continue to rely on invoice submissions included along with the review of individual codes via the RUC process.

We continue to believe that a delay in implementation would be unlikely to result in more accurate pricing information. Therefore, we are finalizing the 4-year pricing transition, beginning in CY 2019. We look forward to working with commenters over the 4-year transition for assistance in identifying individual supply and equipment codes that may require additional research into their pricing. As a reminder, to be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th Start Printed Page 59478deadline used for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices for the following year.

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

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

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

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

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

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

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

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

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

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

Response: The StrategyGen contractor investigated the accuracy of components or features included in an item by researching the identity of the item based on the description contained in the item's supply or equipment code, as well as the identity of any item's prices Start Printed Page 59479in submitted invoices. Additional research into approximately half a dozen supply/equipment codes failed to produce reliable product data sufficient to calculate a recommended price. To price these equipment and supply items accurately, we believe additional information is required. Therefore, we will continue to use the current CMS price for these supply and equipment items pending additional research and analysis. We welcome the submission of updated pricing information regarding these supply and equipment items through submission of valid invoices from commenters and other stakeholders. These supply and equipment codes are also listed in Table 9 at the conclusion of this section.

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

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

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

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

Supply/ equipment codeDescriptionCY 2018 priceProposed CY 2019 priceFinal CY 2019 price
ED033treatment planning system, IMRT (Corvus w-Peregrine 3D Monte Carlo)$350,545.000$157,392.835$197,247.000
EF031table, power6,153.6305,438.1205,906.760
EL015room, ultrasound, general369,945.000130,252.571369,945.000
EL016Room—Ultrasound, vascular/Original submission466,492.000199,449.308466,492.000
EP014flow cytometer119,850.000147,210.980192,000.000
EP088ThermoBrite6,120.0003,467.0004,795.000
EP116VP-2000 Processor30,800.00081,775.46237,993.000
EQ031INR monitor, home2,000.0006,014.819635.000
EQ125glucose continuous monitoring system1,170.540835.527850.000
EQ288ultrasonic cleaning unit895.00076,725.556895.000
EQ312INR analysis and reporting system w-software21,085.0006,014.81919,325.000
EQ340Patient Worn Telemetry System23,537.00018,565.71923,494.000
EQ343Radioaerosol Administration System2,560.25030.000623.000
ER003HDR Afterload System, Nucletron—Oldelft375,000.000111,425.876132,574.780
ER083SRS system, SBRT, six systems, average4,000,000.000931,965.4792,973,721.836
ES052brachytherapy treatment vault175,000.000134,998.000193,114.250
SA026kit, radiofrequency introducer50.000658.70024.160
SA074kit, endovascular laser treatment519.000313.460323.330
SA081pack, drapes, ortho, small1.1281.0002.250
SA099Kit, probe, cryoablation, prostate (Galil-Endocare)4,700.0001,539.5601,539.560
SA100kit, probe, radiofrequency, XIi-enhanced RF probe2,695.000753.4201,966.670
SA105UroVysion test kit176.800132.130129.280
SA106Balloon Sinus Surgery Kit2,599.8602,876.2202,374.330
SA117Universal Detection Kit4.0006.5104.000
SA122Claravein Kit890.000575.000883.330
SB019drape-towel, sterile 18in x 26in0.2820.9200.470
SB026gown, patient0.5333.5400.590
SD109probe, radiofrequency, 3 array (StarBurstSDE)2,233.000871.6602,289.000
SD114sensor, glucose monitoring (interstitial)53.08043.95059.310
Start Printed Page 59480
SD134tubing, suction, non-latex (6ft) with Yankauer tip (1)2.9610.2902.670
SD155catheter, RF endovenous occlusion725.0001,010.550550.000
SD250introducer sheath, Ansel [45 cm 6 Fr Ansel]90.00064.45072.640
SD251Sheath Shuttle (Cook)0.0000.000109.690
SD253atherectomy device (Spectronetics laser or Fox Hollow)4,979.6702,293.1003,048.330
SD254covered stent (VIABAHN, Gore)3,768.0002,573.0003,129.000
SD255Reentry device (Frontier, Outback, Pioneer)0.0000.0002,343.120
SD304IVUS catheter1,025.000727.750858.330
SF040suture, vicryl, 3-0 to 6-0, p, ps7.8524.3108.520
SG055gauze, sterile 4in x 4in0.1590.0300.190
SG056gauze, sterile 4in x 4in (10 pack uou)0.7980.0301.200
SH007antigen, multi (pollen, mite, mold, cat)6.7004.7808.960
SH009antigen, venom20.14027.36030.930
SH010antigen, venom, tri-vespid44.05051.32060.240
SH033fluorescein inj (5ml uou)5.44210.31024.390
SJ055test strip, INR5.6603.7504.710
SL012antibody IgA FITC41.180274.09030.025
SL060embedding mold0.1495.1400.123
SL182mounting media (DAPI II counterstain)67.00014.42054.000
SL184slide, negative control, Her-229.40021.24029.400
SL185slide, positive control, Her-229.40025.00026.200
SL191ethanol, 85%0.0030.1700.021
SL195kit, FISH paraffin pretreatment20.85023.29020.850
SL196kit, HER-2/neu DNA Probe105.00080.45079.050
SL258Control slides228.000279.000203.730
SL261FISH pre-treatment kit549.000454.480579.210
SL474Confirm anti-CD15 Mouse Monoclonal Antibody (Ventana 760-2504)3.6103.8803.820
SL483Hematoxylin II (Ventana 790-2208)0.0230.0230.780
SL484Bluing reagent (Ventana 760-2037)4.5220.2900.450
SL488UltraView Universal DAB Detection Kit10.48515.3909.700
SL493Antibody Estrogen Receptor monoclonal14.470322.40016.117
SL497(EBER) DNA Probe Cocktail8.570420.0608.189
SL498Kappa Probe Cocktail0.0950.0700.910

The updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

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

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

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

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

(2) Breast Biopsy Software (EQ370)

Following the publication of the CY 2018 PFS final rule, a stakeholder contacted us and requested that we update the price for the Breast Biopsy software (EQ370) equipment. This equipment item currently lacks a price in the direct PE database, and when an invoice for the Breast Biopsy software was first submitted during CY 2014 PFS rulemaking, we stated that this item served clinical functions similar to other items already included in the Magnetic Resonance (MR) room equipment package (EL008) included in the same CPT codes under review. Therefore, we did not create new direct PE inputs for this equipment item (78 FR 74344 Start Printed Page 59481through 74345). The stakeholder suggested that this software is used to subtract the imaging raw data series from the MRI Scanner, reformat the images in multiple planes to allow accurate targeting of the lesion to be biopsied, identify the location of a fiducial marker on the patient's skin, and then target the location of the enhancing lesion to be biopsied. The stakeholder requested that EQ370 be renamed as “Breast MRI computer aided detection and biopsy guidance software” and added to existing CPT codes 19085 (Biopsy, breast, with placement of breast localization device(s) (e.g., clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance), 19086 (Biopsy, breast, with placement of breast localization device(s) (e.g., clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including magnetic resonance guidance), 19287 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including magnetic resonance guidance), and 19288 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including magnetic resonance guidance), as well as adding the equipment to two newly created MR breast codes with CAD, CPT codes 77048 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral) and 77049 (Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD-real time lesion detection, characterization and pharmacokinetic analysis) when performed; bilateral). The stakeholder supplied an invoice with a purchase price of $52,275 for the equipment.

After reviewing the use of the Breast Biopsy software (EQ370) equipment in these six codes, we did not propose to update the price or add the software to these procedures. As we stated in the CY 2014 PFS final rule with comment period (78 FR 74345), we continue to believe that equipment item EQ370 serves clinical functions similar to other items already included in the MR room equipment package (EL008), and that it would be duplicative to include this Breast Biopsy software as a separate direct PE input. We also note that the RUC recommendations for the new CPT codes 77048 and 77049 do not include EQ370 in the recommended equipment for these procedures, and we do not have any reason to believe that the inclusion of additional Breast Biopsy software beyond what is already contained in the MR room equipment package would be typical. However, we will update the name of the EQ370 equipment item from “Breast Biopsy software” to the requested “Breast MRI computer aided detection and biopsy guidance software” to help better describe the equipment in question.

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

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

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

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

(3) Invoice Submission

We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2019, we noted that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we would consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.

(4) Adjustment to Allocation of Indirect PE for Some Office-Based Services

In the CY 2018 PFS final rule (82 FR 52999 through 53000), we established criteria for identifying the services most affected by the indirect PE allocation anomaly that does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. We also finalized a modification in the PE methodology for allocating indirect PE RVUs to better reflect the relative indirect PE resources involved in furnishing these services. The methodology, as described, is based on the difference between the ratio of indirect PE to work RVUs for each of the codes meeting eligibility criteria and the ratio of indirect PE to work RVU for the most commonly reported visit code. We refer readers to the CY 2018 PFS final Start Printed Page 59482rule (82 FR 52999 through 53000) for a discussion of our process for selecting services subject to the revised methodology, as well as a description of the methodology, which we began implementing for CY 2018 as the first year of a 4-year transition. For CY 2019, we proposed to continue with the second year of the transition of this adjustment to the standard process for allocating indirect PE.

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

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview

Section 1848(c) of the Act requires that the payment amount for each service paid under the PFS be composed of three components: Work; PE; and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource-based. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs see the CY 2015 PFS proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).

To determine MP RVUs for individual PFS services, our MP methodology is composed of three factors: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums paid by practitioners; (2) service level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service; and (3) an intensity/complexity of service adjustment to the service level risk factor based on either the higher of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.

In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk, intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the 3 most recent years of data instead of a single year of data. Under this approach, for new and revised codes, we generally assign a specialty risk factor to individual codes based on the same utilization assumptions we make regarding the specialty mix we use for calculating PE RVUs and for PFS budget neutrality. We continue to use the work RVU or clinical labor RVU to adjust the MP RVU for each code for intensity and complexity. In finalizing this policy, we stated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.

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

In the CY 2018 PFS proposed rule, we proposed to use the updated MP data to update the specialty risk factors used in calculation of the MP RVUs prior to the next 5-year update (CY 2020). However, in the CY 2018 PFS final rule (82 FR 53000 through 53006), after consideration of the comments received and some differences we observed in the descriptions on the raw rate filings as compared to how those data were categorized to conform with the CMS specialties, we did not finalize our proposal to use the updated MP data. We are required to review, and if necessary, adjust the MP RVUs by CY 2020. We appreciate the feedback provided by commenters in response to the CY 2018 PFS proposed rule.

In the CY 2019 PFS proposed rule, we solicited additional comment regarding the next MP RVU update which must occur by CY 2020. Specifically, we solicited comment on how we might improve the way that specialties in the state-level raw rate filings data are crosswalked for categorization into CMS specialty codes, which are used to develop the specialty-level risk factors and the MP RVUs.

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

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

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

Although all of the kinds of services stated above might be called “telehealth” by patients, other payers and health care providers, we have generally used the term “Medicare telehealth services” to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real-time telecommunication technology. Section 1834(m)(4)(F)(i) of the Act enumerates certain Medicare telehealth services and section 1834(m)(4)(F)(ii) of the Act allows the Secretary to specify Start Printed Page 59483additional Medicare telehealth services using an annual process to add or delete services from the Medicare telehealth list. Section 1834(m)(4)(C) of the Act limits the scope of Medicare telehealth services for which payment may be made to those furnished to a beneficiary who is located in certain types of originating sites in certain, mostly rural, areas. Section 1834(m)(1) of the Act permits only physicians and certain other types of practitioners to furnish and be paid for Medicare telehealth services. Although section 1834(m)(4)(F)(ii) of the Act grants the Secretary the authority to add services to, and delete services from, the list of telehealth services based on the established annual process, it does not provide any authority to change the limitations relating to geography, patient setting, or type of furnishing practitioner because these requirements are specified in statute. However, we note that sections 50302, 50324, and 50325 of the Bipartisan Budget Act of 2018 (BBA 18) (Pub. L. 115-123) have modified or removed the limitations relating to geography and patient setting for certain telehealth services, including for certain home dialysis end-stage renal disease-related services, services furnished by practitioners in certain Accountable Care Organizations, and acute stroke-related services, respectively.

In the CY 2018 PFS proposed rule (82 FR 53012), we solicited information from the public regarding ways that we might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies. Commenters were very supportive of CMS expanding access to these kinds of services. Many commenters noted that Medicare payment for telehealth services is restricted by statute, but encouraged CMS to recognize and support technological developments in healthcare.

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

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

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

For CY 2019, we aimed to increase access for Medicare beneficiaries to physicians' services that are routinely furnished via communication technology by clearly recognizing a discrete set of services that are defined by and inherently involve the use of communication technology. Accordingly, we made several proposals for modernizing Medicare physician payment for communication technology-based services, described below. These services will not be subject to the limitations on Medicare telehealth services in section 1834(m) of the Act because, as we have explained, we do not consider them to be Medicare telehealth services; instead, they will be paid under the PFS like other physicians' services. Additionally, we note that in furnishing these services, practitioners need to comply with any applicable privacy and security laws, including the HIPAA Privacy Rule.

1. Brief Communication Technology-Based Service, e.g. Virtual Check-In (HCPCS Code G2012)

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

Among these services are the kinds of brief check-in services furnished using communication technology that are used to evaluate whether or not an office visit or other service is warranted. When these kinds of check-in services are furnished prior to an office visit, then we would currently consider them to be bundled into the payment for the resulting visit, such as through an evaluation and management (E/M) visit Start Printed Page 59484code. However, in cases where the check-in service does not lead to an office visit, then there is no office visit with which the check-in service can be bundled. To the extent that these kinds of check-ins become more effective at addressing patient concerns and needs using evolving technology, we believe that the overall payment implications of considering the services to be broadly bundled becomes more problematic. This is especially true in a resource-based relative value payment system. Effectively, the better practitioners are in leveraging technology to furnish effective check-ins that mitigate the need for potentially unnecessary office visits, the fewer billable services they furnish. Given the evolving technological landscape, we believe this creates incentives that are inconsistent with current trends in medical practice and potentially undermines payment accuracy.

Therefore, we proposed to pay separately, beginning January 1, 2019, for a newly defined type of physicians' service furnished using communication technology. We stated this service would be billable when a physician or other qualified health care professional has a brief non-face-to-face check-in with a patient via communication technology, to assess whether the patient's condition necessitates an office visit. We understand that the kind of communication technology used to furnish these kinds of services has broadened over time and has enhanced the capacity for medical professionals to care for patients. We solicited comment on what types of communication technology are utilized by physicians or other qualified health care professionals in furnishing these services, including whether audio-only telephone interactions are sufficient compared to interactions that are enhanced with video or other kinds of data transmission.

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

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

Response: Based on the broad support for the proposal, we are creating coding and finalizing our proposal to make separate payment for this service. We note that in the proposed rule we referred to this service as HCPCS code GVCI1, which was a placeholder code. The code will be described as HCPCS code G2012 (Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).

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

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

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

We further proposed that in instances when the brief communication technology-based service originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, that this service would be considered bundled into that previous E/M service and would not be separately billable, which is consistent with code descriptor language for CPT code 99441 (Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion), on which this service is partially modeled. We proposed that in instances when the brief communication technology-based service leads to an E/M service with the same physician or other qualified health care professional, this service would be considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable. We also noted that this service could be used as part of a treatment regimen for opioid use disorders and other substance use disorders to assess whether the patient's condition requires an office visit.

We proposed pricing this distinct service at a rate lower than current E/M in-person visits to reflect the low work time and intensity and to account for the resource costs and efficiencies associated with the use of communication technology. We expect that these services will be initiated by the patient, especially since many beneficiaries would be financially liable for sharing in the cost of these services. For the same reason, we believe it is important for patients to consent to receiving these services. Therefore, we specifically solicited comment on whether we should require, for example, verbal consent that will be noted in the medical record for each service.

Comment: Many commenters stated that it would be burdensome to obtain consent from the patient prior to each occurrence of this service. Some commenters suggested that the patient be informed through the use of a service agreement which could be signed once and kept on file. Several commenters Start Printed Page 59485expressed concern about the cost to beneficiaries, especially since they may have previously received this service without financial liability, and therefore recommended requiring verbal consent that is documented in the medical record.

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

We also proposed that this service can only be furnished for established patients because we believe that the practitioner needs to have an existing relationship with the patient, and therefore, basic knowledge of the patient's medical condition and needs, in order to perform this service.

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

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

We did not propose to apply a frequency limit on the use of this code by the same practitioner with the same patient, but we want to ensure that this code is appropriately utilized for circumstances when a patient needs a brief non-face-to-face check-in to assess whether an office visit is necessary. We solicited comment on whether it would be clinically appropriate to apply a frequency limitation on the use of this code by the same practitioner with the same patient, and on what would be a reasonable frequency limitation.

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

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

We also solicited comment on the timeframes under which this service would be separately billable compared to when it would be bundled. We believe the general construct of bundling the services that lead directly to a billable visit is important, but we are concerned that establishing strict timeframes may create unintended consequences regarding scheduling of care. For example, we do not want to bundle only the services that occur within 24 hours of a visit only to see a significant number of visits occurring at 25 hours after the initial service. In order to mitigate these incentives, we solicited comment on whether we should consider broadening the window of time and/or circumstances in which this service should be bundled into the subsequent related visit. We noted that these services, like any other physicians' service, must be medically reasonable and necessary in order to be paid by Medicare.

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

Response: We agree with commenters that urged caution regarding overutilization of this service and believe that the language stating, `or soonest available appointment' in the code description may serve to reduce potential perverse payment incentives to delay seeing patients to ensure payment for this code. We appreciate the concerns regarding potential difficulty in proving that a particular visit was not the “soonest available.” We agree that in each individual case, it might be challenging to prove whether or not other appointments were available prior to the visit, especially since beneficiary convenience is also presumably a factor for when appointments are scheduled. However, we believe that, as written, the code description could help to guard against the potential for abuse that would be present if we instead adopted a purely time-based window for bundling of this service. We also believe that “soonest available appointment” might allow for clinically appropriate flexibility. Therefore, after consideration of the public comments, we are finalizing the code descriptor for HCPCS code G2012 as proposed. However, we plan to monitor this service with the intention of determining whether changes are Start Printed Page 59486necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.

We solicited comment on how clinicians could best document the medical necessity of this service, consistent with documentation requirements necessary to demonstrate the medical necessity of any service under the PFS.

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

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

Comment: Several commenters stated that the proposed payment rate would be inadequate for modalities that are both audio- and visual-capable, whereas others stated that the proposed valuation was appropriate. One commenter suggested we create a second code for a virtual check-in that only utilizes synchronous audio/video technology, with a higher reimbursement rate associated with the increased complexity of technology.

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

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

Response: We are finalizing maintaining this code as part of the set of codes that is only reportable by those that can furnish E/M services. We believe this is appropriate since the service describes a check-in directly with the billing practitioner to assess whether an office visit is needed. We agree that similar check-ins provided by nurses and other clinical staff can be important aspects of coordinated patient care. We note that these kinds of non-face-to-face services by other medical professionals and clinical staff continue to be included in the RVUs for other codes, including those that describe E/M visits, and for procedures with global periods. We also note that non-face-to-face services provided by clinical staff can be explicitly and separately paid for as part of several care management services, many of which we have introduced over the past several years. However, this service is meant to describe, and account for the resources involved, when the billing practitioner directly furnishes the virtual check-in.

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

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

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

We are finalizing that if the service originates from a related E/M service provided within the previous 7 days by the same physician or other qualified health care professional, that this service would be considered bundled into that previous E/M service and would not be separately billable. In instances when the service leads to an E/M service with the same physician or other qualified health care professional, we are finalizing that this service would be considered bundled into the pre- or post-visit time of the associated E/M service, and therefore, would not be separately billable. We plan to monitor this service with the intention of determining whether changes are necessary to the timeframes under which this service would be separately billable compared to when it would be bundled. We would consider any such changes in future rulemaking.

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

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

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

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

Stakeholders have requested that CMS make separate Medicare payment when a physician uses recorded video and/or images captured by a patient in order to evaluate a patient's condition. These services involve what is referred to under section 1834(m) of the Act as “store-and-forward” communication technology that provides for the “asynchronous transmission of health care information.” We noted in the proposed rule that we believe these services involve pre-recorded patient-generated still or video images. Other types of patient-generated information, such as information from heart rate monitors or other devices that collect patient health marker data, could potentially be reported with CPT codes that describe remote patient monitoring (83 FR 35724). Under section 1834(m) of Start Printed Page 59487the Act, payment for telehealth services furnished using such store-and-forward technology is permitted only under federal telemedicine demonstration programs conducted in Alaska or Hawaii, and these telehealth services remain subject to the other statutory restrictions governing Medicare telehealth services. However, much like the brief communication technology-based service (“virtual check-in service”) that we are finalizing in this rule as described previously, this remote evaluation service would not be a substitute for an in-person service currently separately payable under the PFS. As such, this remote evaluation service is distinct from the telehealth services described under section 1834(m) of the Act. Effective January 1, 2019, we proposed to create specific coding that describes the remote professional evaluation of patient-transmitted information conducted via pre-recorded “store and forward” video or image technology. Because this service would not be considered a Medicare telehealth service, it would not be subject to the geographic and other restrictions on telehealth services under section 1834(m) of the Act; and the proposed valuation reflects the resource costs associated with furnishing services utilizing communication technology.

Also like the virtual check-in service we are finalizing as described previously, this service would be used to determine whether or not an office visit or other service is warranted. When the remote evaluation of pre-recorded patient-submitted images and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we proposed that this remote service will be considered bundled into that office visit and therefore not be separately billable. We further proposed that in instances when the remote service originates from a related E/M service provided within the previous 7 days by the same physician or qualified health care professional that this service will be considered bundled into that previous E/M service and not be separately billable. In summary, we proposed this service to be a stand-alone service that could be separately billed to the extent that there is no resulting E/M office visit and there is no related E/M office visit within the previous 7 days of the remote service being furnished. We believe the coding and separate payment for this service is consistent with the progression of technology and its impact on the practice of medicine in recent years, and would result in increased access to services for Medicare beneficiaries. We note that in the proposed rule we referred to this service as HCPCS code GRAS1, which was a placeholder code. The code for this service is G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). We solicited comment as to whether these services should be limited to established patients; or whether there are certain cases, like dermatological or ophthalmological services, where it might be appropriate for a new patient to receive these services. For example, when a patient seeks care for a specific skin condition from a dermatologist with whom she does not have a prior relationship, and part of the inquiry is an assessment of whether the patient needs an in-person visit, the patient could share, and the dermatologist could remotely evaluate, pre-recorded information. We also noted that this service is distinct from the virtual check-in service described previously in that this service involves the practitioner's evaluation of a patient-generated still or video image transmitted by the patient, and the subsequent communication of the practitioner's response to the patient; while the virtual check-in service describes a service that occurs in real time and does not involve the asynchronous transmission of any recorded image.

The following discussion summarizes particular definitions and billing rules we proposed for this service and the more detailed comments we received regarding these aspects of the proposal. Our responses below include information regarding the service definitions and billing requirements applicable for 2019. We additionally address comments we received regarding whether these services should be limited to established patients; or whether there are certain cases, like dermatological or ophthalmological services, where it might be appropriate for a new patient to receive these services.

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

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

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

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

Response: We are persuaded by comments urging us to permit separate Start Printed Page 59488payment for these services only for established patients. Since this service is furnished directly by the billing practitioner, we believe it should be furnished in the context of an existing patient-clinician relationship. Therefore, we are finalizing the reporting and billing of HCPCS code G2010 only for established patients.

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

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

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

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

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

Comment: A few commenters requested that CMS clarify that the “verbal follow-up” that occurs after the billing practitioner evaluates the images or video submitted by the patient may take place via any mode of communication, including secure text messaging, phone call, or live/asynchronous video chat, so as not to restrict a clinician's interaction with patients. One commenter suggested that CMS should encourage clinicians to recommend that patients have a face-to-face visit (in-person or via telehealth) if the clinician has concerns about the quality of the pre-recorded patient information, such as still or video images.

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

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

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

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

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

In summary, we are creating coding and finalizing our proposal to make separate payment for remote evaluation of recorded video and/or images submitted by the patient. The code will be described as G2010 (Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment). We are finalizing that Start Printed Page 59489HCPCS code G2010 may be billed only for established patients. We are finalizing that the follow-up with the patient could take place via phone call, audio/video communication, secure text messaging, email, or patient portal communication.

When the review of the patient-submitted image and/or video results in an in-person E/M office visit with the same physician or qualified health care professional, we are finalizing that this remote service will be considered bundled into that office visit and therefore will not be separately billable. We are further finalizing that in instances when the remote service originates from a related E/M service provided within the previous 7 days by the same physician or qualified health care professional that this service will be considered bundled into that previous E/M service and also will not be separately billable.

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

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

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

3. Interprofessional Internet Consultation (CPT Codes 99451, 99452, 99446, 99447, 99448, and 99449)

As part of our standard rulemaking process, we received recommendations from the RUC to assist in establishing values for six CPT codes that describe interprofessional consultations. In 2013, CMS received recommendations from the RUC for CPT codes 99446 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review), 99447 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review), 99448 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 21-30 minutes of medical consultative discussion and review), and 99449 (Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review). CMS declined to adopt these codes for separate payment, stating in the CY 2014 PFS final rule with comment period that these kinds of services are considered bundled (78 FR 74343). For CY 2019, the CPT Editorial Panel created two new codes to describe additional consultative services, including a code describing the work of the treating physician when initiating a consult, and the RUC recommended valuation for new codes, CPT codes 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes) and 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time). The RUC also reaffirmed their prior recommendations for the existing CPT codes. The six codes describe assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a consulting physician or qualified healthcare professional with specific specialty expertise to assist with the diagnosis and/or management of the patient's problem without the need for the patient's face-to-face contact with the consulting physician or qualified healthcare professional. Currently, the resource costs associated with seeking or providing such a consultation are considered bundled, which in practical terms means that specialist input is often sought through scheduling a separate visit for the patient when a phone or internet-based interaction between the treating practitioner and the consulting practitioner would have been sufficient. We believe that proposing payment for these interprofessional consultations performed via communications technology such as telephone or internet is consistent with our ongoing efforts to recognize and reflect medical practice trends in primary care and patient-centered care management within the PFS.

Beginning in the CY 2012 PFS proposed rule (76 FR 42793), we have recognized the changing focus in medical practice toward managing patients' chronic conditions, many of which particularly challenge the Medicare population, including heart disease, diabetes, respiratory disease, breast cancer, allergies, Alzheimer's disease, and factors associated with obesity. We have expressed concerns that the current E/M coding does not adequately reflect the changes that have occurred in medical practice, and the activities and resource costs associated with the treatment of these complex patients in the primary care setting. In the years since 2012, we have acknowledged the shift in medical practice away from an episodic treatment-based approach to one that involves comprehensive patient-centered care management, and have taken steps through rulemaking to better reflect that approach in payment under the PFS. In CY 2013, we established new codes to pay separately for transitional care management (TCM) services. Next, we finalized new coding and separate payment beginning in CY 2015 for chronic care management (CCM) services provided by clinical staff (81 FR 80226). In the CY 2017 PFS final rule, we established separate payment for complex CCM services, an add-on code to the visit during which CCM is initiated to reflect the work of the billing practitioner in assessing the beneficiary and establishing the CCM care plan, and established separate payment for Behavioral Health Integration (BHI) services (81 FR 80226 through 80227).

As part of this shift in medical practice, and with the proliferation of team-based approaches to care that are often facilitated by electronic medical record technology, we believe that making separate payment for interprofessional consultations undertaken for the benefit of treating a patient will contribute to payment accuracy for primary care and care management services. We proposed Start Printed Page 59490separate payment for these services, discussed in section II.H. of this final rule, Valuation of Specific Codes.

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

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

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

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

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

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

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

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

The following is a summary of the comments we received regarding whether to require the treating practitioner to obtain verbal beneficiary consent in advance of these services, which would be documented by the treating practitioner in the medical record similar to the conditions of payment associated with the care management services under the PFS, as well as comments on other aspects of this proposal.

Comment: Many commenters stated that verbal patient consent was an appropriate safeguard against unnecessary utilization, while others disagreed, stating that the requirement Start Printed Page 59491to obtain consent may cause unnecessary burden in cases where the patient is unresponsive or the need for the interprofessional consultation is urgent such as in a critical care or emergency setting. Other commenters stated that a single blanket patient consent to receive interprofessional consultation services would be preferable to minimize the need to obtain consent for each of what may be multiple consultations. One commenter questioned whether the consulting physician would need to verify that the beneficiary had consented, given that only the treating physician is in contact with the beneficiary.

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

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

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

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

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

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

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

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

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

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

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

b. Adding Services to the List of Medicare Telehealth Services

In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us. Under this process, we assign any submitted request to add to the list of telehealth services to one of the following two categories:

  • Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on the list of telehealth services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner who is present with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the service; for example, the use of interactive audio and video equipment.
  • Category 2: Services that are not similar to those on the current list of telehealth services. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.

Some examples of clinical benefit include the following:

  • Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
  • Treatment option for a patient population without access to clinically appropriate in-person treatment options.
  • Reduced rate of complications.
  • Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
  • Decreased number of future hospitalizations or physician visits.
  • More rapid beneficial resolution of the disease process treatment.
  • Decreased pain, bleeding, or other quantifiable symptom.
  • Reduced recovery time.

The list of telehealth services, including the proposed additions described later in this section, is included in the Downloads section to this proposed rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html.

Historically, requests to add services to the list of Medicare telehealth services had to be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. However, for CY 2019 and onward, we intend to accept requests through February 10, consistent with the deadline for our receipt of code valuation recommendations from the RUC. To be Start Printed Page 59492considered during PFS rulemaking for CY 2020, requests to add services to the list of Medicare telehealth services must be submitted and received by February 10, 2019. Each request to add a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as the vehicle to make changes to the list of Medicare telehealth services, requesters should be advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the list of Medicare telehealth services, including where to mail these requests, see our website at https://www.cms.gov/​Medicare/​Medicare-General-Information/​Telehealth/​index.html.

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

Under our current policy, we add services to the telehealth list on a Category 1 basis when we determine that they are similar to services on the existing telehealth list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73098), we believe that the Category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.

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

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

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

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

(1) Chronic Care Remote Physiologic Monitoring (CPT Codes 99453, 99454, and 99457)

  • CPT code 99453 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment).
  • CPT code 99454 (Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days).
  • CPT code 99457 (Remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month).

In the CY 2016 PFS final rule with comment period (80 FR 71064), we responded to a request to add CPT code 99490 (Chronic care management services, at least 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored) to the Medicare telehealth list. We discussed that the services described by CPT code 99490 can be furnished without the beneficiary's face-to-face presence and using any number of non-face-to-face means of communication. We stated that it was therefore unnecessary to add that service to the list of Medicare telehealth services. Similarly, CPT codes 99453, 99454, and 99457 describe services that are inherently non face-to-face. As discussed in section II.H. of this final rule, Valuation of Specific Codes, we instead proposed to adopt CPT codes 99453, 99454, and 99457 for payment under the PFS. Because these codes describe services that are inherently non face-to-face, we do not consider them Medicare telehealth services under section 1834(m) of the Act; therefore, we did not propose to add them to the list of Medicare telehealth services.

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

  • CPT code 99452 (Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes).
  • CPT code 99451 (Interprofessional telephone/internet/electronic health record assessment and management service provided by a consultative physician including a written report to the patient's treating/requesting physician or other qualified health care professional, 5 or more minutes of medical consultative time).

As discussed in section II.H. of this final rule, Valuation of Specific Codes, we proposed to adopt CPT codes 99452 and 99451 for payment under the PFS as these are distinct services furnished via communication technology. Because these codes describe services that are inherently non face-to-face, we do not consider them as Medicare telehealth services under section 1834(m) of the Act; therefore we did not propose to add them to the list of Medicare telehealth services for CY 2019.

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

  • CPT code 99221 (Initial hospital care, per day, for the evaluation and Start Printed Page 59493management of a patient, which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of low severity.)
  • CPT code 99222 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of moderate severity.)
  • CPT code 99223 (Initial hospital care, per day, for the evaluation and management of a patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; and Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of high severity.)

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

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

We noted that Medicare beneficiaries who are being treated in the hospital setting can receive reasonable and necessary E/M services using other HCPCS codes that are currently on the Medicare telehealth list, including those for subsequent hospital care, initial and follow-up telehealth inpatient and emergency department consultations, as well as initial and follow-up critical care telehealth consultations.

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

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

  • CPT code 99231 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering or improving. Typically, 15 minutes are spent at the bedside and on the patient's hospital floor or unit.).
  • CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 25 minutes are spent at the bedside and on the patient's hospital floor or unit.).
  • CPT code 99233 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is unstable or has developed a significant complication or a significant new problem. Typically, 35 minutes are spent at the bedside and on the patient's hospital floor or unit.).

CPT codes 99231-99233 are currently on the list of Medicare telehealth services, but can only be billed via telehealth once every 3 days. The requester requested that we remove the frequency limitation. We stated in the CY 2011 PFS final rule with comment period (75 FR 73316) that, although we still believed the potential acuity of hospital inpatients is greater than those patients likely to receive Medicare telehealth services that were on the list at that time, we also believed that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth in order to ensure that hospitalized patients have frequent encounters with their admitting practitioner. We also noted that we continue to believe that the majority of these visits should be in-person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the list of Medicare telehealth services, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns and position on the provision of subsequent hospital care services via telehealth have not changed. Therefore, we did not propose to remove the frequency limitation on these codes.Start Printed Page 59494

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

  • CPT code 99307 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A problem focused interval history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is stable, recovering, or improving. Typically, 10 minutes are spent at the bedside and on the patient's facility floor or unit.).
  • CPT code 99308 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: An expanded problem focused interval history; an expanded problem focused examination; Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient is responding inadequately to therapy or has developed a minor complication. Typically, 15 minutes are spent at the bedside and on the patient's facility floor or unit.).
  • CPT code 99309 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A detailed interval history; a detailed examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the patient has developed a significant complication or a significant new problem. Typically, 25 minutes are spent at the bedside and on the patient's facility floor or unit.).
  • CPT code 99310 (Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires at least 2 of these 3 key components: A comprehensive interval history; a comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. The patient may be unstable or may have developed a significant new problem requiring immediate physician attention. Typically, 35 minutes are spent at the bedside and on the patient's facility floor or unit.).

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

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

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

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

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

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

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

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

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

Section 50302 of the BBA of 2018 amended sections 1881(b)(3) and 1834(m) of the Act to allow an individual determined to have end-stage renal disease receiving home dialysis to choose to receive certain monthly end-stage renal disease-related (ESRD-related) clinical assessments via telehealth on or after January 1, 2019. Start Printed Page 59495The new section 1881(b)(3)(B)(ii) of the Act requires that such an individual must receive a face-to-face visit, without the use of telehealth, at least monthly in the case of the initial 3 months of home dialysis and at least once every 3 consecutive months after the initial 3 months.

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

Our current regulation at § 410.78 specifies the conditions that must be met in order for Medicare Part B to pay for covered telehealth services included on the telehealth list when furnished by an interactive telecommunications system. In accordance with the new subclauses (IX) and (X) of section 1834(m)(4)(C)(ii) of the Act, we proposed to revise our regulation at § 410.78(b)(3) to add a renal dialysis facility and the home of an individual as Medicare telehealth originating sites, but only for purposes of the home dialysis monthly ESRD-related clinical assessment in section 1881(b)(3)(B) of the Act. We proposed to amend § 414.65(b)(3) to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the patient's home. Additionally, we proposed to add new § 410.78(b)(4)(iv)(A), to reflect the provision in section 1834(m)(5) of the Act, added by section 50302 of the BBA of 2018, specifying that the geographic requirements described in section 1834(m)(4)(C)(i) of the Act do not apply with respect to telehealth services furnished on or after January 1, 2019, in originating sites that are hospital-based or critical access hospital-based renal dialysis centers, renal dialysis facilities, or the patient's home, respectively under sections 1834(m)(4)(C)(ii)(VI), (IX) and (X) of the Act, for purposes of section 1881(b)(3)(B) of the Act.

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

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

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

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

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

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

Comment: Commenters supported the expansions to Medicare telehealth. The majority of commenters agreed with our proposed definition of a mobile stroke unit. However, the AMA suggested that CMS specify in the definition that a mobile stroke unit must include a computed tomographic (CT) scanner and a telehealth (audio and video) connection or an in-person physician who is able to interpret the CT scan and prescribe an intravenous thrombolysis and also have a qualified health Start Printed Page 59496professional who is able to administer an intravenous thrombolysis if the physician interpreting the CT scan and prescribing the treatment does so via telehealth. The AMA also suggested that CMS add as an originating site Emergency Medical Service (EMS) transports equipped with a telehealth connection to stroke specialists in order to provide faster national access to patients who require an accurate stroke diagnosis and decision about eligibility for intravenous or endovascular therapy, and to determine where to take them (such as a primary stroke or comprehensive stroke center). One commenter urged CMS to distinguish between a mobile stroke unit and a standard ambulance that is equipped with telemedicine capability and to establish separate payment for each, noting that a telemedicine consult on a mobile stroke unit may involve much greater complexity and critical care treatment than on a standard ambulance that is equipped with telemedicine capability. Another commenter recommended that CMS require specially trained paramedics who can evaluate an acute ischemic stroke patient based on national standards.

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

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

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

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

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

Under the authority of section 2001(b) of the SUPPORT for Patients and Communities Act, we are issuing an interim final rule with comment period to implement the requirements of section 2001(a) of the SUPPORT for Patients and Communities Act. In accordance with section 1834(m)(2)(B)(ii)(X) of the Act, as amended by section 2001(a) of the SUPPORT for Patients and Communities Act, we are revising § 410.78(b)(3) on an interim final basis, by adding § 410.78(b)(3)(xii), which adds the home of an individual as a permissible originating site for telehealth services furnished on or after July 1, 2019 to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder. We are amending § 414.65(b)(3) on an interim final basis to reflect the requirement in section 1834(m)(2)(B)(ii) of the Act that there is no originating site facility fee paid when the originating site for these services is the individual's home. Additionally, we are adding § 410.78(b)(4)(iv)(C) on an interim final basis to specify that the geographic requirements in section 1834(m)(4)(C)(i) of the Act do not apply for telehealth services furnished on or after July 1, 2019, to individuals with a substance use disorder diagnosis for purposes of treatment of a substance use disorder or a co-occurring mental health disorder at an originating site other than a renal dialysis facility.

We note that section 2001 of the SUPPORT for Patients and Communities Act did not amend section 1834(m)(4)(F) of the Act, which limits the scope of telehealth services to those on the Medicare telehealth list. Practitioners would be responsible for assessing whether individuals have a substance use disorder diagnosis and whether it would be clinically appropriate to furnish telehealth services for the treatment of the individual's substance use disorder or a co-occurring mental health disorder. By billing codes on the Medicare telehealth list with the telehealth place of service code, practitioners would be indicating that the codes billed were used to furnish telehealth services to individuals with a substance use disorder diagnosis for the purpose of treating the substance use disorder or a co-occurring mental health disorder. We note that we may issue additional subregulatory guidance in the future for billing these telehealth services.

We note that there is a 60-day period following publication of this interim final rule for the public to comment on these interim final amendments to our regulations. We invite public comment on our policies to implement section 2001 of the SUPPORT for Patients and Communities Act.Start Printed Page 59497

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

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

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

7. Modifying § 414.65 Regarding List of Telehealth Services

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

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

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

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

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

We also believe making separate payment for a bundled episode of care for management and counseling for SUDs could be effective in preventing the need for more acute services. For example, according to the Healthcare Cost and Utilization Project,[2] Medicare pays for one-third of opioid-related hospital stays, and Medicare has seen the largest annual increase in the number of these stays over the past 2 decades. We believe that separate payment for a bundled episode of care could help avoid such hospital admissions by supporting access to management and counseling services that could be important in preventing hospital admissions and other acute care events.

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

We also solicited comment on whether the counseling portion and other MAT components could also be provided by qualified practitioners “incident to” the services of the billing physician who will administer or prescribe any necessary medications and manage the overall care, as well as supervise any other counselors participating in the treatment, similar to the structure of the Behavioral Health Integration codes which include Start Printed Page 59498services provided by other members of the care team under the direction of the billing practitioner on an “incident to” basis (81 FR 80231). We welcomed comments on potentially creating a bundled episode of care for management and counseling treatment for SUDs, which we will consider for future rulemaking.

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

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

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

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

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

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

9. Telehealth Originating Site Facility Fee Payment Amount Update

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

Table 10—The Medicare Telehealth Originating Site Facility Fee

Time periodMEI increaseFacility fee
10/01/2001-12/31/2002N/A$20.00
01/01/2003-12/31/20033.020.60
01/01/2004-12/31/20042.921.20
01/01/2005-12/31/20053.121.86
01/01/2006-12/31/20062.822.47
01/01/2007-12/31/20072.122.94
01/01/2008-12/31/20081.823.35
01/01/2009-12/31/20091.623.72
01/01/2010-12/31/20101.224.00
01/01/2011-12/31/20110.424.10
01/01/2012-12/31/20120.624.24
01/01/2013-12/31/20130.824.43
01/01/2014-12/31/20140.824.63
01/01/2015-12/31/20150.824.83
01/01/2016-12/31/20161.125.10
01/01/2017-12/31/20171.225.40
01/01/2018-12/31/20181.425.76
01/01/2019-12/31/20191.526.15

E. Potentially Misvalued Services Under the PFS

1. Background

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section II.H. of this final rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the RUC, MedPAC, and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section Start Printed Page 594991848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

In its March 2006 Report to the Congress (http://www.medpac.gov/​docs/​default-source/​reports/​Mar06_​Ch03.pdf?​sfvrsn=​0), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE declines. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE rises.

As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/​docs/​default-source/​reports/​march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

  • Codes that have experienced the fastest growth.
  • Codes that have experienced substantial changes in PE.
  • Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
  • Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
  • Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
  • Codes that have not been subject to review since implementation of the fee schedule.
  • Codes that account for the majority of spending under the PFS.
  • Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
  • Codes for which there may be a change in the typical site of service since the code was last valued.
  • Codes for which there is a significant difference in payment for the same service between different sites of service.
  • Codes for which there may be anomalies in relative values within a family of codes.
  • Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
  • Codes with high intraservice work per unit of time.
  • Codes with high PE RVUs.
  • Codes with high cost supplies.
  • Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.

2. Progress in Identifying and Reviewing Potentially Misvalued Codes

To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.

Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed approximately 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055). In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.

In the CY 2013 PFS final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In CY 2009 (73 FR 38589), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as Start Printed Page 59500potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).

In the CY 2016 PFS final rule with comment period, we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT codes 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.

In the CY 2017 PFS final rule, we finalized for review a list of potentially misvalued services, which included eight codes in the end-stage renal disease home dialysis family (CPT codes 90963-90970). We also finalized as potentially misvalued 19 codes identified through our screen for 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.

In the CY 2018 PFS final rule, we finalized arthrodesis of sacroiliac joint (CPT code 27279) as potentially misvalued. Through the use of comment solicitations with regard to specific codes, we also examined the valuations of other services, in addition to, new potentially misvalued code screens (82 FR 53017 through 53018).

3. CY 2019 Identification and Review of Potentially Misvalued Services

In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

  • Documentation in peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following: Technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.
  • An anomalous relationship between the code being proposed for review and other codes.
  • Evidence that technology has changed physician work.
  • Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
  • Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
  • Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
  • Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).
  • National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

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

a. Public Nominations

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

Based on these analyses, the submitter requested that the codes listed in Table 11 be prioritized for review under the potentially misvalued code initiative.

Table 11—Public Nominations Due to Overvaluation

CPT codeShort description
27130Total hip arthroplasty.
27447Total knee arthroplasty.
43239Egd biopsy single/multiple.
45385Colonoscopy w/lesion removal.
70450CT head w/o contrast.
93000Electrocardiogram complete.
93306Tte w/doppler complete.

Another submitter requested that CPT codes 92992 (Atrial septectomy or septostomy; transvenous method, balloon (e.g., Rashkind type) (includes cardiac catheterization)) and 92993 (Atrial septectomy or septostomy; blade method (Park septostomy) (includes cardiac catheterization)) be reviewed under the potentially misvalued code initiative in order to establish national RVU values for these services under the MPFS. These codes are currently priced by the Medicare Administrative Contractors (MACs).

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

Comment: One commenter stated that specific details of the nomination of the seven high-volume codes were not provided in the CY 2019 PFS proposed rule. Several other commenters, including the RUC, expressed concern that the source of the nomination of the seven high-volume codes and its entire nomination letter was not made available. These commenters requested that CMS provide greater transparency and publicly provide all nomination requests identifying potentially misvalued codes.

Response: We believe that we summarized the contents of the public nomination letter and provided the rationale in the CY 2019 PFS proposed rule with enough detail for commenters to comment substantively and provide supporting documentation or data to rebut the suggestion that these codes are potentially misvalued. We recognize the importance of transparency and note that under the public nomination process that was established in CY 2012 rulemaking, the first opportunity for the public to nominate codes was during the 60-day comment period for the CY Start Printed Page 595012012 final rule with comment period; therefore, public nominations were received via submission to www.regulations.gov. In the CY 2015 final rule with comment period (79 FR 67606 through 67608), we finalized a modified process for identifying potentially misvalued codes (fully effective in CY 2017), where we established a new deadline of February 10th for receipt of public nominations for potentially misvalued codes to be considered for inclusion in the proposed rule. Although stakeholders often include public nominations of misvalued codes for consideration in a subsequent year's rulemaking as part of their comments on a current year's proposed rule, the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation to CMS by February 10th of each year. In the future, public nominations that CMS receives by the February 10th deadline will be made available in the form of a public use file with the proposed rule, in the downloads section on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​. We remind submitters that any information that might be considered proprietary or confidential should not be included. Additionally, we have included the submission that nominated these high-volume codes for review as potentially misvalued as a public use file for the CY 2019 PFS final rule.

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

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

Comment: One commenter stated that the codes in Table 8 in the proposed rule and their respective code families should be prioritized for review as potentially misvalued. The commenter suggested revisiting two recent efforts funded by CMS, reports by Urban Institute and RAND Corporation (https://www.urban.org/​sites/​default/​files/​publication/​87771/​2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_​1.pdf, and, https://www.rand.org/​content/​dam/​rand/​pubs/​research_​reports/​RR600/​RR662/​RAND_​RR662.pdf), for prioritization of codes for review to expand the misvalued codes initiative list. The commenter referenced a June 2018 MedPAC report that stated that CMS' review of potentially misvalued codes has not addressed services that account for a substantial share of fee schedule spending and is hampered by the lack of current, accurate, and objective data on clinician work time and practice expenses. Consequently, according to the MedPAC report, work RVUs for procedures, imaging, and tests are systemically overvalued relative to other services, such as ambulatory evaluation and management (E/M) services.

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

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

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

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

Response: We are unclear about the commenter's claim that CMS is using a non-relative measuring approach for the seven high volume codes that have been nominated as potentially misvalued. We did not propose a valuation for the nominated codes, nor did we propose to use a non-relative measuring approach. Rather, as part of our statutory obligation to identify and review potentially misvalued codes, we implemented an annual process whereby the public can nominate potentially misvalued codes with supporting documentation; we then publish the list of nominated codes and the public has the opportunity to comment on these nominations. We continue to maintain that adjustments to work RVUs should be based on the resources involved with each procedure or service, and reiterate that our review of work RVUs and time inputs utilizes information from various resources, including the RUC. We continue to seek information on the best sources of objective, routinely-updated, auditable, and robust data regarding the resource costs of furnishing PFS services.

Comment: Several commenters stated that CPT codes 27130 and 27447 should not be considered potentially misvalued and do not warrant any further action because the current valuation for the codes was established after review by the RUC and CMS in 2013, and since that time there are no new data to indicate a change in the work of performing the procedure or the number of post-operative follow up visits. Another commenter stated that CMS should not subject professions to code Start Printed Page 59502valuations and analysis so frequently, and that doing so calls into question the validity of the RUC process in the first place.

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

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

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

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

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

Comment: A few commenters stated that the current work RVU valuation of 0.85 for CPT code 70450 is inadequate. The commenters stated that the level of effort associated with CPT code 70450 increased between the time the code was originally valued and the 2012 survey, and this increase continued through 2016. The commenters stated that over time, advances in technology led to many more images being created than existed historically. The commenters also stated that volume acquisitions, a CT scan technique that allows for multiple two-dimensional images, has resulted in thinner reconstructions and effortless multiplanar reformats, and other technological advancements have increased the amount of professional work associated with interpreting a non-contrast head CT and should be considered in the work RVU. The commenters expressed concern that the nomination by a single entity threatens the integrity of how physician services are valued generally.

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

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

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

Comment: With regard to CPT codes 93000 and 93306, one commenter stated that while the Urban Institute report concludes that the intraservice time to interpret an electrocardiogram is 6 seconds, practitioners who furnish the service do not believe it is possible to completely interpret a study so quickly. The commenter expressed concern about the large emphasis placed on service time by CMS and some stakeholders when it comes to valuation. The commenter suggested that frequent reviews of long-established mature services like electrocardiography and echocardiography will produce two outcomes—the inputs will remain the same or circumstances at some point will align such that it appears they take less time, which will open the window for payers to try to reduce payment for services that have not actually changed, and eventually these reductive re-valuations produce underpayment. A few commenters stated that CPT code 93306 was recently reviewed and valued in CY 2018. One commenter stated that the current valuation is reflective of numerous accreditation body requirements that were implemented since the service was last valued in 2007, which increased the Start Printed Page 59503work required per study. The commenter stated that the Urban Institute report should not be considered proof that the CPT code is overvalued, and given the recent RUC review of this service, CMS' acceptance of the RUC recommendation, and no change in the physician work of performing the service in the past year, this code should not be included in the potentially misvalued codes list.

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

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

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

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

In addition to comments on the nomination of the seven high-volume codes, we also received comments on the nomination of two contractor-priced codes for review under the potentially misvalued code initiative.

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

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

b. Update on the Global Surgery Data Collection

Payment for postoperative care is currently bundled within 10 or 90 days after many surgical procedures. Historically, we have not collected data on how many postoperative visits are actually performed during the global period. Section 523 of the MACRA added a new paragraph 1848(c)(8) to the Act, and section 1848(c)(8)(B) required CMS to use notice and comment rulemaking to implement a process to collect data on the number and level of postoperative visits and use these data to assess the accuracy of global surgical package valuation. In the CY 2017 PFS final rule, we adopted a policy to collect postoperative visit data. Beginning July 1, 2017, we required practitioners in groups with 10 or more practitioners in nine states (Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island) to use the no-pay CPT code 99024 (Postoperative follow-up visit, normally included in the surgical package, to indicate that an E/M service was performed during a postoperative period for a reason(s) related to the original procedure) to report postoperative visits. Practitioners who only practice in groups with fewer than 10 practitioners are exempted from required reporting, but are encouraged to report if feasible. The 293 procedures for which reporting is required are those furnished by more than 100 practitioners, and either are nationally furnished more than 10,000 times annually or have more than $10 million in annual allowed charges. A list of the procedures for which reporting is required is updated annually to reflect any coding changes and is posted on the CMS website at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​Global-Surgery-Data-Collection-.html.

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

Among 10-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, only 4 percent had one or more matched visit reported with CPT code 99024. The percentage of 10-day global procedures with a matched visit reported with CPT code 99024 varied by specialty. Among procedures with 10-day global periods performed by hand surgeons, critical care, and obstetrics/gynecology, 44, 36, and 23 percent, respectively, of procedures had a matched visit reported using CPT code 99024. In contrast, less than 5 percent of 10-day global procedures performed by many other specialties had a matched visit reported using CPT code 99024. Among 90-day global procedures performed from July 1, 2017 through December 31, 2017, where it is possible to clearly match postoperative visits to specific procedures, 67 percent had one or more matched visits reported using CPT code 99024.

In the CY 2019 PFS proposed rule, we suggested one potential explanation for Start Printed Page 59504these findings is that many practitioners are not consistently reporting postoperative visits using CPT code 99024. We sought comment on how to encourage reporting to ensure the validity of the data without imposing undue burden. Specifically, we sought comment on whether we need to do more to make practitioners aware of their obligation and whether we should consider implementing an enforcement mechanism.

We sought comment on several other issues. Given the very small number of postoperative visits reported using CPT code 99024 during 10-day global periods, we sought comment on whether or not it might be reasonable to assume that many visits included in the valuation of 10-day global packages are not being furnished, or whether there are alternative explanations for what could be a significant level of underreporting of postoperative visits. Alternatively, we sought comment on whether it is possible that some or all of the postoperative visits are occurring after the global period ends and are, therefore, reported and paid separately.

We sought comment on whether we should consider requiring use of modifiers -54 and -55 in cases where the surgeon does not expect to perform the postoperative visits, regardless of whether or not the transfer of care is formalized. We also sought comment on the best approach to 10-day global codes for which the preliminary data suggest that postoperative visits are rarely performed by the practitioner reporting the global code and whether we should consider changing the global period and reviewing the code valuation.

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

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

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

F. Radiologist Assistants

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

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

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

Comment: Many commenters supported our proposed changes to the regulations and stated that they agreed that diagnostic tests performed by RAs be performed under at most direct supervision rather than personal Start Printed Page 59505supervision where permitted by state law and state scope of practice regulations. According to these commenters, the change would allow for greater efficiency, improved patient access, more dedicated time with patients, increased quality of care, and increased patient satisfaction.

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

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

Response: In implementing these changes to the regulation, we will be updating guidance contained in Pub. 100-04, Medicare Claims Processing Manual, Chapter 23 (available on the CMS website at https://www.cms.gov/​Regulations-and-Guidance/​Guidance/​Manuals/​internet-Only-Manuals-IOMs-Items/​Pub100_​23.html). Medicare supervision rules are only directly applicable to diagnostic tests, not procedures. We note that for procedures provided by auxiliary personnel (such as a radiologist assistant) incident to the services of the billing physician or practitioner, Medicare generally requires direct supervision in accordance with the regulation at § 410.26(b)(5).

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

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

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

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

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

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

1. Background

Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that certain items and services furnished by certain off-campus provider-based departments (PBDs) (collectively referenced here as nonexcepted items and services furnished by nonexcepted off-campus PBDs) shall not be considered covered outpatient department (OPD) services for purposes of payment under the Hospital Outpatient Prospective Payment System (OPPS), and payment for those nonexcepted items and services furnished on or after January 1, 2017 shall be made under the applicable payment system under Medicare Part B if the requirements for such payment are otherwise met. These requirements were enacted in section 603 of the Bipartisan Budget Act of 2015 (Pub. L. 114-74, enacted November 2, 2015).

In the CY 2017 OPPS/Ambulatory Surgical Center (ASC) final rule with comment period (81 FR 79699 through 79719), we established several policies and provisions to define the scope of nonexcepted items and services in nonexcepted off-campus PBDs. We also finalized the PFS as the applicable payment system for most nonexcepted items and services furnished by nonexcepted off-campus PBDs. At the same time, we issued an interim final rule with comment period (81 FR 79720 through 79729) in which we established payment policies under the PFS for nonexcepted items and services furnished on or after January 1, 2017. In the following paragraphs, we summarize the policies that we adopted for CY 2017 and CY 2018. We also summarize proposals for CY 2019, respond to public comments, and finalize payment policies for CY 2019. For issues related to the excepted status of off-campus PBDs or the excepted status of items and services, please see the CY 2019 OPPS/ASC final rule.

2. Payment Mechanism

In establishing the PFS as the applicable payment system for most nonexcepted items and services in nonexcepted off-campus PBDs under sections 1833(t)(1)(B)(v) and (t)(21) of the Act, we recognized that there was no technological capability, at least in the near term, to allow off-campus PBDs to bill under the PFS for those nonexcepted items and services. Off-campus PBDs bill under the OPPS for their services on an institutional claim, Start Printed Page 59506while physicians and other suppliers bill under the PFS on a practitioner claim. The two systems that process these different types of claims, the Fiscal Intermediary Standard System (FISS) and the Multi-Carrier System (MCS) system, respectively, were not designed to accept or process claims of a different type. To permit an off-campus PBD to bill directly under a different payment system than the OPPS would have required significant changes to these complex systems as well as other systems involved in the processing of Medicare Part B claims. Consequently, we proposed and finalized a policy for CY 2017 and CY 2018 in which nonexcepted off-campus PBDs continue to bill for nonexcepted items and services on the institutional claim utilizing a new claim line modifier “PN” to indicate that an item or service is a nonexcepted item or service.

We implemented requirements under section 1833(t)(1)(B) of the Act for CY 2017 and CY 2018 by applying an overall downward scaling factor, called the PFS Relativity Adjuster to payments for nonexcepted items and services furnished in nonexcepted off-campus PBDs. The PFS Relativity Adjuster generally reflects the average (weighted by claim line volume times rate) of the site-specific rate under the PFS compared to the rate under the OPPS (weighted by claim line volume times rate) for nonexcepted items and services furnished in nonexcepted off-campus PBDs. As we have discussed extensively in prior rulemaking (81 FR 97920 through 97929 and 82 FR 53021), we established a new set of site-specific payment rates under the PFS that reflect the relative resource cost of furnishing the technical component (TC) of services furnished in nonexcepted off-campus PBDs. For the majority of HCPCS codes, these rates are based on either (1) the difference between the PFS nonfacility payment rate and the PFS facility rate, (2) the TC, or (3) in instances where payment would have been made only to the facility or to the physician, the full nonfacility rate. The PFS Relativity Adjuster refers to the percentage of the OPPS payment amount paid under the PFS for a nonexcepted item or service to the nonexcepted off-campus PBD.

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

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

3. The PFS Relativity Adjuster

The PFS Relativity Adjuster reflects the overall relativity of the applicable payment rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs under the PFS compared with the rate under the OPPS. To develop the PFS Relativity Adjuster for CY 2017, we did not have all of the claims data needed to identify the mix of items and services that would be billed using the “PN” modifier. Instead, we analyzed hospital outpatient claims data from January 1 through August 25, 2016, that contained the “PO” modifier, which was a new mandatory reporting requirement for CY 2016 for claims that were billed by an off-campus department of a hospital. We limited our analysis to those claims billed on the 13X Type of Bill because those claims were used for Medicare Part B billing under the OPPS. We then identified the 25 most frequently billed major codes that were billed by claim line; that is, items and services that were separately payable or conditionally packaged. Specifically, we restricted our analysis to codes with OPPS status indicators (SI) “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. The most frequently billed service with the “PO” modifier in CY 2016 was described by HCPCS code G0463 (Hospital outpatient clinic visit for the assessment and management of a patient), which, in CY 2016, was paid under APC 5012 at a rate of $102.12; the total number of claim lines for this service was approximately 6.7 million as of August 2016. Under the PFS, there are 10 CPT codes describing different levels of office visits for new and established payments. We compared the payment rate under OPPS for HCPCS code G0463 ($102.12) to the average of the difference between the nonfacility and facility rates for CPT code 99213 (Level III office visit for an established patient) and CPT code 99214 (Level IV office visit for an established patient) in CY 2016 and found that the relative payment difference was approximately 22 percent. We did not include HCPCS code G0463 in our calculation of the PFS Relativity Adjuster for CY 2017 because we were concerned that there was no single, directly comparable code under the PFS. As we stated in the CY 2017 PFS final rule (81 FR 79723), we wanted to mitigate the risk of underestimating the overall relativity between the PFS and OPPS rates. From the remaining top 24 most frequently billed codes, we excluded HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under PFS policies, the service was only separately payable under the PFS when no other code was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) because there was no payment for this code under the PFS. For the remaining top 22 codes furnished with the “PO” modifier in CY 2016, the average (weighted by claim line volume times rate) of the nonfacility payment rate estimate for the PFS compared to the estimate for the OPPS was 45 percent. We indicated that, because of our inability to estimate the effect of the packaging difference between the OPPS and the PFS, we would assume a 5 percentage point adjustment upward from the calculated amount of 45 percent; therefore, we established the PFS Relativity Adjuster of 50 percent for CY 2017.

In establishing the PFS Relativity Adjuster for CY 2018, we still did not have claims data for items and services furnished reported with a “PN” modifier. However, we updated the list of the 25 most frequently billed HCPCS codes using an entire year (CY 2016) of claims data for services submitted with a “PO” modifier and we updated the corresponding utilization weights for the codes used in the analysis. The order and composition of the top 25 separately payable HCPCS codes, based on the full year of claims from CY 2016 Start Printed Page 59507submitted with the “PO” modifier, changed minimally from the codes we used in our original analysis for the CY 2017 OPPS/ASC interim final rule with comment period. For a detailed list of the HCPCS codes we used in calculating the CY 2017 PFS Relativity Adjuster and the CY 2018 PFS Relativity Adjuster, we refer readers to the CY 2018 PFS final rule (82 FR 53030 through 53031). As noted earlier, in establishing the PFS Relativity Adjuster of 50 percent for CY 2017, we did not include in the weighted average code comparison, the relative rate for the most frequently billed service furnished in off-campus PBDs, HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient), in part to ensure that we were not underestimating the overall relativity between the PFS and the OPPS. In contrast, in the CY 2018 PFS final rule, we stated that our objective for CY 2018 was to ensure that we did not overestimate the appropriate overall payment relativity, and that the payment made to nonexcepted off-campus PBDs better aligned with the services that are most frequently furnished in the setting. Therefore, in addition to using updated claims data, we revised the PFS Relativity Adjuster to incorporate the relative payment rate for HCPCS code G0463 into our analysis. We followed all other exclusions and assumptions that were made in calculating the CY 2017 PFS Relativity Adjuster. Our analysis resulted in a 35 percent relative difference in payment rates. Similar to our stated rationale in the CY 2017 PFS final rule, we increased the PFS Relativity Adjuster to 40 percent, acknowledging the difficulty of estimating the effect of the packaging differences between the OPPS and the PFS.

4. Payment Policies for CY 2019

In prior rulemaking, we stated our expectation that our general approach of adjusting OPPS payments using a single scaling factor, the PFS Relativity Adjuster, would continue to be an appropriate payment mechanism to implement provisions of section 603 of the Bipartisan Budget Act of 2015, and would remain in place until we are able to establish code-specific reductions that represent the TC of services furnished under the PFS or until we are able to implement system changes needed to enable nonexcepted off-campus PBDs to bill for nonexcepted items and services under the PFS directly (82 FR 53029). As we continue to explore alternative options related to requirements under section 1833(t)(21)(C) of the Act, we believed that this overall approach is still appropriate, and we are finalizing our proposal to continue to allow nonexcepted off-campus PBDs to bill for nonexcepted items and services on an institutional claim using a “PN” modifier until we identify a workable alternative mechanism to improve payment accuracy.

We made several adjustments to our methodology for calculating the PFS Relativity Adjuster for CY 2019. Most importantly, we had access to a full year of claims data from CY 2017 for services submitted with the “PN” modifier. Incorporating these data allows us to improve the accuracy of the PFS Relativity Adjuster by accounting for the specific mix of nonexcepted items and services furnished in nonexcepted off-campus PBDs. In analyzing the CY 2017 claims data, we identified just under 2,000 unique OPPS HCPCS/OPPS status indicator (SI) code pairs reported in CY 2017 with status indicators “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. The data reinforce our previous observation that the single most frequently reported service furnished in nonexcepted off-campus PBDs is HCPCS code G0463. Approximately half of all claim lines for separately payable or conditionally packaged services furnished by nonexcepted off-campus PBDs included HCPCS code G0463 in CY 2017, representing over 30 percent of total Medicare payments for separately payable or conditionally packaged services. The top 30 HCPCS/SI code combinations accounted for over 80 percent of all claim lines and approximately 70 percent of Medicare payments for services that are separately billable or conditionally packaged. In contrast with prior analyses, we also looked at claims units, which reflect HCPCS/SI code combinations that are billed more than once on a claim line. Certain HCPCS codes are much more frequently billed in multiple units than others. The largest differences between the number of claim lines and the number of claims units are for injections and immunizations, which are not typically separately payable or conditionally packaged under the OPPS. For instance, HCPCS code Q9967 (Low osmolar contrast material, 300-399 mg/ml iodine concentration, per ml) was reported in 12,268 claim lines, but 1,168,393 times (claims units) in the aggregate. HCPCS code Q9967 has an OPPS status indicator of “N”, meaning that there is no separate payment under OPPS (items and services are packaged into APC rates). To calculate the PFS Relativity Adjuster using the full range of claims data submitted with a “PN” modifier in CY 2017, we first established site-specific rates under the PFS that reflect the TC of items and services furnished by nonexcepted off-campus PBDs in CY 2017. These HCPCS-level rates reflect our best current estimate of the amount that would have been paid for the service in the office setting under the PFS for practice expenses (PEs) not associated with the professional component (PC) of the service. As discussed in prior rulemaking (81 FR 79720 through 79729), we believe the most appropriate code-level comparison would reflect the TC of each HCPCS code under the PFS. However, we do not currently calculate a separate TC rate for all HCPCS codes under the PFS—only for those for which the PC and TC of the service are distinct and can be separately billed by two different practitioners or other suppliers under the PFS. For most of the remainder of services that do not have a separately payable TC under the PFS, we estimated the site-specific rate as (1) the difference between the PFS nonfacility rate and the PFS facility rate, or (2) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. As with the PFS rates that we developed when calculating the PFS Relativity Adjuster for CY 2017 and CY 2018, there were large code-level differences between the applicable PFS rate and the OPPS rate.

In calculating the proposed PFS Relativity Adjuster for CY 2019, we employed the same fundamental methodology that we used to calculate the PFS Relativity Adjuster for CY 2017 and CY 2018. We began by limiting our analysis to the items and services billed in CY 2017 with a “PN” modifier that are separately payable or conditionally packaged under the OPPS (status indicator = “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”) and compared the rates for these codes under the OPPS with the site-specific rates under the PFS. Next, we imputed PFS rates for a limited number of items and services that are separately payable or conditionally packaged under the OPPS but are contractor priced under the PFS. We also imputed PFS rates for some HCPCS codes that are not separately payable under the OPPS (SI = “N”), but are separately payable under the PFS. This includes items and services with an indicator status of “X” under the PFS, which are statutorily excluded from payment under the PFS, but may be paid under a different fee schedule, such as the Clinical Lab Fee Schedule (CLFS). We summed the HCPCS-level Start Printed Page 59508rates under the PFS across all nonexcepted items and services, weighted by the number of HCPCS code claims units for each service. Next, we calculated the sum of the HCPCS-level OPPS rate for items and services that are separately payable or conditionally packaged, also weighted by the number of HCPCS code claims units. We compared the weighted sum of the site-specific PFS rate with the weighted sum of the OPPS rate for items and services reported in CY 2017 and we found that our updated analysis supports maintaining a PFS Relativity Adjuster of 40 percent. In view of this analysis, we proposed to continue applying a PFS Relativity Adjuster of 40 percent for CY 2019. Moreover, we proposed to maintain this PFS Relativity Adjuster for future years until updated data or other considerations indicate that an alternative adjuster or a change to our approach is warranted, which we will then propose through notice and comment rulemaking. We discuss some of our ongoing data analyses and future plans regarding implementation of section 603 of the Bipartisan Budget Act of 2015 in this section.

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

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

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

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

For CY 2019, our proposed PFS Relativity Adjuster was based on all HCPCS codes that were submitted on an institutional claim form in CY 2017, appended with the “PN” modifier in order to improve the accuracy of the overall payment comparison using the best data available regarding the actual mix of services furnished in nonexcepted off-campus PBDs. In contrast, for CYs 2017 and 2018, we used only a subset of claims from CY 2016 because of known limitations regarding the data available at the time. In particular, the data from CY 2016 were based on claims that were appended with the “PO” modifier, which was a new reporting requirement for CY 2016. Although the “PO” modifier allowed us to distinguish items and services furnished in off-campus PBDs in CY 2016, it did not allow us to distinguish between excepted and nonexcepted off-campus PBDs. The “PN” modifier, which was a new reporting requirement for CY 2017, allows us to make the distinction between excepted and nonexcepted off-campus PBDs.

In updating our analysis for calculating the proposed PFS Relativity Adjuster for CY 2019 to include all HCPCS codes that were reported on an institutional claim with the “PN” modifier, we also extended to all HCPCS Start Printed Page 59509codes our earlier logic with regard to calculating the site specific rates that represent the technical-equivalent of the resource costs of furnishing a service under the PFS. This amount, as we discussed in the proposed rule, generally reflected: (1) The difference between the PFS nonfacility payment rate and the PFS facility rate; (2) the TC; or (3) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. Applying the same logic to the fuller range of HCPCS codes, we developed site specific rates for all HCPCS codes that are nationally priced under the PFS and we referred to them as the technical-equivalent rates.

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

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

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

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

Response: We believe the commenters misunderstood the methodology for allocating direct and indirect costs as part of the PFS ratesetting process. Under the PFS algorithm for allocating indirect costs, nonfacility PFS rates include indirect PE that is directly related to the resources associated with the professional portion of the service alone. In other words, this is the indirect PE that is also paid by Medicare to professionals like physicians when they report services in the hospital setting. In addition to these indirect PE RVUs, nonfacility PFS rates include indirect PE RVUs allocated based on the direct PE inputs. We believe these indirect costs, those associated with provision of the technical aspects of the service alone, are analogous to those incurred by facilities when professionals furnish services there. To be clear, even when the total nonfacility rates are reduced by the facility rates, there are remaining PE RVUs that result from both direct inputs and indirect allocations under the established PFS methodology. We agree with the commenters that nonexcepted off-campus PBDs incur indirect costs, but we believe our calculation for the technical-equivalent PFS rates includes the relative resource costs of indirect expenses involved in furnishing the services. We also note that CMS makes corresponding payments under the PFS at the facility rate for nonexcepted items and services furnished in nonexcepted off-campus PBD settings, meaning that CMS is already paying for some of the indirect expenses associated with the PCs of the service. If CMS were to use the full nonfacility PE RVUs as the basis for comparing PFS rates to OPPS rates, we would effectively be paying twice for a portion of indirect costs, once under the PFS for the PC of services and again through the PFS Relativity Adjusted payment under the OPPS to off-campus PBDs for the facility part of the same service.

We recognize that the process of allocating indirect costs under the PFS is built on assumptions about Start Printed Page 59510organizational practices and healthcare payment structures that may not fully reflect the current health care delivery environment, especially where physicians and other professionals are paid under salaried arrangements by institutions such as hospitals. Under the current PFS payment methodology, we assume that indirect costs associated with professional services furnished in institutions like hospital PBDs are incurred by the individual practitioners and not by the institutions. We may consider this issue for future rulemaking.

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

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

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

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

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

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

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

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

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

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

Response: We previously expressed interest in exploring how hospitals might report and receive payment for nonexcepted items and services furnished in nonexcepted off-campus PBDs using the standard PFS payment rates based on HCPCS-specific RVUs. However, CMS does not currently develop as part of the PFS ratesetting process separate payment rates for the technical aspects of the full range of nonexcepted items and services furnished in nonexcepted off-campus PBDs specifically for services for which there are not separately valued PCs and TCs. As such, we do not have a consistent way for nonexcepted off-campus PBDs and the professionals who furnish services in those settings to bill for the respective portions of the services for which they incurred costs. Additionally, while the statute was amended to change the nature and payment of nonexcepted items and services furnished in nonexcepted off-campus PBDs, the amendments did not Start Printed Page 59511alter the status of non-excepted off-campus PBDs as parts of hospitals. Nonexcepted off-campus PBDs are still required to follow all reporting and regulatory policies consistent with hospital settings.

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

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

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

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

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

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

Comment: Several commenters opposed our inclusion of the proposal related to payment for nonexcepted off-campus PBDs under the CY 2019 PFS rule instead of the CY 2019 OPPS/ASC rule. They suggested that proposals related to the payment rate for nonexcepted items and services furnished in nonexcepted off-campus PBDs are inseparable from proposals and comment solicitations in the OPPS/ASC rule related to service line expansions and other payment policies related to implementation of the amendments under section 603 of the Bipartisan Budget Act of 2015. Some commenters suggested that, for purposes of administrative simplification, the discussion of any changes to site-of-service payments regarding PBDs of a hospital should be fully maintained within a single rule and recommended this be included in the OPPS rule. Some commenters expressed concern that the PFS and OPPS proposed rules were not released at the same time and that this presents challenges for them in reconciling and preparing their comments on each rule.

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

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

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

In the CY 2018 PFS final rule (81FR 53019 through 53031), we finalized policies related to supervision rules, beneficiary cost sharing, and geographic adjustments. We finalized that supervision rules in nonexcepted off-campus PBDs that furnish nonexcepted items and services are the same as those that apply for hospitals, in general. We also finalized that all beneficiary cost sharing rules that apply under the PFS in accordance with sections 1848(g) and 1866(a)(2)(A) of the Act continue to apply when payment is made under the PFS for nonexcepted items and services furnished by nonexcepted off-campus PBDs, regardless of cost sharing obligations under the OPPS. Lastly, we finalized the policy to apply the same geographic adjustments used under the OPPS to nonexcepted items and services furnished in nonexcepted off-campus PBDs. We are maintaining these policies for CY 2019, as finalized in the CY 2018 PFS final rule.

6. Partial Hospitalization

a. Partial Hospitalization Services

Partial hospitalization programs (PHPs) are intensive outpatient psychiatric day treatment programs furnished to patients as an alternative to inpatient psychiatric hospitalization, or as a stepdown to shorten an inpatient stay and transition a patient to a less intensive level of care. Section Start Printed Page 595121861(ff)(3)(A) of the Act specifies that a PHP is a program furnished by a hospital, to its outpatients, or by a community mental health center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the proposed implementation of section 603 of Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish PHP services and are ineligible to be provider-based to a hospital, a nonexcepted off-campus PBD would be eligible for PHP payment if the entity enrolls and bills as a CMHC for payment under the OPPS. We further noted that a hospital may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided it meets all Medicare requirements and conditions of participation.

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

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

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

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

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

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

7. Future Years

We continue to believe the amendments made by section 603 of the Bipartisan Budget Act of 2015 were intended to reduce the Medicare payment incentive for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill under the OPPS for items and services they furnish there. Therefore, we continue to believe the payment policy under this provision should ultimately equalize payment rates between nonexcepted off-campus PBDs and physician offices to the greatest extent possible, while allowing nonexcepted off-campus PBDs to bill in a straight-forward way for services they furnish.

In developing our proposal for CY 2019 as described previously, we incorporated all HCPCS codes that appeared in CY 2017 claims data from nonexcepted off-campus PBDs. We also expanded the number of site specific, technical-equivalent rates for nonexcepted items and services furnished in nonexcepted off-campus PBDs, in order to ensure that Medicare payment to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs reflects the relative resources involved in furnishing the items and services. We recognize that for certain specialties, service lines, and nonexcepted off-campus PBDs, total Medicare payments for the same services might be either higher or lower when furnished by a nonexcepted off-campus PBD rather than in a physician office.

We intend to continue to examine the claims data in order to assess whether a different PFS Relativity Adjuster is warranted and also to consider whether additional adjustments to the methodology are appropriate. In particular, we are monitoring claims for shifts in the mix of services furnished in nonexcepted off-campus PBDs that may affect the relativity between the PFS and OPPS. An increase over time in the share of nonexcepted items and services with lower technical-equivalent rates under the PFS compared with APC rates Start Printed Page 59513under the OPPS might result in a lower PFS Relativity Adjuster, for example. We will also carefully assess annual payment policy updates to the PFS and OPPS, respectively, to identify changes in overall relativity resulting from any new or modified policies, such as expanded packaging under the OPPS or an increase in the number of HCPCS codes with global periods under the PFS. As part of these ongoing efforts, we are also analyzing PFS claims data to identify patterns of services furnished together on the same day. We anticipate that this will ultimately allow us to make refinements to the PFS Relativity Adjuster to better account for the more extensive packaging of services under the OPPS and the potential underreporting of services that are not separately payable under the OPPS but are paid separately under the PFS.

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

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

H. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes

Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.E. of this final rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period, we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule, the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period, we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period, and re-proposed values for those codes in the CY 2017 PFS proposed rule.

We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. For CY 2017, we did not identify any new codes that described such wholly new services. Therefore, we did not establish any code values on an interim final basis.

For CY 2018, we generally proposed the RUC-recommended work RVUs for new, revised, and potentially misvalued codes. We proposed these values based on our understanding that the RUC generally considers the kinds of concerns we historically raised regarding appropriate valuation of work RVUs. However, during our review of these recommended values, we identified some concerns similar to those we recognized in prior years. Given the relative nature of the PFS and our obligation to ensure that the RVUs reflect relative resource use, we included descriptions of potential alternative approaches we might have taken in developing work RVUs that differed from the RUC-recommended values. We sought comment on both the RUC-recommended values, as well as the alternatives considered. Several commenters generally supported the proposed use of the RUC-recommended work RVUs, without refinement. Other commenters expressed concern about the effect of the misvalued code reviews on particular specialties and settings and disappointment with our proposed Start Printed Page 59514approach for valuing codes for CY 2018. A detailed summary of the comments and our responses can be found in the CY 2018 PFS final rule (82 FR 53033-53035).

We clarified in response to commenters that we are not relinquishing our obligation to independently establish appropriate RVUs for services paid under the PFS. We will continue to thoroughly review and consider information we receive from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the federal government as part of our process for establishing valuations. Although generally proposing the RUC-recommended work RVUs for new, revised, and potentially misvalued codes was our approach for CY 2018, we note that we also included alternative values where we believed there was a possible opportunity for increased precision. We also clarified that as part of our obligation to establish RVUs for the PFS, we annually make an independent assessment of the available recommendations, supporting documentation, and other available information from the RUC and other commenters to determine the appropriate valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we propose those values as recommended. Additionally, we will continue to engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.

2. Methodology for Establishing Work RVUs

For each code identified in this section, we conducted a review that included the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally included, but had not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process.

Components that we used in the building block approach may have included preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We used the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refined the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.

We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjusted the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.

Therefore, in many cases when we removed 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also removed a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we did not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.

The following paragraphs contain a general discussion of our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist we also include a summary of stakeholder reactions to Start Printed Page 59515our approach. We note that many commenters and stakeholders have expressed concerns over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.

We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes used the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.

In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value. If we believed that such changes in time were already accounted for in the RUC's recommendation, then we did not make such adjustments. Likewise, we did not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We used the ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options.

We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we have believed that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.

Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed general concerns with CMS refinements to RUC recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule, we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes is one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.

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

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

We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the final valuation considered for specific codes. Table 13 contains a list of codes for which we are finalizing work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2018. The finalized work RVUs, work time and other payment information for all CY 2019 payable codes are available on the CMS website under downloads for the CY 2019 PFS final rule at https://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​index.html). Table 13 also contains the CPT code descriptors for all new, revised, and potentially misvalued codes discussed in this section.Start Printed Page 59516

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

a. Background

On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

Our review and refinement of RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 details our refinements of the RUC's direct PE recommendations at the code-specific level. In this final rule, we address several refinements that are common across codes, and refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.30 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. We also note that nearly half of the refinements listed in Table 14 result in changes under the $0.30 threshold and are unlikely to result in a change to the RVUs.

We also note that the finalized direct PE inputs for CY 2019 are displayed in the CY 2019 direct PE input database, available on the CMS website under the downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. The inputs displayed there have been used in developing the final CY 2019 PE RVUs as displayed in Addendum B.

b. Common Refinements

(1) Changes in Work Time

Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.

(2) Equipment Time

Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time would also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).

(3) Standard Tasks and Minutes for Clinical Labor Tasks

In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

We refer readers to section II.B. of this final rule, Determination of Practice Start Printed Page 59517Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.

(4) Recommended Items That Are Not Direct PE Inputs

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

(5) New Supply and Equipment Items

The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. Some recommendations, however, include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2019, we received invoices for several new supply and equipment items. Tables 14 and 15 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this final rule, we encouraged stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encouraged stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.

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

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

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

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

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

We note that the public use files for the PFS proposed and final rules for each year display the services subject to the MPPR lists on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services. We also include a list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2019 are available on the CMS website under downloads for the CY 2019 PFS final rule at http://www.cms.gov/​Medicare/​Medicare-Fee-for-Service-Payment/​PhysicianFeeSched/​PFS-Federal-Regulation-Notices.html. For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with comment period (78 FR 74261-74263). For more information regarding the history of the OPPS cap, we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659-69662).

4. Valuation of Specific Codes for CY 2019

(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 10007, 10008, 10009, 10010, 10011, 10012, 76492, 77002 and 77021)

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

For CY 2019, we proposed the RUC-recommended work RVU for seven of the ten codes in this family. Specifically, we proposed a work RVU of 0.80 for CPT code 10004 (Fine needle aspiration biopsy; without imaging guidance; each additional lesion), a work RVU of 1.00 for CPT code 10006 (Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion), a work RVU of 1.81 for CPT code 10007 (Fine needle aspiration biopsy, including fluoroscopic guidance; first lesion), a work RVU of 1.18 for CPT code 10008 (Fine needle aspiration biopsy, including fluoroscopic guidance; each additional lesion), and a work RVU of Start Printed Page 595181.65 for CPT code 10010 (Fine needle aspiration biopsy, including CT guidance; each additional lesion). We also proposed to assign the recommended contractor-priced status to CPT codes 10011 (Fine needle aspiration biopsy, including MR guidance; first lesion) and 10012 (Fine needle aspiration biopsy, including MR guidance; each additional lesion) due to low utilization until these services are more widely utilized. In addition, we proposed the recommended work RVU of 1.50 for CPT code 77021 (Magnetic resonance guidance for needle placement (e.g., for biopsy, fine needle aspiration biopsy, injection, or placement of localization device) radiological supervision and interpretation), as well as proposed to reaffirm the current work RVUs of 0.67 for CPT code 76942 (Ultrasonic guidance for needle placement (e.g., biopsy, fine needle aspiration biopsy, injection, localization device), imaging supervision and interpretation) and 0.54 for 77002 (Fluoroscopic guidance for needle placement (e.g., biopsy, fine needle aspiration biopsy, injection, localization device)).

We disagreed with the RUC-recommended work RVU of 1.20 for CPT code 10021 (Fine needle aspiration biopsy; without imaging guidance; first lesion) and proposed a work RVU of 1.03 based on a direct crosswalk to CPT code 36440 (Push transfusion, blood, 2 years or younger). CPT code 36440 is a recently reviewed code with the same intraservice time of 15 minutes and 2 additional minutes of total time. In reviewing CPT code 10021, we noted that the recommended intraservice time is decreasing from 17 minutes to 15 minutes (12 percent reduction), and the recommended total time is decreasing from 48 minutes to 33 minutes (32 percent reduction); however, the RUC-recommended work RVU is only decreasing from 1.27 to 1.20, which is a reduction of just over 5 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 10021, we believed that it was more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to account for these decreases in the surveyed work time.

We disagreed with the RUC-recommended work RVU of 1.63 for CPT code 10005 (Fine needle aspiration biopsy, including ultrasound guidance; first lesion) and proposed a work RVU of 1.46. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10005 is equivalent to the recommended interval of 0.43 RVUs. Therefore, we proposed a work RVU of 1.46 for CPT code 10005, based on the recommended interval of 0.43 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed increment of 0.43 RVUs above CPT code 10021 was also based on the use of two crosswalk codes: CPT code 99225 (Subsequent observation care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components); and CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components). Both of these codes have the same intraservice time and 1 additional minute of total time as compared with CPT code 10005, and both crosswalk codes share a work RVU of 1.39.

We disagreed with the RUC-recommended work RVU of 2.43 for CPT code 10009 (Fine needle aspiration biopsy, including CT guidance; first lesion) and we proposed a work RVU of 2.26. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 10021 and 10009 is equivalent to the recommended interval of 1.23 RVUs. Therefore, we proposed a work RVU of 2.26 for CPT code 10009, based on the recommended interval of 1.23 additional RVUs above our proposed work RVU of 1.03 for CPT code 10021. The proposed use of the recommended increment from CPT code 10021 was also based on the use of a crosswalk to CPT code 74263 (Computed tomographic (CT) colonography, screening, including image postprocessing), another CT procedure with 38 minutes of intraservice time and 50 minutes of total time at a work RVU of 2.28.

We noted that the recommended work pool is increasing by approximately 20 percent for the Fine Needle Aspiration family as a whole, while the recommended work time pool for the same codes is only increasing by about 2 percent. Since time is defined as one of the two components of work, we believed that this indicated a discrepancy in the recommended work values. We do not believe that the recoding of the services in this family has resulted in an increase in their intensity, only a change in the way in which they will be reported, and therefore, we do not believe that it would serve the interests of relativity to propose the recommended work values for all of the codes in this family. We believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. We also noted that through the bundling of some of these frequently reported services, it is reasonable to expect that the new coding system will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular servicers. For example, a practitioner will not be carrying out the full preservice work twice for CPT codes 10022 and 76942, but preservice times were assigned to both of the codes under the old coding. We believe the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed regardless of how the services were previously reported.

For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes for CPT code 77021. This code did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

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

Comment: Several commenters disagreed with the CMS statement in the proposed rule that the RUC-recommended work pool was increasing by approximately 20 percent for this family of codes. Commenters stated that the work pool based on the RUC-recommended values would actually decrease by 15 percent and that the CMS work valuations were based on a flawed methodology that did not account for the associated savings with bundling the image guidance codes. One of the commenters supplied a table with data to support the claim that the work Start Printed Page 59519pool based on the RUC-recommended values would decrease by 15 percent rather than increasing by 20 percent.

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

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

Table 12—Fine Needle Aspiration Work Pool Comparison

HCPCS codeUtilization sourceUtilization destinationWork RVU sourceWork pool sourceWork RVU destinationWork pool destinationWork pool RVU changeWork pool % change
1002123,75521,3801.2730,1691.2025,655−4,513−15
1000402,3760.0000.801,9001,900
100050270,7530.0001.63441,327441,327
10006030,6210.0001.0030,62130,621
1000706,8570.0001.8112,41112,411
1000808730.0001.181,0301,030
10009060,6650.0002.43147,416147,416
1001006,8310.0001.6511,27111,271
100110830.000C00
10012030.000C00
10022186,45501.27236,7980.000−236,798−100
76942558,081488,3210.67373,9140.67327,175−46,739−13
7694226641,346561,1780.67429,7020.67375,989−53,713−13
76942TC8,5887,5150.0000.0000
77002311,280308,7900.54168,0910.54166,746−1,345−1
7700226180,964179,5160.5497,7210.5496,939−782−1
77002TC7,9367,8730.0000.0000
770129,3437,7921.1610,8381.5011,6888508
7701226194,611162,3061.16225,7491.50243,45817,7108
77012TC4693910.0000.0000
770211,4811,4321.502,2221.502,148−73−3
77021261,0381,0041.501,5571.501,506−51−3
77021TC67650.0000.0000
Totals2,125,4142,126,6221,576,7601,897,282320,52320

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

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

Response: We disagree with the commenters that there would be no savings achieved via elimination of duplicative assumptions of the resources involved in furnishing particular services. As we stated in the proposed rule, a practitioner will not be carrying out the full preservice work twice for CPT codes 10022 and 76942, but preservice times were assigned to both of the codes under the old coding. In similar fashion, these codes both separately include immediate postservice work time for dictating a report in their clinical vignettes. This is an example of how savings are achieved via elimination of duplicative assumptions of resources, as the practitioner will only dictate a single report in the newly created CPT code 10005 that bundles these two services together. We continue to believe that the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed regardless of how the services were previously reported.

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

Response: We disagree with the commenter that our analysis of changes in the work pool for this family of codes was the sole basis for the proposed refinements to the work RVUs. While Start Printed Page 59520this was an important factor in our analysis of the work valuation of individual codes, we also detailed in the proposed rule our use of time ratios, increments, and crosswalk codes as part of our larger methodology to determine work RVUs. We specifically stated that we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, but rather that we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. We do consider changes in intensity that have taken place over time as part of our analysis of work valuation, as demonstrated by the fact that we proposed the RUC-recommended work RVUs for seven of the ten codes in this family.

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

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

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

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

Comment: Many commenters disagreed with the proposed work RVU of 1.03 for CPT code 10021 and stated that CMS should finalize the RUC-recommended work RVU of 1.20. Commenters stated that this service has a new coding structure as compared to the past, and that the prior review was last carried out in 1995 when physician work time was evaluated with much less rigor. Commenters stated that the old time values were also based on a crosswalk and not a survey, and that therefore the drop in work time did not warrant a proportional change in work RVU as the previous times were inaccurate.

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

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

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

Comment: Several commenters disagreed with the use of CPT code 36440 as a crosswalk for the work RVU of CPT code 10021. Commenters stated that there were differences in site of service, patient population, and utilization between these two codes, which made CPT code 36440 a poor choice to use for work valuation. One commenter stated that CPT code 36440 is used to report a push transfusion of blood through an already established Start Printed Page 59521access in a vessel, and does not carry the same risk and intensity as CPT code 10021, which involves accessing a lesion in the neck multiple times to aspirate biopsy specimens. Commenters supplied a chart depicting several comparator codes for 10021 that they stated were more appropriate choices for a crosswalk.

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

Comment: Many commenters disagreed with the proposed work RVU of 1.46 for CPT code 10005 and stated that CMS should finalize the RUC-recommended work RVU of 1.63. Commenters stated that CMS should use valid methods of evaluating services, such as survey data and magnitude estimation, instead of relying on an incremental difference in work RVUs between CPT codes 10021 and 10005.

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

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

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

Comment: Commenters disagreed with the proposed work RVU of 2.26 for CPT code 10009 and stated that CMS should finalize the RUC-recommended work RVU of 2.43. Commenters provided similar comments for CPT code 10009 as they provided for CPT code 10005, suggesting that the use of an incremental methodology was inaccurate and that CMS should use more valid methods of evaluating services, such as survey data and magnitude estimation.

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

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

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

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

(2) Biopsy of Nail (CPT Code 11755)

CPT code 11755 (Biopsy of nail unit (e.g., plate, bed, matrix, hyponychium, proximal and lateral nail folds) (separate procedure)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, the HCPAC recommended a work RVU of 1.25 based on the survey median value.

We disagreed with the recommended value and proposed a work RVU of 1.08 for CPT code 11755 based on the survey 25th percentile value. We noted that the recommended intraservice time for CPT code 11755 is decreasing from 25 minutes to 15 minutes (40 percent reduction), and the recommended total time for CPT code 11755 is decreasing from 55 minutes to 39 minutes (29 percent reduction); however, the recommended work RVU is only decreasing from 1.31 to 1.25, which is a reduction of less than 5 percent. Although we did not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. In the case of CPT code 11755, we believed that it would be more accurate to propose the survey 25th percentile work RVU than the survey median to account for these decreases in the surveyed work time.

The proposed work RVU of 1.08 is also based on a crosswalk to CPT code 11042 (Debridement, subcutaneous tissue (includes epidermis and dermis, if performed); first 20 sq cm or less), which has a work RVU of 1.01, the same intraservice time of 15 minutes, and a similar total time of 36 minutes. We also noted that, generally speaking, working with extremities like nails tends to be less intensive in clinical terms than other services, especially as compared to surgical procedures. We believe that Start Printed Page 59522this further supports our proposal of a work RVU of 1.08 for CPT code 11755.

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

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

Comment: A few commenters stated that section 1848(c)(7) of the Act, as amended by section 220(e) of the Protecting Access to Medicare Act of 2014 (PAMA), specifies that for services that are not described by new and revised codes, if the total RVU for a service would be decreased by 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments must be phased in over a 2-year period. These commenters stated that, according to this requirement, CPT code 11755 should be subject to the phase-in for CY 2019.

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

Comment: Many commenters disagreed with the proposed work RVU of 1.08 for CPT code 11755 and stated that CMS should finalize the RUC-recommended work RVU of 1.25. Commenters urged CMS to view the survey and the HCPAC's recommendation for the survey median work value of 1.25 apart from the current work time and work RVU because the primary specialty that currently performs the service was not included in the prior survey conducted in 1993.

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

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

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

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

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

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

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

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

For CY 2019, we proposed the RUC-recommended work RVUs for five of the six codes in the family. We proposed a work RVU of 0.66 for CPT code 11102 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), single lesion), a work RVU of 0.83 for CPT code 11104 (Punch biopsy of skin, (including simple closure when performed), single lesion), a work RVU of 0.45 for CPT code 11105 (Punch biopsy of skin, (including simple closure when performed), each separate/additional lesion), a work RVU of 1.01 for CPT code 11106 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), single lesion), and a work RVU of 0.54 for CPT code 11107 (Incisional biopsy of skin (e.g., wedge), (including simple closure when performed), each separate/additional lesion).

For CPT code 11103 (Tangential biopsy of skin, (e.g., shave, scoop, saucerize, curette), each separate/additional lesion), we disagreed with the RUC-recommended work RVU of 0.38 and proposed a work RVU of 0.29. When we compared the RUC-recommended work RVU of 0.38 to other add-on codes in the RUC database, we found that CPT code 11103 would have the second-highest work RVU for any code with 7 minutes or less of total time, with the recommended work RVU noticeably higher than other related add-on codes, and we did not agree that the tangential biopsy service being performed should have an anomalously high work value in comparison to other similar add-on codes. Our proposed work RVU of 0.29 was based on a crosswalk to CPT code 11201 (Removal of skin tags, multiple fibrocutaneous tags, any area; each additional 10 lesions, or part thereof), a clinically related add-on procedure with 5 minutes of intraservice and total time as opposed to the surveyed 6 minutes for Start Printed Page 59523CPT code 11103. We also noted that the intraservice time ratio between CPT code 11103 and the recommended reference code, CPT code 11732 (Avulsion of nail plate, partial or complete, simple; each additional nail plate), was 75 percent (6 minutes divided by 8 minutes). This 75 percent ratio when applied to the work RVU of CPT code 11732 also produced a work RVU of 0.29 (0.38 * 0.75 = 0.29). Finally, we also supported the proposed work RVU through a crosswalk to CPT code 33508 (Endoscopy, surgical, including video-assisted harvest of vein(s) for coronary artery bypass procedure), which has a higher intraservice time of 10 minutes but a similar work RVU of 0.31. We believed that our proposed work RVU of 0.29 for CPT code 11103 better serves the interests of relativity, as well as better fitting with the other recommended work RVUs within this family of codes.

For the direct PE inputs, we proposed to remove the 2 minutes of clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity for CPT codes 11102, 11104, and 11106. These codes are typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

We proposed to refine the quantity of the “gown, staff, impervious” (SB024) and the “mask, surgical, with face shield” (SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106. We proposed to remove one gown and one surgical mask from these codes as duplicative since these supplies are also included within the surgical instrument cleaning pack (SA043). We also proposed to remove all of the supplies in the three add-on procedures (CPT codes 11103, 11105, and 11107) that were not contained in the previous add-on procedure for this family, CPT code 11101. We do not believe that the use of these supplies would be typical for the “each additional lesion” add-on codes, as these supplies are all included in the base codes and are not currently utilized in CPT code 11101. We noted that the recommended direct PE costs for the three new add-on codes represent an increase of approximately 500 percent from the direct PE costs for CPT code 11101, and believe that this is largely due to the addition of these new supplies.

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

Comment: Many commenters disagreed with the proposed work RVU of 0.29 for CPT code 11103 and stated that CMS should finalize the RUC-recommended work RVU of 0.38. Commenters disagreed that CPT code 11103 would have the second-highest work RVU for any code with 7 minutes or less of total time, stating that the total number of add-on codes with RUC total time of 7 minutes or less is 18. Commenters stated that only five of these services have total time of 6 or 7 minutes and the rest were lower, thus the majority of the work RVUs among these services were lower and not comparable. Commenters stressed that the RUC-recommended work RVU of 0.38 for CPT code 11103 was appropriate since the service is performed on a separate site than the base code and there is additional physician work to transition to a different site. Commenters stated that the RUC's direct crosswalk to CPT code 11732 (Avulsion of nail plate, partial or complete, simple; each additional nail plate), which describes procedures with significant physician effort in removing a nail plate with its anesthesia and hemostasis challenges, was a much better comparator to CPT code 11103 which involves the biopsy of a vascular tumor, typically on the face. Commenters stated that the proposed crosswalk to CPT code 11201 at a work RVU of 0.29 was too low to maintain relativity within the family of codes. One commenter stated that the type of skin biopsies performed in CPT code 11103 can result in the detection of carcinoma, melanoma, sarcoma/lymphoma, and other dangerous pathologies, and that making these diagnoses can save lives and ultimately decrease Medicare spending.

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

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

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

Comment: Several commenters disagreed with the proposed refinements to the “Review home care instructions, coordinate visits/prescriptions” (CA035) clinical labor time. Commenters stated that home care instructions furnished in an E/M visit do not typically include wound care instructions, and that this instruction would be above and beyond instructions proved during an E/M visit in which no procedure is performed.

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

Comment: Several commenters disagreed with the CMS proposal to refine the quantity of the “gown, staff, impervious” (SB024) and the “mask, surgical, with face shield” (SB034) supplies from 2 to 1 for CPT codes 11102, 11104, and 11106 since these supplies are also included within the surgical instrument cleaning pack (SA043). Commenters stated that the SA043 instrument cleaning pack is used in the dirty instrument room as part of the instrument cleaning and sterilization process and therefore cannot be used during a patient procedure as the instrument cleaning occurs after the procedure has been completed. Commenters stated that the personal protective equipment used during the patient procedure is considered contaminated after the procedure is concluded, and that personal protective equipment must be removed and disposed of prior to leaving the procedure room. As a result, these supplies were not duplicative and should not be removed.

Response: We disagree with the commenter and we continue to believe that the impervious staff gown and the surgical mask with face shield would be duplicative supplies given that they are also contained within the instrument cleaning pack. We do not believe that it Start Printed Page 59524would be typical to remove the staff gown and face shield used during a procedure and put on new items afterwards for the purposes of cleaning instruments.

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

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

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

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

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

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

CPT code 20551 (Injection(s); single tendon origin/insertion) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.75 for CPT code 20551.

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

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

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

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

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

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

Response: For the CA011 clinical labor activity, we agree with the commenters that there would be a need for some additional time to obtain consent for the injection, but we do not agree that it would be typical to require the full 3 minutes because we believe there would be some overlap with the same day E/M visit. In similar fashion, we believe that there would also be some overlap with the same-day E/M Start Printed Page 59525visit for the home care instructions described in activity code CA035. We also note that there is 1 minute of clinical labor time assigned to the “Check dressings & wound/home care instructions/coordinate office visits/prescriptions” clinical labor task for CPT code 90471 referenced by the commenters. As a result, we are finalizing the assignment of 1 minute of clinical labor time to both of the CA011 and CA035 activities for CPT code 20551. We are also finalizing an increase of 1 minute in the equipment time for the exam table (EF023) to a total of 15 minutes, in accordance with our standard time formula for non-highly technical equipment.

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

(5) Structural Allograft (CPT Codes 20932, 20933, and 20934)

In February 2017, the CPT Editorial Panel created three new codes to describe allografts. These codes were designated as add-on codes and revised to more accurately describe the structural allograft procedures they represent. For CY 2019, we proposed the RUC-recommended work RVUs for all three codes. We proposed a work RVU of 13.01 for CPT code 20932 (Allograft, includes templating, cutting, placement and internal fixation when performed; osteoarticular, including articular surface and contiguous bone), a work RVU of 11.94 for CPT code 20933 (Allograft, includes templating, cutting, placement and internal fixation when performed; hemicortical intercalary, partial (i.e., hemicylindrical)), and a work RVU of 13.00 for CPT code 20934 (Allograft, includes templating, cutting, placement and internal fixation when performed; intercalary, complete (i.e., cylindrical)).

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

We did not receive any comments on our proposals involving the Structural Allograft family of codes. Therefore we are finalizing the work RVUs for the codes in this family as proposed.

(6) Knee Arthrography Injection (CPT Code 27369)

CPT code 27370 (Injection of contrast for knee arthrography) repeatedly appeared on high volume growth screens between 2008 and 2016, and the RUC expressed concern that the high volume growth for this procedure was likely due to its being reported incorrectly as arthrocentesis or aspiration. In June 2017, the CPT Editorial Panel deleted CPT code 27370 and replaced it with a new code, 27369, to report injection procedure for knee arthrography or enhanced CT/MRI knee arthrography.

The RUC recommended a work RVU of 0.96 for CPT code 27369, which is identical to the work RVU for CPT code 27370 (Injection of contrast for knee arthrography). The RUC's recommendation is based on key reference service, CPT code 23350 (Injection procedure for shoulder arthrography or enhanced CT/MRI shoulder arthrography), with identical intraservice time (15 minutes) and total time (28 minutes) as the new CPT code and a work RVU of 1.00. The RUC notes that its recommendation is lower than the 25th percentile from the survey results, but that the work described by the service should be valued identically with the CPT code being replaced. We disagreed with the RUC's recommended work RVU for CPT code 27369. Both the total (28 minutes) and intraservice (15 minutes) times for the new CPT code are considerably lower than the deleted CPT code 27370. Based on the reduced times and the projected work RVU from the reverse building block methodology (0.60 work RVUs), we believe this CPT code should be valued at 0.77 work RVUs, supported by a crosswalk to CPT code 29075 (Application, cast; elbow to finger (short arm)), with total time of 27 minutes and intraservice time of 15 minutes. Therefore, we proposed a work RVU of 0.77 for CPT code 27369.

For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. The predecessor code for 27369, CPT code 27370, did not have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also noted that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished.

We proposed to remove the clinical labor time for the “Scan exam documents into PACS. Complete exam in RIS system to populate images into work queue” (CA032) activity. CPT code 27369 does not include a PACS workstation among the recommended equipment, and the predecessor code 27370 did not previously include time for this clinical labor activity. We believe that data entry activities such as this task would be classified as indirect PE, as they are considered administrative activities and are not individually allocable to a particular patient for a particular service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

The following is a summary of the public comments we received on our proposals involving CPT code 27369.

Comment: We received one comment regarding our proposed work RVU for CPT code 27369 of 0.77 RVUs. The commenter disagreed with CMS's reference to CPT code 27370, which is being deleted, as a basis for evaluating whether the RUC's proposed work RVU for this CPT code (0.96) adequately accounts for the large reduction in time between the deleted code, CPT code 27370 and the new code, CPT code 27369. The commenter noted that it is particularly inappropriate for CMS to value codes on the basis of time differences when the comparison code had not been previously surveyed by the RUC. The commenter urged CMS to finalize the RUC-recommended work RVU for CPT code 27369 of 0.96.

Response: We use several parameters to review the work RVU for codes including, where applicable, refining the work RVUs in direct proportion to either total time or intraservice time based on the best available information regarding the time resources involved in furnishing particular services. We note that the reason the CPT Editorial Panel was asked to review the code was to prevent incorrect reporting of the code, not to reflect a fundamentally different service. The work involved in furnishing the service described by CPT code 27369 is not fundamentally different from the work involved in furnishing the service described by the deleted code. In such cases we do not believe it is inappropriate to compare the survey times for the new code to the existing time for the code that it is intended to replace as one of several parameters we consider in our review. We are finalizing a work RVU for CPT code 27369 of 0.77 as proposed.

Comment: A commenter stated that in the CMS refinements to the direct PE inputs for CPT code 27369, CMS proposed to remove 1 minute from the CA014 activity code and proposed to add 1 minute to the CA013 activity code. The commenter stated that this refinement was inaccurate and encouraged CMS to modify this proposal by finalizing the RUC-Start Printed Page 59526recommended direct PE inputs for clinical labor.

Response: We addressed this subject in detail in the PE section of this final rule under the Changes to Direct PE Inputs for Specific Services heading (section II.B.3. of this final rule). For CPT code 27369, we are finalizing these clinical labor refinements as proposed.

Comment: One commenter agreed with the proposed CMS refinement to the CA032 clinical labor activity.

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

After consideration of the public comments, we are finalizing the direct PE inputs for CPT code 27369 as proposed.

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

CPT code 29105 (Application of long arm splint (shoulder to hand)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.80 for CPT code 29105. For the direct PE inputs, we proposed to refine the equipment times in accordance with our standard equipment time formulas.

The following is a summary of the public comments we received on our proposals involving CPT code 29105.

Comment: Some commenters expressed support for our proposal to accept the RUC-recommended work RVU for this code.

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

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

Response: For the five equipment items utilized in CPT code 29105, we removed the clinical labor for the CA035 clinical labor activity code in accordance with our standard equipment time formula for non-highly technical equipment.

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 29105 as proposed.

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

CPT codes 29540 (Strapping; ankle and/or foot) and 29550 (Strapping; toes) were identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. For CY 2019, we proposed the HCPAC-recommended work RVU of 0.39 for CPT code 29540 and the HCPAC-recommended work RVU of 0.25 for CPT code 29550.

For the direct PE inputs, we proposed to refine the clinical labor time for the “Provide education/obtain consent” (CA011) activity from 3 minutes to 2 minutes for both codes, as this is the standard clinical labor time assigned for patient education and consent. We also proposed to remove the 2 minutes of clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity for both codes. CPT codes 29540 and 29550 are both typically billed with a same day E/M service, and we believe that it would be duplicative to assign clinical labor time for reviewing home care instructions given that this task would typically be done during the same day E/M service. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

The following is a summary of the public comments we received on our proposals involving the Strapping Lower Extremity family of codes.

Comment: A few commenters supported our proposal to accept the HCPAC-recommended work RVUs.

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

Comment: Several commenters disagreed with the proposed direct PE refinements to CPT codes 29540 and 29550. Commenters stated that CMS mistakenly cited a standard for this activity of 2 minutes, however there is no set standard for CA011, and that 3 minutes is needed for clinical staff to perform this clinical activity.

Response: We disagree with the commenters that 3 minutes would be typically needed for the clinical staff to provide education and obtain consent in these procedures. We have typically assigned 2 minutes for this clinical labor activity unless we had a specific rationale for a higher amount of clinical labor time, and we continue to believe that this standard amount of clinical labor time would be the most accurate value for CPT codes 29540 and 29550.

Comment: Several commenters disagreed that the clinical labor for home care instructions and coordinating visits/prescriptions would be duplicative with the same day E/M office visit in these services. Commenters stated that these home care instructions directly pertain to the strapping procedure and would not be provided during an evaluation of the patient. Commenters stated that the strappings do not work unless left alone and taken care of in a specific manner, and that this important information is included in the home care instructions that the patient receives from clinical staff.

Response: We disagree with the commenters and we continue to believe that this clinical labor would be duplicative with the same day E/M visit. We believe that this clinical labor would take place during the same day E/M visit. Due to the way patients typically present in these procedures, we do not believe that the patients would typically need additional home care instructions above and beyond the E/M visit. We also note that these strapping procedures are frequently repeated for the same patient multiple times, and there would not be a need for repeated home care instructions for subsequent strapping procedures for the same patient. Any home care instructions taking place outside of the same day E/M visit would only be needed the first time that these procedures are performed on a patient, and as a result they would not be typical. As a result, we continue to believe that this clinical labor would not be typical.

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

Response: For the two equipment items utilized in these CPT codes, we removed the clinical labor for the CA035 clinical labor activity code in accordance with our standard equipment time formula for non-highly technical equipment.

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 29540 and 29550 as proposed.

(9) Bronchoscopy (CPT Codes 31623 and 31624)

CPT code 31623 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with Start Printed Page 59527brushing or protected brushings) was identified on a high growth screen of services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2009 through 2014. CPT code 31624 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial alveolar lavage) was also included for review as part of the same family of codes. For CY 2019, we proposed the RUC-recommended work RVU of 2.63 for CPT codes 31623 and 31624.

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

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

Comment: Several commenters disagreed with the proposal to refine the clinical labor time for the “Complete post-procedure diagnostic forms, lab and x-ray requisitions” (CA027) activity from 4 minutes to 2 minutes for CPT codes 31623 and 31624. Commenters stated that there is no standard for the CA027 clinical labor activity and that the CMS logic to conform to such a standard lacks merit. Commenters also stated that these services require verification of samples, and completion of several lab forms and clearly requires more than the standard time for completing forms.

Response: We disagree with the commenters. While it is true that we have not formalized 2 minutes as a standard through rulemaking for this clinical labor activity code, we have typically assigned 2 minutes for the CA027 activity across a wide variety of codes. Out of the 168 HCPCS codes that have clinical labor time for the CA027 clinical labor activity in our database, 64 codes have 2 minutes of assigned clinical labor time while only 9 codes have 4 minutes of assigned clinical labor time, which indicates that 2 minutes is far more typical for this activity. More importantly, commenters did not address our statement that 2 minutes is the current time for this clinical labor activity, and we had no reason to believe that the time to perform this task has increased since the codes were last reviewed. As a result, we are finalizing our refinement to 2 minutes of clinical labor time for the CA027 activity.

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT codes 31623 and 31624 as proposed.

(10) Pulmonary Wireless Pressure Sensor Services (CPT Codes 33289 and 93264)

In September 2017, the CPT Editorial Panel created a code to describe pulmonary wireless sensor implantation and another code for remote care management of patients with an implantable, wireless pulmonary artery pressure sensor monitor. For CY 2019, we proposed the RUC-recommended work RVU of 6.00 for CPT code 33289 (Transcatheter implantation of wireless pulmonary artery pressure sensor for long term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed), and the RUC-recommended work RVU of 0.70 for CPT code 93264 (Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days including at least weekly downloads of pulmonary artery pressure recordings, interpretation(s), trend analysis, and report(s) by a physician or other qualified health care professional).

We did not propose any direct PE refinements for this code family.

The following is a summary of the public comments we received on our proposals involving the Pulmonary Wireless Pressure Sensor Services family of codes.

Comment: Commenters were supportive of our proposal of the RUC-recommended work RVUs.

Response: We thank commenters for their support.

After consideration of the public comments, we are finalizing the RUC-recommended work RVUs for CPT codes 33289 and 93264 as proposed.

(11) Cardiac Event Recorder Procedures (CPT Codes 33285 and 33286)

In February 2017, the CPT Editorial Panel created two new codes replacing cardiac event recorder codes to reflect new technology. For CY 2019, we proposed the RUC-recommended work RVU of 1.53 for CPT code 33285 (Insertion, subcutaneous cardiac rhythm monitor, including programming) and the RUC-recommended work RVU of 1.50 for CPT code 33286 (Removal, subcutaneous cardiac rhythm monitor).

We did not propose any direct PE refinements for this code family.

The following is a summary of the public comments we received on our proposals involving the Cardiac Event Recorder Procedures family of codes.

Comment: Commenters were supportive of our proposal of the RUC-recommended work RVUs.

Response: We thank commenters for their support.

After consideration of the public comments, we are finalizing the RUC-recommended work RVUs and direct PE inputs for CPT codes 33285 and 33286 as proposed.

(12) Aortoventriculoplasty With Pulmonary Autograft (CPT Code 33440)

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

For CY 2019, we proposed the RUC-recommended work RVU of 64.00 for CPT code 33440 (Replacement, aortic valve; by translocation of autologous pulmonary valve and transventricular aortic annulus enlargement of the left ventricular outflow tract with valved conduit replacement of pulmonary valve (Ross-Konno procedure)). When this code is re-reviewed in a few years as part of the new technology screen, we look forward to receiving new recommendations on the whole family, including the related Ross and Konno procedures (CPT codes 33413 and 33412 respectively) that were used as references for CPT code 33440.

For the direct PE inputs, we proposed to refine the preservice clinical labor times to match our standards for 90-day global procedures. We proposed to refine the clinical labor time for the “Coordinate pre-surgery services (including test results)” (CA002) activity from 25 minutes to 20 minutes, to refine the clinical labor time for the “Schedule space and equipment in facility” (CA003) activity from 12 minutes to 8 minutes, and to refine the clinical labor time for the “Provide pre-service education/obtain consent” (CA004) activity from 26 minutes to 20 minutes. We also proposed to add 15 minutes of clinical labor time for the “Perform regulatory mandated quality assurance activity (pre-service)” (CA008) activity. We agreed with the recommendation that the total preservice clinical labor Start Printed Page 59528time for CPT code 33440 is unchanged from the two reference codes at 75 minutes. However, we believed that the clinical labor associated with additional coordination between multiple specialties prior to patient arrival is more accurately described through the use of the CA008 activity code than by distributing this 15 minutes amongst the other preservice clinical labor activities. We previously established standard preservice times for 90-day global procedures, and did not want to propose clinical labor times above those standards for CPT code 33440. We also noted that there is no effect on the total clinical labor direct costs in this situation, since the same 15 minutes of preservice clinical labor time is still being furnished.

The following is a summary of the public comments we received on our proposals involving CPT code 33440.

Comment: A few commenters stated that they had no objections to the CMS proposal to refine the preservice clinical labor times for the direct PE inputs for code 33440 to match the 90-day global procedure standards and to add 15 minutes of clinical labor time to clinical labor activity code CA008. The commenters stated that they believed the RUC-recommended allocation of the preservice activities was appropriate, whereas activity code CA008 was not an accurate description of the additional work being done, and hoped that CMS would not use the allocation of time to CA008 as a way to reduce the preservice time in future rulemaking.

Response: We appreciate the feedback on our proposed direct PE refinements from the commenters.

After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for CPT code 33440 as proposed.

(13) Hemi-Aortic Arch Replacement (CPT Code 33866)

At the September 2017 CPT Editorial Panel meeting, the Panel created one new add-on code to report hemi-aortic arch graft replacement. For CY 2019, we proposed the RUC-recommended work RVU of 19.74 for CPT code 33866 (Aortic hemiarch graft including isolation and control of the arch vessels, beveled open distal aortic anastomosis extending under one or more of the arch vessels, and total circulatory arrest or isolated cerebral perfusion). CPT code 33866 is a facility-only procedure with no recommended direct PE inputs.

The following is a summary of the public comments we received on our proposals involving CPT code 33866.

Comment: We received several comments, including comments from the RUC. The RUC noted in its comment letter that at the April 2018 RUC meeting, the specialty societies determined that the family of services encompassing CPT code 33866 should be submitted to the CPT Editorial Panel for the following revisions: (1) To develop distinct codes for ascending aortic report for dissection and ascending aortic repair for other ascending aortic disease such as aneurysms and congenital anomalies. The specialties noted that there is a difference in the work associated with these procedures and now there is sufficient volume to allow for more accurate capture of the work and outcomes data for these distinct patient populations, which was not the case when the code was first developed, (2) Revise the descriptor for transverse arch code, CPT code 33870, to further clarify the difference in work between the new add on code, CPT code 33866, and (3) Revise the guidelines to provide additional instructions on the appropriate use of these codes. The RUC further noted that the specialty societies had already submitted a new coding proposal for consideration at the May 2018 CPT Editorial Panel for CPT 2020, which the RUC supported. Following the April 2018 RUC meeting, the RUC rescinded its interim value recommendation (work RVU of 19.74) to us for CPT code 33866 for CY 2019. One commenter noted, that although the RUC rescinded the interim work RVU of 19.74 due to a specialty societies' recommendation to submit the family of services to the CPT Editorial Panel, they encouraged CMS to consider using the work RVU of 19.74 as an interim value until the code can be re-surveyed and reviewed by the RUC. The commenter further noted that using the RUC-recommended value would allow physicians to be paid for the service in CY 2019, decreasing the burden of reporting a carrier-priced service to both the carriers and providers.

Response: While we recognize that the RUC rescinded its work RVU recommendation, we note that we proposed the RUC-recommended work RVU for valuation in CY 2019. We also want to remind commenters that we no longer establish interim valuations on a routine basis, and we are not convinced that establishing an interim valuation for CPT code 33866 is necessary. We will review any new coding that the CPT Editorial Panel provides for 2020, and will review any recommendations we receive timely from the RUC or other stakeholders for valuation through CY 2020 rulemaking.

After consideration of the public comments received, we are finalizing the RUC-recommended work RVUs for CPT code 33866 as proposed.

(14) Leadless Pacemaker Procedures (CPT Codes 33274 and 33275)

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

For CPT code 33274 (Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (e.g., fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g., interrogation or programming), when performed), we disagreed with the recommended work RVU of 8.77 and we proposed a work RVU of 7.80 based on a direct crosswalk to one of the top reference codes selected by the RUC survey participants, CPT code 33207 (Insertion of new or replacement of permanent pacemaker with transvenous electrode(s); ventricular). This code has the same 60 minutes of intraservice time as CPT code 33274 and an additional 61 minutes of total time at a work RVU of 7.80. In our review of CPT code 33274, we noted that this reference code had an additional inpatient hospital visit of CPT code 99232 (Subsequent hospital care, per day, for the evaluation and management of a patient, which requires at least 2 of 3 key components) and a full instead of a half discharge visit of CPT code 99238 (Hospital discharge day management; 30 minutes or less) included in its 90-day global period. The combined work RVU of these two visits would be equal to 2.03. However, the recommended work RVU for CPT code 33274 was 0.97 work RVUs higher than CPT code 33207, despite having fewer of these visits and significantly less surveyed total time. While we acknowledge that CPT code 33274 is a more intense procedure than CPT code 33207, we do not believe that it should be valued almost a full RVU higher than the reference code given the fewer visits in the global period and the lower surveyed work time.

Therefore, we proposed to crosswalk CPT code 33274 to CPT code 33207 at the same work RVU of 7.80. The proposed work RVU was also supported through a reference crosswalk to CPT code 38542 (Dissection, deep jugular node(s)), which has 60 minutes of intraservice time, 198 minutes of total time, and a work RVU of 7.95. We believe that our proposed work RVU of Start Printed Page 595297.80 is a more accurate valuation for CPT code 33274, while still recognizing the greater intensity of this procedure in comparison to its reference code.

For CPT code 33275 (Transcatheter removal of permanent leadless pacemaker, right ventricular), we disagreed with the RUC-recommended work RVU of 9.56 and we proposed a work RVU of 8.59. Although we disagreed with the RUC-recommended work RVU, we concurred that the relative difference in work between CPT codes 33274 and 33275 is equivalent to the recommended interval of 0.79 RVUs. Therefore, we proposed a work RVU of 8.59 for CPT code 33275, based on the recommended interval of 0.79 additional RVUs above our proposed work RVU of 7.80 for CPT code 33274. We also noted that our proposed work RVU for CPT code 33275 situates it approximately halfway between the two reference codes from the survey, with CPT code 33270 (Insertion or replacement of permanent subcutaneous implantable defibrillator system, with subcutaneous electrode, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed) having an intraservice time of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an intraservice time of 60 minutes and a work RVU of 7.80. CPT code 33275 has a surveyed intraservice time of 75 minutes and nearly splits the difference between them at our proposed work RVU of 8.59.

We did not propose any direct PE refinements for this code family.

The following is a summary of the public comments we received on our proposals involving the Leadless Pacemaker Procedures family of codes.

Comment: One commenter recommended that CMS adopt the RUC-recommended RVUs for both codes due to the newness of the procedures. The commenter stated that there might not be sufficient evidence or rationale for CMS to disagree with the RUC-recommended values, and again cited the newness of these procedures.

Response: We disagree with the commenter that the newness of a procedure would provide a sufficient rationale for finalizing the RUC-recommended work RVU for a new CPT code without any further consideration. Establishing valuations for newly created CPT codes is a routine part of maintaining the PFS, and we have historically valued new services since the inception of the resource-based relative value system. We also believe that RUC surveys are less likely to be representative of practitioners when evaluating new services, due to the fact that practitioners are not yet sufficiently experienced with the services to provide accurate evaluations, which is why we have been supportive of the RUC's policy to resurvey new services a few years after their creation when typical practice patterns have been more firmly established.

Comment: Many commenters disagreed with the proposed work RVUs for CPT codes 33274 and 33275 and stated that CMS should instead finalize the RUC-recommended work RVUs for these services. Commenters stated that CMS provided no qualitative or quantitative rationale to support their assumption that the difference in time between CPT codes 33274 and the top key reference from the survey (CPT code 33207) completely reflects the difference in intensity. Commenters stated that patients receiving leadless pacemakers are more complex and have more comorbidities and contraindications than transvenous patients, with more significant groin complications and more commonly present tamponade. Commenters stated that there were other issues that make CPT code 33274 more challenging, including: (1) Capture thresholds tend to change more than with transvenous devices; (2) There is a higher risk for complications including embolization and groin complications, which are not associated with tranvenous implants; and (3) Patients undergoing leadless pacemaker procedures are more likely to have chronic atrial fibrillation and poor venous access. Commenters emphasized that they believed the leadless pacemaker procedure described by CPT code 33274 was more intensive than the CMS crosswalk to CPT code 33207.

Response: We disagree with the commenters' assertion that we provided no qualitative or quantitative rationale to support our choice of a crosswalk to CPT code 33207. We stated in the proposed rule that in our review of CPT code 33274, we noted that this reference code had an additional inpatient hospital visit of CPT code 99232 and a full, instead of a half, discharge visit of CPT code 99238 included in its 90-day global period. We acknowledged that CPT code 33274 is a more intense procedure than CPT code 33207; however, we did not believe that it should be valued almost a full RVU higher than the reference code. We also supported the proposed work RVU through the use of a reference code, CPT code 38542, which was not addressed by the commenters.

We also disagree with the commenters that CPT code 33274 has so much additional intensity and complexity as compared to key reference CPT code 33207 that they should be valued at the same work RVU of 8.77. We note that the RUC's research panel selected preservice package 3, “a straightforward patient and a difficult procedure” for CPT code 33274. We believe this indicates that the patient population for CPT code 33274 would not be unusually difficult or complex as suggested by the commenters. We further note that the summary of recommendations for CPT code 33274 states that these patients are typically sent home from the facility the next day. In contrast, reference CPT code 33207 includes a full hospital inpatient day of post procedure care associated with CPT code 99322, as well as a full discharge visit instead of half of a discharge visit. We believe that this further suggests that the patient population for CPT code 33274 would not be more difficult or complex than the patient population for CPT code 33207. As we stated in the proposed rule, we continue to acknowledge that CPT code 33274 is a more intense procedure than CPT code 33207, but we do not believe that it should be valued almost a full RVU higher than the reference code given the fewer visits in the global period and the lower surveyed work time.

Comment: Commenters stated that CMS should use valid methods of evaluating services, such as survey data and magnitude estimation, instead of relying on an incremental difference in work RVUs between CPT codes 33274 and 33275.

Response: We believe the use of an incremental difference between codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Historically, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code or another family of codes. We note that the RUC has also used the same incremental methodology on occasion when it was unable to produce valid survey data for a service. We further note that we did not rely solely on an increment for our proposed work RVU for CPT code 33275, supporting our proposed valuation by noting that the CMS work RVU of 8.59 situated the code approximately halfway between the two reference codes from the survey, with CPT code 33270 having an intraservice time of 90 minutes and a work RVU of 9.10, and CPT code 33207 having an intraservice Start Printed Page 59530time of 60 minutes and a work RVU of 7.80.

Comment: Several commenters stated that while these procedures described in CPT code 33275 will be rare, these patients will still have the elevated risk factors mentioned in discussion of CPT code 33274 and warranted the additional work indicated by survey respondents at the 25th percentile of the survey.

Response: We continue to believe that the patients in CPT code 33274 would not be more difficult or complex than the patients in CPT code 33207 for the reasons detailed above. We continue to believe that the relative difference in work between CPT codes 33274 and 33275 is equivalent to the recommended interval of 0.79 RVUs.

After consideration of the public comments, we are finalizing the work RVUs and direct PE inputs for the codes in the Leadless Pacemaker Procedures family as proposed.

(15) PICC Line Procedures (CPT Codes 36568, 36569, 36572, 36573, and 36584)

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

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

For CPT code 36572 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; younger than 5 years of age), we disagreed with the RUC-recommended work RVU of 2.00 and proposed a work RVU of 1.82 based on a direct crosswalk to CPT code 50435 (Exchange nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation). CPT code 50435 is a recently reviewed code that also includes radiological supervision and interpretation with similar intraservice and total time values. In our review of CPT code 36572, we were concerned about the possibility that the recommended work RVU of 2.00 could create a rank order anomaly in terms of intensity with the other codes in the family. We noted that the recommended intraservice time for CPT code 36572 as compared to CPT code 36568, the most similar code in the family, is decreasing from 38 minutes to 22 minutes (42 percent), and the recommended total time is decreasing from 71 minutes to 51 minutes (38 percent); however, the recommended work RVU is only decreasing from 2.11 to 2.00, which is a reduction of just over 5 percent. We also noted that CPT code 36572 has a lower recommended intraservice time and total time as compared to CPT code 36569, yet has a higher recommended work RVU. Although we did not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs.

In the case of CPT code 36572, we believed that it would be more accurate to propose a work RVU of 1.82 based on a crosswalk to CPT code 50435 to better fit with the recommended work RVUs for CPT codes 36568 and 36569. The proposed work valuation was also based on the use of three additional crosswalk codes: CPT code 32554 (Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging guidance), CPT code 43198 (Esophagoscopy, flexible, transnasal; with biopsy, single or multiple), and CPT code 64644 (Chemodenervation of one extremity; 5 or more muscles). All of these codes were recently reviewed with similar intensity, intraservice time, and total time values, and all three of them share a work RVU of 1.82.

For CPT code 36573 (Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or pump, including all imaging guidance, image documentation, and all associated radiological supervision and interpretation required to perform the insertion; age 5 years or older), we disagreed with the RUC-recommended work RVU of 1.90 and proposed a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. In our review of CPT code 36573, we were again concerned about the possibility that the recommended work RVU of 1.90 could create a rank order anomaly in terms of intensity with the other codes in the family. We noted that the recommended intraservice time for CPT code 36573 as compared to CPT code 36569, the most similar code in the family, was decreasing from 27 minutes to 15 minutes (45 percent), and the recommended total time was decreasing from 60 minutes to 40 minutes (33 percent); however, the RUC-recommended work RVU was exactly the same for these two codes at 1.90. Although we did not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs.

In the case of CPT code 36573, we believed that it would be more accurate to propose a work RVU of 1.70 based on maintaining the current work RVU of CPT code 36569. These two CPT codes describe the same procedure done with (CPT code 36573) and without (CPT code 35659) imaging guidance and radiological supervision and interpretation. Because the inclusion of the imaging described by CPT code 36573 has now become the typical case for this service, we believe that it is more accurate to maintain the current work RVU of 1.70 as opposed to Start Printed Page 59531increasing the work RVU to 1.90, especially considering that the new surveyed work time for CPT code 36573 is lower than the current work time for CPT code 36569. The proposed work RVU of 1.70 was also based on a crosswalk to CPT code 36556 (Insertion of non-tunneled centrally inserted central venous catheter; age 5 years or older). This is a recently reviewed code with the same 15 minutes of intraservice time and the same 40 minutes of total time with a work RVU of 1.75.

For CPT code 36584, we disagreed with the RUC-recommended work RVU of 1.47 and proposed a work RVU of 1.20 based on maintaining the current work RVU. We noted that the recommended intraservice time for CPT code 36584 was decreasing from 15 minutes to 12 minutes (20 percent reduction), and the recommended total time was decreasing from 45 minutes to 34 minutes (25 percent reduction); however, the recommended work RVU was increasing from 1.20 to 1.47, an increase of approximately 23 percent. Although we did not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believed that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. We were especially concerned when the recommended work RVU is increasing despite survey results indicating that the work time is decreasing due to a combination of improving technology and greater efficiencies in practice patterns.

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

We noted that the RUC-recommended work pool was increasing by approximately 68 percent for the PICC Line Procedures family as a whole, while the RUC-recommended work time pool for the same codes was only increasing by about 22 percent. Since time is defined as one of the two components of work, we believe that this indicated a discrepancy in the recommended work values. We do not believe that the recoding of the services in this family has resulted in an increase in their intensity, only a change in the way in which they will be reported, and therefore, we did not believe that it would serve the interests of relativity to propose the RUC-recommended work values for all of the codes in this family. We believe that, generally speaking, the recoding of a family of services should maintain the same total work pool, as the services themselves are not changing, only the coding structure under which they are being reported. We also noted that, through the bundling of some of these frequently reported services, it is reasonable to expect that the new coding system will achieve savings via elimination of duplicative assumptions of the resources involved in furnishing particular servicers. For example, a practitioner would not be carrying out the full preservice work three times for CPT codes 36568, 76937, and 77001, but preservice times were assigned to all of the codes under the old coding. We believed the new coding assigns more accurate work times and thus reflects efficiencies in resource costs that existed but were not reflected in the services as they were previously reported.

For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from 4 minutes to 2 minutes for CPT codes 36572 and 36573. We noted that the two reference codes for the two new codes, CPT codes 36568 and 36569, currently have 2 minutes assigned for this activity, and CPT code 36584 also has a recommended 2 minutes assigned to this same activity. We did not agree that the patient positioning would take twice as long for CPT codes 36572 and 36573 as compared to the rest of the family, and therefore proposed to refine both of them to the same 2 minutes of clinical labor time. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

The following is a summary of the public comments we received on our proposals involving the PICC Line Procedures family of codes.

Comment: One commenter stated that CMS believes it is not accurate to “increase” work RVUs when survey results indicate that work time is “decreasing” due to improving technology and greater efficiencies in practice patterns. The commenter disagreed that the difference between the current codes (without imaging guidance) and the new bundled codes (with imaging guidance) could be characterized as an “increase” or a “decrease,” as it was inappropriate simply to compare the RVUs of the bundled codes to the existing codes, because the bundled codes include imaging services that involve significantly more intense physician work than PICC line insertion without imaging guidance.

Response: We disagree with the commenter that it is methodologically inappropriate to characterize changes in surveyed work time as “increases” or “decreases”. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36572 is a new code resulting from the bundling together of CPT code 36568 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36568 and 76397 will now be reported under CPT code 36572. We believe that it is highly relevant to note how the recommended work times for CPT code 36572 compare to the recommended work times for CPT code 36568, which includes noting that the intraservice time is decreasing from 38 minutes to 22 minutes (42 percent), and the recommended total time is decreasing from 71 minutes to 51 minutes (38 percent). We also do not agree that it is inappropriate to compare the RVUs of the bundled codes to the existing codes, as all of these procedures describe clinically similar procedures that together comprise a family of codes. In more general terms, we continue to believe that the nature of the PFS relative value system is such that all services are appropriately subject to comparisons to one another. Although codes with clinically similar services are sometimes stronger comparator codes, we do not agree that codes must both include imaging guidance or not include imaging guidance to be used as a crosswalk.

Comment: Several commenters disagreed that the recoding of the services in the PICC line code family had only resulted in a change in the way that services will be reported, and stated that that the imaging-related services now bundled into CPT codes 36572, 36573, and 36584 are significantly more intense than PICC line insertion standing alone. One commenter stated that valuing a code using imaging guidance the same or less than the same code without imaging guidance is Start Printed Page 59532specious and treats the use of imaging guidance as a negative work component when in fact there is additional work required in using imaging guidance. Commenters stated that the RUC-recommended values already reflect efficiencies in radiology work, and that the efficiency of radiologists should not diminish the RUC's recognition that their work is significantly more intense in these procedures.

Response: We disagree with the commenters that the addition of imaging guidance has made CPT codes 36572, 36573, and 36584 significantly more intense than the non-imaging guidance version of these procedures. While the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We believe that if these procedures were significantly more intensive to perform, this would be reflected in the surveyed work times associated with these codes. However, the surveyed work times are instead decreasing in all three cases in comparison to the current non-imaging guidance version of the same services. As we stated in the proposed rule, we believe that the work times for these services are decreasing due to a combination of improving technology and greater efficiencies in practice patterns. Based on the RUC-recommended utilization crosswalk for these services, which has 90 to 95 percent of the utilization expected to be reported under the new codes that include imaging guidance, we believe that the use of imaging guidance has become typical for these services and does not represent a dramatic increase in intensity.

Comment: Many commenters disagreed with the proposed work RVU of 1.82 for CPT code 36572 and stated that CMS should finalize the RUC-recommended work RVU of 2.00. Commenters stated that the CMS use of a crosswalk to CPT code 50435 was unsupported on a clinical basis, with significant differences in work intensity and patient population. Commenters stated that CPT code 36572 involves establishing new deep venous access on a pediatric patient while ensuring maximum sterile barrier technique so as to prevent a hospital acquired infection, whereas CPT code 50435 involves the exchange of an existing catheter in an adult who understands the procedure involved and has had previous catheter exchanges to maintain patency. One commenter stated that the RUC crosswalk to CPT code 19283 (Placement of breast localization device(s) (e.g., clip, metallic pellet, wire/needle, radioactive seeds)) was a more accurate choice because this service also uses imaging guidance to obtain de novo percutaneous access to a target and perform an intervention. Commenters stated that the crosswalk code would frequently be less intense than CPT code 36572.

Response: We disagree with the commenters that the work involved in CPT code 50435 would be less clinically intense than the work in CPT code 36572. We believe that the exchange of a nephrostomy catheter taking place in CPT code 50435 is more difficult than the placement of a breast localization device as in the RUC crosswalk to CPT code 19283, percutaneous; first lesion, including stereotactic guidance). We also disagree with the commenters that the crosswalk we identified lacks clinical similarity to CPT code 36572. Both the reviewed code and the crosswalk to CPT code 50435 involve the percutaneous placement of a catheter in a deep structure; we believe that this crosswalk code is more clinically similar than the RUC's choice of a crosswalk to CPT code 19283, which does not involve catheter placement at all.

Commenter: Several commenters disagreed that the RUC-recommended work RVU of 2.00 for CPT code 36572 would create a rank order anomaly within the family of codes. Commenters stated that since CPT code 36568 requires more physician time to complete than CPT code 36572 (38 versus 22 minutes intra-service time), the recommended work RVU of 2.00 for CPT code 36572 maintains the proper rank order within this family of services considering differences in patient population and differences in clinical intensity of work.

Response: The commenters did not address the concerns we expressed regarding a potential rank order anomaly within the family. We noted in the proposed rule that CPT code 36572 had a lower recommended intraservice time and total time as compared to CPT code 36569 (not CPT code 36568), yet had a higher recommended work RVU. We continue to believe that this creates the potential for a rank order anomaly within the family, and we do not believe that this discrepancy can be justified by differences in patient population and differences in clinical intensity of work.

Comment: Several commenters disagreed with the CMS statement that the reduced intraservice and total times in CPT code 36572 as compared to CPT code 36568 should result in a lower work value. Commenters stated that this was a simplistic comparison based on time, and that these were two technically different procedures, involving different patient populations and different service intensity. Commenters stated that each step in the non-image guided CPT code 36568 takes longer, though involves more periods of low intensity intraservice work as compared to CPT code 36572, where each procedural step is performed sequentially without the less intense intraservice work of the non-image guided CPT code 36568.

Response: We disagree with the commenters that the reductions in intraservice and total work time in CPT code 36572 as compared to CPT code 36568 should not result in a lower work value. Although we do not imply that the decreases in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we continue to believe that, since the two components of work are time and intensity, significant decreases in time should typically be reflected in decreases to work RVUs. We disagree that this is a simplistic comparison, and chose a crosswalk to CPT code 50435 to better fit with the recommended work RVUs for CPT codes 36568 and 36569.

We also do not agree that CPT codes 36568 and 36572 have significantly different patient populations and different service intensity. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36572 is a new code resulting from the bundling together of CPT code 36568 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36568 and 76397 will now be reported under CPT code 36572. Given that 90 percent of the services that were formerly reported using CPT code 36568 will now be reported using CPT code 36572, we do not agree that these codes represent significantly different patient populations.

Comment: Many commenters disagreed with the proposed work RVU of 1.70 for CPT code 36573 and stated that CMS should finalize the RUC-recommended work RVU of 1.90. Commenters stated that CMS should not use a code value that is no longer in existence as the service (CPT code 36569) itself has been revised and is currently under review in this family. Commenters stated that the reference was therefore not valid to the old work RVU.Start Printed Page 59533

Response: We disagree with the commenters that it is somehow invalid to use a crosswalk to the current work RVU for CPT code 36569. It is not accurate to state that this code is no longer in existence, as it is being revised for CY 2019, not deleted. The RUC frequently recommends maintaining the current work RVU for reviewed codes rather than using a new work RVU from survey results when it believes that there is appropriate rationale to do so. Given that CPT code 36573 is a new code resulting from the bundling together of CPT code 36569 with imaging guidance, and that the use of imaging guidance has become typical in the performance of this service, we believe that it is appropriate to maintain the same work RVU for these services when they are reported under the new coding, especially in light of the fact that the surveyed intraservice work time for CPT code 36573 remains the same 15 minutes as the current intraservice work time for CPT code 36569.

Comment: Several commenters stated that CPT code 36573 involves a different patient population than CPT code 36569, as the patient population for CPT code 36573 does not have peripheral venous access present that can be used to obtain central venous access. Commenters stated that there is no evidence for a rank order anomaly within the codes in the family considering the differences in intensity and patient population.

Response: As we stated previously with regard to CPT codes 36568 and 36572, we also do not agree that CPT codes 36569 and 36573 have significantly different patient populations and different service intensity. As we stated in the proposed rule, we do not believe that the revised coding of the services in this family has changed the services themselves or resulted in an increase in their intensity, only changed in the way in which they will be reported under the new coding. CPT code 36573 is a new code resulting from the bundling together of CPT code 36569 with imaging guidance. The same services that were previously reported through a combination of CPT codes 36569 and 76397 will now be reported under CPT code 36573. Given that 95 percent of the services that were formerly reported using CPT code 36569 are expected to be reported using CPT code 36573, we do not agree that these codes represent noticeably different patient populations.

Comment: Several commenters disagreed with our use of CPT code 36556 as a reference code. Commenters stated that CPT code 36556 describes line placement in a larger and more central vein such as the internal jugular vein with known anatomical landmarks and a shorter distance between access and where the tip terminates centrally while CPT code 36573 describes access into a smaller vein without anatomic landmarks. Commenters stated that although imaging is inherent to CPT code 36573, the catheter is longer and there is a need to navigate the catheter through these peripheral and central veins for adequate placement, all of which would require more work.

Response: We disagree with the commenters that CPT code 36556 would not be an accurate reference code for CPT code 36573. CPT code 36556 describes the insertion of non-tunneled centrally inserted central venous catheter whereas CPT code 36573 describes the insertion of a peripherally inserted central venous catheter (PICC). We believe that these two codes, which both describe the insertion of central venous catheters, are highly similar to one another on a clinical basis and also from the perspective of work time, as they share the identical intraservice work time and total work time. Moreover, after further consideration, we are not able to identify any other more appropriate reference code for CPT code 36573 than CPT code 36556.

Comment: Many commenters disagreed with the proposed work RVU of 1.20 for CPT code 36584 and stated that CMS should finalize the RUC-recommended work RVU of 1.47. Commenters stated that CMS was completely dismissing the additional work that was bundled in with CPT code 36584 as part of the imaging guidance. Commenters stated that the RUC agreed that the recommended work RVU of 1.47 involves less time but involves a significant increase in intensity, and that the work RVU should not remain at the current work RVU of 1.20 as CPT code 36584 is now a bundled service.

Response: We disagree with the commenters that the bundling of a service or the addition of imaging guidance must necessarily increase the intensity of the service or the work RVU. As we stated above, while the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We believe that if CPT code 36584 had become significantly more intensive to perform, this would be reflected in the surveyed work times associated with the code. However, the surveyed intraservice work time and total work time for CPT code 36584 are both decreasing from their current values. As we stated in the proposed rule, we believe that these work times are decreasing due to a combination of improving technology and greater efficiencies in practice patterns, and we believe that the use of imaging guidance has become now typical for CPT code 36584 and does not represent a dramatic increase in intensity.

Comment: Several commenters disagreed with the proposal to refine the clinical labor time for the “Prepare, set-up and start IV, initial positioning and monitoring of patient” (CA016) activity from 4 minutes to 2 minutes for CPT codes 36572 and 36573. Commenters stated that this additional clinical labor time would be typical since it included positioning of the patient as well as positioning the two forms of imaging equipment which are being bundled into the code (fluoroscopy and ultrasound). Commenters stated that the equipment needs to be positioned in a manner that is specific to the procedure and the chosen extremity, and that it takes approximately 2 additional minutes to position the patient and the equipment for those codes which are imaging-guided as opposed to those procedures which are not. Commenters stated that this difference applies to the two new placement codes (CPT code 36572 and 36573) but not to the replacement code (CPT code 36584) as the equipment is limited to fluoroscopy and the positioning is slightly simpler as the site already contains a PICC line.

Response: After consideration of the new information provided by the commenters regarding the need for additional positioning time, we are not finalizing our proposed refinement to the CA016 clinical labor time. Due to this change in clinical labor time, we are also not finalizing any changes to the RUC-recommended equipment times.

After consideration of the public comments, we are finalizing the work RVUs for the codes in the PICC Line Procedures family as proposed. After considering public comments, we are not finalizing our proposed direct PE refinements, and we are instead finalizing the RUC-recommended direct PE inputs for all five codes.

(16) Biopsy or Excision of Inguinofemoral Node(s) (CPT Code 38531)

In September 2017, the CPT Editorial Panel created a new code to describe biopsy or excision of inguinofemoral node(s). A parenthetical was added to CPT codes 56630 (Vulvectomy, radical, partial) and 56633 (Vulvectomy, radical, complete) to instruct separate reporting of CPT code 38531 with radical Start Printed Page 59534vulvectomy. This service was previously reported with unlisted codes.

CPT code 38531 (Biopsy or excision of lymph node(s); open, inguinofemoral node(s)) is a new CPT code describing a lymph node biopsy without complete lymphadenectomy. The RUC recommended a work RVU of 6.74 for CPT code 38531, with 223 minutes of total time and 65 minutes of intraservice time. We proposed the RUC-recommended work RVU of 6.74 for CPT code 38531. However, we were concerned that this CPT code is described as having a 10-day global period. The two CPT codes that are often reported together with this code, CPT codes 56630 and 56633, are both 90-day global codes. In addition, CPT code 38531 has a discharge visit and two follow up visits in the global period. This is consistent with the number of postoperative visits typically associated with 90-day global codes. Therefore, we proposed to assign a 90-day global indicator for CPT code 38531 rather than the 10-day global time period reflected in the RUC recommendation.

We did not propose any direct PE refinements for this code family.

Comment: Several commenters thanked us for proposing the RUC-recommended work RVU of 6.74 for CPT code 38531.

Response: We appreciate the support from commenters.

Comment: Several stakeholders disagreed with CMS's proposal to change the global status of this code from a 10-day global code to a 90-day global code. They maintained that there are no claims data available to assess how often CPT code 38531 will be billed together with CPT codes 56630 or 56633. Commenters also noted that there is no necessary direct correlation between the two codes (CPT code 56630 and CPT code 56633) having a 90-day global period and the new code having a 90-day global period.

Response: We agree with commenters that when two or more closely related CPT codes are billed together, there is no requirement for them to share the same global period. However, the amount of post service time and the number of visits in CPT code 38531 are consistent with other 90-day global codes. We continue to believe that CPT code 38531 should have a 90-day global period and we are finalizing that change as proposed.

Comment: A few commenters pointed out that CMS has the opportunity to review the global periods for new codes directly after CPT Editorial Panel meetings, and that CMS should have provided input regarding the code's global period at that time.

Response: While some of our staff have the opportunity to review global periods for new or modified CPT codes immediately after the CPT Editorial Panel meeting, the Agency does not systematically review or provide feedback on components of a CPT code, including global period, until we fully consider and address the code as part of the annual PFS notice-and-comment rulemaking process.

After consideration of the public comments, we are finalizing a work RVU of 6.74 for CPT code 38531 as proposed.

(17) Radioactive Tracer (CPT Code 38792)

CPT code 38792 (Injection procedure; radioactive tracer for identification of sentinel node) was identified as potentially misvalued on a screen of codes with a negative intraservice work per unit of time (IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other source codes. For CY 2019, we proposed the RUC-recommended work RVU of 0.65 for CPT code 38792.

For the direct PE inputs, we proposed to refine the clinical labor time for the “Prepare room, equipment and supplies” (CA013) activity to 3 minutes and to refine the clinical labor time for the “Confirm order, protocol exam” (CA014) activity to 0 minutes. CPT code 38792, as well as its alternate reference code, CPT code 78300 (Bone and/or joint imaging; limited area), did not previously have clinical labor time assigned for the “Confirm order, protocol exam” clinical labor task, and we do not have any reason to believe that the services being furnished by the clinical staff have changed, only the way in which this clinical labor time has been presented on the PE worksheets. We also note that there is no effect on the total clinical labor direct costs in these situations, since the same 3 minutes of clinical labor time is still being furnished. We also proposed to refine the equipment times in accordance with our standard equipment time formulas.

The following is a summary of the public comments we received on our proposals involving CPT code 38792.

Comment: A commenter stated that they appreciated and supported our proposal to adopt the RUC-recommended work RVU of 0.65. The commenter also stated that they agreed with and supported the changes CMS proposed in clinical labor time and the standardized equipment time formulas.

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

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 38792 as proposed.

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

CPT code 43760 (Change of gastrostomy tube, percutaneous, without imaging or endoscopic guidance) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years with Medicare utilization greater than 20,000. It was surveyed for the April 2017 RUC meeting and recommendations for work and direct PE inputs were submitted to CMS. However, the RUC also noted that because the data for CPT code 43760 were bimodal, it might be appropriate to consider changes in the CPT descriptors to better differentiate physician work. In September 2017, the CPT Editorial Panel deleted CPT code 43760 and will use two new CPT codes, CPT codes 43762 and 43763, which describe replacement of gastrostomy tube, with and without revision of gastrostomy tract, respectively. (See discussion of these codes below.) Therefore, we did not propose work or direct PE values for CPT code 43760.

Due to the impending deletion of CPT code 43760, we received no comments on this code.

(19) Gastrostomy Tube Replacement (CPT Codes 43762 and 43763)

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

We proposed a work RVU of 0.75 for CPT code 43762 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; not requiring revision of gastrostomy tract.) and a work RVU of 1.41 for CPT code 43763 (Replacement of gastrostomy tube, percutaneous, includes removal, when performed, without imaging or endoscopic guidance; requiring revision of gastrostomy tract.), consistent with the RUC's recommendations for these new CPT codes.Start Printed Page 59535

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

The following is a summary of the public comments we received on our proposals involving the codes in the Gastrostomy Tube Replacement code family.

Comment: Several commenters stated that they appreciated CMS proposing the RUC-recommended work RVU for CPT codes 43762 and 43763.

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

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

Response: For the four equipment items where we made time refinements, we added the clinical labor for the CA029 clinical labor activity in accordance with our standard equipment time formula for non-highly technical equipment.

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for the codes in the as Gastrostomy Tube Replacement code family as proposed.

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

CPT code 45300 (Proctosigmoidoscopy, rigid; diagnostic, with or without collection of specimen(s) by brushing or washing (separate procedure)) was identified as potentially misvalued on a screen of 0-day global services reported with an E/M visit 50 percent of the time or more, on the same day of service by the same patient and the same practitioner, that have not been reviewed in the last 5 years, with Medicare utilization greater than 20,000. For CY 2019, we proposed the RUC-recommended work RVU of 0.80 for CPT code 45300.

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

The following is a summary of the public comments we received on our proposals involving CPT code 45300.

Comment: Commenters were supportive of our proposal of the RUC-recommended work RVUs.

Response: We thank commenters for their support.

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

Response: For the four equipment items where we made time refinements, we removed the clinical labor for the CA035 clinical labor activity in accordance with our standard equipment time formula for non-highly technical equipment.

After consideration of the public comments, we are finalizing the work RVU and direct PE inputs for CPT code 45300 as proposed.

(21) Hemorrhoid Injection (CPT Code 46500)

CPT code 46500 (Injection of sclerosing solution, hemorrhoids) was identified as potentially misvalued on a screen of codes with a negative intraservice work per unit of time (IWPUT), with 2016 estimated Medicare utilization over 10,000 for RUC reviewed codes and over 1,000 for Harvard valued and CMS/Other source codes.

For CPT code 46500, we disagreed with the RUC-recommended work RVU of 2.00 and we proposed a work RVU of 1.74 based on a direct crosswalk to CPT code 68811 (Probing of nasolacrimal duct, with or without irrigation; requiring general anesthesia). This crosswalk code is another recently-reviewed 10-day global code with the same 10 minutes of intraservice time and slightly higher total time. When CPT code 46500 was previously reviewed as described in the CY 2016 PFS final rule with comment period (80 FR 70963), we finalized a proposal to reduce the work RVU from 1.69 to 1.42, which reduced the work RVU by the same ratio as the reduction in the total work time. In light of the additional evidence provided by this new survey, we agree that the work RVU should be increased from the current value of 1.42. However, we believe that our proposed work RVU of 1.74 based on a crosswalk to CPT code 68811 is more accurate than the RUC-recommended work RVU of 2.00.

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

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

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

The following is a summary of the public comments we received on our proposals involving CPT code 46500.

Comment: Many commenters disagreed with the proposed work RVU Start Printed Page 59536of 1.74 for CPT code 46500 and stated that CMS should finalize the RUC-recommended work RVU of 2.00. Commenters stated that they disagreed with CMS calculating intraservice time ratios to account for changes in work time, and that CPT code 46500 possesses a negative IWPUT, which makes the use of time ratios particularly inappropriate.

Response: We disagree with the commenters and continue to believe that the use of time ratios is one of several reasonable methods for identifying potential work RVUs for particular PFS services, particularly when the alternative values do not account for information that suggests the amount of time involved in furnishing the service has changed significantly. We reiterate that, consistent with the statute, we are required to value the work RVU based on the relative resources involved in furnishing the service, which include time and intensity. When our review of recommended values reveals that changes in the resource of time have been unaccounted for in a recommended RVU, then we believe we have the obligation to account for that change in establishing work RVUs since the statute explicitly identifies time as one of the two elements of the work RVUs. We recognize that it would not be appropriate to develop work RVUs solely based on time given that intensity is also an element of work, but in applying the time ratios, we are using derived intensity measures based on current work RVUs for individual procedures. Were we to disregard intensity altogether, the work RVUs for all services would be developed based solely on time values and that is definitively not the case, as indicated by the many services that share the same time values but have different work RVUs. (As an example, CPT codes 38222, 54231, 55870, 75573, and 78814 all share identical CY 2019 work times with 15 minutes of preservice time, 30 minutes of intraservice time, and 15 minutes of postservice time; however these codes have respective CY 2019 work RVUs of 1.44, 2.04, 2.58, 2.55, and 2.20.) Furthermore, we reiterate that we use time ratios to identify potentially appropriate work RVUs, and then use other methods (including estimates of work from CMS medical personnel and crosswalks to key reference or similar codes) to validate these RVUs. For more details on our methodology, we direct readers to the CY 2017 PFS final rule (81 FR 80272 through 80277). We also note that in the case of CPT code 46500, we derived our proposed work RVU of 1.74 by using a direct crosswalk to CPT code 68811 and not a time ratio.

Comment: Several commenters stated that the RUC compared CPT code 46500 to the two key reference services: CPT code 46221 (Hemorrhoidectomy, internal, by rubber band ligation(s)) and CPT code 46930 (Destruction of internal hemorrhoid(s) by thermal energy (e.g., infrared coagulation, cautery, radiofrequency)). Commenters stated that the RUC-recommended work RVU of 2.00 places the value correctly between the key reference services and results in similar procedure intensity, whereas the CMS crosswalk to CPT code 68811 was not well aligned with the top two key reference services due to having a lower intensity.

Response: We disagree with the commenters that our crosswalk to CPT code 68811 would be less accurate for work valuation than the two key references chosen by the survey respondents. We note, for example, that CPT code 46221 has 50 percent more intraservice time than CPT code 46500, and CPT code 46930 has 50 percent less intraservice time than CPT code 46500, whereas the CMS crosswalk to CPT code 68811 shares the same 10 minutes of intraservice time as CPT code 46500. We believe that this closer match in the work time values makes CPT code 68811 a more appropriate choice for a crosswalk code. We also note that at the RUC meeting when CPT code 46500 was under review, the specialty presenters stated that the work RVU had not changed from the historical value of 1.69 before the recommendation was changed to the final value of 2.00. As we stated in the proposed rule, the 3 percent increase in surveyed work time for CPT code 46500 matches a 3 percent increase in the historic work RVU of the code, from 1.69 to 1.74. We continue to believe that this is the most accurate value to finalize for CPT code 46500.

Comment: Several commenters compared CPT code 46500 to CPT code 68810 (Probing of nasolacrimal duct, with or without irrigation) and noted that these codes have the same intraservice work time but the comparison code includes a lower level follow-up visit and therefore correctly has a lower work RVU. Commenters stated that CPT code 46500 includes a follow-up office visit with an anoscopy to determine the effectiveness of the treatment and to monitor for infection or sepsis which adds work to the visit. Commenters stated that the proposed CMS crosswalk to CPT code 68811 includes an even lower level office visit (CPT code 99211) than the office visit in CPT code 68810, which indicated that it was an inappropriate choice for a crosswalk.

Response: We continue to disagree with the commenters that the CMS crosswalk to CPT code 68811 would provide an inappropriate work valuation for CPT code 46500 based on the differences in postoperative work and work time. We would like to clarify again that we used CPT code 68811 as our crosswalk, not CPT code 68810, and we do not understand the comparisons to CPT code 68810 suggested by the commenters. Regarding our crosswalk code, while it is true that CPT code 68811 does not contain a level three (CPT code 99213) office visit in its global period like CPT code 46500, the code does include half of a discharge visit (CPT code 99238) in its global period, which is missing from the reviewed code. Under the building block methodology, the combined work RVU and the work time of a half discharge visit (CPT code 99238) and a level 1 office visit (CPT code 99211) would equal 0.82 RVUs and 26 minutes. This is approximately equal to the level 3 office visit (CPT code 99213 with 0.97 work RVUs and 23 minutes of work time) in the global period of CPT code 46500. As a result, we do not agree with the commenters that CPT code 46500 has a significantly greater amount of postservice work and postservice work time than our crosswalk code.

Comment: Several commenters responded to our request for more information about why the clinical labor associated with the additional staff member was left out of previous reviews and what activities the additional staff member would be undertaking during the procedure. Commenters stated that two clinical staff are needed to assist the physician during the intraservice portion of the service: one staff person is handling suction and holding the retractor while the surgeon identifies and injects anesthetic and sclerosant into the poles of the hemorrhoids, and the second staff person is handing supplies (syringes, gauze) and taking soiled supplies away. The commenters stated that one staff person will assist with tasks such as irrigation, suction, etc. and one circulating staff person will hand syringes, sponges, etc. to the physician.

Response: We appreciate the additional feedback from the commenters regarding what activities the additional staff member would be undertaking during the procedure, although we note that we did not receive a response regarding why the clinical labor associated with this additional staff member was left out of previous reviews. After reviewing the Start Printed Page 59537additional information supplied by the commenters, we are not finalizing our proposal to remove the clinical labor time for the “Assist physician or other qualified healthcare professional” (CA018) activity or the proposal to remove 1 impervious staff gown (SB027), 1 surgical mask with face shield (SB034), and 1 pair of shoe covers (SB039). We are finalizing the RUC-recommended values for these direct PE inputs.

Comment: Several commenters disagreed with the proposal to remove the clinical labor time for the “Review home care instructions, coordinate visits/prescriptions” (CA035) activity. Commenters stated that this clinical activity was not duplicative with the same day E/M office visit, as the home care instructions directly pertain to the procedure and would not be provided during an evaluation of the patient.

Response: We disagree with the commenters that home care instructions would not be provided during the same day E/M visit. The commenters did not provide a rationale to explain why home care instructions would not be provided during the same day E/M visit, which also directly pertains to the procedure. We continue to believe that it would be duplicative to assign clinical labor time for this task, as we believe that the home care instructions would be furnished during the same day E/M visit.

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

Response: For the anoscope with light source (ES002) equipment, we removed the clinical labor for the CA029 and CA035 clinical labor activities in accordance with our standard equipment time formula for scopes.

After consideration of the public comments, we are finalizing the work RVU for CPT code 46500 as proposed. We are finalizing the RUC-recommended direct PE inputs for this code, with the exception of our refinement to the CA035 clinical labor activity and standard equipment time refinements as detailed above.

(22) Removal of Intraperitoneal Catheter (CPT Code 49422)

In October 2016, CPT code 49422 (Removal of tunneled intraperitoneal catheter) was identified as a site of service anomaly because Medicare data from 2012-2014 indicated that it was performed less than 50 percent of the time in the inpatient setting, yet it included inpatient hospital E/M services within the 10-day global period. The code was resurveyed using a 0-day global period for the April 2017 RUC meeting. For CY 2019, we proposed the RUC-recommended work RVU of 4.00 for CPT code 49422.

We did not propose any direct PE refinements for this code family.

The following is a summary of the public comments we received on our proposals involving CPT code 49422.

Comment: Commenters were supportive of our proposal of the RUC-recommended work RVUs. Commenters also supported the change in global period to a 0-day global.

Response: We thank commenters for their support.

After consideration of the public comments, we are finalizing the RUC-recommended work RVU and direct PE inputs for CPT code 49422 as proposed.

(23) Dilation of Urinary Tract (CPT Codes 50436, 50437, 52334, and 74485)

In October 2014, the CPT Editorial Panel deleted 6 codes and created 12 new codes to describe genitourinary catheter procedures and bundle inherent imaging services. In January 2015, the specialty societies indicated that CPT code 50395 (Introduction of guide into renal pelvis and/or ureter with dilation to establish nephrostomy tract, percutaneous), which was identified as part of the family, would be referred to the CPT Editorial Panel to clear up any confusion with overlap in physician work with CPT code 50432 (Placement of nephrostomy catheter, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation). In September 2017, the CPT Editorial Panel deleted CPT code 50395 and created 2 new codes to report dilation of existing tract, and establishment of new access to the collecting system, including percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy), all associated radiological supervision and interpretation, as well as post procedure tube placement when performed.

The specialty society surveyed the new CPT code 50436 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation, as well as post procedure tube placement, when performed), and the RUC recommended a total time of 70 minutes, intraservice time of 30 minutes, and a work RVU of 3.37. The RUC indicated that its recommended work RVU for this CPT code is identical to the work RVU of the CPT code being deleted, even though imaging guidance CPT code 74485 has now been bundled into the valuation of the CPT code. The RUC provided two key reference CPT codes to support its recommendation: CPT code 50694 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, without separate nephrostomy catheter) with total time of 111 minutes, intraservice time of 62 minutes, and a work RVU of 5.25; and CPT code 50695 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, with separate nephrostomy catheter), with total time of 124 minutes and intraservice time of 75 minutes, and a work RVU of 6.80. To further support its recommendation, the RUC also referenced CPT code 52287 (Cystourethroscopy, with injection(s) for chemodenervation of the bladder) with total time of 58 minutes, intraservice time of 21 minutes, and a work RVU of 3.37.

We disagreed with the RUC that the work RVU for this CPT code should be the same as the CPT code being deleted. Survey respondents indicated that the total time for completing the service described by the new CPT code is nearly 30 minutes less than the existing CPT code, even though imaging guidance was described as part of the procedure. We also noted that the reference CPT codes both have substantially higher total and intraservice times than CPT code 50436. We considered a number of parameters to arrive at our proposed work RVU of 2.78, supported by a crosswalk to CPT code 31646 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with therapeutic aspiration of tracheobronchial tree, subsequent, same hospital stay). We examined the intraservice time ratio for the new CPT code in relation to the combination of CPT codes that the service represents and found that this would support a work RVU of 2.55. We also calculated the intraservice time ratio for the new CPT code in relation to each of the two Start Printed Page 59538reference CPT codes. For the comparison with CPT code 50694, the intraservice time ratio is 2.54, while the comparison with the second reference CPT code 50695 yields an intraservice time ratio of 2.72. We took the highest of these three values, 2.72, and found a corresponding crosswalk that we believe appropriately values the service described by the new CPT code. Therefore, we proposed a work RVU of 2.78 for CPT code 50436.

The specialty society also surveyed the new CPT code 50437 (Dilation of existing tract, percutaneous, for an endourologic procedure including imaging guidance (e.g., ultrasound and/or fluoroscopy) and all associated radiological supervision and interpretation, as well as post procedure tube placement, when performed; including new access into the renal collecting system) and the RUC recommended a total time of 100 minutes, an intraservice time of 60 minutes, and a work RVU of 5.44. The recommended intraservice time of 60 minutes reflects the 75th percentile of survey results, rather than the median survey time, which is typically used for determining the intraservice time for new CPT codes. The RUC justified the use of the higher intraservice time because they believe the time better represents the additional time needed to introduce the guidewire into the renal pelvis and/or ureter, above and beyond the work involved in performing CPT code 50436. The RUC compared this CPT code to CPT code 52235 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; MEDIUM bladder tumor(s) (2.0 to 5.0 cm)), with total time of 94 minutes, intraservice time of 45 minutes, and a work RVU of 5.44. The RUC also cited as support the second key reference CPT code 50694 (Placement of ureteral stent, percutaneous, including diagnostic nephrostogram and/or ureterogram when performed, imaging guidance (e.g., ultrasound and/or fluoroscopy), and all associated radiological supervision and interpretation; new access, without separate nephrostomy catheter) with total time 111 minutes, intraservice time 62 minutes, and a work RVU of 5.25.

We did not agree with the RUC's recommended work RVU because we believed that the intraservice time for this CPT code should reflect the survey median rather than the 75th percentile. There is no indication that the additional work of imaging guidance was systematically excluded by survey respondents when estimating the time needed to furnish the service. Therefore, we proposed to reduce the intraservice time for CPT code 50437 from the RUC- recommended 60 minutes to the survey median time of 45 minutes. We noted that this is still 15 minutes more than the intraservice time for CPT code 50436, primarily for the provider to introduce the guidewire into the renal pelvis and/or ureter. We welcomed comments about the amount of time needed to furnish this procedure.

With the revised intraservice time of 45 minutes and a total time of 85 minutes, we believed that the RUC-recommended work RVU for this CPT code is overstated. When we applied the increment between the RUC-recommended values for between CPT codes 50436 and 50437 (2.07 work RVUs) in addition to our proposed work RVU for CPT code 50436, we estimated that this CPT code was more accurately represented by a work RVU of 4.83. This value is supported by a crosswalk to CPT code 36902 (Introduction of needle(s) and/or catheter(s), dialysis circuit, with diagnostic angiography of the dialysis circuit, including all direct puncture(s) and catheter placement(s), injection(s) of contrast, all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava, fluoroscopic guidance, radiological supervision and interpretation and image documentation and report; with transluminal balloon angioplasty, peripheral dialysis segment, including all imaging and radiological supervision and interpretation necessary to perform the angioplasty), which has an intraservice time of 40 minutes and a total time of 86 minutes. We believed that CPT code 36902 describes a service that is similar to the new CPT code 50437) and therefore provides a reasonable crosswalk. We proposed a work RVU of 4.83 for CPT code 50437.

We proposed the RUC-recommended work RVU of 3.37 for CPT code 52334 (Cystourethroscopy with insertion of ureteral guide wire through kidney to establish a percutaneous nephrostomy, retrograde) and the RUC-recommended work RVU of 0.83 for CPT code 74485 (Dilation of ureter(s) or urethra, radiological supervision and interpretation).

For the direct PE inputs, we proposed to remove the clinical labor time for the “Confirm availability of prior images/studies” (CA006) activity for CPT code 52334. This code does not currently include this clinical labor time, and unlike the two new codes in the family (CPT codes 50436 and 50437), CPT code 52334 does not include imaging guidance in its code descriptor. When CPT code 52334 is performed with imaging guidance, it would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images. As a result, we believed that it would be duplicative to include this clinical labor time in CPT code 52334.

The following is a summary of the public comments we received on our proposals involving the Dilation of Urinary Tract family of codes.

Comment: Several commenters responded to our proposals regarding work RVUs for this family of codes. In general, commenters expressed support for our proposed work RVU of 3.37 for CPT code 52334 and 0.83 for CPT code 74485.

Response: We are finalizing the work RVUs for each of these codes as proposed.

Comment: Several commenters did not support our proposals regarding the work RVU for CPT codes 50436 and 50437. The RUC and other commenters stated that CMS misunderstood the RUC's summary of results (SOR) and the purpose of the reference codes and the code comparisons as part of their review process. They suggested that our rejection of the RUC recommendation for CPT code 50436 was based on a mistake about the codes that the RUC cited as reference codes.

Response: We consider a variety of documents and data during our review of the RUC's recommended work RVU for a code. The two reference codes cited in the excel summary work RVU spreadsheet for CPT code 50436 were CPT codes 50694 and 50695, while the two reference codes cited in the SOR were CPT codes 52287 52214. In other words, there was an inconsistency in the documentation. We believe that any of the four reference codes cited in the documentation and/or data are valid points of comparison for evaluating whether the RUC's recommended work RVUs are appropriate.

Comment: Some commenters did not agree with CMS's use of intraservice time ratios as a factor in determining whether a CPT code is appropriately valued. The commenters maintained that CMS's use of these parameters is inappropriate and demonstrates our prioritization of time-related factors above the intensity and complexity of the service.

Response: We routinely use intraservice time ratios to determine whether a recommended work RVU for a new CPT code adequately reflects efficiencies gained when codes are bundled and/or providers become more efficient at furnishing services and we disagree with commenters that time Start Printed Page 59539ratios are an inappropriate metric. We identify a crosswalk for the purpose of establishing the work RVU by comparing the survey code to other codes in the PFS with similar intraservice and total times and also by considering the intensity among codes with similar times. We disagree that this means we are prioritizing time parameters over other factors that are relevant in considering a code's value.

Comment: Commenters disagreed with CMS's proposed work RVU of 2.78 for CPT code 50436, citing CMS's inappropriate use of time parameters in comparing this code with the deleted CPT code 50395.

Response: Even after taking into consideration the bundling of the deleted code, CPT 50395, with CPT code 74485, we believe that there are efficiencies in the work that are not adequately reflected in the RUC-recommended work RVU for this new code, CPT 50436. We examined a number of parameters in seeking an appropriate crosswalk code for CPT 50436, including the intraservice time ratio for this new code in relation to the combination of CPT codes that the service represents and the intraservice time ratio for the new code in relation to each of the RUC's two reference codes. Our crosswalk, CPT code 31646, reflects the work RVU (2.78) corresponding to the most appropriate, and the highest, work RVU (2.72) associated with these calculations. Our identification of a crosswalk code is not dictated by the time parameter calculations alone, but rather is based on a combination of the time parameters and our understanding of the intensity involved in furnishing the service. If we had been looking only at time parameters, we might have chosen a CPT code with a work RVU closest to the lowest of the time parameter calculations (2.54). We continue to believe that the most appropriate crosswalk is CPT code 31646, and we are finalizing our proposed work RVU of 2.78 for CPT code 50436.

Comment: As with CPT code 50436, commenters suggested that CMS mistook the codes included in the SOR as the codes that the RUC cited as reference codes.

Response: As we indicated in our response to this comment for CPT code 50436, we consider all documentation and data provided by the RUC in our assessment of the work RVU for a code. The reference and comparison CPT codes cited in the SOR did not match those in the summary work RVU spreadsheet.

Comment: Several commenters disagreed with our method of proposing a work RVU based on the incremental differences in the RUC-recommended work RVU between codes. Commenters stated that this erroneously considers all time components as having equal intensity.

Response: We generally apply this methodology where we agree with, and seek to maintain the relativity between two codes reflected in the RUC recommendations, but we disagree with the RUC-recommended work RVU for one or both of the codes. We also considered, as an alternative, whether it would be more appropriate to use proportional increments rather than absolute differences between two RUC-recommended work RVUs. Under that scenario, we would have proposed a work RVU of 4.49 for CPT code 50437 [(2.78 * 5.44)/3.37 = 4.49]. However, since our general approach involves applying the absolute difference in work RVUs, our proposed value for CPT code 50437 was 4.83 work RVUs. We thank the commenter for pointing out our calculation error, due to which our proposed work RVU should have been 4.85 instead of 4.83. We continue to believe that relative difference in the RUC's recommendations for work RVUs between codes is a useful and appropriate tool for determining work RVUs for CPT codes, and we are finalizing a work RVU of 4.85 for CPT code 50437 based on a comparison with CPT code 36902, which has a work RVU of 4.83.

Comment: Several commenters disagreed with the proposal to remove the clinical labor time for the “Confirm availability of prior images/studies” (CA006) activity for CPT code 52334. Commenters stated that the equivalent of the CA006 clinical labor activity did not exist when this service was last reviewed by the Practice Expense subcommittee in 2002, and that many surgical procedures and other types of services that do not have imaging bundled involve the physician reviewing images and studies before performing the service. Commenters stated that this review is not duplicative with image-guidance codes as it instead involves reviewing distinct previous studies.

Response: We continue to believe that this clinical labor time should be removed because it is duplicative, as CPT code 52334 would be billed together with a separate imaging code that already includes clinical labor time for confirming the availability of prior images when it is performed with imaging guidance. We believe that the commenters may be conflating the absence of the CA006 clinical labor activity when CPT code 52334 was previously reviewed with the lack of any clinical labor for reviewing images that did not exist previously in this specific code. There were hundreds of procedures that included clinical labor for reviewing images prior to the creation of the CA006 clinical labor code, and CPT code 52334 was not one of them. Similarly, while we agree that there are many services that do not have bundled imaging and nonetheless include the physician reviewing images and studies before performing the service, this does not explain why CPT code 52334 would require clinical labor time for confirming the availability of prior images and studies when the service did not include this clinical labor time previously. We continue to believe that the inclusion of this clinical labor time would be duplicative for this service.

Comment: One commenter requested that CPT code 52334 be added to the phase-in list for codes with significant PE RVU reductions.

Response: Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year period. We proposed to exempt CPT code 52334 from the phase-in due to the fact that it is part of the same family of codes that included new CPT codes 50436 and 50437. We have previously finalized this policy through rulemaking, stating that significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Excluding codes from the phase-in when there are significant revisions to the code family also helps to maintain the appropriate rank order among codes in the family, avoiding years for which RVU changes for some codes in a family are in transition while others were fully implemented. For additional information regarding the phase-in of significant RVU reductions, we direct readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70929).

(24) Transurethral Destruction of Prostate Tissue (CPT Codes 53850, 53852, and 53854)

In September 2017, the CPT Editorial Panel created a new code (CPT code Start Printed Page 5954053854) to report transurethral destruction of prostate tissue by radiofrequency-generated water vapor thermotherapy. CPT codes 53850 (Transurethral destruction of prostate tissue; by microwave thermotherapy) and 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) were also included for review as part of the same family of codes.

For CPT code 53850 (Transurethral destruction of prostate tissue; by microwave thermotherapy), the RUC recommended a work RVU of 5.42, supported by a direct crosswalk to CPT code 33272 (Removal of subcutaneous implantable defibrillator electrode) with a total time of 151 minutes, intraservice time of 45 minutes, and a work RVU of 5.42. The RUC indicated that a work RVU of 5.42 accurately reflects the lowest value of the three CPT codes in this family. We proposed the work RVU of 5.42 for CPT code 53850, as recommended by the RUC.

The RUC recommended a work RVU of 5.93 for CPT code 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) and for CPT code 53854 (Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy). We proposed the RUC-recommended work RVU of 5.93 for CPT code 53852.

CPT code 53854 is a service reflecting the use of a new technology, “radiofrequency generated water vapor thermotherapy,” as distinct from CPT code 53852, which describes destruction of tissue by “radiofrequency thermotherapy.” The RUC indicated that this CPT code is the most intense of the three CPT codes in this family, thereby justifying a work RVU identical to that of CPT code 53852, despite lower intraservice and total times. The RUC stated that 15 minutes of post service time is appropriate due to greater occurrence of post-procedure hematuria necessitating a longer monitoring time. However, the post-service monitoring time for this CPT code, 15 minutes, is identical to that for CPT code 53852. We did not agree with the explanation provided by the RUC for recommending a work RVU identical to that of CPT code 53852, given that the total time is 5 minutes lower, and the post service times are identical. Both the intraservice time ratio between this new CPT code and CPT code 53852 (4.94) and the total time ratio between the two CPT codes (5.72) suggest that the RUC-recommended work RVU of 5.93 overestimates the work involved in furnishing this service. We reviewed other 90-day global CPT codes with similar times and identified CPT code 24071 (Excision, tumor, soft tissue of upper arm or elbow area, subcutaneous; 3 cm or greater) with a total time of 183 minutes, intraservice time of 45 minutes, and a work RVU of 5.70 as an appropriate crosswalk. We believed that this would be a better reflection of the work involved in furnishing CPT code 53854, and therefore, we proposed a work RVU of 5.70 for this CPT code. We welcomed comments about the time and intensity required to furnish this new service. Since this CPT code reflects the use of a new technology, it will be reviewed again in 3 years.

For the direct PE inputs, we proposed to add a new supply (SA128: “kit, Rezum delivery device”), a new equipment item (EQ389: “generator, water thermotherapy procedure”), and proposed to update the price of two supplies (SA036: “kit, transurethral microwave thermotherapy” and SA037: “kit, transurethral needle ablation (TUNA)”) after reviewing invoices that we received. We noted that these invoices were submitted along with additional information listing the vendor discount for these supplies and equipment. We appreciated the inclusion of the discounted prices on these invoices, and we encouraged other invoice submissions to provide the discounted price as well, where available. Based on market research on supply and equipment pricing carried out by our contractors, we believe that a vendor discount of 10-15 percent is common on many supplies and equipment. Since we are obligated by statute to establish RVUs for each service as required based on the resource inputs required to furnish the typical case of a service, we have concerns that relying on invoices for supply and equipment pricing absent these vendor discounts may overestimate the resource cost of some services. We encouraged the submission of additional invoices that include the discounted price of supplies and equipment to more accurately assess the market cost of these resources.

The following is a summary of the public comments we received on our proposals involving the Transurethral Destruction of Prostate Tissue family of codes.

Comment: Several commenters expressed support for our proposed work RVU of 5.42 for CPT code 53850 and 5.93 for CPT code 53852, which reflect the RUC's recommendations for these two codes.

Response: We appreciate the commenters' support and we are finalizing a work RVU of 5.42 for CPT code 53850 and a work RVU of 5.93 for CPT code 53852.

Comment: A commenter pointed out that there is an error in our description of the RUC's time components for this code. We stated that there was less post service time for CPT code 53854 than for CPT code 53852 when, in fact, both codes have a post service time of 15 minutes. The intraservice time between the two codes differs by 5 minutes, with CPT code 53854 having 5 fewer minutes than CPT code 53852.

Response: We thank the commenter for informing us of the error. We note, however, that this does not affect our proposal which is based on a comparison of both intraservice and total time ratios.

Comment: Several commenters, ranging from device manufacturers and professional associations, disagreed with our proposed value of 5.70 for CPT code 53854 instead of the RUC-recommended work RVU of 5.93. Commenters stated that the work involved in furnishing the service described by CPT code 53854 is the most intense of the three CPT codes in this family because of the added risk of bleeding, urinary retention and damage to the external urinary sphincter with resultant incontinence of urine if not performed properly. Commenters also urged CMS to approach the time results from the survey for this code with caution, as few practitioners are likely to have had much experience with the new technology described by this service.

Response: In our proposal, we requested additional information from stakeholders about the time and intensity required to furnish this service because we were not convinced that the work involved in furnishing the service described by CPT code 53854 is more intense than the work involved in furnishing CPT code 53852, which the RUC used as a reference code in developing their recommendation. We were convinced by commenters, however, that the additional risk in furnishing this service supports a higher work RVU than what we proposed. Therefore, we are finalizing a work RVU of 5.93 for this CPT code, as recommended by the RUC.

Comment: One commenter stated that both CPT codes should be subject to the phase-in for CY 2019 because they will decrease more than 20 percent and are not new or revised codes. The commenter urged CMS to add CPT codes 52380 and 52382 to the list of codes subject to the phase-in.

Response: Section 1848(c)(7) of the Act, as added by section 220(e) of the PAMA, specifies that for services that Start Printed Page 59541are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased-in over a 2-year period. We proposed to exempt CPT codes 52380 and 52382 from the phase-in of significant RVU reductions required by section 1848(b)(11) of the Act because these codes are part of the same family of codes that included new CPT code 53854. We have previously finalized this policy through rulemaking, stating that significant coding revisions within a family of codes can change the relationships among codes to the extent that it changes the way that all services in the group are reported, even if some individual codes retain the same number or, in some cases, the same descriptor. Excluding codes from the phase-in when there are significant revisions to the code family also helps to maintain the appropriate rank order among codes in the family, avoiding years for which RVU changes for some codes in a family are in transition while others were fully implemented. For additional information regarding the phase-in of significant RVU reductions, we direct readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70929).

Comment: One commenter stated that they were concerned about substantial reductions in billable staff time and supply costs associated with CPT codes 53850 and 53852. The commenter stated that reductions in billable staff time will require treating physicians to minimize non-procedural time which may include: Comfort control protocols; patient expectation management; patient post-procedure instructions; and recommended best practices for follow-up care. The commenter stated that they were concerned that the proposed supply costs are not in line with actual pricing or with actual cost increases for manufacturing of the product, and indicated that significant reductions in reimbursement will limit patient access to a therapy with demonstrated safety, effectiveness, and cost efficacy.

Response: We appreciate the feedback from the commenter, and we are sensitive to the need for accurate payment under the PFS to ensure that beneficiaries maintain access to care. However, we note that we proposed the RUC-recommended direct PE inputs for this family of codes without refinement, and the decreases in clinical staff time for these procedures were almost entirely due to shorter surveyed intra