# 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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-24170

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** November 23, 2018
- **Citation:** 83 FR 59452

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, 425, and 495
[CMS-1693-F, CMS-1693-IFC, CMS-5522-F3, and CMS-1701-F]
RIN 0938-AT31, 0938-AT13, & 0938-AT45
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program—Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program—Accountable Care Organizations—Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act

AGENCY:

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

ACTION:

Final rules and interim final rule.

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.

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.

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

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

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

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

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

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

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

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

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Provisions of the Final Rule for PFS

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.

• 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.

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

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

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

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

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

furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

(5) PE RVU Methodology

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

(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 code
Modifier
Short descriptor
Expected specialty

2017
utilization

70557
26
Mri brain w/o dye
Diagnostic Radiology
126

70558
26
Mri brain w/dye
Diagnostic Radiology
32

74235
26
Remove esophagus obstruction
Gastroenterology
10

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

74355
26
X-ray guide intestinal tube
Diagnostic Radiology
11

74445
26
X-ray exam of penis
Urology
26

74742
26
X-ray fallopian tube
Diagnostic Radiology
5

74775
26
X-ray exam of perineum
Diagnostic Radiology
80

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

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

75805
26
Lymph vessel x-ray trunk
Diagnostic Radiology
50

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

76941
26
Echo guide for transfusion
Obstetrics/Gynecology
15

76945
26
Echo guide villus sampling
Obstetrics/Gynecology
31

76975
26
Gi endoscopic ultrasound
Gastroenterology
49

78282
26
Gi protein loss exam
Diagnostic Radiology
8

79300
26
Nuclr rx interstit colloid
Diagnostic Radiology
2

86327
26
Immunoelectrophoresis assay
Pathology
24

87164
26
Dark field examination
Pathology
30

88371
26
Protein western blot tissue
Pathology
2

93532
26
R & l heart cath congenital
Cardiology
28

93533
26
R & l heart cath congenital
Cardiology
36

93561
26
Cardiac output measurement
Cardiology
28

93562
26
Card output measure subsq
Cardiology
38

93616
26
Esophageal recording
Cardiology
38

93624
26
Electrophysiologic study
Cardiology
51

95966
26
Meg evoked single
Neurology
72

95967
26
Meg evoked each addl
Neurology
61

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.

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

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

(d) Calculate the Final PE RVUs

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

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

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

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

(e) Setup File Information

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

Table 2—Specialties Excluded From Ratesetting Calculation

Specialty code
Specialty description

49
Ambulatory surgical center.

50
Nurse practitioner.

51
Medical supply company with certified orthotist.

52
Medical supply company with certified prosthetist.

53
Medical supply company with certified prosthetist-orthotist.

54
Medical supply company not included in 51, 52, or 53.

55
Individual certified orthotist.

56
Individual certified prosthetist.

57
Individual certified prosthetist-orthotist.

58
Medical supply company with registered pharmacist.

59

Ambulance service supplier,
e.g.,
private ambulance companies, funeral homes, etc.

60
Public health or welfare agencies.

61
Voluntary health or charitable agencies.

73
Mass immunization roster biller.

74
Radiation therapy centers.

87

All other suppliers (
e.g.,
drug and department stores).

88
Unknown supplier/provider specialty.

89
Certified clinical nurse specialist.

96
Optician.

97
Physician assistant.

A0
Hospital.

A1
SNF.

A2
Intermediate care nursing facility.

A3
Nursing facility, other.

A4
HHA.

A5
Pharmacy.

A6
Medical supply company with respiratory therapist.

A7
Department store.

B2
Pedorthic personnel.

B3
Medical supply company with pedorthic personnel.

•
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.

•
Physical therapy utilization:
Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.

•
Identify professional and technical services not identified under the usual TC and 26 modifiers:
Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).

•
Payment modifiers:
Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 3 details the manner in which the modifiers are applied.

Table 3—Application of Payment Modifiers to Utilization Files

Modifier
Description
Volume adjustment
Time adjustment

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

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

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

51
Multiple Procedure
50%
Intraoperative portion.

52
Reduced Services
50%
50%.

53
Discontinued Procedure
50%
50%.

54
Intraoperative Care only
Preoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process Medicare claims
Preoperative + Intraoperative portion.

55
Postoperative Care only
Postoperative Percentage on the payment files used by Medicare contractors to process Medicare claims
Postoperative portion.

62
Co-surgeons
62.5%
50%.

66
Team Surgeons
33%
33%.

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

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

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

(6) Equipment Cost per Minute

The equipment cost per minute is calculated as:

(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

Price

Useful
life
(years)

Interest
rate
(%)

<$25K
<7
7.50

$25K to $50K
<7
6.50

>$50K
<7
5.50

<$25K
7+
8.00

$25K to $50K
7+
7.00

>$50K
7+
6.00

3. Changes to Direct PE Inputs for Specific Services

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

a. Standardization of Clinical Labor Tasks

As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database

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

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

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

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.

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

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

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

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

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

(2) Scope Video System

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

(3) Scope Accessories

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

(4) Scope Proposals for CY 2019

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

equipment item from “video system, endoscopy (processor, digital capture, monitor, printer, cart)” to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.

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

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

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

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

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

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

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 components
Quantity
Unit
Price

kit, sinus surgery, balloon (maxillary, frontal, or sphenoid)

kit
$2,599.86

Sinus Guide Catheter
1
item
444.00

Sinus Balloon Catheter
1
item
820.80

Sinus Illumination System (100 cm lighted guidewire)
1
item
454.80

Light Guide Cable (8 ft)
1
item
514.80

ACMI/Stryker Adaptor
1
item
42.00

Sinus Guide Catheter Handle
1
item
66.00

Sinus Irrigation Catheter (22 cm)
1
item
150.00

Sinus Balloon Catheter Inflation Device
1
item
89.46

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

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

Number of
post-op office
visits

CY 2018
nonfacility
quantity of
minimum
visit pack
(SA048)

Proposed
CY 2019
nonfacility
quantity of
minimum
visit pack
(SA048)

10040
1
2
1

10060
1
2
1

10061
2
3
2

10080
1
2
1

10120
1
2
1

10121
1
2
1

10180
1
2
1

11200
1
2
1

11300
0
1
0

11301
0
1
0

11302
0
1
0

11303
0
1
0

11306
0
1
0

11307
0
1
0

11310
0
1
0

11311
0
1
0

11312
0
1
0

11400
1
2
1

11750
1
2
1

11900
0
1
0

11901
0
1
0

12001
0
1
0

12002
0
1
0

12004
0
1
0

12011
0
1
0

12013
0
1
0

16020
0
1
0

17000
1
2
1

17004
1
2
1

17110
1
2
1

17111
1
2
1

17260
1
2
1

17270
1
2
1

17280
1
2
1

19100
0
1
0

20005
1
2
1

20520
1
2
1

21215
6
7
6

21550
1
2
1

21920
1
2
1

22310
1.5
2.5
1.5

23500
2.5
3.5
2.5

23570
2.5
3.5
2.5

23620
3
4
3

24500
4
5
4

24530
4
5
4

24650
3
4
3

24670
3
4
3

25530
3
4
3

25600
5
6
5

25605
5
6
5

25622
3.5
4.5
3.5

25630
3
4
3

26600
4
5
4

26720
2
3
2

26740
2.5
3.5
2.5

26750
2
3
2

27508
4
5
4

27520
3.5
4.5
3.5

27530
4
5
4

27613
1
2
1

27750
3.5
4.5
3.5

27760
4
5
4

27780
3.5
4.5
3.5

27786
3.5
4.5
3.5

27808
4
5
4

28190
1
2
1

28400
3
4
3

28450
2.5
3.5
2.5

28490
1.5
2.5
1.5

28510
1.5
2.5
1.5

30901
0
1
0

30903
0
1
0

30905
0
1
0

31000
1
2
1

31231
0
1
0

31233
0
1
0

31235
0
1
0

31238
0
1
0

31525
0
1
0

31622
0
1
0

32554
0
1
0

36600
0
1
0

38220
0
1
0

40490
0
1
0

42800
1
2
1

43200
0
1
0

45330
0
1
0

46040
3
4
3

46050
1
2
1

46083
1
2
1

46320
0.5
1.5
0.5

46600
0
1
0

46604
0
1
0

46900
1
2
1

51102
0
2
0

51701
0
1
0

51702
0
1
0

51703
0
1
0

51710
0
1
0

51725
0
1
0

51736
0
1
0

51741
0
1
0

51792
0
1
0

51798
0
1
0

52000
0
1
0

52001
0
1
0

52214
0
1
0

52265
0
1
0

52281
0
1
0

52285
0
1
0

53601
0
1
0

53621
0
1
0

53660
0
1
0

53661
0
1
0

54050
1
2
1

54056
1
2
1

54100
0
1
0

54235
0
1
0

54450
0
1
0

55000
0
1
0

56405
1
2
1

56605
0
1
0

56820
0
1
0

57061
1
2
1

57100
0
1
0

57420
0
1
0

57500
0
1
0

57505
1
2
1

62252
0
1
0

62367
0
1
0

62368
0
1
0

62370
0
1
0

64413
0
1
0

64420
0
1
0

64450
0
1
0

64611
1
2
1

69000
1
2
1

69100
0
1
0

69145
1.5
2.5
1.5

69210
0
1
0

69420
1
2
1

69433
1
2
1

69610
1
2
1

93292
0
1
0

93303
0
1
0

94667
0
1
0

95044
0
0.028
0

95870
0
1
0

95921
0
1
0

95922
0
1
0

95924
0
1
0

95972
0
1
1

96904
0
1
1

In general, we 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

rulemaking. We are therefore finalizing our proposal to revise the direct PE inputs to reflect the ones previously finalized in CY 2013 for CPT code 11311.

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

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

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

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

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

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

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

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

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

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

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

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

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

Listed in order, the commenter identified these issues:

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

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

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

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

Comment:
For CPT

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-24170. Public record. Not legal advice.