[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Rules and Regulations]
[Pages 85866-86305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26819]
[[Page 85865]]
Vol. 85
Tuesday,
No. 249
December 29, 2020
Part II
Book 2 of 2 Books
Pages 85865-86456
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 410, 411, 412, et al.
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; New Categories for Hospital Outpatient Department Prior
Authorization Process; Clinical Laboratory Fee Schedule: Laboratory
Date of Service Policy; Overall Hospital Quality Star Rating
Methodology; Physician-Owned Hospitals; Notice of Closure of Two
Teaching Hospitals and Opportunity To Apply for Available Slots,
Radiation Oncology Model; and Reporting Requirements for Hospitals and
Critical Access Hospitals (CAHs) To Report COVID-19 Therapeutic
Inventory and Usage and To Report Acute Respiratory Illness During the
Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19);
Final Rule
Federal Register / Vol. 85 , No. 249 / Tuesday, December 29, 2020 /
Rules and Regulations
[[Page 85866]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410, 411, 412, 414, 416, 419, 482, 485, 512
[CMS-1736-FC, 1736-IFC]
RIN 0938-AU12
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; New Categories for Hospital Outpatient Department Prior
Authorization Process; Clinical Laboratory Fee Schedule: Laboratory
Date of Service Policy; Overall Hospital Quality Star Rating
Methodology; Physician-Owned Hospitals; Notice of Closure of Two
Teaching Hospitals and Opportunity To Apply for Available Slots,
Radiation Oncology Model; and Reporting Requirements for Hospitals and
Critical Access Hospitals (CAHs) To Report COVID-19 Therapeutic
Inventory and Usage and To Report Acute Respiratory Illness During the
Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final rule with comment period and interim final rule with
comment period.
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SUMMARY: This final rule with comment period revises the Medicare
hospital outpatient prospective payment system (OPPS) and the Medicare
ambulatory surgical center (ASC) payment system for Calendar Year (CY)
2021 based on our continuing experience with these systems. In this
final rule with comment period, we describe the changes to the amounts
and factors used to determine the payment rates for Medicare services
paid under the OPPS and those paid under the ASC payment system. Also,
this final rule with comment period updates and refines the
requirements for the Hospital Outpatient Quality Reporting (OQR)
Program and the ASC Quality Reporting (ASCQR) Program. In addition,
this final rule with comment period establishes and updates the Overall
Hospital Quality Star Rating beginning with the CY 2021; removes
certain restrictions on the expansion of physician-owned hospitals that
qualify as ``high Medicaid facilities,'' and clarifies that certain
beds are counted toward a hospital's baseline number of operating
rooms, procedure rooms, and beds; adds two new service categories to
the Hospital Outpatient Department (OPD) Prior Authorization Process;
provides notice of the closure of two teaching hospitals and the
opportunity to apply for available slots for purposes of indirect
medical education (IME) and direct graduate medical education (DGME)
payments; and revises the Clinical Laboratory Date of Service (DOS)
policy. This interim final rule with comment period modifies the
Radiation Oncology Model (RO Model) Model performance period for CY
2021, and establishes new requirements in the hospital and critical
access hospital (CAH) Conditions of Participation (CoPs) for tracking
of COVID-19 therapeutic inventory and usage and for tracking of the
incidence and impact of Acute Respiratory Illness (including, but not
limited to, Seasonal Influenza Virus, Influenza-like Illness, and
Severe Acute Respiratory Infection) during the ongoing COVID-19 public
health emergency (PHE).
DATES:
Effective date: This rule is effective January 1, 2021, with the
exceptions of amendatory instructions 21 and 23 (amending 42 CFR 482.42
and 485.640) and 25 through 31 (amending 42 CFR 512.205, 512.210,
512.217, 512.220, 512.245, 512.255, and 512.285), which are effective
on December 4, 2021.
Comment period: To be assured consideration, comments on the
payment classifications assigned to the interim APC assignments and/or
status indicators of new or replacement Level II HCPCS codes in this
final rule with comment period (CMS-1736-FC) must be received at one of
the addresses provided in the ADDRESSES section no later than 5 p.m.
EST on January 4, 2021.
To be assured consideration, comments on the Reporting Requirements
for Hospitals and CAHs to Report Acute Respiratory Illness During the
PHE for COVID-19, instructions 21 and 23 amending Sec. Sec. 482.42 and
485.640, and the Radiation Oncology (RO) Model, instructions 25 through
31 amending 42 CFR 512.205, 512.210, 512.217, 512.220, 512.245,
512.255, and 512.285 in this interim final rule with comment period
(CMS-1736-IFC) must be received at one of the addresses provided below,
no later than 5 p.m. on February 2, 2021.
Applicability dates: The provisions related to the Radiation
Oncology (RO) Model contained in section XXI of this interim final rule
with comment period are applicable beginning July 1, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1736-FC or CMS-
1736-IFC as appropriate, when commenting on the issues in this final
rule with comment period and interim final rule with comment period.
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 (and we encourage you to) submit
electronic comments on this regulation to http://www.regulations.gov.
Follow the instructions under the ``submit a comment'' tab.
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-1736-FC or CMS-1736-IFC, P.O.
Box 8010, Baltimore, MD 21244-1850.
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 via
express or overnight mail to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1736-FC or CMS-1736-IFC, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, we refer readers to the
beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Advisory Panel on Hospital Outpatient
Payment (HOP Panel), contact the HOP Panel mailbox at
[email protected].
Ambulatory Surgical Center (ASC) Payment System, contact Scott
Talaga via email [email protected] or Mitali Dayal via email
[email protected].
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
Administration, Validation, and Reconsideration Issues, contact Anita
Bhatia via email at [email protected].
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
Measures, contact Cyra Duncan via email [email protected].
Blood and Blood Products, contact Josh McFeeters via email
[email protected]. Cancer
[[Page 85867]]
Hospital Payments, contact Scott Talaga via email
[email protected].
CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck
Braver via email [email protected].
Composite APCs (Low Dose Brachytherapy and Multiple Imaging),
contact Au'Sha Washington via email [email protected].
Comprehensive APCs (C-APCs), contact Lela Strong-Holloway via email
[email protected], or Mitali Dayal via email
[email protected].
Hospital Outpatient Quality Reporting (OQR) Program Administration,
Validation, and Reconsideration Issues, contact Shaili Patel via email
[email protected].
Hospital Outpatient Quality Reporting (OQR) Program Measures,
contact Nicole P. Crenshaw via email [email protected].
Hospital Outpatient Visits (Emergency Department Visits and
Critical Care Visits), contact Elise Barringer via email
[email protected].
Hospital Quality Star Rating Methodology, contact Annese Abdullah-
Mclaughlin via email [email protected].
Inpatient Only (IPO) Procedures List, contact Au'Sha Washington via
email [email protected], or Allison Bramlett via email
[email protected], or Lela Strong-Holloway via email
[email protected].
Medical Review of Certain Inpatient Hospital Admissions under
Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule),
contact Elise Barringer via email [email protected].
New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga
via email [email protected].
No Cost/Full Credit and Partial Credit Devices, contact Scott
Talaga via email [email protected].
OPPS Brachytherapy, contact Scott Talaga via email
[email protected].
OPPS Data (APC Weights, Conversion Factor, Copayments, Cost-to-
Charge Ratios (CCRs), Data Claims, Geometric Mean Calculation, Outlier
Payments, and Wage Index), contact Erick Chuang via email
[email protected], or Scott Talaga via email
[email protected], or Josh McFeeters via email at
[email protected].
OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar
Products, contact Josh McFeeters via email at
[email protected], or Gil Ngan via email at
[email protected] or, or Cory Duke via email at
[email protected].
OPPS New Technology Procedures/Services, contact the New Technology
APC mailbox at [email protected].gov.
OPPS Packaged Items/Services, contact Lela Strong-Holloway via
email [email protected], or Mitali Dayal via email at
[email protected].
OPPS Pass-Through Devices, contact the Device Pass-Through mailbox
at [email protected].
OPPS Status Indicators (SI) and Comment Indicators (CI), contact
Marina Kushnirova via email [email protected].
Partial Hospitalization Program (PHP) and Community Mental Health
Center (CMHC) Issues, contact the PHP Payment Policy Mailbox at
[email protected].
Prior Authorization Process and Requirements for Certain Covered
Outpatient Department Services, contact Thomas Kessler via email at
[email protected].
Rural Hospital Payments, contact Josh McFeeters via email at
[email protected].
Skin Substitutes, contact Josh McFeeters via email
[email protected].
Supervision of Outpatient Therapeutic Services in Hospitals and
CAHs, contact Josh McFeeters via email [email protected].
All Other Issues Related to Hospital Outpatient and Ambulatory
Surgical Center Payments Not Previously Identified, contact Elise
Barringer via email [email protected] or at 410-786-9222.
RO Model, contact [email protected] or at 844-711-2664,
Option 5.
CAPT Scott Cooper, USPHS, (410) 786-9465, for the hospital and CAH
COVID-19 Therapeutic Inventory and Usage reporting requirements and for
the Acute Respiratory Illness (including, but not limited to, Seasonal
Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory
Infection) reporting requirements.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov/. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Addenda Available Only Through the Internet on the CMS Website
In the past, a majority of the Addenda referred to in our OPPS/ASC
proposed and final rules were published in the Federal Register as part
of the annual rulemakings. However, beginning with the CY 2012 OPPS/ASC
proposed rule, all of the Addenda no longer appear in the Federal
Register as part of the annual OPPS/ASC proposed and final rules to
decrease administrative burden and reduce costs associated with
publishing lengthy tables. Instead, these Addenda are published and
available only on the CMS website. The Addenda relating to the OPPS are
available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
The Addenda relating to the ASC payment system are available at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.
Current Procedural Terminology (CPT) Copyright Notice
Throughout this final rule with comment period, we use CPT codes
and descriptions to refer to a variety of services. We note that CPT
codes and descriptions are copyright 2019 American Medical Association.
All Rights Reserved. CPT is a registered trademark of the American
Medical Association (AMA). Applicable Federal Acquisition Regulations
(FAR and Defense Federal Acquisition Regulations (DFAR) apply.
Table of Contents
I. Summary and Background
A. Executive Summary of This Document
B. Legislative and Regulatory Authority for the Hospital OPPS
C. Excluded OPPS Services and Hospitals
D. Prior Rulemaking
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel
or the Panel)
F. Public Comments Received in Response to the CY 2021 OPPS/ASC
Proposed Rule
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G. Public Comments Received on the CY 2020 OPPS/ASC Final Rule
With Comment Period
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
B. Conversion Factor Update
C. Wage Index Changes
D. Statewide Average Default Cost-to-Charge Ratios (CCRs)
E. Adjustment for Rural Sole Community Hospitals (SCHs) and
Essential Access Community Hospitals (EACHs) Under Section
1833(t)(13)(B) of the Act for CY 2021
F. Payment Adjustment for Certain Cancer Hospitals for CY 2021
G. Hospital Outpatient Outlier Payments
H. Calculation of an Adjusted Medicare Payment From the National
Unadjusted Medicare Payment
I. Beneficiary Copayments
III. OPPS Ambulatory Payment Classification (APC) Group Policies
A. OPPS Treatment of New and Revised HCPCS Codes
B. OPPS Changes--Variations Within APCs
C. New Technology APCs
D. OPPS APC-Specific Policies
IV. OPPS Payment for Devices
A. Pass-Through Payments for Devices
B. Device-Intensive Procedures
V. OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. OPPS Transitional Pass-Through Payment for Additional Costs
of Drugs, Biologicals, and Radiopharmaceuticals
B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
Without Pass-Through Payment Status
VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
B. Estimate of Pass-Through Spending
VII. OPPS Payment for Hospital Outpatient Visits and Critical Care
Services
VIII. Payment for Partial Hospitalization Services
A. Background
B. PHP APC Update for CY 2021
C. Outlier Policy for CMHCs
IX. Services That Will Be Paid Only as Inpatient Services
A. Background
B. Changes to the Inpatient Only (IPO) List
X. Nonrecurring Policy Changes
A. Changes in the Level of Supervision of Outpatient Therapeutic
Services in Hospitals and Critical Access Hospitals (CAHs)
B. Medical Review of Certain Inpatient Hospital Admissions Under
Medicare Part A for CY 2021 and Subsequent Years
XI. CY 2021 OPPS Payment Status and Comment Indicators
A. CY 2021 OPPS Payment Status Indicator Definitions
B. CY 2021 Comment Indicator Definitions
XII. MedPAC Recommendations
A. OPPS Payment Rates Update
B. ASC Conversion Factor Update
C. ASC Cost Data
XIII. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
B. ASC Treatment of New and Revised Codes
C. Update to the List of ASC Covered Surgical Procedures and
Covered Ancillary Services
D. Update and Payment for ASC Covered Surgical Procedures and
Covered Ancillary Services
E. New Technology Intraocular Lenses (NTIOLs)
F. ASC Payment and Comment Indicators
G. Calculation of the ASC Payment Rates and the ASC Conversion
Factor
XIV. Requirements for the Hospital Outpatient Quality Reporting
(OQR) Program
A. Background
B. Hospital OQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the Hospital
OQR Program
E. Payment Reduction for Hospitals That Fail To Meet the
Hospital OQR Program Requirements for the CY 2021 Payment
Determination
XV. Requirements for the Ambulatory Surgical Center Quality
Reporting (ASCQR) Program
A. Background
B. ASCQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the ASCQR
Program
E. Payment Reduction for ASCs That Fail To Meet the ASCQR
Program Requirements
XVI. Overall Hospital Quality Star Rating Methodology for Public
Release in CY 2021 and Subsequent Years
A. Background
B. Critical Access Hospitals in the Overall Star Rating
C. Veterans Health Administration Hospitals in the Overall Star
Rating
D. History of the Overall Hospital Quality Star Rating
E. Current and Proposed Overall Star Rating Methodology
F. Preview Period
G. Overall Star Rating Suppressions
XVII. Addition of New Service Categories for Hospital Outpatient
Department (OPD) Prior Authorization Process
A. Background
B. Controlling Unnecessary Increases in the Volume of Covered
OPD Services
XVIII. Clinical Laboratory Fee Schedule: Revisions to the Laboratory
Date of Service Policy
A. Background on the Medicare Part B Laboratory Date of Service
Policy
B. Medicare DOS Policy and the ``14-Day Rule''
C. Billing and Payment for Laboratory Services Under the OPPS
D. ADLTs Under the New Private Payor Rate-Based CLFS
E. Additional Laboratory DOS Policy Exception for the Hospital
Outpatient Setting
F. Revision to the Laboratory DOS Policy for Cancer-Related
Protein-Based MAAAs
XIX. Physician-Owned Hospitals
A. Background
B. Prohibition on Facility Expansion
C. Deference to State Law for Purposes of Determining the Number
of Beds for Which a Hospital Is Licensed
XX. Notice of Closure of Two Teaching Hospitals and Opportunity To
Apply for Available Slots
A. Background Section
B. Notice of Closure of Westlake Community Hospital, Located in
Melrose Park, IL, and the Application Process--Round 18
C. Notice of Closure of Astria Regional Medical Center, Located
in Yakima, WA, and the Application Process--Round 19
D. Application Process for Available Resident Slots
XXI. Radiation Oncology (RO) Model
A. Model Performance Period for the Radiation Oncology Model
B. Waiver of Proposed Rulemaking
XXII. Reporting Requirements for Hospitals and Critical Access
Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage
and To Report Acute Respiratory Illness During the Public Health
Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)
XXIII. Files Available to the Public via the Internet
XXIV. Collection of Information Requirements
A. Statutory Requirement for Solicitation of Comments
B. ICRs for the Hospital OQR Program
C. ICRs for the ASCQR Program
D. ICRs for Addition of New Service Categories for Hospital
Outpatient Department (OPD) Prior Authorization Process
E. ICRs for the Overall Hospital Quality Star Ratings
F. ICRs for Physician-Owned Hospitals
XXV. Waiver of the 30-Day and 60-Day Delayed Effective Dates for the
Final Rule With Comment Period and Waiver of Proposed Rulemaking for
Reporting Requirements for Hospitals and Critical Access Hospitals
(CAHs) To Report COVID-19 Therapeutic Inventory and Usage and to
Report Acute Respiratory Illness During the PHE for COVID-19 Interim
Final Rule With Comment Period (IFC)
A. Waiver of the 30-Day and 60-Day Delayed Effective Dates for
the Final Rule With Comment Period
B. Waiver of Proposed Rulemaking for Reporting Requirements for
Hospitals and Critical Access Hospitals (CAHs) To Report Acute
Respiratory Illness During the PHE for COVID-19 Interim Final Rule
With Comment Period (IFC)
XXVI. Response to Comments
XXVII. Economic Analyses
A. Statement of Need
B. Overall Impact for the Provisions of This Final Rule With
Comment Period
C. Detailed Economic Analyses
D. Regulatory Review Costs
E. Regulatory Flexibility Act (RFA) Analysis
F. Unfunded Mandates Reform Act Analysis
G. Reducing Regulation and Controlling Regulatory Costs
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H. Conclusion
XXVIII. Federalism Analysis
I. Summary and Background
A. Executive Summary of This Document
1. Purpose
In this final rule with comment period and interim final rule with
comment period, we are updating the payment policies and payment rates
for services furnished to Medicare beneficiaries in hospital outpatient
departments (HOPDs) and ambulatory surgical centers (ASCs), beginning
January 1, 2021. Section 1833(t) of the Social Security Act (the Act)
requires us to annually review and update the payment rates for
services payable under the Hospital Outpatient Prospective Payment
System (OPPS). Specifically, section 1833(t)(9)(A) of the Act requires
the Secretary to review certain components of the OPPS not less often
than annually, and to revise the groups, the relative payment weights,
and the wage and other adjustments that take into account changes in
medical practices, changes in technology, and the addition of new
services, new cost data, and other relevant information and factors. In
addition, under section 1833(i)(D)(v) of the Act, we annually review
and update the ASC payment rates. This final rule with comment period
also includes additional policy changes made in accordance with our
experience with the OPPS and the ASC payment system and recent changes
in our statutory authority. We describe these and various other
statutory authorities in the relevant sections of this final rule with
comment period. In addition, this final rule with comment period
updates and refines the requirements for the Hospital Outpatient
Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR)
Program.
2. Summary of the Major Provisions
OPPS Update: For CY 2021, we are increasing the payment
rates under the OPPS by an Outpatient Department (OPD) fee schedule
increase factor of 2.4 percent. This increase factor is based on the
final hospital inpatient market basket percentage increase of 2.4
percent for inpatient services paid under the hospital inpatient
prospective payment system (IPPS). Based on this update, we estimate
that total payments to OPPS providers (including beneficiary cost-
sharing and estimated changes in enrollment, utilization, and case-mix)
for calendar year (CY) 2021 would be approximately $83.888 billion, an
increase of approximately $7.541 billion compared to estimated CY 2020
OPPS payments.
We are continuing to implement the statutory 2.0 percentage point
reduction in payments for hospitals that fail to meet the hospital
outpatient quality reporting requirements by applying a reporting
factor of 0.9805 to the OPPS payments and copayments for all applicable
services.
Partial Hospitalization Update: For CY 2021 OPPS/ASC final
rule with comment period, CMS is maintaining the unified rate structure
established in CY 2017, with a single PHP APC for each provider type
for days with 3 or more services per day. We are using the CMHC and
hospital-based PHP (HB PHP) geometric mean per diem costs, consistent
with existing policy, using updated data for each provider type.
Accordingly, we are calculating the CY 2021 PHP APC per diem rates for
HB PHPs and CMHC PHPs based on updated cost and claims data. Given that
the final calculated geometric mean per diem costs are much higher than
the proposed cost floors, we are not extending the cost floors to CY
2021 and subsequent years.
Changes to the Inpatient Only (IPO) List: For CY 2021, we
are eliminating the IPO list over the course of 3 calendar years
beginning with the removal of 266 musculoskeletal-related services. We
are also removing 32 additional HCPCS codes from the IPO list for CY
2021 based on public comments.
Medical Review of Certain Inpatient Hospital Admissions
under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight
Rule): For CY 2021, we are finalizing a policy to exempt procedures
that are removed from the inpatient only (IPO) list under the OPPS
beginning on January 1, 2021 from site-of-service claim denials,
Beneficiary and Family-Centered Care Quality Improvement Organization
(BFCC-QIO) referrals to Recovery Audit Contractor (RAC) for persistent
noncompliance with the 2-midnight rule, and RAC reviews for ``patient
status'' (that is, site-of-service) until such procedures are more
commonly billed in the outpatient setting.
340B--Acquired Drugs: We are continuing our current policy
of paying an adjusted amount of ASP minus 22.5 percent for drugs and
biologicals acquired under the 340B program. We are continuing to
exempt Rural SCHs, PPS-exempt cancer hospitals and children's hospitals
from our 340B payment policy.
Comprehensive APCs: For CY 2021, we are creating two new
comprehensive APCs (C-APCs): C-APC 5378 (Level 8 Urology and Related
Services) and C-APC 5465 (Level 5 Neurostimulator and Related
Procedures). Adding these C-APCs increases the total number of C-APCs
to 69.
Device Pass-Through Payment Applications: For CY 2021, we
evaluated five applications for device pass-through payments. Two of
these applications (CUSTOMFLEX[supreg] ARTIFICIALIRIS and EXALT\TM\
Model D Single-Use Duodenoscope) received preliminary approval for
pass-through payment status through our quarterly review process. Based
on our review and public comments received, we are continuing the pass-
through payment status for CUSTOMFLEX[supreg] ARTIFICIALIRIS and
EXALT\TM\ Model D Single-Use Duodenoscope and approving the remaining
three applications for device pass-through payment status.
Changes to the Level of Supervision of Outpatient
Therapeutic Services in Hospitals and Critical Access Hospitals: For CY
2021 and subsequent years, we are changing the minimum default level of
supervision for non-surgical extended duration therapeutic services
(NSEDTS) to general supervision for the entire service, including the
initiation portion of the service, for which we had previously required
direct supervision. This is consistent with the minimum required level
of general supervision that currently applies for most outpatient
hospital therapeutic services. We are finalizing our proposed policy to
permit direct supervision of pulmonary rehabilitation, cardiac
rehabilitation, and intensive cardiac rehabilitation services using
virtual presence of the physician through audio/video real-time
communications technology subject to the clinical judgment of the
supervising physician until the later of the end of the calendar year
in which the PHE ends or December 31, 2021.
Cancer Hospital Payment Adjustment: For CY 2021, we are
continuing to provide additional payments to cancer hospitals so that a
cancer hospital's payment-to-cost ratio (PCR) after the additional
payments is equal to the weighted average PCR for the other OPPS
hospitals using the most recently submitted or settled cost report
data. However, section 16002(b) of the 21st Century Cures Act requires
that this weighted average PCR be reduced by 1.0 percentage point.
Based on the data and the required 1.0 percentage point reduction, a
target PCR of 0.89 will be used to determine the CY 2021 cancer
hospital payment adjustment to be paid at cost report settlement. That
is, the payment adjustments will be the additional payments needed to
result in
[[Page 85870]]
a PCR equal to 0.89 for each cancer hospital.
ASC Payment Update: For CYs 2019 through 2023, we adopted
a policy to update the ASC payment system using the hospital market
basket update. Using the hospital market basket methodology, for CY
2021, we are increasing payment rates under the ASC payment system by
2.4 percent for ASCs that meet the quality reporting requirements under
the ASCQR Program. This increase is based on a hospital market basket
percentage increase of 2.4 percent minus a multifactor productivity
adjustment of 0.0 percentage point. Based on this update, we estimate
that total payments to ASCs (including beneficiary cost-sharing and
estimated changes in enrollment, utilization, and case-mix) for CY 2021
would be approximately 5.42 billion, an increase of approximately 120
million compared to estimated CY 2020 Medicare payments.
Changes to the List of ASC Covered Surgical Procedures:
For CY 2021, we are adding eleven procedures to the ASC covered
procedures list (CPL), including total hip arthroplasty (CPT 27130).
Additionally, we are revising the criteria we use to add covered
surgical procedures to the ASC CPL, providing that certain criteria we
used to add covered surgical procedures to the ASC CPL in the past will
now be factors for physicians to consider in deciding whether a
specific beneficiary should receive a covered surgical procedure in an
ASC, and adopting a notification process for surgical procedures the
public believes can be added to the ASC CPL under the criteria we are
retaining. Using our revised criteria, we are adding an additional 267
surgical procedures to the ASC CPL beginning in CY 2021.
Hospital Outpatient Quality Reporting (OQR) and Ambulatory
Surgical Center Quality Reporting (ASCQR) Programs: For the Hospital
OQR and ASCQR Programs, we are updating and refining requirements to
further meaningful measurement and reporting for quality of care
provided in these outpatient settings while limiting compliance burden.
We are revising and codifying previously finalized administrative
procedures and are codifying an expanded review and corrections process
to further the programs' alignment while clarifying program
requirements. We are not making any measure additions or removals for
either program.
Overall Hospital Quality Star Ratings: We are establishing
and updating the methodology that will be used to calculate the Overall
Hospital Quality Star Ratings beginning with 2021 and for subsequent
years. We are updating and simplifying how the ratings are calculated,
with policies such as adopting a simple average of measure scores
instead of the latent variable model and reducing the total number of
measure groups from seven to five measure groups due to the removal of
measures through the Meaningful Measure Initiative. Additionally, we
are increasing the comparability of star ratings by peer grouping
hospitals by the number of measure groups. These changes will simplify
the methodology, and therefore, reduce provider burden, improve the
predictability of the star ratings, and increase the comparability
between hospital star ratings. We did not finalize our proposals
related to stratification of the Readmissions group by dual-eligible
patients.
Addition of New Service Categories for Hospital Outpatient
Department Prior Authorization Process: We are adding the following two
categories of services to the prior authorization process for hospital
outpatient departments beginning for dates of service on or after July
1, 2021: (1) Cervical fusion with disc removal and (2) implanted spinal
neurostimulators.
Clinical Laboratory Date of Service (DOS) Policy: We are
excluding certain protein-based Multianalyte Assays with Algorithmic
Analyses (MAAAs), which are not generally performed in the HOPD
setting, from the OPPS packaging policy and adding them to the
laboratory DOS exception at 42 CFR 414.510(b)(5).
Physician-Owned Hospitals: We are removing unnecessary
regulatory restrictions on high Medicaid facilities and including beds
in a physician-owned hospital's baseline consistent with state law.
Radiation Oncology Model (RO Model): On September 29,
2020, we published a final rule in the Federal Register (85 FR 61114)
entitled ``Specialty Care Models to Improve Quality of Care and Reduce
Expenditures'' that finalized the Radiation Oncology Model (RO Model).
To ensure that participation in the RO Model during the public health
emergency (PHE) for the Coronavirus disease 2019 (COVID-19) pandemic
does not further strain RO participants' capacity, we are revising the
RO Model's Model performance period to begin on July 1, 2021 and end
December 31, 2025 in this interim final rule with comment period. We
are requesting comments on this change.
Reporting Requirements for Hospitals and Critical Access
Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and
to Report Acute Respiratory Illness During the Public Health Emergency
(PHE) for Coronavirus Disease 2019 (COVID-19): This interim final rule
with comment period establishes new requirements in the hospital and
critical access hospital (CAH) Conditions of Participation (CoPs) for
tracking COVID-19 therapeutic inventory and usage and for tracking the
incidence and impact of Acute Respiratory Illness (including, but not
limited to, Seasonal Influenza Virus, Influenza-like Illness, and
Severe Acute Respiratory Infection) during the ongoing COVID-19 PHE;
and for providing this information and data to the Secretary of Health
and Human Services (Secretary) in such form and manner, and at such
timing and frequency, as the Secretary may prescribe during the Public
Health Emergency (PHE).
3. Summary of Costs and Benefit
In section XXVII and XXVIII of this final rule with comment period
and interim final rule with comment period, we set forth a detailed
analysis of the regulatory and federalism impacts that the changes will
have on affected entities and beneficiaries. Key estimated impacts are
described below.
a. Impacts of All OPPS Changes
Table 79 in section XXVII.C of the CY 2021 OPPS/ASC final rule with
comment period displays the distributional impact of all the OPPS
changes on various groups of hospitals and CMHCs for CY 2021 compared
to all estimated OPPS payments in CY 2020. We estimate that the
policies in the CY 2021 OPPS/ASC final rule with comment period will
result in a 2.4 percent overall increase in OPPS payments to providers.
We estimate that total OPPS payments for CY 2021, including beneficiary
cost-sharing, to the approximately 3,665 facilities paid under the OPPS
(including general acute care hospitals, children's hospitals, cancer
hospitals, and CMHCs) will increase by approximately $1.61 billion
compared to CY 2020 payments, excluding our estimated changes in
enrollment, utilization, and case-mix.
We estimated the isolated impact of our OPPS policies on CMHCs
because CMHCs are only paid for partial hospitalization services under
the OPPS. Continuing the provider-specific structure we adopted
beginning in CY 2011, and basing payment fully on the type of provider
furnishing the service, we estimate an 11.9 percent increase in CY 2021
payments to CMHCs relative to their CY 2020 payments.
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b. Impacts of the Updated Wage Indexes
We estimate that our update of the wage indexes based on the FY
2021 IPPS final rule wage indexes will result in an estimated increase
in payments of 0.2 percent for urban hospitals under the OPPS and an
estimated increase in payments of 0.4 percent for rural hospitals.
These wage indexes include the continued implementation of the OMB
labor market area delineations based on 2010 Decennial Census data,
with updates, as discussed in section II.C. of this final rule with
comment period.
c. Impacts of the Rural Adjustment and the Cancer Hospital Payment
Adjustment
There are no significant impacts of our CY 2021 payment policies
for hospitals that are eligible for the rural adjustment or for the
cancer hospital payment adjustment. We are not making any change in
policies for determining the rural hospital payment adjustments. While
we are implementing the reduction to the cancer hospital payment
adjustment for CY 2021 required by section 1833(t)(18)(C) of the Act,
as added by section 16002(b) of the 21st Century Cures Act, the target
payment-to-cost ratio (PCR) for CY 2021 is 0.89, equivalent to the 0.89
target PCR for CY 2020, and therefore has no budget neutrality
adjustment.
d. Impacts of the OPD Fee Schedule Increase Factor
For the CY 2021 OPPS/ASC, we are establishing an OPD fee schedule
increase factor of 2.4 percent and applying that increase factor to the
conversion factor for CY 2021. As a result of the OPD fee schedule
increase factor and other budget neutrality adjustments, we estimate
that urban hospitals will experience an increase in payments of
approximately 2.6 percent and that rural hospitals would experience an
increase in payments of 2.9 percent. Classifying hospitals by teaching
status, we estimate nonteaching hospitals will experience an increase
in payments of 2.9 percent, minor teaching hospitals will experience an
increase in payments of 3.0 percent, and major teaching hospitals will
experience an increase in payments of 2.0 percent. We also classified
hospitals by the type of ownership. We estimate that hospitals with
voluntary ownership will experience an increase of 2.6 percent in
payments, while hospitals with government ownership will experience an
increase of 2.2 percent in payments. We estimate that hospitals with
proprietary ownership will experience an increase of 3.5 percent in
payments.
e. Impacts of the ASC Payment Update
For impact purposes, the surgical procedures on the ASC covered
surgical procedure list are aggregated into surgical specialty groups
using CPT and HCPCS code range definitions. The percentage change in
estimated total payments by specialty groups under the CY 2021 payment
rates, compared to estimated CY 2020 payment rates, generally ranges
between an increase of 2 and 5 percent, depending on the service, with
some exceptions. We estimate the impact of applying the hospital market
basket update to ASC payment rates will be an increase in payments of
$120 million under the ASC payment system in CY 2021.
B. Legislative and Regulatory Authority for the Hospital OPPS
When Title XVIII of the Act was enacted, Medicare payment for
hospital outpatient services was based on hospital-specific costs. In
an effort to ensure that Medicare and its beneficiaries pay
appropriately for services and to encourage more efficient delivery of
care, the Congress mandated replacement of the reasonable cost-based
payment methodology with a prospective payment system (PPS). The
Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) added section
1833(t) to the Act, authorizing implementation of a PPS for hospital
outpatient services. The OPPS was first implemented for services
furnished on or after August 1, 2000. Implementing regulations for the
OPPS are located at 42 CFR parts 410 and 419.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106-113) made major changes in the hospital OPPS.
The following Acts made additional changes to the OPPS: The Medicare,
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA) (Pub. L. 106-554); The Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173); the Deficit
Reduction Act of 2005 (DRA) (Pub. L. 109-171), enacted on February 8,
2006; the Medicare Improvements and Extension Act under Division B of
Title I of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA)
(Pub. L. 109-432), enacted on December 20, 2006; the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173),
enacted on December 29, 2007; the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), enacted on July
15, 2008; the Patient Protection and Affordable Care Act (Pub. L. 111-
148), enacted on March 23, 2010, as amended by the Health Care and
Education Reconciliation Act of 2010 (Pub. L. 111-152), enacted on
March 30, 2010 (these two public laws are collectively known as the
Affordable Care Act); the Medicare and Medicaid Extenders Act of 2010
(MMEA, Pub. L. 111-309); the Temporary Payroll Tax Cut Continuation Act
of 2011 (TPTCCA, Pub. L. 112-78), enacted on December 23, 2011; the
Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA, Pub. L.
112-96), enacted on February 22, 2012; the American Taxpayer Relief Act
of 2012 (Pub. L. 112-240), enacted January 2, 2013; the Pathway for SGR
Reform Act of 2013 (Pub. L. 113-67) enacted on December 26, 2013; the
Protecting Access to Medicare Act of 2014 (PAMA, Pub. L. 113-93),
enacted on March 27, 2014; the Medicare Access and CHIP Reauthorization
Act (MACRA) of 2015 (Pub. L. 114-10), enacted April 16, 2015; the
Bipartisan Budget Act of 2015 (Pub. L. 114-74), enacted November 2,
2015; the Consolidated Appropriations Act, 2016 (Pub. L. 114-113),
enacted on December 18, 2015, the 21st Century Cures Act (Pub. L. 114-
255), enacted on December 13, 2016; the Consolidated Appropriations
Act, 2018 (Pub. L. 115-141), enacted on March 23, 2018; and the
Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act (Pub. L. 115-271), enacted
on October 24, 2018.
Under the OPPS, we generally pay for hospital Part B services on a
rate-per-service basis that varies according to the APC group to which
the service is assigned. We use the Healthcare Common Procedure Coding
System (HCPCS) (which includes certain Current Procedural Terminology
(CPT) codes) to identify and group the services within each APC. The
OPPS includes payment for most hospital outpatient services, except
those identified in section I.C. of the CY 2021 OPPS/ASC final rule.
Section 1833(t)(1)(B) of the Act provides for payment under the OPPS
for hospital outpatient services designated by the Secretary (which
includes partial hospitalization services furnished by CMHCs), and
certain inpatient hospital services that are paid under Medicare Part
B.
The OPPS rate is an unadjusted national payment amount that
includes the Medicare payment and the beneficiary copayment. This rate
is divided into a labor-related amount and a nonlabor-related amount.
The labor-related amount is adjusted for area wage
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differences using the hospital inpatient wage index value for the
locality in which the hospital or CMHC is located.
All services and items within an APC group are comparable
clinically and with respect to resource use, as required by section
1833(t)(2)(B) of the Act. In accordance with section 1833(t)(2)(B) of
the Act, subject to certain exceptions, items and services within an
APC group cannot be considered comparable with respect to the use of
resources if the highest median cost (or mean cost, if elected by the
Secretary) for an item or service in the APC group is more than 2 times
greater than the lowest median cost (or mean cost, if elected by the
Secretary) for an item or service within the same APC group (referred
to as the ``2 times rule''). In implementing this provision, we
generally use the cost of the item or service assigned to an APC group.
For new technology items and services, special payments under the
OPPS may be made in one of two ways. Section 1833(t)(6) of the Act
provides for temporary additional payments, which we refer to as
``transitional pass-through payments,'' for at least 2 but not more
than 3 years for certain drugs, biological agents, brachytherapy
devices used for the treatment of cancer, and categories of other
medical devices. For new technology services that are not eligible for
transitional pass-through payments, and for which we lack sufficient
clinical information and cost data to appropriately assign them to a
clinical APC group, we have established special APC groups based on
costs, which we refer to as New Technology APCs. These New Technology
APCs are designated by cost bands which allow us to provide appropriate
and consistent payment for designated new procedures that are not yet
reflected in our claims data. Similar to pass-through payments, an
assignment to a New Technology APC is temporary; that is, we retain a
service within a New Technology APC until we acquire sufficient data to
assign it to a clinically appropriate APC group.
C. Excluded OPPS Services and Hospitals
Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to
designate the hospital outpatient services that are paid under the
OPPS. While most hospital outpatient services are payable under the
OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for
ambulance, physical and occupational therapy, and speech-language
pathology services, for which payment is made under a fee schedule. It
also excludes screening mammography, diagnostic mammography, and
effective January 1, 2011, an annual wellness visit providing
personalized prevention plan services. The Secretary exercises the
authority granted under the statute to also exclude from the OPPS
certain services that are paid under fee schedules or other payment
systems. Such excluded services include, for example, the professional
services of physicians and nonphysician practitioners paid under the
Medicare Physician Fee Schedule (MPFS); certain laboratory services
paid under the Clinical Laboratory Fee Schedule (CLFS); services for
beneficiaries with end-stage renal disease (ESRD) that are paid under
the ESRD prospective payment system; and services and procedures that
require an inpatient stay that are paid under the hospital IPPS. In
addition, section 1833(t)(1)(B)(v) of the Act does not include
applicable items and services (as defined in subparagraph (A) of
paragraph (21)) that are furnished on or after January 1, 2017 by an
off-campus outpatient department of a provider (as defined in
subparagraph (B) of paragraph (21)). We set forth the services that are
excluded from payment under the OPPS in regulations at 42 CFR 419.22.
Under Sec. 419.20(b) of the regulations, we specify the types of
hospitals that are excluded from payment under the OPPS. These excluded
hospitals are:
Critical access hospitals (CAHs);
Hospitals located in Maryland and paid under Maryland's
All-Payer or Total Cost of Care Model;
Hospitals located outside of the 50 States, the District
of Columbia, and Puerto Rico; and
Indian Health Service (IHS) hospitals.
D. Prior Rulemaking
On April 7, 2000, we published in the Federal Register a final rule
with comment period (65 FR 18434) to implement a prospective payment
system for hospital outpatient services. The hospital OPPS was first
implemented for services furnished on or after August 1, 2000. Section
1833(t)(9)(A) of the Act requires the Secretary to review certain
components of the OPPS, not less often than annually, and to revise the
groups, the relative payment weights, and the wage and other
adjustments to take into account changes in medical practices, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors.
Since initially implementing the OPPS, we have published final
rules in the Federal Register annually to implement statutory
requirements and changes arising from our continuing experience with
this system. These rules can be viewed on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the
Panel)
1. Authority of the Panel
Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of
Public Law 106-113, and redesignated by section 202(a)(2) of Public Law
106-113, requires that we consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
annually review (and advise the Secretary concerning) the clinical
integrity of the payment groups and their weights under the OPPS. In CY
2000, based on section 1833(t)(9)(A) of the Act, the Secretary
established the Advisory Panel on Ambulatory Payment Classification
Groups (APC Panel) to fulfill this requirement. In CY 2011, based on
section 222 of the Public Health Service Act, which gives discretionary
authority to the Secretary to convene advisory councils and committees,
the Secretary expanded the panel's scope to include the supervision of
hospital outpatient therapeutic services in addition to the APC groups
and weights. To reflect this new role of the panel, the Secretary
changed the panel's name to the Advisory Panel on Hospital Outpatient
Payment (the HOP Panel or the Panel). The HOP Panel is not restricted
to using data compiled by CMS, and in conducting its review, it may use
data collected or developed by organizations outside the Department.
2. Establishment of the Panel
On November 21, 2000, the Secretary signed the initial charter
establishing the Panel, and, at that time, named the APC Panel. This
expert panel is composed of appropriate representatives of providers
(currently employed full-time, not as consultants, in their respective
areas of expertise) who review clinical data and advise CMS about the
clinical integrity of the APC groups and their payment weights. Since
CY 2012, the Panel also is charged with advising the Secretary on the
appropriate level of supervision for individual hospital outpatient
therapeutic services. The Panel is technical in nature, and it is
governed by the provisions of the Federal Advisory Committee Act
(FACA). The
[[Page 85873]]
current charter specifies, among other requirements, that the Panel--
May advise on the clinical integrity of Ambulatory Payment
Classification (APC) groups and their associated weights;
May advise on the appropriate supervision level for
hospital outpatient services;
May advise on OPPS APC rates for ASC covered surgical
procedures;
Continues to be technical in nature;
Is governed by the provisions of the FACA;
Has a Designated Federal Official (DFO); and
Is chaired by a Federal Official designated by the
Secretary.
The Panel's charter was amended on November 15, 2011, renaming the
Panel and expanding the Panel's authority to include supervision of
hospital outpatient therapeutic services and to add critical access
hospital (CAH) representation to its membership. The Panel's charter
was also amended on November 6, 2014 (80 FR 23009), and the number of
members was revised from up to 19 to up to 15 members. The Panel's
current charter was approved on November 20, 2020, for a 2-year period.
The current Panel membership and other information pertaining to
the Panel, including its charter, Federal Register notices, membership,
meeting dates, agenda topics, and meeting reports, can be viewed on the
CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html.
3. Panel Meetings and Organizational Structure
The Panel has held many meetings, with the last meeting taking
place on August 31, 2020. Prior to each meeting, we publish a notice in
the Federal Register to announce the meeting, new members, and any
other changes of which the public should be aware. Beginning in CY
2017, we have transitioned to one meeting per year (81 FR 31941). In CY
2018, we published a Federal Register notice requesting nominations to
fill vacancies on the Panel (83 FR 3715). As published in this notice,
CMS is accepting nominations on a continuous basis.
In addition, the Panel has established an administrative structure
that, in part, currently includes the use of three subcommittee
workgroups to provide preparatory meeting and subject support to the
larger panel. The three current subcommittees include the following:
APC Groups and Status Indicator Assignments Subcommittee,
which advises and provides recommendations to the Panel on the
appropriate status indicators to be assigned to HCPCS codes, including
but not limited to whether a HCPCS code or a category of codes should
be packaged or separately paid, as well as the appropriate APC
assignment of HCPCS codes regarding services for which separate payment
is made;
Data Subcommittee, which is responsible for studying the
data issues confronting the Panel and for recommending options for
resolving them; and
Visits and Observation Subcommittee, which reviews and
makes recommendations to the Panel on all technical issues pertaining
to observation services and hospital outpatient visits paid under the
OPPS.
Each of these workgroup subcommittees was established by a majority
vote from the full Panel during a scheduled Panel meeting, and the
Panel recommended at the August 31, 2020, meeting that the
subcommittees continue. We accepted this recommendation.
For discussions of earlier Panel meetings and recommendations, we
refer readers to previously published OPPS/ASC proposed and final
rules, the CMS website mentioned earlier in this section, and the FACA
database at http://facadatabase.gov.
F. Public Comments Received in Response to the CY 2021 OPPS/ASC
Proposed Rule
We received approximately 1,350 timely pieces of correspondence on
the CY 2021 OPPS/ASC proposed rule that appeared in the Federal
Register on August 12, 2020 (85 FR 48772). We note that we received
some public comments that were outside the scope of the CY 2021 OPPS/
ASC proposed rule. Out-of-scope-public comments are not addressed in
this CY 2021 OPPS/ASC final rule with comment period. Summaries of
those public comments that are within the scope of the proposed rule
and our responses are set forth in the various sections of this final
rule with comment period under the appropriate headings.
G. Public Comments Received on the CY 2020 OPPS/ASC Final Rule With
Comment Period
We received approximately 22 timely pieces of correspondence on the
CY 2020 OPPS/ASC final rule with comment period that appeared in the
Federal Register on November 12, 2019 (84 FR 61142), most of which were
outside of the scope of the final rule. In-scope comments related to
the interim APC assignments and/or status indicators of new or
replacement Level II HCPCS codes (identified with comment indicator
``NI'' in OPPS Addendum B, ASC Addendum AA, and ASC Addendum BB to that
final rule). Summaries of the public comments on topics that were open
to comment and our responses to them are set forth in various sections
of this final rule with comment period under the appropriate subject-
matter headings. Summaries of the public comments on new or replacement
Level II HCPCS codes are set forth in the CY 2021 OPPS/ASC proposed
rule and this final rule with comment period under the appropriate
subject matter headings.
II. Updates Affecting OPPS Payments
A. Recalibration of APC Relative Payment Weights
1. Database Construction
a. Database Source and Methodology
Section 1833(t)(9)(A) of the Act requires that the Secretary review
not less often than annually and revise the relative payment weights
for APCs. In the April 7, 2000 OPPS final rule with comment period (65
FR 18482), we explained in detail how we calculated the relative
payment weights that were implemented on August 1, 2000 for each APC
group.
For the CY 2021 OPPS/ASC proposed rule (85 FR 48779), we proposed
to recalibrate the APC relative payment weights for services furnished
on or after January 1, 2021, and before January 1, 2022 (CY 2021),
using the same basic methodology that we described in the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61149), using updated CY 2019
claims data. That is, as we proposed, we recalibrate the relative
payment weights for each APC based on claims and cost report data for
hospital outpatient department (HOPD) services, using the most recent
available data to construct a database for calculating APC group
weights.
For the purpose of recalibrating the proposed APC relative payment
weights for CY 2021, we began with approximately 167 million final
action claims (claims for which all disputes and adjustments have been
resolved and payment has been made) for HOPD services furnished on or
after January 1, 2019, and before January 1, 2020, before applying our
exclusionary criteria and other methodological adjustments. After the
application of those data processing changes, we used approximately 87
million final action claims to develop the proposed CY 2021 OPPS
payment weights. For exact numbers of claims used and additional
details on the
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claims accounting process, we refer readers to the claims accounting
narrative under supporting documentation for the CY 2021 OPPS/ASC
proposed rule on the CMS website at: http://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
Addendum N to the CY 2021 OPPS/ASC proposed rule (which is
available via the internet on the CMS website) included the proposed
list of bypass codes for CY 2021. The proposed list of bypass codes
contained codes that were reported on claims for services in CY 2019
and, therefore, included codes that were in effect in CY 2019 and used
for billing, but were deleted for CY 2020. We retained these deleted
bypass codes on the proposed CY 2021 bypass list because these codes
existed in CY 2019 and were covered OPD services in that period, and CY
2019 claims data were used to calculate proposed CY 2021 payment rates.
Keeping these deleted bypass codes on the bypass list potentially
allows us to create more ``pseudo'' single procedure claims for
ratesetting purposes. ``Overlap bypass codes'' that are members of the
proposed multiple imaging composite APCs were identified by asterisks
(*) in the third column of Addendum N to the proposed rule. HCPCS codes
that we proposed to add for CY 2021 were identified by asterisks (*) in
the fourth column of Addendum N.
b. Calculation and Use of Cost-to-Charge Ratios (CCRs)
For CY 2021, in the CY 2020 OPPS/ASC proposed rule (85 FR 48779),
we proposed to continue to use the hospital-specific overall ancillary
and departmental cost-to-charge ratios (CCRs) to convert charges to
estimated costs through application of a revenue code-to-cost center
crosswalk. To calculate the APC costs on which the CY 2021 APC payment
rates are based, we calculated hospital-specific overall ancillary CCRs
and hospital-specific departmental CCRs for each hospital for which we
had CY 2019 claims data by comparing these claims data to the most
recently available hospital cost reports, which, in most cases, are
from CY 2018. For the proposed CY 2021 OPPS payment rates, we used the
set of claims processed during CY 2019. We applied the hospital-
specific CCR to the hospital's charges at the most detailed level
possible, based on a revenue code-to-cost center crosswalk that
contains a hierarchy of CCRs used to estimate costs from charges for
each revenue code. To ensure the completeness of the revenue code-to-
cost center crosswalk, we reviewed changes to the list of revenue codes
for CY 2019 (the year of claims data we used to calculate the proposed
CY 2021 OPPS payment rates) and updates to the NUBC 2019 Data
Specifications Manual. That crosswalk is available for review and
continuous comment on the CMS website at: http://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
In accordance with our longstanding policy, we calculate CCRs for
the standard and nonstandard cost centers accepted by the electronic
cost report database. In general, the most detailed level at which we
calculate CCRs is the hospital-specific departmental level. For a
discussion of the hospital-specific overall ancillary CCR calculation,
we refer readers to the CY 2007 OPPS/ASC final rule with comment period
(71 FR 67983 through 67985). The calculation of blood costs is a
longstanding exception (since the CY 2005 OPPS) to this general
methodology for calculation of CCRs used for converting charges to
costs on each claim. This exception is discussed in detail in the CY
2007 OPPS/ASC final rule with comment period and discussed further in
section II.A.2.a.(1) of the proposed rule and this final rule with
comment period.
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74840
through 74847), we finalized our policy of creating new cost centers
and distinct CCRs for implantable devices, magnetic resonance imaging
(MRIs), computed tomography (CT) scans, and cardiac catheterization.
However, in response to the CY 2014 OPPS/ASC proposed rule, commenters
reported that some hospitals used a less precise ``square feet''
allocation methodology for the costs of large moveable equipment like
CT scan and MRI machines. They indicated that while we recommended
using two alternative allocation methods, ``direct assignment'' or
``dollar value,'' as a more accurate methodology for directly assigning
equipment costs, industry analysis suggested that approximately only
half of the reported cost centers for CT scans and MRIs rely on these
preferred methodologies. In response to concerns from commenters, we
finalized a policy for the CY 2014 OPPS/ASC final rule with comment
period (78 FR 74847) to remove claims from providers that use a cost
allocation method of ``square feet'' to calculate CCRs used to estimate
costs associated with the APCs for CT and MRI. Further, we finalized a
transitional policy to estimate the imaging APC relative payment
weights using only CT and MRI cost data from providers that do not use
``square feet'' as the cost allocation statistic. We provided that this
finalized policy would sunset in 4 years to provide sufficient time for
hospitals to transition to a more accurate cost allocation method and
for the related data to be available for ratesetting purposes (78 FR
74847). Therefore, beginning in CY 2018 with the sunset of the
transition policy, we would estimate the imaging APC relative payment
weights using cost data from all providers, regardless of the cost
allocation statistic employed. However, in the CY 2018 OPPS/ASC final
rule with comment period (82 FR 59228 and 59229) and in the CY 2019
OPPS/ASC final rule with comment period (83 FR 58831), we finalized a
policy to extend the transition policy for 1 additional year and we
continued to remove claims from providers that use a cost allocation
method of ``square feet'' to calculate CT and MRI CCRs for the CY 2018
OPPS and the CY 2019 OPPS.
As we discussed in the CY 2018 OPPS/ASC final rule with comment
period (82 FR 59228), some stakeholders have raised concerns regarding
using claims from all providers to calculate CT and MRI CCRs,
regardless of the cost allocations statistic employed (78 FR 74840
through 74847). Stakeholders noted that providers continue to use the
``square feet'' cost allocation method and that including claims from
such providers would cause significant reductions in the imaging APC
payment rates.
Table 1 demonstrates the relative effect on imaging APC payments
after removing cost data for providers that report CT and MRI standard
cost centers using ``square feet'' as the cost allocation method by
extracting HCRIS data on Worksheet B-1. Table 2 provides statistical
values based on the CT and MRI standard cost center CCRs using the
different cost allocation methods.
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[GRAPHIC] [TIFF OMITTED] TR29DE20.001
Our analysis shows that since the CY 2014 OPPS in which we
established the transition policy, the number of valid MRI CCRs has
increased by 18.7 percent to 2,199 providers and the number of valid CT
CCRs has increased by 16.5 percent to 2,280 providers. Table 1 displays
the impact on OPPS payment rates for CY 2021 if claims from providers
that report using the ``square feet'' cost allocation method were
removed. This can be attributed to the generally lower CCR values from
providers that use a ``square feet'' cost allocation method as shown in
Table 1.
We note that the CT and MRI cost center CCRs have been available
for ratesetting since the CY 2014 OPPS in which we established the
transition policy. Since the initial 4-year transition, we had extended
the transition an additional 2 years to offer providers flexibility in
applying cost allocation methodologies for CT and MRI cost centers
other than ``square feet.'' In the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61152), we finalized a 2-year phased-in approach,
as suggested by some commenters, that applied 50 percent of the payment
impact from ending the transition in CY 2020 and 100 percent of the
payment impact from ending the transition in CY 2021.
We believe we have provided sufficient time for providers to adopt
an alternative cost allocation methodology for CT and MRI cost centers
if they intended to do so and many providers continue to use the
``square feet'' cost allocation methodology, which we believe indicates
that these providers believe this methodology is a sufficient method
for attributing costs to this cost center. Additionally, we generally
believe that increasing the amount of claims data available for use in
ratesetting improves our ratesetting process. Therefore, as finalized
in the CY 2020 OPPS/ASC final rule with comment period (84 FR 61152),
in the CY 2021 OPPS we are using all claims with valid CT and MRI cost
center CCRs, including those that use a ``square feet'' cost allocation
method, to estimate costs for the APCs for CT and MRI identified in
Table 1.
The Deficit Reduction Act (DRA) of 2005 requires Medicare to limit
Medicare payment for certain imaging services covered by the Physician
Fee Schedule (PFS) to not exceed what Medicare pays for these services
under the OPPS. As required by law, for certain imaging services paid
for under the PFS, we cap the technical component of the PFS payment
amount for the applicable year at the OPPS payment amount (71 FR 69659
through
[[Page 85876]]
69661). As we stated in the CY 2014 OPPS/ASC final rule with comment
period (78 FR 74845), we have noted the potential impact the CT and MRI
CCRs may have on other payment systems. We understand that payment
reductions for imaging services under the OPPS could have significant
payment impacts under the PFS where the technical component payment for
many imaging services is capped at the OPPS amount. We will continue to
monitor OPPS imaging payments in the future and consider potential
impacts of payment changes on the PFS and the ASC payment system.
Comment: Several commenters requested that CMS not use the CT and
MRI-specific cost centers and instead estimate cost using the single
diagnostic radiology cost center, believing that this will solve the
inaccurate reporting of costs for CT and MR services. Commenters stated
that many hospitals have ``near zero'' CT and MRI CCRs and the existing
cost centers are inaccurate, too low, and depressing the valuation of
APCs that include CT and MRI services. One commenter recommended that
CMS establish detailed instructions for nonstandard cost centers to
improve the accuracy of the cost center data used to calculate CT and
MRI CCRs. Commenters also noted that the impact of our proposal may
diminish beneficiary access to medical imaging services for
beneficiaries, specifically noting low OPPS payments for cardiac
computed tomography angiography (CCTA). Several commenters noted that
the use of separate CT and MRI CCRs creates unintended consequences on
the technical component of CT and MRI codes in the Medicare Physician
Fee Schedule and on the payment rate under the ASC payment system for
these codes.
Response: We appreciate the thoughtful comments and analysis
regarding the use of the CT and MRI cost center CCRs. However, as
discussed in the CY 2020 OPPS/ASC final rule (84 FR 61152), we
finalized a policy to end the transition policy and use all data
submitted (including all providers, regardless of cost allocation
method) in the CY 2021 OPPS. We did not propose to make any changes in
the CY 2021 OPPS and are not modifying the policy at this time.
2. Final Data Development and Calculation of Costs Used for Ratesetting
In this section of this final rule with comment period, we discuss
the use of claims to calculate the OPPS payment rates for CY 2021. The
Hospital OPPS page on the CMS website on which this final rule with
comment period is posted (http://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/HospitalOutpatientPPS/index.html) provides an
accounting of claims used in the development of the final payment
rates. That accounting provides additional detail regarding the number
of claims derived at each stage of the process. In addition, later in
this section we discuss the file of claims that comprises the data set
that is available upon payment of an administrative fee under a CMS
data use agreement. The CMS website, http://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html,
includes information about obtaining the ``OPPS Limited Data Set,''
which now includes the additional variables previously available only
in the OPPS Identifiable Data Set, including ICD-10-CM diagnosis codes
and revenue code payment amounts. This file is derived from the CY 2019
claims that were used to calculate the final payment rates for this CY
2021 OPPS/ASC final rule with comment period.
Previously, the OPPS established the scaled relative weights, on
which payments are based using APC median costs, a process described in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74188).
However, as discussed in more detail in section II.A.2.f. of the CY
2013 OPPS/ASC final rule with comment period (77 FR 68259 through
68271), we finalized the use of geometric mean costs to calculate the
relative weights on which the CY 2013 OPPS payment rates were based.
While this policy changed the cost metric on which the relative
payments are based, the data process in general remained the same,
under the methodologies that we used to obtain appropriate claims data
and accurate cost information in determining estimated service cost.
For CY 2021, we are finalizing our proposal to continue to use
geometric mean costs to calculate the relative weights on which the
final CY 2021 OPPS payment rates are based.
We used the methodology described in sections II.A.2.a. through
II.A.2.c. of the CY 2021 OPPS/ASC final rule with comment period to
calculate the costs we used to establish the relative payment weights
used in calculating the OPPS payment rates for CY 2021 shown in Addenda
A and B to the CY 2021 OPPS/ASC final rule with comment period (which
are available via the internet on the CMS website). We referred readers
to section II.A.4. of the CY 2021 OPPS/ASC final rule with comment
period for a discussion of the conversion of APC costs to scaled
payment weights.
We note that under the OPPS, CY 2019 was the first year in which
the claims data used for setting payment rates (CY 2017 data) contained
lines with the modifier ``PN'', which indicates nonexcepted items and
services furnished and billed by off-campus provider-based departments
(PBDs) of hospitals. Because nonexcepted services are not paid under
the OPPS, in the CY 2019 OPPS/ASC final rule with comment period (83 FR
58832), we finalized a policy to remove those claim lines reported with
modifier ``PN'' from the claims data used in ratesetting for the CY
2019 OPPS and subsequent years. For the CY 2021 OPPS, we will continue
to remove these claim lines with modifier ``PN'' from the ratesetting
process.
For details of the claims accounting process used in the CY 2021
OPPS/ASC final rule with comment period, we refer readers to the claims
accounting narrative under supporting documentation for this CY 2021
OPPS/ASC final rule with comment period on the CMS website at: http://www.cms .gov/Medicare/Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/index.html.
a. Calculation of Single Procedure APC Criteria-Based Costs
(1) Blood and Blood Products
(a) Methodology
Since the implementation of the OPPS in August 2000, we have made
separate payments for blood and blood products through APCs rather than
packaging payment for them into payments for the procedures with which
they are administered. Hospital payments for the costs of blood and
blood products, as well as for the costs of collecting, processing, and
storing blood and blood products, are made through the OPPS payments
for specific blood product APCs.
We proposed to continue to establish payment rates for blood and
blood products using our blood-specific CCR methodology, which utilizes
actual or simulated CCRs from the most recently available hospital cost
reports to convert hospital charges for blood and blood products to
costs. This methodology has been our standard ratesetting methodology
for blood and blood products since CY 2005. It was developed in
response to data analysis indicating that there was a significant
difference in CCRs for those hospitals with and without blood-specific
cost centers, and past public comments indicating that the former OPPS
policy of defaulting to the overall hospital CCR for hospitals not
reporting a blood-
[[Page 85877]]
specific cost center often resulted in an underestimation of the true
hospital costs for blood and blood products. Specifically, to address
the differences in CCRs and to better reflect hospitals' costs, we
proposed to continue to simulate blood CCRs for each hospital that does
not report a blood cost center by calculating the ratio of the blood-
specific CCRs to hospitals' overall CCRs for those hospitals that do
report costs and charges for blood cost centers. We also proposed to
apply this mean ratio to the overall CCRs of hospitals not reporting
costs and charges for blood cost centers on their cost reports to
simulate blood-specific CCRs for those hospitals. We proposed to
calculate the costs upon which the proposed CY 2021 payment rates for
blood and blood products are based using the actual blood-specific CCR
for hospitals that reported costs and charges for a blood cost center
and a hospital-specific, simulated blood-specific CCR for hospitals
that did not report costs and charges for a blood cost center.
We continue to believe that the hospital-specific, simulated blood-
specific, CCR methodology better responds to the absence of a blood-
specific CCR for a hospital than alternative methodologies, such as
defaulting to the overall hospital CCR or applying an average blood-
specific CCR across hospitals. Because this methodology takes into
account the unique charging and cost accounting structure of each
hospital, we believe that it yields more accurate estimated costs for
these products. We continue to believe that this methodology in CY 2021
will result in costs for blood and blood products that appropriately
reflect the relative estimated costs of these products for hospitals
without blood cost centers and, therefore, for these blood products in
general.
We note that we defined a comprehensive APC (C-APC) as a
classification for the provision of a primary service and all
adjunctive services provided to support the delivery of the primary
service. Under this policy, we include the costs of blood and blood
products when calculating the overall costs of these C-APCs. We
proposed to continue to apply the blood-specific CCR methodology
described in this section when calculating the costs of the blood and
blood products that appear on claims with services assigned to the C-
APCs. Because the costs of blood and blood products will be reflected
in the overall costs of the C-APCs (and, as a result, in the proposed
payment rates of the C-APCs), we proposed not to make separate payments
for blood and blood products when they appear on the same claims as
services assigned to the C-APCs (we refer readers to the CY 2015 OPPS/
ASC final rule with comment period (79 FR 66796)). We refer readers to
Addendum B the CY 2021 OPPS/ASC proposed rule (which is available via
the internet on the CMS website) for the proposed CY 2021 payment rates
for blood and blood products (which are generally identified with
status indicator ``R''). For a more detailed discussion of the blood-
specific CCR methodology, we refer readers to the CY 2005 OPPS proposed
rule (69 FR 50524 through 50525). For a full history of OPPS payment
for blood and blood products, we refer readers to the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66807 through 66810).
For CY 2021, we proposed to continue to establish payment rates for
blood and blood products using our blood-specific CCR methodology. We
did not receive any comments on our proposal to establish payment rates
for blood and blood products using our blood-specific CCR methodology
and we are finalizing this policy as proposed.
(b) Payment for Blood Not Otherwise Classified (NOC) Code
Recently, providers and stakeholders in the blood products field
have reported that product development for new blood products has
accelerated. There may be several additional new blood products
entering the market by the end of CY 2021, compared to only one or two
new products entering the market over the previous 15 to 20 years. To
encourage providers to use these new products, providers and
stakeholders requested that we establish a new HCPCS code to allow for
payment for unclassified blood products prior to these products
receiving their own HCPCS code. Under the OPPS, unclassified procedures
are generally assigned to the lowest APC payment level of an APC
family. However, since blood products are each assigned to their own
unique APC, the concept of a lowest APC payment level does not apply in
this context.
Starting January 1, 2020, we established a new HCPCS code, P9099
(Blood component or product not otherwise classified) which allows
providers to report unclassified blood products. We assigned HCPCS code
P9099 to status indicator ``E2'' (Not payable by Medicare when
submitted on an outpatient claim) for CY 2020. We took this action
because HCPCS code P9099 potentially could be reported for multiple
products with different costs during the same period of time.
Therefore, we could not identify an individual blood product HCPCS code
that would have a similar cost to HCPCS code P9099, and were not able
to crosswalk a payment rate from an established blood product HCPCS
code to HCPCS code P9099. Some stakeholders expressed concerns that
assigning HCPCS code P9099 to a non-payable status in the OPPS meant
that hospitals would receive no payment when they used unclassified
blood products. Also, claim lines billed with P9099 are rejected by
Medicare, which prevents providers from tracking the utilization of
unclassified blood products.
Because of the challenges of determining an appropriate payment
rate for unclassified blood products, we stated in the CY 2021 OPPS/ASC
proposed rule that we were considering packaging the cost of
unclassified blood products into their affiliated primary medical
procedure. Although we typically do not package blood products under
the OPPS, for unclassified blood products, we stated that we do not
believe it is possible to accurately determine an appropriate rate that
would apply for all of the products (potentially several, with varying
costs) that may be reported using HCPCS code P9099. Packaging the cost
of unclassified blood products into the payment for the primary medical
service by assigning HCPCS code P9099 a status indicator of ``N'' would
allow providers to report the cost of unclassified blood products to
Medicare. Over time, the costs of unspecified blood products would be
reflected in the payment rate for the primary medical service if the
blood product remains unclassified. However, we stated that we expect
that most blood products would seek and be granted more specific coding
such that the unclassified HCPCS code P9099 would no longer be
applicable. We also explained that we believe that packaging the costs
of unclassified blood products would be an improvement over the current
non-payable status for HCPCS code P9099 as it would allow for tracking
of the costs and utilization of unclassified blood products.
Another option we considered for the CY 2021 OPPS/ASC proposed
rule, but ultimately rejected was similar to our policy under the OPPS
to assign NOC codes to the lowest APC within the appropriate clinical
family. We stated that we could have cross-walked and assigned the same
payment rate for HCPCS code P9099 as HCPCS code P9043 (Infusion, plasma
protein fraction (human), 5 percent, 50 ml), which is the lowest cost
blood product with a
[[Page 85878]]
proposed CY 2021 payment rate of $8.02 per unit. This option would have
provided a small, separate payment for each unclassified blood product
service, and, similar to our proposal to package the costs of HCPCS
code P9099 into their primary procedure, would have allowed for
tracking of the cost and utilization for unclassified blood products.
However, given that the cross-walked payment rate is potentially
significantly lower than the cost of the product, we concluded that
providers may find that packaging the cost of unclassified blood
products into another medical service may generate more payment for the
products over time.
Thus, for CY 2021, we proposed to package the cost of unclassified
blood products reported by HCPCS code P9099 into the cost of the
associated primary procedure. We proposed to change the status
indicator for HCPCS code P9099 from ``E2'' (not payable by Medicare in
the OPPS) to ``N'' (payment is packaged into other services in the
OPPS). In addition, we also sought comment on the alternative proposal
to make HCPCS code P9099 separately payable with a payment rate
equivalent to the payment rate for the lowest cost blood product, HCPCS
code P9043 (Infusion, plasma protein fraction (human), 5 percent, 50
ml), with a proposed CY 2021 payment rate of $8.02 per unit. We stated
that if we were to adopt this option as our final policy, we would also
change the status indicator for HCPCS code P9099 from ``E2'' (not
payable by Medicare in the OPPS) to ``R'' (blood and blood products,
paid under OPPS).
Comment: Multiple commenters opposed our proposal to reassign HCPCS
code P9099 to status indicator ``N'' and package the payment for
unclassified blood products into the associated primary procedure.
Commenters were concerned that because blood products are usually
separately paid in the OPPS, APC payment rates for the associated
procedures would not reflect the cost of the unclassified blood
products, and that it would take a long time before providers would see
any changes in payments that would include the cost of unclassified
blood products. One commenter was also concerned that packaging the
cost of unclassified blood products would make providers less likely to
report HCPCS code P9099, making it harder to track the utilization of
unclassified blood products, and reluctant to use blood products that
would not receive separate payment.
Response: We agree with the concerns expressed by the commenters,
and we have considered these concerns in determining the payment policy
for the blood NOC code.
Comment: One commenter supported our proposal to reassign HCPCS
code P9099 to status indicator ``N'' and package the payment for
unclassified blood products into the associated primary procedure. The
commenter also encouraged us to work with manufacturers and blood
product stakeholders to move quickly to establish individual HCPCS
codes for these new blood products.
Response: We appreciate the commenter's support for our proposal
and we also support the request that codes be established in a timely
manner for unclassified blood products.
Comment: Multiple commenters opposed our alternative proposal to
pay services billed with HCPCS code P9099 at the lowest payment rate
for a blood product in the OPPS, which is $7.79 per unit. The
commenters believe the payment rate will be too low for new,
unclassified blood products and may discourage manufacturers from
pursuing new innovations in the blood products field.
Response: We understand the concerns of the commenters who believe
paying for unclassified blood products at the lowest payment rate for a
separately payable blood product in the OPPS does not provide adequate
payment for new, unclassified blood products. However, our goal is to
limit the time it is necessary for providers to report HCPCS code P9099
until a new blood product has an individual HCPCS code established for
the product. Once a new blood product has an individual HCPCS code, it
will allow for a payment for the new service that is better aligned
with its costs and make it easier to track utilization for the service.
Establishing a payment rate for the blood NOC code that is equal to the
payment rate for the lowest payment rate for a separately payable blood
product is consistent with OPPS policy for other major categories of
medical care where the payment rate for the unclassified service is
equal to the lowest-paying APC in an APC series for that category of
service.
Comment: The CMS HOP Panel and multiple commenters requested that
unclassified blood products be separately paid using a weighted average
of the payment rates of all separately payable blood products in the
OPPS. The average payment rate would be weighted by the number of units
billed for each service in the OPPS. Commenters believe a weighted
average would be consistent with OPPS policy to provide separate
payment for all blood products and would encourage the use of HCPCS
code P9099 to track the utilization of unclassified blood products
until the new products could receive individual HCPCS codes. The
weighted average also would provide a higher payment for services
billed with HCPCS code P9099 than the alternative proposal of assigning
the lowest payment rate for a separately payable blood product as
payment for unclassified blood products. Other commenters suggested
that unclassified blood products be paid either at charges reduced to
cost or at reasonable cost to appropriately compensate providers
billing unclassified blood products.
Response: Providing payment for HCPCS code P9099 through a weighted
average payment, charges reduced to cost, or reasonable cost could
provide incentives to discourage manufacturers of new blood products
from seeking individual HCPCS codes for their products. A weighted
average payment would encourage manufacturers of relatively inexpensive
unclassified blood products not to seek a HCPCS code for their products
because the payment using P9099 for the products would be substantially
higher than payment the products would receive once an individual code
is established for the blood products. In addition, the level of
payment from a weighted average payment may reduce the urgency of
manufacturers to seek an individual HCPCS cost even for higher-cost
products, which would delay our ability to track payment for individual
blood products. We have similar concerns about paying unclassified
blood products using either charges reduced to cost or reasonable cost.
Although these payment methods would accurately reflect the cost of
unclassified blood products to providers, there would be no incentive
for providers to manage their costs when using unclassified blood
products, and no incentives for the manufacturers to seek individual
HCPCS codes for the unclassified blood products. The OPPS is a
prospective payment system, and we want to limit rather than expand the
types of services within the OPPS that do not receive prospective
payment.
After reviewing the public comments, we are not finalizing our
original proposal to package HCPCS code P9099 into the associated
primary procedure. Instead, we are finalizing our alternative proposal
to make HCPCS code P9099 separately payable, assign it a status
indicator of ``R'', and pay the code at a rate equal to the lowest paid
separately payable blood product in the OPPS, which is P9043 (Infusion,
plasma protein fraction (human), 5 percent, 50 ml) with a payment rate
of $7.79 per unit. Our alternative proposal aligns
[[Page 85879]]
with our general policy in the OPPS to pay NOC codes at the lowest
available APC rate for a service category, while providing a payment
for unclassified blood products when a service is reported on the
claim. We believe our alternative proposal is superior to our original
proposal, which would not have provided any separate payment for blood
products reported using HCPCS code P9099. Our alternative proposal also
provides incentives for manufacturers to seek individual HCPCS codes
for new blood products, which helps us to track the utilization of
these new blood products and establish a payment rate for these new
products that better reflects their cost.
We decided to finalize our alternative proposal, as it gives
providers some payment for unclassified blood products, is consistent
with OPPS policy for other major categories of medical care where the
payment rate for the unclassified service is based on the lowest-paying
APC in an APC series for that category of service, while maintaining
incentives for manufacturers to establish individual HCPCS codes for
their new blood products in a timely manner.
(2) Brachytherapy Sources
Section 1833(t)(2)(H) of the Act mandates the creation of
additional groups of covered OPD services that classify devices of
brachytherapy consisting of a seed or seeds (or radioactive source)
(``brachytherapy sources'') separately from other services or groups of
services. The statute provides certain criteria for the additional
groups. For the history of OPPS payment for brachytherapy sources, we
refer readers to prior OPPS final rules, such as the CY 2012 OPPS/ASC
final rule with comment period (77 FR 68240 through 68241). As we have
stated in prior OPPS updates, we believe that adopting the general OPPS
prospective payment methodology for brachytherapy sources is
appropriate for a number of reasons (77 FR 68240). The general OPPS
methodology uses costs based on claims data to set the relative payment
weights for hospital outpatient services. This payment methodology
results in more consistent, predictable, and equitable payment amounts
per source across hospitals by averaging the extremely high and low
values, in contrast to payment based on hospitals' charges adjusted to
costs. We believe that the OPPS methodology, as opposed to payment
based on hospitals' charges adjusted to cost, also would provide
hospitals with incentives for efficiency in the provision of
brachytherapy services to Medicare beneficiaries. Moreover, this
approach is consistent with our payment methodology for the vast
majority of items and services paid under the OPPS. We refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70323
through 70325) for further discussion of the history of OPPS payment
for brachytherapy sources.
For CY 2021, except where otherwise indicated, we proposed to use
the costs derived from CY 2019 claims data to set the proposed CY 2021
payment rates for brachytherapy sources because CY 2019 is the year of
data we proposed to use to set the proposed payment rates for most
other items and services that would be paid under the CY 2021 OPPS.
With the exception of the proposed payment rate for brachytherapy
source C2645 (Brachytherapy planar source, palladium-103, per square
millimeter), we proposed to base the payment rates for brachytherapy
sources on the geometric mean unit costs for each source, consistent
with the methodology that we proposed for other items and services paid
under the OPPS, as discussed in section II.A.2. of the CY 2021 OPPS/ASC
proposed rule. We also proposed to continue the other payment policies
for brachytherapy sources that we finalized and first implemented in
the CY 2010 OPPS/ASC final rule with comment period (74 FR 60537). We
proposed to pay for the stranded and nonstranded not otherwise
specified (NOS) codes, HCPCS codes C2698 (Brachytherapy source,
stranded, not otherwise specified, per source) and C2699 (Brachytherapy
source, non-stranded, not otherwise specified, per source), at a rate
equal to the lowest stranded or nonstranded prospective payment rate
for such sources, respectively, on a per source basis (as opposed to,
for example, a per mCi), which is based on the policy we established in
the CY 2008 OPPS/ASC final rule with comment period (72 FR 66785). We
also proposed to continue the policy we first implemented in the CY
2010 OPPS/ASC final rule with comment period (74 FR 60537) regarding
payment for new brachytherapy sources for which we have no claims data,
based on the same reasons we discussed in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66786; which was delayed until January
1, 2010 by section 142 of Pub. L. 110-275). Specifically, this policy
is intended to enable us to assign new HCPCS codes for new
brachytherapy sources to their own APCs, with prospective payment rates
set based on our consideration of external data and other relevant
information regarding the expected costs of the sources to hospitals.
The proposed CY 2021 payment rates for brachytherapy sources are
included in Addendum B to the CY 2021 OPPS/ASC proposed rule (which is
available via the internet on the CMS website) and identified with
status indicator ``U''.
For CY 2018, we assigned status indicator ``U'' (Brachytherapy
Sources, Paid under OPPS; separate APC payment) to HCPCS code C2645
(Brachytherapy planar source, palladium-103, per square millimeter) in
the absence of claims data and established a payment rate using
external data (invoice price) at $4.69 per mm\2\. For CY 2019, in the
absence of sufficient claims data, we continued to establish a payment
rate for C2645 at $4.69 per mm\2\. Our CY 2018 claims data available
for the final CY 2020 OPPS/ASC final rule with comment period, included
two claims with a geometric mean cost for HCPCS code C2645 of $1.02 per
mm\2\. In response to comments from stakeholders, we agreed with
commenters that given the limited claims data available and a new
outpatient indication for C2645, a payment rate for HCPCS code C2645
based on the geometric mean cost of 1.02 per mm\2\ may not adequately
reflect the cost of HCPCS code C2645. In the CY 2020 OPPS/ASC final
rule with comment period, we finalized our policy to use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act, which
states that the Secretary shall establish, in a budget neutral manner,
other adjustments as determined to be necessary to ensure equitable
payments, to maintain the CY 2019 payment rate of $4.69 per mm\2\ for
HCPCS code C2645 for CY 2020.
For CY 2021, we proposed to continue to assign status indicator
``U'' to HCPCS code C2645 (Brachytherapy planar source, palladium-103,
per square millimeter). For CY 2020, in the absence of sufficient
claims data, we continued to establish a payment rate for C2645 at
$4.69 per mm\2\. Our CY 2019 claims data available for the proposed CY
2021 rule included one claim with over 4,000 units of HCPCS code C2645.
The geometric mean cost of HCPCS code C2645 from this one claim is
$1.07 per mm\2\ for CY 2019. We do not believe that this one claim is
adequate to establish an APC payment rate for HCPCS code C2645 and to
discontinue our use of external data for this brachytherapy source.
Therefore, for CY 2021, we proposed to continue assigning the
brachytherapy source described by HCPCS code C2645 a payment rate of
$4.69 mm\2\ for CY 2021
[[Page 85880]]
through use of our equitable adjustment authority.
Comment: One commenter recommended that we should review outpatient
claims data for low-volume brachytherapy sources and consider removing
outliers to ensure appropriate and stable brachytherapy source
reimbursement in future years. The commenter contends that
brachytherapy source payments have fluctuated significantly since 2013
and may create barriers to access for individual cancer patients.
Response: We thank the commenter for their recommendation. As we
have stated in past rulemaking, the OPPS relies on the concept of
averaging, where the payment may be more or less than the estimated
cost of providing a service for a particular patient; however, with the
exception of outlier cases, we believe that such a prospective payment
is adequate to ensure access to appropriate care. We acknowledge that
payment for brachytherapy sources based on geometric mean costs from a
small set of claims may be more variable on a year-to-year basis when
compared to the geometric mean costs for brachytherapy sources from a
larger claims set. We will take the commenter's recommendation into
consideration in future rulemaking.
Comment: One commenter recommended that we exclude erroneous claims
data for C2642 (Brachytherapy source, stranded, cesium-131, per source)
from a particular hospital. The commenter stated the hospital reported
costs per source of $42.59 for C2642. Further, the commenter argued the
proposed payment rate for C2642 as a result of including the hospital's
claims information would threaten access to cancer therapy and would be
less than the actual amount paid by any hospital for this source over
the past decade.
Response: In our review of CY 2019 brachytherapy claims used for CY
2021 OPPS ratesetting, we did not find any erroneous billing of C2642
with respect to the particular hospital mentioned by the commenter.
OPPS relative payment weights based on geometric mean costs capture the
range of costs associated with services that are introduced slowly into
the system on a case-by-case or hospital-by-hospital basis. For these
reasons we believe it would be inappropriate to remove any outliers
when determining brachytherapy geometric mean costs and payment rates
for C2642.
After consideration of the public comments we received, we are
finalizing our proposal to assign the brachytherapy source described by
HCPCS code C2645 a payment rate of $4.69 per mm\2\ for CY 2021 through
use of our equitable adjustment authority.
We continue to invite hospitals and other parties to submit
recommendations to us for new codes to describe new brachytherapy
sources. Such recommendations should be direction via email to
[email protected] or by mail to the Division of Outpatient
Care, Mail Stop C4-01-26, Centers for Medicare and Medicaid Services,
7500 Security Boulevard, Baltimore, MD 21244. We will continue to add
new brachytherapy source codes and descriptors to our systems for
payment on a quarterly basis.
b. Comprehensive APCs (C-APCs) for CY 2021
(1) Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74861
through 74910), we finalized a comprehensive payment policy that
packages payment for adjunctive and secondary items, services, and
procedures into the most costly primary procedure under the OPPS at the
claim level. The policy was finalized in CY 2014, but the effective
date was delayed until January 1, 2015, to allow additional time for
further analysis, opportunity for public comment, and systems
preparation. The comprehensive APC (C-APC) policy was implemented
effective January 1, 2015, with modifications and clarifications in
response to public comments received regarding specific provisions of
the C-APC policy (79 FR 66798 through 66810).
A C-APC is defined as a classification for the provision of a
primary service and all adjunctive services provided to support the
delivery of the primary service. We established C-APCs as a category
broadly for OPPS payment and implemented 25 C-APCs beginning in CY 2015
(79 FR 66809 through 66810). In the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70332), we finalized 10 additional C-APCs to be
paid under the existing C-APC payment policy and added 1 additional
level to both the Orthopedic Surgery and Vascular Procedures clinical
families, which increased the total number of C-APCs to 37 for CY 2016.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79584
through 79585), we finalized another 25 C-APCs for a total of 62 C-
APCs. In the CY 2018 OPPS/ASC final rule with comment period, we did
not change the total number of C-APCs from 62. In the CY 2019 OPPS/ASC
final rule with comment period, we created 3 new C-APCs, increasing the
total number to 65 (83 FR 58844 through 58846). Most recently in the CY
2020 OPPS/ASC final rule with comment period, we created two new C-
APCs, increasing the total number to 67 C-APCs (84 FR 61158 through
61166).
Under our C-APC policy, we designate a service described by a HCPCS
code assigned to a C-APC as the primary service when the service is
identified by OPPS status indicator ``J1''. When such a primary service
is reported on a hospital outpatient claim, taking into consideration
the few exceptions that are discussed below, we make payment for all
other items and services reported on the hospital outpatient claim as
being integral, ancillary, supportive, dependent, and adjunctive to the
primary service (hereinafter collectively referred to as ``adjunctive
services'') and representing components of a complete comprehensive
service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services
are packaged into the payments for the primary services. This results
in a single prospective payment for each of the primary, comprehensive
services based on the costs of all reported services at the claim
level.
Services excluded from the C-APC policy under the OPPS include
services that are not covered OPD services, services that cannot by
statute be paid for under the OPPS, and services that are required by
statute to be separately paid. This includes certain mammography and
ambulance services that are not covered OPD services in accordance with
section 1833(t)(1)(B)(iv) of the Act; brachytherapy seeds, which also
are required by statute to receive separate payment under section
1833(t)(2)(H) of the Act; pass-through payment drugs and devices, which
also require separate payment under section 1833(t)(6) of the Act;
self-administered drugs (SADs) that are not otherwise packaged as
supplies because they are not covered under Medicare Part B under
section 1861(s)(2)(B) of the Act; and certain preventive services (78
FR 74865 and 79 FR 66800 through 66801). A list of services excluded
from the C-APC policy is included in Addendum J to the CY 2021 OPPS/ASC
proposed rule (which is available via the internet on the CMS website).
In the interim final with request for comments (IFC) entitled,
``Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency'', published on November 6, 2020, we stated
that effective for services furnished on or
[[Page 85881]]
after the effective date of the IFC and until the end of the PHE for
COVID-19, there is an exception to the OPPS C-APC policy to ensure
separate payment for new COVID-19 treatments that meet certain criteria
(85 FR 71158 through 71160). Under this exception, any new COVID-19
treatment that meets the two following criteria will, for the remainder
of the PHE for COVID-19, always be separately paid and will not be
packaged into a C-APC when it is provided on the same claim as the
primary C-APC service. First, the treatment must be a drug or
biological product (which could include a blood product) authorized to
treat COVID-19, as indicated in section ``I. Criteria for Issuance of
Authorization'' of the letter of authorization for the drug or
biological product, or the drug or biological product must be approved
by the FDA for treating COVID-19. Second, the emergency use
authorization (EUA) for the drug or biological product (which could
include a blood product) must authorize the use of the product in the
outpatient setting or not limit its use to the inpatient setting, or
the product must be approved by the FDA to treat COVID-19 disease and
not limit its use to the inpatient setting. For further information
regarding the exception to the C-APC policy for COVID-19 treatments,
please refer to the IFC (85 FR 71158 through 71160).
The C-APC policy payment methodology set forth in the CY 2014 OPPS/
ASC final rule with comment period for the C-APCs and modified and
implemented beginning in CY 2015 is summarized as follows (78 FR 74887
and 79 FR 66800):
Basic Methodology. As stated in the CY 2015 OPPS/ASC final rule
with comment period, we define the C-APC payment policy as including
all covered OPD services on a hospital outpatient claim reporting a
primary service that is assigned to status indicator ``J1'', excluding
services that are not covered OPD services or that cannot by statute be
paid for under the OPPS. Services and procedures described by HCPCS
codes assigned to status indicator ``J1'' are assigned to C-APCs based
on our usual APC assignment methodology by evaluating the geometric
mean costs of the primary service claims to establish resource
similarity and the clinical characteristics of each procedure to
establish clinical similarity within each APC.
In the CY 2016 OPPS/ASC final rule with comment period, we expanded
the C-APC payment methodology to qualifying extended assessment and
management encounters through the ``Comprehensive Observation
Services'' C-APC (C-APC 8011). Services within this APC are assigned
status indicator ``J2''. Specifically, we make a payment through C-APC
8011 for a claim that:
Does not contain a procedure described by a HCPCS code to
which we have assigned status indicator ``T;''
Contains 8 or more units of services described by HCPCS
code G0378 (Hospital observation services, per hour);
Contains services provided on the same date of service or
1 day before the date of service for HCPCS code G0378 that are
described by one of the following codes: HCPCS code G0379 (Direct
admission of patient for hospital observation care) on the same date of
service as HCPCS code G0378; CPT code 99281 (Emergency department visit
for the evaluation and management of a patient (Level 1)); CPT code
99282 (Emergency department visit for the evaluation and management of
a patient (Level 2)); CPT code 99283 (Emergency department visit for
the evaluation and management of a patient (Level 3)); CPT code 99284
(Emergency department visit for the evaluation and management of a
patient (Level 4)); CPT code 99285 (Emergency department visit for the
evaluation and management of a patient (Level 5)) or HCPCS code G0380
(Type B emergency department visit (Level 1)); HCPCS code G0381 (Type B
emergency department visit (Level 2)); HCPCS code G0382 (Type B
emergency department visit (Level 3)); HCPCS code G0383 (Type B
emergency department visit (Level 4)); HCPCS code G0384 (Type B
emergency department visit (Level 5)); CPT code 99291 (Critical care,
evaluation and management of the critically ill or critically injured
patient; first 30-74 minutes); or HCPCS code G0463 (Hospital outpatient
clinic visit for assessment and management of a patient); and
Does not contain services described by a HCPCS code to
which we have assigned status indicator ``J1''.
The assignment of status indicator ``J2'' to a specific combination
of services performed in combination with each other allows for all
other OPPS payable services and items reported on the claim (excluding
services that are not covered OPD services or that cannot by statute be
paid for under the OPPS) to be deemed adjunctive services representing
components of a comprehensive service and resulting in a single
prospective payment for the comprehensive service based on the costs of
all reported services on the claim (80 FR 70333 through 70336).
Services included under the C-APC payment packaging policy, that
is, services that are typically adjunctive to the primary service and
provided during the delivery of the comprehensive service, include
diagnostic procedures, laboratory tests, and other diagnostic tests and
treatments that assist in the delivery of the primary procedure; visits
and evaluations performed in association with the procedure; uncoded
services and supplies used during the service; durable medical
equipment as well as prosthetic and orthotic items and supplies when
provided as part of the outpatient service; and any other components
reported by HCPCS codes that represent services that are provided
during the complete comprehensive service (78 FR 74865 and 79 FR
66800).
In addition, payment for hospital outpatient department services
that are similar to therapy services and delivered either by therapists
or nontherapists is included as part of the payment for the packaged
complete comprehensive service. These services that are provided during
the perioperative period are adjunctive services and are deemed not to
be therapy services as described in section 1834(k) of the Act,
regardless of whether the services are delivered by therapists or other
nontherapist health care workers. We have previously noted that therapy
services are those provided by therapists under a plan of care in
accordance with section 1835(a)(2)(C) and section 1835(a)(2)(D) of the
Act and are paid for under section 1834(k) of the Act, subject to
annual therapy caps as applicable (78 FR 74867 and 79 FR 66800).
However, certain other services similar to therapy services are
considered and paid for as hospital outpatient department services.
Payment for these nontherapy outpatient department services that are
reported with therapy codes and provided with a comprehensive service
is included in the payment for the packaged complete comprehensive
service. We note that these services, even though they are reported
with therapy codes, are hospital outpatient department services and not
therapy services. We refer readers to the July 2016 OPPS Change Request
9658 (Transmittal 3523) for further instructions on reporting these
services in the context of a C-APC service.
Items included in the packaged payment provided in conjunction with
the primary service also include all drugs, biologicals, and
radiopharmaceuticals, regardless of cost, except those drugs with pass-
through payment status and SADs, unless they function as packaged
supplies (78 FR 74868 through 74869 and 74909 and 79 FR 66800). We
refer readers to Section
[[Page 85882]]
50.2M, Chapter 15, of the Medicare Benefit Policy Manual for a
description of our policy on SADs treated as hospital outpatient
supplies, including lists of SADs that function as supplies and those
that do not function as supplies.
We define each hospital outpatient claim reporting a single unit of
a single primary service assigned to status indicator ``J1'' as a
single ``J1'' unit procedure claim (78 FR 74871 and 79 FR 66801). Line
item charges for services included on the C-APC claim are converted to
line item costs, which are then summed to develop the estimated APC
costs. These claims are then assigned one unit of the service with
status indicator ``J1'' and later used to develop the geometric mean
costs for the C-APC relative payment weights. (We note that we use the
term ``comprehensive'' to describe the geometric mean cost of a claim
reporting ``J1'' service(s) or the geometric mean cost of a C-APC,
inclusive of all of the items and services included in the C-APC
service payment bundle.) Charges for services that would otherwise be
separately payable are added to the charges for the primary service.
This process differs from our traditional cost accounting methodology
only in that all such services on the claim are packaged (except
certain services as described above). We apply our standard data trims,
which exclude claims with extremely high primary units or extreme
costs.
The comprehensive geometric mean costs are used to establish
resource similarity and, along with clinical similarity, dictate the
assignment of the primary services to the C-APCs. We establish a
ranking of each primary service (single unit only) to be assigned to
status indicator ``J1'' according to its comprehensive geometric mean
costs. For the minority of claims reporting more than one primary
service assigned to status indicator ``J1'' or units thereof, we
identify one ``J1'' service as the primary service for the claim based
on our cost-based ranking of primary services. We then assign these
multiple ``J1'' procedure claims to the C-APC to which the service
designated as the primary service is assigned. If the reported ``J1''
services on a claim map to different C-APCs, we designate the ``J1''
service assigned to the C-APC with the highest comprehensive geometric
mean cost as the primary service for that claim. If the reported
multiple ``J1'' services on a claim map to the same C-APC, we designate
the most costly service (at the HCPCS code level) as the primary
service for that claim. This process results in initial assignments of
claims for the primary services assigned to status indicator ``J1'' to
the most appropriate C-APCs based on both single and multiple procedure
claims reporting these services and clinical and resource homogeneity.
Complexity Adjustments. We use complexity adjustments to provide
increased payment for certain comprehensive services. We apply a
complexity adjustment by promoting qualifying paired ``J1'' service
code combinations or paired code combinations of ``J1'' services and
certain add-on codes (as described further below) from the originating
C-APC (the C-APC to which the designated primary service is first
assigned) to the next higher paying C-APC in the same clinical family
of C-APCs. We apply this type of complexity adjustment when the paired
code combination represents a complex, costly form or version of the
primary service according to the following criteria:
Frequency of 25 or more claims reporting the code
combination (frequency threshold); and
Violation of the 2 times rule, as stated in section
1833(t)(2) of the Act and section III.B.2. of the CY 2021 OPPS/ASC
proposed rule, in the originating C-APC (cost threshold).
These criteria identify paired code combinations that occur
commonly and exhibit materially greater resource requirements than the
primary service. The CY 2017 OPPS/ASC final rule with comment period
(81 FR 79582) included a revision to the complexity adjustment
eligibility criteria. Specifically, we finalized a policy to
discontinue the requirement that a code combination (that qualifies for
a complexity adjustment by satisfying the frequency and cost criteria
thresholds described above) also not create a 2 times rule violation in
the higher level or receiving APC.
After designating a single primary service for a claim, we evaluate
that service in combination with each of the other procedure codes
reported on the claim assigned to status indicator ``J1'' (or certain
add-on codes) to determine if there are paired code combinations that
meet the complexity adjustment criteria. For a new HCPCS code, we
determine initial C-APC assignment and qualification for a complexity
adjustment using the best available information, crosswalking the new
HCPCS code to a predecessor code(s) when appropriate.
Once we have determined that a particular code combination of
``J1'' services (or combinations of ``J1'' services reported in
conjunction with certain add-on codes) represents a complex version of
the primary service because it is sufficiently costly, frequent, and a
subset of the primary comprehensive service overall according to the
criteria described above, we promote the claim including the complex
version of the primary service as described by the code combination to
the next higher cost C-APC within the clinical family, unless the
primary service is already assigned to the highest cost APC within the
C-APC clinical family or assigned to the only C-APC in a clinical
family. We do not create new APCs with a comprehensive geometric mean
cost that is higher than the highest geometric mean cost (or only) C-
APC in a clinical family just to accommodate potential complexity
adjustments. Therefore, the highest payment for any claim including a
code combination for services assigned to a C-APC would be the highest
paying C-APC in the clinical family (79 FR 66802).
We package payment for all add-on codes into the payment for the C-
APC. However, certain primary service add-on combinations may qualify
for a complexity adjustment. As noted in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70331), all add-on codes that can be
appropriately reported in combination with a base code that describes a
primary ``J1'' service are evaluated for a complexity adjustment.
To determine which combinations of primary service codes reported
in conjunction with an add-on code may qualify for a complexity
adjustment for CY 2021, we proposed to apply the frequency and cost
criteria thresholds discussed above, testing claims reporting one unit
of a single primary service assigned to status indicator ``J1'' and any
number of units of a single add-on code for the primary ``J1'' service.
If the frequency and cost criteria thresholds for a complexity
adjustment are met and reassignment to the next higher cost APC in the
clinical family is appropriate (based on meeting the criteria outlined
above), we make a complexity adjustment for the code combination; that
is, we reassign the primary service code reported in conjunction with
the add-on code to the next higher cost C-APC within the same clinical
family of C-APCs. As previously stated, we package payment for add-on
codes into the C-APC payment rate. If any add-on code reported in
conjunction with the ``J1'' primary service code does not qualify for a
complexity adjustment, payment for the add-on service continues to be
packaged into the payment for the
[[Page 85883]]
primary service and is not reassigned to the next higher cost C-APC. We
listed the complexity adjustments for ``J1'' and add-on code
combinations for CY 2021, along with all of the other proposed
complexity adjustments, in Addendum J to the CY 2021 OPPS/ASC proposed
rule (which is available via the internet on the CMS website).
Addendum J to the CY 2021 OPPS/ASC proposed rule includes the cost
statistics for each code combination that would qualify for a
complexity adjustment (including primary code and add-on code
combinations). Addendum J to the CY 2021 OPPS/ASC proposed rule also
contains summary cost statistics for each of the paired code
combinations that describe a complex code combination that would
qualify for a complexity adjustment and are proposed to be reassigned
to the next higher cost C-APC within the clinical family. The combined
statistics for all proposed reassigned complex code combinations are
represented by an alphanumeric code with the first 4 digits of the
designated primary service followed by a letter. For example, the
proposed geometric mean cost listed in Addendum J for the code
combination described by complexity adjustment assignment 3320R, which
is assigned to C-APC 5224 (Level 4 Pacemaker and Similar Procedures),
includes all paired code combinations that are proposed to be
reassigned to C-APC 5224 when CPT code 33208 is the primary code.
Providing the information contained in Addendum J to the CY 2021 OPPS/
ASC proposed rule allows stakeholders the opportunity to better assess
the impact associated with the proposed reassignment of claims with
each of the paired code combinations eligible for a complexity
adjustment.
Comment: A commenter stated that CMS should not use claims data
from complexity adjustment code pairs in calculating the geometric mean
cost for the next higher paying APC to which the complexity adjusted
code pair is assigned and that doing so can decrease the geometric mean
cost of APCs with a low number of claims, specifically C-APC 5493--
Level 3 Intraocular Procedures. The commenter stated that CMS did not
intend to include the costs of complexity-adjusted code pairs in
calculating the geometric mean cost for the higher-paying APCs to which
the complexity-adjustment code pair is assigned when the C-APC
complexity adjustment policy was initially established and that
complexity adjustments were intended as payment adjustments for complex
versions of the comprehensive service only. To further support their
claim that CMS intended for complexity adjustments to only provide
higher payment for claims including complex comprehensive services, the
commenter noted that, unlike other HCPCS codes with a significant
number of claims assigned to an APC, complexity adjusted code pairs are
not evaluated for a 2 times rule violation in the higher-paying APC to
which they are promoted.
Response: We disagree with the commenter's assertion regarding the
policy of including the costs of a complexity adjusted code pair in the
calculation of the geometric mean costs of the next higher paying C-APC
to which the code pair is assigned. The current C-APC complexity
adjustment policy, including the calculation of the geometric mean cost
of APCs that include complexity-adjusted code pairs, was initially
described in the CY 2014 OPPS/ASC final rule with comment period (78 FR
74887). In that rule, we stated the following: ``We then considered
reassigning complex subsets of claims for each primary service HCPCS
code. All claims reporting more than one procedure described by HCPCS
codes assigned to status indicator ``J1'' are evaluated for the
existence of commonly occurring combinations of procedure codes
reported on claims that exhibit a materially greater comprehensive
geometric mean cost relative to the geometric mean cost of the claims
reporting that primary HCPCS code. This indicates that the subset of
procedures identified by the secondary HCPCS code has increased
resource requirements relative to less complex subsets of that
procedure. If a combination of procedure codes reported on claims is
identified that meets these requirements, that is, commonly occurring
and exhibiting materially greater resource requirements, it is further
evaluated to confirm clinical validity as a complex subset of the
primary procedure and the combination of procedure codes is then
identified as complex, and primary service claims with that combination
of procedure codes are subsequently reassigned as appropriate. If a
combination of procedure codes does not meet the requirement for a
materially different cost or does not occur commonly, it is not
considered to be a complex, and primary service claims with that
combination of procedure codes are not reassigned. All combinations of
procedures described by HCPCS codes assigned to status indicator ``J1''
for each primary HCPCS code are similarly evaluated.
Once all combinations of procedures described by HCPCS codes
assigned to status indicator ``J1'' have been evaluated, all claims
identified for reassignment for each primary service are combined and
the group is assigned to a higher level comprehensive APC within a
clinical family of comprehensive APCs, that is, an APC with greater
estimated resource requirements than the initially assigned
comprehensive APC and with appropriate clinical homogeneity. We
assessed resource variation for reassigned claims within the receiving
APC using the geometric mean cost for all reassigned claims for the
primary service relative to other services assigned to that APC using
the 2 times rule criteria. For new HCPCS codes and codes without data,
we will use the best data available to us to identify combinations of
procedures that represent a more complex form of the primary procedure
and warrant reassignment to a higher level APC. We will reevaluate our
APC assignments, and identification and APC placement of complex claims
once claims data become available. We then recalculate all APC
comprehensive geometric mean costs and ensure clinical and resource
homogeneity.''
We believe that the final statement clearly communicates our policy
of including the costs of the complexity-adjusted codes pairs in
calculating the geometric mean cost for the higher-paying APCs to which
the complexity-adjustment code pairs are assigned. While the commenter
is correct that we no longer require that a code combination (that
qualifies for a complexity adjustment by satisfying the frequency and
cost criteria thresholds described above) not create a 2 times rule
violation in the higher level or receiving APC, this change was based
on our belief that the requirement was not useful because most code
combinations fall below our established frequency threshold for
considering 2 times rule violations (81 FR 79582). In summary, we do
not believe it is necessary to change the current policy that includes
the costs of the paired code combinations in the next higher-paying APC
at this time.
Comment: Several commenters requested that CMS alter the
established C-APC complexity adjustment eligibility criteria to allow
additional code combinations to qualify for complexity adjustments. We
also received several comments requesting that CMS modify its
complexity adjustment criteria by eliminating the claims frequency
requirement to determine eligibility for the complexity adjustment and
expanding the eligibility for a complexity adjustment to other APCs
besides C-APCs to apply the
[[Page 85884]]
complexity adjustment to all blue light cystoscopy with Cysview
procedures in the HOPD, even those assigned to clinical APCs.
Response: We appreciate these comments. However, at this time, we
do not believe changes to the C-APC complexity adjustment criteria are
necessary or that we should make exceptions to the criteria to allow
claims with the code combinations suggested by the commenters to
receive complexity adjustments. As stated previously (81 FR 79582), we
continue to believe that the complexity adjustment criteria, which
require a frequency of 25 or more claims reporting a code combination
and a violation of the 2 times rule in the originating C-APC in order
to receive payment in the next higher cost C-APC within the clinical
family, are adequate to determine if a combination of procedures
represents a complex, costly subset of the primary service. If a code
combination meets these criteria, the combination receives payment at
the next higher cost C-APC. Code combinations that do not meet these
criteria receive the C-APC payment rate associated with the primary
``J1'' service. A minimum of 25 claims is already a very low threshold
for a national payment system. Lowering the minimum of 25 claims
further could lead to unnecessary complexity adjustments for service
combinations that are rarely performed.
With regard to the requests for complexity adjustments for blue
light cystoscopy procedures involving the use of Cysview, in CY 2018 we
created a HCPCS C-code (C9738--Adjunctive blue light cystoscopy with
fluorescent imaging agent (list separately in addition to code for
primary procedure)) to describe blue light cystoscopy with fluorescent
imaging agent and allowed this code to be eligible for complexity
adjustments when billed with procedure codes used to describe white
light cystoscopy of the bladder, although this code is not a ``J1''
service or an add-on code for the primary ``J1'' service. For CY 2021,
there is one code combination, of the six total available combinations
involving C9738 and procedure codes used to describe white light
cystoscopy, that qualifies for a complexity adjustment (HCPCS code
52204 Cystourethroscopy, with biopsy(s) + C9738 Adjunctive blue light
cystoscopy with fluorescent imaging agent (list separately in addition
to code for primary procedure)). The remaining five code combinations
do not meet the cost and frequency criteria to qualify for a complexity
adjustment. At this time, we do not believe that further modifications
to the C-APC complexity adjustment policy, including allowing services
assigned to clinical APCs to qualify for complexity adjustments, are
necessary to allow for complexity adjustments for these procedures.
After consideration of the public comments we received on the
proposed complexity adjustment policy, we are finalizing the C-APC
complexity adjustment policy for CY 2021, as proposed, without
modification.
(2) Exclusion of Procedures Assigned to New Technology APCs From the C-
APC Policy
Services that are assigned to New Technology APCs are typically new
procedures that do not have sufficient claims history to establish an
accurate payment for the procedures. Beginning in CY 2002, we retain
services within New Technology APC groups until we gather sufficient
claims data to enable us to assign the service to an appropriate
clinical APC. This policy allows us to move a service from a New
Technology APC in less than 2 years if sufficient data are available.
It also allows us to retain a service in a New Technology APC for more
than 2 years if sufficient data upon which to base a decision for
reassignment have not been collected (82 FR 59277).
The C-APC payment policy packages payment for adjunctive and
secondary items, services, and procedures into the most costly primary
procedure under the OPPS at the claim level. Prior to CY 2019, when a
procedure assigned to a New Technology APC was included on the claim
with a primary procedure, identified by OPPS status indicator ``J1'',
payment for the new technology service was typically packaged into the
payment for the primary procedure. Because the new technology service
was not separately paid in this scenario, the overall number of single
claims available to determine an appropriate clinical APC for the new
service was reduced. This was contrary to the objective of the New
Technology APC payment policy, which is to gather sufficient claims
data to enable us to assign the service to an appropriate clinical APC.
To address this issue and ensure that there is sufficient claims
data for services assigned to New Technology APCs, in the CY 2019 OPPS/
ASC final rule with comment period (83 FR 58847), we finalized
excluding payment for any procedure that is assigned to a New
Technology APC (APCs 1491 through 1599 and APCs 1901 through 1908) from
being packaged when included on a claim with a ``J1'' service assigned
to a C-APC. In the CY 2020 OPPS/ASC final rule with comment period, we
finalized that payment for services assigned to a New Technology APC
would be excluded from being packaged into the payment for
comprehensive observation services assigned status indicator ``J2''
when they are included on a claim with a ``J2'' service starting in CY
2020 (84 FR 61167).
(3) Additional C-APCs for CY 2021
For CY 2021 and subsequent years, we proposed to continue to apply
the C-APC payment policy methodology. We refer readers to the CY 2017
OPPS/ASC final rule with comment period (81 FR 79583) for a discussion
of the C-APC payment policy methodology and revisions.
Each year, in accordance with section 1833(t)(9)(A) of the Act, we
review and revise the services within each APC group and the APC
assignments under the OPPS. As a result of our annual review of the
services and the APC assignments under the OPPS, we did not propose to
convert any conventional APCs to C-APCs in CY 2021. However, as
discussed in section III.D.7, we proposed to create an additional level
in the ``Urology and Related Services'' APC series and, as discussed in
section III.D.1, we proposed to create an additional level in the
``Neurostimulator and Related Procedures'' APC series. Table 3 lists
the proposed C-APCs for CY 2021, all of which were established in past
rules.
Comment: Commenters supported the creation of the two new proposed
C-APCs, based on resource cost and clinical characteristics.
Response: We appreciate the commenters' support.
Comment: Several commenters expressed concern that the C-APC
payment rates may not adequately reflect the costs associated with
services. These comments stated that the C-APC methodology does not
account for the complexity of certain care processes, fails to capture
the necessary claims, and the resulting data may lead to inaccurate
payment rates that will negatively impact access to services.
Commenters also had concerns around the claims data used for
ratesetting, due to variations in clinical practice and billing
patterns across the hospitals that submit these claims, and urged CMS
to consider alternatives to the current methodology. Some commenters
were concerned that hospitals are not correctly charging for procedures
assigned to C-APCs and urged CMS to invest in policies and education
for hospitals regarding correct
[[Page 85885]]
billing patterns. These commenters also requested that CMS provide an
analysis of the impact of the C-APC policy on affected procedures and
patient access to services. One commenter requested that CMS review and
use Part B claims data in order to estimate costs for the appropriate
C-APCs for CY 2021 ratesetting.
Response: We appreciate the comments. We continue to believe that
the current C-APC methodology is appropriate. We also note that, in the
CY 2018 OPPS/ASC final rule with comment period (82 FR 59246), we
conducted an analysis of the effects of the C-APC policy. The analysis
used claims data for the CY 2016 OPPS/ASC final rule with comment
period, the CY 2017 OPPS/ASC final rule with comment period, and the CY
2018 OPPS/ASC proposed rule, which were for the period from CY 2014
(before C-APCs became effective) to CY 2016. We looked at separately
payable codes that were then assigned to C-APCs and, overall, we
observed an increase in claim line frequency, units billed, and
Medicare payment for those procedures, which suggest that the C-APC
payment policy did not adversely affect access to care or reduce
payments to hospitals and is working as intended.
Comment: Several commenters requested that CMS discontinue the C-
APC payment policy for all surgical insertion codes required for
brachytherapy treatment. The commenters stated concerns about how the
C-APC methodology impacts radiation oncology, particularly the delivery
of brachytherapy for the treatment of cervical cancer. They also stated
that they oppose C-APC payment for cancer care given the complexity of
coding, serial billing for cancer care, and potentially different sites
of service for the initial surgical device insertion and subsequent
treatment delivery or other supportive services. These commenters
suggested that CMS allow brachytherapy to be reported through the
traditional APC methodology, move procedures to a higher C-APC, or
separately pay for preparation and planning services to fully account
for accurate reflection of the costs associated with these procedures.
Response: While we continue to believe that the C-APC policy is
appropriately applied to these surgical procedures, we will continue to
examine these concerns and will determine if any modifications to this
policy are warranted in future rulemaking.
Comment: One commenter urged CMS to eliminate the C-APC policy for
single-session stereotactic radiosurgery codes (77371 and 77372). The
commenter requested that CMS continue to make separate payments for the
10 planning and preparation codes related to SRS and include the HCPCS
code for IMRT planning (77301) on the list of planning and preparation
codes, stating that the service has become more common in single
fraction radiosurgery treatment planning.
Response: At this time, we do not believe that it is necessary to
discontinue the C-APCs that include single session SRS procedures. We
continue to believe that the C-APC policy is appropriately applied to
these surgical procedures for the reasons cited when this policy was
first adopted and note that the commenters did not provide any
empirical evidence to support their claims that the existing C-APC
policy does not adequately pay for these procedures. Also, we will
continue in CY 2021 to pay separately for the 10 planning and
preparation services (HCPCS codes 70551, 70552, 70553, 77011, 77014,
77280, 77285, 77290, 77295, and 77336) adjunctive to the delivery of
the SRS treatment using either the Cobalt-60-based or LINAC-based
technology when furnished to a beneficiary within 1 month of the SRS
treatment for CY 2021.
Comment: We received one comment requesting that CMS carefully
consider the proper location of care before establishing a C-APC for
autologous hematopoietic stem cell transplant.
Response: We thank the commenter for this comment. This comment
relates to a recommendation from last year's Advisory Panel on Hospital
Outpatient Payment (HOP Panel), which recommended that CMS consider
creating a C-APC for autologous stem cell transplantation and that CMS
provide a rationale if it decides not to create such an APC. In the CY
2020 OPPS/ASC final rule with comment period, we evaluated the
possibility of creating this C-APC and found that it was not
appropriate to create a C-APC for autologous hematopoietic stem cell
transplant at that time for the reasons discussed in that rule (84 FR
61162).
After consideration of the public comments we received, we are
finalizing the proposed C-APCs for CY 2021. Table 3 below lists the
final C-APCs for CY 2021. All C-APCs are displayed in Addendum J to
this final rule with comment period (which is available via the
internet on the CMS website). Addendum J to this final rule with
comment period also contains all of the data related to the C-APC
payment policy methodology, including the list of complexity
adjustments and other information for CY 2021.
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c. Calculation of Composite APC Criteria-Based Costs
As discussed in the CY 2008 OPPS/ASC final rule with comment period
(72 FR 66613), we believe it is important that the OPPS enhance
incentives for hospitals to provide necessary, high quality care as
efficiently as possible. For CY 2008, we developed composite APCs to
provide a single payment for groups of services that are typically
performed together during a single clinical encounter and that result
in the provision of a complete service.
[[Page 85888]]
Combining payment for multiple, independent services into a single OPPS
payment in this way enables hospitals to manage their resources with
maximum flexibility by monitoring and adjusting the volume and
efficiency of services themselves. An additional advantage to the
composite APC model is that we can use data from correctly coded
multiple procedure claims to calculate payment rates for the specified
combinations of services, rather than relying upon single procedure
claims which may be low in volume and/or incorrectly coded. Under the
OPPS, we currently have composite policies for mental health services
and multiple imaging services. (We note that, in the CY 2018 OPPS/ASC
final rule with comment period, we finalized a policy to delete the
composite APC 8001 (LDR Prostate Brachytherapy Composite) for CY 2018
and subsequent years.) We refer readers to the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66611 through 66614 and 66650 through
66652) for a full discussion of the development of the composite APC
methodology, and the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74163) and the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59241 through 59242 and 59246 through 52950) for more recent
background.
(1) Mental Health Services Composite APC
We proposed to continue our longstanding policy of limiting the
aggregate payment for specified less resource-intensive mental health
services furnished on the same date to the payment for a day of partial
hospitalization services provided by a hospital, which we consider to
be the most resource-intensive of all outpatient mental health
services. We refer readers to the April 7, 2000 OPPS final rule with
comment period (65 FR 18452 through 18455) for the initial discussion
of this longstanding policy and the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74168) for more recent background.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79588
through 79589), we finalized a policy to combine the existing Level 1
and Level 2 hospital-based PHP APCs into a single hospital-based PHP
APC, and thereby discontinue APCs 5861 (Level 1--Partial
Hospitalization (3 services) for Hospital-Based PHPs) and 5862 (Level--
2 Partial Hospitalization (4 or more services) for Hospital-Based PHPs)
and replace them with APC 5863 (Partial Hospitalization (3 or more
services per day)).
In the CY 2018 OPPS/ASC proposed rule and final rule with comment
period (82 FR 33580 through 33581 and 59246 through 59247,
respectively), we proposed and finalized the policy for CY 2018 and
subsequent years that, when the aggregate payment for specified mental
health services provided by one hospital to a single beneficiary on a
single date of service, based on the payment rates associated with the
APCs for the individual services, exceeds the maximum per diem payment
rate for partial hospitalization services provided by a hospital, those
specified mental health services will be paid through composite APC
8010 (Mental Health Services Composite). In addition, we set the
payment rate for composite APC 8010 for CY 2018 at the same payment
rate that will be paid for APC 5863, which is the maximum partial
hospitalization per diem payment rate for a hospital, and finalized a
policy that the hospital will continue to be paid the payment rate for
composite APC 8010. Under this policy, the I/OCE will continue to
determine whether to pay for these specified mental health services
individually, or to make a single payment at the same payment rate
established for APC 5863 for all of the specified mental health
services furnished by the hospital on that single date of service. We
continue to believe that the costs associated with administering a
partial hospitalization program at a hospital represent the most
resource intensive of all outpatient mental health services. Therefore,
we do not believe that we should pay more for mental health services
under the OPPS than the highest partial hospitalization per diem
payment rate for hospitals.
We proposed that when the aggregate payment for specified mental
health services provided by one hospital to a single beneficiary on a
single date of service, based on the payment rates associated with the
APCs for the individual services, exceeds the maximum per diem payment
rate for partial hospitalization services provided by a hospital, those
specified mental health services would be paid through composite APC
8010 for CY 2021. In addition, we proposed to set the proposed payment
rate for composite APC 8010 at the same payment rate that we proposed
for APC 5863, which is the maximum partial hospitalization per diem
payment rate for a hospital, and that the hospital continue to be paid
the proposed payment rate for composite APC 8010.
We did not receive any public comment on these proposals.
Therefore, we are finalizing our proposal, without modification, that
when the aggregate payment for specified mental health services
provided by one hospital to a single beneficiary on a single date of
service, based on the payment rates associated with the APCs for the
individual services, exceeds the maximum per diem payment rate for
partial hospitalization services provided by a hospital, those
specified mental health services would be paid through composite APC
8010 for CY 2021. In addition, we are finalizing our proposal to set
the payment rate for composite APC 8010 for CY 2021 at the same payment
rate that we set for APC 5863, which is the maximum partial
hospitalization per diem payment rate for a hospital.
(2) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and
8008)
Effective January 1, 2009, we provide a single payment each time a
hospital submits a claim for more than one imaging procedure within an
imaging family on the same date of service, to reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session (73 FR 41448 through 41450). We
utilize three imaging families based on imaging modality for purposes
of this methodology: (1) Ultrasound; (2) computed tomography (CT) and
computed tomographic angiography (CTA); and (3) magnetic resonance
imaging (MRI) and magnetic resonance angiography (MRA). The HCPCS codes
subject to the multiple imaging composite policy and their respective
families are listed in Table 12 of the CY 2014 OPPS/ASC final rule with
comment period (78 FR 74920 through 74924).
While there are three imaging families, there are five multiple
imaging composite APCs due to the statutory requirement under section
1833(t)(2)(G) of the Act that we differentiate payment for OPPS imaging
services provided with and without contrast. While the ultrasound
procedures included under the policy do not involve contrast, both CT/
CTA and MRI/MRA scans can be provided either with or without contrast.
The five multiple imaging composite APCs established in CY 2009 are:
APC 8004 (Ultrasound Composite);
APC 8005 (CT and CTA without Contrast Composite);
APC 8006 (CT and CTA with Contrast Composite);
APC 8007 (MRI and MRA without Contrast Composite); and
APC 8008 (MRI and MRA with Contrast Composite).
We define the single imaging session for the ``with contrast''
composite APCs
[[Page 85889]]
as having at least one or more imaging procedures from the same family
performed with contrast on the same date of service. For example, if
the hospital performs an MRI without contrast during the same session
as at least one other MRI with contrast, the hospital will receive
payment based on the payment rate for APC 8008, the ``with contrast''
composite APC.
We make a single payment for those imaging procedures that qualify
for payment based on the composite APC payment rate, which includes any
packaged services furnished on the same date of service. The standard
(noncomposite) APC assignments continue to apply for single imaging
procedures and multiple imaging procedures performed across families.
For a full discussion of the development of the multiple imaging
composite APC methodology, we refer readers to the CY 2009 OPPS/ASC
final rule with comment period (73 FR 68559 through 68569).
For CY 2021, we proposed to continue to pay for all multiple
imaging procedures within an imaging family performed on the same date
of service using the multiple imaging composite APC payment
methodology. We continue to believe that this policy would reflect and
promote the efficiencies hospitals can achieve when performing multiple
imaging procedures during a single session.
The proposed CY 2021 payment rates for the five multiple imaging
composite APCs (APCs 8004, 8005, 8006, 8007, and 8008) were based on
proposed geometric mean costs calculated from CY 2019 claims available
for the CY 2021 OPPS/ASC proposed rule that qualified for composite
payment under the current policy (that is, those claims reporting more
than one procedure within the same family on a single date of service).
To calculate the proposed geometric mean costs, we used the same
methodology that we have used to calculate the geometric mean costs for
these composite APCs since CY 2014, as described in the CY 2014 OPPS/
ASC final rule with comment period (78 FR 74918). The imaging HCPCS
codes referred to as ``overlap bypass codes'' that we removed from the
bypass list for purposes of calculating the proposed multiple imaging
composite APC geometric mean costs, in accordance with our established
methodology as stated in the CY 2014 OPPS/ASC final rule with comment
period (78 FR 74918), are identified by asterisks in Addendum N to this
CY 2021 OPPS/ASC proposed rule (which is available via the internet on
the CMS website) and are discussed in more detail in section II.A.1.b.
of this CY 2021 OPPS/ASC proposed rule.
For the CY 2021 OPPS/ASC proposed rule, we were able to identify
approximately 964,000 ``single session'' claims out of an estimated 4.9
million potential claims for payment through composite APCs from our
ratesetting claims data, which represents approximately 14 percent of
all eligible claims, to calculate the proposed CY 2021 geometric mean
costs for the multiple imaging composite APCs. Table 4 of the CY 2021
OPPS/ASC proposed rule lists the proposed HCPCS codes that would be
subject to the multiple imaging composite APC policy and their
respective families and approximate composite APC proposed geometric
mean costs for CY 2021.
We did not receive any public comments on this proposal. Therefore,
we are finalizing our proposal to continue the use of multiple imaging
composite APCs to pay for services providing more than one imaging
procedure from the same family on the same date, without modification.
Table 4 lists the HCPCS codes that will be subject to the multiple
imaging composite APC policy and their respective families and
approximate composite APC final geometric mean costs for CY 2021.
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3. Changes to Packaged Items and Services
a. Background and Rationale for Packaging in the OPPS
Like other prospective payment systems, the OPPS relies on the
concept of averaging to establish a payment rate for services. The
payment may be more or less than the estimated cost of providing a
specific service or a bundle of specific services for a particular
beneficiary. The OPPS packages payments for multiple interrelated items
and services into a single payment to create incentives for hospitals
to furnish services most efficiently and to manage their resources with
maximum flexibility. Our packaging policies support our strategic goal
of using larger payment bundles in the OPPS to maximize hospitals'
incentives to provide care in the most efficient manner. For example,
where there are a variety of devices, drugs, items, and supplies that
could be used to furnish a service, some of which are more costly than
others, packaging encourages hospitals to use the most cost-efficient
item that meets the patient's needs, rather than to routinely use a
more expensive item, which may occur if separate payment is provided
for the item.
Packaging also encourages hospitals to effectively negotiate with
manufacturers and suppliers to reduce the purchase price of items and
services or to explore alternative group purchasing arrangements,
thereby encouraging the most economical health care delivery.
Similarly, packaging encourages hospitals to establish protocols that
ensure that necessary services are furnished, while scrutinizing the
services ordered by practitioners to maximize the efficient use of
hospital resources. Packaging payments into larger payment bundles
promotes the predictability and accuracy of payment for services over
time. Finally, packaging may reduce the importance of refining service-
specific payment because packaged payments include costs associated
with higher cost cases requiring many ancillary items and services and
lower cost cases requiring fewer ancillary items and services. Because
packaging encourages efficiency and is an essential component of a
prospective payment system, packaging payments for items and services
that are typically integral, ancillary, supportive, dependent, or
adjunctive to a primary service has been a fundamental part of the OPPS
since its implementation in August 2000. For an extensive discussion of
the history and background of the OPPS packaging policy, we refer
readers to the CY 2000 OPPS final rule (65 FR 18434), the CY 2008 OPPS/
ASC final rule with comment period (72 FR 66580), the CY 2014 OPPS/ASC
final rule with comment period (78 FR 74925), the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66817), the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70343), the CY 2017 OPPS/ASC
final rule with comment period (81 FR 79592), the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59250), the CY 2019 OPPS/ASC
final rule with comment period (83 FR 58854), and the CY 2020 OPPS/ASC
final rule with comment period (84 FR 61173). As we continue to develop
larger payment groups that more broadly reflect services provided in an
encounter or episode of care, we have expanded the OPPS packaging
policies. Most, but not necessarily all, categories of items and
services currently packaged in the OPPS are listed in 42 CFR 419.2(b).
Our overarching goal is to make payments for all services under the
OPPS more consistent with those of a prospective payment system and
less like those of a per-service fee schedule, which pays separately
for each coded item. As a part of this effort, we have continued to
examine the payment for items and services provided under the OPPS to
determine which OPPS services can be packaged to further achieve the
objective of advancing the OPPS toward a more prospective payment
system.
For CY 2021, we examined the items and services currently provided
under the OPPS, reviewing categories of integral, ancillary,
supportive, dependent, or adjunctive items and services for which we
believe payment would be appropriately packaged into payment for the
primary service that they support. Specifically, we examined the HCPCS
code definitions (including CPT code descriptors) and outpatient
hospital billing patterns to determine whether there were categories of
codes for which packaging would be appropriate according to existing
OPPS packaging policies or a logical expansion of those existing OPPS
packaging policies. In CY 2021, we proposed no changes to this policy.
We will continue to conditionally package the costs of selected newly
identified ancillary services into payment for a primary service where
we believe that the packaged item or service is integral, ancillary,
supportive, dependent, or adjunctive to the provision of care that was
reported by the primary service HCPCS code. Below we discuss the
proposed changes to the packaging policies in CY 2021.
Comment: We received one comment asking CMS for an update regarding
a comment solicitation from the CY 2018 OPPS/ASC Proposed Rule
regarding the ``Comment Solicitation on Packaging of
[[Page 85895]]
Items and Services Under the OPPS'' (82 FR 33588).
Response: We thank the commenter for their inquiry. As noted in our
response in the CY 2018 OPPS/ASC final rule with comment period, we
appreciated the comments we received in response to this comment
solicitation and will take them into consideration as we continue to
explore and evaluate packaging policies that apply under the OPPS (82
FR 59254).
Comment: We received a comment on balancing packaging policy with
market access concerns after pass-through status expires. The commenter
noted that some packaging policies create incentives that could limit
patient access to certain items, services, and care. They requested
that CMS reconsider packaging policies, especially in the ASC and HOPD
setting, and review packaging decisions on a case-by-case basis upon
pass-through status expiration and not via the ``integral to'' policy,
applying a holistic separate payment policy for innovations.
Specifically, this commenter asked CMS to evaluate drugs and devices on
a case-by-case basis in order to determine the item's packaging status
after pass-through expires. This commenter also stated CMS should take
into consideration the drug or device's clinical value when determining
packaging status.
Response: We thank the commenter for their input. We continue to
believe our packaging policies support our strategic goal of using
larger payment bundles to maximize incentives to provide care in the
most efficient manner. However, we will take this comment into
consideration for future rulemaking.
Comment: We received several comments from patient advocates,
physicians, drug manufacturers, and professional medical societies
regarding payment for blue light cystoscopy procedures involving
Cysview[supreg] (hexaminolevulinate HCl) (described by HCPCS code
C9275). Cysview[supreg] is a drug that functions as a supply in a
diagnostic test or procedure and therefore payment for this product is
packaged with payment for the primary procedure in the OPPS and ASC
settings. Commenters stated that utilization of Cysview[supreg] is low
in the HOPD and ASC settings, which they attributed to the fact that
Cysview is packaged as a drug that functions as a supply in a
diagnostic test or procedure. Commenters indicated that packaged
payment does not adequately pay for the blue light cystoscopy
procedures, particularly in the ASC setting where payment is generally
approximately 55 percent of the HOPD payment. Commenters believe that
providers have been deterred from the use of this technology,
especially in the ASC setting, and as a result, a significant
percentage of beneficiaries are not able to access the procedure.
Commenters also stated that there has been literature published
showing that Blue Light Cystoscopy with Cysview[supreg] is more
effective than white light cystoscopy alone at detecting and
eliminating nonmuscle invasive bladder cancer tumors, leading to a
reduction in bladder cancer recurrence.
Commenters made various recommendations for payment for blue light
cystoscopy procedures involving Cysview[supreg], including to pay
separately for Cysview[supreg] when it is used with blue light
cystoscopy in the HOPD and ASC settings, similar to the policy
finalized for Exparel[supreg] in the CY 2019 OPPS/ASC final rule with
comment period (83 FR 58860), or to utilize our equitable adjustment
authority at section 1833(t)(2)(E) of the Act to provide an ``add-on''
or ``drug intensive'' payment to ASCs when using Cysview[supreg] in
blue light cystoscopy procedures. Other commenters requested separate
payment for all diagnostic imaging drugs (radiopharmaceuticals and
contrast agents).
Response: We acknowledge the concerns of the numerous stakeholders
who commented on this issue and understand the importance of blue light
cystoscopy procedures involving Cysview[supreg]. Cysview has been
packaged as a drug, biological, or radiopharmaceutical that functions
as a supply in a diagnostic test or procedure since CY 2014 (78 FR
74930). As we stated in the CY 2018 OPPS/ASC final rule with comment
period (82 FR 59244), we recognize that blue light cystoscopy
represents an additional elective but distinguishable service as
compared to white light cystoscopy that, in some cases, may allow
greater detection of bladder tumors in beneficiaries relative to white
light cystoscopy alone. Given the additional equipment, supplies,
operating room time, and other resources required to perform blue light
cystoscopy in addition to white light cystoscopy, in CY 2018, we
created a new HCPCS C-code to describe blue light cystoscopy and since
CY 2018 have allowed for complexity adjustments to higher paying C-APCs
for qualifying white light and blue light cystoscopy code combinations.
At this time, we continue to believe that Cysview[supreg] is a drug
that functions as a supply in a diagnostic test or procedure, and
therefore, payment for this drug should be packaged with payment for
the diagnostic procedure. Therefore, we do not believe it is necessary
to pay separately for Cysview[supreg] when it is used with blue light
cystoscopy in either the HOPD or ASC setting. We also do not believe
that it would be appropriate to utilize our equitable adjustment
authority at section 1833(t)(2)(E) of the Act to provide an ``add-on''
or ``drug intensive'' payment to ASCs when using Cysview[supreg] in
blue light cystoscopy procedures, as our equitable adjustment authority
at section (t)(2)(E) only authorizes adjustments under the OPPS, not
the ASC payment system. We do not have any evidence to show that
separate payment for blue light cystoscopy procedures involving Cysview
is required, based on commenter concerns regarding utilization and
access issues for Cysview. However, we will continue to examine payment
for blue light cystoscopy procedures involving Cysview to determine if
any changes to this policy would be appropriate in future rulemaking.
Comment: Some commenters requested that we eliminate the packaging
policy for drugs that function as a supply when used in a diagnostic
test or procedure.
Response: In the CY 2014 OPPS/ASC final rule with comment period,
we established a policy to package drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure. In particular, we referred to drugs,
biologicals, and radiopharmaceuticals that function as supplies as a
part of a larger, more encompassing service or procedure, namely, the
diagnostic test or procedure in which the drug, biological, or
radiopharmaceutical is employed (78 FR 74927). At this time, we do not
believe it is necessary to eliminate this policy. As previously noted,
the OPPS packages payments for multiple interrelated items and services
into a single payment to create incentives for hospitals to furnish
services most efficiently and to manage their resources with maximum
flexibility. Our packaging policies support our strategic goal of using
larger payment bundles in the OPPS to maximize hospitals' incentives to
provide care in the most efficient manner.
Comment: One commenter requested separate payment for add-on codes
for Fractional Flow Reserve Studies (FFR/iFR) and Intravascular
Ultrasound (IVUS). The commenter stated that they believe the packaging
of these codes will disincentivize physicians to perform these adjunct
procedures because of cost. The codes are:
[[Page 85896]]
93571--Intravascular doppler velocity and/or pressure
derived coronary flow reserve measurement (coronary vessel or graft)
during coronary angiography including pharmacologically induced stress;
initial vessel (list separately in addition to code for primary
procedure);
93572--Intravascular doppler velocity and/or pressure
derived coronary flow reserve measurement (coronary vessel or graft)
during coronary angiography including pharmacologically induced stress;
each additional vessel (list separately in addition to code for primary
procedure));
92978--Endoluminal imaging of coronary vessel or graft
using intravascular ultrasound (ivus) or optical coherence tomography
(oct) during diagnostic evaluation and/or therapeutic intervention
including imaging supervision, interpretation and report; initial
vessel (list separately in addition to code for primary procedure); and
92979--Endoluminal imaging of coronary vessel or graft
using intravascular ultrasound (ivus) or optical coherence tomography
(oct) during diagnostic evaluation and/or therapeutic intervention
including imaging supervision, interpretation and report; each
additional vessel (list separately in addition to code for primary
procedure)).
Response: As stated in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66630), we continue to believe that IVUS and FFR are
dependent services that are always provided in association with a
primary service. Add-on codes represent services that are integral,
ancillary, supportive, dependent, or adjunctive items and services for
which we believe payment is appropriately packaged into payment for the
primary service that they support. As we have noted in past rules, add-
on codes do not represent standalone procedures and are inclusive to
other procedures performed at the same time (79 FR 66818). We continue
to believe it is unnecessary to provide separate payment for the
previously mentioned add-on codes at this time.
b. Packaging Policy for Non-Opioid Pain Management Therapies
(1) Background on OPPS/ASC Non-Opioid Pain Management Packaging
Policies
In the CY 2018 OPPS/ASC proposed rule (82 FR 33588), within the
framework of existing packaging categories, such as drugs that function
as supplies in a surgical procedure or diagnostic test or procedure, we
requested stakeholder feedback on common clinical scenarios involving
currently packaged items and services described by HCPCS codes that
stakeholders believe should not be packaged under the OPPS. We also
expressed interest in stakeholder feedback on common clinical scenarios
involving separately payable HCPCS codes for which payment would be
most appropriately packaged under the OPPS. Commenters who responded to
the CY 2018 OPPS/ASC proposed rule expressed a variety of views on
packaging under the OPPS. The public comments ranged from requests to
unpackage most items and services that are unconditionally packaged
under the OPPS, including drugs and devices, to specific requests for
separate payment for a specific drug or device.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
52485), we reiterated our position with regard to payment for
Exparel[supreg], a non-opioid analgesic that functions as a surgical
supply, stating that we believed that payment for this drug is
appropriately packaged with the primary surgical procedure. We also
stated in the CY 2018 OPPS/ASC final rule with comment period that we
would continue to explore and evaluate packaging policies under the
OPPS and consider these policies in future rulemaking.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 58855
through 58860), we finalized a policy to unpackage and pay separately
at ASP+6 percent for the cost of non-opioid pain management drugs that
function as surgical supplies when they are furnished in the ASC
setting for CY 2019, due to decreased utilization in the ASC setting.
For the CY 2020 OPPS/ASC proposed rule (84 FR 39423 through 39427),
as required by section 1833(t)(22)(A)(i) of the Act, as added by
section 6082(a) of the SUPPORT Act, we reviewed payments under the OPPS
for opioids and evidence-based non-opioid alternatives for pain
management (including drugs and devices, nerve blocks, surgical
injections, and neuromodulation) with a goal of ensuring that there are
not financial incentives to use opioids instead of non-opioid
alternatives. We used currently available data to analyze the payment
and utilization patterns associated with specific non-opioid
alternatives, including drugs that function as a supply, nerve blocks,
and neuromodulation products, to determine whether our packaging
policies have reduced the use of non-opioid alternatives. For the CY
2020 OPPS/ASC proposed rule (84 FR 39423 through 39427), we proposed to
continue our policy to pay separately at ASP+6 percent for the cost of
non-opioid pain management drugs that function as surgical supplies in
the performance of surgical procedures when they are furnished in the
ASC setting and to continue to package payment for non-opioid pain
management drugs that function as surgical supplies in the performance
of surgical procedures in the hospital outpatient department setting
for CY 2020. In the CY 2020 OPPS/ASC final rule with comment period (84
FR 61173 through 61180), after reviewing data from stakeholders and
Medicare claims data, we did not find compelling evidence to suggest
that revisions to our OPPS payment policies for non-opioid pain
management alternatives were necessary for CY 2020. We finalized our
proposal to continue to unpackage and pay separately at ASP+6 percent
for the cost of non-opioid pain management drugs that function as
surgical supplies when furnished in the ASC setting for CY 2020. Under
this policy, the only drug that met these criteria in CY 2020 was
Exparel.
(2) Evaluation and CY 2021 Payment for Non-Opioid Alternatives
Section 1833(t)(22)(A)(i) of the Act, as added by section 6082(a)
of the SUPPORT Act, states that the Secretary must review payments
under the OPPS for opioids and evidence-based non-opioid alternatives
for pain management (including drugs and devices, nerve blocks,
surgical injections, and neuromodulation) with a goal of ensuring that
there are not financial incentives to use opioids instead of non-opioid
alternatives. As part of this review, under section 1833(t)(22)(A)(iii)
of the Act, the Secretary must consider the extent to which revisions
to such payments (such as the creation of additional groups of covered
OPD services to separately classify those procedures that utilize
opioids and non-opioid alternatives for pain management) would reduce
the payment incentives for using opioids instead of non-opioid
alternatives for pain management. In conducting this review and
considering any revisions, the Secretary must focus on covered OPD
services (or groups of services) assigned to C-APCs, APCs that include
surgical services, or services determined by the Secretary that
generally involve treatment for pain management. If the Secretary
identifies revisions to payments pursuant to section
1833(t)(22)(A)(iii) of the Act, section
[[Page 85897]]
1833(t)(22)(C) of the Act requires the Secretary to, as determined
appropriate, begin making revisions for services furnished on or after
January 1, 2020. Any revisions under this paragraph are required to be
treated as adjustments for purposes of paragraph (9)(B), which requires
any adjustments to be made in a budget neutral manner.
As noted in the background section above, we conducted an
evaluation to determine whether there are payment incentives for using
opioids instead of non-opioid alternatives in the CY 2020 OPPS/ASC
final rule with comment period (84 FR 61176 through 61180). The results
of our review and evaluation of our claims data did not provide
evidence to indicate that the OPPS packaging policy had the unintended
consequence of discouraging the use of non-opioid treatments for
postsurgical pain management in the hospital outpatient department.
Higher utilization may be a potential indicator that the packaged
payment is not causing an access to care issue and that the payment
rate for the primary procedure adequately reflects the cost of the
drug. Our updated review of claims data showed a continued decline in
the utilization of Exparel[supreg] in the ASC setting, which supported
our proposal to continue paying separately for Exparel[supreg] in the
ASC setting. Decreased utilization could potentially indicate that the
packaging policy is discouraging use of that treatment and that
providers are choosing less expensive treatments. However, it is
difficult to attribute causality of changes in utilization to Medicare
packaging payment policy only. We believe that unpackaging and paying
separately for Exparel addresses decreased utilization because it
eliminates any potential Medicare payment disincentive for the use of
this non-opioid alternative, rather than prescription opioids.
We believe we fulfilled the statutory requirement to review
payments for opioids and evidence-based non-opioid alternatives to
ensure that there are not financial incentives to use opioids instead
of non-opioid alternatives in CY 2020 OPPS/ASC rulemaking. We are
committed to evaluating our current policies to adjust payment
methodologies, if necessary, in order to ensure appropriate access for
beneficiaries amid the current opioid epidemic. However, we did not
believe conducting a similar CY 2021 review would yield significantly
different outcomes or new evidence that would prompt us to change our
payment policies under the OPPS or ASC payment system.
Therefore, for CY 2021, we proposed to continue our policy to pay
separately at ASP+6 percent for the cost of non-opioid pain management
drugs that function as surgical supplies in the performance of surgical
procedures when they are furnished in the ASC setting and to continue
to package payment for non-opioid pain management drugs that function
as surgical supplies in the performance of surgical procedures in the
hospital outpatient department setting for CY 2021.
Comment: Multiple commenters, including medical specialty societies
and drug manufacturers, requested that we pay separately for Exparel
and other drugs that may function as surgical supplies in the hospital
outpatient setting. Some of these commenters noted that Exparel is more
frequently used in this setting and the use of non-opioid pain
management treatments should also be encouraged in the hospital
outpatient department. Commenters believed that separate payment in the
hospital outpatient department would significantly increase
utilization, which would be beneficial in reducing opioid use.
Response: As we stated in the CY 2019 and CY 2020 OPPS/ASC final
rules with comment period (83 FR 58856 and 84 FR 61177, respectively),
we do not believe that there is sufficient evidence that non-opioid
pain management drugs should be paid separately in the hospital
outpatient setting at this time. The commenters did not provide
convincing evidence that the OPPS packaging policy for Exparel (or
other non-opioid drugs) creates a barrier to use of Exparel in the
hospital setting. Further, while we received some public comments
suggesting that, as a result of using Exparel in the OPPS setting,
providers may prescribe fewer opioids for Medicare beneficiaries, we do
not believe that the OPPS payment policy presents a barrier to use of
Exparel or affects the likelihood that providers will prescribe fewer
opioids in the HOPD setting. Several drugs are packaged under the OPPS
and payment for such drugs is included in the payment for the
associated primary procedure. We were not persuaded by the information
supplied by commenters suggesting that some providers avoid use of non-
opioid alternatives in the outpatient hospital setting (including
Exparel) solely because of the OPPS packaged payment policy, as there
was no evidence in our review and evaluation of claims data in the CY
2020 OPPS/ASC final rule with comment period (84 FR 61176 through
61180) to indicate that the OPPS packaging policy had the unintended
consequence of discouraging the use of non-opioid treatments for
postsurgical pain management in the hospital outpatient department. As
noted above, we do not believe conducting a similar CY 2021 review
would yield significantly different outcomes or new evidence that would
prompt us to change our payment policy. Based on previously conducted
analysis, we observed increasing Exparel utilization in the HOPD
setting with the total units increasing from 14.8 million in 2018 to
19.5 million in 2019, despite the drug payment being packaged into the
procedure payment in the OPPS setting. This upward trend has been
consistent since 2015, as the data shows approximately 6.5 million
total units in 2015 and 8.1 million total units in 2016. Therefore, we
do not believe that the current OPPS payment methodology for Exparel or
other non-opioid pain management drugs presents a widespread barrier to
their use.
In addition, increased use in the hospital outpatient setting not
only supports the notion that the packaged payment for Exparel is not
causing an access to care issue, but also that the payment rate for
primary procedures in the HOPD using Exparel adequately reflects the
cost of the drug. That is, because Exparel is commonly used and billed
under the OPPS, the APC rates for the primary procedures reflect such
utilization. Therefore, the increased utilization in the OPPS setting
seems to indicate that the payment amount is sufficient for hospitals
to furnish the drug. We remind readers that the OPPS is a prospective
payment system, not a cost-based system and, by design, is based on a
system of averages under which payment for certain cases may exceed the
costs incurred, while for others, it may not. The OPPS packages
payments for multiple interrelated items and services into a single
payment to create incentives for hospitals to furnish services most
efficiently and to manage their resources with maximum flexibility. Our
packaging policies support our strategic goal of using larger payment
bundles in the OPPS to maximize hospitals' incentives to provide care
in the most efficient manner. We continue to invite stakeholders to
share evidence, such as published peer-reviewed literature, on these
non-opioid alternatives. We also intend to continue to analyze the
evidence and monitor utilization of non-opioid alternatives in the HOPD
setting for potential future rulemaking.
Comment: Some commenters encouraged CMS to establish permanent
separate payment for drugs that are currently on drug pass-through
status in
[[Page 85898]]
the OPPS and ASC settings, such as Dexycu (HCPCS code J1095). Regarding
Dexycu specifically, the commenters stated they were conducting a new,
comprehensive study of a longitudinal claim dataset that will provide
deeper insights into the association between cataract surgery and
opioid utilization, as well as the role of Dexycu in reducing the
prescribing of opioids.
Response: We refer readers to section V.A., ``OPPS Transitional
Pass-Through Payment for Additional Costs of Drugs, Biologicals, and
Radiopharmaceuticals'' of this final rule with comment period regarding
pass-through payments under the OPPS. Dexycu will receive separate
payment due to its drug pass-through status through CY 2021. We will
determine whether separate payment for this drug should be applied
under the policy to pay separately for non-opioid pain management drugs
that function as a surgical supply when furnished in the ASC setting
when Dexycu's pass-through status expires. We thank commenters for
conducting studies regarding their specific products and look forward
to reviewing the results.
Comment: Several commenters requested that the drug Omidria, CPT
J1097, (phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic
irrigation solution, 1 ml), be excluded from the OPPS policy to package
drugs that function as surgical supplies once its pass-through status
expires on September 30, 2020. Omidria is indicated for maintaining
pupil size by preventing intraoperative miosis and reducing
postoperative ocular pain in cataract or intraocular surgeries. The
commenters stated that there is extensive clinical evidence and medical
literature which supports their claims that Omidria reduces dependence
on opioids for patients undergoing cataract surgery and postoperative
prescription opioids. The commenters asserted that Omidria meets all of
the requirements in regulation to qualify for separate payment in the
ASC setting, as Omidria is FDA-approved for intraocular use in cataract
procedures, a pain management drug, a non-opioid, and functions as a
surgical supply during cataract surgery according to CMS' definition of
a surgical supply. Commenters asserted that the use of Omidria
decreases patients' need for fentanyl during surgeries and provided a
manuscript stating that Omidria reduces opioid use based on pill counts
after surgery.
Response: We thank commenters for their feedback on Omidria.
Omidria received pass-through status for a 3-year period from 2015 to
2017. After expiration of its pass-through status, payment for Omidria
was packaged under both the OPPS and the ASC payment system.
Subsequently, Omidria's pass-through status under the OPPS was
reinstated beginning on October 1, 2018 through September 30, 2020, as
required by section 1833(t)(6)(G) of the Act, as added by section
1301(a)(1)(C) of the Consolidated Appropriations Act of 2018 (Pub. L.
115-141), which means that Omidria continued to be paid separately
under the ASC payment system through September 30, 2020.
Our previous review of the clinical evidence submitted indicated
that the studies the commenter supplied were not sufficient to
demonstrate that Omidria reduces opioid use. Moreover, the results of a
CMS analysis of cataract procedures performed on Medicare beneficiaries
in HOPDs and ASCs between January 2015 and July 2019, which compared
procedures performed with Omidria to procedures performed without
Omidria, did not demonstrate a significant decrease in fentanyl
utilization during the cataract surgeries in the HOPDs and ASCs when
Omidria was used. Our findings also did not suggest any decrease in
opioid utilization post-surgery for procedures involving Omidria.
However, we will continue to apply separate payment for non-opioid
pain management drugs that function as surgical supplies when furnished
in the ASC setting for CY 2021, as discussed in section XIII.D.3, and
as we have described in regulation at 42 CFR 416.164 and 416.171(b)(1).
After careful consideration of the commenters' assertion that Omidria
meets this definition, we believe that Omidria does qualify as a non-
opioid pain management drug that functions as a surgical supply and are
excluding Omidria from packaging under the ASC payment system beginning
October 1, 2020 and in CY 2021, in accordance with this policy.
Comment: Two commenters briefly mentioned the drug IV acetaminophen
(CPT code J0131), which they believe may reduce opioid usage if CMS
paid separately for the drug. These commenters believed IV
acetaminophen decreases use of post-operative opioids.
Response: We thank commenters for their comments. We do not find it
appropriate to pay separately for IV acetaminophen as suggested by the
commenters due to our drug packaging threshold policies. We remind
stakeholders of our drug packaging threshold policies, as described in
section V.B.1.a to this final rule with comment period. In accordance
with section 1833(t)(16)(B) of the Act, we finalized our proposal to
set the drug packaging threshold for CY 2021 to $130. To the extent
that the items and services mentioned by the commenters are effective
alternatives to opioid prescriptions, we encourage providers to use
them when medically necessary. Additionally, please see section
XIII.D.3 for a full discussion on our policies in the ASC setting.
Comment: Commenters suggested modified payment for ``pain block''
CPT codes 64415, 64416, 64417, 64445, 64446, 64447, 64448, and 64450.
Two commenters stated that providers use these pain blocks to mitigate
the post-operative pain that is otherwise typically addressed with
short-term opioid use. Additionally, a few commenters stated that CPT
code J1096 (Dexamethasone, lacrimal ophthalmic insert, 0.1 mg) used for
treatment of ocular inflammation and pain following ophthalmic surgery
is administered through CPT code 0356T (Insertion of drug-eluting
implant (including punctal dilation and implant removal when performed)
into lacrimal canaliculus, each). These commenters felt CPT code 0356T,
which describes the administration of the drug, should also receive
separate or additional payment due to the purported clinical benefits
of the drug, including treatment of pain.
Response: We thank the commenters for their suggestions. At this
time, we have not found compelling evidence for the non-opioid pain
management alternatives described above to warrant separate or modified
payment under the OPPS or ASC payment systems for CY 2021.
Additionally, we do not believe that the ``pain blocks'' described by
stakeholders qualify as non-opioid pain management drugs that function
as a surgical supply as the codes provided by stakeholders are used to
describe procedures under the OPPS and not drugs. To the extent that
the items and services mentioned by the commenters are effective
alternatives to opioid prescriptions, we encourage providers to use
them when medically necessary. For a greater discussion of CPT code
0356T, please see section III. D. (Administration of Lacrimal
Ophthalmic Insert Into Lacrimal Canaliculus (APC 5692)) of this final
rule with comment period.
Comment: Commenters also requested separate payments for various
non-opioid pain management treatments, such as ERAS[supreg] protocols
or spinal cord stimulators (SCS), that they believe decrease the number
of opioid prescriptions beneficiaries receive during and following an
outpatient visit or procedure. For SCS, several commenters noted that
this therapy may lead to a reduction in the use of opioids
[[Page 85899]]
for chronic pain patients. They noted that neurostimulation is a key
alternative to opioid prescription for pain management and recommended
that CMS increase access to SCS.
Response: We appreciate the commenters' information on this topic.
At this time, we have not found compelling evidence for the non-opioid
pain management alternatives described above to warrant separate
payment under the OPPS or ASC payment systems for CY 2021. However, we
plan to take these comments and suggestions into consideration for
future rulemaking. We agree that providing incentives to avoid or
reduce opioid prescriptions may be one of several strategies for
addressing the opioid epidemic. To the extent that the items and
services mentioned by the commenters are effective alternatives to
opioid drugs, we encourage providers to use them when medically
appropriate.
We look forward to working with stakeholders as we further consider
suggested refinements to the OPPS and the ASC payment system that will
encourage use of medically necessary items and services that have
demonstrated efficacy in decreasing opioid prescriptions and/or opioid
abuse or misuse during or after an outpatient visit or procedure.
After consideration of the public comments we received, we are
finalizing the proposed policy, without modification, to unpackage and
pay separately at ASP+6 percent for the cost of non-opioid pain
management drugs that function as surgical supplies when they are
furnished in the ASC setting for CY 2021. We will continue to analyze
the issue of access to non-opioid pain management alternatives in the
OPPS and the ASC settings as part of any subsequent reviews we conduct
under section 1833(t)(22)(A)(ii). We are continuing to examine whether
there are other non-opioid pain management alternatives for which our
payment policy should be revised to allow separate payment. We will be
reviewing evidence-based support, such as published peer-reviewed
literature, that we could use to determine whether these products help
to deter or avoid prescription opioid use and addiction as well as
evidence that the current packaged payment for such non-opioid
alternatives presents a barrier to access to care and therefore
warrants revised, including possibly separate, payment under the OPPS.
This policy is also discussed in section XIII.D.3 of this final rule
with comment period.
c. Clinical Diagnostic Laboratory Tests Packaging Policy
(1) Background
Prior to CY 2014, clinical diagnostic laboratory tests were
excluded from payment under the hospital OPPS because they were paid
separately under the Clinical Laboratory Fee Schedule (CLFS). Section
1833(t)(1)(B)(i) of the Act authorizes the Secretary to designate the
hospital outpatient services that are paid under the OPPS. Under this
authority, the Secretary excluded from the OPPS those services that are
paid under fee schedules or other payment systems. Because laboratory
services are paid separately under the CLFS, laboratory tests were
excluded from separate payment under the OPPS. We codified this policy
at 42 CFR 419.22(l).
However, in CY 2014, we revised the categories of packaged items
and services under the OPPS to include certain laboratory tests. We
stated that certain laboratory tests, similar to other covered
outpatient services that are packaged under the OPPS, are typically
integral, ancillary, supportive, dependent, or adjunctive to a primary
hospital outpatient service and should be packaged under the hospital
OPPS. We stated that laboratory tests and their results support
clinical decision making for a broad spectrum of primary services
provided in the hospital outpatient setting, including surgery and
diagnostic evaluations (78 FR 74939). Consequently, we finalized the
policy to package payment for most laboratory tests in the OPPS when
they are integral, ancillary, supportive, dependent, or adjunctive to a
primary service or services provided in the hospital outpatient setting
(78 FR 74939 through 74942 and 42 CFR 419.2(b)(17)). In the same final
rule, we clarified that certain laboratory tests would be excluded from
packaging. Specifically, we stated that laboratory tests would be paid
separately under the CLFS when the laboratory test is the only service
provided to a beneficiary or when a laboratory test is conducted on the
same date of service (DOS) as the primary service but is ordered for a
different purpose than the primary service by a practitioner different
than the practitioner who ordered the primary service or when the
laboratory test is a molecular pathology test (78 FR 74942). As
explained in the CY 2014 OPPS/ASC final rule, we excluded molecular
pathology tests from packaging because we believe these tests are
relatively new and may have a different pattern of clinical use, which
may make them generally less tied to a primary service in the hospital
outpatient setting than the more common and routine laboratory tests
that we package (78 FR 74939). Based on these changes, we revised the
regulation text at Sec. Sec. [thinsp]419.2(b) and 419.22(l) to reflect
this laboratory test packaging policy.
In CY 2016, we made some modifications to this policy (80 FR 70348
through 70350). First, we clarified that all molecular pathology tests
would be excluded from our packaging policy, including any new codes
that also describe molecular pathology tests. In the CY 2014 OPPS/ASC
final rule, we stated that only those molecular pathology codes
described by CPT codes in the ranges of 81200 through 81383, 81400
through 81408, and 81479 were excluded from OPPS packaging (78 FR 74939
through 74942). However, in 2016, we expanded this policy to include
not only the original code range but also all new molecular pathology
test codes (80 FR 70348). Secondly, we excluded preventive laboratory
tests from OPPS packaging and provided that they would be paid
separately under the CLFS. Laboratory tests that are considered
preventive are listed in Section 1.2, Chapter 18 of the Medicare Claims
Processing Manual (Pub. L. 100-04). As stated in the CY 2016 OPPS/ASC
final rule, we make an exception to conditional packaging of ancillary
services for ancillary services that are also preventive services (80
FR 70348). For consistency, we excluded from OPPS packaging those
laboratory tests that are classified as preventive services. In
addition, we modified our conditional packaging policy so that
laboratory tests provided during the same outpatient stay (rather than
specifically provided on the same DOS as the primary service) are
considered as integral, ancillary, supportive, dependent, or adjunctive
to a primary service or services, except when a laboratory test is
ordered for a different diagnosis and by a different practitioner than
the practitioner who ordered the other hospital outpatient services. We
explained in the CY 2016 OPPS/ASC final rule that this modification did
not affect our policy to provide separate payment for laboratory tests:
(1) If they are the only services furnished to an outpatient and are
the only services on a claim and have a payment rate on the CLFS; or
(2) if they are ordered for a different diagnosis than another hospital
outpatient service by a practitioner different than the practitioner
who ordered the other hospital outpatient service (80 FR 70349 through
70350).
In CY 2017, we modified the policy to remove the ``unrelated''
laboratory test exclusion and to expand the laboratory
[[Page 85900]]
test packaging exclusion to apply to laboratory tests designated as
advanced diagnostic laboratory tests (ADLTs) under the CLFS. We
clarified that the exception would only apply to those ADLTs that meet
the criteria of section 1834A(d)(5)(A) of the Act, which are defined as
tests that provide an analysis of multiple biomarkers of DNA, RNA, or
proteins combined with a unique algorithm to yield a single patient-
specific result (81 FR 79592 through 79594).
(2) Current Categories of Clinical Diagnostic Laboratory Tests Excluded
From OPPS Packaging
As we discussed in the CY 2021 OPPS/ASC proposed rule (85 FR
48798), under our current policy, certain clinical diagnostic
laboratory tests (CDLTs) that are listed on the CLFS are packaged as
integral, ancillary, supportive, dependent, or adjunctive to the
primary service or services provided in the hospital outpatient setting
during the same outpatient encounter and billed on the same claim.
While we package most CDLTs under the OPPS, when a CDLT is listed on
the CLFS and meets one of the following four criteria, we do not pay
for the test under the OPPS, but rather, we pay for it under the CLFS
when it is: (1) The only service provided to a beneficiary on a claim;
(2) considered a preventive service; (3) a molecular pathology test; or
(4) an ADLT that meets the criteria of section 1834A(d)(5)(A) of the
Act. Generally, when laboratory tests are not packaged under the OPPS
and are listed on the CLFS, they are paid under the CLFS instead of the
OPPS.
(3) New Category of Laboratory Tests Excluded From OPPS Packaging
(a) Background on Protein-Based MAAAs
As part of recent rulemaking cycles, stakeholders have suggested
that some protein-based Multianalyte Assays with Algorithmic Analyses
tests (MAAAs) may have a pattern of clinical use that makes them
relatively unconnected to the primary hospital outpatient service (84
FR 61439). In the CY 2018 OPPS/ASC final rule (82 FR 59299), we stated
that stakeholders indicated that certain protein-based MAAAs,
specifically those described by CPT codes 81490, 81503, 81535, 81536,
81538, and 81539, are generally not performed in the HOPD setting and
have similar clinical patterns of use as the DNA and RNA-based MAAA
tests that are assigned to status indicator ``A'' under the OPPS and
are paid separately under the CLFS. Notably, all of the tests described
by these CPT codes (with the exception of CPT code 81490, which we
discuss below) are cancer-related protein-based MAAAs. In the same
final rule, stakeholders suggested that, based on the June 23, 2016
CLFS final rule entitled ``Medicare Program; Medicare Clinical
Diagnostic Laboratory Tests Payment System,'' in which CMS defined an
ADLT under section 1834A(d)(5)(A) of the Act to include DNA, RNA, and
protein-based tests, they believe that the reference to ``protein-based
tests'' in the definition applies equally to the tests they identified,
that is, protein-based MAAAs. Consequently, the stakeholders believed
that protein-based MAAAs should be excluded from OPPS packaging and
paid separately under the CLFS. As we noted in the CY 2021 OPPS/ASC
proposed rule, one of the protein-based MAAAs previously requested by
stakeholders to be excluded from OPPS packaging policy is CPT code
81538 (Oncology (lung), mass spectrometric 8-protein signature,
including amyloid a, utilizing serum, prognostic and predictive
algorithm reported as good versus poor overall survival), which has
been designated as an ADLT under section 1834A(d)(5)(A) of the Act as
of December 21, 2018. Therefore, CPT code 81538 is currently excluded
from the OPPS packaging policy and paid under the CLFS instead of the
OPPS when it also meets the laboratory DOS requirements.
(b) CY 2021 Cancer-Related Protein-Based MAAAs
As discussed in the CY 2021 OPPS/ASC proposed rule (85 FR 49032),
we have continued to consider previous stakeholder requests to exclude
some protein-based MAAAs from the OPPS packaging policy. We stated
that, after further review of this issue, we believe that cancer-
related protein-based MAAAs, in particular, may be relatively
unconnected to the primary hospital outpatient service during which the
specimen was collected from the patient. Similar to molecular pathology
tests, which are currently excluded from the OPPS packaging policy,
cancer-related protein-based MAAAs appear to have a different pattern
of clinical use, which may make them generally less tied to the primary
service in the hospital outpatient setting than the more common and
routine laboratory tests that are packaged.
As we noted previously in the CY 2021 OPPS/ASC proposed rule and in
this section of the final rule, commenters to the CY 2018 OPPS/ASC
final rule identified specific cancer-related protein-based MAAAs as
tests that are generally not performed in the HOPD setting (82 FR
59299). In fact, those tests identified by commenters are used to guide
future surgical procedures and chemotherapeutic interventions.
Treatments that are based on the results of cancer-related protein-
based MAAAs are typically furnished after the patient is no longer in
the hospital, in which case they are not tied to the same hospital
outpatient encounter during which the specimen was collected.
For these reasons, we proposed to exclude cancer-related protein-
based MAAAs from the OPPS packaging policy and pay for them separately
under the CLFS.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48799), we explained
that the AMA CPT 2020 manual currently describes MAAAs, in part, as
``procedures that utilize multiple results derived from panels of
analyses of various types, including molecular pathology assays,
fluorescent in situ hybridization assays, and non-nucleic acid based
assays (for example, proteins, polypeptides, lipids, carbohydrates).''
\1\ Additionally, the AMA CPT 2020 manual provides a MAAA code
descriptor format which includes several specific characteristics,
including but not limited to disease type (for example, oncology,
autoimmune, tissue rejection), and material(s) analyzed (for example,
DNA, RNA, protein, antibody). We noted that as the AMA CPT 2020 manual
describes a MAAA, and the code descriptor of each MAAA distinguishes
MAAAs that are cancer-related assays from those that test for other
disease types, the AMA CPT manual is a potentially instructive tool to
identify cancer-related MAAA tests that are ``protein-based''.
Accordingly, in following the AMA CPT 2020 manual intent to identify
MAAA tests that are cancer-related, and, of those tests, identifying
the ones whose test analytes are proteins, we have determined there are
currently six cancer-related protein-based MAAAs: CPT codes 81500,
81503, 81535, 81536, 81538 and 81539. As discussed previously in the CY
2021 OPPS/ASC proposed rule and in this section of the final rule, CPT
code 81538 has been designated as an ADLT under section 1834A(d)(5)(A)
of the Act as of December 21, 2018 and therefore, is already paid under
the CLFS instead of the OPPS. As such, we proposed to assign status
indicator ``A'' (``Not paid under OPPS. Paid by MACs under a fee
schedule or payment system other than
[[Page 85901]]
OPPS'') to cancer-related protein-based MAAAs as described by CPT codes
81500, 81503, 81535, 81536, and 81539. We also proposed that we would
apply this policy to cancer-related protein-based MAAAs that do not
currently exist, but that are developed in the future. Additionally, we
stated that we intend to continue to study the list of laboratory tests
excluded from the OPPS packaging policy and determine whether any
additional changes are warranted and may consider proposing future
changes to the laboratory DOS policy through notice-and-comment
rulemaking.
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In the CY 2021 OPPS/ASC proposed rule (85 FR 49032), we noted that
commenters to the CY 2018 OPPS/ASC proposed rule also identified CPT
code 81490 as a protein-based MAAA that should be excluded from the
OPPS packaging policy and paid outside of the OPPS. However, we stated
that we believed that the results for the test described by CPT code
81490 are used to determine disease activity in rheumatoid arthritis
patients, guide current therapy to reduce further joint damage, and may
be tied to the primary hospital outpatient service, that is, the
hospital outpatient encounter during which the specimen was collected.
Therefore, we stated that we believed that payment for CPT code 81490
remains appropriately packaged under the OPPS.
We refer readers to section XVIII. of the CY 2021 OPPS/ASC proposed
rule and section XVIII. of this final rule with comment period, which
describe the related proposal to revise the laboratory DOS policy for
cancer-related protein-based MAAAs.
We received public comments on the proposal to exclude cancer-
related protein-based MAAAs from the OPPS packaging policy and pay for
them separately under the CLFS. The following is a summary of the
comments we received and our responses.
Comment: Generally, commenters supported the proposal to exclude
cancer-related protein-based MAAAs from the OPPS packaging policy and
add them to the list of test codes subject to the laboratory DOS
exception for the hospital outpatient setting, leading to the test
being paid at the CLFS rate and requiring that the laboratory bill
Medicare for the test instead of seeking payment from the hospital.
Commenters stated that changes to this policy will lead to improved
beneficiary access to diagnostic tests while also reducing hospital
administrative burden.
Response: We appreciate the support from commenters for our
proposed revisions to the OPPS packaging policy for CDLTs. We agree
that the revisions to the laboratory DOS policy that we proposed in the
CY 2021 OPPS/ASC proposed rule and finalized in section XVIII of this
final rule with comment period may potentially serve to reduce delay in
access to laboratory tests by minimizing the likelihood that a hospital
will postpone ordering a test until at least 14 days after the patient
is discharged from the hospital outpatient department, or even cancel
the order in order to avoid having to bill Medicare for the test under
the laboratory DOS policy.
Comment: In addition to excluding the cancer-related protein-based
MAAAs from OPPS packaging, several commenters suggested a similar
change for pathology tests. Specifically, they recommended revising the
existing laboratory test packaging policy to allow separate payment
under the CLFS for the technical component of pathology tests.
Response: We appreciate the feedback and will consider the issue
for future rulemaking.
Comment: Some commenters recommended further expansion of the list
of test codes excluded from OPPS packaging to include various other
CDLTs, including all protein-based MAAAs, AMA CPT Proprietary
Laboratory Analyses (PLA) test codes that may have similar
characteristics to AMA CPT MAAA tests but are not currently categorized
as AMA CPT MAAA test codes, and several specific CPT test codes,
including the OVERA test from Aspira Labs (CPT 0003U), EPI assay by
Bio-Techne (CPT 0005U), TissueCypher assay from Cernostics (CPT 0108U),
and KidneyIntelX (CPT 0105U).
Commenters also noted that while PLA test codes are not
automatically included in the outpatient laboratory test packaging
exclusion, some tests described by PLA codes are included under these
policies if they qualify as a molecular pathology test or Criterion A
ADLT. Therefore, the commenters asserted that CMS should continue its
historical practice of applying the laboratory test packaging exclusion
to PLA test codes as occurs with molecular pathology tests and ADLTs
that have been assigned PLA codes.
Response: We believe that the commenters' suggested modifications
to the list of codes excluded from OPPS packaging to include various
CDLTs, including all protein-based MAAAs, AMA CPT PLA test codes that
may have similar characteristics to AMA CPT MAAA tests but are not
currently categorized as AMA CPT MAAA codes, and several specific AMA
CPT test codes, are inconsistent with the current OPPS packaging policy
and would result in allowing the laboratory to bill Medicare directly
for a test that should be incorporated into the hospital OPPS bundled
rate. CMS does not believe that all AMA CPT PLA test codes demonstrate
a different pattern of clinical use that makes them less tied to the
primary service in the hospital outpatient setting such that they
should be included in the list of codes excepted from the OPPS
packaging policy. Commenters asserted that these tests, as a group,
should be excluded from OPPS packaging policy because the results of
these tests may inform future interventions beyond the hospital
outpatient encounter during which the specimen was collected and may be
used by other health care providers to developed long-term plans for
treatment. However, we are not convinced based on the commenters'
descriptions of these tests that they are generally unconnected to the
hospital encounter, the chief requirement for exclusion from OPPS
packaging. Although commenters noted that the recommended tests may be
utilized for the development of longer-term treatment plans, it is not
clear that the clinical usage of these tests reaches the threshold of
being ``generally unconnected'' to the hospital encounter.
Any addition to the list of test codes excluded from OPPS packaging
requires careful evaluation as to whether a different pattern of
clinical use makes a test generally less tied to a primary service in
the hospital outpatient setting than the more common and routine
laboratory tests that we package. For instance, as noted in the CY 2021
OPPS/ASC proposed rule (85 FR 49035), in response to the changes in the
laboratory DOS policy outlined in the CY 2018 OPPS/ASC final rule with
comment period, stakeholders stated that some entities performing
molecular pathology testing included on the list of codes excluded from
OPPS packaging and subject to the laboratory DOS exception, such as
blood banks and blood centers, may perform molecular pathology testing
to enable hospitals to prevent adverse conditions associated with blood
transfusions, rather than perform molecular pathology testing for
diagnostic purposes. This led us to consider whether the molecular
pathology testing performed by blood banks and centers is appropriately
separable from the hospital stay.
We do not believe all protein-based MAAAs would meet this standard
for exclusion from OPPS packaging. CMS has considered expanding the
list of codes excluded from OPPS packaging to
[[Page 85902]]
include various additional categories of codes, including protein-based
MAAAs. However, we note that some protein-based MAAAs include simple
and commonly used protein analytes that may also be commonly performed
to assist in managing patient care during a hospital outpatient
encounter. Therefore, we believe that we cannot conclude that this
category of tests is generally less tied to a primary service in the
hospital outpatient setting, as some protein-based MAAA tests use
common routine protein analytes that are appropriately packaged into
OPPS payment. For these reasons, CMS does not believe that all protein-
based MAAAs should be included in the list of codes excluded from the
OPPS packaging policy.
However, we note that a protein-based MAAA that is designated by
CMS as an ADLT under paragraph (1) of the definition of an ADLT in
Sec. 414.502 would be added to the list of codes excluded from OPPS
packaging, in accordance with our established policy.
Comment: Commenters also recommended that we exclude a particular
protein-based MAAA test described by CPT code 81490 from the OPPS
packaging policy. Commenters asserted that the use of the test
described by CPT code 81490 is unconnected to the hospital outpatient
encounter during which the specimen is collected and that the results
of the test are used to determine potential future interventions
outside of the hospital outpatient encounter. Commenters stated that
this test appears to be generally less tied to a primary service in the
hospital outpatient setting and does not appear to be a common or
routine laboratory test that would otherwise be packaged into OPPS
payment.
Response: In the CY 2021 OPPS/ASC proposed rule (85 FR 48799), we
stated that we believed the results for the test described by CPT code
81490 are used to determine disease activity in rheumatoid arthritis
patients, guide current therapy to reduce further joint damage, and may
be tied to the primary hospital outpatient service, that is, the
hospital outpatient encounter during which the specimen was collected.
Therefore, we stated that we believed that payment for CPT code 81490
remains appropriately packaged under the OPPS.
However, given commenter feedback, we are convinced that the
pattern of clinical use for CPT code 81490 is generally unconnected to
the hospital outpatient encounter during which the specimen is
collected as it is typically used to determine potential interventions
outside of the hospital outpatient encounter and is generally used by
the rheumatologist to make longer-term changes in RA treatment.
Commenters informed us that physicians and patients utilize the
objective information provided by the results of the test to make
longer-term modifications in treatment, to monitor disease activity,
and to prevent joint damage progression, and the results generally
would not be utilized for purposes of the hospital outpatient
encounter. The commenters further stated that the output of the test is
used to assess disease activity, including evaluating response to
therapy, directing choice of second-line treatment in patients with
inadequate response to the current first line therapy, and identifying
patients in stable remission for therapy reduction. The test results
appear to guide longer-term therapies and treatments; therefore, we
believe that this test, identified by CPT code 81490, is generally less
tied to the primary service the patient receives in the hospital
outpatient setting and does not appear to be a common or routine
laboratory test that would otherwise be packaged into OPPS payment.
Consequently, we believe that CPT code 81490 should be excluded from
OPPS packaging policy.
As stated previously, we intend to continue to study the list of
laboratory tests excluded from the OPPS packaging policy to determine
whether any additional changes are warranted and may consider proposing
future changes to this policy and the laboratory DOS policy through
notice-and-comment rulemaking.
In conclusion, we continue to believe that cancer-related protein-
based MAAAs, that is, those represented by CPT codes 81500, 81503,
81535, 81536 and 81539, appear to have a different pattern of clinical
use that make them generally less tied to a primary service in the
hospital outpatient setting than the more common and routine laboratory
tests that are packaged. We also believe that, given the similarity in
its clinical pattern of use to the cancer-related protein-based MAAAs,
CPT code 81490 should also be added to the list of codes excluded from
the OPPS packaging and subject to the laboratory DOS exception at Sec.
414.510(b)(5), which is discussed in section III.XX in this final rule.
For the reasons discussed, we are revising the list of test codes
excluded from the OPPS packaging policy to include CPT codes 81500,
81503, 81535, 81536, 81539, and 81490. We are also finalizing that we
will exclude cancer-related protein-based MAAAs that do not currently
exist, but that are developed in the future, from the OPPS packaging
policy.
4. Calculation of OPPS Scaled Payment Weights
We established a policy in the CY 2013 OPPS/ASC final rule with
comment period (77 FR 68283) of using geometric mean-based APC costs to
calculate relative payment weights under the OPPS. In the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61180 through 61182), we
applied this policy and calculated the relative payment weights for
each APC for CY 2020 that were shown in Addenda A and B to that final
rule with comment period (which were made available via the internet on
the CMS website) using the APC costs discussed in sections II.A.1. and
II.A.2. of that final rule with comment period. For CY 2021, as we did
for CY 2020, we proposed to continue to apply the policy established in
CY 2013 and calculate relative payment weights for each APC for CY 2021
using geometric mean-based APC costs.
For CY 2012 and CY 2013, outpatient clinic visits were assigned to
one of five levels of clinic visit APCs, with APC 0606 representing a
mid-level clinic visit. In the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75036 through 75043), we finalized a policy that created
alphanumeric HCPCS code G0463 (Hospital outpatient clinic visit for
assessment and management of a patient), representing any and all
clinic visits under the OPPS. HCPCS code G0463 was assigned to APC 0634
(Hospital Clinic Visits). We also finalized a policy to use CY 2012
claims data to develop the CY 2014 OPPS payment rates for HCPCS code
G0463 based on the total geometric mean cost of the levels one through
five CPT E/M codes for clinic visits previously recognized under the
OPPS (CPT codes 99201 through 99205 and 99211 through 99215). In
addition, we finalized a policy to no longer recognize a distinction
between new and established patient clinic visits.
For CY 2016, we deleted APC 0634 and reassigned the outpatient
clinic visit HCPCS code G0463 to APC 5012 (Level 2 Examinations and
Related Services) (80 FR 70372). For CY 2021, as we did for CY 2020, we
proposed to continue to standardize all of the relative payment weights
to APC 5012. We believe that standardizing relative payment weights to
the geometric mean of the APC to which HCPCS code G0463 is assigned
maintains consistency in calculating unscaled weights that represent
the cost of some of the most frequently provided OPPS services. For
[[Page 85903]]
CY 2021, as we did for CY 2020, we proposed to assign APC 5012 a
relative payment weight of 1.00 and to divide the geometric mean cost
of each APC by the geometric mean cost for APC 5012 to derive the
unscaled relative payment weight for each APC. The choice of the APC on
which to standardize the relative payment weights does not affect
payments made under the OPPS because we scale the weights for budget
neutrality.
We note that in the CY 2019 OPPS/ASC final rule with comment period
(83 FR 59004 through 59015) and the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61365 through 61369), we discuss our policy,
implemented on January 1, 2019, to control for unnecessary increases in
the volume of covered outpatient department services by paying for
clinic visits furnished at excepted off-campus provider-based
department (PBD) at a reduced rate. While the volume associated with
these visits is included in the impact model, and thus used in
calculating the weight scalar, the policy has a negligible effect on
the scalar. Specifically, under this policy, there is no change to the
relativity of the OPPS payment weights because the adjustment is made
at the payment level rather than in the cost modeling. Further, under
this policy, the savings that result from the change in payments for
these clinic visits are not budget neutral. Therefore, the impact of
this policy will generally not be reflected in the budget neutrality
adjustments, whether the adjustment is to the OPPS relative weights or
to the OPPS conversion factor. We note that the volume control method
for clinic visit services furnished by non-excepted off-campus PBDs is
subject to litigation. For a full discussion of this policy and the
litigation, we refer readers to the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61142).
Section 1833(t)(9)(B) of the Act requires that APC reclassification
and recalibration changes, wage index changes, and other adjustments be
made in a budget neutral manner. Budget neutrality ensures that the
estimated aggregate weight under the OPPS for CY 2021 is neither
greater than nor less than the estimated aggregate weight that would
have been calculated without the changes. To comply with this
requirement concerning the APC changes, we proposed to compare the
estimated aggregate weight using the CY 2020 scaled relative payment
weights to the estimated aggregate weight using the proposed CY 2021
unscaled relative payment weights.
For CY 2020, we multiplied the CY 2020 scaled APC relative payment
weight applicable to a service paid under the OPPS by the volume of
that service from CY 2019 claims to calculate the total relative
payment weight for each service. We then added together the total
relative payment weight for each of these services in order to
calculate an estimated aggregate weight for the year. For CY 2021, we
proposed to apply the same process using the estimated CY 2021 unscaled
relative payment weights rather than scaled relative payment weights.
We proposed to calculate the weight scalar by dividing the CY 2020
estimated aggregate weight by the unscaled CY 2021 estimated aggregate
weight.
For a detailed discussion of the weight scalar calculation, we
refer readers to the OPPS claims accounting document available on the
CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Click on the CY 2021 OPPS
proposed rule link and open the claims accounting document link at the
bottom of the page.
We proposed to compare the estimated unscaled relative payment
weights in CY 2021 to the estimated total relative payment weights in
CY 2020 using CY 2019 claims data, holding all other components of the
payment system constant to isolate changes in total weight. Based on
this comparison, we proposed to adjust the calculated CY 2021 unscaled
relative payment weights for purposes of budget neutrality. We proposed
to adjust the estimated CY 2021 unscaled relative payment weights by
multiplying them by a proposed weight scalar of 1.4443 to ensure that
the proposed CY 2021 relative payment weights are scaled to be budget
neutral. The proposed CY 2021 relative payment weights listed in
Addenda A and B to the CY 2021 OPPS/ASC proposed rule (which are
available via the internet on the CMS website) are scaled and
incorporate the recalibration adjustments discussed in sections II.A.1.
and II.A.2. of the CY 2021 OPPS/ASC proposed rule.
Section 1833(t)(14) of the Act provides the payment rates for
certain SCODs. Section 1833(t)(14)(H) of the Act provides that
additional expenditures resulting from this paragraph shall not be
taken into account in establishing the conversion factor, weighting,
and other adjustment factors for 2004 and 2005 under paragraph (9), but
shall be taken into account for subsequent years. Therefore, the cost
of those SCODs (as discussed in section V.B.2. of proposed rule) is
included in the budget neutrality calculations for the CY 2021 OPPS.
We did not receive any public comments on the proposed weight
scalar calculation. Therefore, we are finalizing our proposal to use
the calculation process described in the proposed rule, without
modification, for CY 2021. Using updated final rule claims data, we are
updating the estimated CY 2021 unscaled relative payment weights by
multiplying them by a weight scalar of 1.4341 to ensure that the final
CY 2021 relative payment weights are scaled to be budget neutral. The
final CY 2021 relative payments weights listed in Addenda A and B to
this final rule with comment period (which are available via the
internet on the CMS website) were scaled and incorporate the
recalibration adjustments discussed in sections II.A.1. and II.A.2. of
this final rule with comment period.
B. Conversion Factor Update
Section 1833(t)(3)(C)(ii) of the Act requires the Secretary to
update the conversion factor used to determine the payment rates under
the OPPS on an annual basis by applying the OPD fee schedule increase
factor. For purposes of section 1833(t)(3)(C)(iv) of the Act, subject
to sections 1833(t)(17) and 1833(t)(3)(F) of the Act, the OPD fee
schedule increase factor is equal to the hospital inpatient market
basket percentage increase applicable to hospital discharges under
section 1886(b)(3)(B)(iii) of the Act. In the FY 2021 IPPS/LTCH PPS
proposed rule (85 FR 32738), consistent with current law, based on IHS
Global, Inc.'s fourth quarter 2019 forecast of the FY 2021 market
basket increase, the proposed FY 2021 IPPS market basket update was 3.0
percent. Accordingly, we proposed a CY 2021 OPD fee schedule increase
factor of 3.0 percent.
Specifically, section 1833(t)(3)(F)(i) of the Act requires that,
for 2012 and subsequent years, the OPD fee schedule increase factor
under subparagraph (C)(iv) be reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment as
equal to the 10-year moving average of changes in annual economy-wide,
private nonfarm business multifactor productivity (MFP) (as projected
by the Secretary for the 10-year period ending with the applicable
fiscal year, year, cost reporting period, or other annual period) (the
``MFP adjustment''). In the FY 2012 IPPS/LTCH PPS final rule (76 FR
51689 through 51692), we finalized our methodology for calculating and
[[Page 85904]]
applying the MFP adjustment, and then revised this methodology, as
discussed in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49509). In the
FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32739), the proposed MFP
adjustment for FY 2021 was 0.4 percentage point.
Therefore, we proposed that the MFP adjustment for the CY 2021 OPPS
would be 0.4 percentage point. We also proposed that if more recent
data become subsequently available after the publication of the CY 2021
OPPS/ASC proposed rule (for example, a more recent estimate of the
market basket increase and/or the MFP adjustment), we would use such
updated data, if appropriate, to determine the CY 2021 market basket
update and the MFP adjustment, which are components in calculating the
OPD fee schedule increase factor under sections 1833(t)(3)(C)(iv) and
1833(t)(3)(F) of the Act, in the CY 2021 OPPS/ASC final rule.
We note that section 1833(t)(3)(F) of the Act provides that
application of this subparagraph may result in the OPD fee schedule
increase factor under section 1833(t)(3)(C)(iv) of the Act being less
than 0.0 percent for a year, and may result in OPPS payment rates being
less than rates for the preceding year. As described in further detail
below, we proposed for CY 2021 an OPD fee schedule increase factor of
2.6 percent for the CY 2021 OPPS (which is the proposed estimate of the
hospital inpatient market basket percentage increase of 3.0 percent,
less the proposed 0.4 percentage point MFP adjustment).
We proposed that hospitals that fail to meet the Hospital OQR
Program reporting requirements would be subject to an additional
reduction of 2.0 percentage points from the OPD fee schedule increase
factor adjustment to the conversion factor that would be used to
calculate the OPPS payment rates for their services, as required by
section 1833(t)(17) of the Act. For further discussion of the Hospital
OQR Program, we refer readers to section XIV. of the proposed rule.
The adjustment described in section 1833(t)(3)(F)(ii) was required
only through 2019. The requirement in section 1833(t)(3)(F)(i) of the
Act that we reduce the OPD fee schedule increase factor by the
productivity adjustment described in section 1886(b)(3)(B)(xi)(II),
however, applies for 2012 and subsequent years, and thus, continues to
apply. In the CY 2020 OPPS/ASC final rule with comment period, we
inadvertently did not amend the regulation at 42 CFR
419.32(b)(1)(iv)(B) to reflect that the adjustment required by section
1833(t)(3)(F)(i) of the Act is the only adjustment under section
1833(t)(3)(F) that applies in CY 2020 and subsequent years.
Accordingly, we proposed to amend our regulation at 42 CFR
419.32(b)(1)(iv)(B) by adding a new paragraph (b)(1)(iv)(B)(11) to
provide that, for CY 2020 and subsequent years, we reduce the OPD fee
schedule increase factor by the MFP adjustment as determined by CMS.
To set the OPPS conversion factor for CY 2021, we proposed to
increase the CY 2020 conversion factor of $80.793 by 2.6 percent. In
accordance with section 1833(t)(9)(B) of the Act, we proposed further
to adjust the conversion factor for CY 2021 to ensure that any
revisions made to the wage index and rural adjustment were made on a
budget neutral basis. We proposed to calculate an overall budget
neutrality factor of 1.0017 for wage index changes. This adjustment was
comprised of a 1.0027 proposed budget neutrality adjustment, using our
standard calculation of comparing proposed total estimated payments
from our simulation model using the proposed FY 2021 IPPS wage indexes
to those payments using the FY 2020 IPPS wage indexes, as adopted on a
calendar year basis for the OPPS as well as a 0.9990 proposed budget
neutrality adjustment for the proposed CY 2021 5 percent cap on wage
index decreases to ensure that this transition wage index is
implemented in a budget neutral manner, consistent with the proposed FY
2021 IPPS wage index policy (85 FR 32706). We stated in the proposed
rule that we believed it was appropriate to ensure that the proposed
wage index transition policy (that is, the proposed CY 2021 5 percent
cap on wage index decreases) did not increase estimated aggregate
payments under the OPPS beyond the payments that would be made without
this transition policy. We proposed to calculate this budget neutrality
adjustment by comparing total estimated OPPS payments using the FY 2021
IPPS wage index, adopted on a calendar year basis for the OPPS, where a
5 percent cap on wage index decreases is not applied to total estimated
OPPS payments where the 5 percent cap on wage index decreases is
applied. We stated in the proposed rule that these two proposed wage
index budget neutrality adjustments would maintain budget neutrality
for the proposed CY 2021 OPPS wage index (which, as we discuss in
section II.C of the proposed rule, would use the FY 2021 IPPS post-
reclassified wage index and any adjustments, including without
limitation any adjustments finalized under the IPPS related to the
proposed adoption of the revised OMB delineations).
We did not receive any public comments on our proposed methodology
for calculating the wage index budget neutrality adjustment as
discussed above. Therefore, for the reasons discussed above and in the
CY 2021 OPPS/ASC proposed rule (85 FR 48801), we are finalizing our
methodology for calculating the wage index budget neutrality adjustment
as proposed, without modification. For CY 2021, based on updated data
for this final rule with comment period, we are finalizing an overall
budget neutrality factor of 1.0012 for wage index changes. This
adjustment is comprised of a 1.0020 budget neutrality adjustment using
our standard calculation of comparing total estimated payments from our
simulation model using the final FY 2021 IPPS wage indexes to those
payments using the FY 2020 IPPS wage indexes, as adopted on a calendar
year basis for the OPPS, as well as a 0.9992 budget neutrality
adjustment for the CY 2021 5 percent cap on wage index decreases to
ensure that this transition wage index is implemented in a budget
neutral manner.
For the CY 2021 OPPS, we proposed to maintain the current rural
adjustment policy, as discussed in section II.E. of the CY 2021 OPPS/
ASC proposed rule. Therefore, the proposed budget neutrality factor for
the rural adjustment was 1.0000.
We proposed to continue previously established policies for
implementing the cancer hospital payment adjustment described in
section 1833(t)(18) of the Act, as discussed in section II.F. of the CY
2021 OPPS/ASC proposed rule. We proposed to calculate a CY 2021 budget
neutrality adjustment factor for the cancer hospital payment adjustment
by comparing estimated total CY 2021 payments under section 1833(t) of
the Act, including the proposed CY 2021 cancer hospital payment
adjustment, to estimated CY 2021 total payments using the CY 2020 final
cancer hospital payment adjustment, as required under section
1833(t)(18)(B) of the Act. The proposed CY 2021 estimated payments
applying the proposed CY 2021 cancer hospital payment adjustment were
the same as estimated payments applying the CY 2020 final cancer
hospital payment adjustment. Therefore, we proposed to apply a budget
neutrality adjustment factor of 1.0000 to the conversion factor for the
cancer hospital payment adjustment. In accordance with section
1833(t)(18)(C), as added by section 16002(b) of the 21st Century Cures
Act (Pub. L. 114-255), we
[[Page 85905]]
proposed to apply a budget neutrality factor calculated as if the
proposed cancer hospital adjustment target payment-to-cost ratio was
0.90, not the 0.89 target payment-to-cost ratio we applied as stated in
section II.F. of the proposed rule.
For the CY 2021 OPPS/ASC proposed rule, we estimated that proposed
pass-through spending for drugs, biologicals, and devices for CY 2021
would equal approximately $783.2 million, which represented 0.93
percent of total projected CY 2021 OPPS spending. Therefore, we stated
that the proposed conversion factor would be adjusted by the difference
between the 0.88 percent estimate of pass-through spending for CY 2020
and the 0.93 percent estimate of proposed pass-through spending for CY
2021, resulting in a proposed decrease to the conversion factor for CY
2021 of 0.05 percent.
We also estimated a 0.85 percent upward adjustment to nondrug OPPS
payment rates as a result of our payment proposal for separately
payable nonpass-through drugs purchased under the 340B Program at a net
rate of ASP minus 28.7 percent. Applying the proposed payment policy
for drugs purchased under the 340B Program, as described in section
V.B.6. of the CY 2021 OPPS/ASC proposed rule, would have resulted in an
estimated reduction of approximately $427 million in separately paid
OPPS drug payments. To ensure budget neutrality under the OPPS after
applying this proposed payment methodology for drugs purchased under
the 340B Program, we proposed to apply an offset of approximately $427
million to the OPPS conversion factor, which would result in an
adjustment of 1.0085 to the OPPS conversion factor.
Proposed estimated payments for outliers would remain at 1.0
percent of total OPPS payments for CY 2021. We estimated for the
proposed rule that outlier payments would be 1.01 percent of total OPPS
payments in CY 2020; the 1.00 percent for proposed outlier payments in
CY 2021 would constitute a 0.01 percent decrease in payment in CY 2021
relative to CY 2020.
For the CY 2021 OPPS/ASC proposed rule, we also proposed that
hospitals that fail to meet the reporting requirements of the Hospital
OQR Program would continue to be subject to a further reduction of 2.0
percentage points to the OPD fee schedule increase factor. For
hospitals that fail to meet the requirements of the Hospital OQR
Program, we proposed to make all other adjustments discussed above, but
use a reduced OPD fee schedule update factor of 0.6 percent (that is,
the proposed OPD fee schedule increase factor of 2.6 percent further
reduced by 2.0 percentage points). This would result in a proposed
reduced conversion factor for CY 2021 of $82.065 for hospitals that
fail to meet the Hospital OQR Program requirements (a difference of
1.632 in the conversion factor relative to hospitals that met the
requirements).
In summary, for CY 2021, we proposed to amend Sec. 419.32 by
adding a new paragraph (b)(1)(iv)(B)(11) to reflect the reductions to
the OPD fee schedule increase factor that are required for CY 2020, CY
2021, and subsequent years to satisfy the statutory requirements of
section 1833(t)(3)(F) of the Act. We proposed to use a reduced
conversion factor of $82.065 in the calculation of payments for
hospitals that fail to meet the Hospital OQR Program requirements (a
difference of -1.632 in the conversion factor relative to hospitals
that met the requirements).
For CY 2021, we proposed to use a conversion factor of $83.697 in
the calculation of the national unadjusted payment rates for those
items and services for which payment rates are calculated using
geometric mean costs; that is, the proposed OPD fee schedule increase
factor of 2.6 percent for CY 2021, the required proposed wage index
budget neutrality adjustment of approximately 1.0017, the proposed
cancer hospital payment adjustment of 1.0000, the proposed budget
neutrality adjustment of 1.0085 applying the proposed payment
methodology of ASP minus 28.7 percent for CY 2021 for drugs purchased
under the 340B Program, and the proposed adjustment of 0.05 percentage
point of projected OPPS spending for the difference in pass-through
spending that resulted in a proposed conversion factor for CY 2021 of
$83.697.
Comment: One commenter suggested that we eliminate the MFP
adjustment because of economic uncertainty as a result of the COVID-19
pandemic. The commenter stated that CMS rules for fiscal year 2021 had
a 0.0 percent multifactor productivity adjustment.
Response: We note that under section 1886(b)(3)(B)(xi)(I) of the
Act, the Secretary is required to reduce the hospital market basket
percentage increase by the 10-year moving average of changes in annual
economy-wide, private nonfarm business MFP.
Comment: Multiple commenters supported our proposed CY 2021 OPD fee
schedule increase factor percentage increase of 2.6 percent.
Response: We appreciate the support of the commenters.
After reviewing the public comments we received, we are finalizing
these proposals with modification. For CY 2021, we proposed to continue
previously established policies for implementing the cancer hospital
payment adjustment described in section 1833(t)(18) of the Act
(discussed in section II.F. of this final rule with comment period).
Based on the final rule updated data used in calculating the cancer
hospital payment adjustment in section II.F. of this final rule with
comment period, the target payment-to-cost ratio for the cancer
hospital payment adjustment, which was 0.89 for CY 2020, is also 0.89
for CY 2021. As a result, we are applying a budget neutrality
adjustment factor of 1.0000 to the conversion factor for the cancer
hospital payment adjustment. We are implementing our alternative
proposal for CY 2021 for the payment of drugs acquired through the 340B
program. Drugs obtained through the 340B program will be paid at a net
rate of ASP minus 22.5 percent. This has been the payment rate for
drugs acquired through the 340B program in the OPPS since the policy
was initially established in CY 2018. Since there is no change in the
net payment rate, the final budget neutral adjustment factor regarding
the payment of drugs acquired through the 340B program is 1.0000.
For this CY 2021 OPPS/ASC final rule with comment period, as
published in the FY 2021 IPPS/LTCH PPS final rule, based on IGI's 2020
second quarter forecast with historical data through the first quarter
of 2020, the hospital market basket update for CY 2021 is 2.4 percent.
As described in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58797),
it has typically been our practice to base the projection of the market
basket price proxies and MFP for the IPPS/LTCH final rule on the second
quarter IGI forecast. At the time of the FY 2021 IPPS/LTCH final rule,
the 10-year moving average growth of MFP for FY 2021 based on IGI's
second quarter 2020 forecast was 0.7 percentage point. However, for the
FY 2021 IPPS/LTCH final rule, we finalized the use of the IGI June 2020
macroeconomic forecast for MFP because it represented a more recent
forecast, and we believed it was important to use more recent data
during this period when economic trends, particularly employment and
labor productivity, are notably uncertain because of the COVID-19
pandemic. Based on these more recent data available for the FY 2021
IPPS/LTCH final rule, the current estimate of the 10-year moving
average growth of MFP for FY 2021 was -0.1 percentage point (85 FR
58797).
[[Page 85906]]
Mechanically subtracting the negative 10-year moving average growth
of MFP from the hospital market basket percentage increase using the
data from the IGI June 2020 macroeconomic forecast would have resulted
in a 0.1 percentage point increase in the FY 2021 market basket update.
However, we explained that under section 1886(b)(3)(B)(xi)(I) of the
Act, the Secretary is required to reduce (not increase) the hospital
market basket percentage increase by changes in economy-wide
productivity. Accordingly, we applied a 0.0 percent MFP adjustment to
the FY 2021 IPPS market basket percentage increase.
Section 1833(t)(3)(F)(i) of the Act also requires us to reduce (not
increase) the OPD fee schedule increase factor by the MFP adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Accordingly, we
are applying a 0.0 percentage point MFP adjustment to the CY 2021 OPD
fee schedule increase factor for the OPPS.
As a result of these finalized policies, the OPD fee schedule
increase factor for the CY 2021 OPPS is 2.4 percent (which reflects the
2.4 percent final estimate of the hospital inpatient market basket
percentage increase with a 0.0 percentage point MFP adjustment since
the 10-year moving average growth in MFP was estimated to be less than
0.0 percent). For CY 2021, we are using a conversion factor of $82.797
in the calculation of the national unadjusted payment rates for those
items and services for which payment rates are calculated using
geometric mean costs; that is, the OPD fee schedule increase factor of
2.4 percent for CY 2021, the required wage index budget neutrality
adjustment of 1.0012, the budget neutrality adjustment of 1.0000
applying the final payment methodology for drugs purchased under the
340B Program for CY 2021 of ASP minus 22.5 percent, and the adjustment
of 0.04 percentage point of projected OPPS spending for the difference
in pass-through spending that results in a conversion factor for CY
2021 of $82.797.
We also are finalizing our proposal to amend the regulation at 42
CFR 419.32(b)(1)(iv)(B) by adding a new paragraph (b)(1)(iv)(B)(11) to
provide that, for CY 2020 and subsequent years, we reduce the OPD fee
schedule increase factor by the MFP adjustment as determined by CMS.
C. Wage Index Changes
Section 1833(t)(2)(D) of the Act requires the Secretary to
determine a wage adjustment factor to adjust the portion of payment and
coinsurance attributable to labor-related costs for relative
differences in labor and labor-related costs across geographic regions
in a budget neutral manner (codified at 42 CFR 419.43(a)). This portion
of the OPPS payment rate is called the OPPS labor-related share. Budget
neutrality is discussed in section II.B. of the CY 2021 OPPS/ASC
proposed rule.
The OPPS labor-related share is 60 percent of the national OPPS
payment. This labor-related share is based on a regression analysis
that determined that, for all hospitals, approximately 60 percent of
the costs of services paid under the OPPS were attributable to wage
costs. We confirmed that this labor-related share for outpatient
services is appropriate during our regression analysis for the payment
adjustment for rural hospitals in the CY 2006 OPPS final rule with
comment period (70 FR 68553). We proposed to continue this policy for
the CY 2021 OPPS (85 FR 48802). We referred readers to section II.H. of
the CY 2021 OPPS/ASC proposed rule for a description and an example of
how the wage index for a particular hospital is used to determine
payment for the hospital. We did not receive any public comments on
this proposal. Accordingly, for the reasons discussed above and in the
CY 2021 OPPS/ASC proposed rule, we are finalizing our proposal, without
modification, to continue this policy for the CY 2021 OPPS.
As discussed in the claims accounting narrative included with the
supporting documentation for this final rule with comment period (which
is available via the internet on the CMS website), for estimating APC
costs, we are standardizing 60 percent of estimated claims costs for
geographic area wage variation using the same FY 2021 pre-reclassified
wage index that we use under the IPPS to standardize costs. This
standardization process removes the effects of differences in area wage
levels from the determination of a national unadjusted OPPS payment
rate and copayment amount.
Under 42 CFR 419.41(c)(1) and 419.43(c) (published in the OPPS
April 7, 2000 final rule with comment period (65 FR 18495 and 18545)),
the OPPS adopted the final fiscal year IPPS post-reclassified wage
index as the calendar year wage index for adjusting the OPPS standard
payment amounts for labor market differences. Therefore, the wage index
that applies to a particular acute care, short-stay hospital under the
IPPS also applies to that hospital under the OPPS. As initially
explained in the September 8, 1998 OPPS proposed rule (63 FR 47576), we
believe that using the IPPS wage index as the source of an adjustment
factor for the OPPS is reasonable and logical, given the inseparable,
subordinate status of the HOPD within the hospital overall. In
accordance with section 1886(d)(3)(E) of the Act, the IPPS wage index
is updated annually.
The Affordable Care Act contained several provisions affecting the
wage index. These provisions were discussed in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74191). Section 10324 of the
Affordable Care Act added section 1886(d)(3)(E)(iii)(II) to the Act,
which defines a frontier State and amended section 1833(t) of the Act
to add paragraph (19), which requires a frontier State wage index floor
of 1.00 in certain cases, and states that the frontier State floor
shall not be applied in a budget neutral manner. We codified these
requirements at Sec. 419.43(c)(2) and (3) of our regulations. For CY
2021, we proposed to implement this provision in the same manner as we
have since CY 2011 (85 FR 48802). Under this policy, the frontier State
hospitals would receive a wage index of 1.00 if the otherwise
applicable wage index (including reclassification, the rural floor, and
rural floor budget neutrality) is less than 1.00. Because the HOPD
receives a wage index based on the geographic location of the specific
inpatient hospital with which it is associated, we stated that the
frontier State wage index adjustment applicable for the inpatient
hospital also would apply for any associated HOPD. We referred readers
to the FY 2011 through FY 2020 IPPS/LTCH PPS final rules for
discussions regarding this provision, including our methodology for
identifying which areas meet the definition of ``frontier States'' as
provided for in section 1886(d)(3)(E)(iii)(II) of the Act: for FY 2011,
75 FR 50160 through 50161; for FY 2012, 76 FR 51793, 51795, and 51825;
for FY 2013, 77 FR 53369 through 53370; for FY 2014, 78 FR 50590
through 50591; for FY 2015, 79 FR 49971; for FY 2016, 80 FR 49498; for
FY 2017, 81 FR 56922; for FY 2018, 82 FR 38142; for FY 2019, 83 FR
41380; and for FY 2020, 84 FR 42312. We did not receive any public
comments on this proposal. Accordingly, for the reasons discussed above
and in the CY 2021 OPPS/ASC proposed rule, we are finalizing our
proposal, without modification, to continue to implement the frontier
State floor under the OPPS in the same manner as we have since CY 2011.
In addition to the changes required by the Affordable Care Act, we
noted in the CY 2021 OPPS/ASC proposed rule (85
[[Page 85907]]
FR 48802) that the FY 2021 IPPS wage indexes continue to reflect a
number of adjustments implemented in past years, including, but not
limited to, reclassification of hospitals to different geographic
areas, the rural floor provisions, an adjustment for occupational mix,
an adjustment to the wage index based on commuting patterns of
employees (the out-migration adjustment), and an adjustment to the wage
index for certain low wage index hospitals to help address wage index
disparities between low and high wage index hospitals. We referred
readers to the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32695 through
32734) for a detailed discussion of all proposed changes to the FY 2021
IPPS wage indexes.
Furthermore, as discussed in the FY 2015 IPPS/LTCH PPS final rule
(79 FR 49951 through 49963) and in each subsequent IPPS/LTCH PPS final
rule, including the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743), the
Office of Management and Budget (OMB) issued revisions to the labor
market area delineations on February 28, 2013 (based on 2010 Decennial
Census data), that included a number of significant changes, such as
new Core Based Statistical Areas (CBSAs), urban counties that became
rural, rural counties that became urban, and existing CBSAs that were
split apart (OMB Bulletin 13-01). This bulletin can be found at:
https://obamawhitehouse.archives.gov/sites/default/files/omb/bulletins/2013/b13-01.pdf. In the FY 2015 IPPS/LTCH PPS final rule (79 FR 49950
through 49985), for purposes of the IPPS, we adopted the use of the OMB
statistical area delineations contained in OMB Bulletin No. 13-01,
effective October 1, 2014. For purposes of the OPPS, in the CY 2015
OPPS/ASC final rule with comment period (79 FR 66826 through 66828), we
adopted the use of the OMB statistical area delineations contained in
OMB Bulletin No. 13-01, effective January 1, 2015, beginning with the
CY 2015 OPPS wage indexes. In the FY 2017 IPPS/LTCH PPS final rule (81
FR 56913), we adopted revisions to statistical areas contained in OMB
Bulletin No. 15-01, issued on July 15, 2015, which provided updates to
and superseded OMB Bulletin No. 13-01 that was issued on February 28,
2013. For purposes of the OPPS, in the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79598), we adopted the revisions to the OMB
statistical area delineations contained in OMB Bulletin No. 15-01,
effective January 1, 2017, beginning with the CY 2017 OPPS wage
indexes.
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. The attachments to OMB Bulletin No. 17-01
provided detailed information on the update to the statistical areas
since July 15, 2015, and were based on the application of the 2010
Standards for Delineating Metropolitan and Micropolitan Statistical
Areas to Census Bureau population estimates for July 1, 2014 and July
1, 2015. In the CY 2019 OPPS/ASC final rule with comment period (83 FR
58863 through 58865), we adopted the updates set forth in OMB Bulletin
No. 17-01, effective January 1, 2019, beginning with the CY 2019 wage
index.
On April 10, 2018 OMB issued OMB Bulletin No. 18-03 which
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14,
2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10,
2018 OMB Bulletin No. 18-03. Typically, interim OMB bulletins (those
issued between decennial censuses) have only contained minor
modifications to labor market delineations. However, as we stated in
the FY 2021 IPPS/LTCH PPS proposed and final rules (85 FR 32696 through
32697 and 58743), the April 10, 2018 OMB Bulletin No. 18-03 and the
September 14, 2018 OMB Bulletin No. 18-04 included more modifications
to the labor market areas than are typical for OMB bulletins issued
between decennial censuses, including some material modifications that
have a number of downstream effects, such as IPPS hospital
reclassification changes. These bulletins established revised
delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the delineations of these statistical areas. A
copy of OMB Bulletin No. 18-04 may be obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/09/Bulletin-18-04.pdf.
According to OMB, ``[t]his bulletin provides the delineations of all
Metropolitan Statistical Areas, Metropolitan Divisions, Micropolitan
Statistical Areas, Combined Statistical Areas, and New England City and
Town Areas in the United States and Puerto Rico based on the standards
published on June 28, 2010 (75 FR 37246), and Census Bureau data.''
As noted previously, while OMB Bulletin No. 18-04 is not based on
new census data, it includes some material changes to the OMB
statistical area delineations. Specifically, as we stated in the CY
2021 OPPS/ASC proposed rule (85 FR 48803), under the revised OMB
delineations, there would be some new CBSAs, urban counties that would
become rural, rural counties that would become urban, and some existing
CBSAs that would be split apart. In addition, we stated in the FY 2021
IPPS/LTCH PPS proposed rule that the revised OMB delineations would
affect various hospital reclassifications, the outmigration adjustment
(established by section 505 of Pub. L. 108-173), and treatment of
hospitals located in certain rural counties (that is, ``Lugar''
hospitals) under section 1886(d)(8)(B) of the Act. In the CY 2021 OPPS/
ASC proposed rule, we referred readers to the FY 2021 IPPS/LTCH PPS
proposed rule for a complete discussion of the revised OMB delineations
we proposed to adopt under the IPPS and the effects of these revisions
on the FY 2021 IPPS wage indexes (85 FR 32696 through 32707, 32717
through 32728). We stated in the FY 2021 IPPS/LTCH PPS proposed rule
that we believe using the revised delineations based on OMB Bulletin
No. 18-04 would increase the integrity of the IPPS wage index system by
creating a more accurate representation of geographic variations in
wage levels. Therefore, in the FY 2021 IPPS/LTCH PPS proposed rule, we
proposed to implement the revised OMB delineations as described in the
September 14, 2018 OMB Bulletin No. 18-04, effective October 1, 2020
beginning with the FY 2021 IPPS wage index. In addition, in the FY 2021
IPPS/LTCH PPS proposed rule, we proposed to apply a 5 percent cap for
FY 2021 on any decrease in a hospital's final wage index from the
hospital's final wage index for FY 2020 as a proposed transition wage
index to help mitigate any significant negative impacts of adopting the
revised OMB delineations (85 FR 32706 through 32707). As discussed in
the FY 2021 IPPS/LTCH PPS final rule (85 FR 58742 through 58755), as we
proposed, we adopted the revised OMB delineations as described in the
September 14, 2018 OMB Bulletin No. 18-04, effective October 1, 2020
beginning with the FY 2021 IPPS wage index and a 5 percent cap for FY
2021 on any decrease in a hospital's final wage index from the
hospital's final wage index for FY 2020.
As further discussed below, in the CY 2021 OPPS/ASC proposed rule
(85 FR 48803), we proposed to use the FY 2021 IPPS post-reclassified
wage index including the updated OMB delineations and related IPPS wage
index adjustments to calculate the CY 2021 OPPS wage indexes. Similar
to our discussion in the FY 2021 IPPS/LTCH PPS proposed rule, we stated
in the CY
[[Page 85908]]
2021 OPPS/ASC proposed rule that we believe using the revised
delineations based on OMB Bulletin No. 18-04 would increase the
integrity of the OPPS wage index system by creating a more accurate
representation of geographic variations in wage levels.
A summary of the comments we received regarding the updated OMB
delineations and our responses to those comments appear below:
Comment: One commenter supported our proposed adoption of the
revised OMB delineations, but several commenters opposed our proposed
implementation of the revised OMB delineations. These commenters stated
that CMS is not bound to adopt the revised delineations, and suggested
that CMS delay adoption of the revised delineations until the
completion of the 2020 decennial census. Several comments specifically
cited the lack of advance notice and the significant negative financial
impacts to hospitals in several counties in the New York-Newark-Jersey
City MSA resulting from the adoption of the revised delineations.
Additional commenters recommended that CMS engage further with
stakeholders to develop more comprehensive wage index reform to address
the disparities that exist within the current wage index system.
Response: We appreciate these comments. We refer readers to the FY
2021 IPPS/LTCH PPS final rule (85 FR 58744 through 58753) for a
detailed discussion of the implementation of the revised OMB
delineations and for responses to these and other comments relating to
the revised delineations.
Consistent with our longstanding policy, we proposed in the CY 2021
OPPS/ASC proposed rule (85 FR 48803) to use the FY 2021 IPPS post-
reclassified wage index, which is based on the updated statistical area
delineations set forth in OMB Bulletin No. 18-04, in determining the
wage adjustments for both the OPPS payment and copayment rates for CY
2021. Thus, as discussed in the CY 2021 OPPS/ASC proposed rule (85 FR
48803), any adjustments for the FY 2021 IPPS post-reclassified wage
index, including without limitation a one year 5 percent cap on any
wage index decrease, would be reflected in the final CY 2021 OPPS wage
index beginning on January 1, 2021. As we explained in the CY 2021
OPPS/ASC proposed rule, we continue to believe that using the IPPS
post-reclassified wage index as the source of an adjustment factor for
the OPPS is reasonable and logical given the inseparable, subordinate
status of the HOPD within the hospital overall. For this reason, as
discussed later in this section, we are finalizing our proposal to use
the FY 2021 IPPS post-reclassified wage index and applicable IPPS wage
index adjustments in determining the wage adjustments for both the OPPS
payment rate and the copayment rates for CY 2021. As noted above, in
the FY 2021 IPPS/LTCH PPS final rule (85 FR 58742 through 58755), for
purposes of calculating the IPPS wage index, we adopted the revised OMB
delineations as described in OMB Bulletin No. 18-04 effective October
1, 2020. Thus, effective January 1, 2021, the OPPS wage index also will
be based on these updated OMB delineations. As we explained in the CY
2021 OPPS/ASC proposed rule, we believe using the revised delineations
based on OMB Bulletin No. 18-04 will increase the integrity of the wage
index system by creating a more accurate representation of geographic
variations in wage levels.
We concur with commenters that CMS is not bound by statute to use
the OMB definitions in calculating the OPPS wage index. However, we
believe we have broad authority under section 1833(t)(2)(D) of the Act
to determine the methodology for calculating the OPPS wage index,
including the labor market areas used for the OPPS wage index. As
discussed above, we believe using the IPPS post-reclassified wage
index, which is based on the revised OMB delineations, in determining
the wage adjustments for both the OPPS payment rate and the copayment
rate for CY 2021 is reasonable and logical given the inseparable,
subordinate status of the HOPD within the hospital overall. In
addition, consistent with our discussion in the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58745), we believe it is important to use the updated
labor market area delineations in order to maintain a more accurate and
up-to-date payment system that reflects the reality of current labor
market conditions. In response to comments citing a lack of advance
notice provided to hospitals regarding the proposed adoption of the
revised delineations, as we stated in the FY 2021 IPPS/LTCH PPS final
rule (85 FR 58746), the delineation files produced by OMB have been
public for nearly 2 years, and OMB definitions and criteria are subject
to separate notice and comment rulemaking. Finally, we note that to
help mitigate significant negative impacts of the revised OMB
delineations, consistent with the FY 2021 IPPS wage index, the CY 2021
OPPS wage index will reflect a 5 percent cap on any wage index decrease
compared to a hospital's final CY 2020 wage index. For these reasons,
we do not believe it is necessary or appropriate to delay or alter
implementation of the revised delineations.
In response to commenters who recommended that CMS engage further
with stakeholders to develop a more comprehensive wage index reform to
address wage index disparities, we appreciate the continued interest in
wage index reform. As we noted in the FY 2021 IPPS/LTCH PPS final rule
(85 FR 58745), as a first step toward comprehensive wage index reform,
the FY 2021 President's Budget proposes the Secretary conduct and
report on a demonstration to improve the Medicare inpatient hospital
wage index.
After consideration of the public comments we received, for the
reasons discussed above and in the CY 2021 OPPS/ASC proposed rule, we
are finalizing, without modification, our proposal to adopt the revised
OMB delineations as described in the September 14, 2018 OMB Bulletin
No. 18-04, and related IPPS wage index adjustments to calculate the CY
2021 OPPS wage index effective beginning January 1, 2021.
CBSAs are made up of one or more constituent counties. Each CBSA
and constituent county has its own unique identifying codes. The FY
2018 IPPS/LTCH PPS final rule (82 FR 38130) discussed the two different
lists of codes to identify counties: Social Security Administration
(SSA) codes and Federal Information Processing Standard (FIPS) codes.
Historically, CMS listed and used SSA and FIPS county codes to identify
and crosswalk counties to CBSA codes for purposes of the IPPS and OPPS
wage indexes. However, the SSA county codes are no longer being
maintained and updated, although the FIPS codes continue to be
maintained by the U.S. Census Bureau. The Census Bureau's most current
statistical area information is derived from ongoing census data
received since 2010; the most recent data are from 2015. The Census
Bureau maintains a complete list of changes to counties or county
equivalent entities on the website at: https://www.census.gov/geo/reference/county-changes.html (which, as of May 6, 2019, migrated to:
https://www.census.gov/programs-surveys/geography.html). In the FY 2018
IPPS/LTCH PPS final rule (82 FR 38130), for purposes of crosswalking
counties to CBSAs for the IPPS wage index, we finalized our proposal to
discontinue the use of the SSA county codes and begin using only the
FIPS county codes. Similarly, for the purposes of crosswalking counties
to CBSAs for the OPPS wage index, in the CY 2018 OPPS/ASC final rule
with comment period (82 FR 59260), we finalized our proposal to
discontinue
[[Page 85909]]
the use of SSA county codes and begin using only the FIPS county codes.
For CY 2021, under the OPPS, we are continuing to use only the FIPS
county codes for purposes of crosswalking counties to CBSAs.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48803), we proposed to
use the FY 2021 IPPS post-reclassified wage index for urban and rural
areas as the wage index for the OPPS to determine the wage adjustments
for both the OPPS payment rate and the copayment rate for CY 2021.
Therefore, we stated that any adjustments for the FY 2021 IPPS post-
reclassified wage index, including, but not limited to, any adjustments
that we may finalize related to the proposed adoption of the revised
OMB delineations (such as a cap on wage index decreases and revisions
to hospital reclassifications), would be reflected in the final CY 2021
OPPS wage index beginning on January 1, 2021. (In the proposed rule, we
referred readers to the FY 2021 IPPS/LTCH PPS proposed rule (85 FR
32695 through 32734) and the proposed FY 2021 hospital wage index files
posted on the CMS website.) With regard to budget neutrality for the CY
2021 OPPS wage index, in the proposed rule, we referred readers to
section II.B. of the CY 2021 OPPS/ASC proposed rule. We stated that we
continue to believe that using the IPPS post-reclassified wage index as
the source of an adjustment factor for the OPPS is reasonable and
logical, given the inseparable, subordinate status of the HOPD within
the hospital overall.
We received comments regarding certain adjustments included in the
FY 2021 IPPS post-reclassified wage index (which would be reflected in
the CY 2021 OPPS wage index). A summary of those comments and our
responses appear below:
Comment: Some commenters, while opposing the proposed adoption of
revised OMB delineations, generally supported the concept of the 5
percent cap on any wage index decrease for FY 2021 (if the delineations
are finalized). Some commenters requested that CMS reduce the amount of
potential reduction in FY 2021, and extend transition adjustments to
affected hospitals in future years. Other commenters suggested a
multiple year transition period. One commenter requested that we apply
the 5 percent cap policy to wage index increases as well.
Response: We thank the commenters for their suggestions. We refer
readers to the FY 2021 IPPS/LTCH PPS final rule (85 FR 85753 through
58755) for a detailed discussion of our rationale for adopting a one
year 5 percent cap on any wage index decrease and for responses to
these and other comments regarding this transition wage index.
As discussed previously, in the CY 2021 OPPS/ASC proposed rule (85
FR 48803), we proposed to use the FY 2021 IPPS post-reclassified wage
index, including any adjustments such as the one year 5 percent cap on
wage index decreases, as the wage index for the OPPS to determine the
wage adjustments for both the OPPS payment rate and the copayment rate
for CY 2021. We continue to believe that using the IPPS post-
reclassified wage index, including any adjustments, as the source of an
adjustment factor for the OPPS is reasonable and logical given the
inseparable, subordinate status of the HOPD within the hospital
overall, and thus, as discussed below, we are finalizing this proposal
without modification.
In response to the commenter that requested we also apply the 5
percent cap to wage index increases, we note that as we explained in
the FY 2021 IPPS/LTCH PPS final rule (85 FR 58753 through 58755), the
purpose of the 5 percent cap is to mitigate significant wage index
decreases and provide wage index stability for affected hospitals in
light of our adoption of the revised OMB delineations. The purpose of
the 5 percent cap is not to curtail the positive impact of such
revisions. Thus, we do not think it would be appropriate to apply the
cap to wage index increases as well.
Comments: Many commenters thanked CMS for implementing the IPPS low
wage index hospital policy (pursuant to which CMS increases the IPPS
wage index for certain low wage index hospitals) beginning in FY 2020
in response to rural and other health care stakeholders' requests that
CMS address ``circularity'' in the wage index (the cyclical effect of
hospitals with relatively high wages receiving higher reimbursement due
to relatively high wage indexes, which allows them to afford paying
higher wages) and halt the ``death spiral'' perpetuating wage index
disparities where relatively low wage index hospitals are forced to
keep wages low due to low Medicare reimbursements that lag behind areas
with higher wage indexes.
Other commenters opposed continuing the low wage index hospital
policy in FY 2021. The commenters stated that the policy fails to
recognize the legitimate differences in geographic labor markets.
Commenters also noted that there is no requirement for hospitals to use
the increased reimbursement to boost employee compensation, and
suggested CMS begin evaluating the cost report data filed by hospitals
in the lowest quartile to ascertain whether the increased funds are
being used to raise employee compensation in deciding whether to
continue this policy for FY 2022. Some commenters stated that the data
lag CMS described in its rationale applies equally to all hospitals,
not only those in the lowest quartile. Commenters questioned CMS's
statutory authority to promulgate this IPPS policy under 42 U.S.C.
1395ww(d)(3)(E), which requires the agency to adjust payments to
reflect area differences in wages, because it artificially inflates
wage index values and creates a wage index system not based on actual
data. These commenters stated that CMS is using the wage index as a
policy vehicle, not as a technical correction, and needs Congressional
authority to provide additional funding to low-wage hospitals.
Response: We appreciate the many comments we received regarding our
policy to provide an increase in the IPPS wage index beginning in FY
2020 for hospitals with wage index values below the 25th percentile
wage index value for a year (referred to as the low wage index hospital
policy). We note that we did not propose or finalize any changes to
this policy in the FY 2021 IPPS/LTCH PPS proposed and final rules. We
refer readers to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42326
through 42332) and FY 2021 IPPS/LTCH PPS final rule (85 FR 58765
through 58768) for a detailed discussion of the IPPS low wage index
hospital policy and for responses to these and other comments regarding
this policy. In the CY 2021 OPPS/ASC proposed rule (85 FR 48803), we
proposed to use the FY 2021 IPPS post-reclassified wage index including
any adjustments, such as the IPPS low wage index hospital policy, as
the wage index for the OPPS to determine the wage adjustments for both
the OPPS payment rate and the copayment rate for CY 2021. We continue
to believe that using the IPPS post-reclassified wage index, including
any adjustments, as the source of an adjustment factor for the OPPS is
reasonable and logical given the inseparable, subordinate status of the
HOPD within the hospital overall, and thus, as discussed below, we are
finalizing this proposal without modification.
Comment: Many commenters supported increasing the wage index values
of low-wage hospitals, but suggested that CMS do so in a non-budget-
neutral manner. Commenters stated that this redistribution is
counterproductive to CMS's larger goals
[[Page 85910]]
of high quality care and healthcare access because it forces high-wage,
mostly urban hospitals to bear the cost of supporting lower-wage
hospitals. Commenters stated that the budget neutrality adjustment
penalizes many hospitals, including rural hospitals. Other commenters
requested that CMS ensure that the budget neutrality adjustment factor
not apply to hospitals falling below the 25th percentile.
Response: We refer readers to the FY 2020 IPPS/LTCH PPS final rule
(84 FR 42328 through 42332) and FY 2021 IPPS/LTCH PPS final rule (85 FR
58765 through 58768) for a detailed discussion of the budget neutrality
adjustment for the IPPS low wage index hospital policy and for
responses to these and other comments regarding this adjustment.
We refer readers to section II.B. of this final rule with comment
period for a discussion of the OPPS wage index budget neutrality
adjustment.
Comment: Many commenters recommended that CMS develop a
comprehensive, long-term approach to wage index reform in place of the
low wage index hospital policy finalized in the FY 2020 IPPS/LTCH PPS
final rule. Two commenters suggested alternative solutions to address
wage index disparities, including a national wage index floor for all
hospitals. Other commenters recommended that CMS proactively address
the effects of COVID-19, which the commenters believed would exacerbate
wage index disparities, by excluding wage data collected during the
public health emergency from future wage index calculations.
Response: We appreciate the commenters' suggested alternatives. We
received similar comments in response to the FY 2021 IPPS/LTCH PPS
proposed rule (85 FR 58767 through 58768). In the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58768), we stated that we considered these comments
to be outside the scope of the FY 2021 IPPS/LTCH PPS proposed rule, and
thus we did not address them in that final rule but stated that we may
consider them in future rulemaking. Similarly, we consider these
comments to be outside the scope of the CY 2021 OPPS/ASC proposed rule
and thus are not addressing them in this final rule with comment
period.
Comment: Multiple commenters specifically supported CMS's
continuation of the policy, adopted in the FY 2020 IPPS/LTCH PPS final
rule (84 FR 42332 through 42336), to exclude the wage data of urban
hospitals that reclassify to rural when calculating each state's rural
floor. Commenters stated that the change to the calculation of the
rural floor limits the ability of hospitals to game the system and
supports the overall goal of making the wage index reflective of
variances in labor markets.
Response: We appreciate the commenters' support of our policy to
exclude the wage data of hospitals reclassified under Sec. 412.103
from the IPPS rural floor calculation. As stated in the FY 2020 IPPS/
LTCH PPS final rule, we believe this policy is necessary and
appropriate to address the unanticipated effects of rural
reclassifications on the rural floor and the resulting wage index
disparities, including the effects of the manipulation of the rural
floor by certain hospitals (84 FR 42333 through 42336). We refer
readers to the FY 2020 IPPS/LTCH PPS final rule (84 FR 42332 through
42336) and the FY 2021 IPPS/LTCH PPS final rule (85 FR 58768) for a
detailed discussion of this policy and for responses to these and other
comments regarding this policy.
Comment: One commenter supported our proposals regarding the wage
index and requested that we carry over policies from the IPPS to the
OPPS to ensure consistency in hospital payments.
Response: We appreciate the commenter's support of our proposals
regarding the wage index. As we discuss below, we are finalizing our
proposal to use the FY 2021 IPPS post-reclassified wage index for urban
and rural areas (including any applicable adjustments for the FY 2021
IPPS post-reclassified wage index), as the wage index for the OPPS to
determine the wage adjustments for both the OPPS payment rate and the
copayment rate for CY 2021.
After consideration of the comments received, for the reasons
discussed in this final rule with comment period and in the CY 2021
OPPS/ASC proposed rule, we are finalizing, without modification, our
proposal to use the FY 2021 IPPS post-reclassified wage index for urban
and rural areas, based on the revised OMB delineations set forth in OMB
Bulletin No. 18-04, as the wage index for the OPPS to determine the
wage adjustments for both the OPPS payment rate and the copayment rate
for CY 2021. Therefore, any applicable adjustments for the FY 2021 IPPS
post-reclassified wage index (including, but not limited to, the low
wage index hospital policy, the one year 5 percent cap on wage index
decreases, the rural floor, and the frontier State floor) will be
reflected in the final CY 2021 OPPS wage index beginning on January 1,
2021. We continue to believe that using the IPPS post-reclassified wage
index as the source of an adjustment factor for the OPPS is reasonable
and logical given the inseparable, subordinate status of the HOPD
within the hospital overall.
Hospitals that are paid under the OPPS, but not under the IPPS, do
not have an assigned hospital wage index under the IPPS. Therefore, for
non-IPPS hospitals paid under the OPPS, it is our longstanding policy
to assign the wage index that would be applicable if the hospital was
paid under the IPPS, based on its geographic location and any
applicable wage index adjustments. In the CY 2021 OPPS/ASC proposed
rule, we proposed to continue this policy for CY 2021, and included a
brief summary of the major FY 2021 IPPS wage index policies and
adjustments that we proposed to apply to these hospitals under the OPPS
for CY 2021, which we have summarized below. We referred readers to the
FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32695 through 32734) for a
detailed discussion of the proposed changes to the FY 2021 IPPS wage
indexes.
It has been our longstanding policy to allow non-IPPS hospitals
paid under the OPPS to qualify for the out-migration adjustment if they
are located in a section 505 out-migration county (section 505 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)). Applying this adjustment is consistent with our policy of
adopting IPPS wage index policies for hospitals paid under the OPPS. We
note that, because non-IPPS hospitals cannot reclassify, they are
eligible for the out-migration wage index adjustment if they are
located in a section 505 out-migration county. This is the same out-
migration adjustment policy that applies if the hospital were paid
under the IPPS. For CY 2021, we proposed to continue our policy of
allowing non-IPPS hospitals paid under the OPPS to qualify for the
outmigration adjustment if they are located in a section 505 out-
migration county (section 505 of the MMA). Furthermore, we stated in
the proposed rule that the wage index that would apply for CY 2021 to
non-IPPS hospitals paid under the OPPS would continue to include the
rural floor adjustment and adjustments to the wage index finalized in
the FY 2020 IPPS/LTCH PPS final rule to address wage index disparities
(84 FR 42325 through 42337). In addition, we proposed that the wage
index that would apply to non-IPPS hospitals paid under the OPPS would
include any adjustments we may finalize for the FY 2021 IPPS post-
reclassified wage index related to the adoption of the revised OMB
delineations, as discussed in the CY 2021 OPPS/ASC proposed rule. We
did not receive any public comments on these proposals. Accordingly,
for the
[[Page 85911]]
reasons discussed above and in the CY 2021 OPPS/ASC proposed rule, we
are finalizing these proposals, without modification.
For CMHCs, for CY 2021, we proposed to continue to calculate the
wage index by using the post-reclassification IPPS wage index based on
the CBSA where the CMHC is located. We also proposed that the wage
index that would apply to CMHCs would include any adjustments we may
finalize for the FY 2021 IPPS post-reclassified wage index related to
the adoption of the revised OMB delineations, as discussed in the CY
2021 OPPS/ASC proposed rule. In addition, we proposed that the wage
index that would apply to CMHCs for CY 2021 would continue to include
the rural floor adjustment and adjustments to the wage index finalized
in the FY 2020 IPPS/LTCH PPS final rule to address wage index
disparities. Also, we proposed that the wage index that would apply to
CMHCs would not include the outmigration adjustment because that
adjustment only applies to hospitals. We did not receive any public
comments on these proposals. Therefore, for the reasons discussed above
and in the CY 2021 OPPS/ASC proposed rule, we are finalizing these
proposals without modification.
Table 4A associated with the FY 2021 IPPS/LTCH PPS final rule
(available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index)
identifies counties eligible for the out-migration adjustment. Table 2
associated with the FY 2021 IPPS/LTCH PPS final rule (available for
download via the website above) identifies IPPS hospitals that receive
the out-migration adjustment for FY 2021. We are including the
outmigration adjustment information from Table 2 associated with the FY
2021 IPPS/LTCH PPS final rule as Addendum L to this CY 2021 OPPS/ASC
final rule with comment period with the addition of non-IPPS hospitals
that will receive the section 505 outmigration adjustment under this CY
2021 OPPS/ASC final rule with comment period. Addendum L is available
via the internet on the CMS website. We refer readers to the CMS
website for the OPPS at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index. At this link, readers will
find a link to the final FY 2021 IPPS wage index tables and Addendum L.
D. Statewide Average Default Cost-To-Charge Ratios (CCRs)
In addition to using CCRs to estimate costs from charges on claims
for ratesetting, we use overall hospital-specific CCRs calculated from
the hospital's most recent cost report to determine outlier payments,
payments for pass-through devices, and monthly interim transitional
corridor payments under the OPPS during the PPS year. For certain
hospitals, under the regulations at 42 CFR 419.43(d)(5)(iii), we use
the statewide average default CCRs to determine the payments mentioned
earlier if it is not possible to determine an accurate CCR for a
hospital in certain circumstances. This includes hospitals that are
new, hospitals that have not accepted assignment of an existing
hospital's provider agreement, and hospitals that have not yet
submitted a cost report. We also use the statewide average default CCRs
to determine payments for hospitals whose CCR falls outside the
predetermined ceiling threshold for a valid CCR or for hospitals in
which the most recent cost report reflects an all-inclusive rate status
(Medicare Claims Processing Manual (Pub. 100-04), Chapter 4, Section
10.11).
We discussed our policy for using default CCRs, including setting
the ceiling threshold for a valid CCR, in the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68594 through 68599) in the context of
our adoption of an outlier reconciliation policy for cost reports
beginning on or after January 1, 2009. For details on our process for
calculating the statewide average CCRs, we refer readers to the CY 2021
OPPS proposed rule Claims Accounting Narrative that is posted on our
website. We proposed to update the default ratios for CY 2021 using the
most recent cost report data. We stated that we would update these
ratios in this final rule with comment period if more recent cost
report data are available.
We are no longer publishing a table in the Federal Register
containing the statewide average CCRs in the annual OPPS proposed rule
and final rule with comment period. These CCRs with the upper limit
will be available for download with each OPPS CY proposed rule and
final rule on the CMS website. We refer readers to our website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html;
click on the link on the left of the page titled ``Hospital Outpatient
Regulations and Notices'' and then select the relevant regulation to
download the statewide CCRs and upper limit in the Downloads section of
the web page.
We did not receive any public comments on our proposal to use
statewide average default CCRs if a MAC cannot calculate a CCR for a
hospital and to use these CCRs to adjust charges to costs on claims
data for setting the final CY 2021 OPPS relative payment weights.
Therefore, we are finalizing our proposal without modification.
E. Adjustment for Rural Sole Community Hospitals (SCHs) and Essential
Access Community Hospitals (EACHs) Under Section 1833(t)(13)(B) of the
Act for CY 2021
In the CY 2006 OPPS final rule with comment period (70 FR 68556),
we finalized a payment increase for rural sole community hospitals
(SCHs) of 7.1 percent for all services and procedures paid under the
OPPS, excluding drugs, biologicals, brachytherapy sources, and devices
paid under the pass-through payment policy, in accordance with section
1833(t)(13)(B) of the Act, as added by section 411 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173). Section 1833(t)(13) of the Act provided the
Secretary the authority to make an adjustment to OPPS payments for
rural hospitals, effective January 1, 2006, if justified by a study of
the difference in costs by APC between hospitals in rural areas and
hospitals in urban areas. Our analysis showed a difference in costs for
rural SCHs. Therefore, for the CY 2006 OPPS, we finalized a payment
adjustment for rural SCHs of 7.1 percent for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, brachytherapy sources, items paid at charges reduced to
costs, and devices paid under the pass-through payment policy, in
accordance with section 1833(t)(13)(B) of the Act.
In the CY 2007 OPPS/ASC final rule with comment period (71 FR 68010
and 68227), for purposes of receiving this rural adjustment, we revised
our regulations at Sec. 419.43(g) to clarify that essential access
community hospitals (EACHs) are also eligible to receive the rural SCH
adjustment, assuming these entities otherwise meet the rural adjustment
criteria. Currently, two hospitals are classified as EACHs, and as of
CY 1998, under section 4201(c) of Public Law 105-33, a hospital can no
longer become newly classified as an EACH.
This adjustment for rural SCHs is budget neutral and applied before
calculating outlier payments and
[[Page 85912]]
copayments. We stated in the CY 2006 OPPS final rule with comment
period (70 FR 68560) that we would not reestablish the adjustment
amount on an annual basis, but we may review the adjustment in the
future and, if appropriate, would revise the adjustment. We provided
the same 7.1 percent adjustment to rural SCHs, including EACHs, again
in CYs 2008 through 2020. Further, in the CY 2009 OPPS/ASC final rule
with comment period (73 FR 68590), we updated the regulations at Sec.
419.43(g)(4) to specify, in general terms, that items paid at charges
adjusted to costs by application of a hospital-specific CCR are
excluded from the 7.1 percent payment adjustment.
For CY 2021, we proposed to continue the current policy of a 7.1
percent payment adjustment that is done in a budget neutral manner for
rural SCHs, including EACHs, for all services and procedures paid under
the OPPS, excluding separately payable drugs and biologicals,
brachytherapy sources, items paid at charges reduced to costs, and
devices paid under the pass-through payment policy.
Comment: Multiple commenters supported the proposal to continue the
7.1 percent payment adjustment.
Response: We appreciate the commenters' support.
Comment: Multiple commenters requested that CMS make the 7.1
percent rural adjustment permanent. The commenters appreciated the
policy that CMS adopted in CY 2019 and reaffirmed in CY 2020 where we
stated that the 7.1 percent rural adjustment would continue to be in
place until our data support establishing a different rural adjustment
percentage. However, the commenters believed that this policy still
does not provide enough certainty for rural SCHs and EACHs to know
whether they should take into account the rural SCH adjustment when
attempting to calculate expected revenues for their hospital budgets.
Response: We thank the commenters for their input. We believe that
our current policy, which states that the 7.1 percent payment
adjustment for rural SCHs and EACHs will remain in effect until our
data show that a different percentage for the rural payment adjustment
is necessary, provides sufficient budget predictability for rural SCHs
and EACHs. Providers would receive notice in a proposed rule and have
the opportunity to provide comments before any changes to the rural
adjustment percentage would be implemented.
Comment: One commenter requested that CMS expand the payment
adjustment for rural SCHs and EACHs to additional types of hospitals.
The commenter requested that the payment adjustment apply to include
urban SCHs because, according to the commenter, urban SCHs care for
patient populations similar to rural SCHs and EACHs, face similar
financial challenges to rural SCHs and EACHs, and act as safety net
providers for rural areas despite their designation as urban providers.
The same commenter requested that the payment adjustment also apply to
Medicare-dependent hospitals (MDHs) because, according to the
commenter, these hospitals face similar financial challenges to rural
SCHs and EACHs, and MDHs play a similar safety net role to rural SCHs
and EACHs, especially for Medicare. The commenter asked that CMS study
whether it would be appropriate to provide a payment adjustment to MDHs
that is similar to the current adjustment for rural SCHs.
Response: We thank the commenters for their comments. The analysis
we did to compare costs of urban providers to those of rural providers
did not support an add-on adjustment for providers other than rural
SCHs and EACHs. In addition, section 1833(t)(13)(B) of the Act
authorizes an adjustment for rural hospitals only. Accordingly, we do
not believe we have a basis to expand the payment adjustment to any
providers other than rural SCHs and EACHs under our authority at
section 1833(t)(13)(B) of the Act.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to continue the current
policy of a 7.1 percent payment adjustment that is done in a budget
neutral manner for rural SCHs, including EACHs, for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, devices paid under the pass-through payment policy, and
items paid at charges reduced to costs.
F. Payment Adjustment for Certain Cancer Hospitals for CY 2021
1. Background
Since the inception of the OPPS, which was authorized by the
Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), Medicare has paid
the 11 hospitals that meet the criteria for cancer hospitals identified
in section 1886(d)(1)(B)(v) of the Act under the OPPS for covered
outpatient hospital services. These cancer hospitals are exempted from
payment under the IPPS. With the Medicare, Medicaid and SCHIP Balanced
Budget Refinement Act of 1999 (Pub. L. 106-113), the Congress
established section 1833(t)(7) of the Act, ``Transitional Adjustment to
Limit Decline in Payment,'' to determine OPPS payments to cancer and
children's hospitals based on their pre-BBA payment amount (often
referred to as ``held harmless'').
As required under section 1833(t)(7)(D)(ii) of the Act, a cancer
hospital receives the full amount of the difference between payments
for covered outpatient services under the OPPS and a ``pre-BBA
amount.'' That is, cancer hospitals are permanently held harmless to
their ``pre-BBA amount,'' and they receive transitional outpatient
payments (TOPs) or hold harmless payments to ensure that they do not
receive a payment that is lower in amount under the OPPS than the
payment amount they would have received before implementation of the
OPPS, as set forth in section 1833(t)(7)(F) of the Act. The ``pre-BBA
amount'' is the product of the hospital's reasonable costs for covered
outpatient services occurring in the current year and the base payment-
to-cost ratio (PCR) for the hospital defined in section
1833(t)(7)(F)(ii) of the Act. The ``pre-BBA amount'' and the
determination of the base PCR are defined at 42 CFR 419.70(f). TOPs are
calculated on Worksheet E, Part B, of the Hospital Cost Report or the
Hospital Health Care Complex Cost Report (Form CMS-2552-96 or Form CMS-
2552-10, respectively), as applicable each year. Section 1833(t)(7)(I)
of the Act exempts TOPs from budget neutrality calculations.
Section 3138 of the Affordable Care Act amended section 1833(t) of
the Act by adding a new paragraph (18), which instructs the Secretary
to conduct a study to determine if, under the OPPS, outpatient costs
incurred by cancer hospitals described in section 1886(d)(1)(B)(v) of
the Act with respect to APC groups exceed outpatient costs incurred by
other hospitals furnishing services under section 1833(t) of the Act,
as determined appropriate by the Secretary. Section 1833(t)(18)(A) of
the Act requires the Secretary to take into consideration the cost of
drugs and biologicals incurred by cancer hospitals and other hospitals.
Section 1833(t)(18)(B) of the Act provides that, if the Secretary
determines that cancer hospitals' costs are higher than those of other
hospitals, the Secretary shall provide an appropriate adjustment under
section 1833(t)(2)(E) of the Act to reflect these higher costs. In
2011, after conducting the study required by section 1833(t)(18)(A) of
the Act, we determined that outpatient costs incurred by the 11
specified cancer
[[Page 85913]]
hospitals were greater than the costs incurred by other OPPS hospitals.
For a complete discussion regarding the cancer hospital cost study, we
refer readers to the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74200 through 74201).
Based on these findings, we finalized a policy to provide a payment
adjustment to the 11 specified cancer hospitals that reflects their
higher outpatient costs, as discussed in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74202 through 74206). Specifically, we
adopted a policy to provide additional payments to the cancer hospitals
so that each cancer hospital's final PCR for services provided in a
given calendar year is equal to the weighted average PCR (which we
refer to as the ``target PCR'') for other hospitals paid under the
OPPS. The target PCR is set in advance of the calendar year and is
calculated using the most recently submitted or settled cost report
data that are available at the time of final rulemaking for the
calendar year. The amount of the payment adjustment is made on an
aggregate basis at cost report settlement. We note that the changes
made by section 1833(t)(18) of the Act do not affect the existing
statutory provisions that provide for TOPs for cancer hospitals. The
TOPs are assessed, as usual, after all payments, including the cancer
hospital payment adjustment, have been made for a cost reporting
period. For CYs 2012 and 2013, the target PCR for purposes of the
cancer hospital payment adjustment was 0.91. For CY 2014, the target
PCR was 0.90. For CY 2015, the target PCR was 0.90. For CY 2016, the
target PCR was 0.92, as discussed in the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70362 through 70363). For CY 2017, the
target PCR was 0.91, as discussed in the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79603 through 79604). For CY 2018, the
target PCR was 0.88, as discussed in the CY 2018 OPPS/ASC final rule
with comment period (82 FR 59265 through 59266). For CY 2019, the
target PCR was 0.88, as discussed in the CY 2019 OPPS/ASC final rule
with comment period (83 FR 58871 through 58873). For CY 2020, the
target PCR was 0.89, as discussed in the CY 2020 OPPS/ASC final rule
with comment period (83 FR 61190 through 61192).
2. Policy for CY 2021
Section 16002(b) of the 21st Century Cures Act (Pub. L. 114-255)
amended section 1833(t)(18) of the Act by adding subparagraph (C),
which requires that in applying Sec. 419.43(i) (that is, the payment
adjustment for certain cancer hospitals) for services furnished on or
after January 1, 2018, the target PCR adjustment be reduced by 1.0
percentage point less than what would otherwise apply. Section 16002(b)
also provides that, in addition to the percentage reduction, the
Secretary may consider making an additional percentage point reduction
to the target PCR that takes into account payment rates for applicable
items and services described under section 1833(t)(21)(C) of the Act
for hospitals that are not cancer hospitals described under section
1886(d)(1)(B)(v) of the Act. Further, in making any budget neutrality
adjustment under section 1833(t) of the Act, the Secretary shall not
take into account the reduced expenditures that result from application
of section 1833(t)(18)(C) of the Act.
We proposed to provide additional payments to the 11 specified
cancer hospitals so that each cancer hospital's final PCR is equal to
the weighted average PCR (or ``target PCR'') for the other OPPS
hospitals, using the most recent submitted or settled cost report data
that were available at the time of the development of the proposed
rule, reduced by 1.0 percentage point, to comply with section 16002(b)
of the 21st Century Cures Act.
We did not propose an additional reduction beyond the 1.0
percentage point reduction required by section 16002(b) for CY 2021. To
calculate the proposed CY 2021 target PCR, we used the same extract of
cost report data from HCRIS, as discussed in section II.A. of this CY
2021 OPPS/ASC proposed rule, used to estimate costs for the CY 2021
OPPS. Using these cost report data, we included data from Worksheet E,
Part B, for each hospital, using data from each hospital's most recent
cost report, whether as submitted or settled.
We then limited the dataset to the hospitals with CY 2019 claims
data that we used to model the impact of the proposed CY 2021 APC
relative payment weights (3,527 hospitals) because it is appropriate to
use the same set of hospitals that are being used to calibrate the
modeled CY 2021 OPPS. The cost report data for the hospitals in this
dataset were from cost report periods with fiscal year ends ranging
from 2014 to 2019. We then removed the cost report data of the 49
hospitals located in Puerto Rico from our dataset because we did not
believe their cost structure reflected the costs of most hospitals paid
under the OPPS, and, therefore, their inclusion may bias the
calculation of hospital-weighted statistics. We also removed the cost
report data of 14 hospitals because these hospitals had cost report
data that were not complete (missing aggregate OPPS payments, missing
aggregate cost data, or missing both), so that all cost reports in the
study would have both the payment and cost data necessary to calculate
a PCR for each hospital, leading to a proposed analytic file of 3,464
hospitals with cost report data.
Using this smaller dataset of cost report data, we estimate that,
on average, the OPPS payments to other hospitals furnishing services
under the OPPS were approximately 90 percent of reasonable cost
(weighted average PCR of 0.90). Therefore, after applying the 1.0
percentage point reduction, as required by section 16002(b) of the 21st
Century Cures Act, we proposed that the payment amount associated with
the cancer hospital payment adjustment to be determined at cost report
settlement would be the additional payment needed to result in a
proposed target PCR equal to 0.89 for each cancer hospital.
We did not receive any public comments on our proposals. Therefore,
we are finalizing our proposed cancer hospital payment adjustment
methodology without modification. For this final rule with comment
period, we are using the most recent cost report data through June 30,
2020 to update the adjustment. This update yields a target PCR of 0.90.
We limited the dataset to the hospitals with CY 2019 claims data that
we used to model the impact of the CY 2021 APC relative payment weights
(3,555 hospitals) because it is appropriate to use the same set of
hospitals that we are using to calibrate the modeled CY 2021 OPPS. The
cost report data for the hospitals in the dataset were from cost report
periods with fiscal year ends ranging from 2014 to 2019. We then
removed the cost report data of the 47 hospitals located in Puerto Rico
from our dataset because we do not believe their cost structure
reflects the cost of most hospitals paid under the OPPS and, therefore,
their inclusion may bias the calculation of hospital-weighted
statistics. We also removed the cost report data of 14 hospitals
because these hospitals had cost report data that were not complete
(missing aggregate OPPS payments, missing aggregate cost data, or
missing both), so that all cost report in the study would have both the
payment and cost data necessary to calculate a PCR for each hospital,
leading to an analytic file of 3,494 hospitals with cost report data.
Using this smaller dataset of cost report data, we estimated a
target PCR of 0.90. Therefore, after applying the 1.0 percentage point
reduction as required by section 1602(b) of the 21st Century
[[Page 85914]]
Cures Act, we are finalizing that the payment amount associated with
the cancer hospital adjustment to be determined at cost report
settlement will be the additional payment needed to result in a PCR
equal to 0.89 for each cancer hospital.
Table 5 shows the estimated percentage increase in OPPS payments to
each cancer hospital for CY 2021, due to the cancer hospital payment
adjustment policy. The actual amount of the CY 2021 cancer hospital
payment adjustment for each cancer hospital will be determined at cost
report settlement and will depend on each hospital's CY 2021 payments
and costs. We note that the requirements contained in section
1833(t)(18) of the Act do not affect the existing statutory provisions
that provide for TOPs for cancer hospitals. The TOPs will be assessed,
as usual, after all payments, including the cancer hospital payment
adjustment, have been made for a cost reporting period.
[GRAPHIC] [TIFF OMITTED] TR29DE20.009
G. Hospital Outpatient Outlier Payments
1. Background
The OPPS provides outlier payments to hospitals to help mitigate
the financial risk associated with high-cost and complex procedures,
where a very costly service could present a hospital with significant
financial loss. As explained in the CY 2015 OPPS/ASC final rule with
comment period (79 FR 66832 through 66834), we set our projected target
for aggregate outlier payments at 1.0 percent of the estimated
aggregate total payments under the OPPS for the prospective year.
Outlier payments are provided on a service-by-service basis when the
cost of a service exceeds the APC payment amount multiplier threshold
(the APC payment amount multiplied by a certain amount) as well as the
APC payment amount plus a fixed-dollar amount threshold (the APC
payment plus a certain amount of dollars). In CY 2020, the outlier
threshold was met when the hospital's cost of furnishing a service
exceeded 1.75 times (the multiplier threshold) the APC payment amount
and exceeded the APC payment amount plus $5,075 (the fixed-dollar
amount threshold) (84 FR 61192 through 61194). If the cost of a service
exceeds both the multiplier threshold and the fixed-dollar threshold,
the outlier payment is calculated as 50 percent of the amount by which
the cost of furnishing the service exceeds 1.75 times the APC payment
amount. Beginning with CY 2009 payments, outlier payments are subject
to a reconciliation process similar to the IPPS outlier reconciliation
process for cost reports, as discussed in the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68594 through 68599).
It has been our policy to report the actual amount of outlier
payments as a percent of total spending in the claims being used to
model the OPPS. Our estimate of total outlier payments as a percent of
total CY 2019 OPPS payments, using CY 2019 claims available for the CY
2021 OPPS/ASC proposed rule, was approximately 1.0 percent of the total
aggregated OPPS payments. Therefore, for CY 2019, we estimated that we
paid the outlier target of 1.0 percent of total aggregated OPPS
payments. Using an updated claims dataset for this CY 2021 OPPS/ASC
final rule, we estimate that we paid approximately 0.97 percent of the
total aggregated OPPS payments in outliers for CY 2019.
For the CY 2021 OPPS/ASC proposed rule, using CY 2019 claims data
and CY
[[Page 85915]]
2020 payment rates, we estimated that the aggregate outlier payments
for CY 2020 would be approximately 1.01 percent of the total CY 2020
OPPS payments. We provided estimated CY 2021 outlier payments for
hospitals and CMHCs with claims included in the claims data that we
used to model impacts in the Hospital-Specific Impacts--Provider-
Specific Data file on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
2. Outlier Calculation for CY 2021
In the CY 2021 OPPS/ASC proposed rule (85 FR 48807 through 48808),
for CY 2021, we proposed to continue our policy of estimating outlier
payments to be 1.0 percent of the estimated aggregate total payments
under the OPPS. We proposed that a portion of that 1.0 percent, an
amount equal to less than 0.01 percent of outlier payments (or 0.0001
percent of total OPPS payments), would be allocated to CMHCs for PHP
outlier payments. This is the amount of estimated outlier payments that
would result from the proposed CMHC outlier threshold as a proportion
of total estimated OPPS outlier payments. As discussed in section
VIII.C. of the CY 2021 OPPS/ASC proposed rule, we proposed to continue
our longstanding policy that if a CMHC's cost for partial
hospitalization services, paid under APC 5853 (Partial Hospitalization
for CMHCs), exceeds 3.40 times the payment rate for proposed APC 5853,
the outlier payment would be calculated as 50 percent of the amount by
which the cost exceeds 3.40 times the proposed APC 5853 payment rate.
For further discussion of CMHC outlier payments, we refer readers
to section VIII.C. of the CY 2021 OPPS/ASC proposed rule and this final
rule with comment period.
To ensure that the estimated CY 2021 aggregate outlier payments
would equal 1.0 percent of estimated aggregate total payments under the
OPPS, we proposed that the hospital outlier threshold be set so that
outlier payments would be triggered when a hospital's cost of
furnishing a service exceeds 1.75 times the APC payment amount and
exceeds the APC payment amount plus $5,300.
We calculated the proposed fixed-dollar threshold of $5,300 using
the standard methodology most recently used for CY 2020 (84 FR 61192
through 61194). For purposes of estimating outlier payments for the
proposed rule, we used the hospital-specific overall ancillary CCRs
available in the April 2020 update to the Outpatient Provider-Specific
File (OPSF). The OPSF contains provider-specific data, such as the most
current CCRs, which are maintained by the MACs and used by the OPPS
Pricer to pay claims. The claims that we use to model each OPPS update
lag by 2 years.
In order to estimate the CY 2021 hospital outlier payments for the
proposed rule, we inflated the charges on the CY 2019 claims using the
same inflation factor of 1.131096 that we used to estimate the IPPS
fixed-dollar outlier threshold for the FY 2021 IPPS/LTCH PPS proposed
rule (85 FR 32908). We used an inflation factor of 1.06353 to estimate
CY 2020 charges from the CY 2019 charges reported on CY 2019 claims.
The methodology for determining this charge inflation factor is
discussed in the FY 2020 IPPS/LTCH PPS final rule (84 FR 42626 through
42630). As we stated in the CY 2005 OPPS final rule with comment period
(69 FR 65845), we believe that the use of these charge inflation
factors is appropriate for the OPPS because, with the exception of the
inpatient routine service cost centers, hospitals use the same
ancillary and outpatient cost centers to capture costs and charges for
inpatient and outpatient services.
As noted in the CY 2007 OPPS/ASC final rule with comment period (71
FR 68011), we are concerned that we could systematically overestimate
the OPPS hospital outlier threshold if we did not apply a CCR inflation
adjustment factor. Therefore, we proposed to apply the same CCR
inflation adjustment factor that we proposed to apply for the FY 2021
IPPS outlier calculation to the CCRs used to simulate the proposed CY
2021 OPPS outlier payments to determine the fixed-dollar threshold.
Specifically, for CY 2021, we proposed to apply an adjustment factor of
0.975271 to the CCRs that were in the April 2020 OPSF to trend them
forward from CY 2020 to CY 2021. The methodology for calculating the
proposed adjustment is discussed in the FY 2021 IPPS/LTCH PPS proposed
rule (85 FR 32908 through 32909).
To model hospital outlier payments for the proposed rule, we
applied the overall CCRs from the April 2020 OPSF after adjustment
(using the proposed CCR inflation adjustment factor of 0.97571 to
approximate CY 2021 CCRs) to charges on CY 2019 claims that were
adjusted (using the proposed charge inflation factor of 1.131096 to
approximate CY 2021 charges). We simulated aggregated CY 2021 hospital
outlier payments using these costs for several different fixed-dollar
thresholds, holding the 1.75 multiplier threshold constant and assuming
that outlier payments would continue to be made at 50 percent of the
amount by which the cost of furnishing the service would exceed 1.75
times the APC payment amount, until the total outlier payments equaled
1.0 percent of aggregated estimated total CY 2021 OPPS payments. We
estimated that a proposed fixed-dollar threshold of $5,300, combined
with the proposed multiplier threshold of 1.75 times the APC payment
rate, would allocate 1.0 percent of aggregated total OPPS payments to
outlier payments. For CMHCs, we proposed that, if a CMHC's cost for
partial hospitalization services, paid under APC 5853, exceeds 3.40
times the payment rate for APC 5853, the outlier payment would be
calculated as 50 percent of the amount by which the cost exceeds 3.40
times the APC 5853 payment rate.
Section 1833(t)(17)(A) of the Act, which applies to hospitals, as
defined under section 1886(d)(1)(B) of the Act, requires that hospitals
that fail to report data required for the quality measures selected by
the Secretary, in the form and manner required by the Secretary under
section 1833(t)(17)(B) of the Act, incur a 2.0 percentage point
reduction to their OPD fee schedule increase factor; that is, the
annual payment update factor. The application of a reduced OPD fee
schedule increase factor results in reduced national unadjusted payment
rates that will apply to certain outpatient items and services
furnished by hospitals that are required to report outpatient quality
data and that fail to meet the Hospital OQR Program requirements. For
hospitals that fail to meet the Hospital OQR Program requirements, as
we proposed, we are continuing the policy that we implemented in CY
2010 that the hospitals' costs will be compared to the reduced payments
for purposes of outlier eligibility and payment calculation. For more
information on the Hospital OQR Program, we refer readers to section
XIV. of this CY 2021 OPPS/ASC final rule with comment period.
We received no public comments on our proposal. Therefore, we are
finalizing our proposal, without modification, to continue our policy
of estimating outlier payments to be 1.0 percent of the estimated
aggregate total payments under the OPPS and to use our established
methodology to set the OPPS outlier fixed-dollar loss threshold for CY
2021.
3. Final Outlier Calculation
Consistent with historical practice, we used updated data for this
final rule with comment period for outlier calculations. For CY 2021,
we are
[[Page 85916]]
applying the overall CCRs from the October 2020 OPSF file after
adjustment (using the CCR inflation adjustment factor of 0.974495 to
approximate CY 2021 CCRs) to charges on CY 2019 claims that were
adjusted using a charge inflation factor of 1.13218 to approximate CY
2021 charges. These are the same CCR adjustment and charge inflation
factors that were used to set the IPPS fixed-dollar threshold for the
FY 2021 IPPS/LTCH PPS final rule (85 FR 59039 through 59040). We
simulated aggregated CY 2021 hospital outlier payments using these
costs for several different fixed-dollar thresholds, holding the 1.75
multiple-threshold constant and assuming that outlier payments will
continue to be made at 50 percent of the amount by which the cost of
furnishing the service would exceed 1.75 times the APC payment amount,
until the total outlier payment equaled 1.0 percent of aggregated
estimated total CY 2021 OPPS payments. We estimated that a fixed-dollar
threshold of $5,300 combined with the multiple-threshold of 1.75 times
the APC payment rate, will allocate the 1.0 percent of aggregated total
OPPS payments to outlier payments.
For CMHCs, if a CMHC's cost for partial hospitalization services,
paid under APC 5853, exceeds 3.40 times the payment rate the outlier
payment will be calculated as 50 percent of the amount by which the
cost exceeds 3.40 times APC 5853.
H. Calculation of an Adjusted Medicare Payment From the National
Unadjusted Medicare Payment
The basic methodology for determining prospective payment rates for
HOPD services under the OPPS is set forth in existing regulations at 42
CFR part 419, subparts C and D. For this CY 2021 OPPS/ASC final rule
with comment period, the payment rate for most services and procedures
for which payment is made under the OPPS is the product of the
conversion factor calculated in accordance with section II.B. of this
final rule with comment period and the relative payment weight
determined under section II.A. of this final rule with comment period.
Therefore, the national unadjusted payment rate for most APCs contained
in Addendum A to this final rule with comment period (which is
available via the internet on the CMS website) and for most HCPCS codes
to which separate payment under the OPPS has been assigned in Addendum
B to this final rule with comment period (which is available via the
internet on the CMS website) was calculated by multiplying the final CY
2021 scaled weight for the APC by the CY 2021 conversion factor.
We note that section 1833(t)(17) of the Act, which applies to
hospitals, as defined under section 1886(d)(1)(B) of the Act, requires
that hospitals that fail to submit data required to be submitted on
quality measures selected by the Secretary, in the form and manner and
at a time specified by the Secretary, incur a reduction of 2.0
percentage points to their OPD fee schedule increase factor, that is,
the annual payment update factor. The application of a reduced OPD fee
schedule increase factor results in reduced national unadjusted payment
rates that apply to certain outpatient items and services provided by
hospitals that are required to report outpatient quality data and that
fail to meet the Hospital OQR Program (formerly referred to as the
Hospital Outpatient Quality Data Reporting Program (HOP QDRP))
requirements. For further discussion of the payment reduction for
hospitals that fail to meet the requirements of the Hospital OQR
Program, we refer readers to section XIV of this final rule with
comment period.
We demonstrate the steps used to determine the APC payments that
will be made in a CY under the OPPS to a hospital that fulfills the
Hospital OQR Program requirements and to a hospital that fails to meet
the Hospital OQR Program requirements for a service that has any of the
following status indicator assignments: ``J1'', ``J2'', ``P'', ``Q1'',
``Q2'', ``Q3'', ``Q4'', ``R'', ``S'', ``T'', ``U'', or ``V'' (as
defined in Addendum D1 to the final rule, which is available via the
internet on the CMS website), in a circumstance in which the multiple
procedure discount does not apply, the procedure is not bilateral, and
conditionally packaged services (status indicator of ``Q1'' and ``Q2'')
qualify for separate payment. We noted that, although blood and blood
products with status indicator ``R'' and brachytherapy sources with
status indicator ``U'' are not subject to wage adjustment, they are
subject to reduced payments when a hospital fails to meet the Hospital
OQR Program requirements.
Individual providers interested in calculating the payment amount
that they will receive for a specific service from the national
unadjusted payment rates presented in Addenda A and B to this final
rule with comment period (which are available via the internet on the
CMS website) should follow the formulas presented in the following
steps. For purposes of the payment calculations below, we refer to the
national unadjusted payment rate for hospitals that meet the
requirements of the Hospital OQR Program as the ``full'' national
unadjusted payment rate. We refer to the national unadjusted payment
rate for hospitals that fail to meet the requirements of the Hospital
OQR Program as the ``reduced'' national unadjusted payment rate. The
reduced national unadjusted payment rate is calculated by multiplying
the reporting ratio of 0.9805 times the ``full'' national unadjusted
payment rate. The national unadjusted payment rate used in the
calculations below is either the full national unadjusted payment rate
or the reduced national unadjusted payment rate, depending on whether
the hospital met its Hospital OQR Program requirements to receive the
full CY 2021 OPPS fee schedule increase factor.
Step 1. Calculate 60 percent (the labor-related portion) of the
national unadjusted payment rate. Since the initial implementation of
the OPPS, we have used 60 percent to represent our estimate of that
portion of costs attributable, on average, to labor. We refer readers
to the April 7, 2000 OPPS final rule with comment period (65 FR 18496
through 18497) for a detailed discussion of how we derived this
percentage. During our regression analysis for the payment adjustment
for rural hospitals in the CY 2006 OPPS final rule with comment period
(70 FR 68553), we confirmed that this labor-related share for hospital
outpatient services is appropriate.
The formula below is a mathematical representation of Step 1 and
identifies the labor-related portion of a specific payment rate for a
specific service.
X is the labor-related portion of the national unadjusted payment
rate.
X = .60 * (national unadjusted payment rate).
Step 2. Determine the wage index area in which the hospital is
located and identify the wage index level that applies to the specific
hospital. We note that, for the CY 2021 OPPS wage index, we are
adopting the updated OMB delineations based on OMB Bulletin No. 18-04
and any related IPPS wage index adjustments that were finalized in the
FY 2021 IPPS/LTCH PPS final rule, as discussed in section II.C. of this
final rule with comment period. The wage index values assigned to each
area reflect the geographic statistical areas (which are based upon OMB
standards) to which hospitals are assigned for FY 2021 under the IPPS,
reclassifications through the Medicare Geographic Classification Review
Board (MGCRB), section 1886(d)(8)(B) ``Lugar'' hospitals, and
reclassifications under section 1886(d)(8)(E) of the Act, as
implemented in Sec. 412.103 of the regulations. We also are continuing
to apply for the CY 2021
[[Page 85917]]
OPPS wage index any other adjustments for the FY 2021 IPPS post-
reclassified wage index, including, but not limited to, the rural floor
adjustment, a wage index floor of 1.00 in frontier states, in
accordance with section 10324 of the Affordable Care Act of 2010, and
an adjustment to the wage index for certain low wage index hospitals.
For further discussion of the wage index we are applying for the CY
2021 OPPS, we refer readers to section II.C. of this final rule with
comment period.
Step 3. Adjust the wage index of hospitals located in certain
qualifying counties that have a relatively high percentage of hospital
employees who reside in the county, but who work in a different county
with a higher wage index, in accordance with section 505 of Public Law
108-173. Addendum L to this final rule with comment period (which is
available via the internet on the CMS website) contains the qualifying
counties and the associated wage index increase developed for the final
FY 2021 IPPS wage index, which are listed in Table 2 associated with
the FY 2021 IPPS/LTCH PPS final rule and available via the internet on
the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/AcuteInpatientPPS/index.html. (Click on the link on the
left side of the screen titled ``FY 2021 IPPS Final Rule Home Page''
and select ``FY 2021 Final Rule Tables.'') This step is to be followed
only if the hospital is not reclassified or redesignated under section
1886(d)(8) or section 1886(d)(10) of the Act.
Step 4. Multiply the applicable wage index determined under Steps 2
and 3 by the amount determined under Step 1 that represents the labor-
related portion of the national unadjusted payment rate.
The formula below is a mathematical representation of Step 4 and
adjusts the labor-related portion of the national unadjusted payment
rate for the specific service by the wage index.
Xa is the labor-related portion of the national unadjusted payment
rate (wage adjusted).
Xa = .60 * (national unadjusted payment rate) *
applicable wage index.
Step 5. Calculate 40 percent (the nonlabor-related portion) of the
national unadjusted payment rate and add that amount to the resulting
product of Step 4. The result is the wage index adjusted payment rate
for the relevant wage index area.
The formula below is a mathematical representation of Step 5 and
calculates the remaining portion of the national payment rate, the
amount not attributable to labor, and the adjusted payment for the
specific service.
Y is the nonlabor-related portion of the national unadjusted
payment rate.
Y = .40 * (national unadjusted payment rate).
Adjusted Medicare Payment = Y + Xa.
Step 6. If a provider is an SCH, as set forth in the regulations at
Sec. 412.92, or an EACH, which is considered to be an SCH under
section 1886(d)(5)(D)(iii)(III) of the Act, and located in a rural
area, as defined in Sec. 412.64(b), or is treated as being located in
a rural area under Sec. 412.103, multiply the wage index adjusted
payment rate by 1.071 to calculate the total payment.
The formula below is a mathematical representation of Step 6 and
applies the rural adjustment for rural SCHs.
Adjusted Medicare Payment (SCH or EACH) = Adjusted Medicare Payment
* 1.071.
We are providing examples below of the calculation of both the full
and reduced national unadjusted payment rates that will apply to
certain outpatient items and services performed by hospitals that meet
and that fail to meet the Hospital OQR Program requirements, using the
steps outlined previously. For purposes of this example, we are using a
provider that is located in Brooklyn, New York that is assigned to CBSA
35614. This provider bills one service that is assigned to APC 5071
(Level 1 Excision/Biopsy/Incision and Drainage). The final CY 2021 full
national unadjusted payment rate for APC 5071 is $621.97. The reduced
national unadjusted payment rate for APC 5071 for a hospital that fails
to meet the Hospital OQR Program requirements is $609.84. This reduced
rate is calculated by multiplying the reporting ratio of 0.9805 by the
full unadjusted payment rate for APC 5071.
The final FY 2021 wage index for a provider located in CBSA 35614
in New York, which includes the adoption of IPPS 2021 wage index
policies, is 1.3468. The labor-related portion of the final full
national unadjusted payment is approximately $502.60 (.60 * $621.97 *
1.3468). The labor-related portion of the reduced national unadjusted
payment is approximately $492.80 (.60 * $609.84 * 1.3468). The
nonlabor-related portion of the full national unadjusted payment is
approximately $248.79 (.40 * $621.97). The nonlabor-related portion of
the reduced national unadjusted payment is approximately $243.94 (.40 *
$609.84). The sum of the labor-related and nonlabor-related portions of
the full national adjusted payment is approximately $751.39 ($502.60 +
$248.79). The sum of the portions of the reduced national adjusted
payment is approximately $736.74 ($492.80 + $243.94).
We did not receive any public comments on these steps under the
methodology that we included in the proposed rule to determine the APC
payments for CY 2021. Therefore, we are using the steps in the
methodology specified above, to demonstrate the calculation of the
final CY 2021 OPPS payments using the same parameters.
I. Beneficiary Copayments
1. Background
Section 1833(t)(3)(B) of the Act requires the Secretary to set
rules for determining the unadjusted copayment amounts to be paid by
beneficiaries for covered OPD services. Section 1833(t)(8)(C)(ii) of
the Act specifies that the Secretary must reduce the national
unadjusted copayment amount for a covered OPD service (or group of such
services) furnished in a year in a manner so that the effective
copayment rate (determined on a national unadjusted basis) for that
service in the year does not exceed a specified percentage. As
specified in section 1833(t)(8)(C)(ii)(V) of the Act, the effective
copayment rate for a covered OPD service paid under the OPPS in CY
2006, and in CYs thereafter, shall not exceed 40 percent of the APC
payment rate.
Section 1833(t)(3)(B)(ii) of the Act provides that, for a covered
OPD service (or group of such services) furnished in a year, the
national unadjusted copayment amount cannot be less than 20 percent of
the OPD fee schedule amount. However, section 1833(t)(8)(C)(i) of the
Act limits the amount of beneficiary copayment that may be collected
for a procedure (including items such as drugs and biologicals)
performed in a year to the amount of the inpatient hospital deductible
for that year.
Section 4104 of the Affordable Care Act eliminated the Medicare
Part B coinsurance for preventive services furnished on and after
January 1, 2011, that meet certain requirements, including flexible
sigmoidoscopies and screening colonoscopies, and waived the Part B
deductible for screening colonoscopies that become diagnostic during
the procedure. Our discussion of the changes made by the Affordable
Care Act with regard to copayments for preventive services furnished on
and after January 1, 2011, may be found in section XII.B. of the CY
2011 OPPS/ASC final rule with comment period (75 FR 72013).
2. OPPS Copayment Policy
For CY 2021, we proposed to determine copayment amounts for new
[[Page 85918]]
and revised APCs using the same methodology that we implemented
beginning in CY 2004. (We refer readers to the November 7, 2003 OPPS
final rule with comment period (68 FR 63458).) In addition, we proposed
to use the same standard rounding principles that we have historically
used in instances where the application of our standard copayment
methodology would result in a copayment amount that is less than 20
percent and cannot be rounded, under standard rounding principles, to
20 percent. (We refer readers to the CY 2008 OPPS/ASC final rule with
comment period (72 FR 66687) in which we discuss our rationale for
applying these rounding principles.) The proposed national unadjusted
copayment amounts for services payable under the OPPS that would be
effective January 1, 2021 are included in Addenda A and B to the
proposed rule with comment period (which are available via the internet
on the CMS website).
We did not receive any public comments on the proposed copayment
amounts for new and revised APCs using the same methodology we
implemented beginning in CY 2004 or the standard rounding principles we
apply to our copayment amounts. Therefore, we are finalizing our
proposed copayment policies, without modification.
As discussed in section XIV.E. of the CY 2021 OPPS/ASC proposed
rule and this final rule with comment period, for CY 2021, the Medicare
beneficiary's minimum unadjusted copayment and national unadjusted
copayment for a service to which a reduced national unadjusted payment
rate applies will equal the product of the reporting ratio and the
national unadjusted copayment, or the product of the reporting ratio
and the minimum unadjusted copayment, respectively, for the service.
We note that OPPS copayments may increase or decrease each year
based on changes in the calculated APC payment rates, due to updated
cost report and claims data, and any changes to the OPPS cost modeling
process. However, as described in the CY 2004 OPPS final rule with
comment period, the development of the copayment methodology generally
moves beneficiary copayments closer to 20 percent of OPPS APC payments
(68 FR 63458 through 63459).
In the CY 2004 OPPS final rule with comment period (68 FR 63459),
we adopted a new methodology to calculate unadjusted copayment amounts
in situations including reorganizing APCs, and we finalized the
following rules to determine copayment amounts in CY 2004 and
subsequent years.
When an APC group consists solely of HCPCS codes that were
not paid under the OPPS the prior year because they were packaged or
excluded or are new codes, the unadjusted copayment amount would be 20
percent of the APC payment rate.
If a new APC that did not exist during the prior year is
created and consists of HCPCS codes previously assigned to other APCs,
the copayment amount is calculated as the product of the APC payment
rate and the lowest coinsurance percentage of the codes comprising the
new APC.
If no codes are added to or removed from an APC and, after
recalibration of its relative payment weight, the new payment rate is
equal to or greater than the prior year's rate, the copayment amount
remains constant (unless the resulting coinsurance percentage is less
than 20 percent).
If no codes are added to or removed from an APC and, after
recalibration of its relative payment weight, the new payment rate is
less than the prior year's rate, the copayment amount is calculated as
the product of the new payment rate and the prior year's coinsurance
percentage.
If HCPCS codes are added to or deleted from an APC and,
after recalibrating its relative payment weight, holding its unadjusted
copayment amount constant results in a decrease in the coinsurance
percentage for the reconfigured APC, the copayment amount would not
change (unless retaining the copayment amount would result in a
coinsurance rate less than 20 percent).
If HCPCS codes are added to an APC and, after
recalibrating its relative payment weight, holding its unadjusted
copayment amount constant results in an increase in the coinsurance
percentage for the reconfigured APC, the copayment amount would be
calculated as the product of the payment rate of the reconfigured APC
and the lowest coinsurance percentage of the codes being added to the
reconfigured APC.
We noted in the CY 2004 OPPS final rule with comment period that we
would seek to lower the copayment percentage for a service in an APC
from the prior year if the copayment percentage was greater than 20
percent. We noted that this principle was consistent with section
1833(t)(8)(C)(ii) of the Act, which accelerates the reduction in the
national unadjusted coinsurance rate so that beneficiary liability will
eventually equal 20 percent of the OPPS payment rate for all OPPS
services to which a copayment applies, and with section 1833(t)(3)(B)
of the Act, which achieves a 20-percent copayment percentage when fully
phased in and gives the Secretary the authority to set rules for
determining copayment amounts for new services. We further noted that
the use of this methodology would, in general, reduce the beneficiary
coinsurance rate and copayment amount for APCs for which the payment
rate changes as the result of the reconfiguration of APCs and/or
recalibration of relative payment weights (68 FR 63459).
3. Calculation of an Adjusted Copayment Amount for an APC Group
Individuals interested in calculating the national copayment
liability for a Medicare beneficiary for a given service provided by a
hospital that met or failed to meet its Hospital OQR Program
requirements should follow the formulas presented in the following
steps.
Step 1. Calculate the beneficiary payment percentage for the APC by
dividing the APC's national unadjusted copayment by its payment rate.
For example, using APC 5071, $124.40 is approximately 20 percent of the
full national unadjusted payment rate of $621.97. For APCs with only a
minimum unadjusted copayment in Addenda A and B to this final rule
(which are available via the internet on the CMS website), the
beneficiary payment percentage is 20 percent.
The formula below is a mathematical representation of Step 1 and
calculates the national copayment as a percentage of national payment
for a given service.
B is the beneficiary payment percentage.
B = National unadjusted copayment for APC/national unadjusted
payment rate for APC.
Step 2. Calculate the appropriate wage-adjusted payment rate for
the APC for the provider in question, as indicated in Steps 2 through 4
under section II.H. of this final rule with comment period. Calculate
the rural adjustment for eligible providers, as indicated in Step 6
under section II.H. of this final rule with comment period.
Step 3. Multiply the percentage calculated in Step 1 by the payment
rate calculated in Step 2. The result is the wage-adjusted copayment
amount for the APC.
The formula below is a mathematical representation of Step 3 and
applies the beneficiary payment percentage to the adjusted payment rate
for a service calculated under section II.H. of this final rule with
comment period, with and without the rural adjustment, to
[[Page 85919]]
calculate the adjusted beneficiary copayment for a given service.
Wage-adjusted copayment amount for the APC = Adjusted Medicare
Payment * B.
Wage-adjusted copayment amount for the APC (SCH or EACH) =
(Adjusted Medicare Payment * 1.071) * B.
Step 4. For a hospital that failed to meet its Hospital OQR Program
requirements, multiply the copayment calculated in Step 3 by the
reporting ratio of 0.9805.
The finalized unadjusted copayments for services payable under the
OPPS that will be effective January 1, 2021, are shown in Addenda A and
B to this final rule with comment period (which are available via the
internet on the CMS website). We note that the finalized national
unadjusted payment rates and copayment rates shown in Addenda A and B
to this final rule with comment period reflect the CY 2021 OPD fee
schedule increase factor discussed in section II.B. of this final rule
with comment period.
In addition, as noted earlier, section 1833(t)(8)(C)(i) of the Act
limits the amount of beneficiary copayment that may be collected for a
procedure performed in a year to the amount of the inpatient hospital
deductible for that year.
III. OPPS Ambulatory Payment Classification (APC) Group Policies
A. OPPS Treatment of New and Revised HCPCS Codes
Payments for OPPS procedures, services, and items are generally
based on medical billing codes, specifically, Healthcare Common
Procedure Coding System (HCPCS) codes, that are reported on hospital
outpatient department (HOPD) claims. The HCPCS is divided into two
principal subsystems, referred to as Level I and Level II of the HCPCS.
Level I is comprised of Current Procedural Terminology (CPT), a numeric
and alphanumeric coding system maintained by the American Medical
Association (AMA), and consists of Category I, II, and III CPT codes.
Level II, which is maintained by Centers for Medicare & Medicaid
Services (CMS), is a standardized coding system that is used primarily
to identify products, supplies, and services not included in the CPT
codes. HCPCS codes are used to report surgical procedures, medical
services, items, and supplies under the hospital OPPS. Specifically,
CMS recognizes the following codes on OPPS claims:
Category I CPT codes, which describe surgical procedures,
diagnostic and therapeutic services, and vaccine codes;
Category III CPT codes, which describe new and emerging
technologies, services, and procedures; and
Level II HCPCS codes (also known as alphanumeric codes),
which are used primarily to identify drugs, devices, ambulance
services, durable medical equipment, orthotics, prosthetics, supplies,
temporary surgical procedures, and medical services not described by
CPT codes.
CPT codes are established by the AMA while the Level II HCPCS codes
are established by the CMS HCPCS Workgroup. These codes are updated and
changed throughout the year. CPT and Level II HCPCS code changes that
affect the OPPS are published through the annual rulemaking cycle and
through the OPPS quarterly update Change Requests (CRs). Generally,
these code changes are effective January 1, April 1, July 1, or October
1. CPT code changes are released by the AMA via their website while
Level II HCPCS code changes are released to the public via the CMS
HCPCS website. CMS recognizes the release of new CPT and Level II HCPCS
codes and makes the codes effective (that is, the codes can be reported
on Medicare claims) outside of the formal rulemaking process via OPPS
quarterly update CRs. Based on our review, we assign the new codes to
interim status indicators (SIs) and APCs. These interim assignments are
finalized in the OPPS/ASC final rules with comment period. This
quarterly process offers hospitals access to codes that more accurately
describe items or services furnished and provides payment for these
items or services in a timelier manner than if we waited for the annual
rulemaking process. We solicit public comments on the new CPT and Level
II HCPCS codes and finalize policies for these codes through our annual
rulemaking process.
We note that, under the OPPS, the APC assignment determines the
payment rate for an item, procedure, or service. Those items,
procedures, or services not paid separately under the hospital OPPS are
assigned to appropriate SIs. Certain payment SIs provide separate
payment while other payment SIs do not. In section XI. (CY 2021 OPPS
Payment Status and Comment Indicators) of this final rule with comment
period, we discuss the various SIs used under the OPPS. We also provide
a complete list of the SIs and their definitions in Addendum D1 to this
CY 2021 OPPS/ASC final rule with comment period.
1. HCPCS Codes That Were Effective April 1, 2020 for Which We Solicited
Public Comments in the CY 2021 OPPS/ASC Proposed Rule
For the April 2020 update, there were no new CPT codes. However,
thirteen new Level II HCPCS codes were established and made effective
on April 1, 2020. These codes and their long descriptors were included
in Table 6 of the proposed rule and are now listed in Table 6 of this
final rule with comment period. Through the April 2020 OPPS quarterly
update CR (Transmittal 10013, Change Request 11691, dated March 25,
2020), we recognized several new Level II HCPCS codes for separate
payment under the OPPS. In the CY 2021 OPPS/ASC proposed rule (85 FR
48812 through 48813), we solicited public comments on the proposed APC
and status indicator (SI) assignments for these Level II HCPCS codes,
which were listed in Table 6 of the proposed rule.
We did not receive any public comments on the proposed OPPS APC and
SI assignments for the new Level II HCPCS codes implemented in April
2020. Therefore, we are finalizing the proposed APC and SI assignments
for these codes, as indicated in Table 6. We note that several of the
HCPCS C-codes have been replaced with HCPCS J-codes, effective January
1, 2021. Their replacement codes are listed in Table 6. The final
payment rates for these codes can be found in Addendum B to this final
rule with comment period. In addition, the SI definitions can be found
in Addendum D1 to this final rule with comment period. Both Addendum B
and Addendum D1 are available via the internet on the CMS website.
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3. October 2020 HCPCS Codes for Which We Are Soliciting Public Comments
in This CY 2021 OPPS/ASC Final Rule With Comment Period
As has been our practice in the past, we incorporate those new
HCPCS codes that are effective October 1 in the final rule with comment
period, thereby updating the OPPS for the following calendar year, as
displayed in Table 8 of the proposed rule and reprinted as Table 8 of
this final rule with comment period. These codes are released to the
public through the October OPPS
[[Page 85930]]
quarterly update CRs and via the CMS HCPCS website (for Level II HCPCS
codes). For CY 2021, these codes are flagged with comment indicator
``NI'' in Addendum B to this OPPS/ASC final rule with comment period to
indicate that we are assigning them an interim payment status which is
subject to public comment. Specifically, the interim SI and APC
assignments for codes flagged with comment indicator ``NI'' are open to
public comment in this final rule with comment period, and we will
respond to these public comments in the OPPS/ASC final rule with
comment period for the next year's OPPS/ASC update.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48823), we proposed to
continue this process for CY 2021. Specifically, for CY 2021, we
proposed to include in Addendum B to the CY 2021 OPPS/ASC final rule
with comment period the new HCPCS codes effective October 1, 2020 that
would be incorporated in the October 2020 OPPS quarterly update CR.
Also, as stated above, the October 1, 2020 codes are flagged with
comment indicator ``NI'' in Addendum B to this CY 2021 OPPS/ASC final
rule with comment period to indicate that we have assigned the codes an
interim OPPS payment status for CY 2021. We are inviting public
comments on the interim SI and APC assignments for these codes, if
applicable, that will be finalized in the CY 2021 OPPS/ASC final rule
with comment period.
We note that we received a comment related to HCPCS codes C9757
(Laminotomy (hemilaminectomy), with decompression of nerve root(s),
including partial facetectomy, foraminotomy and excision of herniated
intervertebral disc, and repair of annular defect with implantation of
bone anchored annular closure device, including annular defect
measurement, alignment and sizing assessment, and image guidance; 1
interspace, lumbar) and P9099 (Blood component or product not otherwise
classified), which were assigned to comment indicator ``NI'' (new code;
comments will be accepted on the interim APC assignment) in Addendum B
of the CY 2020 OPPS/ASC final rule with comment period. The comments
and our responses can be found in section II.A.2(a)(1) (Blood Products)
and III.D. (APC-Specific Policies) of this CY 2021 OPPS/ASC final rule
with comment period.
4. January 2021 HCPCS Codes
a. New Level II HCPCS Codes for Which We Are Soliciting Public Comments
in this CY 2021 OPPS/ASC Final Rule With Comment Period
As shown in Table 8, and as stated in the CY 2021 OPPS/ASC proposed
rule (85 FR 48823 through 48825), consistent with past practice, we
solicit comments on the new Level II HCPCS codes that will be effective
January 1 in the OPPS/ASC final rule with comment period, thereby
allowing us to finalize the SIs and APC assignments for the codes in
the next OPPS/ASC final rule with comment period. Unlike the CPT codes
that are effective January 1 and are included in the OPPS/ASC proposed
rules, most Level II HCPCS codes are not released until sometime around
November to be effective January 1. Because these codes are not
available until November, we are unable to include them in the OPPS/ASC
proposed rules. Consequently, for CY 2021, we proposed to include in
Addendum B to the CY 2021 OPPS/ASC final rule with comment period the
new Level II HCPCS codes effective January 1, 2021, that would be
incorporated in the January 2021 OPPS quarterly update CR. These codes
will be released to the public through the January OPPS quarterly
update CRs and via the CMS HCPCS website (for Level II HCPCS codes).
For CY 2021, the Level II HCPCS codes effective January 1, 2021 are
flagged with comment indicator ``NI'' in Addendum B to this CY 2021
OPPS/ASC final rule with comment period to indicate that we have
assigned the codes an interim OPPS payment status for CY 2021. We are
inviting public comments on the interim SI and APC assignments for
these codes, if applicable, that will be finalized in the CY 2021 OPPS/
ASC final rule with comment period.
b. CPT Codes For Which We Solicited Public Comments in the CY 2021
OPPS/ASC Proposed Rule
For CY 2021, we received the CY 2021 CPT code updates that would be
effective January 1, 2021, from AMA in time for inclusion in the CY
2021 OPPS/ASC proposed rule. We note that in the CY 2015 OPPS/ASC final
rule with comment period (79 FR 66841 through 66844), we finalized a
revised process of assigning APC and SIs for new and revised Category I
and III CPT codes that would be effective January 1. Specifically, for
the new/revised CPT codes that we receive in a timely manner from the
AMA's CPT Editorial Panel, we finalized our proposal to include the
codes that would be effective January 1 in the OPPS/ASC proposed rules,
along with proposed APC and SI assignments for them, and to finalize
the APC and SI assignments in the OPPS/ASC final rules beginning with
the CY 2016 OPPS update. For those new/revised CPT codes that were
received too late for inclusion in the OPPS/ASC proposed rule, we
finalized our proposal to establish and use HCPCS G-codes that mirror
the predecessor CPT codes and retain the current APC and SI assignments
for a year until we can propose APC and SI assignments in the following
year's rulemaking cycle. We note that even if we find that we need to
create HCPCS G-codes in place of certain CPT codes for the PFS proposed
rule, we do not anticipate that these HCPCS G-codes will always be
necessary for OPPS purposes. We will make every effort to include
proposed APC and SI assignments for all new and revised CPT codes that
the AMA makes publicly available in time for us to include them in the
annual proposed rule, and to avoid the resort to HCPCS G-codes and the
resulting delay in utilization of the most current CPT codes. Also, we
finalized our proposal to make interim APC and SI assignments for CPT
codes that are not available in time for the proposed rule and that
describe wholly new services (such as new technologies or new surgical
procedures), solicit public comments, and finalize the specific APC and
SI assignments for those codes in the following year's final rule.
As stated above, for the CY 2021 OPPS update, we received the CY
2021 CPT codes from AMA in time for inclusion in the CY 2021 OPPS/ASC
proposed rule. The new, revised, and deleted CY 2021 Category I and III
CPT codes were included in Addendum B to the proposed rule (which is
available via the internet on the CMS website). We noted in the
proposed rule that the new and revised codes are assigned to new
comment indicator ``NP'' to indicate that the code is new for the next
calendar year or the code is an existing code with substantial revision
to its code descriptor in the next calendar year as compared to current
calendar year with a proposed APC assignment, and that comments will be
accepted on the proposed APC and SI assignments.
Further, we reminded readers that the CPT code descriptors that
appear in Addendum B are short descriptors and do not accurately
describe the complete procedure, service, or item described by the CPT
code. Therefore, we included the 5-digit placeholder codes and their
long descriptors for the new and revised CY 2021 CPT codes in Addendum
O to
[[Page 85931]]
the proposed rule (which is available via the internet on the CMS
website) so that the public could adequately comment on the proposed
APCs and SI assignments. The 5-digit placeholder codes were included in
Addendum O, specifically under the column labeled ``CY 2021 OPPS/ASC
Proposed Rule 5-Digit AMA Placeholder Code,'' to the proposed rule. We
noted that the final CPT code numbers would be included in this CY 2021
OPPS/ASC final rule with comment period. We also noted that not every
code listed in Addendum O is subject to public comment. For the new and
revised Category I and III CPT codes, we requested public comments on
only those codes that are assigned comment indicator ``NP''.
In summary, in the CY 2021 OPPS/ASC proposed rule, we solicited
public comments on the proposed CY 2021 SI and APC assignments for the
new and revised Category I and III CPT codes that will be effective
January 1, 2021. The CPT codes were listed in Addendum B to the
proposed rule with short descriptors only. We listed them again in
Addendum O to the proposed rule with long descriptors. We also proposed
to finalize the SI and APC assignments for these codes (with their
final CPT code numbers) in the CY 2021 OPPS/ASC final rule with comment
period. The proposed SI and APC assignments for these codes were
included in Addendum B to the proposed rule (which is available via the
internet on the CMS website).
Commenters addressed several of the new CPT codes that were
assigned to comment indicator ``NP'' in Addendum B to the CY 2021 OPPS/
ASC proposed rule. We have responded to those public comments in
sections III.C. (New Technology APCs), III.D. (OPPS APC-Specific
Policies), and IV. (OPPS Payment for Devices) of this CY 2021 OPPS/ASC
final rule with comment period.
The final SIs, APC assignments, and payment rates for the new CPT
codes that are effective January 1, 2021 can be found in Addendum B to
this final rule with comment period. In addition, the SI meanings can
be found in Addendum D1 (OPPS Payment Status Indicators for CY 2021) to
this final rule with comment period. Both Addendum B and D1 are
available via the internet on the CMS website.
Finally, Table 8, which is a reprint of Table 8 from the CY 2021
OPPS/ASC proposed rule, shows the comment timeframe for new and revised
HCPCS codes. The table provides information on our current process for
updating codes through our OPPS quarterly update CRs, seeking public
comments, and finalizing the treatment of these codes under the OPPS.
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B. OPPS Changes--Variations Within APCs
1. Background
Section 1833(t)(2)(A) of the Act requires the Secretary to develop
a classification system for covered hospital outpatient department
services. Section 1833(t)(2)(B) of the Act provides that the Secretary
may establish groups of covered OPD services within this classification
system, so that services classified within each group are comparable
clinically and with respect to the use of resources. In accordance with
these provisions, we developed a grouping classification system,
referred to as Ambulatory Payment Classifications (APCs), as set forth
in regulations at 42 CFR[thinsp]419.31. We use Level I (also known as
CPT codes) and Level II HCPCS codes (also known as alphanumeric codes)
to identify and
[[Page 85932]]
group the services within each APC. The APCs are organized such that
each group is homogeneous both clinically and in terms of resource use.
Using this classification system, we have established distinct groups
of similar services. We also have developed separate APC groups for
certain medical devices, drugs, biologicals, therapeutic
radiopharmaceuticals, and brachytherapy devices that are not packaged
into the payment for the procedure.
We have packaged into the payment for each procedure or service
within an APC group the costs associated with those items and services
that are typically ancillary and supportive to a primary diagnostic or
therapeutic modality and, in those cases, are an integral part of the
primary service they support. Therefore, we do not make separate
payment for these packaged items or services. In general, packaged
items and services include, but are not limited to, the items and
services listed in regulations at 42 CFR 419.2(b). A further discussion
of packaged services is included in section II.A.3. of this final rule
with comment period.
Under the OPPS, we generally pay for covered hospital outpatient
services on a rate-per-service basis, where the service may be reported
with one or more HCPCS codes. Payment varies according to the APC group
to which the independent service or combination of services is
assigned. In the CY 2021 OPPS/ASC proposed rule (85 FR 48799), for CY
2021, we proposed that each APC relative payment weight represents the
hospital cost of the services included in that APC, relative to the
hospital cost of the services included in APC 5012 (Clinic Visits and
Related Services). The APC relative payment weights are scaled to APC
5012 because it is the hospital clinic visit APC and clinic visits are
among the most frequently furnished services in the hospital outpatient
setting.
2. Application of the 2 Times Rule
Section 1833(t)(9)(A) of the Act requires the Secretary to review,
not less often than annually, and revise the APC groups, the relative
payment weights, and the wage and other adjustments described in
paragraph (2) to take into account changes in medical practice, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors. Section 1833(t)(9)(A) of the Act also
requires the Secretary to consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
review (and advise the Secretary concerning) the clinical integrity of
the APC groups and the relative payment weights. We note that the
Hospital Outpatient Payment (HOP) Panel recommendations for specific
services for the CY 2021 OPPS update are discussed in the relevant
specific sections throughout this CY 2021 OPPS/ASC final rule with
comment period.
In addition, section 1833(t)(2) of the Act provides that, subject
to certain exceptions, the items and services within an APC group
cannot be considered comparable with respect to the use of resources if
the highest cost for an item or service in the group is more than 2
times greater than the lowest cost for an item or service within the
same group (referred to as the ``2 times rule''). The statute
authorizes the Secretary to make exceptions to the 2 times rule in
unusual cases, such as low-volume items and services (but the Secretary
may not make such an exception in the case of a drug or biological that
has been designated as an orphan drug under section 526 of the Federal
Food, Drug, and Cosmetic Act). In determining the APCs with a 2 times
rule violation, we consider only those HCPCS codes that are significant
based on the number of claims. We note that, for purposes of
identifying significant procedure codes for examination under the 2
times rule, we consider procedure codes that have more than 1,000
single major claims or procedure codes that both have more than 99
single major claims and contribute at least 2 percent of the single
major claims used to establish the APC cost to be significant (75 FR
71832). This longstanding definition of when a procedure code is
significant for purposes of the 2 times rule was selected because we
believe that a subset of 1,000 or fewer claims is negligible within the
set of approximately 100 million single procedure or single session
claims we use for establishing costs. Similarly, a procedure code for
which there are fewer than 99 single claims and that comprises less
than 2 percent of the single major claims within an APC will have a
negligible impact on the APC cost (75 FR 71832). In the CY 2021 OPPS/
ASC proposed rule (85 FR 48826 through 48827), for CY 2021, we proposed
to make exceptions to this limit on the variation of costs within each
APC group in unusual cases, such as for certain low-volume items and
services.
In the CY 2021 OPPS/ASC proposed rule, we identified the APCs with
violations of the 2 times rule. Therefore, we proposed changes to the
procedure codes assigned to these APCs in Addendum B to the proposed
rule. We noted that Addendum B does not appear in the printed version
of the Federal Register as part of the CY 2021 OPPS/ASC proposed rule.
Rather, it is published and made available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. To eliminate a violation of
the 2 times rule and improve clinical and resource homogeneity, we
proposed to reassign these procedure codes to new APCs that contain
services that are similar with regard to both their clinical and
resource characteristics. In many cases, the proposed procedure code
reassignments and associated APC reconfigurations for CY 2021 included
in the proposed rule were related to changes in costs of services that
were observed in the CY 2019 claims data newly available for CY 2021
ratesetting. Addendum B to the CY 2021 OPPS/ASC proposed rule
identified with a comment indicator ``CH'' those procedure codes for
which we proposed a change to the APC assignment or SI, or both, that
were initially assigned in the July 1, 2020 OPPS Addendum B Update
(available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html), which was the latest payment
rate file for 2019 prior to issuance of the proposed rule.
3. APC Exceptions to the 2 Times Rule
Taking into account the APC changes that we proposed to make for CY
2021 in the CY 2021 OPPS/ASC proposed rule, we reviewed all of the APCs
to determine which APCs would not meet the requirements of the 2 times
rule. We used the following criteria to evaluate whether to propose
exceptions to the 2 times rule for affected APCs:
Resource homogeneity;
Clinical homogeneity;
Hospital outpatient setting utilization;
Frequency of service (volume); and
Opportunity for upcoding and code fragments.
Based on the CY 2019 claims data available for the CY 2021 proposed
rule, we found 18 APCs with violations of the 2 times rule. We applied
the criteria as described above to identify the APCs for which we
proposed to make exceptions under the 2 times rule for CY 2021, and
found that all of the 18 APCs we identified met the criteria for an
exception to the 2 times rule based on the CY 2019 claims data
available for the proposed rule. We did not include in that
determination those APCs where
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a 2 times rule violation was not a relevant concept, such as APC 5401
(Dialysis), which only has two HCPCS codes assigned to it that have a
similar geometric mean costs and do not create a 2 time rule violation.
Therefore, we only identified those APCs, including those with
criteria-based costs, with violations of the 2 times rule.
We note that, for cases in which a recommendation by the HOP Panel
appears to result in or allow a violation of the 2 times rule, we may
accept the HOP Panel's recommendation because those recommendations are
based on explicit consideration (that is, a review of the latest OPPS
claims data and group discussion of the issue) of resource use,
clinical homogeneity, site of service, and the quality of the claims
data used to determine the APC payment rates.
Table 9 of the proposed rule listed the 18 APCs for which we
proposed to make an exception for under the 2 times rule for CY 2021
based on the criteria cited above and claims data submitted between
January 1, 2019, and December 31, 2019, and processed on or before
December 31, 2019. In the proposed rule, we stated that for the final
rule with comment period, we intended to use claims data for dates of
service between January 1, 2019, and December 31, 2019, that were
processed on or before June 30, 2020, and updated CCRs, if available.
We stated that the proposed geometric mean costs for covered hospital
outpatient services for these and all other APCs that were used in the
development of the proposed rule could be found on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
Based on the updated final rule CY 2019 claims data used for this
CY 2021 final rule with comment period, we found a total of 23 APCs
with violations of the 2 times rule. Of these 23 total APCs, 18 were
identified in the proposed rule and five are newly identified APCs. The
five newly identified APCs with violations of the 2 times rule include
the following:
APC 5101 (Level 1 Strapping and Cast Application)
APC 5161 (Level 1 ENT Procedures)
APC 5593 (Level 3 Nuclear Medicine and Related Services)
APC 5673 (Level 3 Pathology)
APC 5734 (Level 4 Minor Procedures)
Although we did not receive any comments on Table 9 of the proposed
rule, we did receive comments on APC assignments for specific HCPCS
codes. The comments, and our responses, can be found in section III.D.
(OPPS APC-Specific Policies) of this final rule with comment period.
After considering the public comments we received on APC
assignments and our analysis of the CY 2019 costs from hospital claims
and cost report data available for this CY 2021 final rule with comment
period, we are finalizing our proposals with some modifications.
Specifically, we are finalizing our proposal to except 18 of the 18
proposed APCs from the 2 times rule for CY 2021 and also excepting five
additional APCs (APCs 5101, 5161, 5593, 5673, and 5734) for a total of
23 APCs.
In summary, Table 9 lists the 23 APCs that we are excepting from
the 2 times rule for CY 2021 based on the criteria described earlier
and a review of updated claims data for dates of service between
January 1, 2019 and December 31, 2019, that were processed on or before
June 30, 2020, and updated CCRs, if available. We note that, for cases
in which a recommendation by the HOP Panel appears to result in or
allow a violation of the 2 times rule, we generally accept the HOP
Panel's recommendation because those recommendations are based on
explicit consideration of resource use, clinical homogeneity, site of
service, and the quality of the claims data used to determine the APC
payment rates. The geometric mean costs for hospital outpatient
services for these and all other APCs that were used in the development
of this final rule with comment period can be found on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
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C. New Technology APCs
1. Background
In the CY 2002 OPPS final rule (66 FR 59903), we finalized changes
to the time period in which a service can be eligible for payment under
a New Technology APC. Beginning in CY 2002, we retain services within
New Technology APC groups until we gather sufficient claims data to
enable us to assign the service to an appropriate clinical APC. This
policy allows us to move a service from a New Technology APC in less
than 2 years if sufficient data are available. It also allows us to
retain a service in a New Technology APC for more than 2 years if
sufficient data upon which to base a decision for reassignment have not
been collected.
In the CY 2004 OPPS final rule with comment period (68 FR 63416),
we restructured the New Technology APCs to make the cost intervals more
consistent across payment levels and refined the cost bands for these
APCs to retain two parallel sets of New Technology APCs, one set with a
status indicator of ``S'' (Significant Procedures, Not Discounted when
Multiple. Paid under OPPS; separate APC payment) and the other set with
a status indicator of ``T'' (Significant Procedure, Multiple Reduction
Applies. Paid under OPPS; separate APC payment). These current New
Technology APC configurations allow us to price new technology services
more appropriately and consistently.
For CY 2020, there were 52 New Technology APC levels, ranging from
the lowest cost band assigned to APC 1491 (New Technology--Level 1A
($0-$10)) through the highest cost band assigned to APC 1908 (New
Technology--Level 52 ($145,001-$160,000)). We note that the cost bands
for the New Technology APCs, specifically, APCs 1491 through 1599 and
1901 through 1908, vary with increments ranging from $10 to $14,999.
These cost bands identify the APCs to which new technology procedures
and services with estimated service costs that fall within those cost
bands are assigned under the OPPS. Payment for each APC is made at the
mid-point of the APC's assigned cost band. For example, payment for New
Technology APC 1507 (New Technology--Level 7 ($501-$600)) is made at
$550.50.
Under the OPPS, one of our goals is to make payments that are
appropriate for the services that are necessary for the treatment of
Medicare beneficiaries. The OPPS, like other Medicare payment systems,
is budget neutral and increases are limited to the annual hospital
inpatient market basket increase adjusted for multifactor productivity.
We believe that our payment rates reflect the costs that are associated
with providing care to Medicare beneficiaries and are adequate to
ensure access to services (80 FR 70374).
For many emerging technologies, there is a transitional period
during which utilization may be low, often because providers are first
learning about the technologies and their clinical
[[Page 85935]]
utility. Quite often, parties request that Medicare make higher payment
amounts under the New Technology APCs for new procedures in that
transitional phase. These requests, and their accompanying estimates
for expected total patient utilization, often reflect very low rates of
patient use of expensive equipment, resulting in high per-use costs for
which requesters believe Medicare should make full payment. Medicare
does not, and we believe should not, assume responsibility for more
than its share of the costs of procedures based on projected
utilization for Medicare beneficiaries and does not set its payment
rates based on initial projections of low utilization for services that
require expensive capital equipment. For the OPPS, we rely on hospitals
to make informed business decisions regarding the acquisition of high-
cost capital equipment, taking into consideration their knowledge about
their entire patient base (Medicare beneficiaries included) and an
understanding of Medicare's and other payers' payment policies. We
refer readers to the CY 2013 OPPS/ASC final rule with comment period
(77 FR 68314) for further discussion regarding this payment policy.
We note that, in a budget neutral system, payments may not fully
cover hospitals' costs in a particular circumstance, including those
for the purchase and maintenance of capital equipment. We rely on
hospitals to make their decisions regarding the acquisition of high-
cost equipment with the understanding that the Medicare program must be
careful to establish its initial payment rates, including those made
through New Technology APCs, for new services that lack hospital claims
data based on realistic utilization projections for all such services
delivered in cost-efficient hospital outpatient settings. As the OPPS
acquires claims data regarding hospital costs associated with new
procedures, we regularly examine the claims data and any available new
information regarding the clinical aspects of new procedures to confirm
that our OPPS payments remain appropriate for procedures as they
transition into mainstream medical practice (77 FR 68314). For CY 2021,
we included the proposed payment rates for New Technology APCs 1491 to
1599 and 1901 through 1908 in Addendum A to this CY 2021 OPPS/ASC
proposed rule (which is available via the internet on the CMS website).
2. Establishing Payment Rates for Low-Volume New Technology Services
Services that are assigned to New Technology APCs are typically new
services that do not have sufficient claims history to establish an
accurate payment for the services. One of the objectives of
establishing New Technology APCs is to generate sufficient claims data
for a new service so that it can be assigned to an appropriate clinical
APC. Some services that are assigned to New Technology APCs have very
low annual volume, which we consider to be fewer than 100 claims. We
consider services with fewer than 100 claims annually to be low-volume
services because there is a higher probability that the payment data
for a service may not have a normal statistical distribution, which
could affect the quality of our standard cost methodology that is used
to assign services to an APC. In addition, services with fewer than 100
claims per year are not generally considered to be a significant
contributor to the APC ratesetting calculations and, therefore, are not
included in the assessment of the 2 times rule. As we explained in the
CY 2019 OPPS/ASC final rule with comment period (83 FR 58890), we were
concerned that the methodology we use to estimate the cost of a service
under the OPPS by calculating the geometric mean for all separately
paid claims for a HCPCS service code from the most recent available
year of claims data may not generate an accurate estimate of the actual
cost of the service for these low-volume services.
In accordance with section 1833(t)(2)(B) of the Act, services
classified within each APC must be comparable clinically and with
respect to the use of resources. As described earlier, assigning a
service to a new technology APC allows us to gather claims data to
price the service and assign it to the APC with services that use
similar resources and are clinically comparable. However, where
utilization of services assigned to a New Technology APC is low, it can
lead to wide variation in payment rates from year to year, resulting in
even lower utilization and potential barriers to access to new
technologies, which ultimately limits our ability to assign the service
to the appropriate clinical APC. To mitigate these issues, we
determined in the CY 2019 OPPS/ASC final rule with comment period that
it was appropriate to utilize our equitable adjustment authority at
section 1833(t)(2)(E) of the Act to adjust how we determined the costs
for low-volume services assigned to New Technology APCs (83 FR 58892
through 58893). We have utilized our equitable adjustment authority at
section 1833(t)(2)(E) of the Act, which states that the Secretary shall
establish, in a budget neutral manner, other adjustments as determined
to be necessary to ensure equitable payments, to estimate an
appropriate payment amount for low-volume new technology services in
the past (82 FR 59281). Although we have used this adjustment authority
on a case-by-case basis in the past, we stated in the CY 2019 OPPS/ASC
final rule with comment period that we believe it is appropriate to
adopt an adjustment for low-volume services assigned to New Technology
APCs in order to mitigate the wide payment fluctuations that have
occurred for new technology services with fewer than 100 claims and to
provide more predictable payment for these services.
For purposes of this adjustment, we stated that we believe that it
is appropriate to use up to 4 years of claims data in calculating the
applicable payment rate for the prospective year, rather than using
solely the most recent available year of claims data, when a service
assigned to a New Technology APC has a low annual volume of claims,
which, for purposes of this adjustment, we define as fewer than 100
claims annually. We adopted a policy to consider services with fewer
than 100 claims annually as low-volume services because there is a
higher probability that the payment data for a service may not have a
normal statistical distribution, which could affect the quality of our
standard cost methodology that is used to assign services to an APC. We
explained that we were concerned that the methodology we use to
estimate the cost of a service under the OPPS by calculating the
geometric mean for all separately paid claims for a HCPCS procedure
code from the most recent available year of claims data may not
generate an accurate estimate of the actual cost of the low-volume
service. Using multiple years of claims data will potentially allow for
more than 100 claims to be used to set the payment rate, which would,
in turn, create a more statistically reliable payment rate.
In addition, to better approximate the cost of a low-volume service
within a New Technology APC, we stated that we believe using the median
or arithmetic mean rather than the geometric mean (which ``trims'' the
costs of certain claims out) could be more appropriate in some
circumstances, given the extremely low volume of claims. Low claim
volumes increase the impact of ``outlier'' claims; that is, claims with
either a very low or very high payment
[[Page 85936]]
rate as compared to the average claim, which would have a substantial
impact on any statistical methodology used to estimate the most
appropriate payment rate for a service. We also explained that we
believe having the flexibility to utilize an alternative statistical
methodology to calculate the payment rate in the case of low-volume new
technology services would help to create a more stable payment rate.
Therefore, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 58893), we established that, in each of our annual rulemakings, we
will seek public comments on which statistical methodology should be
used for each low-volume service assigned to a New Technology APC. In
the preamble of each annual rulemaking, we stated that we would present
the result of each statistical methodology and solicit public comment
on which methodology should be used to establish the payment rate for a
low-volume new technology service. In addition, we will use our
assessment of the resources used to perform a service and guidance from
the developer or manufacturer of the service, as well as other
stakeholders, to determine the most appropriate payment rate. Once we
identify the most appropriate payment rate for a service, we will
assign the service to the New Technology APC with the cost band that
includes its payment rate.
Accordingly, for CY 2021, we proposed to continue the policy we
adopted in CY 2019 under which we will utilize our equitable adjustment
authority under section 1833(t)(2)(E) of the Act to calculate the
geometric mean, arithmetic mean, and median using multiple years of
claims data to select the appropriate payment rate for purposes of
assigning services with fewer than 100 claims per year to a New
Technology APC. Additional details on our policy is available in the CY
2019 OPPS/ASC final rule with comment period (83 FR 58892 through
58893).
We did not receive any public comments on our proposal. Therefore,
we are finalizing our proposal without modification.
3. Procedures Assigned to New Technology APC Groups for CY 2021
As we described in the CY 2002 OPPS final rule with comment period
(66 FR 59902), we generally retain a procedure in the New Technology
APC to which it is initially assigned until we have obtained sufficient
claims data to justify reassignment of the procedure to a clinically
appropriate APC.
In addition, in cases where we find that our initial New Technology
APC assignment was based on inaccurate or inadequate information
(although it was the best information available at the time), where we
obtain new information that was not available at the time of our
initial New Technology APC assignment, or where the New Technology APCs
are restructured, we may, based on more recent resource utilization
information (including claims data) or the availability of refined New
Technology APC cost bands, reassign the procedure or service to a
different New Technology APC that more appropriately reflects its cost
(66 FR 59903).
Consistent with our current policy, for CY 2021, we proposed to
retain services within New Technology APC groups until we obtain
sufficient claims data to justify reassignment of the service to a
clinically appropriate APC. The flexibility associated with this policy
allows us to reassign a service from a New Technology APC in less than
2 years if sufficient claims data are available. It also allows us to
retain a service in a New Technology APC for more than 2 years if
sufficient claims data upon which to base a decision for reassignment
have not been obtained (66 FR 59902). We received no public comments on
our proposal. Therefore, we will implement our proposal without
modification.
a. Magnetic Resonance-Guided Focused Ultrasound Surgery (MRgFUS)
Currently, there are four CPT/HCPCS codes that describe magnetic
resonance image-guided, high-intensity focused ultrasound (MRgFUS)
procedures, three of which we proposed to continue to assign to
standard APCs, and one that we proposed to continue to assign to a New
Technology APC for CY 2021. These codes include CPT codes 0071T, 0072T,
and 0398T, and HCPCS code C9734. CPT codes 0071T and 0072T describe
procedures for the treatment of uterine fibroids, CPT code 0398T
describes procedures for the treatment of essential tremor, and HCPCS
code C9734 describes procedures for pain palliation for metastatic bone
cancer.
For the procedure described by CPT code 0398T, we have identified
169 paid claims for CY 2019 with a geometric mean of $12,027.76. The
number of claims for the service means that the procedure is no longer
a low-volume new technology service, and we will use the geometric mean
of the CY 2019 claims data to determine the cost of the service for its
APC assignment. We reviewed the OPPS to determine whether CPT code
0398T could be assigned to a clinical APC. The most appropriate
clinical APC family for the service would be the Neurostimulator and
Related Procedures APC series (APCs 5461 through 5464). However, there
was a large payment rate difference between Level 2 Neurostimulator and
Related Procedures (APC 5462) with a payment rate of $6,169.27 and
Level 3 Neurostimulator and Related Procedures (APC 5463) with a
payment rate of $19,737.37. Based on the geometric mean cost of CPT
code 0398T available for the CY 2021 OPPS/ASC proposed rule, we believe
the payment rate for APC 5462 would be too low for CPT code 0398T since
it is more than $6,000 less than the geometric mean cost for CPT code
0398T, and we believe the payment rate for APC 5463 would be too high
since it is around $6,800 more than the geometric mean cost for CPT
code 0398T.
In addition, given the significant difference in the payment rate
between APC 5462 and 5463, we believed a restructuring of the APC
family would be appropriate. We believed that creating an additional
payment level between the two existing APC levels would allow for a
smoother distribution of the costs between the different levels based
on their resource costs and clinical characteristics. Please refer to
section III.D.1 for detailed explanation of our proposal to reorganize
the Neurostimulator and Related Procedures APCs (APCs 5461-5464).
Reorganizing the Neurostimulator and Related Procedures APCs would
create a proposed Level 3 APC to be referred to as ``Proposed APC
5463'' with a payment rate of approximately $12,286 that is close to
the geometric mean of CPT code 0398T which is approximately $12,798.
The payment rate of proposed APC 5463 is representative of the cost of
the service described by CPT code 0398T. Therefore, we proposed to
reassign the service described by CPT code 0398T to the proposed new
Level 3 APC for Neurostimulator and Related Procedures (Proposed APC
5463) for CY 2021.
Comment: Multiple commenters supported our proposal to reassign CPT
code 0398T to proposed new APC 5463 (Level 3 Neurostimulator and
Related Procedures).
Response: We appreciate the support of the commenters for our
proposal.
The final rule data shows the payment rate for the new APC 5463
(Level 3 Neurostimulator and Related Procedures) is $11,236.21. While
this payment rate is lower than what was calculated for the proposed
rule, we continue to believe APC 5463 is an appropriate placement for
CPT code 0398T. After our review of the public comments, we have
decided to
[[Page 85937]]
implement our proposal to assign CPT code 0398T to APC 5463 for CY
2021. The final APC assignment, status indicator, and payment rate for
CPT code 0398T are found in Table 10. We refer readers to Addendum B of
the final rule for the final payment rates for all codes reportable
under the OPPS. Addendum B is available via the internet on the CMS
website.
[GRAPHIC] [TIFF OMITTED] TR29DE20.022
Retinal Prosthesis Implant Procedure
CPT code 0100T (Placement of a subconjunctival retinal prosthesis
receiver and pulse generator, and implantation of intra-ocular retinal
electrode array, with vitrectomy) describes the implantation of a
retinal prosthesis, specifically, a procedure involving the use of the
Argus[supreg] II Retinal Prosthesis System. This first retinal
prosthesis was approved by FDA in 2013 for adult patients diagnosed
with severe to profound retinitis pigmentosa. Pass-through payment
status was granted for the Argus[supreg] II device under HCPCS code
C1841 (Retinal prosthesis, includes all internal and external
components) beginning October 1, 2013, and this status expired on
December 31, 2015. We note that after pass-through payment status
expires for a medical device, the payment for the device is packaged
into the payment for the associated surgical procedure. Consequently,
for CY 2016, the device described by HCPCS code C1841 was assigned to
OPPS status indicator ``N'' to indicate that payment for the device is
packaged and included in the payment rate for the surgical procedure
described by CPT code 0100T. For CY 2016, the procedure described by
CPT code 0100T was assigned to New Technology APC 1599, with a payment
rate of $95,000, which was the highest paying New Technology APC for
that year. This payment included both the surgical procedure (CPT code
0100T) and the use of the Argus[supreg] II device (HCPCS code C1841).
However, stakeholders (including the device manufacturer and hospitals)
believed that the CY 2016 payment rate for the procedure involving the
Argus[supreg] II System was insufficient to cover the hospital cost of
performing the procedure, which includes the cost of the retinal
prosthesis at the retail price of approximately $145,000.
For CY 2017, analysis of the CY 2015 OPPS claims data used for the
CY 2017 OPPS/ASC final rule with comment period showed 9 single claims
(out of 13 total claims) for the procedure described by CPT code 0100T,
with a geometric mean cost of approximately $142,003 based on claims
submitted between January 1, 2015, through December 31, 2015, and
processed through June 30, 2016. Based on the CY 2015 OPPS claims data
available for the final rule with comment period and our understanding
of the Argus[supreg] II procedure, we reassigned the procedure
described by CPT code 0100T from New Technology APC 1599 to New
Technology APC 1906, with a final payment rate of $150,000.50 for CY
2017. We noted that this payment rate included the cost of both the
surgical procedure (CPT code 0100T) and the retinal prosthesis device
(HCPCS code C1841).
For CY 2018, the reported cost of the Argus[supreg] II procedure
based on CY 2016 hospital outpatient claims data for 6 claims used for
the CY 2018 OPPS/ASC final rule with comment period was approximately
$94,455, which was more than $55,000 less than the payment rate for the
procedure in CY 2017, but closer to the CY 2016 payment rate for the
procedure. We noted that the costs of the Argus[supreg] II procedure
are extraordinarily high compared to many other procedures paid under
the OPPS. In addition, the number of claims submitted has been very low
and has not exceeded 10 claims within a single year. We believed that
it is important to mitigate significant payment differences, especially
shifts of several tens of thousands of dollars, while also basing
payment rates on available cost information and claims data. In CY
2016, the payment rate for the Argus[supreg] II procedure was
$95,000.50. The payment rate increased to $150,000.50 in CY 2017. For
CY 2018, if we had established the payment rate based on updated final
rule claims data, the
[[Page 85938]]
payment rate would have decreased to $95,000.50 for CY 2018, a decrease
of $55,000 relative to CY 2017. We were concerned that these large
fluctuations in payment could potentially create an access to care
issue for the Argus[supreg] II procedure, and we wanted to establish a
payment rate to mitigate the potential sharp decline in payment from CY
2017 to CY 2018.
In accordance with section 1833(t)(2)(B) of the Act, we must
establish that services classified within each APC are comparable
clinically and with respect to the use of resources. Therefore, for CY
2018, we used our equitable adjustment authority under section
1833(t)(2)(E) of the Act, which states that the Secretary shall
establish, in a budget neutral manner, other adjustments as determined
to be necessary to ensure equitable payments, to maintain the payment
rate for this procedure, despite the lower geometric mean costs
available in the claims data used for the final rule with comment
period. For CY 2018, we reassigned the Argus[supreg] II procedure to
APC 1904 (New Technology--Level 50 ($115,001-$130,000)), which
established a payment rate for the Argus[supreg] II procedure of
$122,500.50, which was the arithmetic mean of the payment rates for the
procedure for CY 2016 and CY 2017.
For CY 2019, the reported cost of the Argus[supreg] II procedure
based on the geometric mean cost of 12 claims from the CY 2017 hospital
outpatient claims data was approximately $171,865, which was
approximately $49,364 more than the payment rate for the procedure for
CY 2018. In the CY 2019 OPPS/ASC final rule with comment period, we
continued to note that the costs of the Argus[supreg] II procedure are
extraordinarily high compared to many other procedures paid under the
OPPS (83 FR 58897 through 58898). In addition, the number of claims
submitted continued to be very low for the Argus[supreg] II procedure.
We stated that we continued to believe that it is important to mitigate
significant payment fluctuations for a procedure, especially shifts of
several tens of thousands of dollars, while also basing payment rates
on available cost information and claims data because we are concerned
that large decreases in the payment rate could potentially create an
access to care issue for the Argus[supreg] II procedure. In addition,
we indicated that we wanted to establish a payment rate to mitigate the
potential sharp increase in payment from CY 2018 to CY 2019, and
potentially ensure a more stable payment rate in future years.
As discussed in section III.C.2. of the CY 2019 OPPS/ASC final rule
with comment period (83 FR 58892 through 58893), we used our equitable
adjustment authority under section 1833(t)(2)(E) of the Act, which
states that the Secretary shall establish, in a budget neutral manner,
other adjustments as determined to be necessary to ensure equitable
payments, to establish a payment rate that is more representative of
the likely cost of the service. We stated that we believed the likely
cost of the Argus[supreg] II procedure is higher than the geometric
mean cost calculated from the claims data used for the CY 2018 OPPS/ASC
final rule with comment period but lower than the geometric mean cost
calculated from the claims data used for the CY 2019 OPPS/ASC final
rule with comment period.
For CY 2019, we analyzed claims data for the Argus[supreg] II
procedure using 3 years of available data from CY 2015 through CY 2017.
These data included claims from the last year that the Argus[supreg] II
received transitional device pass-through payments (CY 2015) and the
first 2 years since device pass-through payment status for the
Argus[supreg] II expired. We found that the geometric mean cost for the
procedure was approximately $145,808, the arithmetic mean cost was
approximately $151,367, and the median cost was approximately $151,266.
As we do each year, we reviewed claims data regarding hospital costs
associated with new procedures. We regularly examine the claims data
and any available new information regarding the clinical aspects of new
procedures to confirm that OPPS payments remain appropriate for
procedures like the Argus[supreg] II procedure as they transition into
mainstream medical practice (77 FR 68314). We noted that the proposed
payment rate included both the surgical procedure (CPT code 0100T) and
the use of the Argus[supreg] II device (HCPCS code C1841). For CY 2019,
the estimated costs using all three potential statistical methods for
determining APC assignment under the New Technology low-volume payment
policy fell within the cost band of New Technology APC 1908, which is
between $145,001 and $160,000. Therefore, we reassigned the
Argus[supreg] II procedure (CPT code 0100T) to APC 1908 (New
Technology--Level 52 ($145,001-$160,000)), with a payment rate of
$152,500.50 for CY 2019.
For CY 2020, we identified 35 claims reporting the procedure
described by CPT code 0100T for the 4-year period of CY 2015 through CY
2018. We found the geometric mean cost for the procedure described by
CPT code 0100T to be approximately $146,059, the arithmetic mean cost
to be approximately $152,123, and the median cost to be approximately
$151,267. All of the resulting estimates from using the three
statistical methodologies fell within the same New Technology APC cost
band ($145,001-$160,000), where the Argus[supreg] II procedure was
assigned for CY 2019. Consistent with our policy stated in section
III.C.2, we presented the result of each statistical methodology in the
proposed rule, and we sought public comments on which method should be
used to assign procedures described by CPT code 0100T to a New
Technology APC. All three potential statistical methodologies used to
estimate the cost of the Argus[supreg] II procedure fell within the
cost band for New Technology APC 1908, with the estimated cost being
between $145,001 and $160,000. Accordingly, we assigned CPT code 0100T
in APC 1908 (New Technology--Level 52 ($145,001-$160,000)), with a
payment rate of $152,500.50 for CY 2020.
For CY 2021, the number of reported claims for the Argus[supreg] II
procedure continues to be very low with a substantial fluctuation in
cost from year to year. The high annual variability of the cost of the
Argus[supreg] II procedure continues to make it difficult to establish
a consistent and stable payment rate for the procedure. As previously
mentioned, in accordance with section 1833(t)(2)(B) of the Act, we are
required to establish that services classified within each APC are
comparable clinically and with respect to the use of resources.
Therefore, for CY 2021, we proposed to apply the policy we adopted in
CY 2019, under which we utilize our equitable adjustment authority
under section 1833(t)(2)(E) of the Act to calculate the geometric mean,
arithmetic mean, and median costs using multiple years of claims data
to select the appropriate payment rate for purposes of assigning the
Argus[supreg] II procedure (CPT code 0100T) to a New Technology APC.
For CY 2021, we identified 35 claims reporting the procedure
described by CPT code 0100T for the 4-year period of CY 2016 through CY
2019. We found the geometric mean cost for the procedure described by
CPT code 0100T to be approximately $148,807, the arithmetic mean cost
to be approximately $154,504, and the median cost to be approximately
$151,974. All three potential statistical methodologies used to
estimate the cost of the Argus[supreg] II procedure fall within the
cost band for New Technology APC 1908, with the estimated cost being
between $145,001 and $160,000.
Accordingly, we proposed to maintain the assignment of the
procedure
[[Page 85939]]
described by CPT code 0100T in APC 1908 (New Technology--Level 52
($145,001-$160,000)), with a proposed payment rate of $152,500.50 for
CY 2021. We note that the proposed payment rate includes both the
surgical procedure (CPT code 0100T) and the use of the Argus[supreg] II
device (HCPCS code C1841). We refer readers to Addendum B to the
proposed rule for the proposed payment rates for all codes reportable
under the OPPS. Addendum B is available via the internet on the CMS
website.
For our analysis for the CY 2021 final rule, we identified 35
claims reporting the procedure described by CPT code 0100T for the 4-
year period of CY 2016 through CY 2019. We found the geometric mean
cost for the procedure described by CPT code 0100T to be approximately
$148,148, the arithmetic mean cost to be approximately $153,682, and
the median cost to be approximately $151,974. The slight differences
from the calculations using the proposed rule data are caused by
changes to the wage indexes of a few providers. All three potential
statistical methodologies used to estimate the cost of the
Argus[supreg] II procedure fall within the cost band for New Technology
APC 1908, with the estimated cost being between $145,001 and $160,000.
We received no public comments on our proposal. Therefore, we are
finalizing our proposal without modification. We will maintain the
assignment of the procedure described by CPT code 0100T in APC 1908
(New Technology--Level 52 ($145,001-$160,000)), with a payment rate of
$152,500.50 for CY 2021. We note that the final payment rate includes
both the surgical procedure (CPT code 0100T) and the use of the
Argus[supreg] II device (HCPCS code C1841). We refer readers to
Addendum B to the final rule for the final payment rates for all codes
reportable under the OPPS. Addendum B is available via the internet on
the CMS website.
c. Administration of Subretinal Therapies Requiring Vitrectomy (APC
1561)
CPT code J3398 (Injection, voretigene neparvovec-rzyl, 1 billion
vector genomes) is a gene therapy for a rare mutation-associated
retinal dystrophy. Voretigene neparvovec-rzyl (Luxturna[supreg]), was
approved by FDA in December of 2017, and is indicated as an adeno-
associated virus vector-based gene therapy indicated for the treatment
of patients with confirmed biallelic RPE65 mutation-associated retinal
dystrophy.\2\ This therapy is administered through a subretinal
injection, which stakeholders describe as an extremely delicate and
sensitive surgical procedure. The FDA package insert describes one of
the steps for administering Luxturna as, ``after completing a
vitrectomy, identify the intended site of administration. The
subretinal injection can be introduced via pars plana.'' \1\
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\2\ Luxturna. FDA Package Insert. Available: https://www.fda.gov/media/109906/download.
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Stakeholders, including the manufacturer of Luxturna[supreg],
recommended HCPCS code 67036 (Vitrectomy, mechanical, pars plana
approach) for the administration of the gene therapy.\3\ However, the
manufacturer contends the administration is not currently described by
any existing codes as HCPCS code 67036 (Vitrectomy, mechanical, pars
plana approach) does not account for the administration itself. For
HCPCS code J3398, a typical patient would receive a standard dose of
150 billion vector genomes, with an approximate payment rate of
$432,480 (we refer readers to Addendum B of the CY 2021 OPPS/ASC Final
Rule with comment period rule for the payment rate associated with
HCPCS code J3398).
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\3\ LUXTURNA REIMBURSEMENT GUIDE FOR TREATMENT CENTERS. https://mysparkgeneration.com/pdf/Reimbursement_Guide_for_Treatment_Centers_Interactive_010418_FINAL.pdf.
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It is important to note that HCPCS code J3398 was granted drug
pass-through status under the OPPS as of July 1, 2018 and is assigned
status indicator ``G''. (We refer readers to Addendum D of the CY 2021
OPPS/ASC Final rule for the list of status indicator definitions for
CY2021). HCPCS code J3398 is scheduled to have its drug pass-through
status expire June 30, 2021, at which point the code would be packaged
into the payment for any primary service with which it is billed when
that primary service is assigned to a comprehensive APC (C-APC). A C-
APC packages payment for adjunctive and secondary items, services, and
procedures into the most costly primary procedure. (For a full
discussion and background on C-APCs, see section II.A.2.b). Based on
information from the manufacturer of Luxturna, we believe that HCPCS
code J3398 (Injection, voretigene neparvovec-rzyl, 1 billion vector
genomes) would commonly be billed with the service described by HCPCS
code 67036 (Vitrectomy, mechanical, pars plana approach), which
describes the administration of the gene therapy, and which is assigned
to a comprehensive APC, (APC 5492--Level 2 Intraocular Procedures).
Thus, when its pass-through status expires, payment for HCPCS code
J3398, the primary therapy, would be packaged into payment for HCPCS
code 67036, its administration procedure.
CMS recognizes the need to accurately describe the unique
administration procedure that is required to administer the therapy
described by HCPCS code J3398. We proposed to establish a new HCPCS
code, C97X1 (Vitrectomy, mechanical, pars plana approach, with
subretinal injection of pharmacologic/biologic agent) to describe this
process. We believe that this new HCPCS code accurately describes the
service associated with intraocular administration of HCPCS code J3398.
CMS recognized that HCPCS code 67036 represents a similar procedure and
process that approximates similar resource utilization that is
associated with C97X1. CMS also recognized that it is not prudent for
the code that describes the administration of this gene therapy, C97X1,
to be assigned to the same C-APC to which HCPCS code 67036 is assigned,
as this would package the primary therapy, HCPCS code J3398, into the
code that represents the process to administer the gene therapy.
For CY 2021, we proposed to assign the services described by C97X1
to a new technology payment band based on the geometric mean cost for
HCPCS code 67036. For the CY 2021 OPPS/ASC Proposed Rule, HCPCS code
67036 had a geometric mean cost of $3,407.84. Therefore, for the
proposed rule we proposed to assign C97X1 to APC 1561--New Technology--
Level 24 ($3001-$3500). See Table 11 for proposed descriptors and APC
assignment.
[[Page 85940]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.023
Comment: Commenters were largely supportive of our proposal to
create a ``C'' code to describe the administration of J3398 and assign
this newly created ``C'' code to New Technology APC 1561. Commenters
largely advised CMS to finalize our proposal as proposed.
Response: We thank the commenters for their support on our
proposal.
Comment: A small minority of commenters supported our approach to
create a ``C'' code to describe the administration of J3398 and assign
the newly created ``C'' code to a New Technology APC, but suggested
alternate APC placements. The commenters' suggested alternate APC
placements included APC 1562, based on a crosswalk of HCPCS code 67042,
as well as APC 1564. Additionally, one commenter expressed uncertainty
about when it would be appropriate to bill this code.
Response: We thank commenters for their feedback. Based on our
review, we believe assigning C9770 to APC 1561 based on the geometric
mean costs of HCPCS code 67036 is the most appropriate APC placement
for this code. Our clinical review along with an overwhelming number of
stakeholders have found that HCPCS code 67036 represents a similar
procedure and process that approximates similar resource utilization
that is associated with C9770. Additionally, regarding when C9770 may
be billed, we remind stakeholders that HOPDs and ASCs may bill C9770
under Medicare in the HOPD and ASC settings when reasonable and
necessary services are furnished. HCPCS C-codes are reportable only on
Medicare OPPS and ASC claims. HOPDs and ASCs are expected to make
appropriate coding decisions based on instructions and other
information available to them (for example, federal regulations, CMS
instructions, MAC instructions, etc.).
Based on the above discussion, for CY 2021 we are finalizing our
proposal without modification to establish C9770 and assign the code to
a New Technology APC based on the geometric mean cost of HCPCS code
67036. For CY 2021, HCPCS code 67036 has a geometric mean cost of
$3,435.61. Therefore, as shown in Table 12, for CY 2021 we are
finalizing our proposal to create C9770 (Vitrectomy, mechanical, pars
plana approach, with subretinal injection of pharmacologic/biologic
agent) and assign this code to APC 1561 (New Technology--Level 24
($3001-$3500)).
[GRAPHIC] [TIFF OMITTED] TR29DE20.024
d. Bronchoscopy With Transbronchial Ablation of Lesion(s) by Microwave
Energy
Effective January 1, 2019, CMS established HCPCS code C9751
(Bronchoscopy, rigid or flexible, transbronchial ablation of lesion(s)
by microwave energy, including fluoroscopic guidance, when performed,
with computed tomography acquisition(s) and 3-D rendering, computer-
assisted, image-guided navigation, and endobronchial ultrasound (EBUS)
guided transtracheal and/or transbronchial sampling (for example,
aspiration[s]/biopsy[ies]) and all mediastinal and/or hilar lymph node
stations or structures and therapeutic intervention(s)). This microwave
ablation procedure utilizes a flexible catheter to access the lung
tumor via a working channel and may be used as an alternative procedure
to a percutaneous microwave approach. Based on our review of the New
Technology APC application for this service and the service's clinical
similarity to existing services paid under the OPPS, we estimated the
likely cost of the procedure would be between $8,001 and $8,500.
In claims data available for CY 2019 for the CY 2021 OPPS/ASC
proposed rule, there were 4 claims reported for bronchoscopy with
transbronchial ablation of lesions by microwave energy. Given the low
volume of claims for the service, we proposed for CY 2021 to apply the
policy we adopted in CY 2019, under which we utilize our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to
calculate the geometric mean, arithmetic mean, and median costs to
calculate an
[[Page 85941]]
appropriate payment rate for purposes of assigning bronchoscopy with
transbronchial ablation of lesions by microwave energy to a New
Technology APC. We found the geometric mean cost for the service to be
approximately $4,051, the arithmetic mean cost to be approximately
$4,067, and the median cost to be approximately $4,067. All three
potential statistical methodologies used to estimate the cost of the
service procedure fall within the cost band for New Technology APC
1563, with the estimated cost being between $4,001 and $4,500.
Accordingly, we proposed to change the assignment of the HCPCS code
C9751 to APC 1563 (New Technology--Level 26 ($4001-$4500)), with a
proposed payment rate of $4,250.50 for CY 2021.
Comment: Two commenters did not support our proposal to assign
HCPCS code C9751 to APC 1563 (New Technology--Level 26 ($4001-$4500)),
with a proposed payment rate of $4,250.50 for CY 2021. The commenters
stated that there was not enough claims data to change the APC
assignment for HCPCS code C9751, and that HCPCS code C9751 should
continue to be assigned to APC 1571 (New Technology--Level 34 ($8001-
$8500)) with a proposed payment rate of $8,250.50.
Response: Because of the low number of claims for HCPCS C9751, we
utilized our equitable adjustment authority under section 1833(t)(2)(E)
of the Act for our final rule analysis to calculate the geometric mean,
arithmetic mean, and median costs to calculate a payment rate to assign
bronchoscopy with transbronchial ablation of lesions by microwave
energy to a New Technology APC. Even though the number of claims are
small, it is the best data available to determine the cost of the
procedure. The assignment of HCPCS code C9751 to APC 1571 was based on
guidance from the developer of the procedure and our best estimates of
the cost of the procedure. The claims data, however limited, provide
evidence of the cost of the procedure based on service utilization
rather than having to forecast the cost of procedure.
Therefore, we decided to use our low-volume methodology for new
technology services to determine the payment rate for the service
described by HCPCS code C9751. We found for our final rule analysis
that the geometric mean cost for the service to be approximately
$2,693, the arithmetic mean cost to be approximately $3,086, and the
median cost to be approximately $3,708. The median was the statistical
methodology that estimated the highest cost for the service and
provides a reasonable estimate of the midpoint cost of the three claims
that have been paid for this service. The payment rate calculated using
this methodology falls within the cost band for New Technology APC 1562
(New Technology--Level 25 ($3501-$4000)). Based on our updated analysis
of the data, we have decided to implement our original proposal with
modifications. For CY 2021, we will change the assignment of HCPCS code
C9751 to APC 1562 (New Technology--Level 25 ($3501-$4000)) using our
equitable adjustment authority under section 1833(t)(2)(E) of the Act
and our low-volume new technology service methodology. The payment rate
for C9751 will be based on the median cost of claims reported for the
service since CY 2019 as the median cost is the highest estimated cost
for the service, and the median provides a reasonable estimate of the
midpoint cost of the three claims that have been paid for this service.
Details regarding HCPCS code C9751 are shown in Table 13. We refer
readers to Addendum B of the final rule for the final payment rates for
all codes reportable under the OPPS. Addendum B is available via the
internet on the CMS website.
[GRAPHIC] [TIFF OMITTED] TR29DE20.025
e. Fractional Flow Reserve Derived From Computed Tomography (FFRCT)
Fractional Flow Reserve Derived from Computed Tomography (FFRCT),
also known by the trade name HeartFlow, is a noninvasive diagnostic
service that allows physicians to measure coronary artery disease in a
patient through the use of coronary CT scans. The HeartFlow procedure
is intended for clinically stable symptomatic patients with coronary
artery disease, and, in many cases, may avoid the need for an invasive
coronary angiogram procedure. HeartFlow uses a proprietary data
analysis process performed at a central facility to develop a three-
dimensional image of a patient's coronary arteries, which allows
physicians to identify the fractional flow reserve to assess whether or
not patients should undergo further invasive testing (that is, a
coronary angiogram).
For many services paid under the OPPS, payment for analytics that
are performed after the main diagnostic/
[[Page 85942]]
image procedure are packaged into the payment for the primary service.
However, in CY 2018, we determined that HeartFlow should receive a
separate payment because the service is performed by a separate entity
(that is, a HeartFlow technician who conducts computer analysis
offsite) rather than the provider performing the CT scan. We assigned
CPT code 0503T, which describes the analytics performed, to New
Technology APC 1516 (New Technology--Level 16 ($1,401-$1,500)), with a
payment rate of $1,450.50 based on pricing information provided by the
developer of the procedure that indicated the price of the procedure
was approximately $1,500. We did not have Medicare claims data in CY
2019 for CPT code 0503T, and we continued to assign the service to New
Technology APC 1516 (New Technology--Level 16 ($1,401-$1,500)), with a
payment rate of $1,450.50.
CY 2020 was the first year we had Medicare claims data to calculate
the cost of HCPCS code 0503T. For the CY 2020 OPPS/ASC final rule,
there were 957 claims with CPT code 0503T of which 101 of the claims
were single frequency claims that were used to calculate the geometric
mean of the procedure. We planned to use the geometric mean to report
the cost of HeartFlow. However, the number of single frequency claims
for CPT code 0503T was below the low-volume payment policy threshold
for the proposed rule, and the number of single frequency claims was
only two claims above the threshold for the new technology APC low-
volume policy for the final rule. Therefore, we decided to use our
equitable adjustment authority under section 1833(t)(2)(E) of the Act
to calculate the geometric mean, arithmetic mean, and median using the
CY 2018 claims data to determine an appropriate payment rate for
HeartFlow using our new technology APC low-volume payment policy. While
the number of single frequency claims was just above our threshold to
use the low-volume payment policy, we still had concerns about the
normal cost distribution of the claims used to calculate the payment
rate for HeartFlow, and we decided the low-volume payment policy would
be the best approach to address those concerns.
Our analysis found that the geometric mean cost for CPT code 0503T
was $768.26, the arithmetic mean cost for CPT code 0503T was $960.12
and that the median cost for CPT code 0503T was $900.28. Of the three
cost methods, the highest amount was for the arithmetic mean. The
arithmetic mean fell within the cost band for New Technology APC 1511
(New Technology--Level 11 ($901-$1000)) with a payment rate of $950.50.
The arithmetic mean helped to account for some of the higher costs of
CPT code 0503T identified by the developer and other stakeholders that
may not have been reflected by either the median or the geometric mean.
For CY 2021, we observed a significant increase in the number of
claims billed with CPT code 0503T that were available for the CY 2021
OPPS/ASC proposed rule. Specifically, using the most recently available
data for the CY 2021 OPPS/ASC proposed rule (that is, CY 2019), we
identified 2,820 claims billed with CPT code 0503T including 415 single
frequency claims. These totals were well above the threshold of 100
claims for a procedure to be evaluated using the new technology APC
low-volume policy. Therefore, we proposed to use our standard
methodology rather than the low-volume methodology we previously used
to determine the cost of CPT code 0503T.
Our analysis of the available claims data for the proposed rule
found the geometric mean cost for CPT code 0503T was approximately
$851. Therefore, we proposed to reassign the service described by CPT
code 0503T in order to adjust the payment rate to better reflect the
cost for the service. While we considered proposing to reassign CPT
code 0503T to APC 5724 (Level 4--Diagnostic Tests and Related
Services), which had a proposed payment rate of around $903 based on
the clinical and resource similarity to other services within that APC,
we did not propose such reassignment because the payment rate for the
new technology APC was closer to the geometric mean costs of CPT code
0503T. Nonetheless, we welcomed comments on whether reassignment to the
clinical APC would be more appropriate. Therefore, we proposed to
reassign the service described by CPT code 0503T to New Technology APC
1510 (New Technology--Level 10 ($801-$900)), with a proposed payment
rate of $850.50 for CY 2021.
Comment: The developer of HeartFlow and multiple other commenters
stated that the CPT code 0503T should not be assigned to New Technology
APC 1510. Instead, they suggested that the HeartFlow procedure be
assigned to APC 5593 (Level 3 Nuclear Medicine and Related Services)
with a payment rate of around $1,270. The developer asserted that even
though the payment for APC 5593 is substantially higher than the
estimated cost of CPT code 0503T, the cost of the service fits
reasonably well with the cost of other procedures assigned to APC 5593.
The developer and other commenters also assert that the HeartFlow
procedure has enough clinical similarity to other procedures currently
assigned to the nuclear medicine and related services family. According
to the developer and the other commenters, HeartFlow is comparable to
other nuclear medicine procedures that are image analysis tests
characterizing organ-specific function. The developer and the other
commenters also note that cardiac CT procedures, which are used to
identify coronary artery disease, are assigned to the nuclear medicine
APC family. Finally, the developer cited two examples of procedures in
the OPPS that are assigned to APCs where the procedure in question does
not have clinical similarity to the other procedures in the APC.
Response: We disagree with the suggestion that CPT code 0503T
should be assigned to APC 5593. The nuclear medicine and related
procedures APC family describes diagnostic and therapeutic procedures,
many of them involving imaging, where radiopharmaceuticals and other
nuclear materials are critical supplies for the performance of the
procedure. In comparison, HeartFlow is a computer algorithm that does
not directly take images nor is it used on its own to generate a
diagnosis for a patient. Instead, HeartFlow analyzes diagnostic images
obtained through other medical procedures and assists with the
interpretation of those diagnostic images to determine if a patient has
coronary artery disease. There is little clinical similarity between
the HeartFlow procedure and the procedures currently assigned to the
nuclear medicine and related procedures, and we cannot support
assigning CPT code 0503T to APC 5593.
Comment: Several commenters asserted the proposed payment rate for
CPT code 0503T is too low and does not reflect their individual
hospital's cost to use HeartFlow. Commenters mentioned cost issues,
including the $1,100 list price for each individual HeartFlow service
and the staff resources involved to transmit data to the HeartFlow
analysis facility and review the results of the analyses performed by
HeartFlow. Commenters suggested a range of potential payments for a
HeartFlow procedure from $1,051 up to $1,451, and they encouraged CMS
to use our equitable adjustment authority at section 1833(t)(2)(E) of
the Act to establish a payment rate that would more closely reflect the
costs the
[[Page 85943]]
commenters believe they are incurring to perform the HeartFlow
procedure.
Response: For this CY 2021 OPPS/ASC final rule, we identified 3,188
claims billed with CPT code 0503T including 465 single frequency claims
for CPT code 0503T. Our analysis has found that the geometric mean for
CPT code 0503T is $804.35, and the geometric mean cost falls within the
cost band for New Technology APC 1510 (New Technology--Level 10 ($801-
$900)), which is similar to our results for the proposed rule. However,
multiple commenters have noted that the FFRCT service costs $1,100 and
that there are additional staff costs related to the submission of
coronary CT image data for processing by HeartFlow.
HeartFlow is one of the first procedures utilizing artificial
intelligence to be separately payable in the OPPS, and providers are
still learning how to accurately report their charges to Medicare when
billing for artificial intelligence services. This is especially the
case for allocating the cost of staff resources between the HeartFlow
procedure and the coronary CT imaging services. Therefore, we feel it
would be appropriate to use our equitable adjustment authority under
section 1833(t)(2)(E) of the Act to assign CPT code 0503T to the same
New Technology APC in CY 2021 as in CY 2020 in order to provide payment
stability and equitable payment for providers as they continue to
become more familiar with the proper cost reporting for HeartFlow and
other artificial intelligence services. As mentioned earlier in this
section, CPT code 0503T was assigned to New Technology APC 1511 (New
Technology--Level 11 ($901-$1000)) with a payment rate of $950.50 for
CY 2020, and we will continue to assign CPT code 0503T to New
Technology APC 1511 for CY 2021.
After reviewing all of the public comments, we have decided to
finalize our proposal with modification by using our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to continue
to assign CPT code 0503T to New Technology APC 1511 (New Technology--
Level 11 ($901-$1000)) for CY 2021. We refer readers to Addendum B of
the final rule for the final payment rates for all codes reportable
under the OPPS. Addendum B is available via the internet on the CMS
website.
f. Cardiac Positron Emission Tomography (PET)/Computed Tomography (CT)
Studies
Effective January 1, 2020, we assigned three CPT codes (78431,
78432, and 78433) that describe the services associated with cardiac
PET/CT studies to New Technology APCs. CPT code 78431 was assigned to
APC 1522 (New Technology--Level 22 ($2001-$2500)) with a payment rate
of $2,250.50. CPT codes 78432 and 78433 were assigned to APC 1523 (New
Technology--Level 23 ($2501-$3000)) with a payment rate of $2,750.50.
We had not received any claims billed with CPT codes 78431, 78432,
or 78433 prior to the proposed rule. Therefore, we proposed to continue
to assign these CPT codes to the same new technology APCs as they were
in CY 2020. The proposed CY 2021 payment rate for the codes can be
found in Addendum B to the CY 2021 OPPS/ASC proposed rule (which is
available via the internet on the CMS website).
Comment: Several commenters expressed their support for our
proposal to assign CPT code 78431 to APC 1522 (New Technology--Level 22
($2001-$2500)) with a payment rate of $2,250.50, and to assign CPT
codes 78432 and 78433 to APC 1523 (New Technology--Level 23 ($2501-
$3000)) with a payment rate of $2,750.50.
Response: We appreciate the support of the commenters for our
proposal.
We have not received any claims for these services prior to this
final rule. After our review of the public comments, we have decided to
implement our proposal without modification. Table 14 reports code
descriptors, status indicators, and APC assignments for these CPT
codes.
[[Page 85944]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.026
g. Pathogen Test for Platelets/Rapid Bacterial Testing
For the July 2017 update, the HCPCS Workgroup established HCPCS
code Q9987 (Pathogen(s) test for platelets) effective July 1, 2017.
This new code and the OPPS APC assignment was announced in the July
2017 OPPS quarterly update CR (Transmittal 3783, Change Request 10122,
dated May 26, 2017). Because HCPCS code Q9987 represented a test to
identify bacterial or other pathogen contamination in blood platelets,
we assigned the code to a new technology APC, specifically, New
Technology APC 1493 (New Technology--Level 1C ($21-$30)) with a status
indicator ``S'' and a payment rate of $25.50. We note that temporary
HCPCS code Q9987 was subsequently deleted on December 31, 2017, and
replaced with permanent HCPCS code P9100 (Pathogen(s) test for
platelets) effective January 1, 2018. For the January 2018 update, we
continued to assign the new code to the same APC and status indicator
as its predecessor code. Specifically, we assigned HCPCS code P9100 to
New Technology APC 1493 and status indicator ``S''. For the CY 2019
update, we made no change to the APC or status indicator assignment for
P9100, however, for the CY 2020 update, we revised the APC assignment
from New Technology APC 1493 to 1494 (New Technology--Level 1D ($31-
$40) based on the latest claims data used to set the payment rates for
CY 2020. We discussed the revision in the CY 2020 OPPS/ASC final rule
(84 FR 61219) and indicated that the reassignment to APC 1494
appropriately reflected the cost of the service.
For the CY 2021 OPPS/ASC proposed rule, we stated that we believed
we had sufficient claims data to reassign the code from a New
Technology APC to a clinical APC, and noted that HCPCS code P9100 has
been assigned to a New Technology APC for over 3 years. As stated in
section III.D. (New Technology APCs), a service is paid under a New
Technology APC until sufficient claims data have been collected to
allow CMS to assign the procedure to a clinical APC group that is
appropriate in clinical and resource terms. We expect this to occur
within two to three years from the time a new HCPCS code becomes
effective. However, if we are able to collect sufficient claims data in
less than 2 years, we would consider reassigning the service to an
appropriate clinical APC. Since HCPCS code P9100 has been assigned to a
new technology APC since July 2017, we believe that we should reassign
the code to a clinical APC. Specifically, our claims data for the CY
2021 OPPS/ASC proposed rule showed a geometric mean cost of
approximately $30 for HCPCS code P9100 based on 70 single claims (out
of 1,835 total claims).
[[Page 85945]]
Based on resource cost and clinical homogeneity to the other services
assigned to APC 5732 (Level 2 Minor Procedures), we believed that HCPCS
code P9100 should be reassigned to clinical APC 5732, which had a
geometric mean cost of approximately $33.
As we have stated several times since the implementation of the
OPPS on August 1, 2000, we review, on an annual basis, the APC
assignments for all services and items paid under the OPPS based on our
analysis of the latest claims data. For the CY 2021 OPPS update, based
on claims submitted between January 1, 2019, and December 30, 2019, our
analysis of the latest claims data for the CY 2021 OPPS/ASC proposed
rule supports reassigning HCPCS code P9100 to APC 5732 based on its
clinical and resource homogeneity to the procedures and services in the
APC. Therefore, we proposed to reassign HCPCS code P9100 from New
Technology APC 1494 to clinical APC 5732 for CY 2021. The proposed CY
2021 payment rate for HCPCS code P9100 can be found in Addendum B to
the CY 2021 OPPS/ASC proposed rule with comment period. In addition, we
refer readers to Addendum D1 of the CY 2021 OPPS/ASC proposed rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
Comment: Two commenters expressed their support for our proposal.
Response: We appreciate the support of the commenters.
After reviewing the public comments for this proposal, we have
decided to finalize our proposal without modification to reassign HCPCS
code P9100 from New Technology APC 1494 to clinical APC 5732 for CY
2021. The final rule data supports our decision. The data show a
geometric mean cost of approximately $31 for HCPCS code P9100 based on
75 single claims (out of 2,038 total claims), which is close to the
payment rate of around $33 for APC 5732. The final CY 2021 payment rate
for HCPCS code P9100 can be found in Addendum B to this CY 2021 OPPS/
ASC final rule with comment period. In addition, we refer readers to
Addendum D1 of this CY 2021 OPPS/ASC final rule with comment period for
the status indicator (SI) meanings for all codes reported under the
OPPS. Both Addendum B and D1 are available via the internet on the CMS
website.
h. V-Wave Medical Interatrial Shunt Procedure
A randomized, double-blinded, controlled IDE study is currently in
progress for the V-Wave interatrial shunt. The V-Wave interatrial shunt
is for patients with severe symptomatic heart failure and is designed
to regulate left atrial pressure in the heart. All participants who
passed initial screening for the study receive a right heart
catheterization procedure described by CPT code 93451 (Right heart
catheterization including measurement(s) of oxygen saturation and
cardiac output, when performed). Participants assigned to the
experimental group also receive the V-Wave interatrial shunt procedure
while participants assigned to the control group only receive right
heart catheterization. The developer of V-Wave was concerned that the
current coding of these services by Medicare would reveal to the study
participants whether they have received the interatrial shunt because
an additional procedure code, CPT code 93799 (Unlisted cardiovascular
service or procedure), would be included on the claims for participants
receiving the interatrial shunt. Therefore, we created a temporary
HCPCS code to describe the V-wave interatrial shunt procedure for both
the experimental group and the control group in the study.
Specifically, we established HCPCS code C9758 (Blinded procedure for
NYHA class III/IV heart failure; transcatheter implantation of
interatrial shunt or placebo control, including right heart
catheterization, trans-esophageal echocardiography (TEE)/intracardiac
echocardiography (ICE), and all imaging with or without guidance (for
example, ultrasound, fluoroscopy), performed in an approved
investigational device exemption (IDE) study) to describe the service,
and we assigned the service to New Technology APC 1589 (New
Technology--Level 38 ($10,001-$15,000)).
No claims have been reported for HCPCS code C9758. Therefore, we
proposed to continue to assign the service to New Technology APC 1589
for CY 2021. The proposed CY 2021 payment rate for V-Wave interatrial
shunt procedure can be found in Addendum B to the proposed rule (which
is available via the internet on the CMS website).
Comment: Three commenters including the developer of the V-Wave
interatrial shunt procedure and the developer of the Corvia Medical
interatrial shunt procedure requested that we delete HCPCS code C9758
because V-Wave has decided to no longer seek Medicare payment for its
interatrial shunt procedure trial. The commenters believe that deleting
HCPCS code C9758 will help prevent provider confusion with billing
procedures describing the implementation of interatrial shunts.
Response: We do not intend to delete HCPCS code C9758 and believe
that HCPCS code C9758 is sufficiently distinct from HCPCS code C9760
(Non-randomized, non-blinded procedure for nyha class ii, iii, iv heart
failure; transcatheter implantation of interatrial shunt or placebo
control, including right and left heart catheterization, transeptal
puncture, trans-esophageal echocardiography (tee)/intracardiac
echocardiography (ice), and all imaging with or without guidance (for
example, ultrasound, fluoroscopy), performed in an approved
investigational device exemption (ide) study) that providers will not
be confused about the appropriate service code to report.
Comment: Two commenters, including the developer of the V-Wave
interatrial shunt procedure and the developer of the Corvia Medical
interatrial shunt procedure, provided information about procedures that
had comparable non-device service costs similar to the interatrial
shunt procedures. One commenter suggested using the non-device cost of
CPT code 93580 (Percutaneous transcatheter closure of congenital
interatrial communication (that is, fontan fenestration, atrial septal
defect) with implant) to approximate non-device costs for this
procedure. The other commenter suggested that interatrial septal shunt
procedures and percutaneous intracardiac closure procedures (CPTs
93580-93591) assigned to APC 5194 (Level 4--Endovascular Procedures)
would describe the non-device costs of the interatrial shunt
procedures.
Response: Based on the suggestions of the commenters, we averaged
the non-device costs of the interatrial septal shunt procedures and
percutaneous intracardiac closure procedures to estimate the non-device
costs of the interatrial shunt procedures. Our estimate of the non-
device costs of both the V-Wave interatrial shunt and Corvia Medical
interatrial shunt procedures was around $6,500.
Comment: One commenter requested that we assign the V-Wave
interatrial shunt procedure to a New Technology APC that reflects the
cost of the procedure.
Response: We will assign the V-Wave interatrial shunt procedure to
an APC that reasonably reflects the cost of the
[[Page 85946]]
procedure both when the device is implanted and when a placebo
treatment occurs.
After reviewing the public comments and analyzing the cost of both
the V-Wave interatrial shunt procedure and the Corvia Medical
interatrial shunt procedure, we will finalize our proposal with
modifications. We believe that similar resources and device costs are
involved with the V-Wave interatrial shunt procedure and the Corvia
Medical interatrial shunt procedure. Therefore, the difference in the
payment for HCPCS codes C9758 and C9760 is based on how often the
interatrial shunt is implanted when each code is billed. An interatrial
shunt is implanted one-half of the time HCPCS code C9758 is billed.
Therefore, we will reassign HCPCS code C9758 to New Technology APC
1590, which reflects the cost of having surgery every time and
receiving the interatrial shunt one-half of the time when the procedure
is performed. Details about the HCPCS code and its APC assignment are
shown in Table 15. The final CY 2021 payment rate for the V-Wave
interatrial shunt procedure can be found in Addendum B to the final
rule.
[GRAPHIC] [TIFF OMITTED] TR29DE20.027
i. Corvia Medical Interatrial Shunt Procedure
Corvia Medical is currently conducting their pivotal trial for
their interatrial shunt procedure. The trial started in Quarter 1 of CY
2017 and is scheduled to continue through CY 2021. On July 1, 2020, we
established HCPCS code C9760 (Non-randomized, non-blinded procedure for
nyha class ii, iii, iv heart failure; transcatheter implantation of
interatrial shunt or placebo control, including right and left heart
catheterization, transeptal puncture, trans-esophageal echocardiography
(tee)/intracardiac echocardiography (ice), and all imaging with or
without guidance (for example, ultrasound, fluoroscopy), performed in
an approved investigational device exemption (ide) study) to facilitate
the implantation of the Corvia Medical interatrial shunt.
In the CY 2021 OPPS/ASC proposed rule, we proposed to assign HCPCS
code C9760 to New Technology APC 1589. The proposed CY 2021 payment
rate for Corvia Medical interatrial shunt procedure was found in
Addendum B to the proposed rule (which is available via the internet on
the CMS website).
Comment: Several commenters recommended revising the code
descriptor for HCPCS code C9760 since the current descriptor
inaccurately suggests that the code may include placebo control
subjects who would not receive a shunt implant. The commenters
specifically requested deleting the phrase ``or placebo control'' to
eliminate any confusion on how this code should be reported.
Response: We agree with the commenters and have revised the long
descriptor effective January 1, 2021 to read ``Non-randomized, non-
blinded procedure for NYHA Class II, III, IV heart failure;
transcatheter implantation of interatrial shunt, including right and
left heart catheterization, transeptal puncture, trans-esophageal
echocardiography (TEE)/intracardiac echocardiography (ICE), and all
imaging with or without guidance (for example, ultrasound,
fluoroscopy), performed in an approved investigational device exemption
(IDE) study.'' The revised long descriptor for HCPCS code C9760 can
also be found in the 2021 Alpha Numeric HCPCS File that is posted on
the CMS HCPCS website, specifically, at https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.
Comment: Two commenters, including the developer of the Corvia
Medical interatrial shunt procedure and the developer of the V-Wave
interatrial shunt procedure, provided information about procedures that
had comparable non-device service costs similar to the interatrial
shunt procedures. One commenter suggested using the non-device cost of
CPT code 93580 (Percutaneous transcatheter closure of congenital
interatrial communication (that is, fontan fenestration, atrial septal
defect) with implant). The other commenter suggested that interatrial
septal shunt procedures and percutaneous intracardiac closure
procedures (CPTs 93580-93591) assigned to APC 5194 (Level 4--
Endovascular Procedures) would describe the non-device costs of the
interatrial shunt procedures.
Response: Based on the suggestions of the commenters, we averaged
the non-device costs of the interatrial septal shunt procedures and
percutaneous intracardiac closure procedures to estimate the non-device
costs of the interatrial shunt procedures. Our estimated cost of the
non-device costs of the both the Corvia Medical interatrial shunt and
V-Wave interatrial shunt procedures was around $6,500.
Comment: Multiple commenters, including the developer of the Corvia
Medical interatrial shunt procedure and the developer of the V-Wave
interatrial shunt procedure, requested a higher payment rate for the
procedure. Several commenters were concerned that the payment rate
established for HCPCS
[[Page 85947]]
code C9760 would discourage providers from participating in the
clinical trial, and the developer of the Corvia Medical interatrial
shunt procedure stated that they had to assume all costs for the trial
because of inadequate payment for the Corvia Medical interatrial shunt
procedure. The developer of the V-Wave interatrial shunt procedure
mentioned that HCPCS code C9760 is the service code they will use to
report interatrial shunt procedures for their continuing study.
Response: As mentioned earlier, we decided to estimate the non-
device costs of both the Corvia Medical interatrial shunt procedure and
the V-Wave interatrial shunt procedure. We also plan to combine the
non-device costs of the procedures with the costs of the interatrial
shunt device to create a new estimate of the payment rate for HCPCS
code C9760. HCPCS code C9760 can be used to report any non-randomized,
non-blinded study related to the implantation of interatrial shunts
where the device is implanted for every procedure reported.
After our review of the public comments, we intend to finalize our
proposal with modifications. We believe that similar resources and
device costs are involved with the Corvia Medical interatrial shunt
procedure and the V-Wave interatrial shunt procedure. Therefore, the
difference in the payment for HCPCS codes C9760 and C9758 is based on
how often the interatrial shunt is implanted when each code is billed.
The Corvia Medical interatrial shunt is implanted every time HCPCS code
C9760 is billed. Therefore, we will reassign HCPCS code C9760 to New
Technology APC 1592. We also will implement the commenters' suggestion
to modify the code descriptor for HCPCS code C9760 to remove the phrase
``or placebo control,'' from the descriptor. Details about the HCPCS
code and its APC assignment are shown in Table 16. The final CY 2021
payment rate for the Corvia Medical interatrial shunt procedure can be
found in Addendum B to the final rule.
[GRAPHIC] [TIFF OMITTED] TR29DE20.028
j. Supervised Visits for Esketamine Self-Administration (HCPCS Codes
G2082 and G2083 APCs 1508 and 1511)
On March 5, 2019, FDA approved Spravato\TM\ (esketamine) nasal
spray, used in conjunction with an oral antidepressant, for treatment
of depression in adults who have tried other antidepressant medicines
but have not benefited from them (treatment-resistant depression
(TRD)). Because of the risk of serious adverse outcomes resulting from
sedation and dissociation caused by Spravato administration, and the
potential for abuse and misuse of the product, it is only available
through a restricted distribution system under a Risk Evaluation and
Mitigation Strategy (REMS). A REMS is a drug safety program that FDA
can require for certain medications with serious safety concerns to
help ensure the benefits of the medication outweigh its risks.
A treatment session of esketamine consists of instructed nasal
self-administration by the patient, followed by a period of post-
administration observation of the patient under direct supervision of a
health care professional. Esketamine is a noncompetitive N-methyl D-
aspartate (NMDA) receptor antagonist. It is a nasal spray supplied as
an aqueous solution of esketamine hydrochloride in a vial with a nasal
spray device. This is the first FDA approval of esketamine for any use.
Each device delivers two sprays containing a total of 28 mg of
esketamine. Patients would require either two (2) devices (for a 56mg
dose) or three (3) devices (for an 84 mg dose) per treatment.
Because of the risk of serious adverse outcomes resulting from
sedation and dissociation caused by Spravato administration, and the
potential for abuse and misuse of the product, Spravato is only
available through a restricted distribution system under a REMS;
patients must be monitored by a health care provider for at least 2
hours after receiving their Spravato dose; the prescriber and patient
must both sign a Patient Enrollment Form; and the product will only be
administered in a certified medical office where the health care
provider can monitor the patient. Please refer to the CY 2020 PFS final
rule and interim final rule for more information about supervised
visits for esketamine self-administration (84 FR 63102 through 63105).
To facilitate prompt beneficiary access to the new, potentially
life-saving treatment for TRD using esketamine, we created two new
HCPCS G codes, G2082 and G2083, effective January 1, 2020. HCPCS code
G2082 is for an outpatient visit for the evaluation and management of
an established patient that requires the supervision of a physician or
other qualified health care professional and provision of up to 56 mg
of esketamine nasal self-administration and includes 2 hours post-
administration observation. HCPCS code G2082 was assigned to New
Technology APC 1508 (New
[[Page 85948]]
Technology--Level 8 ($601-$700)) with a payment rate of $650.50. HCPCS
code G2083 describes a similar service to HCPCS code G2082, but
involves the administration of more than 56 mg of esketamine. HCPCS
code G2083 was assigned to New Technology APC 1511 (New Technology--
Level 11 ($901-$1000)) with a payment rate of $950.50.
No Medicare OPPS claims had been reported for either HCPCS code
G2082 or G2083 prior to the CY 2021 OPPS/ASC proposed rule. Therefore,
we proposed to continue to assign HCPCS code G2082 to New Technology
APC 1508 and to assign HCPCS code G2083 to New Technology APC 1511. The
proposed CY 2021 payment rate for esketamine self-administration can be
found in Addendum B to proposed rule (which is available via the
internet on the CMS website).
Comment: Two commenters supported our proposal.
Response: We appreciate the support of the commenters.
We have not received any OPPS claims for this code prior to this
final rule. After reviewing the public comments for this proposal, we
have decided to implement our proposal without modification to assign
HCPCS code G2082 to New Technology APC 1508 and to assign HCPCS code
G2083 to New Technology APC 1511. Details about the HCPCS codes and
their APC assignments are shown in Table 17. The final CY 2021 payment
rate for esketamine self-administration can be found in Addendum B to
the proposed rule (which is available via the internet on the CMS
website).
[GRAPHIC] [TIFF OMITTED] TR29DE20.029
D. APC-Specific Policies
1. Administration of Lacrimal Ophthalmic Insert Into Lacrimal
Canaliculus (APC 5692)
HCPCS code J1096 (Dexamethasone, lacrimal ophthalmic insert, 0.1
mg) is a drug indicated ``for the treatment of ocular inflammation and
pain following ophthalmic surgery.''\4\ Stakeholders assert that this
drug is administered through CPT code 0356T (Insertion of drug-eluting
implant (including punctal dilation and implant removal when performed)
into lacrimal canaliculus, each). Stakeholders also state the drug is
inserted in a natural opening in the eyelid (called the punctum) and
that the drug is designed to deliver a tapered dose of dexamethasone to
the ocular surface for up to 30 days.
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\4\ 1 Dextenza. FDA Package Insert. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208742s001lbl.pdf.
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HCPCS code J1096 is currently on pass-through status and assigned
to APC 9308 (Dexametha opth insert 0.1 mg) with status indicator ``G''.
Please see section V.A.5. of this final rule with comment period for
further information
[[Page 85949]]
regarding the pass-through status of J1096. CPT code 0356T is currently
assigned to status indicator ``Q1,'' indicating conditionally packaged
payment under the OPPS. Packaged payment applies if a code assigned
status indicator ``Q1'' is billed on the same claim as a HCPCS code
assigned status indicator ``S'', ``T'', or ``V''. Accordingly, based on
the OPPS assigned status indicator, CPT code 0356T is assigned to
payment indicator ``N1'' in the ASC setting, meaning a packaged
service/item.
We refer readers to Addendum D1 of this final rule for a list of
OPPS status indicators and their definitions, available via the
internet on the CMS website. We also refer readers to Addendum AA for
ASC payment indicator assignments and to Addendum DD1 for payment
indicator definitions, available via the internet on the CMS website.
CPT code 0356T is assigned to APC 5692 (Level 2 Drug
Administration). With regards to APCs 5691 (Level 1 Drug
Administration) and APC 5692 (Level 2 Drug Administration), and as
stated in the CY 2018 OPPS/ASC final rule with comment period, our
overarching goal is to make OPPS payments for all services paid under
the OPPS more consistent with those of a prospective payment system and
less like those of a per-service fee schedule. To achieve this goal, it
is important that we are consistent in our approach to packaging items
and services under the established packaging categories. Therefore, in
the CY 2018 OPPS/ASC final rule with comment period, after
consideration of the public comments we received, we finalized, without
modification, the proposed policy to conditionally package low-cost
drug administration services assigned to APC 5691 and APC 5692 (82 FR
52391 through 52393). Additionally, conditional packaging for Levels 1
and 2 Drug Administration services is consistent with the ancillary
packaging policy that was adopted in the 2015 OPPS/ASC Final Rule with
comment period (79 FR 66819 through 66822). Accordingly, in the CY 2021
OPPS/ASC Proposed Rule, we did not propose to change the OPPS status
indicator assignment and APC placement, or ASC payment indicator
assignment for CPT code 0356T.
Comment: Several commenters had concerns with continuing the same
APC placement of APC 5692 for CPT code 0356T for CY 2021. Commenters
generally advocated for separate payment for this CPT code through a
change in status indicator. A few commenters suggested alternative APC
placements, such as APC 5501 (Level 1 Extraocular, Repair, and Plastic
Eye Procedures), APC 5693 (Level 3 Drug Administration), or APC 1504
(New Technology--Level 4), whereas other commenters requested a larger
payment in general without a specific APC placement suggestion. Several
stakeholders commented that the clinical importance of providing HCPCS
code J1096 to patients is that it reduces ocular pain, inflammation,
and reduces the burden of topical eyedrop application.
Additionally, providers stated that they usually perform CPT code
0356T to administer HCPCS code J1096 after the conclusion of ophthalmic
surgeries. Most commonly, providers cited using CPT code 0356T to
administer HCPCS code J1096 after surgeries such as cataract, glaucoma,
and corneal surgeries. Commenters believe the procedure is a distinct
surgical procedure that requires additional operating room time and
resources. Commenters were concerned that the lack of increased or
separate payment may reduce access to HCPCS J1096, particularly in the
ASC setting.
Response: We thank commenters for their feedback. After careful
consideration of the statements from commenters, we continue to believe
that assignment of CPT code 0356T to APC 5692, with an OPPS status
indicator ``Q1'' and an associated ASC payment indicator of ``N1'', is
appropriate based on its clinical and resource use similarity to other
services assigned to that APC. Commenters have stated that CPT code
0356T is performed during ophthalmic surgeries such as cataract
surgeries. We do not find it appropriate to compare CPT code 0356T to
that of an independent procedure when performed during these other
ophthalmic surgeries. We continue to believe that conditionally
packaging the payment for CPT code 0356T into the payment for these
primary procedures is appropriate. This is consistent with our policy
to conditionally package low-cost drug administration services assigned
to APC 5691 (Level 1 Drug Administration) and APC 5692 (Level 2 Drug
Administration). We note the policy established in the CY 2018 OPPS to
conditionally package low-cost drug administration services assigned to
APC 5691 and APC 5692 (82 FR 52391 through 52393). Also, we note that
the conditional packaging of drug administration supports our
overarching goal to make payments for all services paid under the OPPS
and ASC payment system more consistent with those of a prospective
payment system and less like those of a per-service fee schedule. We
believe that packaging encourages efficiency and is an essential
component of a prospective payment system, and that packaging payments
for items and services that are typically integral, ancillary,
supportive, dependent, or adjunctive to a primary service is a
fundamental part of the OPPS.
After consideration of the public comments, we are finalizing our
proposed policy without modification to assign CPT code 0356T to APC
5692 (Level 2 Drug Administration) with OPPS status indicator ``Q1'' in
the CY 2021 OPPS. Based on those assignments, we are also finalizing an
ASC payment indicator for CPT code 0356T of ``N1'' under the CY 2021
ASC payment system.
2. Chimeric Antigen Receptor T-Cell (CAR T-Cell) Therapy (APCs 5694,
9035, 9194, and 9391)
Chimeric Antigen Receptor T-Cell (CAR T-cell) therapy is a cell-
based gene therapy in which T-cells are collected and genetically
engineered to express a chimeric antigen receptor that will bind to a
certain protein on a patient's cancerous cells. The CAR T-cells are
then administered to the patient to attack certain cancerous cells and
the individual is observed for potential serious side effects that
would require medical intervention. We refer readers to previous
discussions in the OPPS/ASC final rules with comment period for
background regarding the specific CAR T-cell products, in both the CY
2020 OPPS/ASC final rule with comment period (84 FR 61231 through
61234) and the CY 2019 OPPS/ASC final rule with comment period (83 FR
58904 through 58908). In addition, for discussion about CY 2021 OPPS
payment policies for separately paid drugs with pass-through status
expiring or continuing in CY 2021, please see sections V.A.4. and
V.A.5. of this final rule with comment period.
The AMA created four Category III CPT codes that are related to CAR
T-cell therapy, effective January 1, 2019. As discussed in the CY 2019
OPPS/ASC final rule with comment period (83 FR 58904 through 58908) and
the CY 2020 OPPS/ASC final rule with comment period (84 FR 61231
through 61234), we finalized our proposal to assign procedures
described by CPT codes 0537T, 0538T, and 0539T to status indicator
``B'' (Codes that are not recognized by OPPS when submitted on an
outpatient hospital Part B bill type (12x and 13x)) to indicate that
the services are not paid under the OPPS. The procedures described by
CPT codes 0537T, 0538T, and 0539T describe the various steps required
to collect and
[[Page 85950]]
prepare the genetically modified T-cells, and Medicare does not
generally pay separately for each step used to manufacture a drug or
biological. We also finalized that the procedures described by CPT code
0540T would be assigned status indicator ``S'' (Procedure or Service,
Not Discounted when Multiple) and APC 5694 (Level 4 Drug
Administration) for CY 2019 and CY 2020, and made no proposal to change
the assignment for CY 2021. Additionally, the National Uniform Billing
Committee (NUBC) established CAR T-cell-related revenue codes and a
value code to be reportable on Hospital Outpatient Department (HOPD)
claims effective for claims received on or after April 1, 2019.
We made no specific proposal related to the CAR T-cell preparation
codes, as described by CPT codes 0537T, 0538T, 0539T. As listed in
Addendum B of the CY 2021 OPPS/ASC proposed rule, we proposed to
continue to assign procedures described by these CPT codes, 0537T,
0538T, and 0539T, to status indicator ``B'' (Codes that are not
recognized by OPPS when submitted on an outpatient hospital Part B bill
type (12x and 13x)) to indicate that the services are not paid under
the OPPS. We proposed to continue to assign CPT code 0540T to status
indicator ``S'' (Procedure or Service, Not Discounted when Multiple)
and APC 5694 (Level IV Drug Administration).
Comment: Several commenters opposed our proposal to continue to
assign status indicator ``B'' to CPT codes 0537T, 0538T, and 0539T for
CY 2021. Commenters stated that a change in status indicator would be
appropriate, with a preference for assigning CPT codes 0537T, 0538T,
and 0539T to status indicator ``Q1''. Commenters believed that the
procedures these CPT codes describe did not represent the steps
required to manufacture the CAR T-cell product, as CMS has stated.
Generally, those advocating for a change in status indicator contend
this change is necessary to allow services furnished to the patient to
be eligible for payment and for hospitals to be paid appropriately for
the services they provide during each step of the CAR T-cell process.
Commenters asked CMS to release new cost centers and to revise the
instructions in MLN Matters Article SE19009 accordingly.
Response: We thank the commenters for their feedback. CMS does not
believe that separate or packaged payment under the OPPS is necessary
for the procedures described by CPT codes 0537T, 0538T, and 0539T for
CY 2021. The procedures described by CPT codes 0537T, 0538T, and 0539T
describe the various steps required to collect and prepare the
genetically modified T-cells and Medicare does not generally pay
separately for each step used to manufacture a drug or biological
product. Additionally, we note that CAR T-cell therapy is a unique
therapy approved as a biologic, with unique preparation procedures,
that cannot be directly compared to other therapies or existing CPT
codes. We note that the current HCPCS coding for the currently approved
CAR T-cell therapies include leukapheresis and dose preparation
procedures, as these services are included in the manufacturing of
these biologicals. Therefore, payment for these services is
incorporated into the drug codes. Please see Table 18 for HCPCS coding
for CAR T-cell therapies.
[GRAPHIC] [TIFF OMITTED] TR29DE20.030
We note that although there is no payment associated with CPT codes
0537T, 0538T, and 0539T for reasons stated previously, these codes can
still be reported to CMS for tracking purposes. We thank commenters for
their feedback related to cost centers and our guidance contained in
MLN Matters Article SE19009.\5\ We are not revising this document at
this time, but appreciate the feedback from stakeholders. Also, we
would like to note that HOPDs can bill Medicare for reasonable and
necessary services that are otherwise payable under the OPPS, and we
believe that the comments in reference to payment for services in
settings not payable under the OPPS are outside the scope of this
proposed rule. Accordingly, we are not revising the existing codes for
CAR T-cell therapies to remove leukapheresis and dose preparation
procedures, and we are not accepting the recommendations at this time
to revise the status indicators for procedures described by CPT codes
0537T, 0538T, and 0539T. We will continue to evaluate and monitor
payment for CAR T-cell therapies.
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\5\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19009.pdf.
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In summary, after consideration of the public comments we received,
we are finalizing our proposal to assign status indicator ``B'' to CPT
codes 0537T, 0538T, and 0539T for CY 2021. Additionally, we are
continuing our policy from CY 2019 to assign status indicator ``S'' to
CPT code 0540T for CY 2021. Table 19 below shows the final SI
[[Page 85951]]
and APC assignments for HCPCS codes 0537T, 0538T, 0539T, and 0540T for
CY 2021. For more information on CY 2021 OPPS final status indicators,
APC assignments, and payment rates for HCPCS codes, including the CAR
T-cell drug codes, we refer readers to Addendum B to this final rule
with comment period. In addition, the status indicator definitions can
be found in Addendum D1 (OPPS Payment Status Indicators for CY 2021) to
this final rule with comment period. Both Addendum B and D1 are
available via the internet on the CMS website.
[GRAPHIC] [TIFF OMITTED] TR29DE20.031
3. Eustachian Tube Balloon Dilation Procedure (APC 5165)
For the CY 2021 update, the CPT Editorial Panel established CPT
codes 69705 and 69706 to describe the eustachian tube balloon dilation
(ETBD) surgical procedure effective January 1, 2021. Prior to CY 2021,
this surgical procedure was described by HCPCS code C9745.
In 2017, CMS received a new technology application for the
transnasal flexible balloon catheter eustachian tube dilation surgical
procedure, which is associated with the Acclarent Aera Eustachian Tube
Balloon Dilation System, and established a new code, specifically,
HCPCS code C9745. Based on the estimated cost for the bilateral
placement of the eustachian tube balloon dilation devices, we assigned
the code to APC 5165 (Level 5 ENT Procedures) with a payment rate of
$4,130.94 effective July 1, 2017. We announced the new code, interim SI
and APC assignments, and payment rate in the July 2017 quarterly update
to the OPPS (Transmittal 3783, Change Request 10122, dated May 26,
2017).
For the CY 2018 update, we made no change to the APC assignment and
continued to assign HCPCS code C9745 to APC 5165 with a payment rate of
$4,338.79. We note that OPPS payment rates for the CY 2018 update were
based on claims submitted between January 1, 2016 through December 30,
2016, that were processed on or before June 30, 2017. Because HCPCS
code C9745 was established on July 1, 2017, we had no claims data for
the procedure for use in CY 2018 ratesetting.
For the CY 2019 update, based on our analysis of the claims data,
we made no change to the payment assignment and continued to assign
HCPCS code C9745 to APC 5165. Specifically, our claims data showed a
geometric mean cost of approximately $4,385 for HCPCS code C9745 based
on 217 single claims (out of 218 total claims), which was consistent
with the geometric mean cost of about $4,462 for APC 5165.
Consequently, we retained HCPCS code C9745 in APC 5165.
Similarly, for CY 2020, we made no change to the APC assignment for
HCPCS code C9745, consistent with our claims data. Based on claims
submitted between January 1, 2018 through December 30, 2018, that were
processed on or before June 30, 2019, the geometric mean cost for HCPCS
code C9745 was approximately $4,547 based on 577 single claims (out of
582 total claims), which is in line with the geometric mean cost of
$4,746 for APC 5165. Therefore, we maintained HCPCS code C9745 in APC
5165.
For CY 2021, we proposed to delete HCPCS code C9745 and assign CPT
code 69705 to APC 5164 (Level 4 ENT Procedures) with a proposed OPPS
payment of $2,776.63 and assign CPT code 69706 to APC 5165 (Level 5 ENT
Procedures) with a proposed OPPS payment of $5,150.60. Because HCPCS
code C9745 was on the ASC Covered Surgical Procedures list, we also
proposed to assign CPT code 69705 to ASC payment indicator ``J8''
(device-intensive) with a proposed ASC payment of $1,564.17. Similarly,
we proposed to assign CPT code 69706 to ASC payment indicator ``J8''
(device-intensive) with a proposed ASC payment of $3,453.23. We note
that CPT codes 69705 and 69706 were listed as placeholder codes 697XX
and 697X1, respectively, in OPPS Addendum B and ASC Addendum AA to the
CY 2021 OPPS/ASC proposed rule.
Comment: Some commenters expressed concern with the proposed
assignment to APC 5164 for CPT code 69705 (unilateral procedure) and
stated that the proposed assignment will negatively affect the
reimbursement of the procedure in the ASC setting, and ultimately
decrease access to the procedure. They stated that the major portion of
the procedure cost is the device used in the procedure, and reported
the device cost is about $2,180, which is used for each procedure,
regardless of whether it is a unilateral or bilateral procedure. In
addition, they stated that in the CY 2021 Physician Fee Schedule (PFS)
proposed rule, the
[[Page 85952]]
estimate for the non-facility payment for CPT codes 69705 and 69706
includes the full cost of the device kit, specifically, $3,092.81 for
CPT code 69705 (unilateral) and $3,183.14 for CPT code 69706
(bilateral). To ensure fair reimbursement for unilateral procedures,
they recommended that CMS assign both codes to APC 5165. However, in
the event the recommendation is not accepted, they urged CMS to
reconsider the device-intensive calculation for CPT code 69705 to
reflect the cost of the device kit for unilateral procedures in the ASC
setting; otherwise, commenters contended the ASC payment will be
reduced below the actual cost of the device kit.
Response: Our medical advisors advised that the procedure described
by CPT code 69705, while performed in the hospital outpatient setting,
will primarily be performed in either the physician office or ASC
setting. To ensure that Medicare beneficiaries have access to the
procedure, we believe that it is appropriate to reassign CPT code 69705
(unilateral) to the same APC as CPT code 69706 (bilateral). That is, we
believe that reassigning CPT code 69705 to APC 5165 will better reflect
the device cost to perform this procedure either unilaterally or
bilaterally when furnished in either the hospital outpatient or the ASC
setting.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, to assign CPT code 69706
to APC 5165. However, we are finalizing our proposal, with
modification, to assign CPT code 69705 to APC 5165 for CY 2021. We note
that we are deleting HCPCS code C9745 on December 31, 2020, since it
has been replaced with CPT codes 69705 and 69706 effective January 1,
2021. Table 20 lists the final SI and APC assignments for the two
codes. The final CY 2021 OPPS payment rate for the codes can be found
in Addendum B to this final rule with comment period. In addition, we
refer readers to Addendum D1 of this final rule with comment period for
the status indicator (SI) meanings for all codes reported under the
OPPS. Both Addendum B and D1 are available via the internet on the CMS
website.
[GRAPHIC] [TIFF OMITTED] TR29DE20.032
4. Eye-Movement Analysis Without Spatial Calibration (APC 5734)
For July 2020, the CPT Editorial Panel established a new CPT code
0615T, effective July 1, 2020, to describe eye-movement analysis
without spatial calibration that involves the use of the EyeBOX system
as an aid in the diagnosis of concussion, also known as mild traumatic
brain injury (mTBI). The EyeBOX is intended to measure and analyze eye
movements as an aid in the diagnosis of concussion within one week of
head injury in patients 5 through 67 years of age in conjunction with a
standard neurological assessment of concussion. A negative EyeBOX
classification may correspond to eye movement that is consistent with a
lack of concussion. A positive EyeBOX classification corresponds to eye
movement that may be present in both patients with or without a
concussion.
We included this new code in the July quarterly OPPS update CR
(Transmittal 10224, Change Request 11814, dated July 15, 2020).
Effective July 1, 2020, we assigned CPT code 0615T to APC 5734 (Level 4
Minor Procedures) with status indicator ``Q1'' (conditionally packaged)
and a CY 2020 OPPS payment rate of $109.03 as reflected in the Addendum
B to the July 2020 quarterly OPPS update.
As displayed in the Addendum B to the 2021 ASC/OPPS Proposed Rule,
we proposed to assign 0615T to APC 5734 with status indicator ``Q1''
and a proposed OPPS payment rate of $113.23 for CY 2021. We also
assigned this code to comment indicator ``NP'' in Addendum B to
indicate that this code is new effective July 1, 2020, and that public
comments would be accepted on its proposed status indicator assignment.
Comment: A commenter was concerned that what they believed was a
lack of adequate, separate payment would strongly discourage hospitals
from providing this important new technology to their patients. The
commenter urged CMS to: (1) Change the APC assignment of CPT code 0615T
to APC 5722 (Level 2 Diagnostic Tests and Related Services) with a
proposed OPPS payment rate of $269.85 and (2) change the status
indicator for the service to ``S'' to allow for a separate payment
under the OPPS.
The commenter asked that CMS assign CPT code 0615T to APC 5722 for
two reasons: (1) The current and proposed reimbursement rates for
services in APC 5734 are inadequate to pay hospitals appropriately for
the costs
[[Page 85953]]
of furnishing the EyeBOX test; and (2) the clinical characteristics and
resources associated with 0615T are more similar to codes in APC 5722
than services in APC 5734.
Response: We note that OPPS payment rates for the CY 2021 final
rule are based on claims submitted between January 1, 2019 through
December 31, 2019, that were processed on or before June 30, 2020.
Because HCPCS code 0615T was established on July 1, 2020, we did not
have claims data for CY 2021 OPPS ratesetting.
In terms of the resource similarity of CPT code 0615T to other eye-
related diagnostic tests that are assigned to APC 5722, such as CPT
code 92240 (Indocyanine-green angiography (includes multiframe imaging)
with interpretation and report, unilateral or bilateral) and CPT code
92242 (Fluorescein angiography and indocyanine-green angiography
(includes multiframe imaging) performed at the same patient encounter
with interpretation and report, unilateral or bilateral), the EyeBOX
test does not involve an injection. Therefore, we do not believe that
the resource costs for CPT code 0615T are comparable to other eye-
related diagnostic tests in APC 5722. Updated claims data for this
final rule with comment period indicate that the geometric mean cost of
APC 5722 is $257.61, while the geometric mean cost of APC 5734 is
$109.05. However, because there were no claims for CPT code 0615T in
the CY 2021 updated data set, we have decided not to make any changes
to the proposed CY 2021 APC assignment and to assign the code to the
APC with the lower geometric mean cost. Based on these findings, we
believe that maintaining assignment of APC 5734 for CPT code 0615T for
CY 2021 is appropriate.
In response to the comment related to status indicator ``Q1'', we
note that status indicator ``Q1'' listed in the OPPS Addendum D1 to
this 2021 OPPS/ASC final rule with comment period allows for up to
three potential payment assignments:
Packaged APC payment if billed on the same claim as a
HCPCS code assigned status indicator ``S'', ``T'', or ``V''; or
Composite APC payment if billed with specific combinations
of services based on OPPS composite-specific payment criteria. Payment
is packaged into a single payment for specific combinations of
services; or
In other circumstances, payment is made through a separate
APC payment.
Depending on the procedures submitted on the claim and whether the
procedure described by CPT code 0615T is performed with any other
services on the same day, the procedure described by CPT code 0615T may
be paid separately through an APC (in this case APC 5734) or receive
packaged payment when accompanying a more significant procedure that is
reported on the claim. Based on the nature of this procedure, which may
be performed by itself or with other procedures on the same claim, we
believe that the continued assignment of status indicator ``Q1'' is
appropriate for the procedure described by CPT code 0615T.
As we do every year, we will reevaluate the APC assignment for CPT
code 0615T for the next rulemaking cycle. We note that we review, on an
annual basis, the APC assignments for all services and items paid under
the OPPS.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to assign CPT code 0615T
to status indicator ``Q1'' and APC 5734 for CY 2021. The final CY 2021
payment rate for the CPT code can be found in Addendum B to this final
rule with comment period (which is available via the internet on the
CMS website).
5. Gynecologic Procedures and Services (APC 5416)
For CY 2021, we proposed to continue to assign CPT code 0404T
(Transcervical uterine fibroid(s) ablation with ultrasound guidance,
radiofrequency) to APC 5416 (Level 6 Gynecologic Procedures) with a
proposed payment of $6,929.92. CPT code 0404T describes the procedure
associated with the Sonata System, which is used for the treatment of
symptomatic uterine fibroids. We note that CPT code 0404T was effective
on January 1, 2016.
Comment: Several commenters stated that the proposed APC payment
rate is insufficient to compensate hospital outpatient departments for
the resources needed to perform the procedure. They indicated that the
combined cost of the single-use handpiece, capital equipment, supplies,
screening labs, anesthesia, medication, and facility and personnel
overhead are higher than the OPPS payment rate. The commenters asserted
that the proposed payment will significantly limit patient access to
the procedure because it does not cover the total cost of the surgery.
One commenter acknowledged that the proposed payment appropriately
reimburses for hospital outpatient costs, but believed the ASC proposed
payment of $2,763.68 significantly underpays for the procedure in the
ASC setting. The same commenter explained that CMS has no claims data
for the code because the procedure is rarely performed on Medicare
patients, and also due to the device's commercial availability.
Although the CPT code was effective January 2016, because of
manufacturing issues, the company was unable to submit their FDA
application until a couple of years later. The company eventually
received market approval from the FDA in August 2018 and the device was
commercially available in late summer/early Fall 2019. To ensure access
to the procedure, the commenters suggested reassigning CPT code 0404T
to either:
APC 5362 (Level 2 Laparoscopy and Related Services) with a
proposed payment rate of $9,041.94 because the procedure cost is
similar to these procedures:
[cir] CPT code 43210 (Esophagogastroduodenoscopy, flexible,
transoral; with esophagogastric fundoplasty, partial or complete,
includes duodenoscopy when performed);
[cir] CPT code 50593 (Ablation, renal tumor(s), unilateral,
percutaneous, cryotherapy);
[cir] CPT code 58546 (Laparoscopy, surgical, myomectomy, excision;
5 or more intramural myomas and/or intramural myomas with total weight
greater than 250 g); and
[cir] CPT code 58674 (Laparoscopy, surgical, ablation of uterine
fibroid(s) including intraoperative ultrasound guidance and monitoring,
radiofrequency), or
APC 5376 (Level 6 Urology and Related Services) with a
proposed payment of $8,395.62 because the procedure cost is similar to
these procedures:
[cir] CPT code 55873 (Cryosurgical ablation of the prostate
(includes ultrasonic guidance and monitoring); and
[cir] CPT code 0421T (Transurethral waterjet ablation of prostate,
including control of post-operative bleeding, including ultrasound
guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral
calibration and/or dilation, and internal urethrotomy are included when
performed)).
Response: For CY 2021, OPPS payments are developed based on claims
submitted between January 1, 2019 through December 31, 2019, and
processed through June 30, 2020. For this final rule with comment
period, we have no claims data for this code. As explained by a
commenter, CPT code 0404T is a procedure not commonly performed on
Medicare beneficiaries. In addition, we disagree with the commenters'
assessment that CPT code
[[Page 85954]]
0404T is similar to the codes they have referenced. CPT code 0404T is
not a urology, kidney, or esophagogastroduodenum-related procedure, nor
is it a laparoscopy procedure. We believe that the code is
appropriately placed in APC 5416 based on its clinical homogeneity and
resource costs to the other gynecology-related procedures in the APC.
We agree with the commenter who believed that the proposed OPPS payment
for the service is adequate to cover the cost of providing the
procedure in the hospital outpatient setting.
For a discussion on the ASC payment for CPT code 0404T, we refer
readers to the ASC payment section of this CY 2021 OPPS/ASC final rule
with comment period, specifically, section XIII. (Updates to the
Ambulatory Surgical Center (ASC) Payment System).
Comment: Some commenters suggested designating CPT code 0404T as
device-intensive under the OPPS so that facilities can be paid
appropriately for furnishing the procedure in the ASC setting. They
also recommended establishing an offset percentage that is higher than
the default 31 percent based on invoice pricing data provided to CMS by
the device manufacturer so that payment for the procedure in the ASC
setting includes the cost of the device.
Response: We refer readers to section IV. B. (Device-Intensive
Procedures) for the discussion related to the OPPS device offset for
the code. For a discussion of the ASC procedures designed as device
intensive, please see section XIII.C.1. of this final rule with comment
period.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, and assigning CPT code
0404T to APC 5416 for CY 2021. The final CY 2021 OPPS payment rate for
the code can be found in Addendum B to this final rule with comment
period. In addition, we refer readers to Addendum D1 of this final rule
with comment period for the status indicator (SI) assignments for all
codes reported under the OPPS. Both Addendum B and D1 are available via
the internet on the CMS website.
6. Hemodialysis Arteriovenous Fistula (AVF) Procedures (APC 5194)
For CY 2019, based on two new technology applications received by
CMS for hemodialysis arteriovenous fistula creation, CMS established
two new HCPCS codes to describe the surgical procedure associated with
the two technologies since no specific CPT codes exist. Specifically,
CMS established HCPCS code C9754 for the Ellipsys System and C9755 for
the WavelinQ System effective January 1, 2019. The complete descriptors
for both codes are as follows:
C9754 (Creation of arteriovenous fistula, percutaneous;
direct, any site, including all imaging and radiologic supervision and
interpretation, when performed and secondary procedures to redirect
blood flow (e.g., transluminal balloon angioplasty, coil embolization,
when performed))
C9755 (Creation of arteriovenous fistula, percutaneous
using magnetic-guided arterial and venous catheters and radiofrequency
energy, including flow-directing procedures (e.g., vascular coil
embolization with radiologic supervision and interpretation, when
performed) and fistulogram(s), angiography, venography, and/or
ultrasound, with radiologic supervision and interpretation, when
performed)
Both HCPCS codes were assigned to APC 5193 (Level 3 Endovascular
Procedures) with a payment rate of $9,669.04 for CY 2019. For CY 2020,
as discussed in the CY 2020 OPPS/ASC final rule with comment period (84
FR 61246), we revised the assignment for both codes to APC 5194 (Level
4 Endovascular Procedures) with a payment rate of $15,939.97.
For the July 2020 update, we deleted HCPCS codes C9754 and C9755 on
June 30, 2020, and replaced them with G-codes effective July 1, 2020 to
enable physicians to report the procedures when performed in the
physician office setting. Specifically, we deleted HCPCS code C9754 on
June 30, 2020 because it was replaced with HCPCS code G2170 effective
July 1, 2020. Similarly, we deleted HCPCS code C9755 on June 30, 2020
because it was replaced with HCPCS code G2171 effective July 1, 2020.
Below are the complete descriptors for HCPCS codes G2170 and G2171:
G2170 (Percutaneous arteriovenous fistula creation (AVF),
direct, any site, by tissue approximation using thermal resistance
energy, and secondary procedures to redirect blood flow (e.g.,
transluminal balloon angioplasty, coil embolization) when performed,
and includes all imaging and radiologic guidance, supervision and
interpretation, when performed)
G2171 (Percutaneous arteriovenous fistula creation (AVF),
direct, any site, using magnetic-guided arterial and venous catheters
and radiofrequency energy, including flow-directing procedures (e.g.,
vascular coil embolization with radiologic supervision and
interpretation, when performed) and fistulogram(s), angiography,
enography, and/or ultrasound, with radiologic supervision and
interpretation, when performed)
We deleted the C-codes based on concerns from stakeholders that
physicians are reluctant to perform the Ellipsys procedure in the
physician office setting without a specific HCPCS code. With the
deletion of the C-codes, we crosswalked the APC assignment and payment
rate for the C-codes to the new G-codes. We note that C-codes are not
reportable on Medicare physician office claims, whereas G-codes are
reportable on physician office, hospital outpatient, and ambulatory
surgical center claims.
For CY 2021, we proposed to reassign HCPCS code G2170 (Ellipsys
System) from APC 5194 to APC 5193 (Level 3 Endovascular Procedures)
with a proposed payment rate of $10,222.32, based on the latest claims
data. Specifically, based on the predecessor HCPCS code C9754, our
claims data for the proposed rule showed a HCPCS geometric mean cost of
approximately $10,068 based on 57 single claims (out of 57 total
claims), which is comparable to the geometric mean cost of about $9,850
for APC 5193 rather than the geometric mean cost of approximately
$15,753 for APC 5194. In addition, we proposed to maintain the
assignment to APC 5194 for G2171 (WavelinQ System) because our claims
data for the proposed rule, based on predecessor HCPCS code C9755,
showed a geometric mean cost of about $13,519 based on 182 single
claims (out of 186 total claims), which is consistent with the
geometric mean cost of about $15,753 for APC 5194.
At the August 31, 2020 HOP Panel Meeting, a presenter requested
that we maintain the assignment for the WavelinQ procedure (HCPCS code
G2170) to APC 5194. The presenter stated that the number of single
claims is too small to support a reassignment to APC 5193. Based on the
discussion during the meeting, the HOP Panel recommended that CMS
maintain the assignment of HCPCS code G2170 in APC 5194 for CY 2021.
Comment: Most commenters opposed the reassignment to APC 5193 for
G2170 and suggested that we continue to assign the code to APC 5194
based on the HOP Panel recommendation at the August 31, 2020 meeting.
They argued that the number of single claims on which to base the
reassignment is too low, and recommended that CMS maintain the current
assignment to APC 5194 until more claims data can be gathered for
appropriate APC assignment. However, one commenter suggested that we
reassign HCPCS code G2170 to APC 5193 based on the 1-year
[[Page 85955]]
claims data, and stated that the HOP Panel recommendation to maintain
the assignment to APC 5194 is not supported by the hospital claims
data. This same commenter suggested that the 1-year hospital claims
data does support maintaining HCPCS code G2171 in APC 5194. One
commenter reported that reassigning the code to APC 5193 would be
insufficient to cover the cost of the procedure in the ASC setting.
According to the commenter, the proposed CY 2021 ASC payment for HCPCS
code G2170 is $5,887.63, which does not cover the cost of the $6,000
device used in the procedure.
Response: As noted above, HCPCS codes G2170 and G2171 are two
technologies used for hemodialysis arteriovenous fistula creation. We
note that these procedures are furnished to dialysis patients with
chronic kidney disease, which affects thousands of Medicare
beneficiaries. To ensure Medicare access to these dialysis-related
procedures in both the hospital outpatient and ASC settings, which is
in line with various HHS initiatives, including the HHS Initiative on
``Advancing American Kidney Health'', we believe that we should
maintain both codes in APC 5194 for CY 2021. In addition, maintaining
the assignment to APC 5194 for both codes is consistent with the HOP
Panel's recommendation at the August 31, 2020 meeting. Moreover, given
the low frequency of claims for HCPCS code G2170 (predecessor HCPCS
code C9754), we also reviewed the arithmetic mean and median costs for
the code, as we would do for New Technology APC services with fewer
than 100 claims. We noted that HCPCS code G2170 and HCPCS code G2171
(predecessor HCPCS code C9755) have very similar median costs, and
combined with the low claims data for HCPCS code G2170, the fact that
this is the first year of claims data available for these services, as
well as the public comments and the HOP Panel recommendation, we
believe that it would be inappropriate to assign these two services to
different APCs. As a result, we are using 1833(t)(2)(E) to assign HCPCS
code G2170 (predecessor HCPCS code C9754) to APC 5194 because its cost
is similar to HCPCS code G2171 and both procedures are performed for
ESRD patients that need dialysis. Therefore, we are using our equitable
adjustment authority under section 1833(t)(2)(E) of the Act, which
states that the Secretary shall establish, in a budget neutral manner,
other adjustments as determined to be necessary to ensure equitable
payments, to assign G2170 to APC 5194. We note that we review, on an
annual basis, the APC assignments for all services and items paid under
the OPPS, and continue to monitor the updated claims data for these
codes as they become available.
In summary, after consideration of the public comments, we are
finalizing our proposal with modification. Specifically, we are
finalizing our APC proposal to assign HCPCS code G2171 to APC 5194, and
assigning HCPCS code G2170 to APC 5194 for CY 2021 using our equitable
adjustment authority. The final CY 2021 OPPS payment rates for the
codes can be found in Addendum B to this final rule with comment
period. In addition, we refer readers to Addendum D1 of this final rule
with comment period for the status indicator (SI) meanings for all
codes reported under the OPPS. Both Addendum B and D1 are available via
the internet on the CMS website.
7. Health and Behavior Services (APC 5822)
For CY 2021, we proposed to revise the payment rate associated with
APC 5822 (Level 2 Health and Behavior Services) from $78.54 to $75.26
based on the latest OPPS claims data.
Comment: Some commenters expressed concern with the proposed
payment decrease for APC 5822. Several commenters noted that the APC
includes a number of needed behavioral health services. Those services
include group therapy as well as outpatient programs that are less
intensive than PHPs but are still important for those who may not need
a full day of treatment all week, but who still require substantial
support. The commenters noted that the proposed payment rate decrease
of $3.10 per group per patient equates to a reduction of approximately
$9.30 per patient per day and that group psychotherapy makes up well
over 95 percent of the services provided by programs under Hospital
Partial Hospitalization Services. The commenters urged CMS to reexamine
the data used in developing the payment for APC 5822. Other commenters
requested we reconsider the proposed 4.2 percent payment rate decrease
for APC 5822.
Response: The CY 2021 OPPS payment rates are based on claims
submitted January 1, 2019 through December 31, 2019, processed through
June 30, 2020. Based on our evaluation of the claims data for this
final rule with comment period, the geometric mean cost of APC 5822 is
approximately $72.94 based on 1,069,622 single claims (out of 1,085,044
total claims).
Based on our review, we have no reason to believe that the services
are miscoded. In addition, based on our analysis of the CY 2021 claims
data used for this final rule with comment period, we are unable to
determine whether facilities are misreporting the services. It is
generally not our policy to judge the accuracy of provider coding and
charging for purposes of ratesetting. We rely on providers to
accurately report the use of HCPCS codes in accordance with their code
descriptors and CPT and CMS instructions, and to report services on
claims and charges and costs for the services on their Medicare
hospital cost report appropriately. Also, we generally do not specify
the methodologies that providers use to set charges for this or any
other service. Furthermore, we state in Chapter 4 of the Medicare
Claims Processing Manual that it is extremely important that facilities
report all HCPCS codes consistent with their descriptors; CPT and/or
CMS instructions; and correct coding principles, and that all charges
for services they furnish, whether payment for the services is made
separately paid or is packaged, are reported to enable CMS to establish
future ratesetting for OPPS services. Therefore, we are finalizing our
proposal, without modification, for APC 5822.
8. High-Density Lipoprotein (HDL) Therapy (APC 5243)
For CY 2021, we proposed to continue to assign CPT code 0342T
(Therapeutic apheresis with selective hdl delipidation and plasma
reinfusion) to APC 5243 (Level 3 Blood Product Exchange and Related
Services) with a proposed payment of $4,074.81.
Comment: One commenter reported that their company expects FDA
Humanitarian Device Exemption approval in Q4 of 2020 for its ``PDS-2
System,'' an HDL Therapy system that is designed to reduce plaque in
coronary arteries and increase HDL levels in patients diagnosed with
homozygous familial hypercholesterolemia (HoFH). The commenter
indicated that the code associated with their device is CPT code 0342T.
The commenter stated that they intend to apply to CMS for a new
technology APC in early 2021. According to the commenter, the cost of
the therapy described by CPT code 0342T is $77,100. The commenter
suggested that the proposed payment of $4,074.81 for APC 5243 (Level 3
Blood Product Exchange and Related Services) and $37,470.54 for APC
5244 (Level 4 Blood Product Exchange and Related Services) does not
capture the cost of providing the therapy, and
[[Page 85956]]
consequently, the company intends to submit an application for a new
technology APC in 2021.
Response: We thank the commenter for making us aware of their
intent to submit a new technology APC application. Once we receive the
application, we will review it and make the appropriate determination.
9. Imaging With and Without Contrast (APCs 5523, 5524, 5571, 5572, and
5573)
a. Cardiac Computed Tomography (CT) (APC 5571)
For CY 2021, we proposed to continue to assign the following
cardiac CT exam codes to APC 5571 (Level 1 Imaging with Contrast) with
a proposed payment rate of $181.41.
75572 (Computed tomography, heart, with contrast material,
for evaluation of cardiac structure and morphology (including 3d image
postprocessing, assessment of cardiac function, and evaluation of
venous structures, if performed))
75573 (Computed tomography, heart, with contrast material,
for evaluation of cardiac structure and morphology in the setting of
congenital heart disease (including 3d image postprocessing, assessment
of lv cardiac function, rv structure and function and evaluation of
venous structures, if performed))
75574 (Computed tomographic angiography, heart, coronary
arteries and bypass grafts (when present), with contrast material,
including 3d image postprocessing (including evaluation of cardiac
structure and morphology, assessment of cardiac function, and
evaluation of venous structures, if performed))
We received many comments related to our proposed payment for the
cardiac CT codes. Below is a summary of the public comments and our
responses to the comments.
Comment: Many commenters opposed the assignment of CPT codes 75572,
75573, and 75574, which are the codes that describe cardiac CT exams,
to APC 5571. They stated that the proposed CY 2021 OPPS payment rate of
$181.41 for APC 5571 is inadequate to cover the total cost of providing
the service. They also indicated that the proposed payment will result
in decreased reimbursement for cardiac CT for the fourth consecutive
year. Commenters were particularly concerned with the proposed payment
for CPT code 75574, for which, according to the commenters, the payment
rate has decreased by 30 percent over the past 3 years. They reported
that the cardiac CT exam is a complex exam and more time-consuming to
perform and interpret than any other type of contrast CT scan. They
also believe that the resource costs required to perform cardiac CT
scans are similar to the tests that are assigned to APC 5573 rather
than APC 5571. They noted that the low payment for the test limits
patient access, and requested that CMS take action to increase
reimbursement to levels in line with the actual testing costs. The
commenters requested an APC reassignment for all three codes.
Specifically, the commenters suggested reassigning CPT codes 75572 and
75573 to APC 5572 and CPT code 75574 to APC 5573. Most of the
commenters reported that cardiac CT scans are more resource intensive
than other CT and x-ray scans and are similar to other cardiac stress
imaging modalities like nuclear stress testing; therefore, cardiac CT
scans should be reimbursed accordingly.
Another commenter reported that the test described by CPT code
75574 generally takes about four times longer to perform than a CT scan
of the thorax with contrast that is described by CPT code 71260
(Computed tomography, thorax; with contrast material(s)) and also
assigned to APC 5571. The commenters noted that based on clinical
indications and performance/interpretation, CPT code 75574 is very much
like a SPECT nuclear scan, which is described by CPT code 78452
(Myocardial perfusion imaging, tomographic (spect) (including
attenuation correction, qualitative or quantitative wall motion,
ejection fraction by first pass or gated technique, additional
quantification, when performed); multiple studies, at rest and/or
stress (exercise or pharmacologic) and/or redistribution and/or rest
reinjection) and assigned to APC 5593 (Level 3 Nuclear Medicine and
Related Services) with a proposed payment rate of $1,336.28, rather
than a CT scan of the thorax. The commenters further asserted that
cardiac CT scans prior to invasive angiography lead to lower
utilization of cardiac catheterization, PCI, and costs.
Response: Payments under the OPPS are based on our analysis of the
latest available claims and cost report data submitted to Medicare. We
have many years of claims data for CPT codes 75572, 75573, and 75574.
The AMA established specific CPT codes for cardiac CT services
beginning in 2006 when they were first described by Category III codes.
The Category III CPT codes were subsequently deleted on December 31,
2009, and replaced with Category I CPT codes 75572, 75573, and 75574,
which were effective on January 1, 2010. Because OPPS payments are
updated every year based on our analysis of the latest claims data, the
payment rates have varied each year based on that data.
For CY 2021, OPPS payments are based on claims submitted between
January 1, 2019 through December 31, 2019, that were processed on or
before June 30, 2020. Based on our evaluation of the claims data for
this final rule, the geometric mean costs for the cardiac CT scan codes
range between $157 and $196. Specifically, as shown in Table 21, our
analysis show a geometric mean cost of approximately $157 for CPT code
75572 based on 14,262 single claims, approximately $194 for CPT code
75573 based on 317 single claims, and approximately $196 for CPT code
75574 based on 32,556 single claims. Based on the geometric mean costs
for these codes, we do not believe that CPT codes 75572, 75573, and
75574 utilize similar resources as the exams assigned to APC 5572 or
APC 5573. The geometric mean costs for the tests placed in APC 5571
range between $157 and $196, while the tests in APC 5572 range between
$265 and $510, and for APC 5573, between $534 and $961.
In addition, our data shows that the resources associated with
cardiac CT exams are unlike those of single photon emission CT (SPECT)
nuclear scans (CPT code 78452). As listed in Table 21, our data shows
that SPECT nuclear scans are more often performed on Medicare patients
than cardiac CT exams. Specifically, CPT code 78452 shows a geometric
mean cost of approximately $1,288 based on 591,344 single claims
compared to 47,135 single claims for cardiac CT (CPT codes 75572,
75573, and 75574). Although the commenters have indicated that the
resource costs associated with cardiac CT exams are similar to SPECT
nuclear scans, our analysis of the latest OPPS claims data reveal
otherwise. Similarly, we found the same results for nuclear stress
tests (CPT codes 93350 and 93351). That is, that the estimated resource
costs to perform nuclear stress tests are higher than for cardiac CT.
As noted in Table 21, the geometric mean costs for nuclear stress test
range between $529 and $671 based on 92,670 single claims for CPT codes
93350 and 93351, while the geometric mean costs for the cardiac CT
codes range between $157 and $196.
[[Page 85957]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.033
We believe our claims data accurately reflects the resources
associated with providing cardiac CT exams in the HOPD setting. Because
CPT codes 75572, 75573, and 5574 have been active for some time now, we
have no reason to believe that HOPDs have issues with coding or
reporting these exams correctly. We believe that HOPDs have had
sufficient time to learn how to code and report these services
accurately using the Category I CPT codes that were established in
2010.
Moreover, we believe that we have substantial claims data for the
cardiac CT services upon which to base the CY 2021 final OPPS payment
rates. As noted in Table 22, the total number of claims for these codes
has increased each year. The historical OPPS payments for cardiac CT
services does not appear to have affected Medicare beneficiaries'
access to these services. Given that these services have been paid
under the OPPS for many years, with payments based on the latest
hospital claims and Medicare cost report data, we believe we are
providing a stable and consistent payment methodology that
appropriately reflects the hospital resources required for cardiac CT.
[GRAPHIC] [TIFF OMITTED] TR29DE20.034
Further, reassigning CPT codes 75572 and 75573 from APC 5571 to APC
5572, and CPT code 75574 from APC 5571 to APC 5573 would potentially
significantly overpay for the exams. As noted in Table 23, which shows
the percent change for each code, reassigning the codes to APC 5572 and
APC 5573 would pay at a rate that is two and three times the estimated
cost of the service as reflected in the hospital outpatient claims
data, and we do not believe that overpaying for the exams is
appropriate. We note that we monitor our claims data every year to
assess the appropriateness of the APC assignments for all services
under the hospital OPPS.
[[Page 85958]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.035
Every year, since the implementation of the OPPS on August 1, 2000,
we receive many requests from specialty associations, device
manufacturers, drug manufacturers, and consultants to increase the
payments for codes associated with specific drugs, devices, services,
and surgical procedures. Under the OPPS, one of our goals is to make
payments that are appropriate for the items and services that are
necessary for the treatment of Medicare beneficiaries. The OPPS, like
other Medicare payment systems, is budget neutral and increases are
generally limited to the annual payment update factor. As a budget
neutral payment system, the OPPS does not pay the full hospital costs
of services, however, we believe that our payment rates generally
reflect the costs that are associated with providing care to Medicare
beneficiaries. Furthermore, we believe that our payment rates are
adequate to ensure access to services.
Comment: Commenters stated that the current methodology for
determining OPPS payments disadvantages cardiac CT exams
disproportionately and requested that CMS exercise its authority to
create an exception to the current payment methodology for the three
cardiac CT codes. As an alternative to the current methodology for
establishing OPPS payment rates, the commenters suggested using the
general cardiology revenue code to set the payment rates for CPT codes
75572, 75573, and 75574. They stated that based on their study that
used claims data from CY 2021 OPPS proposed rulemaking, the use of a
general cardiology revenue code to set the payment rates matches the
actual cost of cardiac exams. Specifically, their results reveal a
geometric mean cost of about $400.55 for CPT code 75572, $479.74 for
CPT code 75573, and $505.89 for CPT code 75574. Based on their
analysis, the commenters contended that the geometric mean costs for
CPT codes 75572 and 75573 justify their assignment to APC 5572, and CPT
code 75574 to APC 5573.
Response: It is our standard ratesetting methodology to rely on
hospital cost and charge information as it is reported to us through
the claims and cost report data. We believe that the assignment to APC
5571 for the cardiac CT codes is fully consistent with our standard
ratesetting methodology, which provides appropriate incentives for
efficiency. The OPPS is a prospective payment system that relies on
hospital charges on the claims and cost report data from the hospitals
that furnish the services in order to determine relative costs for OPPS
ratesetting. We believe that the prospective payment rates for CPT
codes 75572, 75573, and 75574, calculated based on the costs of those
providers that furnished the services in CY 2019, provide appropriate
payment to the providers who will furnish the services in CY 2021. We
continue to believe that this standard ratesetting methodology
accurately provides payment for cardiac CT exams furnished to hospital
outpatients.
Comment: One commenter recommended that we decrease the payment for
CPT code 78452 because the commenter believes SPECT is an outdated test
for chest pain evaluation. The commenter also stated that the test is
overutilized with no evidence of improvement in patient outcomes.
Response: As stated above, we review, on an annual basis, the APC
assignments for all services and items paid under the OPPS based on our
analysis of the latest claims data. For CY 2021, OPPS payments are
based on claims data submitted between January 1, 2019 through December
30, 2019, that were processed on or before June 30, 2020. Based on our
analysis, and as shown in Table 21 above, the claims data for CPT code
78452 show a geometric mean cost of approximately $1,288 based on
591,344 single claims, which is consistent with the geometric mean cost
of about $1,272 for APC 5593 (Level 3 Nuclear Medicine and Related
Services). We believe that CPT code 78452 is appropriately assigned to
APC 5593. Therefore, based on the latest claims data, we have no basis
to reassign the SPECT exam CPT code 78452 to another APC with a lower
payment rate.
Comment: Some commenters recommended that CMS allow facilities to
submit charges for cardiac CT using revenue codes that they believe
would more accurately estimate costs. They added that CMS should
provide explicit permission via a line item to allow hospitals to
submit charges for cardiac
[[Page 85959]]
CT tests under the cardiology stress testing revenue/cost centers. They
noted that CMS guidance for all non-CT and MR CPT codes is for
hospitals to submit claims utilizing revenue codes that most accurately
reflect clinical and resource homogeneity. They believe that making an
exception to the current policy and allowing HOPDs to submit charges
for cardiac CT tests under the cardiology stress testing revenue/cost
centers would provide better data in the future that reflects actual
resource costs for cardiac CT.
Response: Hospital outpatient facilities make the final
determination for reporting the appropriate cost centers and revenue
codes. As stated in section 20.5 in Chapter 4 (Part B Hospital) of the
Medicare Claims Processing, CMS ``does not instruct hospitals on the
assignment of HCPCS codes to revenue codes for services provided under
OPPS since hospitals' assignment of cost vary. Where explicit
instructions are not provided, providers should report their charges
under the revenue code that will result in the charges being assigned
to the same cost center to which the cost of those services are
assigned in the cost report.'' Therefore, HOPDs must determine the most
appropriate cost center and revenue code for the cardiac CT exams.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, to assign the cardiac CT
exam codes, specifically, CPT codes 75572, 75573, and 75574 to APC
5571. The final CY 2021 OPPS payment rates for the codes can be found
in Addendum B to this final rule with comment period. In addition, we
refer readers to Addendum D1 of this final rule with comment period for
the status indicator (SI) meanings for all codes reported under the
OPPS. Both Addendum B and D1 are available via the internet on the CMS
website.
b. Cardiac Magnetic Resonance (CMR) Imaging (APC 5523, 5524, 5572, and
5573)
For CY 2021, we proposed to continue to assign the following
cardiac magnetic resonance imaging (MRI) CPT codes to APC 5523, 5524,
5572, and 5573, respectively:
CPT code 75557 (Cardiac magnetic resonance imaging for
morphology and function without contrast material) to APC 5523 (Level 3
Imaging without Contrast) with a proposed payment of $235.05;
CPT code 75559 (Cardiac magnetic resonance imaging for
morphology and function without contrast material; with stress imaging)
to APC 5524 (Level 3 Imaging without Contrast) with a proposed payment
of $490.52;
CPT code 75561 (Cardiac magnetic resonance imaging for
morphology and function without contrast material(s), followed by
contrast material(s) and further sequences) to APC 5572 (Level 2
Imaging with Contrast) with a proposed payment of $375.33; and
CPT code 75563 (Cardiac magnetic resonance imaging for
morphology and function without contrast material(s), followed by
contrast material(s) and further sequences; with stress imaging) to APC
5573 (Level 3 Imaging with Contrast) with a proposed payment of
$722.74.
Comment: Some commenters expressed concern with the lack of payment
stability for cardiac MRI services, specifically, those described by
CPT codes 75557, 75559, 75561, and 75563. They indicated that the
payments for these codes have decreased in the last several years, and
prior to CY 2017, the codes were placed in appropriate APCs. Of
significant concern are the payment rates for CPT codes 75561 and
75563, which, according to the commenters, are grouped with services
that are not clinically similar. The commenters stated that CPT code
75561 is unlike CT of the abdomen or pelvis or MRI of the neck and
spine in APC 5572, and instead, the code should be placed in APC 5573
with comparable services. The commenters further added that CPT code
75563 is labor-intensive and should be assigned to APC 5593 (Level 3
Nuclear Medicine and Related Services).
Response: Payment changes from one year to the next are unavoidable
in a relative weight payment system that depends on updated hospital
charges and costs and in which reassignment of HCPCS codes from one APC
to another is required by law in cases of 2 times rule violations. The
statutory design of the OPPS and the evolution in the delivery of
outpatient hospital services include elements that are responsible for
some of the fluctuation in payment rates from year to year. The OPPS is
based on HCPCS coding for which there are hundreds of changes each
year. In addition, the entry of new technology into a budget neutral
payment system results in a shift of funds away from previously
existing services to provide payments for new services. These factors
are reflections of the changes in services in the outpatient
department, and shifts in payment mirror those changes.
Moreover, section 1833(t)(9)(A) of the Act requires the Secretary
to review, not less often than annually, and revise the APC groups, the
relative payment weights, and the wage and other adjustments to take
into account changes in medical practice, changes in technology, the
addition of new services, new cost data, and other relevant information
and factors. Consequently, we review, on an annual basis, the APC
assignments for all services and items paid under the OPPS based on our
analysis of the latest claims data. For CY 2021, OPPS payments are
based on claims data submitted between January 1, 2019 through December
30, 2019, that were processed on or before June 30, 2020. Based on our
analysis, and as shown in Table 24, the claims data for CPT code 75557
show a geometric mean cost of approximately $250 based on 1,941 single
claims, which is consistent with the geometric mean cost of about $224
for APC 5523 (Level 3 Imaging Without Contrast). Similarly, the
geometric mean cost for CPT code 75559 is approximately $403 based on
57 single claims, which is in line with the geometric mean cost of
about $470 for APC 5524. For CPT code 75561, the geometric mean cost is
approximately $426 based on 17,216 single claims, which is in line with
the geometric mean cost of approximately $359 for APC 5572. We note
that the geometric mean cost of approximately $426 for CPT code 75561
is within the range of the significant geometric mean cost for APC
5572, which is between approximately $265 (for CPT code 74174) and
about $510 (for CPT code 73525). For CPT code 75563, the geometric mean
cost is about $761 based on 2,370 single claims, which is close to the
geometric mean cost of approximately $697 for APC 5573. The geometric
cost of approximately $761 for CPT code 75563 is within the range of
the significant geometric mean cost for APC 5573, which is
approximately between $534 (for CPT code C8923) and about $961 (for
HCPCS code C8928). Based on the latest claims data, we believe that the
cardiac MRI codes are appropriately assigned to APCs 5523, 5524, 5572,
and 5573.
[[Page 85960]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.036
In addition, based on the commenters' belief that the APC
assignments for the cardiac MRI codes were appropriately placed prior
to CY 2017 and not currently, we reviewed the OPPS payment rates from
CY 2016 through CY 2021. Based on our evaluation, we believe that the
payments for the cardiac MRI codes are appropriate. The OPPS, like
other Medicare payment systems, is a prospective payment system based
on averages. In some individual cases payment exceeds the average cost
and in other cases payment is less than the average cost. Based on our
review, we believe that the historical and current payment rates for
CPT codes 75557, 75559, 75561, and 75563, reflect the geometric mean
costs associated with the service that are consistent with providing
cardiac MRI to Medicare beneficiaries in cost efficient settings.
Comment: Some commenters expressed concern with the clinical
homogeneity in the Imaging APCs and requested more transparency. They
also questioned the criteria for assigning HCPCS codes to specific APCs
and as well as why the Imaging APCs were reduced from 17 to 7 APCs.
Response: Every year we publish an OPPS/ASC proposed rule that
informs the public of our proposed policies, which include payment
rates for specific HCPCS codes, for the upcoming year that will become
effective on January 1. The proposed rules are subject to a 60-day
public comment period, and comments received by the due dates are
addressed in the final rules. In the April 7, 2000 OPPS final rule, we
defined the term ``clinical homogeneity.'' As stated in the April 7,
2000 final rule, ``The definition of each APC group should be
`clinically meaningful,' that is, the procedures or services included
within the APC group relate generally to a common organ system or
etiology, have the same degree of extensiveness, and utilize the same
method of treatment, for example, surgical, endoscopic, etc. The
definition of clinical meaningfulness is, of course, dependent on the
goal of the classification system. For APCs, the definition of clinical
meaningfulness relates to the medical rationale for differences in
resource use. If, on the other hand, classifying patient prognosis were
the goal, the definition of patient characteristics that were
clinically meaningful might be different.'' (68 FR 18457).
In addition, we believe that the combined annual proposed and final
rules with their accompanying addenda and cost statistics files, as
well as the quarterly OPPS and ASC update change request documents that
are issued by CMS provide substantial transparency on APCs and,
overall, the OPPS payment system.
With regard to the reduction from 17 to 7 APCs for the Imaging
APCs, we discussed the issue in the CY 2017 OPPS/ASC final rule (81 FR
79628 through 79631) and stated that the change was based on
stakeholder recommendations. As a part of our CY 2016 (80 FR 70392
through 70397) and CY 2017 (81 FR 79628 through 79631) comprehensive
review of the structure of the imaging APCs and procedure code
assignments, we examined the APCs that contained imaging services. For
CY 2017, we proposed and updated the restructuring of the OPPS APC
groupings for imaging services to more appropriately reflect the costs
and clinical characteristics of the procedures within each APC grouping
in the context of the OPPS. We believe that the updated restructuring
and reconfiguration of the Imaging APCs appropriately reflect the
similar resource costs and clinical characteristics of the procedures
within each APC. We also believe that the current broader categories of
Imaging APCs are appropriate for ratesetting under the OPPS because
they support greater similarities in clinical characteristics and
resource use of procedures assigned to the APCs, while improving the
homogeneity of the APC structure.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, to assign CPT code 75557
to APC 5523, CPT code 75559 to APC 5524, CPT code 75561 to APC 5572,
and CPT code 75563 to APC 5573. The final CY 2021 payment rates for the
codes can be found in Addendum B to this final rule with comment
period. In addition, we refer readers to Addendum D1 of this final rule
with comment period for the status indicator (SI) meanings for all
codes reported under the OPPS. Both Addendum B and D1 are available via
the internet on the CMS website.
10. IDx-DR: Artificial Intelligence System To Detect Diabetic
Retinopathy (APC 5733)
As stated in a press release issued by the FDA on April 11, 2018,
the IDx-DR is the ``first medical device to use artificial intelligence
(AI) to detect greater than a mild level of the eye disease diabetic
retinopathy in adults who have diabetes'' (https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-artificial-intelligence-based-device-detect-certain-diabetes-related-eye).
Approved for marketing by the FDA in April 2018, the artificial
intelligence
[[Page 85961]]
algorithm provides a clinical decision without the need for a clinician
to also interpret the image. A provider uploads the digital images of
the patient's retinas to a cloud server on which the IDx-DR software is
installed, and once analysis is completed, the provider is given one of
the following two results:
More than mild diabetic retinopathy detected: Refer to an
eye care professional; or
negative for more than mild diabetic retinopathy; rescreen
in 12 months.
The test itself generally takes about 5 minutes to complete and
does not need to be performed by a clinician. The test associated with
the IDx-DR technology received a new CPT code effective January 1,
2021, specifically, CPT code 92229. With the establishment of the new
code, the CPT Editorial Panel also revised the descriptors associated
with existing CPT codes 92227 and 92228 to appropriately differentiate
them from the IDx-DR test. Below are the complete descriptors for CPT
codes 92227, 92228, and 92229 for CY 2021. We note that CPT code 92229
was listed as placeholder 9225X in Addendum B of the CY 2021 OPPS/ASC
proposed rule:
92227 (Imaging of retina for detection or monitoring of
disease; with remote clinical staff review and report, unilateral or
bilateral);
92228 (Imaging of retina for detection or monitoring of
disease; with remote physician or other qualified health care
professional interpretation and report, unilateral or bilateral); and
92229 (Imaging of retina for detection or monitoring of
disease; point-of-care automated analysis and report, unilateral or
bilateral).
As stated in the CY 2021 OPPS/ASC proposed rule (85 FR 48839),
based on our evaluation of the service, we believe that IDx-DR is a
diagnostic test that should be payable under the hospital OPPS, similar
to existing CPT codes 92227 and 92228, which are assigned to APC 5732
(Level 2 Minor Procedures) and status indicator ``Q1.'' Based on its
clinical similarity to CPT codes 92227 and 92228, we believe that the
IDx-DR test should also be assigned to APC 5732. Consequently, for CY
2021, we proposed to assign the new IDx-DR CPT code to APC 5732 with a
proposed payment rate of $33.16. We also proposed to assign the code to
status indicator ``Q1'' to indicate that the code is conditionally
packaged when performed with another service on the same day. Because
the IDx-DR test will most often be performed as part of a visit, we
believed that packaging the cost into the primary service is
appropriate. We note that under the OPPS, the HOPD E&M visit code
(G0463; CY 2021 OPPS proposed payment rate of $120.88) is paid
separately when not billed with a C-APC, and we believed that payment
would include the cost of providing the IDx-DR test. Generally, our
policy for tests with minimal costs is to package the cost into the
primary service.
Comment: Some commenters disagreed with the proposed payment amount
and requested a revision in the assignment from APC 5732 to APC 5734
(Level 4 Minor Procedures) with a proposed payment rate of $113.23 and
assignment to status indicator ``Q1''. The commenters reported that the
service described by new CPT code 92229, which was listed as
placeholder CPT code 9225X in Addendum B to the CY 2021 OPPS/ASC
proposed rule), is similar to the technical components described by
existing CPT code 92250 (Fundus photography with interpretation and
report), which was proposed for assignment to APC 5734 and status
indicator ``Q1''. They stated that providers are currently billing on
an interim basis under CPT code 92250 for the same service. The
commenters further disagreed with the comparison to CPT code 92227 and
92228, which are assigned to APC 5732 with a status indicator ``Q1''
and stated that the tests described by these codes involve human
readers while the service described by CPT code 92229 is artificial
(AI) intelligence-related. The commenters indicated that APC 5734,
which is the APC assigned to the predecessor CPT code 92250, is the
more appropriate assignment for new CPT code 92229 until sufficient
Medicare claims data can be collected by CMS to either retain that
assignment or reassign to another APC.
Response: We stated in the CY 2021 OPPS/ASC proposed rule with
comment period (85 FR 48839) that the CPT Editorial Panel revised the
descriptors associated with existing CPT codes 92227 and 92228 to
appropriately differentiate them from the IDx-DR test, which is
described by new CPT code 92229. We note that the descriptors for all
three codes involve tests that use imaging of the retina for detection
or monitoring of disease. Based on the revisions to CPT code 92227 and
92228 and placement of the new code, we believe that the IDx-DR test is
similar to CPT code 92227 and 92228. We do not believe that CPT code
92250, which the commenters reported to be the predecessor code, is
similar to the IDx-DR test; otherwise, the placement of the new IDx-DR
code would have been close to CPT code 92250. However, after further
review and consideration of the issue, we believe that CPT code 92229
should be assigned to APC 5733 (Level 3 Minor Procedures) rather than
APC 5732 (Level 2 Minor Procedures).
We note that under the OPPS, one of our goals is to make payments
that are appropriate for the services that are necessary for the
treatment of Medicare beneficiaries. The OPPS, like other Medicare
payment systems, is a prospective payment system. The payment rates
that are established reflect the geometric mean costs associated with
items and services assigned to an APC and we believe that our payment
rates generally reflect the costs that are associated with providing
care to Medicare beneficiaries in cost efficient settings. Moreover, we
strive to establish rates that are adequate to ensure access to
medically necessary services for Medicare beneficiaries.
For many emerging technologies there is a transitional period
during which utilization may be low, often because providers are first
learning about the techniques and their clinical utility. Quite often,
the requests for higher payment amounts are for new procedures in that
transitional phase. These requests, and their accompanying estimates
for expected Medicare beneficiary or total patient utilization, often
reflect very low rates of patient use, resulting in high per use costs
for which requesters believe Medicare should make full payment.
Medicare does not, and we believe should not, assume responsibility for
more than its share of the costs of procedures based on Medicare
beneficiary projected utilization and does not set its payment rates
based on initial projections of low utilization for services that
require expensive capital equipment.
We note that in a budget neutral environment, payments may not
fully cover hospitals' costs, including those for the purchase and
maintenance of capital equipment. We rely on hospitals to make their
decisions regarding the acquisition of high cost equipment with the
understanding that the Medicare program must be careful to establish
its initial payment rates for new services that lack hospital claims
data based on realistic utilization projections for all such services
delivered in cost-efficient hospital outpatient settings. As the OPPS
acquires claims data regarding hospital costs associated with new
procedures, we annually review the claims data and any available new
information regarding the clinical aspects of new procedures to confirm
that OPPS payments remain appropriate for procedures as they transition
into mainstream medical practice.
[[Page 85962]]
Comment: Several commenters requested a reassignment from proposed
APC 5732 to APC 5733 (Level 3 Minor Procedures) consistent with the APC
assignment for CPT codes 92285 (External ocular photography with
interpretation and report for documentation of medical progress (e.g.,
close-up photography, slit lamp photography, goniophotography, stereo-
photography) and 92134 (Scanning computerized ophthalmic diagnostic
imaging, posterior segment, with interpretation and report, unilateral
or bilateral; retina).
Response: The IDx-DR test generally takes about 5 minutes to
complete and does not need to be performed by a clinician. Based on our
evaluation of the service, we believe that IDx-DR is a diagnostic test
that should be payable under the hospital OPPS. We do not believe that
the services described by CPT code 92285 or 92134 are appropriate
comparisons for the IDx-DR test because these tests generally involve
physician work and require approximately 10 minutes to perform.
However, after further review and deliberation of the issue, we believe
that CPT code 92229 should be assigned to APC 5733 (Level 3 Minor
Procedures) rather than APC 5732 (Level 2 Minor Procedures).
Comment: Some commenters requested a change in the proposed status
indicator assignment for CPT code 92229 from ``Q1'' to ``S'' to ensure
that the test is separately reimbursed when provided with an outpatient
clinic visit or other service. The commenters indicated that assigning
the code to ``Q1'' will not support patient access in the outpatient
setting and will encourage less efficient care. They suggested that
HOPDs would likely schedule patients to receive only the IDx-DR test
during an outpatient visit, instead of performing the test during a
clinic visit, and could discourage hospitals from offering the test
altogether. They further suggested that diabetic patients receiving
diabetic care in the outpatient setting would likely be asked to make
separate appointments as a result of the status indicator ``Q1''
assignment.
Response: With regard to HOPDs potentially scheduling the IDx-DR
test on a separate day from the clinic visit to receive separate
payment, we have concerns about this kind of manipulation of patient
scheduling because such a practice could create an undue burden for
Medicare beneficiaries. We expect HOPDs to furnish services in the most
efficient way that meets the needs of the patient. After further review
and deliberation on the issue, we are revising the status indicator to
``S'' to ensure patient access to the test.
In summary, after consideration of the public comments, we are
finalizing our proposal, with modification. Specifically, we are
assigning CPT code 92229 to APC 5733 with status indicator ``S.'' The
final CY 2021 payment rate for the code can be found in Addendum B to
this final rule with comment period. In addition, we refer readers to
Addendum D1 of this final rule with comment period for the status
indicator (SI) meanings for all codes reported under the OPPS. Both
Addendum B and D1 are available via the internet on the CMS website.
11. Implantable Interstitial Glucose Sensor System (APC 5051 and 5054)
For CY 2021, we proposed to assign CPT code 0447T to APC 5051
(Level 1 Skin Procedures) with a proposed OPPS payment of $182.38. In
addition, we proposed to assign CPT codes 0446T and 0448T to APC 5053
(Level 3 Skin Procedures) with a proposed OPPS payment of $530.98. We
note that the long descriptors for these codes can be found in Table 25
below.
Comment: A commenter agreed with the proposed APC assignment for
CPT code 0447T to APC 5051 but opposed the proposed assignment for CPT
codes 0446T and 0448T to APC 5053. The commenter stated that the
payment for APC 5053 does not include the provision of the service
associated with the Eversense Implantable Continuous Glucose System
(CGS), which is a technology that provides real-time glucose
monitoring. Specifically, the payment for APC 5053 does not account for
providing the glucose sensor and wireless transmitter, as well as
implanting, removing, and replacing the glucose sensor. In contrast,
the commenter believed that CPT codes 0446T and 0448T include those
costs, referring to the discussion in the CY 2020 PFS final rule (84 FR
62627). The commenter added that assignment to APC 5053 is
inappropriate based on clinical homogeneity and resource cost, and
suggested reassigning CPT codes 0446T and 0448T to either APC 5054
(Level 4 Skin Procedures) with a proposed OPPS payment of $1,733.06 or
New Technology APC 1523 (New Technology--Level 23 ($2501-$3000)) with a
proposed OPPS payment of $2,750.50.
Response: Although CPT codes 0446T, 0447T, and 0448T were effective
January 1, 2017, the Eversense CGM technology was only recently
approved for marketing by the FDA on June 6, 2019. For CY 2021, OPPS
payments are developed based on claims submitted between January 1,
2019 through December 31, 2019, and processed through June 30, 2020.
For this final rule with comment period, we have no claims data for CPT
codes 0446T, 0447T, or 0448T for OPPS ratesetting purposes. However,
based on our review of the issue, and feedback from our medical
advisors, as well as the expected device costs associated with CPT
codes 0446T and 0448T as discussed in the CY 2021 PFS proposed rule (85
FR 50174), we believe that these codes should be reassigned to APC 5054
(Level 4 Skin Procedures) rather than New Technology APC 1523 (New
Technology--Level 23 ($2501-$3000)). Because we have neither claims
data nor specific HOPD costs, including the cost to perform each exam
(other than the supply cost discussed in the CY 2021 PFS proposed
rule), we believe that APC 5054 is the most appropriate assignment at
this time for CPT codes 0446T and 0448T.
Therefore, after consideration of the public comment, we are
finalizing our proposal, with modification. Specifically, we are
finalizing our proposal for CPT code 0447T and assigning the code to
APC 5051, however, we are reassigning CPT codes 0446T and 0448T to APC
5054. Table 25 list the long descriptors and final SI and APC
assignments for the codes. The final CY 2021 payment rate for the codes
can be found in Addendum B to this final rule with comment period. In
addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
[[Page 85963]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.037
12. Intervertebral Disc Allogeneic Cellular and/or Tissue-Based Product
Percutaneous Injection (APC 5115)
In the CY 2021 OPPS/ASC Proposed Rule, we proposed to assign the
procedures described by CPT codes 0627T (Percutaneous injection of
allogeneic cellular and/or tissue-based product, intervertebral disc,
unilateral or bilateral injection, with fluoroscopic guidance, lumbar;
first level) and 0629T (Percutaneous injection of allogeneic cellular
and/or tissue-based product, intervertebral disc, unilateral or
bilateral injection, with CT guidance, lumbar; first level) to status
indicator ``T'', APC 5443 (Level 3 Nerve Injections) with a proposed
OPPS payment rate of $836.26 based on the estimated costs of these
procedures.
We proposed to assign the procedures described by CPT codes 0628T
(Percutaneous injection of allogeneic cellular and/or tissue-based
product, intervertebral disc, unilateral or bilateral injection, with
fluoroscopic guidance, lumbar; each additional level (List separately
in addition to code for primary procedure) and 0630T (Percutaneous
injection of allogeneic cellular and/or tissue-based product,
intervertebral disc, unilateral or bilateral injection, with CT
guidance, lumbar; each additional level (List separately in addition to
code for primary procedure) to status indicator ``N'' to indicate that
they are packaged under OPPS since they are add-on codes. These codes
were listed as 0X32T, 0X33T, 0X34T, and 0X37T (the 5-digit CMS
placeholder codes) in Addendum B with the short descriptor and also in
Addendum O with the long descriptor, to the CY 2021 OPPS/ASC proposed
rule.
We also proposed to assign these codes to comment indicator ``NP''
in Addendum B to indicate that the codes are new for CY 2021 and that
public comments would be accepted on the proposed status indicator
assignment. We note that these codes will be effective January 1, 2021.
Comment: Some commenters disagreed with the assignment of codes
0627T and 0629T to APC 5443 based on what the commenters believed was a
lack of clinical and resource coherence with other procedures in this
APC. They stated that CPT codes 0627T and 0629T involve percutaneous
placement of an allogeneic cellular and/or tissue-based biologics to
supplement and support deteriorating vertebral discs in patients
suffering from degenerative disc disease. They believe that these
procedures are not comparable to a simple nerve injection.
One commenter explained that the cost of these procedures is
significantly higher than the proposed Level 3 Nerve Injection APC
payment, which is $836.26. The cost of the VIA Disc Matrix Kit used for
these procedures is $8,000 per kit. Therefore, they believed that a
higher APC payment level more appropriately covers both the cost of the
device and the non-device costs of the procedure.
Another commenter noted that the non-device costs of procedures
0627T and 0629T are most appropriately crosswalked to CPT code 22514
(Percutaneous vertebral augmentation, including cavity creation
(fracture reduction and bone biopsy included when performed) using
mechanical device (e.g. kyphoplasty), 1 vertebral body, unilateral or
bilateral cannulation, inclusive of all imaging guidance; lumbar) that
is assigned to APC 5114 (Level 4 Musculoskeletal Procedures) with the
payment rate of $6,368.58.
A medical device company recently submitted a new technology APC
application to CMS for VIA[supreg] Disc Allograft Supplementation
described by codes 0627T and 0629T and requested that CMS assign CPT
codes 0627T and 0629 to APC 1575 (New Technology APC Level 38 ($10,001-
$15,000)) for CY 2021 based on total estimated non-device-related cost
of APC 5114 ($4,524) plus the device-related costs ($8,000) or $12,524
which is closest to APC 1575 with a CY 2021 proposed payment rate of
$12,500.50.
The same device company recommended, because 0628T and 0630T are
add-on codes used in conjunction with their primary procedural codes
0627T and 0629T, that CMS uses the device-related cost for each
additional VIA Disc mixing system kit of $8,000 plus an incremental
thirty minute non-device cost to capture the additional operative time
and costs in performing a separate intervertebral disc injection.
The commenter requested that CMS assign CPT codes 0628T and 0630T
to APC 1571 (New Technology APC Level 34 ($8001-$8500)) for CY 2021
since the total estimated cost of these codes is closest to APC 1571
with a CY 2021 proposed payment rate of $8,250.50.
[[Page 85964]]
Response: Based on our review of the application and input from our
clinical advisors, we agree that the codes would be appropriately
placed in an alternative APC that might better reflect their resource
costs. Our updated claims data for this final rule with comment period
shows that the geometric mean cost of APC 5115 is about $11,996.45,
which is more similar to the device and procedure costs associated with
these codes. Therefore, we are assigning CPT codes 0627T and 0629T to
comprehensive APC 5115 (Level 5 Musculoskeletal Procedures) with status
indicator ``J1'' for the CY 2021 OPPS.
CPT codes 0628T and 0630T would be assigned to status indicator
``N'' under OPPS for CY 2021 because the cost of an add-on code is
packaged into the primary procedure under OPPS packaging policy, as
discussed in the CY 2014 OPPS/ASC final rule (78 FR 74942).
In summary, after consideration of the public comments and our
analysis of updated claims data for this final rule and other
additional information, we are finalizing our proposal related to codes
0627T and 0629T with modification. Specifically, we are revising the
APC assignment for CPT codes 0627T and 0629T to APC 5115 and revising
their status indicator to ``J1'' for the CY 2021 OPPS. For CPT codes
0628T and 0630T, we are finalizing our proposal without modification
and maintaining the assignment of status indicator ``N'' to these
codes.
The final CY 2021 OPPS payment rate for CPT codes 0627T and 0629T
and final status indicator assignment for 0628T and 0630T can be found
in Addendum B to this final rule with comment period. In addition, we
refer readers to Addendum D1 of this final rule with comment period for
the status indicator (SI) meanings for all codes reported under the
OPPS. Both Addendum B and D1 are available via the internet on the CMS
website.
The final CY 2021 APC and SI assignments for 0627T through 0630T
can be found in Table 26.
[GRAPHIC] [TIFF OMITTED] TR29DE20.038
13. Intraocular Procedures (APCs 5491 Through 5495)
In prior years, CPT code 0308T (Insertion of ocular telescope
prosthesis including removal of crystalline lens or intraocular lens
prosthesis) was assigned to the APC 5495 (Level 5 Intraocular
Procedures) based on its estimated costs. In addition, its relative
payment weight has been based on its median cost under our payment
policy for low-volume device-intensive procedures because the APC
contained a low volume of claims. The low volume device-intensive
procedures payment policy was discussed in more detail in section
III.C.2. of the proposed rule.
In the CY 2019 OPPS, we assigned procedure code CPT code 0308T to
the APC 5494 (Level 4 Intraocular Procedures) (83 FR 58917 through
58918). We made this change based on the similarity of the estimated
cost for the single claim of $12,939.75 to that of the APC
($11,427.14). However, this created a discrepancy in payments between
the OPPS setting and the ASC setting in which the ASC payments would be
significantly lower than the OPPS payments for the same service because
of the difference in estimated cost for the encounter determined under
a comprehensive methodology within the OPPS and the estimated cost
determined under the payment methodology for device intensive services
within the ASC payment system.
In CY 2020 OPPS/ASC rulemaking, we reestablished APC 5495 (Level 5
Intraocular Procedures) because we believed that the procedure
described by CPT code 0308T would be most appropriately placed in the
APC based on its estimated cost (84 FR 61249 through 61250). Assignment
of the procedure to the Level 5 Intraocular Procedures APC was
consistent with its historical placement and would also address the
large discrepancy in payment for the procedure between the OPPS and the
ASC payment system. We note that we also implemented a policy where the
payment for a service when performed in an ASC (84 FR 61399 through
61400), would be no higher than the OPPS payment rate for the
[[Page 85965]]
service when performed in the hospital outpatient setting.
In reviewing the claims data available for CY 2021 ratesetting,
there was a single claim containing the code 0308T that was unable to
be used for the ratesetting process. In addition, this code and its APC
have historically had relatively low claims volume for ratesetting
purposes. While there were no claims usable for ratesetting in the CY
2021 OPPS proposed data under our standard process, we still needed to
determine a payment weight for the APC. We believed that the most
recently available data that we used to set payment for this service in
the CY 2020 OPPS final rule was an appropriate proxy for both the
procedure's estimated cost and its relative payment weight. We note
that the proposed policy to use prior year claims data in ratesetting
is similar to the application of a geometric mean cost floor to the
Partial Hospitalization APCs, as initially established in the CY 2020
OPPS/ASC final rule (84 FR 61339 through 61347). Therefore, we believed
it was appropriate to propose to use the median cost of $20,229.78 for
CPT 0308T, calculated from claims data used in the CY 2020 OPPS final
rule with comment period, to establish the payment weight for the CY
2021 OPPS for CPT code 0308T. We will continue to monitor the claims
available for the procedure for ratesetting purposes.
To summarize, for CY 2021, we proposed to assign 0308T a payment
weight based on the most recently available data, from the CY 2020 OPPS
final rule, and therefore proposed to assign CPT code 0308T to APC 5495
(Level 5 Intraocular Procedures). Under the proposal, the proposed CY
2021 OPPS payment rate for the service would be established based on
the median cost, as discussed in section V.A.5. of the proposed rule,
because it is a device intensive procedure assigned to an APC with
fewer than 100 total annual claims within the APC. Therefore, the
proposed APC assignment for CPT code 0308T would be based on the CY
2020 OPPS final rule median cost of $20,229.78.
Comment: We received one comment supporting our proposal to
continue to assign the CPT code 0308T to APC 5495 (Level 5 Intraocular
Procedures) and use the CY 2020 median cost as a proxy for use in
developing the CY 2021 OPPS payment rate.
Response: We appreciate the commenter's support. While the updated
final rule claims data includes two claims containing the code 0308T,
those claims are unusable for OPPS ratesetting purposes. Therefore, we
are finalizing our proposed policy to assign CPT code 0308T to APC 5495
and use the CY 2020 median cost in determining a CY 2021 OPPS payment
rate.
After consideration of the public comment we received, we are
finalizing our proposal to continue to assign CPT code 0308T to APC
5495 (Level 5 Intraocular Procedures) for the CY 2021 OPPS and, as a
device intensive procedure assigned to an APC with fewer than 100 total
claims, to establish the CY 2021 OPPS payment rate for the service
using its CY 2020 median cost. Therefore, the CY 2021 OPPS payment rate
for CPT 0308T will be based on the CY 2020 OPPS final rule median cost
of $20,229.78.
14. Irreversible Electroporation Ablation of Tumors (NanoKnife[supreg]
System) (APC 5362)
Electroporation is a technique in which an electrical field is
applied to cells in order to increase the permeability of the cell
membranes through the formation of nanoscale defects in the lipid
bilayer. The result is creation of nanopores in the cell membrane and
disruption of intra-cellular homeostasis, ultimately causing cell
death. After the NanoKnife[supreg] System delivers a sufficient number
of high voltage pulses; the cells surrounded by the electrodes will be
irreversibly damaged. This mechanism, which causes permanent cell
damage, is referred to as Irreversible Electroporation (IRE). The
NanoKnife[supreg] System with six outputs for the treatment of Stage
III pancreatic cancer received FDA Breakthrough Device designation on
January 18, 2018 and approval of an FDA investigational device
exemption (IDE G180278) on March 28, 2019.
The CPT Editorial Panel established two new codes; specifically CPT
codes 0600T and 0601T, to describe NanoKnife[supreg] System procedures
effective July 1, 2020. The manufacturer also submitted a new
technology application requesting new technology APC assignments for
CPT codes 0600T and 0601T. Based on our review of the new technology
APC application for the NanoKnife[supreg] System, we provided temporary
APC and status indicators assignments for 0600T and 0601T. The
temporary APC and SI assignments were publicly released in the July
2020 quarterly update to the OPPS (Transmittal 10224, Change Request
11814, and dated July 15, 2020). In addition, in the CY 2021 OPPS/ASC
proposed rule with comment period, we proposed to assign the codes to
APC 5361 (Level 1 Laparoscopy and Related Procedures) with a payment
rate of $5,148.34, and status indicator `J1'' (Hospital Part B services
paid through a comprehensive APC) based on clinical and resource
similarities between 0600T, 0601T and other procedures in the same APC.
We also proposed to assign these codes to comment indicator (CI) ``NP''
in Addendum B to the proposed rule to indicate that the codes are new
for CY 2020 and that public comments would be accepted on their
proposed APC assignments.
Comment: We received one comment from the applicant on the proposed
assignment to APC 5361 (Level 1 Laparoscopy and Related Procedures).
According to the applicant, new Category III CPT codes 0600T and 0601T
should not be assigned to APC 5361 because the clinical characteristics
and resource costs associated with the procedures are significantly
different from existing procedures assigned to that APC. The applicant
noted that under the IPPS, the NanoKnife[supreg] System was estimated
to have a technology added cost of approximately $11,086, and that the
procedures for which the system would apply generally were not
significantly different in the inpatient and outpatient settings. They
believe that the codes would be more appropriately placed in New
Technology APC 1576 (New Technology--Level 39 ($15,001-$20,000)) with a
payment rate of $17,500.50, based on the estimated costs and complexity
of the procedures.
Response: We thank the applicant for their comment and the
additional information they have provided regarding the procedures and
in particular their estimated costs. While we recognize that there are
differences between the various ablation modalities, we believe that
the APC levels 5361 and 5362 for ``Laparoscopy and Related Services''
appropriately describe the resource costs and clinical characteristics
of these procedures. However, we agree with the commenter that an
alternative APC might better reflect the resource costs of the
procedures. Therefore, we are revising the CY 2021 APC assignments for
these codes. Specifically, we are assigning CPT codes 0600T and 0601T
to APC 5362 (Level 2 Laparoscopy and Related Procedures) with a status
indicator of ``J1'' in the CY 2021 OPPS.
After consideration of the public comment for the new irreversible
electroporation codes, and based on our evaluation of the new
technology application which provided the estimated costs for the
services and described the components and characteristics of the new
codes, we are finalizing our proposal with
[[Page 85966]]
modification, and reassigning CPT codes 0600T and 0601T to the final CY
2021 OPPS APC 5362 (Level 2 Laparoscopy and Related Services). Table 27
lists the four Category III CPT codes for the NanoKnife[supreg] System
and their APC and SI assignments for CY 2021. The final CY 2021 OPPS
payment rate for the codes can be found in Addendum B to this final
rule with comment period (which is available via the internet on the
CMS website).
[GRAPHIC] [TIFF OMITTED] TR29DE20.039
15. Medical Physics Dose Evaluation (APC 5611)
For CY 2021, we proposed to assign CPT code 76145 (Medical physics
dose evaluation for radiation exposure that exceeds institutional
review threshold, including report (medical physicist/dosimetrist)) in
APC 5611 (Level 1 Therapeutic Radiation Treatment Preparation) with a
proposed payment rate of $129.86. We note this is a new code that will
be effective on January 1, 2021. Because the code is new, we requested
public comments on the APC assignment for CY 2021. We also note that
CPT code 76145 was listed as placeholder code 7615X in Addendum B and
Addendum O of the CY 2021 OPPS/ASC proposed rule.
Comment: Several commenters disagreed with the assignment to APC
5611 and requested a reassignment to APC 5724 (Level 4 Diagnostic Tests
and Related Services) with a proposed payment rate of $936.70. The
commenters indicated that CPT code 76145 is not a radiation oncology
code, rather, it is a service that will be performed in interventional
radiology or interventional cardiology. The commenters stated that the
resource consumption in APC 5724 more closely aligns with the resources
used to perform CPT code 76145. One commenter explained that CPT code
76145 is used to describe the medical physicist's work in performing a
patient-specific peak organ dose calculation subsequent to an
interventional radiology or interventional cardiology procedure. The
same commenter expressed concern that the new code will be included on
the Deficit Reduction Act (DRA) cap designation list.
Response: Section 5102(b) of the Deficit Reduction Act of 2005
(DRA) added section 1848(b)(4) to the statute to place a payment cap on
the technical component (TC) of certain diagnostic imaging procedures
and the TC portions of the global diagnostic imaging services at the
amount paid under the OPPS. To implement this provision, the physician
fee schedule (PFS) amount is compared to the OPPS payment amount and
the lower amount is used for payment under the PFS. However, we note
that the OPPS cap is a policy that applies to the PFS payment and is
not applicable under the OPPS; and the list of services that are
subject to the OPPS cap is published as part of the annual PFS final
rules. In addition, based on our review of the service associated with
CPT code 76145 and input from our medical advisors, we believe that APC
code 5611 is the most appropriate assignment for the code. The code is
new for CY 2021 and therefore we have no claims data available for OPPS
ratesetting. However, once we have claims data, we will review the APC
assignment and determine whether a change is necessary. We note that we
review, on an annual basis, the APC assignments for all items and
services paid under the OPPS.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, and assigning CPT code
76145 to APC 5611 for CY 2021. The final CY 2021 payment rate for the
code can be found in Addendum B to this final rule with comment period.
In addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
16. Musculoskeletal Procedures (APCs 5111 Through 5116)
Prior to CY 2016, OPPS payment for musculoskeletal procedures was
primarily divided according to anatomy and the type of musculoskeletal
procedure. As part of the CY 2016 reorganization to better structure
the OPPS payments towards prospective payment packages, we consolidated
those individual APCs so that they became a general Musculoskeletal APC
series (80 FR 70397 through 70398).
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59300), we continued to apply a six-level structure for the
Musculoskeletal APCs because doing so provided an appropriate
distinction for resource costs at each level and provided clinical
homogeneity. However, we indicated that we would continue to review the
structure of these APCs to determine whether additional granularity
would be necessary.
In the CY 2019 OPPS proposed rule (83 FR 37096), we recognized that
commenters had previously expressed concerns regarding the granularity
of the current APC levels and, therefore, requested comment on the
establishment of additional levels. Specifically, we solicited comments
on the creation of a new APC level between the current Level 5 and
Level 6 within
[[Page 85967]]
the Musculoskeletal APC series. While some commenters suggested APC
reconfigurations and requests for change to APC assignments, many
commenters requested that we maintain the current six-level structure
and continue to monitor the claims data as they become available.
Therefore, in the CY 2019 OPPS/ASC final rule with comment period, we
maintained the six-level APC structure for the Musculoskeletal
Procedures APCs (83 FR 58920 through 58921).
Based on the claims data available for the CY 2021 OPPS/ASC
proposed rule, we stated that we continued to believe that the six-
level APC structure for the Musculoskeletal Procedures APC series is
appropriate. Therefore, we proposed to maintain the APC structure for
the CY 2021 OPPS update.
In the CY 2020 OPPS/ASC final rule, we discussed issues related to
the APC assignment of CPT code 22869 (Insertion of interlaminar/
interspinous process stabilization/distraction device, without open
decompression or fusion, including image guidance when performed,
lumbar; single level) to APC 5115 (84 FR 61253 through 61254).
Specifically, commenters believed that the code was inappropriately
assigned to APC 5115 due to one hospital inaccurately reporting its
costs and charges. While we recognized the concerns that the commenters
described, we noted that it is generally not our policy to judge the
accuracy of hospital coding and charging for purposes of ratesetting.
For the proposed CY 2021 OPPS, the geometric mean cost of CPT code
22869 increased slightly relative to the prior year, from $11,023.45 to
$12,788.56. However, the proposed geometric mean costs of the Level 5
and Level 6 Musculoskeletal Procedures APCs were $12,102.02 and
$15,975.08, respectively, and so, based on the data that was available,
we continued to believe that it is appropriate to assign CPT code 22869
to APC 5115 (Level 5 Musculoskeletal Procedures APC).
For the CY 2021 OPPS, we also proposed to eliminate the Inpatient
Only (IPO) list over a three-year transition and to assign codes
removed from the IPO list to clinical APCs. Many of the codes proposed
to be removed from the IPO list are musculoskeletal procedures that we
proposed to assign to APCs in the Musculoskeletal Procedures APC
series, and so there may be effects on the geometric means as the
limited claims data for those codes is included in OPPS ratesetting.
For a more detailed discussion of the proposal to remove certain codes
from the IPO list, please see section IX.B. of the CY 2021 OPPS/ASC
proposed rule.
Table 28 displays the final CY 2021 Musculoskeletal Procedures APC
series' structure and APC geometric mean costs.
[GRAPHIC] [TIFF OMITTED] TR29DE20.040
Comment: One commenter recommended that CMS create a seventh
Musculoskeletal APC level above APC 5116 to account for complex
procedures that were proposed to be removed from the IPO list. Another
commenter requested that CMS consider the development of an additional
Musculoskeletal APC between current APCs 5114 and 5115.
Response: We appreciate the commenters' recommendation. We
understand that the addition of codes removed from the IPO list may
affect the geometric means of the Musculoskeletal Procedures APCs and
we will continue to monitor the claims data as they become available.
We also appreciate the goal of developing APC levels that appropriately
reflect resource costs. At this time, we believe the six-level
structure for the Musculoskeletal APCs continues to be appropriate.
However, we will take these comments into consideration for future
rulemaking
Comment: We received one comment recommending that CMS reassign CPT
codes 28297 (Correction, hallux valgus (bunionectomy), with
sesamoidectomy, when performed; with first metatarsal and medial
cuneiform joint arthrodesis, any method) and 28740 (Arthrodesis,
midtarsal or tarsometatarsal, single joint) to APC 5115 (Level 5
Musculoskeletal Procedures) to resolve any 2 times rule violations.
Response: We appreciate the commenter's recommendation regarding
the APC assignment of CPT 28297 and 28740. CPT codes 28297 and 28740
are currently assigned to APC 5114 (Level 4 Musculoskeletal
Procedures). Our review did not find that APC 5114 violates the 2 times
rule. We also note that for purposes of identifying significant
procedure codes for examination under the 2 times rule, we only
consider procedure codes that have more than 1,000 single major claims
or procedure codes that both have more than 99 single major claims and
[[Page 85968]]
contribute at least 2 percent of the single major claims used to
establish the APC cost to be significant (75 FR 71832). Neither of
these codes met this requirement and therefore were not considered
significant procedure codes for 2 times rule purposes. Therefore, we
are finalizing our proposal to continue to assign CPT codes 28297 and
28740 to APC 5114 in the CY 2021 OPPS.
Comment: Commenters supported our proposal to continue to assign
CPT code 22869 to APC 5115 (Level 5 Musculoskeletal Procedures). One
commenter requested that CMS continue to monitor the geometric mean
cost for CPT code 22869 and reestablish the code with assignment to APC
5116 (Level 6 Musculoskeletal Procedures) when appropriate.
Response: We appreciate commenters' support. We will continue to
review the most recent data and update the APC assignment for CPT code
22869 as necessary.
Comment: One commenter requested that we assign CPT code 23473
(Revision of total shoulder arthroplasty, including allograft when
performed; humeral or glenoid component) from APC 5115 to APC 5116,
based on their belief that the claims data was inaccurate and that the
time required to perform the procedure was not reflected in the
resource costs of the proposed APC placement.
Response: We note that CPT code 23473 has been established for some
time, with an effective date of January 1, 2013 and that it was the
initially established with a status indicator of ``T'' in the CY 2013
OPPS. Therefore, some of the issues related to codes transitioning off
the IPO list do not necessarily apply in this case and the actual data
for the claims are more appropriate in ratesetting than alternative
proxies. In the updated final rule claims data available for
ratesetting, the estimated geometric mean cost of CPT 23473 is
approximately $10,634 based on 287 claims, which is within the range of
the significant procedure costs of APC 5115 from approximately $9,644
to $12,902. As a result, we believe that the code is appropriately
placed in APC 5115.
Comment: For the CY 2020 OPPS/ASC final rule, HCPCS code C9757
(Laminotomy (hemilaminectomy), with decompression of nerve root(s),
including partial facetectomy, foraminotomy and excision of herniated
intervertebral disc, and repair of annular defect with implantation of
bone anchored annular closure device, including annular defect
measurement, alignment and sizing assessment, and image guidance; 1
interspace, lumbar) was assigned to comment indicator ``NI'' in the
OPPS Addendum B to indicate that the code was new and that we would be
accepting comments on the interim APC assignment. A commenter supported
the assignment to APC 5115 (Level 5 Musculoskeletal Procedures) with a
CY 2020 payment rate of $11,900.71.
Response: As we stated in the CY 2020 OPPS/ASC final rule, we
accepted comments on the interim OPPS payment assignment for new codes
effective January 1, 2020 that are assigned to comment indicator ``NI''
in the OPPS Addendum B (84 FR 61207). We further stated that the
comments would be addressed, and if applicable, the APC assignment
would be finalized in the CY 2021 OPPS/ASC final rule comment period.
We appreciate the feedback. We note that for CY 2021, we are finalizing
the assignment to APC 5115 (Level 5 Musculoskeletal Procedures) for
HCPCS code C9757. The final payment rate for the code can be found in
Addendum B to this final rule with comment period. In addition, the
status indicator definitions can be found in Addendum D1 to this final
rule with comment period. Both Addendum B and Addendum D1 are available
via the internet on the CMS website.
After consideration of the comments, we are finalizing our proposal
to maintain the six-level Musculoskeletal Procedures APC structure. We
are also finalizing the proposed assignment of CPT codes 28297 and
28740 to APC 5114, and the proposed assignment of CPT codes 22869 and
23473 to APC 5115 for the CY 2021 OPPS.
17. Neurostimulator and Related Procedures (APCs 5461 Through 5465)
In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66807
through 66808), we finalized a restructuring of what were previously
several neurostimulator procedure-related APCs into a four-level
series. Since CY 2015, the four-level APC structure for the series has
remained unchanged. In addition to that restructuring, in the CY 2015
OPPS/ASC final rule, we also made the Level 2 through 4 APCs
comprehensive APCs (79 FR 66807 through 66808). Later, in the CY 2020
OPPS final rule, we also established the Level 1 Neurostimulator and
Related Procedure APC (APC 5461) as a comprehensive APC (84 FR 61162
through 61166).
In reviewing the claims data available for the CY 2021 OPPS
proposed rule, we believed that it was appropriate to create an
additional Neurostimulator and Related Procedures level, between the
current Level 2 and 3 APCs. Creating this APC allows for a smoother
distribution of the costs between the different levels based on their
resource costs and clinical characteristics. Therefore, for the CY 2021
OPPS, we proposed to establish a five-level APC structure for the
Neurostimulator and Related Procedures series. We noted that in
addition to creating the new level, we also proposed to assign CPT code
0398T (Magnetic resonance image guided high intensity focused
ultrasound (mrgfus), stereotactic ablation lesion, intracranial for
movement disorder including stereotactic navigation and frame placement
when performed) to the new Level 3 APC, as discussed in further detail
in section III.C.3.A of the CY 2021 OPPS/ASC proposed rule with comment
period.
Comment: Multiple commenters requested that we add a Level 6
Neurostimulator and Related Procedures APC. The commenters are
concerned that the payment rate for the current Level 4 APC and the
proposed Level 5 APC is dominated by CPT code 63685 (Insertion or
replacement of spinal neurostimulator pulse generator or receiver,
direct or inductive coupling) which has a geometric mean of $29,123.02.
The commenter indicated this means that higher cost neurostimulator
services that have relatively low utilization are substantially
underpaid. The commenters believe the lack of payment for these
services is discouraging their use, and they want a Level 6 APC to
establish a payment rate that more closely reflects the cost of these
expensive, low utilization services.
Response: We appreciate the concerns of the commenters, but we
reiterate that the OPPS is a prospective payment system. We group
procedures with similar clinical characteristics and resource costs
into APCs and establish a payment rate that reflects the geometric mean
of all services in the group even though the cost of each service
within the APC may be higher or lower than the APC's geometric mean. As
a result, in the OPPS any individual procedure may potentially be
overpaid or underpaid because the payment rate is based on the
geometric mean of the entire group of services in the APC. However, the
impact of these payment differences should be mitigated when
distributed across a large number of APCs. If we were to establish a
Level 6 APC for Neurostimulators and Related Procedures based on the
commenters' request, we would find the payment rate for the APC would
be closer to some of the services assigned to that APC but
[[Page 85969]]
other services would continue to receive payment that is substantially
lower than those services' geometric mean cost. In the end, the only
way to ensure each service receives payment equivalent to the cost of
the service would be to establish separate APCs for each service the
commenters believe is underpaid. That solution would be contrary to
payment principles of the OPPS, which is based on prospective payment.
Therefore, we believe it is appropriate to maintain the same five level
structure as proposed in the CY 2021 OPPS.
Comment: Most commenters supported our proposal to create an
additional Neurostimulator and Related Procedures level, between the
current Level 2 and 3 APCs, which is described as the Level 3
Neurostimulator and Related Procedures APC in our proposal.
Response: We appreciate the support of the commenters for our
proposal.
Comment: One commenter noted that our proposal to establish an
additional APC level would lead to a decrease in payment for services
described by CPT codes 63650 (Percutaneous implantation of
neurostimulator electrode array, epidural), 63685 (Insertion or
replacement of spinal neurostimulator pulse generator or receiver,
direct or inductive coupling), and 63688 (Revision or removal of
implanted spinal neurostimulator pulse generator or receiver).
Response: We did not find that there would be a substantial
decrease in the payment for the procedures described by CPT codes
63650, 63685, and 63688 due to our proposal. Based on a review of our
claims data, we found only a modest payment decrease for CPT code 63650
and modest payment increases for CPT codes 63685 and 63688.
In addition, for CY 2021, we proposed to continue to assign CPT
code 0587T to APC 5442 (Level 2 Nerve Injections) with a proposed
payment of $644.55. We also proposed to continue to assign CPT code
0588T to APC 5441 (Level 1 Nerve Injections) with a proposed payment of
$267.50. We note that because both codes were effective on January 1,
2020, we have no claims data available for OPPS ratesetting, as the CY
2021 OPPS payment rates are based on claims submitted between January
1, 2019 through December 31, 2019, and processed through June 30, 2020.
The long descriptors for both codes can be found in Table 29 below.
Comment: A commenter explained that in May 2019 the AMA CPT
Editorial Panel approved four (4) Category III CPT codes to describe
the surgical procedures associated with the PROTECT PNS
Neurostimulation System, specifically, CPT codes 0587T, 0588T, 0589T,
and 0590T. The PROTECT PNS device is used for the treatment of
overactive bladder (OAB) symptoms. The commenter added that on October
19, 2016, CMS approved Medicare coverage for the Category B IDE study
associated with the PROTECT PNS device. In addition, the commenter also
stated that CMS incorrectly assigned CPT codes 0587T and 0588T to
inappropriate APC assignments.
For CPT code 0587T, the commenter clarified that CPT code 0587T is
not an injection; rather, the code describes an implantation or
replacement of an integrated single device neurostimulation system,
similar to the procedures assigned to the Neurostimulator and Related
Procedures (APCs 5461 through 5465) family. The commenter recommended
reassigning CPT code 0587T to one of these APCs to adequately capture
the correct clinical characteristics and resource costs of the
technology similar to other neurostimulation devices in APCs 5461
through 5465. The commenter specifically recommended the reassignment
to APC 5464 (Level 4 Neurostimulator and Related Procedures) with a
proposed payment rate of $20,789.82, since the procedure is very
similar to CPT code 64590 (Insertion or replacement of peripheral or
gastric neurostimulator pulse generator or receiver, direct or
inductive coupling), which is assigned to APC 5464. According to the
commenter, the cost of the PROTECT implantable device and transmitter
kit that is used in the procedure is about $15,820. Based on the
commenter's estimated cost of approximately $20,032, which includes the
non-device cost of $2,737 and the PROTECT device cost of $15,820, the
appropriate assignment for the code until OPPS claims are available is
APC 5464.
For CPT code 0588T, the commenter explained that the code is not an
injection procedure, rather, the code describes the surgical removal of
the device. The commenter suggested reassigning the code to APC 5461
(Level 1 Neurostimulator and Related Procedures) with a proposed
payment of $3,498.13 because it is comparable to CPT code 64595
(Revision or removal of peripheral or gastric neurostimulator pulse
generator or receiver) based on clinical similarity and resource costs.
Response: We do not agree that CPT code 0587T is comparable to CPT
code 64590. Based on our review of the clinical characteristics of the
procedure and input from our medical advisors, we believe CPT code
0587T is more similar to the procedures assigned to APC 5462 (Level 2
Neurostimulator and Related Procedures). However, we agree that CPT
code 0588T is similar to the procedures in APC 5461, and are therefore
assigning the code to APC 5461 in the CY 2021 OPPS.
In summary, after consideration of the public comment, we are
finalizing our proposal with modification, and reassigning CPT code
0587T to APC 5462 and CPT code 0588T to APC 5461. Table 29 below list
the four Category III CPT codes for the PROTECT PNS System and their
APC and SI assignments for CY 2021. The final CY 2021 OPPS payment
rates for the codes can be found in Addendum B of this final rule with
comment period. In addition, we refer readers to Addendum D1 of this
final rule with comment period for the status indicator meanings for
all codes reported under the OPPS for CY 2021. Both Addendum B and
Addendum D1 are available via the internet on the CMS website.
BILLING CODE 4120-01-P
[[Page 85970]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.041
Comment: Two commenters supported our proposal to change the APC
assignment for CPT code 0398T (Magnetic resonance image guided high
intensity focused ultrasound (mrgfus), stereotactic ablation lesion,
intracranial for movement disorder including stereotactic navigation
and frame placement when performed) to the proposed new Level 3
Neurostimulator and Related Procedures APC.
Response: We appreciate the support of the commenters for our
proposal.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to establish a five-
level APC structure for the Neurostimulator and Related Procedures
series. In addition to creating this new level, we also finalizing our
proposal to assign CPT 0398T (Magnetic resonance image guided high
intensity focused ultrasound (mrgfus), stereotactic ablation lesion,
intracranial for movement disorder including stereotactic navigation
and frame placement when performed) to this new Level 3 APC. Table 30
displays the proposed and final CY 2021 Neurostimulator and Related
Procedures APC series' structure and APC geometric mean costs.
[[Page 85971]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.043
BILLING CODE 4120-01-C
18. Noncontact Real-Time Fluorescence Wound Imaging/MolecuLight (APC
5722)
For the July 2020 update, the CPT Editorial Panel established two
new codes, specifically, CPT codes 0598T and 0599T, to report
noncontact real-time fluorescence wound imaging for bacterial presence
in chronic and acute wounds. The codes and their long descriptors were
listed in Table 7 (New HCPCS Codes Effective July 1, 2020) of the CY
2021 OPPS/ASC final rule with comment period (85 FR 48815 through
48823). We note that CMS recently received a new technology application
for the MolecuLight i: X procedure, which is described by CPT codes
0598T and 0599T. In determining the appropriate payment for CPT code
0598T, we considered whether there should be separate or conditionally
packaged payment for the procedure since the use of the MolecuLight
imaging device will most often involve another procedure or service
during the same session (for example, debridement of the wound,
laboratory service, or another skin-related procedure). In addition, we
considered whether the code should be placed in either the Diagnostic
Procedures or Minor Procedures APC group. Based on our review of the
application and input from our physicians, we assigned CPT code 0598T
to APC 5722 (Level 2 Diagnostic Tests and Related Services) and status
indicator ``T'' with a payment rate of $253.10 effective July 1, 2020.
In addition, because CPT code 0599T is an add-on code, we assigned the
code to status indicator ``N'' to indicate that the payment is included
in the primary procedure. We note that the new technology application
indicated a higher projected cost involving care in an operating room
(OR), however, based on our review of the MolecuLight service, we
removed OR-associated costs because it was not clear to us that the
test would routinely be performed in the OR setting. However, in the CY
2021 OPPS/ASC proposed rule we solicited public comments from hospital-
based providers that have used MolecuLight on the appropriate OPPS
payment, particularly with respect to the cost of providing the service
in the hospital outpatient setting.
For CY 2021, we proposed to continue to assign CPT code 0598T to
APC 5722 (Level 2 Diagnostic Tests and Related Services) with a
proposed payment rate of $269.85. We proposed to maintain a status
indicator of ``N'' for CPT code 0599T, which is an add-on code, to
indicate that the payment is included in the primary procedure. The
long descriptors and proposed SI and APC assignments for both codes can
be found in Table 31 below.
Comment: Some commenters agreed with the APC assignment to APC 5722
for CPT code 0598T, however, they had concerns with the packaged status
indicator assignment for CPT code 0599T, and suggested assigning the
code to a different APC and revising the status indicator from ``N''
(packaged) to ``S'' (Procedure or Service, Not Discounted When
Multiple). One commenter indicated that the payment is insufficient to
cover the cost of the procedure and contended that the low
reimbursement will dissuade hospitals from offering the service. The
commenter reported that the procedure requires the use of a Dark Drape
technology and also requires significant time because the second ulcer
and subsequent ulcers typically involve different anatomical locations.
Another commenter reported that hospital outpatient charges for CPT
code 0598T are between $850 and $2,500 for the first wound and between
$850 and $1,850 for subsequent anatomic sites. The same commenter
suggested that OPPS payment is inadequate, especially in cases that
involve additional wounds in different anatomic sites such as the
sacrum, abdomen, toe, or leg, all of which require additional resource
costs. Consequently, the commenter requested a revision in the APC
assignment for both codes. Specifically, the commenter recommended
reassigning CPT code 0598T from APC 5722 to APC 5723 (Level 3
Diagnostic Tests and Related Services) with a proposed payment of
$497.96, and to assign CPT code 0599T to APC 5722 with a proposed
payment of $269.85. In addition, the commenter recommended assigning
both codes status indicator ``S''.
Response: With regard to CPT code 0598T, based on our evaluation of
the new technology application submitted to CMS as well as input from
our physicians, we believe that we should maintain the assignment to
APC 5722 for CY 2021. In addition, because CPT code 0599T is an add-on
code, we are maintaining its status indicator assignment of ``N''
(packaged). As specified in section Sec. 419.2(b)(18), add-on codes
are generally packaged under
[[Page 85972]]
the hospital OPPS. As explained in the CY 2014 OPPS/ASC final rule with
comment period (78 FR 74942 through 74945), we finalized a policy to
unconditionally package procedures described by add-on codes.
Procedures described by add-on codes represent an extension or
continuation of a primary procedure, which means that they are
typically supportive, dependent, or adjunctive to a primary service.
The primary code defines the purpose and typical scope of the patient
encounter and the add-on code describes incremental work, when the
extent of the procedure encompasses a range rather than a single
defined endpoint applicable to all patients. Given the dependent nature
and adjunctive characteristics of procedures described by add-on codes
and in light of longstanding OPPS packaging principles, we finalized a
policy to unconditionally package add-on codes with the primary
procedure.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, to assign CPT code 0598T
to APC 5722 with status indicator ``T'' and to assign CPT code 0599T
status indicator ``N'' for CY 2021. The final CY 2021 payment rate for
CPT code 0598T can be found in Addendum B to this final rule with
comment period. In addition, we refer readers to Addendum D1 of this
final rule with comment period for the status indicator (SI) meanings
for all codes reported under the OPPS. Both Addendum B and D1 are
available via the internet on the CMS website.
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19. Nuclear Medicine Services: Single-Photon Emission Computed
Tomography (SPECT) Studies (APC 5593)
For CY 2021, we proposed to reassign CPT code 78803
(Radiopharmaceutical localization of tumor, inflammatory process or
distribution of radiopharmaceutical agent(s) (includes vascular flow
and blood pool imaging, when performed); tomographic (spect), single
area (e.g., head, neck, chest, pelvis), single day imaging) from APC
5593 (Level 3 Nuclear Medicine and Related Services) with a payment
rate of $1,272.19 to APC 5592 (Level 2 Nuclear Medicine and Related
Services) with a proposed payment rate of $501.45.
Comment: Several commenters objected to the reassignment of CPT
code 78803 to APC 5592 and requested that we not finalize our proposal
but rather maintain the current placement in APC 5593. They stated that
the significant payment decrease would limit patient access, affect
patient care, and restrict hospitals from offering the test. One
commenter reported that the Medicare payment for CPT code 78803 is
insufficient, and as a result, many hospitals refuse to offer the
service. This same commenter reported that lowering the payment for the
test may force some hospitals that currently offer the test to stop
providing it altogether. The commenter added that many patients travel
hours to access a SPECT scan exam and lowering the payment for the test
would not improve patient care. Some commenters reminded us that for CY
2020, CPT code 78803 replaced seven codes that were deleted on December
31, 2019. Most commenters stated that the more appropriate placement
for CPT code 78803 is APC 5593, based on resource use and clinical
similarity to the other procedures in the APC.
Response: We discussed the issue related to the seven deleted codes
in the CY 2020 OPPS/ASC final rule (84 FR 61257 through 61258) and
noted that based on the geometric mean costs for CPT code 78803 and the
deleted codes, we believe it was necessary for us to maintain the APC
assignment for CPT code 78803 in APC 5593. Because the CY 2021 OPPS
payments are based on claims submitted between January 1, 2019 through
December 31, 2019, and processed through June 30, 2020, we again
reviewed the claims data for the deleted codes to determine the
appropriate placement for CPT code 78803. As listed in Table 32, the
range of geometric mean costs for CPT code 78803 and the seven deleted
codes is between $408 and $1,508. Similar to our CY 2020 findings, we
note that several of the deleted codes were assigned to APC 5593, and
based on our review of these codes, we believe it would be appropriate
to maintain assignment of CPT code 78803 to APC 5593 for CY 2021.
[[Page 85973]]
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Comment: One commenter agreed with the proposal to maintain the
four levels of nuclear medicine APCs for CY 2021 but requested that CMS
consider establishing additional APCs as needed to ensure that the
nuclear medicine APCs do not violate the 2-times rule when the cost of
packaged diagnostic radiopharmaceuticals drugs are included.
Response: We appreciate the feedback and will consider in future
rulemaking whether establishing additional nuclear medicine APCs would
be appropriate.
In summary, after consideration of the public comments, and after
our analysis of the updated claims data for this final rule with
comment period, we are finalizing a modification to our proposal.
Specifically, we are revising the APC assignment for CPT code 78803 to
APC 5593 for CY 2021. The final CY 2021 payment rate for the code can
be found in Addendum B to this final rule with comment period (which is
available via the internet on the CMS website).
As we do every year, we will reevaluate the APC assignment for CPT
code 78803 for the next rulemaking cycle. We note that we review, on an
annual basis, the APC assignments for all services and items paid under
the OPPS.
20. Pathogen Test for Platelets/Rapid Bacterial Testing (APC 5732)
For the July 2017 update, the HCPCS Workgroup established HCPCS
code Q9987 (Pathogen(s) test for platelets) effective July 1, 2017.
This new code and the OPPS APC assignment were announced in the July
2017 OPPS quarterly update CR (Transmittal 3783, Change Request 10122,
dated May 26, 2017). Because HCPCS code Q9987 represented a test to
identify bacterial or other pathogen contamination in blood platelets,
we assigned the code to a new technology APC, specifically, New
Technology APC 1493 (New Technology--Level 1C ($21-$30)) with a status
indicator ``S'' and a payment rate of $25.50. We note that temporary
HCPCS code Q9987 was subsequently deleted on December 31, 2017, and
replaced with permanent HCPCS code P9100 (Pathogen(s) test for
platelets) effective January 1, 2018. For the January 2018 update, we
continued to assign the new code to the same APC and status indicator
as its predecessor code. Specifically, we assigned HCPCS code P9100 to
New Technology APC 1493 and status indicator ``S''. For the CY 2019
update, we made no change to the APC or status indicator assignment for
P9100, however, for the CY 2020 update, we revised the APC assignment
from New Technology APC 1493 to 1494 (New Technology--Level 1D ($31-
$40)) based on the latest claims data used to set the payment rates for
CY 2020. We discussed the revision in the CY 2020 OPPS/ASC final rule
(84 FR 61219) and indicated that the reassignment to APC 1494
appropriately reflected the cost of the service.
For the CY 2021 proposed rule, we believed that we had sufficient
claims data to reassign the code from a New Technology APC to a
clinical APC, and noted that HCPCS code P9100 had been assigned to a
New Technology APC for over 3 years. As stated in section III.D. (New
Technology APCs), a service is paid under a New Technology APC until
sufficient claims data have been collected to allow CMS to assign the
procedure to a clinical APC group that is appropriate in clinical and
resource terms. We expect this to occur within two to three years from
the time a new HCPCS code becomes effective. However, if we are able to
collect sufficient claims data in less than 2 years, we would consider
reassigning the service to an appropriate clinical APC. Since HCPCS
code P9100 has been assigned to a new technology APC since July 2017,
we believed that we should reassign the code to a clinical APC.
Specifically, our claims data for the proposed rule showed a geometric
mean cost of approximately $30 for HCPCS code P9100 based on 70 single
claims (out of 1,835 total claims). Based on resource cost and clinical
homogeneity to the other services assigned to APC 5732 (Level 2 Minor
Procedures), we believed that HCPCS code P9100 should be reassigned to
clinical APC 5732, which had a geometric mean cost of approximately
$33.
As we have stated several times since the implementation of the
OPPS on August 1, 2000, we review, on an annual basis, the APC
assignments for all services and items paid under the OPPS based on our
analysis of the latest claims data. For the CY 2021 OPPS update, based
on claims submitted between January 1, 2019, and December
[[Page 85974]]
30, 2019, our analysis of the latest claims data for the proposed rule
supported reassigning HCPCS code P9100 to APC 5732 based on its
clinical and resource similarity to the procedures and services in the
APC. Therefore, we proposed to reassign HCPCS code P9100 from New
Technology APC 1494 to clinical APC 5732 for CY 2021.
Comment: A commenter supported our proposal to revise the APC
assignment for HCPCS code P9100 to APC 5732.
Response: We appreciate the support for our proposal. Based on our
review of the updated claims data for this final rule with comment
period, which is based on claims submitted between January 1, 2019, and
December 30, 2019, and processed through June 30, 2020, we continue to
believe that reassigning HCPCS code P9100 to APC 5732 is appropriate.
Specifically, our claims data show a geometric mean cost of
approximately $30.86 for HCPCS P9100 based on 75 single claims (out of
2,038 total claims), which is consistent with the geometric mean cost
of about $32.97 for APC 5732.
In summary, after consideration of the public comment, and after
our analysis of the updated claims data for this final rule with
comment period, we are finalizing our proposal, without modification,
to assign HCPCS code P9100 to APC 5732 for CY 2021. The final CY 2021
payment rate for the code can be found in Addendum B to this final rule
with comment period. In addition, we refer readers to Addendum D1 of
this final rule with comment period for the status indicator (SI)
meanings for all codes reported under the OPPS. Both Addendum B and D1
are available via the internet on the CMS website.
21. Payment for Radioisotopes Derived From Non-Highly Enriched Uranium
(Non-HEU) Sources (APC 1442)
Radioisotopes are widely used in modern medical imaging,
particularly for cardiac imaging and predominantly for the Medicare
population. Some of the Technetium-99 (Tc-99m), the radioisotope used
in the majority of such diagnostic imaging services, is produced in
legacy reactors outside of the United States using highly enriched
uranium (HEU).
The United States would like to eliminate domestic reliance on
these reactors, and is promoting the conversion of all medical
radioisotope production to non-HEU sources. Alternative methods for
producing Tc-99m without HEU are technologically and economically
viable, and conversion to such production has begun. We expect that
this change in the supply source for the radioisotope used for modern
medical imaging will introduce new costs into the payment system that
are not accounted for in the historical claims data.
Therefore, beginning in CY 2013, we finalized a policy to provide
an additional payment of $10 for the marginal cost for radioisotopes
produced by non-HEU sources (77 FR 68323). Under this policy, hospitals
report HCPCS code Q9969 (Tc-99m from non-highly enriched uranium
source, full cost recovery add-on per study dose) once per dose along
with any diagnostic scan or scans furnished using Tc-99m as long as the
Tc-99m doses used can be certified by the hospital to be at least 95
percent derived from non-HEU sources (77 FR 68321).
Comment: One commenter requested that we increase the payment rate
for HCPCS add-on code Q9969 from $10. The commenter noted that we have
not increased the payment rate for Q9969 since the code was established
in CY 2013. The commenter suggested increasing the payment for Q9969 by
the annual market basket increase for CY 2021 along with a one-time
increase to reflect prior increases to the market basket between CY
2013 and CY 2021. Alternatively, the commenter suggested the payment
rate could be increased by the change in the drug cost threshold
packaging amount between CY 2013 and CY 2021.
Response: We appreciate the information we received from the
commenter supporting an increase to the payment rate of $10 for HCPCS
code Q9969. As discussed in the CY 2013 OPPS/ASC final rule with
comment period, we did not finalize a policy to use the usual OPPS
methodologies to update the non-HEU add-on payment (77 FR 68317). The
purpose of the additional payment is limited to mitigating any adverse
impact of transitioning to non-HEU sources and we believe the add-on is
appropriate at this time.
Comment: Multiple commenters supported the current payment amount
for HCPCS code Q9969 and they requested that we finalize our proposed
payment rate for the add-on.
Response: We appreciate the support of the commenters for the
proposed payment rate for HCPCS code Q9969.
After consideration of the public comments we received, we are
finalizing our proposal, without modification, to continue the policy
of providing an additional $10 payment for radioisotopes produced by
non-HEU sources for CY 2021 and subsequent years as represented by
HCPCS code Q9969.
22. Percutaneous Transcatheter Ultrasound Nerve Ablation
The Therapeutic Intra-Vascular Ultrasound System
(TIVUSTM) is a high intensity, non-focused, ultrasound
catheter system, which enables remote, localized, controlled and
repeatable thermal modulation of nerves adjacent to arterial vessel
wall for performing therapeutic pulmonary artery sympathetic
denervation and is used for the treatment of pulmonary arterial
hypertension (PAH). In 2020, the TIVUSTM system was approved
by FDA for a Category B (Nonexperimental/investigational)
Investigational Device Exemption (IDE) for the device to be used in a
clinical study. The study sponsors have also requested Medicare
coverage of the Category B IDE study to allow for coverage of the
TIVUSTM system and the routine care items and services in
the clinical trial. To date, CMS has not established approval of
Medicare coverage for the Category B IDE study for the
TIVUSTM system.
The TIVUSTM system is used with CPT code 0632T
(Percutaneous transcatheter ultrasound ablation, nerves innervating the
pulmonary arteries, including right heart catheterization, radiological
supervision and interpretation and pulmonary artery angiography), which
will become effective January 1, 2021. In the CY 2021 OPPS/ASC proposed
rule, CPT code 0632T was assigned status indicator ``E1'', which
describes items, codes, and services not covered by any Medicare
outpatient benefit category, statutorily excluded by Medicare, or not
reasonable and necessary. These items, codes, and services are not paid
by Medicare when submitted on outpatient claims.
Comment: One commenter, the manufacturer of the TIVUSTM
system, requested that, in anticipation of approval of Medicare
coverage for the Category B IDE study for the TIVUSTM
system, CMS assign CPT code 0632T status indicator ``J1'', which
describes services paid through a comprehensive APC (C-APC) instead of
status indicator ``E1'' for CY 2021. The commenter also requested that
CMS assign CPT code 0632T to C-APC 5213 (Level 3 Electrophysiologic
Procedures) for CY 2021, stating that the procedure is similar in
clinical characteristics and resource costs to CPT code 93656
(Comprehensive electrophysiologic evaluation including transseptal
catheterizations, insertion and repositioning of multiple electrode
catheters with induction or attempted induction of an arrhythmia
including
[[Page 85975]]
left or right atrial pacing/recording, when necessary, right
ventricular pacing/recording when necessary, and his bundle recording
when necessary with intracardiac catheter ablation of atrial
fibrillation by pulmonary vein isolation), which is assigned to C-APC
5213 for CY 2021.
Response: For approved Category B IDE studies, CMS allows for
coverage of the Category B device and the routine care items and
services in the clinical trial. To date, coverage for the Category B
IDE clinical study for the TIVUSTM system has not been
approved by CMS. We do not believe that it is appropriate to assign a
payable status indicator under the OPPS to CPT code 0632T prior to the
approval of the Category B IDE study. Therefore, for CY 2021, we are
finalizing the assignment of status indicator ``E1'' to CPT code 0632T.
23. Peripheral Intravascular Lithotripsy (IVL) Procedure (APCs 5192,
5193, and 5194)
The IVL system has three components: A proprietary IVL Catheter, an
IVL Generator, and an IVL Connector Cable. It is a lithotripsy-enhanced
balloon catheter used to dilate lesions, including calcified lesions,
in the peripheral vasculature, including the iliac, femoral, ilio-
femoral, popliteal, infra-popliteal, and renal arteries. The IVL
catheter has integrated lithotripsy emitters and is designed to enhance
percutaneous transluminal angioplasty by enabling delivery of the
calcium disrupting capability of lithotripsy prior to full balloon
dilatation at low pressures. The application of lithotripsy mechanical
pulse waves alters the structure of an occlusive vascular deposit
(stenosis) prior to low-pressure balloon dilation of the stenosis and
facilitates the passage of blood and is used for the treatment of
peripheral artery disease (PAD).
In 2019, FDA cleared 510(k) submission based on a determination of
substantial equivalence to a legally marketed predicate device. The
manufacturer also submitted a new technology application requesting new
technology APC assignment for IVL procedures. Based on our review of
the New Technology APC application for this service and the service's
clinical similarity to existing APCs in the OPPS, we created four new
HCPCS codes for these services and assigned these codes to existing
clinical APCs. Specifically, CMS proposed to add HCPCS code C9764
(Revascularization, endovascular, open or percutaneous, any vessel(s);
with intravascular lithotripsy, includes angioplasty within the same
vessel(s), when performed), C9765 (Revascularization, endovascular,
open or percutaneous, any vessel(s); with intravascular lithotripsy,
and transluminal stent placement(s), includes angioplasty within the
same vessel(s), when performed) C9766 (Revascularization, endovascular,
open or percutaneous, any vessel(s); with intravascular lithotripsy and
atherectomy, includes angioplasty within the same vessel(s), when
performed), and C9767 (Revascularization, endovascular, open or
percutaneous, any vessel(s); with intravascular lithotripsy and
transluminal stent placement(s), and atherectomy, includes angioplasty
within the same vessel(s), when performed), effective July 1, 2020. We
assigned code C9764 to APC 5192 (Level 2 Endovascular Procedures) with
a payment rate of $4,953.91; C9765 and C9766 to APC 5193 (Level 3
Endovascular Procedures) with a payment rate of $9,908.48; and C9767 to
APC 5194 (Level 4 Endovascular Procedures) with a payment rate of
$15,939.97 for CY 2020. In the CY 2021 OPPS/ASC proposed rule, we
proposed to maintain these APC assignments for these codes in CY 2021.
At the August 31, 2020 HOP Panel Meeting, a presenter requested
that we reassign IVL procedure C9764 to APC 5193 and procedures C9765
and C9766 to APC 5194. The presenter indicated that the APC payment
associated with HCPCS code(s) C9764, C9765 and C9766 is inadequate to
cover the cost of the procedures. According to the presenter, the
proposed CY 2021 geometric mean cost for the procedures range from
$6,619.26 to $22,305.36, not including the additional cost of the IVL
catheter. The presenter reported that the cost of one catheter is
$2,800 but each procedure requires an average of 1.2 catheters,
bringing the total cost of catheters to $3,360 per procedure. The
presenter stated that the payment rate for the IVL procedures on tibial
and peroneal vessels was lower than the payment rate for similar
procedures without IVL. The presenter believed that hospitals will
limit access to IVL, reducing patient access, because payment for the
procedure is inadequate. They argued that limiting IVL access to
patients suffering from critical limb ischemia in tibial and peroneal
arteries could lead to higher complications associated with current
treatment modalities. They believe that traditional treatments are
associated with higher risk of distal embolization, perforation and
possible amputation. Based on the information presented at the meeting,
the HOP Panel recommended CMS reassign HCPCS code C9764 to APC 5193 and
HCPCS codes C9765 and C9766 to APC 5194, as long as the cost of the IVL
device is within 10 percent of other devices currently available.
However, we are unable to identify devices that are similar to IVL and
therefore cannot complete the data analysis recommended by the HOP
Panel.
Comment: Several commenters disagreed with CMS' proposed APC
assignments for the peripheral intravascular lithotripsy service
described by HCPCS codes C9764, C9765 and C9766. They reported that,
based on the resource cost of the service described by HCPCS code
C9764, APC 5192 does not provide adequate reimbursement for the
service, and recommended reassignment to APC 5193 (Level 3 Endovascular
Procedures) with a proposed payment rate of $10,222.32. Similarly, for
HCPCS codes C9765 and C9766, the commenters indicated that APC 5193
would not adequately cover the resource costs associated with these
procedures, and recommended their reassignment to APC 5194 (Level 4
Endovascular Procedures) with a proposed payment rate of $16,348.66.
Response: APC assignment for a code is based on similarity to other
codes within an APC in terms of clinical homogeneity and resource
costs. As specified in 42 CFR 419.31(a)(1), CMS classifies outpatient
services and procedures that are comparable clinically and in terms of
resource use into APC groups. As we stated in the CY 2012 OPPS/ASC
final rule (76 FR 74224), the OPPS is a prospective payment system that
provides payment for groups of services that share clinical and
resource use characteristics. For all new codes, our policy has been to
assign the service or procedure to an APC informed by a variety of
sources, including but not limited to, review of the clinical
similarity of the service to existing procedures; advice from CMS
medical advisors; information from interested specialty societies; and
review of all other information available to us, including information
provided to us by the public, whether through meetings with
stakeholders or additional information that is mailed or otherwise
communicated to us.
Based on the comments we received, the HOP Panel recommendation,
information provided in the new technology application, and advice from
our medical advisors, we believe we should add new HCPCS codes to
describe tibial and peroneal IVL procedures, for a total of eight IVL
procedure codes, and revise the long
[[Page 85976]]
descriptors for HCPCS codes C9764, C9765, C9766, and C9767 by deleting
the words ``any vessel(s)'' and replacing with ``lower extremity
artery(ies), except tibial/peroneal'' effective January 1, 2021. We
agree with commenters that the resources associated with tibial and
peroneal IVL procedures are higher than iliac, femoral and popliteal
procedures. Therefore, we are creating new HCPCS codes C9772, C9773,
C9774, and C9775 to describe tibial and peroneal procedures and
assigning these codes to APCs as listed in the Table 33 below.
In summary, after consideration of public comments, we are
finalizing our proposal with modification, to provide new HCPCS codes
C9772, C9773, C9774 and C9775 and assign these codes to APCs listed in
Table 33. Table 33 also lists revised long descriptors for HCPCS codes
C9764, C9765, C9766, and C9767, and final SI and APC assignments for
all eight codes. The final CY 2021 payment rate for these codes can be
found in Addendum B to this final rule with comment period. In
addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
BILLING CODE 4120-01-P
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[[Page 85977]]
BILLING CODE 4120-01-C
24. Remote Physiological Monitoring (APC 5741)
a. Initial Remote Monitoring of Physiologic Parameters (APC 5741)
For the CY 2019 update, the CPT Editorial Panel established a new
code, specifically, CPT code 99454, to describe initial remote
monitoring of physiological parameters effective January 1, 2019. In
the CY 2019 update, we assigned this code to APC 5741 (Level 1
Electronic Analysis of Devices) with status indicator ``Q1''
(conditionally packaged) and a payment rate of $37.16 effective January
1, 2019, based on the clinical and resource similarity with CPT code
93270 (External patient and, when performed, auto activated
electrocardiographic rhythm derived event recording with symptom-
related memory loop with remote download capability up to 30 days, 24-
hour attended monitoring; recording (includes connection, recording,
and disconnection)). The new code appeared in the OPPS Addendum B of
the CY 2019 OPPS/ASC final rule.
For CY 2020 OPPS/ASC final rule, we maintained the assignment of
CPT code 99454 to APC 5741 with a payment rate of $36.25. We note that
we had no claims data for CPT code 99454 for the CY 2020 final rule
since the code was established on January 1, 2019. For the CY 2021
OPPS/ASC proposed rule, we proposed to maintain the assignment of CPT
code 99454 to APC 5741 with the proposed payment rate of $37.76.
Comment: One commenter was concerned that the current reimbursement
rate is too low, which the commenter believes discourages providers
from using much-needed equipment and services. The commenter stated
that CMS must ensure that life-saving RPM technology would be available
to Medicare beneficiaries by updating the status indicator and
increasing reimbursement rate for CPT code 99454. The commenter
requested: (1) A change in the status indicator for CPT code 99454 from
``Q1'' to ``S,'' so that it will be paid when used in conjunction with
other services; and (2) reassignment of CPT code 99454 from APC 5741
(Level 1 Electronic Analysis of Devices) to APC 5742 (Level 2
Electronic Analysis of Devices).
Response: As we have stated every year since the implementation of
the OPPS on August 1, 2000, we review, on an annual basis, the APC
assignments for all services and items paid under the OPPS based on our
analysis of the latest claims data. For CY 2021, based on claims
submitted between January 1, 2019 through December 31, 2019, that were
processed on or before June 30, 2020, our analysis of the latest claims
data for this final rule with comment period supports continuing to
assign CPT code 99454 to APC 5741. Specifically, our claims data shows
a geometric mean cost of approximately $28.06 for CPT 99454 based on
185 single claims (out of 275 total claims), which is comparable to the
geometric mean cost of about $36.19 for APC 5741, rather than the
geometric mean cost of approximately $97.72 for APC 5742.
We proposed to assign code 99454 to status indicator ``Q1'' for CY
2021 to indicate that the payment for CPT code 99454 is packaged when
the code is billed on the same claim as a HCPCS code assigned to OPPS
status indicator ``S'', ``T'', or ``V'', but is paid separately when it
is the only major service on the claim. Because the service described
by CPT code 99454 will most often be performed as part of another
significant procedure, we believe that packaging the cost associated
with CPT code 99454 into the primary service is appropriate. Therefore,
assignment of status indicator ``Q1'' to CPT 99454 is appropriate.
In summary, after consideration of the public comments and after
evaluation of our claims data for this final rule with comment period,
we are finalizing our proposal, without modification, for CPT code
99454. The final CY 2021 payment rate for the CPT code 99454 can be
found in Addendum B to this final rule with comment period (which is
available via the internet on the CMS website).
As we do every year, we will reevaluate the APC assignment for CPT
code 99454 for the next rulemaking cycle. We remind hospitals that we
review, on an annual basis, the APC assignments for all services and
items paid under the OPPS based on the latest claims data.
b. Remote Physiological Monitoring Services, Virtual Check-In, E-
Visits, Telephone E/M, and Medication Management Services
For CY 2021, we proposed to continue to assign CPT code 99091
(Collection and interpretation of physiologic data (e.g., ecg, blood
pressure, glucose monitoring) digitally stored and/or transmitted by
the patient and/or caregiver to the physician or other qualified health
care professional, qualified by education, training, licensure/
regulation (when applicable) requiring a minimum of 30 minutes of time,
each 30 days) to status indicator ``N'' (packaged) to indicate that the
payment for the service is included in the primary service reported
with the code. We also proposed to continue to assign CPT codes 99457
(Remote physiologic monitoring treatment management services, clinical
staff/physician/other qualified health care professional time in a
calendar month requiring interactive communication with the patient/
caregiver during the month; first 20 minutes) and 99458 (Remote
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar
month requiring interactive communication with the patient/caregiver
during the month; each additional 20 minutes (list separately in
addition to code for primary procedure)) to status indicator ``B'' (not
recognized under OPPS) to indicate that the codes are not paid under
the hospital OPPS but may be paid under a different Medicare payment
system other than the OPPS. However, if the services described by
either CPT code 99457 or 99458 are performed in the hospital outpatient
facility, the facility should report an alternate code. These codes are
listed in Table 34 along with the descriptors and status indicator
assignments. In addition, the definitions for all the OPPS status
indicators can be found in Addendum D1.
We note that for CY 2020, we revised the status indicator for CPT
code 99457 from ``M'' (Items and Services Not Billable to the MAC. Not
paid under OPPS) to ``B,'' and for CPT code 99458, which is an add-on
code, from ``N'' (packaged) to ``B'' effective March 1, 2020. We made
the changes to enable Critical Access Hospitals (CAHs) to bill under
CAH's Method II for these waiver services so that claims with these
codes would process appropriately in the Integrated Outpatient Code
Editor (IOCE). We announced the revisions in the July 2020 OPPS
Quarterly Update CR (Transmittal 10224, Change Request 11814, dated
July 15, 2020).
At the August 31, 2020 HOP Panel Meeting, a presenter requested
that we revise the status indicators for these codes. Specifically, the
presenter suggested that CPT codes 99091 and 99457 should be treated
similar to HCPCS G0463 (Hospital outpatient clinic visit for assessment
and management of a patient), which is assigned to status indicator
``V'' (Clinic or Emergency Department Visit) and APC 5012 (Clinic
Visits and Related Services) which has a CY 2021 proposed payment rate
of $120.88. Based on the discussion at the Panel Meeting, the HOP Panel
recommended that the status indicator for CPT codes 99091 and 99457 be
revised to ``V'' and the status indicator for CPT code 99458 be revised
[[Page 85978]]
to ``N''. We note that we are not accepting the Panel's recommendation
because we believe that we need further review to determine whether
these type of services (i.e., remote physiologic monitoring) should be
paid separately under the OPPS. We appreciate the HOP Panel's
recommendations on the status indicator revisions for CPT codes 99091,
99457, and 99458, and will consider them in future rulemaking.
Comment: For CPT code 99091, one commenter disagreed with the
status indicator assignment of ``N,'' and stated the code should not be
packaged because the service may be the only OPPS service furnished
during a month for a registered hospital outpatient. The commenter
recommended assigning the code to either status indicator ``V'' or
treating it similar to CPT code 99454 (Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory
flow rate), initial; device(s) supply with daily recording(s) or
programmed alert(s) transmission, each 30 days), which has a payable
status indicator of ``Q1'' (STV-Packaged Codes) and assigned to APC
5741 (Level 1 Electronic Analysis of Devices) with a CY 2021 proposed
payment of $37.76.
Response: Although we are sensitive to the concern raised by the
commenter, we do not believe that revising the status indicator for CPT
code 99091 would be appropriate at this time. We believe we need
further review of this code, along with all the remote physiological
monitoring (PRM) service codes, to determine whether these types of
services should be separately payable under the OPPS. Therefore, for CY
2021, we are finalizing our proposal, without modification and will
continue to assign CPT code 99091 to status indicator ``N,'' and
consider the suggestion to revise the status indicator in future
rulemaking. The final CY 2021 status indicator for CPT code 99091 can
also be found in Table 34 below.
Comment: For CPT code 99457, several commenters suggested
reassigning the code to status indicator ``V,'' similar to CPT code
99453 (Remote monitoring of physiologic parameter(s) (e.g., weight,
blood pressure, pulse oximetry, respiratory flow rate), initial; set-up
and patient education on use of equipment), which has a payable status
indicator of ``V'' and assigned to APC 5012 with a CY 2021 proposed
payment of $120.88. The commenters stated that in the CY 2020 Physician
Fee Schedule (PFS), CMS clarified that ``CPT codes 99457 and 99458 can
be furnished by clinical staff under the general supervision of the
physician or NPP.'' Based on this statement, the commenters believe
that CPT code 99457 should be paid separately under the OPPS. The
commenters reported that because the code is currently assigned to
status indicator ``B,'' hospital outpatient facilities do not receive
any reimbursement when the service is provided by clinical staff in a
hospital outpatient setting. One commenter stated that the status
indicator should be revised to ``V'' to support the service being
provided to Medicare beneficiaries under the order of a physician.
Response: We appreciate the commenters' suggestions, however, we
believe we need further evaluation of this code, along with the rest of
the RPM service codes, to determine whether this type of service should
be separately payable under the OPPS. Therefore, for CY 2021, we are
finalizing our proposal, without modification, to assign CPT code 99457
to status indicator ``B.'' We will consider the commenters' suggestion
to revise the status indicator for future rulemaking. The final CY 2021
status indicator for CPT code 99457 can also be found in Table 34
below. Also, as noted above, we revised the status indicator for CPT
code 99457 from ``M'' to ``B'' effective March 1, 2020, to enable
Critical Access Hospitals (CAHs) to bill under CAH's Method II for
these waiver services so that claims with this code would process
appropriately in the Integrated Outpatient Code Editor (IOCE). We
announced the revisions in the July 2020 OPPS Quarterly Update CR
(Transmittal 10224, Change Request 11814, dated July 15, 2020).
Comment: For CPT code 99458, the commenters suggested the
reassignment to status indicator ``N'' because this is an add-on code.
Response: As noted above, similar to CPT code 99457, we revised the
status indicator for CPT code 99458 to ``B'' effective March 1, 2020,
to enable Critical Access Hospitals (CAHs) to bill under CAH's Method
II for the service so that claims with this code would process
appropriately in the Integrated Outpatient Code Editor (IOCE). We
announced the revisions in the July 2020 OPPS Quarterly Update CR
(Transmittal 10224, Change Request 11814, dated July 15, 2020). We
appreciate the commenters' suggestions, however, we believe we need
further evaluation of this code, along with the rest of the RPM service
codes, to determine whether this type of service should be separately
payable under the OPPS. Therefore, for CY 2021, we are finalizing our
proposal, without modification, to assign CPT code 99458 to status
indicator ``B,'' and we will consider the suggestion to revise the
status indicator in future rulemaking. The final CY 2021 status
indicator for CPT code 99458 can be found in Table 34 below.
Comment: One commenter indicated that CMS is currently paying
separately for certain RPM services and have assigned the codes to
separately payable status indicator ``V,'' ``S,'' or ``Q1,'' however,
some other RPM codes are assigned to non-payable status indicators such
as ``B'' and ``M''. The commenter added that the status indicator
assignments for the RPM codes are inconsistent and confusing to
providers. The same commenter suggested that CMS recognize each
distinct RPM CPT code that require hospital resources and assign the
codes consistently to payable status indicators. The commenter
recommended reassigning CPT codes 93264, 93268, 93297, 93298 from
status indicator ``M'' to ``S'' and assigning the code to either APC
5741 (Level 1 Electronic Analysis of Devices) with a proposed CY 2021
payment rate of $37.76, APC 5742 (Level 2 Electronic Analysis of
Devices) with a proposed CY 2021 payment rate of $101.76, or APC 5743
(Level 3 Electronic Analysis of Devices) with a proposed CY 2021
payment rate of $272.91. The commenter stated that CPT codes 93264,
93268, 93297, 93298 should be covered and payable, similar to CPT code
93296 (Interrogation device evaluation(s) (remote), up to 90 days;
single, dual, or multiple lead pacemaker system, leadless pacemaker
system, or implantable defibrillator system, remote data
acquisition(s), receipt of transmissions and technician review,
technical support and distribution of results), which is assigned to
APC 5741 with a proposed CY 2021 payment rate of $37.76. The same
commenter suggested reassigning CPT code 99474 from status indicator
``B'' to ``V'' and assigning it to APC 5012, similar to CPT code 99453
(Remote monitoring of physiologic parameter(s) (e.g., weight, blood
pressure, pulse oximetry, respiratory flow rate), initial; set-up and
patient education on use of equipment).
Response: We appreciate the commenter's suggestions, however, we
believe that we need further evaluation of the codes to determine
whether all RPM CPT codes should be paid separately under the OPPS.
Therefore, for CY 2021, we are finalizing our proposal, without
modification, to assign CPT codes 93264, 93268, 93297, and 93298 to
status indicator ``M,'' and consider the suggestions to revise the
status indicator and assign appropriate APCs to the codes in future
rulemaking. Similarly, we are finalizing our
[[Page 85979]]
proposal, without modification, to assign CPT code 99474 to status
indicator B'' for CY 2021. The final status indicators for CPT codes
93264, 93268, 93297, 93298, and 99474 can be found in Table 34 below.
Commenter: One commenter suggested revising the status indicator
for 19 CPT codes that describe virtual check-ins, e-visits, and
telephone evaluation and management services from non-payable to
separately payable under the OPPS. The 19 codes, along with the
proposed status indicator assignments and descriptors, can be found in
Table 34 below. The commenter explained that when clinicians furnish
virtual check-ins, e-visits, and telephone E/M services to hospital
outpatients, hospital resources are used to support the clinician. The
commenter stated that while the codes are separately payable under the
PFS, the hospital resources are not paid separately under the OPPS. The
commenter believes that under 42 CFR 419.22, virtual or remote services
are not excluded from OPPS and, therefore, the facility expense should
be paid separately under the OPPS.
Response: We appreciate the commenter's suggestions, however, we
believe that we need further evaluation of the 19 codes to determine
whether the services should be paid separately under the OPPS.
Therefore, for CY 2021, we are finalizing our proposal, without
modification, to assign the codes to either status indicator ``A'' or
``B'' for the 19 codes listed in Table 34 as virtual check-in, e-visit,
and telephone E/M services.
Comment: One commenter suggested revising the status indicator for
two medication therapy management (MTM) codes from ``E1'' to ``B,'' and
indicated that the codes should be assigned to the same status
indicator as genetic counseling code CPT 96040 (Medical genetics and
genetic counseling services, each 30 minutes face-to-face with patient/
family), which is assigned to status indicator ``B'' under the OPPS.
Specifically, the commenter recommended reassigning CPT codes 99605
(Medication therapy management service(s) provided by a pharmacist,
individual, face-to-face with patient, with assessment and intervention
if provided; initial 15 minutes, new patient) and 99606 (Medication
therapy management service(s) provided by a pharmacist, individual,
face-to-face with patient, with assessment and intervention if
provided; initial 15 minutes, established patient) from ``E1'' to
``B.'' The commenter explained that the CY 2021 PFS proposed rule
clarified that genetic counseling and pharmacist services can be
considered ``incident to'' a professional service in the office
setting. Specifically, the commenter noted that the 2021 PFS proposed
rule (85 FR 50146) states ``Medication management is covered under both
Medicare Part B and Part D. We are reiterating the clarification we
provided in the May 1st COVID-19 IFC (85 FR 27550 through 27629), that
pharmacists fall within the regulatory definition of auxiliary
personnel under our regulations at Sec. 410.26. As such, pharmacists
may provide services incident to the services, and under the
appropriate level of supervision, of the billing physician or NPP, if
payment for the services is not made under the Medicare Part D
benefit.'' In light of the statements, the commenter believes that when
MTM services are furnished in the HOPD setting, the hospital outpatient
facility is reporting for the pharmacists' services, which the
commenter believes meet the definition of outpatient services at 42 CFR
410.27 and the definition of OPPS services at 42 CFR 419.21.
Consequently, the commenter believes that MTM services should be paid
separately under the OPPS.
Response: We appreciate the commenter's suggestions, however, we
believe that we need further evaluation of the two MTM codes to
determine whether the services should be paid separately under the
OPPS. We note that policies discussed in the PFS proposed rules
typically do not apply to OPPS policies; however, we will review the
issue. Therefore, for CY 2021, we are finalizing our proposal, without
modification, to assign the codes to status indicator ``E1'' for the 2
MTM codes listed in Table 34.
Comment: One commenter suggested that CMS treat all telehealth and
communication technology-based services (CTBS) consistently with OPPS
payable status indicators and ambulatory payment classification (APC)
assignments. The commenter explained that these issues were discussed
in the 2021 PFS proposed rule.
Response: We appreciate the commenter's suggestion, however, we
believe that we need further evaluation of the issue to determine
whether all the codes that describe telehealth and communication
technology-based services (CTBS) should be paid separately under the
OPPS. In addition, we made no proposals regarding these issues in the
CY 2021 OPPS/ASC proposed rule. As stated above, the proposed policies
discussed in the PFS proposed rules typically do not apply to OPPS
policies because they are two different Medicare payment systems.
However, we will review the issue for potential future rulemaking.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, for the 29 codes listed
in Table 34 for CY 2021. In addition, we refer readers to Addendum D1
of this final rule with comment period for the status indicator (SI)
meanings for all codes reported under the OPPS. Both Addendum B and D1
are available via the internet on the CMS website.
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TR29DE20.047
[[Page 85981]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.048
[[Page 85982]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.049
BILLING CODE 4120-01-C
25. Review of Electrocorticograms From an Implanted Brain
Neurostimulator (APC 5741)
For CY 2021, we proposed to continue to assign CPT code 95836
(Electrocorticogram from an implanted brain neurostimulator pulse
generator/transmitter, including recording, with interpretation and
written report, up to 30 days) to APC 5741 (Level 1 Electronic Analysis
of Devices) with a proposed payment of $37.76.
Comment: A commenter urged CMS to reassign CPT code 95836 from APC
5741 to APC 5742 (Level 2 Electronic Analysis of Devices) with a
proposed payment rate of $101.76, and stated that the payment for APC
5741 does not adequately reflect the resources used by HOPDs in
performing this procedure.
Response: Based on our analysis of the hospital outpatient claims
data for this final rule, we disagree that the resource cost to perform
the service is inappropriate. Our evaluation of the latest claims data
show a geometric mean cost of about $14 based on 21 single claims (out
of 213 total claims). We believe that reassigning the code to APC 5742,
whose geometric mean cost is approximately $98, would significantly
overpay for the service. Additionally, we believe that the payment for
CPT code 95836 is sufficient to cover the hospital cost of performing
the service.
In summary, after consideration of the public comment, we are
finalizing our proposal, without modification, to continue to assign
CPT code 95836 to APC 5741 for CY 2021. The final CY 2021 payment rate
for the code can be found in Addendum B to this final rule with comment
period. In addition, we refer readers to Addendum D1 of this final rule
with comment period for the status indicator (SI) meanings for all
codes reported under the OPPS. Both Addendum B and D1 are available via
the internet on the CMS website.
As we do every year, we will reevaluate the APC assignment for CPT
code 95836 in the next rulemaking cycle. We remind hospitals that we
review, on an annual basis, the APC assignments for all services and
items paid under the OPPS based on the latest claims data available to
us.
26. Therapeutic Apheresis
The LIXELLE[supreg] [beta]2-microglobulin Apheresis Column is
indicated for use in the treatment of dialysis-related amyloidosis
(DRA), a disease that affects people with end-stage renal disease
(ESRD) who have been receiving dialysis for five or more years. The
LIXELLE[supreg] device is used in an apheresis procedure that
selectively removes [beta]2-microglobulin (``[beta]2m'') from the
circulating blood of patients with DRA. LIXELLE[supreg] is used
pursuant to a physician prescription in conjunction with hemodialysis
and is intended to be used at each hemodialysis session (i.e.,
frequency of treatment is expected to be three times per week).
In March 2015, FDA approved LIXELLE[supreg] as a Class III
Humanitarian Use Device (HUD) with an approved Humanitarian Device
Exemption (HDE). FDA regulations require the manufacturer to conduct a
post-approval study (PAS) to evaluate the safety of the LIXELLE[supreg]
Apheresis procedure in U.S. patients on chronic hemodialysis with
clinically-diagnosed DRA, and assess the probable benefit of
LIXELLE[supreg] Apheresis to increase the [beta]2m reduction rate in
these patients in successive dialysis sessions (compared to dialysis
without LIXELLE[supreg]). Currently, there is no payment under the OPPS
for the apheresis procedure used with the LIXELLE[supreg] device.
Comment: One commenter, the manufacturer of the LIXELLE[supreg]
device,
[[Page 85983]]
requested that CMS provide payment for the apheresis procedure used
with the device under the OPPS. The commenter stated that the
LIXELLE[supreg] apheresis procedure may be administered in either a
dialysis facility or the hospital outpatient department and that the
HOPD was the more clinically appropriate setting. Specifically, the
commenter requested that CMS provide payment through the OPPS via one
of three potential pathways: (1) Allow payment for the apheresis
procedure used with the LIXELLE[supreg] device through CPT code 36516
(Therapeutic apheresis with extracorporeal immunoadsorption, selective
adsorption or selective filtration and plasma reinfusion), which was
proposed to be assigned to APC 5243 (Level 3 Blood Product Exchange and
Related Services) for CY 2021, and require the use of a modifier or
add-on code when the LIXELLE[supreg] apheresis procedure is billed to
reduce the payment for the procedure to the payment rate for APC 5242
(Level 2 Blood Product Exchange and Related Services); (2) allow
payment for the dialysis performed as part of LIXELLE[supreg] apheresis
procedure through HCPCS code G0257 (Unscheduled or emergency dialysis
treatment for an ESRD patient in a hospital outpatient department that
is not certified as an ESRD facility), which is assigned to APC 5401
(Dialysis) for CY 2021, and require the use of a modifier or add-on
code to provide additional payment beyond that provided by APC 5401; or
(3) create a HCPCS C code or G code for the LIXELLE[supreg] apheresis
procedure and assign the code to APC 5242 (Level 2 Blood Product
Exchange and Related Services). Finally, the commenter also noted that
they have been unable to complete the FDA-required post-approval study
as a condition of the HDE, due to difficulty in securing patient
enrollment because of lack of CMS payment for the LIXELLE[supreg]
apheresis procedure.
Response: We appreciate these comments and understand the various
issues related to coverage and payment for the LIXELLE[supreg]
apheresis procedure. We will consider these comments for future
rulemaking.
27. Tympanostomy Using an Automated Tube Delivery System (APC 5163)
As displayed in Addendum B to the CY 2021 OPPS/ASC proposed rule,
we proposed to assign CPT code 0583T (Tympanostomy (requiring insertion
of ventilating tube), using an automated tube delivery system,
iontophoresis local anesthesia) to status indicator (SI) ``E1'' to
indicate that the code is not payable by Medicare when submitted on
outpatient claims (any outpatient bill type) because the services
associated with these codes are either not covered by any Medicare
outpatient benefit category, are statutorily excluded from Medicare
payment, or are not reasonable and necessary.
Comment: Some commenters reported that the device associated with
CPT code 0583T received FDA approval in November 2019 and requested
separate payment for the code. They specifically requested assignment
to APC 5164 (Level 4 ENT Procedures), with a proposed payment of
$2,776.63, and also requested assignment to either status indicator
``S'' (Procedure or Service, Not Discounted When Multiple) or ``T''
(Procedure or Service, Multiple Procedure Reduction Applies). They
reported that assignment to APC 5164 would match the resources
furnished when providing this service. The manufacturer for the device
associated with the code explained that while the surgical procedure
described by CPT code 0583T is primarily performed on children, the
device is approved for all ages above 6 months. The manufacturer also
indicated that the procedure will be extremely important for the
Medicaid population and Medicaid programs who often refer to Medicare
to establish coverage and payment. One commenter reported that the
total cost for the complete procedure is approximately $2,776, while
the device manufacturer reported a cost of about $1,400 for the device.
Response: Based on our review of the procedure and input from our
medical advisors, we believe that the surgical procedure described by
CPT code 0583T is most similar, in terms of clinical homogeneity and
resource cost, to CPT code 69436 (Tympanostomy (requiring insertion of
ventilating tube), local or topical anesthesia), which is assigned to
APC 5163 (Level 3 ENT Procedures) with a proposed payment of about
$1,395. Both procedures (as described by CPT codes 0583T and 69436)
require ventilating tubes that require anesthesia. Therefore, we
believe that the most appropriate APC assignment for CPT code 0583T is
APC 5163, which is associated with status indicator ``J1'' (Hospital
Part B services paid through a comprehensive APC).
In summary, after consideration of the public comments, we are
finalizing our proposal with modification, and assigning CPT code 0583T
to APC 5163 with a status indicator of ``J1'' for CY 2021. The final CY
2021 payment rate for the code can be found in Addendum B to this final
rule with comment period. In addition, we refer readers to Addendum D1
of this final rule with comment period for the status indicator (SI)
meanings for all codes reported under the OPPS. Both Addendum B and D1
are available via the internet on the CMS website.
28. Unlisted Dental Procedure (APC 5161)
For CY 2021, we proposed to continue to assign CPT code 41899
(Unlisted procedure, dentoalveolar structures) to APC 5161 (Level 1 ENT
Procedures) with a payment rate of $213.59.
Comment: Two dental specialty societies expressed concern with the
payment rate for CPT code 41899. They explained that this is the only
CPT code available for dental surgery and its low reimbursement is
insufficient to cover the facility costs. The commenters added that the
low payment rate has resulted in many dentists, especially pediatric
dentists, experiencing difficulty in obtaining operating room (OR) time
to perform surgical procedures under general anesthesia. They stated
that the problem has been exacerbated by the COVID-19 pandemic, with
further limited access to ORs to address patient dental needs.
Response: CPT code 41899 is designated as an unlisted code. Some
HCPCS codes are used to report items, services, and procedures that do
not define the exact item, service, or surgical procedure furnished.
They are commonly called ``unlisted'' codes. The code descriptors often
contain phrases such as: ``unlisted procedure,'' ``not otherwise
classified,'' or ``not otherwise specified.'' The unlisted codes
typically fall within a clinical or procedural category, but they lack
the specificity needed to describe the resources used. Until a more
specific HCPCS code is established, as an interim, the unlisted code
provides a way for providers to report items, services, and procedures
furnished. In general, unlisted codes are reported when no other
specific CPT or Level II HCPCS code accurately describes the item,
procedure, or service. Because of the lack of specificity, unlisted
codes are assigned to the lowest level, clinically appropriate APC
group under the OPPS. The assignment of the unlisted codes to the
lowest level APC in the clinical category specified in the code
provides a reasonable means for interim payment until such time as
there is a code that specifically describes what is being paid. It also
encourages the creation of codes where appropriate and protects against
overpayment of services that are not clearly identified on the claim.
As a reminder, unlisted codes are not used in establishing the percent
of claims contributing to the APC, nor are their
[[Page 85984]]
costs used in the calculation of the APC geometric mean (80 FR 70321),
because, by the code's definition, we do not know what service or
combination of services is reflected in the claims billed with the
unlisted code. Currently, we have five levels of ENT Procedure APCs,
Levels 1 through 5, with Level 1 assigned to the lowest paying of the
five APCs. Because the code is designated as an unlisted code, we
believe that CPT 41899 code is appropriately assigned to APC 5161,
which is the lowest level ENT APC.
In addition, because unlisted codes are non-specific, HOPDs are
reminded that Medicare Administrative Contractors (MACs) may have
additional documentation requirements for how the codes should be
reported to receive payment. Refer to section 180.3 (Unlisted Service
or Procedure) in Chapter 4 (Part B Hospital) of the Medicare Claims
Processing Manual for information on how MACs review claims with
unlisted codes.
We note that AMA establishes new CPT codes, depending on the code
type, quarterly and annually. Interested parties that desire more
specific codes for unlisted codes should consult the AMA. Information
on CPT codes and the process for requesting new codes can be found on
the AMA website: https://www.ama-assn.org/about/cpt-editorial-panel/cpt-code-process.
In summary, after consideration of the public comments, we are
finalizing our proposal, without modification, to assign CPT code 41899
to APC 5161 for CY 2021. The final CY 2021 payment rate for the code
can be found in Addendum B to this final rule with comment period. In
addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
29. Urology and Related Services (APCs 5371 Through 5378)
We received comments on the CY 2020 OPPS/ASC proposed rule
suggesting we revise the APC assignments for the services assigned to
the Urology & Related Services APCs. The commenter specifically noted
that a reorganization for APCs 5374 through 5376 would be appropriate,
but added that there were other adjustments across services within the
Urology APCs that could improve the structure of these APCs. In
response to this comment, we stated in the CY 2020 OPPS/ASC final rule
with comment period that we would consider revisions to the urology
APCs in future rulemaking.
Currently, for CY 2020, there are seven levels of APCs for urology
services. We reviewed the geometric mean cost for APCs 5371 through
5377 and, after our analysis of the claims data for the CY 2021 OPPS/
ASC proposed rule, we believed that a modification to the urology APCs
would be appropriate.
For the CY 2021 OPPS/ASC proposed rule, we evaluated the claims
data and noted the large difference in geometric mean cost between APC
5376 (level 6) and APC 5377 (level 7) has continued to grow. This
difference in the geometric mean cost from APC 5376 to APC 5377 would
have been about $9,700, with the geometric mean cost for APC 5377 at
approximately 220 percent of the geometric mean cost of APC 5376. Based
on the proposed rule claims data, which showed an unusually large
difference between the geometric mean costs of the Level 6 Urology APC
and the Level 7 Urology APC on both a dollar and percentage basis, we
believed that creating an additional APC in the urology and related
series would provide an appropriate structure, distinguishing between
clinical and cost similarity for the procedures in the different
levels. Therefore, for CY 2021, we proposed to establish an additional
level for the urology and related services APCs, specifically, APC 5378
(Level 8 Urology and Related Services) and to re-organize the current
APCs 5376 (Level 6 Urology and Related Services) and 5377 (Level 7
Urology and Related Services). We believed this re-organization would
address the lack of an appropriate level for procedures with geometric
mean costs that fall between current APC 5376 and current APC 5377.
As we stated in the proposed rule (85 FR 48842), the proposed
reorganization would reassign CPT 53440 (Male sling procedure) and CPT
0548T (Transperineal periurethral balloon continence device; bilateral
placement, including cystoscopy and fluoroscopy) from the current APC
5376 to APC 5377.
In addition, the proposed revision would reassign the following
services from APC 5377 to APC 5378:
CPT 54416 (Removal and replacement of non-inflatable
(semi-rigid) or inflatable (self-contained) penile prosthesis at the
same operative session).
CPT 53444 (Insert tandem cuff).
CPT 54410 (Removal and replacement of all component(s) of
a multi-component, inflatable penile prosthesis at the same operative
session).
CPT 54411 (Removal and replacement of all components of a
multi-component inflatable penile prosthesis through an infected field
at the same operative session, including irrigation and debridement of
infected tissue).
CPT 54401 (Insertion of penile prosthesis; inflatable
(self-contained)).
CPT 54405 (Insertion of multi-component, inflatable penile
prosthesis, including placement of pump, cylinders, and reservoir).
CPT 53447 (Removal and replacement of inflatable urethral/
bladder neck sphincter including pump, reservoir, and cuff at the same
operative session).
CPT 53445 (Insertion of inflatable urethral/bladder neck
sphincter, including placement of pump, reservoir, and cuff).
As further stated in the proposed rule, the proposed APC
reassignment for these 10 codes results in geometric mean costs for
Levels 6, 7, and 8 of the Urology APCs that we believe more
appropriately align with the geometric mean costs for services in these
APCs than the current structure. Specifically, as listed in Table 19 of
the proposed rule, and reprinted below, the geometric mean cost of
$8,089.78 for APC 5376, $11,275.15 for APC 5377, and $18,015.54 for APC
5378 reduces the unusually large gaps on both a dollar and percentage
basis in geometric mean costs between each APC level.
[[Page 85985]]
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We received many comments on our proposal. Below are the comments
and our responses.
Comment: Several commenters supported our proposal to establish an
additional Urology and Related Services APC, specifically, APC 5378
(Level 8 Urology and Related Services), and re-organize the current
APCs 5376 (Level 6 Urology and Related Services) and 5377 (Level 7
Urology and Related Services). These commenters agreed that the
addition of APC 5378 within the Urology APCs would better align
procedures based on their resource cost and clinical homogeneity.
Response: We appreciate the commenters' support for our proposal to
establish new APC 5378 and to re-organize the procedures in the Urology
APCs. We note that each year, under the OPPS, we revise and make
changes to the APC groupings based on the latest hospital outpatient
claims data to appropriately place procedures and services in APCs
based on clinical characteristics and resource similarity. We note that
based on our review of the claims data for the final rule, we are also
finalizing our proposal without modification to reassign CPT codes
53440 and 0548T to APC 5377. Similarly, we are finalizing our proposal
without modification to reassign CPT codes 54416, 53444, 54410, 54411,
54401, 54405, 53447, and 53445 to APC 5378.
Comment: A commenter supported the continued assignment of HCPCS
code C9739 (Cystourethroscopy, with insertion of transprostatic
implant; 1 to 3 implants) to APC 5375 and HCPCS C9740
(Cystourethroscopy, with insertion of transprostatic implant; 4 or more
implants) to APC 5376.
Response: We appreciate the commenter's support for our APC
assignments, which are based on our review of the latest claims data.
We are finalizing our proposal and assigning these codes to the
proposed APCs in this final rule.
Comment: Several commenters also recommended additional changes
within APCs 5371 to APC 5376. Specifically, for APCs 5371 and 5372, the
commenters recommended the following reassignments from APC 5371 to APC
5372:
CPT 51720 (Bladder instillation of anticarcinogenic agent
(including retention time);
CPT 43763 (lacement of gastrostomy tube, percutaneous,
includes removal, when performed, without imaging or endoscopic
guidance; requiring revision of gastrostomy tract);
51725 Simple cystometrogram (cmg) (e.g., spinal
manometer);
51726 Complex cystometrogram (i.e., calibrated electronic
equipment); and
51040 Cystostomy, cystotomy with drainage.
Also, the commenters suggested the reassignment of the following
codes from APC 5373 to APC 5374:
52287 Cystourethroscopy, with injection(s) for
chemodenervation of the bladder
52276 Cystourethroscopy with direct vision internal
urethrotomy
54840 Excision of spermatocele, with or without
epididymectomy
53854 Transurethral destruction of prostate tissue; by
radiofrequency generated water vapor thermotherapy
In addition, the commenters recommended reassigning the following
codes from APC 5375 to APC 5376:
53420 Urethroplasty, 2-stage reconstruction or repair of
prostatic or membranous urethra; first stage;
C9747 Ablation of prostate, transrectal, high intensity
focused ultrasound (hifu), including imaging guidance;
53410 Urethroplasty, 1-stage reconstruction of male
anterior urethra;
50553 Renal endoscopy through established nephrostomy or
pyelostomy, with or without irrigation, instillation, or
ureteropyelography, exclusive of radiologic service; with ureteral
catheterization, with or without dilation of ureter;
54111 Excision of penile plaque (peyronie disease); with
graft to 5 cm in length;
55875 Transperineal placement of needles or catheters into
prostate for interstitial radioelement application, with or without
cystoscopy;
54660 Insertion of testicular prosthesis (separate
procedure);
50576 Renal endoscopy through nephrotomy or pyelotomy,
with or without irrigation, instillation, or ureteropyelography,
exclusive of radiologic service; with fulguration and/or incision, with
or without biopsy; and
0549T Transperineal periurethral balloon continence
device; unilateral placement, including cystoscopy and fluoroscopy;
Further, the commenters suggested revising the assignment for these
codes from APC 5376 to APC 5377:
[[Page 85986]]
55873 Cryosurgical ablation of the prostate (includes
ultrasonic guidance and monitoring);
50081 Percutaneous nephrostolithotomy or
pyelostolithotomy, with or without dilation, endoscopy, lithotripsy,
stenting, or basket extraction; over 2 cm; and
50562 Renal endoscopy through established nephrostomy or
pyelostomy, with or without irrigation, instillation, or
ureteropyelography, exclusive of radiologic service; with resection of
tumor.
Response: Based on our review of the claims data for the final
rule, we do not believe that reassigning these 21 urology procedures to
the suggested APCs is appropriate. Our review of the claims data for
this CY 2021 OPPS/ASC final rule with comment period show that the
procedures are appropriately placed in the proposed APCs based on
clinical homogeneity and resource costs. Consequently, we are
finalizing our proposal without modification for the 21 urology
procedures discussed above.
In summary, after consideration of the public comments, and after
our analysis of the updated claims data for this final rule with
comment period, we are finalizing our proposal, without modification,
to reorganize the Urology and Related Services APCs. The final CY 2021
payment rate for the codes for all the codes discussed above can be
found in Addendum B to this final rule with comment period. In
addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
a. High-Intensity Focused Ultrasound of the Prostate (HIFU) Procedure
(APC 5375)
In 2017, CMS received a new technology application for the prostate
HIFU procedure and established a new code, specifically, HCPCS code
C9747 (Ablation of prostate, transrectal, high intensity focused
ultrasound (hifu), including imaging guidance). Based on the estimated
cost provided in the new technology application, we assigned the new
code to APC 5376 (Level 6 Urology and Related Services) with a payment
rate of $7,452.66 effective July 1, 2017. We announced the SI and APC
assignment in the July 2017 OPPS quarterly update CR (Transmittal 3783,
Change Request 10122, dated May 26, 2017).
For the CY 2018 update, we maintained the assignment of HCPCS code
C9747 to APC 5376 with a payment rate of $7,596.26. We note that the
payment rates for the CY 2018 OPPS update were based on claims
submitted between January 1, 2016 through December 30, 2016, that were
processed on or before June 30, 2017. Since HCPCS code C9747 was
established on July 1, 2017, we had no claims data for the procedure
for use in ratesetting for CY 2018.
However, for the CY 2019 update, based on the latest claims data
for the final rule, we revised the APC assignment for HCPCS code C9747
from APC 5376 to APC 5375 with a payment rate of $4,020.54. We note
that the payment rates for CY 2019 were based on claims submitted
between January 1, 2017 through December 30, 2017, that were processed
on or before June 30, 2018. Our claims data showed a geometric mean
cost of approximately $5,000 for HCPCS code C9747 based on 64 single
claims (out of 64 total claims), which was significantly lower than the
geometric mean cost of about $7,717 for APC 5376. We believed that the
geometric mean cost for HCPCS code C9747 was more comparable to the
geometric mean cost of approximately $4,055 for APC 5375. Consequently,
we reassigned the code from APC 5376 to APC 5375 (Level 5 Urology and
Related Services) for CY 2019 and C9747 remained in APC 5376 for CY
2020.
For CY 2021, we proposed to continue to assign HCPCS code C9747 to
APC 5375 with a proposed payment rate $4,487.87. In addition, we noted
that HCPCS C9747 will be replaced with CPT 55880 beginning January
2021.
Comment: Many commenters stated that the APC 5375 payment rate does
not cover the hospital facility cost for this procedure, and thus,
discourages hospitals from providing this procedure for Medicare
patients. Some commenters argued that HIFU is a device-intensive
procedure, believed that the average cost of the HIFU procedure is
closer to the APC 5376 proposed payment rate of $8,395.87, and
requested a reassignment to enable Medicare beneficiaries to receive
the treatment. They projected that maintaining the assignment in APC
5375 will deter HOPD facilities from offering the HIFU treatment to
Medicare beneficiaries because the payment is insufficient to cover the
cost of the procedure. Several commenters recommended we assign this
procedure to APC 5376 because they believe the service is clinically
similar and comparable in terms of resources to cryoablation of the
prostate, which is described by CPT code 55873 (Cryosurgical ablation
of the prostate (includes ultrasonic guidance and monitoring) and
assigned to APC 5376 (Level 6 Urology and Related Services), with a
proposed payment rate of $8,395.62.
Response: As we have stated every year since the implementation of
the OPPS on August 1, 2000, we review, on an annual basis, the APC
assignments for all services and items (including devices) paid under
the OPPS based on our analysis of the latest claims data. For CY 2021,
based on claims submitted between January 1, 2019 through December 30,
2019, that were processed on or before June 30, 2020, our analysis of
the latest claims data for this final rule supports maintaining HCPCS
code C9747 in APC 5375. Specifically, our claims data shows a geometric
mean cost of approximately $5,744 for HCPCS code C9747 based on 279
single claims, which is more comparable to the geometric mean cost of
about $4,300 for APC 5375, rather than the geometric mean cost of
approximately $8,045 for APC 5376. Furthermore, the claims data do not
indicate that HCPCS code C9747 meets the device-intensive threshold of
30 percent. Therefore, we are not designating HCPCS code C9747 as a
device-intensive procedure.
With regard to the issue of similarity to CPT code 55873, while we
agree both procedures are intended to treat prostate cancer, we
disagree that the resource costs associated with the prostate HIFU
procedure are necessarily similar to those of cryoablation of the
prostate. Specifically, our claims data for cryoablation of the
prostate shows a geometric mean cost of about $8,423 based on 1,226
single claims. The geometric mean cost for CPT code 55873 is reasonably
consistent with APC 5376, which has a geometric mean cost of
approximately $8,045.
In summary, after careful consideration of the public comments and
after our analysis of the updated claims data for this final rule with
comment period, we are maintaining the APC assignment for HCPCS code
C9747 in APC 5375. We note that for the CY 2021 update, the CPT
Editorial Panel established CPT code 55880 (Ablation of malignant
prostate tissue, transrectal, with high intensity--focused ultrasound
(HIFU), including ultrasound guidance) to describe HIFU effective
January 1, 2021. Therefore, we are deleting HCPCS code C9747 on
December 31, 2020 because it will be replaced with CPT code 55880. The
final CY 2021 payment rate for CPT code 55880 can be found in Addendum
B to this final rule with comment period. In addition, we refer readers
to Addendum D1 of this final rule with comment period for the status
indicator (SI) meanings for all codes
[[Page 85987]]
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
b. Optilume Procedure--Optilume Drug Coated Balloon Catheter System
(APC 5375)
For the July 2020 update, the CPT Editorial Panel established a new
code, specifically, Category III CPT code 0619T (Cystourethroscopy with
transurethral anterior prostate commissurotomy and drug delivery,
including transrectal ultrasound and fluoroscopy, when performed), to
describe the surgical procedure associated with the Optilume Drug
Coated Balloon Catheter System used to treat benign prostate
hyperplasia (BPH). We announced the APC assignment for CPT code 0619T
in the July 2020 OPPS quarterly update CR (Transmittal 10207, Change
Request 11814, dated July 2, 2020).
Specifically, we assigned CPT code 0619T to APC 5375 (Level 5
Urology and Related Services) with a payment rate of approximately
$4,232 effective July 1, 2020 and also assigned the code a status
indicator of ``J1'' (Hospital Part B services paid through a
comprehensive APC). Based on input from our medical advisors and the
nature of the procedure, we believed that the procedure described by
CPT code 0619T was similar, based on clinical homogeneity and resource
cost, to CPT code 52601 (Transurethral electrosurgical resection of
prostate, including control of postoperative bleeding, complete
(vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or
dilation, and internal urethrotomy are included)).
Comment: A commenter asserted that CPT code 0619T should be
reassigned to APC 5376 (Level 6 Urology and Related Services). The
commenter reported that the CPT code 0619T is more clinically similar
to HCPCS C9740 (Cystourethroscopy, with insertion of transprostatic
implant; 4 or more implants) in terms of clinical characteristics,
physician work/intraoperative intensity, and resource costs including
both non-device related and device related costs. Furthermore, the
commenter also indicated that CPT code 0619T has additional non-device
costs, including transrectal ultrasound, fluoroscopy and use of a
rectal steeper device. The commenter stated that CPT code 0619T has
similar resource cost to HCPCS code C9740 in terms of its device and
non-device cost.
Response: We appreciate the commenter's input on this subject and
we understand that this is a new procedure without a predecessor code.
Based on our evaluation, we do not agree that CPT code 0619T is similar
to HCPCS code C9740. Based on the nature of the procedure and input
from our medical advisors, we believe CPT code 0619T is more comparable
to HCPCS code C9739 (Cystourethroscopy, with insertion of
transprostatic implant; 1 to 3 implants), and CPT 52601 (Transurethral
electrosurgical resection of prostate, including control of
postoperative bleeding, complete (vasectomy, meatotomy,
cystourethroscopy, urethral calibration and/or dilation, and internal
urethrotomy are included)), which are both currently assigned to APC
5375 (Level 5 Urology and Related Services). We believe the assignment
of CPT code 0619T to APC 5375 and its device-offset of 31 percent is
appropriate until CMS receives more cost data to support a reassignment
to another APC or a different device offset adjustment.
In summary, after consideration of the comment, we are finalizing
our proposal without modification to continue to assign CPT code 0619T
to APC 5375 for CY 2021. The final CY 2021 payment rate for this code
can be found in Addendum B to this final rule with comment period. In
addition, we refer readers to Addendum D1 of this final rule with
comment period for the status indicator (SI) meanings for all codes
reported under the OPPS. Both Addendum B and D1 are available via the
internet on the CMS website.
30. Venous Mechanical Thrombectomy (APC 5193)
For CY 2020, CPT code 37187 (Percutaneous transluminal mechanical
thrombectomy, vein(s), including intraprocedural pharmacological
thrombolytic injections and fluoroscopic guidance) is assigned to APC
5192 (Level 2 Endovascular Procedures) with a payment of $4,953.91. For
CY 2021, we proposed to reassign CPT code 37187 from APC 5192 to APC
5193 (Level 3 Endovascular Procedures) with a proposed payment of
$10,222.32.
Comment: A commenter approved of our proposal to reassign CPT code
37187 to APC 5193 and requested that CMS finalize the proposal. The
commenter noted that the geometric mean cost of CPT code 37187 is well
aligned with APC 5193, and stated that the cost of the venous
mechanical thrombectomy procedure is comparable to other clinically
similar procedures within the APC.
Response: We appreciate the support for our proposal to reassign
CPT code 37187 from APC 5192 to APC 5193. The claims data for the final
rule, which is based on claims submitted between January 1, 2019,
through December 31, 2019, processed through June 30, 2020, show that
the geometric mean cost for CPT code 37187 is approximately $10,385,
which is within the range of procedures of significant volume within
APC 5193. Procedures with significant volume in APC 5193 range between
$7,278 for CPT code 36905 and $13,492 for CPT code 37225. We believe
that reassigning CPT code 37187 is appropriate based on its clinical
homogeneity and similarity in resource costs to the other thrombectomy
procedures (e.g., 36905, 37225) assigned to APC 5193.
In summary, after consideration of the public comment, we are
finalizing our proposal to assign CPT code 37187 to APC 5193 for CY
2021. The final CY 2021 payment rate for this code can be found in
Addendum B to this final rule with comment period. In addition, we
refer readers to Addendum D1 of this final rule with comment period for
the status indicator (SI) meanings for all codes reported under the
OPPS. Both Addendum B and D1 are available via the internet on the CMS
website.
IV. OPPS Payment for Devices
A. Pass-Through Payment for Devices
1. Beginning Eligibility Date for Device Pass-Through Status and
Quarterly Expiration of Device Pass-Through Payments
a. Background
The intent of transitional device pass-through payment, as
implemented at 42 CFR 419.66, is to facilitate access for beneficiaries
to the advantages of new and truly innovative devices by allowing for
adequate payment for these new devices while the necessary cost data is
collected to incorporate the costs for these devices into the procedure
APC rate (66 FR 55861). Under section 1833(t)(6)(B)(iii) of the Act,
the period for which a device category eligible for transitional pass-
through payments under the OPPS can be in effect is at least 2 years
but not more than 3 years. Prior to CY 2017, our regulation at 42 CFR
419.66(g) provided that this pass-through payment eligibility period
began on the date CMS established a particular transitional pass-
through category of devices, and we based the pass-through status
expiration date for a device category on the date on which pass-through
payment was effective for the category. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79654), in accordance with section
1833(t)(6)(B)(iii)(II) of the Act, we amended Sec. 419.66(g) to
provide that the
[[Page 85988]]
pass-through eligibility period for a device category begins on the
first date on which pass-through payment is made under the OPPS for any
medical device described by such category.
In addition, prior to CY 2017, our policy was to propose and
finalize the dates for expiration of pass-through status for device
categories as part of the OPPS annual update. This means that device
pass-through status would expire at the end of a calendar year when at
least 2 years of pass-through payments had been made, regardless of the
quarter in which the device was approved. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79655), we changed our policy to allow
for quarterly expiration of pass-through payment status for devices,
beginning with pass-through devices approved in CY 2017 and subsequent
calendar years, to afford a pass-through payment period that is as
close to a full 3 years as possible for all pass-through payment
devices.
We refer readers to the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79648 through 79661) for a full discussion of the current
device pass-through payment policy.
We also have an established policy to package the costs of the
devices that are no longer eligible for pass-through payments into the
costs of the procedures with which the devices are reported in the
claims data used to set the payment rates (67 FR 66763).
b. Expiration of Transitional Pass-Through Payments for Certain Devices
As stated earlier, section 1833(t)(6)(B)(iii) of the Act requires
that, under the OPPS, a category of devices be eligible for
transitional pass-through payments for at least 2 years, but not more
than 3 years. There currently are 7 device categories eligible for
pass-through payment: C1823-Generator, neurostimulator (implantable),
nonrechargeable, with transvenous sensing and stimulation leads);
C1824-Generator, cardiac contractility modulation (implantable); C1982-
Catheter, pressure-generating, one-way valve, intermittently occlusive;
C1839-Iris prosthesis; C1734-Orthopedic/device/drug matrix for opposing
bone-to-bone or soft tissue-to bone (implantable); C2596-Probe, image-
guided, robotic, waterjet ablation; and C1748-Endoscope, single-use
(that is disposable), Upper GI, imaging/illumination device
(insertable).
The pass-through payment status of the device category for HCPCS
code C1823 will end on December 31, 2021; the pass-through payment
status of the device category for HCPCS code C1748 will end on June 30,
2023; and the pass-through payment status of the device categories for
HCPCS codes C1824, C1982, C1839, C1734, and C2596 will end on December
31, 2022. Table 35 shows the expiration of transitional pass-through
payments for these devices. All of these HCPCS codes will have pass-
through payment status and will continue to receive pass-through
payments in CY 2021.
[GRAPHIC] [TIFF OMITTED] TR29DE20.051
[[Page 85989]]
2. New Device Pass-Through Applications
a. Background
Section 1833(t)(6) of the Act provides for pass-through payments
for devices, and section 1833(t)(6)(B) of the Act requires CMS to use
categories in determining the eligibility of devices for pass-through
payments. As part of implementing the statute through regulations, we
have continued to believe that it is important for hospitals to receive
pass-through payments for devices that offer substantial clinical
improvement in the treatment of Medicare beneficiaries to facilitate
access by beneficiaries to the advantages of the new technology.
Conversely, we have noted that the need for additional payments for
devices that offer little or no clinical improvement over previously
existing devices is less apparent. In such cases, these devices can
still be used by hospitals, and hospitals will be paid for them through
appropriate APC payment. Moreover, a goal is to target pass-through
payments for those devices where cost considerations might be most
likely to interfere with patient access (66 FR 55852; 67 FR 66782; and
70 FR 68629). We note that, as discussed in section IV.A.4. of this CY
2021 OPPS/ASC proposed rule, we created an alternative pathway in the
CY 2020 OPPS/ASC final rule that granted fast-track device pass-through
payment under the OPPS for devices approved under the FDA Breakthrough
Device Program for OPPS device pass-through payment applications
received on or after January 1, 2020. We refer readers to section
IV.A.4. of this CY 2021 OPPS/ASC proposed rule for a complete
discussion of this pathway.
As specified in regulations at 42 CFR 419.66(b)(1) through (3), to
be eligible for transitional pass-through payment under the OPPS, a
device must meet the following criteria:
If required by FDA, the device must have received FDA
marketing authorization (except for a device that has received an FDA
investigational device exemption (IDE) and has been classified as a
Category B device by the FDA), or meet another appropriate FDA
exemption; and the pass-through payment application must be submitted
within 3 years from the date of the initial FDA marketing
authorization, if required, unless there is a documented, verifiable
delay in U.S. market availability after FDA marketing authorization is
granted, in which case CMS will consider the pass-through payment
application if it is submitted within 3 years from the date of market
availability;
The device is determined to be reasonable and necessary
for the diagnosis or treatment of an illness or injury or to improve
the functioning of a malformed body part, as required by section
1862(a)(1)(A) of the Act; and
The device is an integral part of the service furnished,
is used for one patient only, comes in contact with human tissue, and
is surgically implanted or inserted (either permanently or
temporarily), or applied in or on a wound or other skin lesion.
In addition, according to Sec. 419.66(b)(4), a device is not
eligible to be considered for device pass-through payment if it is any
of the following: (1) Equipment, an instrument, apparatus, implement,
or item of this type for which depreciation and financing expenses are
recovered as depreciation assets as defined in Chapter 1 of the
Medicare Provider Reimbursement Manual (CMS Pub. 15-1); or (2) a
material or supply furnished incident to a service (for example, a
suture, customized surgical kit, or clip, other than a radiological
site marker).
Separately, we use the following criteria, as set forth under Sec.
419.66(c), to determine whether a new category of pass-through payment
devices should be established. The device to be included in the new
category must--
Not be appropriately described by an existing category or
by any category previously in effect established for transitional pass-
through payments, and was not being paid for as an outpatient service
as of December 31, 1996;
Have an average cost that is not ``insignificant''
relative to the payment amount for the procedure or service with which
the device is associated as determined under Sec. 419.66(d) by
demonstrating: (1) The estimated average reasonable cost of devices in
the category exceeds 25 percent of the applicable APC payment amount
for the service related to the category of devices; (2) the estimated
average reasonable cost of the devices in the category exceeds the cost
of the device-related portion of the APC payment amount for the related
service by at least 25 percent; and (3) the difference between the
estimated average reasonable cost of the devices in the category and
the portion of the APC payment amount for the device exceeds 10 percent
of the APC payment amount for the related service (with the exception
of brachytherapy and temperature-monitored cryoablation, which are
exempt from the cost requirements as specified at Sec. 419.66(c)(3)
and (e)); and
Demonstrate a substantial clinical improvement, that is,
substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment.
Beginning in CY 2016, we changed our device pass-through evaluation
and determination process. Device pass-through applications are still
submitted to CMS through the quarterly subregulatory process, but the
applications will be subject to notice-and-comment rulemaking in the
next applicable OPPS annual rulemaking cycle. Under this process, all
applications that are preliminarily approved upon quarterly review will
automatically be included in the next applicable OPPS annual rulemaking
cycle, while submitters of applications that are not approved upon
quarterly review will have the option of being included in the next
applicable OPPS annual rulemaking cycle or withdrawing their
application from consideration. Under this notice-and-comment process,
applicants may submit new evidence, such as clinical trial results
published in a peer-reviewed journal or other materials for
consideration during the public comment process for the proposed rule.
This process allows those applications that we are able to determine
meet all of the criteria for device pass-through payment under the
quarterly review process to receive timely pass-through payment status,
while still allowing for a transparent, public review process for all
applications (80 FR 70417 through 70418).
In the CY 2020 annual rulemaking process, we finalized an
alternative pathway for devices that are granted a Breakthrough Device
designation (84 FR 61295) and receive Food and Drug Administration
(FDA) marketing authorization. Under this alternative pathway, devices
that are granted a FDA Breakthrough Device designation are not
evaluated in terms of the current substantial clinical improvement
criterion at Sec. 419.66(c)(2) for the purposes of determining device
pass-through payment status, but do need to meet the other requirements
for pass-through payment status in our regulation at Sec. 419.66.
Devices that are part of the Breakthrough Devices Program, have
received FDA marketing authorization, and meet the other criteria in
regulation can be approved through the quarterly process and announced
through that process (81 FR 79655). Proposals regarding these devices
and whether pass-through
[[Page 85990]]
payment status should continue to apply are included in the next
applicable OPPS rulemaking cycle. This process promotes timely pass-
through payment status for innovative devices, while also recognizing
that such devices may not have a sufficient evidence base to
demonstrate substantial clinical improvement at the time of FDA
marketing authorization.
More details on the requirements for device pass-through payment
applications are included on the CMS website in the application form
itself at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/HospitalOutpatientPPS/passthrough_payment.html, in the
``Downloads'' section. In addition, CMS is amenable to meeting with
applicants or potential applicants to discuss research trial design in
advance of any device pass-through application or to discuss
application criteria, including the substantial clinical improvement
criterion.
Comment: Some commenters requested that CMS waive the criteria for
establishing new device categories specified at Sec. 419.66(c)(1),
which states that a device to be included in the category is not
appropriately described by any of the existing categories or by any
category previously in effect, and was not being paid for as an
outpatient service as of December 31, 1996, for devices that are
granted a FDA Breakthrough Device designation. The commenters stated
that these devices should automatically be considered not to be
described by any of the existing (either currently active or expired)
categories established for transitional device pass-through payments
because the FDA Breakthrough Device designation implies that the device
is a first of kind. These commenters noted that under the IPPS New
Technology Add-on Payment (NTAP), devices granted a Breakthrough Device
designation that have received FDA marketing authorization are
considered new and not substantially similar to an existing technology
for purposes of the NTAP.
Response: We continue to believe that it is necessary to evaluate
whether a device that has been granted a FDA Breakthrough Device
designation is already described by any of the current device pass-
through categories or by any category previously in effect to ensure
that no device is described by more than one category. We also remind
stakeholders that the criteria for establishing a new device category
described in the regulation at 42 CFR 419.66(c)(1) are unique to the
OPPS device pass-through policy.
b. Applications Received for Device Pass-Through Payment for CY 2021
We received five complete applications by the March 1, 2020
quarterly deadline, which was the last quarterly deadline for
applications to be received in time to be included in the CY 2021 OPPS/
ASC proposed rule. We received one of the applications in the second
quarter of 2019, two of the applications in the fourth quarter of 2019,
and two of the applications in the first quarter of 2020. Two of the
applications were approved for device pass-through payment during the
quarterly review process: CUSTOMFLEX[supreg] ARTIFICIALIRIS and
EXALTTM Model D Single-Use Duodenoscope. CUSTOMFLEX[supreg]
ARTIFICIALIRIS received fast-track approval under the alternative
pathway effective January 1, 2020. EXALTTM Model D Single-
Use Duodenoscope received fast-track approval under the alternative
pathway effective July 1, 2020. As previously stated, all applications
that are preliminarily approved upon quarterly review will
automatically be included in the next applicable OPPS annual rulemaking
cycle. Therefore, CUSTOMFLEX[supreg] ARTIFICIALIRIS and
EXALTTM Model D Single-Use Duodenoscope are discussed below
in section IV.2.b.1.
Applications received for the later deadlines for the remaining
2020 quarters (June 1, September 1, and December 1), if any, will be
presented in the CY 2022 OPPS/ASC proposed rule. We note that the
quarterly application process and requirements have not changed in
light of the addition of rulemaking review. Detailed instructions on
submission of a quarterly device pass-through payment application are
included on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/catapp.pdf.
A discussion of the applications received by the March 1, 2020
deadline is presented below.
1. Alternative Pathway Device Pass-Through Applications
We received three device pass-through applications by the March
2020 quarterly application deadline for devices that have received
Breakthrough Device designation from FDA and FDA marketing
authorization, and therefore are eligible to apply under the
alternative pathway. As stated above in section IV.2.a of this final
rule with comment, under this alternative pathway, devices that are
granted a FDA Breakthrough Device designation are not evaluated in
terms of the substantial clinical improvement criterion at Sec.
419.66(c)(2)(i) for purposes of determining device pass-through payment
status, but will need to meet the other requirements for pass-through
payment status in our regulation at Sec. 419.66.
(1) CUSTOMFLEX[supreg] ARTIFICIALIRIS
VEO Ophthalmics submitted an application for a new device category
for transitional pass-through payment status for the CUSTOMFLEX[supreg]
ARTIFICIALIRIS by the June 2019 quarterly deadline. The
CUSTOMFLEX[supreg] ARTIFICIALIRIS device is described as a foldable
iris prosthesis that is custom-made for each individual patient who
requires one. The applicant stated that the CUSTOMFLEX[supreg]
ARTIFICIALIRIS comes in two models-With Fiber or Fiber Free. The two
models are identical in every respect except that the With Fiber model
has a polyester meshwork layer embedded in it to provide adequate tear
strength to withstand suturing.
The applicant provided that the CUSTOMFLEX[supreg] ARTIFICIALIRIS
is intended to serve as an artificial iris prosthesis, inserted at the
time of cataract surgery or during a subsequent stand-alone procedure.
The CUSTOMFLEX[supreg] ARTIFICIALIRIS is indicated for use in children
and adults for the treatment of full or partial aniridia resulting from
congenital aniridia, acquired defects, or other conditions associated
with full or partial aniridia. The conditions that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS treats are rare; congenital aniridia
is present in approximately 1.8 in 100,000 live births (1 in 40,000 to
1 in 100,000),6-2 congenital IridoCorneal Endothelial
Syndrome (ICE) syndrome is even less common (incidence not available).
Iris defects such as iatrogenic iridodialysis as a complication of
cataract surgery has variable prevalence, ranging from 0-0.84 percent
of surgeries,3-8 and may
[[Page 85991]]
occur in approximately 0.2 percent of blunt orbital trauma.\9\ Although
rare, these conditions are cosmetically and functionally limiting. The
applicant provided that in addition to a noticeably absent or irregular
iris/pupil, affected patients frequently experience photophobia (light
sensitivity) and glare as well as symptoms such as dry
eye.10 11
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\6\ Berlin HS, Ritch R. The treatment of glaucoma secondary to
aniridia. Mt Sinai J Med. 1981;48:11.
\2\ Nelson LB, Spaeth GL, Nowinski TS, et al. Aniridia. A
review. Surv Ophthalmol. 1984; 28:621-642.
\3\ Greenberg PB, Tseng VL, Wu WC, et.al. Prevalence and
predictors of ocular complications associated with cataract surgery
in United States veterans. Ophthalmology. 2011 Mar;118(3):507-14.
\4\ Jaycock P, Johnston RL, Taylor H, et al., UK EPR User Group.
The Cataract National Dataset electronic multi-centre audit of
55,567 operations: Updating benchmark standards of care in the
United Kingdom and internationally. Eye (Lond). 2009;23:38-49.
\5\ Lum F, Schein O, Schachat AP, et al. Initial two years of
experience with the AAO National Eyecare Outcomes Network (NEON)
cataract surgery database. Ophthalmology. 2000;107:691-697.
\6\ Steinberg EP, Tielsch JM, Schein OD, et.al. National study
of cataract surgery outcomes: Variation in 4-month postoperative
outcomes as reflected in multiple outcomes measures Ophthalmology.
1994;101:1131-1140.
\7\ Schein OD, Steinberg EP, Javitt JC, et al. Variation in
cataract surgery practice and clinical outcomes. Ophthalmology.
1994;101:1142-1152.
\8\ Powe NR, Schein OD, Gieser SC, et al. Cataract Patient
Outcome Research Team Synthesis of the literature on visual acuity
and complications following cataract extraction with intraocular
lens implantation. Arch Ophthalmol, 1994;112:239-252.
\9\ Kreidl KO, Kim DY, Mansour SE. Prevalence of significant
intraocular sequelae in blunt orbital trauma. Am J Emerg Med. 2003
Nov;21(7):525-8.
\10\ Weissbart SB, Ayres BD. Management of aniridia and iris
defects: An update on iris prosthesis options. Curr Opin Ophthalmol.
2016 May;27(3):244-9.
\11\ Lee HJ, Colby KA. A review of the clinical and genetic
aspects of aniridia. Semin Ophthalmol. 2013 Sep-Nov;28(5-6):306-12.
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According to the applicant, currently available treatments for
symptomatic glare, photophobia, and cosmesis are limited, and an FDA-
approved, commercially available iris prosthesis fills a needed gap.
Alternatives include tinted spectacles or contact lenses, iris
reconstruction (for example, pupilloplasty or iridodialysis repair),
and corneal tattooing.\10\ Among these, tinted spectacles can provide
some symptomatic relief, but the applicant stated that they do not
address the underlying problem and cannot be used in all settings. Iris
reconstruction requires that sufficient iris tissue be present. Tinted
contact lenses and corneal tattooing are cosmetically not ideal and
have an associated risk of corneal infection (corneal ulcer and
infectious keratitis). According to the applicant, in addition, corneal
tattooing has a risk of surface toxicity, anterior segment
inflammation, and/or corneal epithelial defect. The only other
artificial iris devices in the U.S. were previously available under FDA
compassionate use exemption (Morcher 50F, 96F; Ophtec 311 aniridia
lens).\10\ However, these devices are no longer available following FDA
approval of the CUSTOMFLEX[supreg] ARTIFICIALIRIS.
With respect to the newness criterion at Sec. 419.66(b)(1), the
FDA designated the CUSTOMFLEX[supreg] ARTIFICIALIRIS as a Breakthrough
Device on December 21, 2017, and approved the premarket approval
application (PMA) for CUSTOMFLEX[supreg] ARTIFICIALIRIS (P170039) on
May 30, 2018 for use in the treatment of full or partial aniridia
resulting from congenital or acquired defects. The applicant provided
that there was a roughly 3-month market delay after receipt of PMA
approval while final labeling in its printed form was submitted to FDA
and FDA completed its review and approval process. The applicant notes
that commercial availability of the device commenced on September 12,
2018 after it received FDA approval for the final labeling. We received
the application for a new device category for transitional pass-through
payment status for the CUSTOMFLEX[supreg] ARTIFICIALIRIS on May 31,
2019, which is within 3 years of the date of the initial FDA marketing
authorization. We solicited public comment on whether the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the newness criterion.
Comment: Commenters claimed that the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the newness criterion as described at Sec.
419.66(b)(1).
Response: After consideration of the public comments and our review
of the application, we agree that the CUSTOMFLEX[supreg] ARTIFICIALIRIS
meets the newness criterion as described at Sec. 419.66(b)(1).
With respect to the eligibility criterion at Sec. 419.66(b)(3),
the applicant stated that the device is implanted via injection through
a 2.75-4 mm clear corneal incision. Depending on the site of
implantation (capsular bag, ciliary sulcus, sutured to sclera), the
device is cut (trephined) to the correct diameter. The device can also
be sutured to an intraocular lens if an intraocular lens is also
implanted at the time of surgery. The applicant further provided that
the CUSTOMFLEX[supreg] ARTIFICIALIRIS is integral to the service
provided, is used for one patient only, comes in contact with human
tissue, and is surgically implanted. The applicant also claimed that
the CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the device eligibility
requirements of Sec. 419.66(b)(4) because it is not an instrument,
apparatus, implement, or item for which depreciation and financing
expenses are recovered, and it is not a supply or material furnished
incident to a service. We solicited public comment on whether the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the eligibility criteria at
Sec. 419.66(b).
Comment: Commenters believed that the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the eligibility criteria as described at Sec.
419.66(b).
Response: After consideration of the public comments we received
and our review of the application, we agree that the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the eligibility criteria as described at Sec.
419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. Upon review,
it did not appear that there were any other existing pass-through
payment categories that might apply to the CUSTOMFLEX[supreg]
ARTIFICIALIRIS and we solicited public comments on this issue.
Comment: Commenters claimed that the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the criterion for establishing new device
categories specified at Sec. 419.66(c)(1).
Response: After consideration of the public comments we received,
we have determined that there are no existing pass-through categories
that appropriately describe the CUSTOMFLEX[supreg] ARTIFICIALIRIS and
we have determined the CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the
criterion for establishing new device categories specified at Sec.
419.66(c)(1).
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. As stated in section IV.2.a
above, devices that apply under the alternative pathway for devices
that have a Breakthrough Device designation with a FDA marketing
authorization are not subject to evaluation for substantial clinical
improvement (84 FR 61295). The CUSTOMFLEX[supreg] ARTIFICIALIRIS was
designated as a Breakthrough Device by FDA on December 21, 2017.
We did not receive comments on whether the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the second criterion for establishing a device
category at Sec. 419.66(c)(2)(i). Based on its Breakthrough Device
designation, we
[[Page 85992]]
have determined that CUSTOMFLEX[supreg] ARTIFICIALIRIS meets this
criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS would be reported with CPT code
66999--Unlisted procedure, anterior segment of eye, which was assigned
to APC 5491 (Level 1 Intraocular Procedures) for Calendar Year (CY)
2020. To meet the cost criterion for device pass-through payment
status, a device must pass all three tests of the cost criterion for at
least one APC. For our calculations, we used APC 5491, which had a CY
2019 payment rate of $1,917. Beginning in CY 2017, we calculated the
device offset amount at the HCPCS/CPT code level instead of the APC
level (81 FR 79657). CPT code 66999 had a device offset amount of
$149.80 at the time the application was received. According to the
applicant, the cost of the CUSTOMFLEX[supreg] ARTIFICIALIRIS is $7,700,
for both the Fiber Free and with Fiber models.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $7,700 for the CUSTOMFLEX[supreg]
ARTIFICIALIRIS is 402 percent of the applicable APC payment amount for
the service related to the category of devices of $1,917 (($7,700/
$1,917) x 100 = 402 percent). Therefore, we stated in the CY 2021 OPPS/
ASC proposed rule that we believe the CUSTOMFLEX[supreg] ARTIFICIALIRIS
meets the first cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $7,700 for the
CUSTOMFLEX[supreg] ARTIFICIALIRIS is 5,140 percent of the cost of the
device-related portion of the APC payment amount for the related
service of $150 (($7,700/$150) x 100 = 5,140 percent). Therefore, we
stated in the CY 2021 OPPS/ASC proposed rule that we believe that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the second cost significance
requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $7,700 for the CUSTOMFLEX[supreg] ARTIFICIALIRIS and
the portion of the APC payment amount for the device of $1,917 is 394
percent of the APC payment amount for the related service of $150
(($7,700 - $150)/$1,917) x 100 = 394 percent). Therefore, we stated in
the CY 2021 OPPS/ASC proposed rule that we believe that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the third cost significance
requirement.
We solicited public comment on whether the CUSTOMFLEX[supreg]
ARTIFICIALIRIS meets the device pass-through payment criteria discussed
in this section, including the cost criterion.
Comment: We received comments indicating that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the device pass-through payment
criteria, including the cost criterion.
Response: After considering the public comments received and our
review of the application, we have determined that the
CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the device pass-through payment
criteria, including the cost criterion.
As stated above, we received the application for the
CUSTOMFLEX[supreg] ARTIFICIALIRIS application by the June 1, 2019
quarterly deadline and preliminarily approved it for transitional pass-
through payment under the alternative pathway for CY 2020, effective
January 1, 2020. We solicited public comment on whether the
CUSTOMFLEX[supreg] ARTIFICIALIRIS should continue to receive
transitional pass-through payment under the alternative pathway for
devices that have FDA's Breakthrough Device designation and marketing
authorization.
Comment: Commenters stated that CUSTOMFLEX[supreg] ARTIFICIALIRIS
should continue to receive transitional pass-through payment.
Response: After consideration of the public comments we received
and our review of the device pass-through application, we have
determined that the CUSTOMFLEX[supreg] ARTIFICIALIRIS meets the
requirements for device pass-through payment status described at Sec.
419.66. As stated previously, devices that are granted a FDA
Breakthrough Device designation are not evaluated in terms of the
current substantial clinical improvement criterion at Sec.
419.66(c)(2)(i) for purposes of determining device pass-through payment
status, but must meet the other criteria for device pass-through
status, which we believe CUSTOMFLEX[supreg] ARTIFICIALIRIS does.
Therefore, we are finalizing approval for device pass-through payment
status for CUSTOMFLEX[supreg] ARTIFICIALIRIS under the alternative
pathway for devices that have a FDA Breakthrough Device designation and
are FDA market authorized. For CY 2021, we will continue the device
pass-through payment status for CUSTOMFLEX[supreg] ARTIFICIALIRIS.
(2) EXALTTM Model D Single-Use Duodenoscope
Boston Scientific Corporation submitted an application before the
March 2020 quarterly deadline for a new device category for
transitional pass-through payment status for the EXALTTM
Model D Single-Use Duodenoscope. The EXALTTM Model D Single-
Use Duodenoscope is described as a sterile, single-use, flexible
duodenoscope used to examine the duodenum and perform endoscopic
retrograde cholangiopancreatography (ERCP) procedures by facilitating
access to the pancreaticobiliary system. The applicant stated that it
has designed the technology of the EXALTTM Model D Single-
Use Duodenoscope to eliminate the risk of nosocomial infections due to
improper reprocessing of a reusable duodenoscope. As stated above, the
EXALTTM Model D Single-Use Duodenoscope is used during ERCP
procedures that are performed to examine bile and pancreatic ducts.
According to the applicant, the EXALTTM Model D Single-Use
Duodenoscope enables passage and manipulation of accessory devices in
the pancreaticobiliary system for diagnostic and therapeutic purposes,
as necessary. During the ERCP procedure, the physician inserts the
duodenoscope through the patient's mouth, passes the duodenoscope
through the esophagus and stomach and enters into the first part of the
small intestine (duodenum). The applicant stated that during ERCP a
cannula is passed through the duodenoscope via a working channel and
used to cannulate a small opening on the duodenal wall. Once that step
is complete, the physician injects contrast while x-rays are taken to
study the bile and/or pancreatic ducts. If the physician
[[Page 85993]]
identifies an area that warrants further investigation, accessory
devices can be inserted through the working channel of the scope and
into the pancreaticobiliary system for diagnosis or treatment.
According to the applicant, after the conclusion of the procedure, the
single-use EXALTTM Model D Single-Use Duodenoscope device
has no further medical use and is fully disposable.
With respect to the newness criterion at Sec. 419.66(b)(1), the
FDA designated the EXALTTM Model D Single-Use Duodenoscope
as a Breakthrough Device on November 19, 2019, and approved the
premarket approval application (K193202) for EXALTTM Model D
Single-Use Duodenoscope on December 13, 2019. We received the
application for a new device category for transitional pass-through
payment status for the EXALTTM Model D Single-Use
Duodenoscope on January 17, 2020, which is within 3 years of the date
of the initial FDA premarket approval. We solicited public comment on
whether the EXALTTM Model D Single-Use Duodenoscope meets
the newness criterion.
Comment: The manufacturer of EXALTTM Model D Single-Use
Duodenoscope believes the device meets the eligibility criteria for
device pass-through payment under the regulation at Sec. 419.66, which
includes the newness criterion, based on FDA Breakthrough Device
designation it received on December 13, 2019 and the 510(k) premarket
approval it received on November 19, 2019.
Response: We appreciate the commenter's input. After consideration
of the public comment we received and based on the fact that the
EXALTTM Model D Single-Use Duodenoscope application was
received January 17, 2020, within 3 years of FDA premarket approval,
which was on November 19, 2019, and FDA Breakthrough Device designation
on December 13, 2019, we believe that the EXALTTM Model D
Single-Use Duodenoscope meets the newness criterion.
With regard to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the EXALTTM Model D Single-Use
Duodenoscope is integral to the ERCP service provided, is used for one
patient only, and is surgically inserted as it is inserted through the
patient's mouth, down the esophagus, into the stomach, and then into
the first part of the small intestine. The applicant also stated that
the EXALTTM Model D Single-Use Duodenoscope meets the device
eligibility requirements of Sec. 419.66(b)(4) because it is not an
instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service.
Comment: The manufacturer of EXALTTM Model D Single-Use
Duodenoscope believed that the EXALTTM Model D Single-Use
Duodenoscope met the eligibility criteria at Sec. 419.66(b). They
maintained that the EXALTTM Model D Single-Use Duodenoscope
meets the criterion at Sec. 419.66(b)(3) because it is integral to the
ERCP service provided, is used for one patient only, and is surgically
inserted through the patient's mouth, down the esophagus, into the
stomach, and then into the first part of the small intestine. The
commenter believes the device meets eligibility requirements at Sec.
419.66(b)(4) because it is not an instrument, apparatus, implement, or
item for which depreciation and financing expenses are recovered, and
it is not a supply or material furnished incident to a service.
Response: We appreciate the commenter's feedback. Based on the
information we have received from the commenter and our review of the
application, we have determined that EXALTTM Model D Single-
Use Duodenoscope meets the eligibility criteria at Sec. 419.66(b)(3)
and (b)(4) because, as previously discussed, the device is integral to
the service furnished, is used for one patient only, and is inserted
through the patient's mouth, down the esophagus, into the stomach, and
finally into the first part of the small intestine. It also is not an
instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service.
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. With respect
to the existence of a previous pass-through device category that
describes EXALTTM Model D Single-Use Duodenoscope, the
applicant suggested a category descriptor of ``Duodenoscope, single-
use.'' The applicant also provided an existing device category ``C1749,
Endoscope, retrograde imaging/illumination colonoscope device
(implantable),'' for pass-through payment for another endoscope and
explained why they believe the category descriptor is not applicable to
EXALTTM Model D Single-Use Duodenoscope. The applicant
stated that HCPCS C1749 does not appropriately describe the EXALT Model
D, as C1749 is intended to describe endoscopic imaging devices that are
inserted through a colonoscope and into the colon. The applicant argued
that EXALT Model D is the first and only single-use duodenoscope
through which devices can be passed, and it is utilized in ERCP
procedures. The applicant further stated that the scope that is the
subject of this request provides access to a different part of the
anatomy, specifically, the pancreaticobiliary system and facilitates
access for diagnostic and therapeutic purposes, as opposed to the
devices described by C1749, which are endoscopic imaging devices that
are inserted through a colonoscope and into the colon, providing access
to a different part of the anatomy. Upon review, we agreed with the
applicant that it does not appear that there are any other existing
pass-through payment categories that might apply and we solicited
public comment on this issue.
Comment: Several commenters stated they did not believe there is an
existing pass-through payment category that describes the
EXALTTM Model D Single-Use Duodenoscope. They commented that
the existing device category that CMS identified does not adequately
describe critical aspects of the device. The commenters also noted that
existing category, C1749 Endoscope, retrograde imaging/illumination
colonoscope device (implantable), does not appropriately describe
single-use endoscopes that provide access to a different part of the
anatomy, specifically the upper gastrointestinal (GI) tract.
Response: We appreciate the commenters' input. After consideration
of the public comments we received, we agree there is no existing pass-
through payment category that appropriately describes the
EXALTTM Model D Single-Use Duodenoscope because it is a
single use endoscope with internal channel that provides access to the
duodenum and the hepatopancreatic duct. Based on this information, we
have determined that the EXALTTM Model D Single-Use
Duodenoscope meets the eligibility criterion at Sec. 419.66(c)(1).
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part
[[Page 85994]]
compared to the benefits of a device or devices in a previously
established category or other available treatment; or (ii) for devices
for which pass-through status will begin on or after January 1, 2020,
as an alternative to the substantial clinical improvement criterion,
the device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. As previously discussed in
section IV.2.a above, we finalized the alternative pathway for devices
that are granted a Breakthrough Device designation and receive FDA
marketing authorization in the CY 2020 OPPS/ASC final rule (84 FR
61295). The EXALTTM Model D Single-Use Duodenoscope has a
Breakthrough Device designation and marketing authorization from the
FDA and therefore is not evaluated based on substantial clinical
improvement.
We did not receive comments on whether EXALTTM Model D
Single-Use Duodenoscope meets the second criterion for establishing a
device category at Sec. 419.66(c)(2). We have determined that the
EXALTTM Model D Single-Use Duodenoscope meets this
criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that the
EXALTTM Model D Single-Use Duodenoscope would be reported
with CPT code 43274 which is associated with APC 5331 (Complex GI
Procedures). To meet the cost criterion for device pass-through payment
status, a device must pass all three tests of the cost criterion for at
least one APC. We used APC 5331 for our calculations, which had a CY
2020 payment rate of $4,780.30 at the time the application was
received. Beginning in CY 2017, we calculate the device offset amount
at the HCPCS/CPT code level instead of the APC level (81 FR 79657). CPT
code 43274 had a device offset amount of $1,287.81 at the time the
application was received. According to the applicant, the cost of the
EXALTTM Model D Single-Use Duodenoscope is $2,930.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $2,930 for the EXALTTM Model D
Single-Use Duodenoscope is 61 percent of the applicable APC payment
amount for the service related to the category of devices of $4,780.30
($2,930/$4,780.30 x 100 = 61.3 percent). Therefore, we believe the
EXALTTM Model D Single-Use Duodenoscope meets the first cost
significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $2,930 for the
EXALTTM Model D Single-Use Duodenoscope is 228 percent of
the cost of the device-related portion of the APC payment amount for
the related service of $1,287.81 ($2,930/$1,287.81) x 100 = 227.5
percent. Therefore, we believe that the EXALTTM Model D
Single-Use Duodenoscope meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $2,930 for the EXALTTM Model D Single-Use
Duodenoscope and the portion of the APC payment amount for the device
of $1,287.81 is 34 percent of the APC payment amount for the related
service of $4,780.30 (($2,930-$1,287.81)/$4,780.30) x 100 = 34.4
percent). Therefore, we believe that the EXALTTM Model D
Single-Use Duodenoscope meets the third cost significance requirement.
We solicited public comment on whether the EXALTTM Model D
Single-Use Duodenoscope meets the device pass-through payment criteria
discussed in this section, including the cost criterion.
As specified above, the EXALTTM Model D Single-Use
Duodenoscope application was preliminarily approved for transitional
pass-through payment under the alternative pathway effective July 1,
2020. We solicited public comment on whether the EXALTTM
Model D Single-Use Duodenoscope should continue to receive transitional
pass-through payment under the alternative pathway for devices that
have a FDA Breakthrough Device designation and are FDA market
authorized.
Comment: Several commenters, including the manufacturer of the
EXALTTM Model D Single-Use Duodenoscope, believed that the
device meets the cost criterion for device pass-through payment status.
Some commenters recommended we not apply a device offset amount for
EXALTTM Model D Single-Use Duodenoscope because they
believed that single-use duodenscopes are not replacing devices that
are packaged into the APC payment rate and thus, should not be subject
to the device offset.
Response: We appreciate the commenters input. Section
1833(t)(6)(D)(ii) of the Act requires that the amount of payment for a
pass-through device be the amount by which a hospital's charges,
adjusted to cost, exceeds the portion of the otherwise applicable APC
payment amount that the Secretary determines is associated with the
device. The portion of the APC payment amount that we determine is
associated with the cost of the pass-through device is referred to as
the device offset. The device offset is used to reduce the otherwise
applicable APC payment amount for the applicable pass-through device.
After further review, we agree with the commenters. We have
determined that the costs associated with the EXALTTM Model
D Single-Use Duodenoscope are not already reflected in the device
portions of APCs 5303 (Level 3 Upper GI Procedures) or 5331 (Complex GI
Procedures) because there were no single-use duodenoscopes on the
market previously so no operating cost data associated with such
devices could be included historical OPPS claims data. Therefore, we
are not applying a device offset for the EXALTTM Model D
Single-Use Duodenoscope.
After consideration of the public comments we received, we believe
that EXALTTM Model D Single-Use Duodenoscope meets the cost
criterion for device pass-through payment status.
For CY 2021, we will continue the device pass-through payment
status for EXALTTM Model D Single-Use Duodenoscope. As
stated previously, devices that are designated as Breakthrough Devices
by the FDA are not evaluated in terms of the current substantial
clinical improvement criterion at Sec. 419.66(c)(2)(i) for purposes of
determining device pass-through payment status, but must meet the other
criteria for device pass-through status, which we believe
EXALTTM Model D Single-Use Duodenoscope does. Therefore, we
are finalizing approval for
[[Page 85995]]
device pass-through payment status for EXALTTM Model D
Single-Use Duodenoscope under the alternative pathway for devices that
have FDA Breakthrough Device designation and FDA market authorization
beginning CY 2021.
(3) BAROSTIM NEOTM System
CVRx, Inc. submitted an application for the BAROSTIM
NEOTM System by the December 2019 quarterly deadline. The
applicant provided that the BAROSTIM NEOTM is indicated for
the treatment of symptoms of patients with advanced heart failure. The
applicant asserted that the BAROSTIM therapy triggers the body's main
cardiovascular reflex to regulate blood pressure and address the
underlying causes of the progression of heart failure. According to the
applicant, increased sympathetic and decreased parasympathetic activity
contribute to heart failure (HF) symptoms and disease progression.
Barostim's mechanism of action is stimulating the carotid baroreceptor
which results in centrally mediated reduction of sympathetic and
increase in parasympathetic activity. A single 2 mm coated electrode
with a 7 mm silicone backer is sutured to the carotid artery to
activate the baroreceptors. It is connected to an implantable pulse
generator in the chest which provides control of baroreflex activation
energy. The BAROSTIM NEOTM System uses CVRx patented
BAROSTIM THERAPYTM technology to trigger the body's own
natural systems (baroreflex) by electrically activating the carotid
baroreceptors, the body's natural cardiovascular regulation sensors.
According to the applicant, in conditions such as hypertension and
heart failure, it is believed the baroreceptors, the body's natural
sensors, are not functioning properly and are not sending sufficient
signals to the brain. This results in the brain sending signals to
other parts of the body (heart, blood vessels, kidneys) to constrict
the blood vessels, retain water and salt by the kidneys and increase
stress-related hormones. The applicant provided that when the
baroreceptors are activated by the BAROSTIM NEOTM system,
signals are sent through neural pathways to the brain. In response, the
brain works to counteract this stimulation by sending signals to other
parts of the body (heart, blood vessels, and kidneys) that relax the
blood vessels and inhibit the production of stress-related hormones.
These changes act to reduce cardiac after-load and enable the heart to
increase blood output, while maintaining or reducing its workload.
Parameters are programmed into the Implantable Pulse Generator (IPG)
using telemetry via a wireless external programming system. The
applicant stated that the BAROSTIM NEOTM System is fully
programmable to adjust the therapy to each patient's needs.
With respect to the newness criterion at Sec. 419.66(b)(1), the
FDA designated the BAROSTIM NEOTM System as a Breakthrough
Device and approved the premarket approval application (P180050) on
August 16, 2019 based on the improvement of symptoms of heart failure--
quality of life, six-minute hall walk, and functional status--for
patients who remain symptomatic despite treatment with guideline-
directed medical therapy, are New York Heart Association (NYHA) Class
III or Class II (who had a recent history of Class III), have a left
ventricular ejection fraction <=35 percent, a NT-proBNP <1600 pg/ml and
excluding patients indicated for Cardiac Resynchronization Therapy
(CRT) according to AHA/ACC/ESC guidelines. We received the application
for a new device category for transitional pass-through payment status
for the BAROSTIM NEOTM on November 27, 2019, which is within
3 years of the date of the initial FDA premarketing approval. We
solicited public comment on whether the BAROSTIM NEOTM meets
the newness criterion.
Comment: The manufacturer stated that BAROSTIM NEOTM
meets the newness criterion as described by Sec. 419.66(b) because the
FDA designated the BAROSTIM NEOTM System as a Breakthrough
Device and approved the premarket application (P180050) on August 16,
2019 based on the improvement of symptoms of heart failure--quality of
life, six-minute hall walk, and functional status--for patients who
remain symptomatic despite treatment.
Response: We appreciate the commenter's input. After consideration
of the public comments we received and because the BAROSTIM
NEOTM application was received November 27, 2019 and
received FDA premarketing approval on August 16, 2019 which is within 3
years, we agree that the BAROSTIM NEOTM meets the newness
criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the use of BAROSTIM NEOTM is
integral to the service of providing baroreflex therapy, is used for
one patient only, comes in contact with human skin and is surgically
implanted or inserted. The applicant also claimed the BAROSTIM
NEOTM meets the device eligibility requirements of Sec.
419.66(b)(4) because it is not an instrument, apparatus, implement, or
item for which depreciation and financing expenses are recovered, and
it is not a supply or material furnished incident to a service. We
solicited public comments on whether the BAROSTIM NEOTM
meets the eligibility criteria at Sec. 419.66(b).
Comment: The manufacturer of BAROSTIM NEOTM felt that
their device met the eligibility criteria at Sec. 419.66(b) because it
is used for one patient only, comes in contact with human skin and is
surgically implanted or inserted. The applicant claimed the BAROSTIM
NEOTM meets the device eligibility requirements of Sec.
419.66(b)(4) because it is not an instrument, apparatus, implement, or
item for which depreciation and financing expenses are recovered, and
it is not a supply or material furnished incident to a service.
Response: Based on the information we have received and our review
of the application, we agree with the commenter that the device is used
for one patient only, comes in contact with human skin and is
surgically implanted or inserted. We also agree with the commenter that
BAROSTIM NEOTM meets the device eligibility requirements of
Sec. 419.66(b)(4) because it is not an instrument, apparatus,
implement, or item for which depreciation and financing expenses are
recovered, and it is not a supply or material furnished incident to a
service. Based on this assessment we have determined that BAROSTIM
NEOTM meets the eligibility criterion at Sec. 419.66(b)(3)
and (4).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any existing categories or
by any category previously in effect, and was not being paid for as an
outpatient service as of December 31, 1996. With respect to the
existence of a previous pass-through device category that described
BAROSTIM NEOTM, the applicant suggested a category
descriptor of ``Generator, neurostimulator (implantable), non-
rechargeable with carotid sinus stimulation lead.'' The applicant also
provided a list of current and expired device categories for pass-
through payment for other neurostimulation systems and their rationale
for why they believed the category descriptors are not applicable to
BAROSTIM NEOTM.
The applicant stated that BAROSTIM NEOTM is not
described by existing device category C1767, Generator, neurostimulator
(implantable), non-
[[Page 85996]]
rechargeable. The applicant stated that similar to the traditional
spinal cord stimulation (SCS) systems included in this category, the
BAROSTIM NEOTM System is not rechargeable; however, it is
the only system that works to deliver CVRx's proprietary baroreflex
activation therapy (BAT). The applicant provided that BAT uses afferent
signaling to the brain by stimulating the carotid artery to reduce the
sympathetic signal and increase the parasympathetic signal. The
applicant stated that this unique therapy works to rebalance the
autonomic input to the heart to improve heart failure symptoms.
Additionally, the applicant stated that traditional devices provide
pain relief by disrupting the pain signals traveling between the spinal
cord's nervous system and the brain, but the BAROSTIM NEO System uses
the generator to stimulate the baroreceptors in the carotid artery to
treat the symptoms of patients with advanced heart failure. The
applicant stated that the BAROSTIM NEO generator is unique in its
capability to drive electricity up to 20 mA/100 Hz with sufficient
battery capacity to provide the required therapy through the BAROSTIM
NEOTM carotid sinus lead. The applicant described that the
BAROSTIM NEOTM carotid sinus lead is sutured to the carotid
wall, where the baroreceptors (stretch fibers) are located. Electrical
current radiating from the carotid sinus lead activates the
baroreceptors. When activated, the baroreceptors send afferent signals
through the Carotid Sinus Nerve to the brain. The brain interprets
these afferent signals and reacts by reducing the sympathetic tone and
increasing the parasympathetic tone. The applicant stated that the
BAROSTIM NEOTM System is the only device currently approved
by FDA that leverages this mechanism of action to treat the symptoms of
patients with advanced heart failure.
The applicant stated that BAROSTIM NEOTM is not
described by existing device category C1823, Generator, neurostimulator
(implantable), non-rechargeable, with transvenous sensing and
stimulation leads. They contended that existing device category C1823
is exclusively used to describe a complete system comprised of a
generator implanted in the chest, a stimulation lead attached to the
phrenic nerve and a sensing lead to control the function of the
diaphragm for the treatment of moderate to severe central sleep apnea.
The applicant also stated that the BAROSTIM NEOTM System
utilizes a single stimulation lead positioned on the carotid artery to
stimulate baroreceptors. The stimulation of the baroreceptors creates
afferent nerve traffic through the Carotid Sinus Nerve, and results in
the activation of the baroreflex. The applicant again stated that the
BAROSTIM NEOTM System is the only device currently approved
by FDA that leverages this mechanism of action to improve quality of
life and functional status in heart failure.
The applicant also provided that BAROSTIM NEOTM is not
described by existing device category C1778, Lead, neurostimulator
(implantable). The applicant stated that leads used in traditional
neurostimulation are implanted on nerves (for example, spinal cord,
peripheral nerves). The applicant contended that in contrast, the
BAROSTIM NEO carotid sinus lead is sutured onto the carotid artery and
is the only lead that is designed to be secured on an arterial wall to
stimulate sensors located inside the arterial wall (baroreceptors). The
applicant provided that stimulation is delivered to the arterial wall,
where the baroreceptors (stretch fibers) are located. The applicant
stated that the BAROSTIM NEOTM generator is uniquely
designed to send electric current via the BAROSTIM NEOTM
carotid sinus lead and that the BAROSTIM NEOTM carotid sinus
lead is uniquely designed to only interface with the BAROSTIM NEO
generator. Again, the applicant provided that the BAROSTIM
NEOTM System is the only device currently approved by FDA
that leverages this mechanism of action to treat the symptoms of
patients with advanced heart failure.
We stated in the CY 2021 OPPS/ASC proposed rule that we were
concerned that the BAROSTIM NEOTM System may be
appropriately described by existing pass-through payment categories.
For example, we believed that the BAROSTIM NEOTM System may
be appropriately described by C1767 as the BAROSTIM NEOTM
device consists of a generator, a neurostimulator, and a lead. We
solicited public comment on this issue.
Comment: The manufacturer of the device stated that it does not
believe there is an existing pass-through payment category that
describes the BAROSTIM NEOTM System, commenting that the
existing device categories that CMS identified do not adequately
describe critical aspects of the device. The manufacturer noted that
existing categories, such as C1767, Generator, neurostimulator
(implantable), non-rechargeable, C1823, Generator, neurostimulator
(implantable), non-rechargeable, with transvenous sensing and
stimulation leads, and C1778, Lead, neurostimulator (implantable), do
not appropriately describe systems that activate special receptors in
the carotid artery known as baroreceptors, which are in a different
anatomical location than nerves. The manufacturer stated that
baroreceptors are sensory cells that respond to mechanical pressure.
They have ion channels that open to allow ions to pass through when
they are stretched. Baroreceptors are mechanosensitive ion channels,
which according to the manufacturer, are functionally very different
from the voltage gate ion channels of nerves. In addition, the
manufacturer continued, BAROSTIM NEO stimulates baroreceptors deep
within the arterial wall of the carotid sinus, as opposed to direct
activation of the carotid sinus nerve. The manufacturer explained that
the carotid sinus nerve contains afferent nerve fibers leading from
baroreceptors, but also contains afferent nerve fibers leading from the
chemoreceptors, which can cause unwanted side effects. The manufacturer
stated that BAROSTIM NEOTM uses electricity to activate the
baroreceptors and stimulate the baroreflex and does not directly
stimulate neurons and therefore, is not appropriately described by
existing categories.
Response: We appreciate the commenter's input. After consideration
of the public comments we received, we agree that there is no existing
pass-through payment category that appropriately describes BAROSTIM
NEOTM because it is an implantable generator with surgically
placed lead providing selective stimulation of carotid sinus
baroreceptors and activation of baroreflex, which then stimulates the
autonomic nervous system. Based on this information, we have determined
that BAROSTIM NEOTM meets the eligibility criterion at Sec.
419.66(c)(1).
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device has received FDA marketing authorization and is part of the
FDA's Breakthrough Devices Program. As stated in section IV.2.a above,
devices
[[Page 85997]]
that apply under the alternative pathway for devices with FDA
premarketing approval and a Breakthrough Device designation are not
subject to evaluation for substantial clinical improvement (84 FR
61295). The BAROSTIM NEOTM System has Breakthrough Device
designation and FDA premarketing approval, and therefore is not
evaluated based on substantial clinical improvement.
We did not receive comments on whether BAROSTIM NEOTM
meets the second criterion for establishing a device category at Sec.
419.66(c)(2). We have determined that the BAROSTIM NEOTM
meets this criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that the BAROSTIM
NEOTM would be reported with CPT code 0266T, which they
consider to be a total system code. CPT code 0266T is assigned to APC
5464 (Level 4 Neurostimulator and Related Procedures). To meet the cost
criterion for device pass-through payment status, a device must pass
all three tests of the cost criterion for at least one APC. For our
calculations, we used APC 5464, which has a CY 2020 payment rate of
$29,115.50. Beginning in CY 2017, we calculated the device offset
amount at the HCPCS/CPT code level instead of the APC level (81 FR
79657). CPT code 0266T had a device offset amount of $24,253 at the
time the application was received. According to the applicant, the cost
of the BAROSTIM NEOTM is $35,000.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $35,000 for the BAROSTIM NEOTM is
120 percent of the applicable APC payment amount for the service
related to the category of devices of $29,116 (($35,000/29,116) x 100 =
120.2 percent). Therefore, we believe the BAROSTIM NEOTM
meets the first cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $35,000 for the
BAROSTIM NEOTM is 144 percent of the cost of the device-
related portion of the APC payment amount for the related service of
$24,253 (($35,000/$24,253) x 100 = 144.3 percent). Therefore, we
believe that the BAROSTIM NEOTM meets the second cost
significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $35,000 for BAROSTIM NEOTM and the
portion of the APC payment amount for the device of $24,253 is 37
percent of the APC payment amount for the related service of $29,116
(($35,000-$24,253)/$29,116) x 100 = 36.9 percent). Therefore, we
believe that the BAROSTIM NEOTM System meets the third cost
significance requirement.
We solicited public comment on whether the BAROSTIM
NEOTM System meets the device pass-through payment criteria
discussed in this section, including the cost criterion.
Comment: The manufacturer of the BAROSTIM NEOTM System
believed that the device meets the cost criterion for device pass-
through payment status.
Response: We appreciate the manufacturer's input. After
consideration of the public comments we received and our cost threshold
calculations, we agree that BAROSTIM NEOTM meets the cost
criterion for device pass-through payment status.
After consideration of the public comments we received and our
review of the device pass-through application, we have determined that
the BAROSTIM NEOTM qualifies for device pass-through
payment. As stated previously, devices that receive FDA Breakthrough
Device designation are not evaluated in terms of the current
substantial clinical improvement criterion at Sec. 419.66(c)(2)(i) for
purposes of determining device pass-through payment status, but must
meet the other criteria for device pass-through status, which we
believe BAROSTIM NEOTM does. Therefore, we are finalizing
approval for device pass-through payment status beginning CY 2021 for
BAROSTIM NEOTM under the alternative pathway for devices
that receive FDA Breakthrough Device designation and FDA premarket
approval. Please refer to section IV.B.1.b of this final rule with
comment for more information on the device offset for BAROSTIM
NEOTM device.
2. Traditional Device Pass-Through Applications
(1) Hemospray[supreg] Endoscopic Hemostat
Cook Medical submitted an application for a new device category for
transitional pass-through payment status for the Hemospray[supreg]
Endoscopic Hemostat (Hemospray) for CY 2021. Hemospray[supreg]
Endoscopic Hemostat is a prescription use device consisting of a
hemostatic agent and a delivery system. The hemostatic agent is an
inert, bentonite powder, naturally sourced from aluminum phyllosilicate
clay, developed for endoscopic hemostasis. According to the applicant,
Hemospray[supreg] is indicated by the FDA for hemostasis of nonvariceal
gastrointestinal bleeding. Using an endoscope to access the
gastrointestinal tract, the Hemospray delivery system is passed through
the accessory channel of the endoscope and positioned just above the
bleeding site without making contact with the GI tract wall. The
Hemospray[supreg] powder is propelled through the application catheter,
either a 7 or 10 French polyethylene catheter, by release of
CO2 from the cartridge located in the device handle and
sprayed onto the bleeding site. Bentonite can absorb five to ten times
its weight in water and swell up to 15 times its dry volume. Bentonite
rapidly absorbs water and becomes cohesive to itself and adhesive to
tissue, forming a physical barrier to aqueous fluid (for example,
blood). Hemospray[supreg] is not absorbed by the body and does not
require removal as it passes through the GI tract within 72 hours.
Hemospray[supreg] is single-use and disposable.
With respect to the newness criterion at Sec. 419.66(b)(1), the
FDA granted a de novo request classifying the Hemospray[supreg]
Endoscopic Hemostat (Hemospray[supreg]) as a Class II device under
section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act on May 7,
2018. We received the application for a new device category for
transitional pass-through payment status for the Hemospray[supreg]
Endoscopic Hemostat on December 2, 2019, which is within 3 years of the
date of the initial FDA marketing authorization. We solicited public
comments on whether Hemospray[supreg] meets the newness criterion.
Comment: The manufacturer of Hemospray[supreg] believed this device
meets
[[Page 85998]]
the newness eligibility criteria for device pass-through payment under
the regulation at Sec. 419.66(b)(1) since Hemospray[supreg] was
granted de novo marketing authorization and classified as a Class II
device on May 7, 2018.
Response: We appreciate the commenter's input. After consideration
of the public comments we received and based on the fact that the
Hemospray[supreg] application was received on May 7, 2018, within 3
years of FDA approval, we agree that the Hemospray[supreg] System meets
the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, Hemospray[supreg] is integral to the
service provided, is used for one patient only, comes in contact with
human skin, and is applied in or on a wound or other skin lesion. The
applicant also claimed that Hemospray[supreg] meets the device
eligibility requirements of Sec. 419.66(b)(4) because it is not an
instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service. We solicited public comments on
whether Hemospray[supreg] meets the eligibility criteria at Sec.
419.66(b).
Comment: Three commenters, including the manufacturer of
Hemospray[supreg], believed that the Hemospray[supreg] meets the
eligibility criteria at Sec. 419.66(b)(3) stating that
Hemospray[supreg] is a prescription single use device consisting of a
hemostatic agent and a delivery system that is integral to the service
provided.
Response: We appreciate the commenters' input. Based on the public
comments we have received and our review of the application, we have
determined that Hemospray[supreg] meets the eligibility criterion at
Sec. 419.66(b)(3) and (4).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. We stated in
the CY 2021 OPPS/ASC proposed rule that we have not identified an
existing pass-through payment category that describes
Hemospray[supreg]. We solicited public comment on whether
Hemospray[supreg] meets the device category criterion.
Comment: Two commenters, including the manufacturer of the
Hemospray[supreg], indicated that there is not an existing pass-through
payment category that describes the device.
Response: We appreciate the commenters' input. After consideration
of the public comments we received, we continue to believe that there
is not an existing pass-through payment category that describes
Hemospray[supreg], and therefore, Hemospray[supreg] meets the device
category eligibility criterion at Sec. 419.66(c)(1).
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. The applicant stated that
Hemospray[supreg] represents a substantial clinical improvement over
existing technologies. With respect to this criterion, the applicant
submitted studies that examined the impact of Hemospray[supreg] on
endoscopic hemostasis outcomes, rebleeding occurrence, and mortality.
According to the applicant, Hemospray[supreg] is a topically
applied mineral powder that offers a novel primary treatment option for
endoscopic bleeding management, serves as an option for patients who
fail conventional endoscopic treatments, and serves as an alternative
to interventional radiology hemostasis (IRH) and surgery. Broadly, the
applicant outlined two treatment areas in which it stated
Hemospray[supreg] would provide a substantial clinical improvement: (1)
As a primary treatment or a rescue treatment after the failure of a
conventional method, and (2) in use for the treatment of malignant
lesions. The applicant provided seven articles specifically for the
purpose of addressing the substantial clinical improvement criterion.
The first article provided by the applicant was a prospective,
single-armed, multicenter Phase 2 safety and efficacy study performed
in France.\7\ From March 2013 to January 2015, 64 endoscopists in 20
centers enrolled 202 patients in the study in which Hemospray[supreg]
was used as either a first line treatment (46.5 percent) or salvage
therapy (53.5 percent) following unsuccessful treatment with another
method. The indication for Hemospray[supreg] as a first-line therapy or
salvage therapy was at the discretion of the endoscopist. Of the 202
patients, the mean age was 68.9, 69.3 percent were male, and all
patients were classified into four primary etiologic groups: Ulcers
(37.1 percent), malignant lesions (30.2 percent), post-endoscopic
bleeding (17.3 percent), and other (15.3 percent). Patients were
further classified by the American Society of Anesthesiologist (ASA)
physical status scores with 4.5 percent as a normal healthy patient,
24.3 percent as a patient with mild systemic disease, 46 percent as a
patient with severe systemic disease, 22.8 percent as a patient with
severe systemic disease that is a constant threat to life, and 2.5
percent as a moribund patient who is not expected to survive without an
operation.8 9 Immediate hemostasis was achieved in 96.5
percent across all patients; among treatment subtypes, immediate
hemostasis was achieved in 96.8 percent of first-line treated patients
and 96.3 percent of salvage therapy patients. At day 30, the overall
rebleeding was 33.5 percent of 185 patients with cumulative incidences
of 41.4 percent for ulcers, 37.7 percent for malignant lesions, 17.6
percent for post-endoscopic bleedings, and 25 percent for others. When
Hemospray[supreg] was used as a first-line treatment, rebleeding at day
30 occurred in 26.5 percent (22/83) of overall lesions, 30.8 percent of
ulcers, 33.3 percent of malignant lesions, 13.6 percent of post-
endoscopic bleedings, and 22.2 percent of other. When Hemospray[supreg]
was used as a salvage therapy, rebleeding at day 30 occurred in 39.2
percent (40/102) of overall lesions, 43.9 percent of ulcers, 50.0
percent of malignant lesions, 25.0 percent of post-endoscopic
bleedings, and 26.3 percent for others. According to the article, the
favorable hemostatic results seen from Hemospray[supreg] are due to its
threefold mechanism of action: Formation of a mechanical barrier;
concentration of clotting factors at the bleeding site; and enhancement
of clot formation.\10\ No severe adverse events
[[Page 85999]]
were noted, however the authors note the potential for pain exists due
to the use of carbon dioxide. Lastly, the authors stated that while
Hemospray[supreg] was found to reduce the need for radiological
embolization and surgery as salvage therapies, it was not found to be
better than other hemostatic methods in terms of preventing rebleeding
of ulcers.
---------------------------------------------------------------------------
\7\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
\8\ Ibid.
\9\ ASA House of Delegates/Executive Committee. (2014, October
15). ASA Physical Status Classification System. Retrieved from
American Society of Anesthesiologists: https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-system.
\10\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
---------------------------------------------------------------------------
The applicant provided a second article consisting of an abstract
from another systematic review article.\11\ The abstract purports to
cover a review of prospective, retrospective, and randomized control
trials evaluating Hemospray[supreg] as a rescue therapy. Eighty-five
articles were initially identified and 23 were selected for review. Of
those, 5 studies were selected which met the inclusion criteria of the
analysis. The median age of patients was 69; 68 percent were male. The
abstract concludes that when used as a rescue therapy after the failure
of conventional endoscopic modalities in nonvariceal gastrointestinal
bleeding, Hemospray[supreg] seems to have significantly higher rates of
immediate hemostasis.
---------------------------------------------------------------------------
\11\ Moole, V., Chatterjee, T., Saca, D., Uppu, A., Poosala, A.,
& Duvvuri, A. A Systematic review and meta-analysis: Analyzing the
efficacy of hemostatic nanopowder (TC-325) as rescue therapy in
patients with nonvariceal upper gastrointestinal bleeding.
Gastroenterology 2019; 156(6), S-741
---------------------------------------------------------------------------
A third article provided by the applicant described a single-arm
retrospective analytical study of 261 enrolled patients conducted at 21
hospitals in Spain.\12\ The mean age was 67 years old, 69 percent of
patients were male, and the overall technical success, defined as
correct assembled and delivery of Hemospray[supreg] to a bleeding
lesion, was 97.7 percent (95.1 percent-99.2 percent). The most common
causes of bleeding in patients were peptic ulcer (28 percent),
malignancy (18.4 percent), therapeutic endoscopy-related (17.6
percent), and surgical anastomosis (8.8 percent). Overall, 93.5 percent
(89.5 percent to 96 percent) of procedures achieved hemostasis.
Recurrent bleeding, defined as (1) a new episode of bleeding symptoms,
(2) a decrease in hemoglobin of >2 g/dL within 48 hours of an index
endoscopy or >3g/dL in 24 hours, or (3) direct visualization of active
bleeding at the previously treated lesion on repeat endoscopy, had a
cumulative incidence at 3 and 30 days of 16.1 percent (11.9 percent-21
percent) and 22.9 percent (17.8 percent-28.3 percent) respectively. The
overall risk of Hemospray[supreg] failure at 3 and 30 days was 21.1
percent (16.4 percent-26.2 percent) and 27.4 percent (22.1 percent-32.9
percent) respectively with no statistically significant differences
(p=0.07) between causes at 30 days (for example, peptic ulcer,
malignancy, anastomosis, therapeutic endoscopy-related, and other
causes). With the use of multivariate analysis, spurting bleeding vs.
nonspurting bleeding (subdistribution hazard ratio [sHR] 1.97 (1.24-
3.13)), hypotension vs. normotensive (sHR 2.14 (1.22-3.75)), and the
use of vasoactive drugs (sHR 1.80 (1.10-2.95)) were independently
associated with Hemospray[supreg] failure. The overall 30-day survival
was 81.9 percent (76.5 percent-86.1 percent) with 46 patients dying
during follow-up and 22 experiencing bleeding related deaths; twenty
patients (7.6 percent) with intraprocedural hemostasis died before day
30. The authors indicated the majority of Hemospray[supreg] failures
occurred within the first 3 days and the rate of immediate hemostasis
was similar to literature reports of intraprocedural success rates of
over 90 percent. The authors stated that the hemostatic powder of
Hemospray[supreg] is eliminated from the GI tract as early as 24 hours
after use, which could explain the wide ranging recurrent bleeding
percentage. The authors reported that importantly, adverse events are
rare, but cases of abdominal distension, visceral perforation,
transient biliary obstruction, and splenic infarct have been reported;
one patient involved in this study experienced an esophageal
perforation without a definitive causal relationship.
---------------------------------------------------------------------------
\12\ Rodriguez de Santiago E, Burgos-Santamaria D, Perez-Carazo
L, et al. Hemostatic spray TC-325 for GI bleeding in a nationwide
study: Survival analysis and predictors of failure via competing
risks analysis. Gastrointest Endosc 2019; 90(4), 581-590.
---------------------------------------------------------------------------
A fourth article provided by the applicant described a single-arm
multicenter prospective registry involving 314 patients in Europe which
collected data on days 0, 1, 3, 7, 14, and 30 after endotherapy with
Hemospray[supreg].\13\ The outcomes of interest in this study were
immediate endoscopic hemostasis (observed cessation of bleeding within
5 minutes post Hemospray[supreg] application) with secondary outcomes
of rebleeding immediately following treatment and during follow-up, 7
and 30 day all-cause mortality, and adverse events. The sample was 74
percent male with a median age of 71 with the most common pathologies
of peptic ulcer (53 percent), malignancy (16 percent), post-endoscopic
bleeding (16 percent), bleeding from severe inflammation (11 percent),
esophageal variceal bleeding (2.5 percent), and cases with no obvious
cause (1.6 percent). The median baseline Blatchford score (BS) and RS
were 11 and 7 respectively. The BS ranges from 0 to 23 with higher
scores indicating increasing risk for required endoscopic intervention
and is based upon the blood urea nitrogen, hemoglobin, systolic blood
pressure, pulse, presence of melena, syncope, hepatic disease, and/or
cardiac failure.\14\ The RS ranges from 0 to 11 with higher scores
indicating worse potential outcomes and is based upon age, presence of
shock, comorbidity, diagnosis, and endoscopic stigmata of recent
hemorrhage.\15\ Immediate hemostasis was achieved in 89.5 percent of
patients following the use of Hemospray[supreg]; only the BS was found
to have a positive correlation with treatment failure in multivariate
analysis (OR 1.21 (1.10-1.34)). Rebleeding occurred in 10.3 percent of
patients who achieved immediate hemostasis again with only the BS
having a positive correlation with rebleeding (OR: 1.13 (1.03-1.25)).
At 30 days, the all-cause mortality was 20.1 percent; 78 percent of
these patients had achieved immediate endoscopic hemostasis and had a
cause of death resulting from the progression of other comorbidities. A
subgroup analysis of treatment type (monotherapy, combination therapy,
and rescue therapy groups) was performed showing no statistically
significant difference in immediate hemostasis across groups (92.4
percent, 88.7 percent, and 85.5 percent respectively). Higher all-cause
mortality rates at 30 days were highest in the monotherapy group (25.4
percent, p=0.04) as compared to all other groups. According to the
authors, in comparison to major recent studies, they were able to show
lower rebleeding rates overall and in all subgroups despite the high-
risk population.\16\ The authors further note limitations in that the
inclusion of patients was nonconsecutive and at the discretion of the
endoscopist at the time of the endoscopy, which allows for the
potential introduction of selection bias,
[[Page 86000]]
which may have affected these study results.
---------------------------------------------------------------------------
\13\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\14\ Saltzman, J. (2019, October). Approach to acute upper
gastrointestinal bleeding in adults. (M. Feldman, Editor) Retrieved
from UpToDate: https://www.uptodate.com/contents/approach-to-acute-upper-gastrointestinal-bleeding-in-adults.
\15\ Ibid.
\16\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
---------------------------------------------------------------------------
The fourth article also described the utility of Hemospray[supreg]
in the treatment of malignant lesions. According to the applicant,
malignant lesions pose a significant clinical challenge as successful
hemostasis rates are as low as 40 percent with high recurrent bleeding
over 50 percent within 1 month following standard
treatments.17 18 The applicant added that bleeding from
tumors is often diffuse and consists of friable mucosa decreasing the
utility of traditional treatments (for example, ligation, cautery).
From the fourth article, the applicant noted that 50 patients were
treated for malignant bleeding with an overall immediate hemostasis in
94 percent of patients.\19\ Of the 50 patients, 33 were treated with
Hemospray[supreg] alone, 11 were treated with Hemospray[supreg] as the
final treatment, and 4 were treated with Hemospray[supreg] as a rescue
therapy of which 100 percent, 84.6 percent and 75 percent experienced
immediate hemostasis respectively.\20\ Similarly, from the first
discussed article, the applicant noted that among malignant bleeding
patients, 95.1 percent achieved immediate hemostasis with lower
rebleeding rates at 8 days when Hemospray[supreg] was used as a primary
treatment compared to when used as a rescue therapy (17.1 percent vs.
46.7 percent respectively).\21\ The applicant concluded that
Hemospray[supreg] may provide an advantage as a primary treatment to
patients with malignant bleeding.
---------------------------------------------------------------------------
\17\ Kim YI, Choi IJ, Cho SJ, et al. Outcome of endoscopic
therapy for cancer bleeding in patients with unresectable gastric
cancer. J Gastroenterol Hepatol 2013;28:1489-95.
\18\ Roberts SE, Button LA, Williams JG. Prognosis following
upper gastrointestinal bleeding. PLoS One 2012;7:e49507.
\19\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\20\ Alzoubaidi D, Hussein M, Rusu R, et al. Outcomes from an
international multicenter registry of patients with acute
gastrointestinal bleeding undergoing endoscopic treatment with
Hemospray. Digestive Endoscopy 2019.
\21\ Haddara S, Jacques J, Lecleire S et al. A novel hemostatic
powder for upper gastrointestinal bleeding: A multicenter study (the
GRAPHE registry). Endoscopy 2016; 48: 1084-95.
---------------------------------------------------------------------------
The applicant provided a fifth article, which consisted of a
journal pre-proof article detailing a 1:1 randomized control trial of
20 patients treated with Hemospray[supreg] versus the standard of care
(for example, thermal and injection therapies) in the treatment of
malignant gastrointestinal bleeding.\22\ The goals of this pilot study
were to determine the feasibility of a definitive trial. The primary
outcome of the study was immediate hemostasis (absence of bleeding
after 3 minutes) with secondary outcomes of recurrent bleeding at days
1, 3, 30, 90, and 180 and adverse events at days 1, 30, and 180. The
mean age of patients was 67.2, 75 percent were male, and on average
patients presented with 2.9 1.7 comorbidities. All
patients had active bleeding at endoscopy and the majority of patients
had an ASA score of 2 (45 percent) or 3 (40 percent). Immediate
hemostasis was achieved in 90 percent of Hemospray[supreg] patients and
40 percent of standard of care patients (5 injection alone, 3 thermal,
1 injection with clips, and 1 unknown). Of those patients in the
control group, 83.3 percent crossed over to the Hemospray[supreg]
treatment. One patient died while being treated with Hemospray[supreg]
from exsanguination; post-mortem examination demonstrated that bleeding
was caused by rupture of a malignant inferior mesenteric artery
aneurysm. Overall, 86.7 percent of patients treated with
Hemospray[supreg] initially or as crossover treatment achieved
hemostasis. Recurrent bleeding was lower in the Hemospray[supreg] group
(20 percent) as compared to the control group (60 percent) at 180 days.
Forty percent of the treated group received blood transfusions as
compared to 70 percent of the control group. The overall length of stay
was 14.6 days among treated patients as compared to 9.4 in the control
group. Mortality at 180 days was 80 percent in both the treated and
control groups. The authors noted the potential for operator bias in
the use of Hemospray[supreg] prior to switching to another method when
persistent bleeding exists. Lastly, the authors noted that while they
did not occur during this study, there are concerns around the risks of
perforation, obstruction, and systemic embolization with the use of
Hemospray[supreg].
---------------------------------------------------------------------------
\22\ Chen Y-I, Wyse J, Lu Y, Martel M, Barkun AN, TC-325
hemostatic powder versus current standard of care in managing
malignant GI bleeding: A pilot randomized clinical trial.
Gastrointestinal Endoscopy (2019), doi: https://doi.org/10.1016/j.gie.2019.08.005.
---------------------------------------------------------------------------
A sixth article provided by the applicant was a case-controlled
study with 10 patients with active upper gastrointestinal bleeding from
tumor compared with 10 conventional therapy patients selected as
historical controls, matched by type of tumor.\23\ The study evaluated
efficacy for tumor-related bleeding and compared Hemospray[supreg] to
conventional therapies, specifically examining 14-day rebleeding rates,
lengths of hospital stay (LOS), and mortality rate at 30-day follow up.
Historical controls were selected from patient medical records from
2010 to 2014. Among the patients who received Hemospray[supreg], the
14-day rebleeding rate (10 percent vs. 30 percent; P=0.60) and the 30-
day mortality rates (10 percent vs. 30 percent, P=0.7) were three times
lower compared to the control group; neither rate was statistically
significant. There was no difference in LOS between the
Hemospray[supreg] and conventional therapy patients.
---------------------------------------------------------------------------
\23\ Pittayanon, R., Prueksapanich, P., & Rerknimitr, R. (2016).
The efficacy of Hemospray in patients with upper gastrointestinal
bleeding from tumor. Endoscopy international open, 4(09), E933-E936.
---------------------------------------------------------------------------
A seventh article provided by the applicant described a single-arm
multicenter retrospective study from 2011 to 2016 involving 88 patients
who bled as a result of either a primary GI tumor or metastases to the
GI tract.\24\ In this study the authors define immediate hemostasis as
no further bleeding at least one minute after treatment with
Hemospray[supreg], and recurrent bleeding was suspected if one of seven
criteria were met: (1) Hematemesis or bloody nasogastric tube >6 hours
after endoscopy; (2) melena after normalization of stool color; (3)
hematochezia after normalization of stool color or melena; (4)
development of tachycardia or hypotension after >1 hour of vital sign
stability without other cause; (5) decrease in hemoglobin level greater
than or equal to 3 hours apart; (6) tachycardia or hypotension that
does not resolve within 8 hours after index endoscopy; or (7)
persistent decreasing hemoglobin of >3 g/dL in 24 hours associated with
melena or hematochezia). The sample for this study consisted of 88
patients (with a mean age of 65 years old and 70.5 percent male) of
which 33.3 percent possessed no co-morbid illness, and 25 percent were
on current antiplatelet/anticoagulant medication. The mean BS was 8.7
plus or minus 3.7 with a range from 0 to 18. Overall, 72.7 percent of
patients had a stage 4 adenocarcinoma, squamous cell carcinoma, or
lymphoma. Immediate hemostasis was achieved in 97.7 percent of
patients. Recurrent bleeding occurred in 13 of 86 (15 percent) and 1 of
53 (1.9 percent) at 3 and 30 days, respectively. A total of 25 patients
(28.4 percent) died during the 30-day follow up period. Overall, 27.3
percent of patients re-bled within 30 days after treatment of which
half were within 3 days. Using multivariate analysis, the authors found
patients
[[Page 86001]]
with good performance status, no end-stage cancer, or receiving any
combination of definitive hemostasis treatment modalities had
significantly greater survival. The authors acknowledged the recurrent
bleeding rate post Hemospray[supreg] treatment at 30 days of 38 percent
is comparable with that seen in sole conventional hemostatic techniques
and state this implies that Hemospray[supreg] does not differ from
conventional techniques and remains unsatisfactory.
---------------------------------------------------------------------------
\24\ Pittayanon R, Rerknimitr R, Barkun A. Prognostic factors
affecting outcomes in patients with malignant GI bleeding treated
with a novel endoscopically delivered hemostatic powder.
Gastrointest Endosc 2018; 87:991-1002.
---------------------------------------------------------------------------
Ultimately, the applicant concluded nonvariceal gastrointestinal
bleeding is associated with significant morbidity and mortality in
older patients with multiple co-morbid conditions. Inability to achieve
hemostasis and early rebleeding are associated with increased cost and
greater resource utilization. According to the applicant, patients with
bleeding from malignant lesions have few options that can provide
immediate hemostasis without further disrupting fragile mucosal tissue
and worsening the active bleed. The applicant stated Hemospray[supreg]
is an effective agent that provides immediate hemostasis in patients
with GI bleeding as part of multimodality treatment, as well as when
used as rescue therapy in patients who have failed more conventional
endoscopic modalities. Furthermore, the applicant stated that in
patients with malignant bleeding in the GI tract, Hemospray[supreg]
provides a high rate of immediate hemostasis and fewer recurrent
bleeding episodes, which, in combination with definitive cancer
treatment, may lead to improvements in long term survival. Lastly, the
applicant stated Hemospray[supreg] is an important new technology that
permits immediate and long-term hemostasis in GI bleeding cases where
standard of care treatment with clip ligation or cautery are not
effective.
In the CY 2021 OPPS/ASC proposed rule, we noted that the majority
of studies provided lacked a comparator when assessing the
effectiveness of Hemospray[supreg]. Three of the articles provided were
systematic reviews of the literature. While we found these articles
helpful in establishing a background for the use of Hemospray[supreg],
we were concerned that they may not provide strong evidence of
substantial clinical improvement. Four studies appeared to be single-
armed studies assessing the efficacy of Hemospray[supreg] in the
patient setting. In all of these articles, comparisons were made
between Hemospray[supreg] and standard of care treatments; however,
without the ability to control for factors such as study design,
patient characteristics, etc., it is difficult to determine if any
differences seen resulted from Hemospray[supreg] or confounding
variables. Furthermore, within the retrospective and prospective
studies lacking a control subset, some level of selection bias appeared
to potentially be introduced in that providers may have been allowed to
select the manner and order in which patients were treated, thereby
potentially influencing outcomes seen in these studies.
Additionally, one randomized control trial provided by the
applicant appeared to be in the process of peer-review and was not yet
published. Furthermore, this article was written as a feasibility study
for a potentially larger randomized control trial and contained a
sample of only 20 patients. This small sample size left us concerned
that the results were not representative of the larger Medicare
population. Lastly, as described, we were concerned the control group
could receive one of multiple treatments which lacked a clear
designation methodology beyond physician choice. For instance, 50
percent of the control patients received injection therapy alone, which
according to the literature provided by the applicant is not an
acceptable treatment for endoscopic bleeding. Accordingly, it was not
clear whether performance seen in the treated group as compared to the
control group was due to Hemospray[supreg] itself or due to confounding
factors.
Third, we stated in the CY 2021 OPPS/ASC proposed rule that we were
concerned with the samples chosen in many of the studies presented.
Firstly, the Medicare population is approximately 54 percent female and
46 percent male.\25\ Many of the samples provided by the applicant were
overwhelmingly male. Secondly, many of the studies provided were
performed in Europe and other settings outside of the U.S. We were
therefore concerned that the samples chosen within the literature
provided may not represent the Medicare population.
---------------------------------------------------------------------------
\25\ https://www.cms.gov/files/document/2018-mdcr-enroll-ab-5.pdf.
---------------------------------------------------------------------------
Lastly, we were concerned about the potential for adverse events
resulting from Hemospray[supreg]. It was unclear from the literature
provided by the applicant what the likelihood of these events is and
whether or not an evaluation for the safety of Hemospray[supreg] was
performed. About one-third of the articles submitted specifically
addressed adverse events with Hemospray[supreg]. However, the
evaluation of adverse events was limited and most of the patients in
the studies died of disease progression. A few of the provided articles
mentioned the potential for severe adverse reactions (for example,
abdominal distension, visceral perforation, biliary obstruction,
splenic infarct). Specifically, one article \26\ recorded adverse
events related to Hemospray[supreg], including abdominal distention and
esophageal perforation.
---------------------------------------------------------------------------
\26\ Rodriguez de Santiago E, Burgos-Santamaria D, Perez-Carazo
L, et al. Hemostatic spray TC-325 for GI bleeding in a nationwide
study: Survival analysis and predictors of failure via competing
risks analysis. Gastrointest Endosc 2019; 90(4), 581-590.
---------------------------------------------------------------------------
According to information submitted by the applicant, Cook Medical
had voluntarily recalled Hemospray[supreg] Endoscopic Hemostat due to
complaints received that the handle and/or activation knob on the
device in some cases had cracked or broken when the device was
activated and in some cases had caused the carbon dioxide cartridge to
exit the handle. The applicant stated that Cook Medical had received
one report of a superficial laceration to the user's hand that had
required basic first aid; however, there were no reports of laceration,
infection, or permanent impairment of a body structure to users or to
patients due to the carbon dioxide cartridge exiting the handle. The
applicant stated that Cook Medical had initiated an investigation and
would determine the appropriate corrective action(s) to prevent
recurrence of this issue. According to the applicant, although the
recall did restrict availability of the device, they wished to continue
their application as they believed the use of Hemospray[supreg]
significantly improves clinical outcomes for certain patient
populations compared to currently available treatments.
Based upon the evidence presented, we solicited public comments on
whether the Hemospray[supreg] Endoscopic Hemostat meets the substantial
clinical improvement criterion.
Comment: The manufacturer responded to several statements regarding
Hemospray[supreg] and substantial clinical improvement in the CY 2021
OPPS/ASC proposed rule, and asserted that Hemospray[supreg] meets the
substantial clinical improvement criterion. The manufacturer agreed the
data presented is primarily from single arm and retrospective studies
and may suffer from selection bias. However, the manufacturer suggested
that CMS should consider that Hemospray[supreg] is commonly used when
the conventional standard of care, such as injection plus clips or
cautery, is inadequate to treat patients undergoing an urgent catheter-
based embolization or surgery. The manufacturer stated that the
selection
[[Page 86002]]
bias is toward patients with the highest risk of morbidity or mortality
and the high rate of successful treatment for those patients with
Hemospray[supreg] represents substantial clinical improvement. They
cited several studies that found that, after all other conventional
treatments failed, there was overall treatment success in cases where
Hemospray[supreg] was used.
In response to CMS' concerns about the unpublished randomized
controlled trial presented, the manufacturer stated that the study has
been published with no changes and noted that, despite the small sample
size, they believe the results are representative of the general
population with malignant gastrointestinal bleeding and consistent with
other published retrospective studies.
The manufacturer stated that the research and studies for
Hemospray[supreg] are largely international because Hemospray[supreg]
was commercially available outside the U.S. for 5 to 7 years before the
FDA awarded the product de Novo 510(k) status. They believed that this
data is representative of the U.S. population, as the treatment
strategy and patient outcomes are similar. The manufacturer
acknowledged that study populations are predominantly male but noted
that 60 percent of patients undergoing endoscopic control of bleeding
are male, according to the 2016 Healthcare Cost and Utilization
Project. The manufacturer mentioned that the mean age of study
populations varied from 67-71 years, which is representative of the
Medicare population.
Regarding the potential for adverse events, the manufacturer stated
that FDA has determined the product is safe and effective for its
intended use, has an acceptable risk/benefit ratio, and cleared
Hemospray[supreg] to return to the market as of July 2020 after the
issue was addressed. The manufacturer also mentioned that they
understand the potential risks associated with Hemospray[supreg] and
have clearly labeled the product, conducted physician training,
diligently monitor reported complaints or complications, and will take
appropriate steps to correct any future issues that arise.
Response: We appreciate the manufacturer's response to our
questions regarding Hemospray[supreg]. After reviewing the information
provided in the public comment, we agree with the applicant's
statements that any potential bias introduced was toward the patients
with the highest risk of negative outcomes and that this potential bias
is no longer a concern. Regarding the applicant's comment on study
samples, we agree with the applicant that these samples are adequately
representative of the Medicare population. We also appreciate the
comment response regarding the potential for adverse events and the
update on the status of the Hemospray[supreg] voluntary recall. We will
continue to monitor available data for Hemospray[supreg] in regard to
any potential risk of adverse events.
As we noted in the FY 2021 IPPS final rule (85 FR 58672), while we
acknowledge some of the data limitations, we believe that
Hemospray[supreg] represents a substantial clinical improvement for the
treatment of gastrointestinal bleeding for the following reasons. We
believe that, given the results from the RCT trials and the single-
armed studies, Hemospray[supreg] provides a treatment benefit for those
with bleeding from gastrointestinal malignancies. We also see the
clinical importance of Hemospray as an alternative to invasive
treatments traditionally used as salvage therapy. Lastly, we note that
Hemospray[supreg] provides treatment for bleeding, without requiring
tissue trauma or precise targeting.
After consideration of the public comments we received, we have
determined that Hemospray[supreg] meets the substantial clinical
improvement criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Hemospray[supreg]
would be reported with HCPCS codes 43227, 43255, 44366, 44378, 44391,
45334, and 45382. To meet the cost criterion for device pass-through
payment status, a device must pass all three tests of the cost
criterion for at least one APC. For our calculations in the CY 2021
OPPS/ASC proposed rule, we used APC 5312, which had a CY 2020 payment
rate of $1,004.10 at the time the application was received. Beginning
in CY 2017, we calculate the device offset amount at the HCPCS/CPT code
level instead of the APC level (81 FR 79657). HCPCS code 45382 had a
device offset amount of $33.54 at the time the application was
received. According to the applicant, the cost of the Hemospray[supreg]
Endoscopic Hemostat is $2,500.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $2,500 for Hemospray[supreg] was 249 percent
of the applicable APC payment amount for the service related to the
category of devices of $1004.10 (($2,500/$1,004.10) x 100 = 249
percent). Therefore, we stated in the CY 2021 OPPS/ASC proposed rule
that we believe Hemospray[supreg] meets the first cost significance
requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $2,500 for
Hemospray[supreg] was 7,454 percent of the cost of the device-related
portion of the APC payment amount for the related service of $33.54
(($2,500/$33.54) x 100 = 7,453.8 percent). Therefore, we stated in the
CY 2021 OPPS/ASC proposed rule that we believe that Hemospray[supreg]
meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $2,500 for Hemospray[supreg] and the portion of the
APC payment amount for the device of $33.54 was 246 percent of the APC
payment amount for the related service of $1004.10 t ((($2,500-$33.54)/
$1004.10) x 100 = 245.6 percent). Therefore, we stated in the CY 2021
OPPS/ASC proposed rule that we believe that Hemospray[supreg] meets the
third cost significance requirement.
We solicited public comment on whether the Hemospray[supreg]
Endoscopic Hemostat meets the device pass-through payment criteria
discussed in this section, including the cost criterion for device
pass-through payment status.
Comment: Three commenters, including the manufacturer of the
Hemospray[supreg], believe that the device meets the cost criterion for
device pass-through payment status.
Response: We appreciate the manufacturer's input. After
consideration of the public comments we received and consideration of
the
[[Page 86003]]
cost criterion, we have determined that Hemospray[supreg] meets the
cost criterion for device pass-through payment status.
After consideration of the public comments we received, we are
approving the Hemospray[supreg] for device pass-through payment status
beginning in CY 2021.
(2) The SpineJack[supreg] Expansion Kit
Stryker, Inc., submitted an application for a new device category
for transitional pass-through payment status for the SpineJack[supreg]
Expansion Kit (hereinafter referred to as the SpineJack[supreg] system)
by the March 2020 quarterly deadline. The applicant described the
SpineJack[supreg] system as an implantable fracture reduction system,
which is indicated for use in the reduction of painful osteoporotic
vertebral compression fractures (VCFs) and is intended to be used in
combination with Stryker VertaPlex and VertaPlex High Viscosity (HV)
bone cement.
The applicant described the SpineJack[supreg] system as including
two cylindrical implants constructed from Titanium-6-Aluminum-4-
Vanadium (Ti6Al4V) with availability in three sizes: 4.2 mm (12.5 mm
expanded), 5.0 mm (17 mm expanded) and 5.8 mm (20 mm expanded). The
applicant explained implant size selection is based upon the internal
cortical diameter of the pedicle. According to the SpineJack[supreg]
system Instructions for Use, the use of two implants is recommended to
treat a fractured VB. According to the applicant, multiple VBs can also
be treated in the same operative procedure as required. Additionally,
the applicant explained that titanium alloy allows for plastic
deformation when it encounters the hard cortical bone of the endplate
yet still provides the lift force required to restore midline VB height
in the fractured vertebra. The applicant stated that the
SpineJack[supreg] system notably contains a self-locking security
mechanism that restricts further expansion of the device when extreme
load forces are concentrated on the implant. As a result, the applicant
stated that this feature significantly reduces the risk of vertebral
endplate breakage while it further allows functional recovery of the
injured disc.\27\
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\27\ Vanni D et al. ``Third-generation percutaneous vertebral
augmentation systems.'' Journal of Spine Surgery. 2016, vol 2(1),
pp. 13-20.
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The applicant stated that the implants are then progressively
expanded though actuation of an implant tube that pulls the two ends of
the implant towards each other in situ to mechanically restore VB
height. The applicant explained that the mechanical working system of
the implant allows for progressive and controlled reduction of the
vertebral fracture.\28\ The applicant stated that when expanded, each
SpineJack[supreg] implant exerts a lifting pressure on the fracture
through a mechanism that may be likened to the action of a scissor car
jack, and that the longitudinal compression on the implant causes it to
open in a craniocaudal direction. The applicant explained that the
implant is locked into the desired expanded position as determined and
controlled by the treating physician.\29\
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\28\ Vanni D., et al., ``Third-generation percutaneous vertebral
augmentation systems,'' J. Spine Surg., 2016, vol. 2(1) pp. 13-20.
\29\ Noriega D. et al., ``Clinical Performance and Safety of 108
SpineJack Implantations: 1-Year Results of a Prospective Multicentre
Single-Arm Registry Study,'' BioMed Res. Int., 2015, vol. 173872.
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The applicant further explained that the expansion of the
SpineJack[supreg] implants creates a preferential direction of flow for
the bone cement, and once the desired expansion has been obtained,
polymethylmethacrylate (PMMA) bone cement is deployed from the center
of the implant into the VB. The applicant stated that when two implants
are symmetrically positioned in the VB, this allows for a more
homogenous spread of PMMA bone cement. The applicant stated that the
interdigitation of bone cement creates a broad supporting ring under
the endplate, which is essential to confer stability to the VB.
According to the applicant, osteoporosis is one of the most common
bone diseases worldwide that disproportionately affects aging
individuals. The applicant explained that in 2010, approximately 54
million Americans aged 50 years or older had osteoporosis or low bone
mass,\30\ which resulted in more than 2 million osteoporotic fragility
fractures in that year alone.\31\ The applicant stated it has been
estimated that more than 700,000 VCFs occur each year in the United
States (U.S.),\32\ and of these VCFs, about 70,000 result in hospital
admissions with an average length of stay of 8 days per patient.\33\
Furthermore, the applicant noted that in the first year after a painful
vertebral fracture, patients have been found to require primary care
services at a rate 14 times greater than the general population.\34\
The applicant explained that medical costs attributed to VCFs in the
U.S. exceeded $1 billion in 2005 and are predicted to surpass $1.6
billion by 2025.\35\
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\30\ National Osteoporosis Foundation. (2019). What is
osteoporosis and what causes it? Available from: https://www.nof.org/patients/what-is-osteoporosis/.
\31\ King A and Fiorentino D. ``Medicare payment cuts for
osteoporosis testing reduced use despite tests' benefit in reducing
fractures.'' Health Affairs (Millwood), 2011, vol. 30(12), pp. 2362-
2370.
\32\ Riggs B and Melton L. ``The worldwide problem of
osteoporosis: Insights afforded by epidemiology.'' Bone, 1995, vol.
17(Suppl 5), pp. 505-511.
\33\ Siemionow K and Lieberman I. ``Vertebral augmentation in
osteoporotic and osteolytic fractures: Current Opinion in Supportive
and Palliative Care.'' 2009, vol. 3(3), pp. 219-225.
\34\ Wong C and McGirt M. ``Vertebral compression fractures: A
review of current management and multimodal therapy.'' Journal of
Multidisciplinary Healthcare, 2013, vol 6, pp. 205-214.
\35\ Burge R et al. ``Incidence and economic burden of
osteoporosis-related fractures in the United States: 2005-2025.''
Journal of Bone and Mineral Research. 2007, vol 22(3), pp. 465-475.
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The applicant explained that osteoporotic VCFs occur when the
vertebral body (VB) of the spine collapses and can result in chronic
disabling pain, excessive kyphosis, loss of functional capability,
decreased physical activity, and reduced quality of life. The applicant
stated that as the spinal deformity progresses, it reduces the volume
of the thoracic and abdominal cavities, which may lead to crowding of
internal organs. The applicant noted that the crowding of internal
organs may cause impaired pulmonary function, abdominal protuberance,
early satiety and weight loss. The applicant indicated that other
complications may include bloating, distention, constipation, bowel
obstruction, and respiratory disturbances such as pneumonia,
atelectasis, reduced forced vital capacity and reduced forced
expiratory volume in 1 second.
The applicant explained that the SpineJack[supreg] implants provide
symmetric, broad load support for osteoporotic vertebral collapse,
which is based upon precise placement of bilateral ``struts'' that are
encased in PMMA bone cement, whereas BKP and vertebroplasty (VP) do not
provide structural support via an implanted device. The applicant
explained that the inflatable balloon tamps utilized in BKP are not
made from titanium and are not a permanent implant. According to the
applicant, the balloon tamps are constructed from thermoplastic
polyurethane, which have limited load bearing capacity. The applicant
noted that although the balloon tamps are expanded within the VB to
create a cavity for bone cement, they do not remain in place and are
removed before the procedure is completed. The applicant explained that
partial lift to the VB is obtained during inflation, resulting in
kyphotic deformity
[[Page 86004]]
correction and partial gains in anterior VB height restoration, but
inflatable balloon tamps are deflated prior to removal so some of the
VB height restoration obtained is lost upon removal of the bone tamps.
According to the applicant, BKP utilizes the placement of PMMA bone
cement to stabilize the fracture and does not include an implant that
remains within the VB to maintain fracture reduction and midline VB
height restoration.
The applicant stated that if VB collapse is >50 percent of the
initial height, segmental instability will ensue. As a result, the
applicant explained that adjacent levels of the VB must support the
additional load and this increased strain on the adjacent levels may
lead to additional VCFs. Furthermore, the applicant summarized that
VCFs also lead to significant increases in morbidity and mortality risk
among elderly patients, as evidenced by a 2015 study by Edidin et al.,
in which researchers investigated the morbidity and mortality of
patients with a newly diagnosed VCF (n = 1,038,956) between 2005 to
2009 in the U.S. Medicare population. For the osteoporotic VCF
subgroup, the adjusted 4-year mortality was 70 percent higher in the
conservatively managed group than in the balloon kyphoplasty procedures
(BKP)-treated group, and 17 percent lower in the BKP group than in the
vertebroplasty (VP) group. According to the applicant, when evaluating
treatment options for osteoporotic VCFs, one of the main goals of
treatment is to restore the load bearing bone fracture to its normal
height and stabilize the mechanics of the spine by transferring the
adjacent level pressure loads across the entire fractured vertebra and
in this way, the intraspinal disc pressure is restored and the risk of
adjacent level fractures (ALFs) is reduced.
The applicant explained that treatment of osteoporotic VCFs in
older adults most often begins with conservative care, which includes
bed rest, back bracing, physical therapy and/or analgesic medications
for pain control. According to the applicant, for those patients that
do not respond to conservative treatment and continue to have
inadequate pain relief or pain that substantially impacts quality of
life, vertebral augmentation (VA) procedures may be indicated. The
applicant explained that VP and BKP are two minimally invasive
percutaneous VA procedures that are most often used in the treatment of
osteoporotic VCFs, and another VA treatment option includes the use of
a spiral coiled implant made from polyetheretherketone (PEEK), which is
part of the Kiva[supreg] system.
According to the applicant, among the treatment options available,
BKP is the most commonly performed procedure and the current gold
standard of care for VA treatment. The applicant stated that it is
estimated that approximately 73 percent of all vertebral augmentation
procedures performed in the U.S. between 2005 and 2010 were BKP.\36\
According to the applicant, the utilization of the Kiva[supreg] system
is relatively low in the U.S. and volume information was not available
in current market research data.\37\
---------------------------------------------------------------------------
\36\ Goz V et al. ``Vertebroplasty and kyphoplasty: National
outcomes and trends in utilization from 2005 through 2010.'' The
Spine Journal. 2015, vol. 15(5), pp. 959-965.
\37\ Lin M. ``Minimally invasive vertebral compression fracture
treatments. Medtech 360, Market Insights, Millennium Research Group.
2019.
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The applicant stated that VA treatment with VP may alleviate pain,
but it cannot restore VB height or correct spinal deformity. The
applicant stated that BKP attempts to restore VB height, but the
temporary correction obtained cannot be sustained over the long term.
The applicant stated that the Kiva[supreg] implant attempts to
mechanically restore VB height, but it has not demonstrated superiority
to BKP for this clinical outcome.\38\
---------------------------------------------------------------------------
\38\ Ibid.
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The applicant provided additional detail comparing the construction
and mechanism of action for other VA treatments, provided below.
According to the applicant the Kiva[supreg] system is constructed of a
nitinol coil and PEEK-OPTIMA sheath, with sizes including a 4-loop
implant (12 mm expanded) and a 5-loop implant (15 mm expanded), and
unlike the SpineJack[supreg] system, is not made of titanium and does
not include a locking scissor jack design. The applicant stated that
the specific mechanism of action for the Kiva[supreg] system is
different from the SpineJack[supreg] system. The applicant explained
that during the procedure that involves implanting the Kiva[supreg]
system, nitinol coils are inserted into the VB to form a cylindrical
columnar cavity. The applicant stated that the PEEK-OPTIMA is then
placed over the nitinol coil. The applicant explained that the nitinol
coil is removed from the VB and the PEEK material is filled with PMMA
bone cement. The applicant stated that the deployment of 5 coils
equates to a maximum height of 15 mm. The applicant stated that the
lifting direction of the Kiva implant is caudate and unidirectional.
According to the applicant, in the KAST (Kiva Safety and Effectiveness
Trial) pivotal study, it was reported that osteoporotic VCF patients
treated with the Kiva[supreg] system had an average of 2.6 coils
deployed.\39\ Additionally, in a biomechanical comparison conducted for
the Kiva[supreg] system and BKP using a loading cycle of 200-500
Newtons in osteoporotic human cadaver spine segments filled with bone
cement, there were no statistically significant differences observed
between the two procedures for VB height restoration, stiffness at high
or low loads, or displacement under compression.\40\
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\39\ Tutton S et al. KAST Study: The Kiva system as a vertebral
augmentation treatment--a safety and effectiveness trial: A
randomized, noninferiority trial comparing the Kiva system with
balloon kyphoplasty in treatment of osteoporotic vertebral
compression fractures. Spine. 2015; 40(12):865-875.
\40\ Wilson D et al. An ex vivo biomechanical comparison of a
novel vertebral compression fracture treatment system to
kyphoplasty. Clinical Biomechanics. 2012; 27(4):346-353.
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The applicant summarized the differences and similarities of the
SpineJack[supreg], BKP, and PEEK coiled implant as follows: (1) With
respect to construction, SpineJack[supreg] is made of Titanium-6-
Aluminum-4-Vanadium compared to thermoplastic polyurethanes for BKP and
nitinol and PEEK for the PEEK coiled implant; (2) with respect to
mechanism of action, the SpineJack[supreg] uses a locking scissor jack
encapsulated in PMMA bone cement compared to hydrodynamic cavity
creation and PMMA cavity filler for BKP and coil cavity creation and
PEEK implant filled with PMMA bone cement for the PEEK coiled implant;
(3) with respect to plastic deformation, SpineJack[supreg] and BKP
allow for plastic deformation while the PEEK coiled implant does not;
(4) with respect to craniocaudal expansion, SpineJack[supreg] allows
for craniocaudal expansion, whereas BKP and the PEEK coiled implant do
not; (5) with respect to bilateral load support, SpineJack[supreg]
provides bilateral load support whereas BKP and the PEEK coiled implant
do not; and (6) with respect to lift pressure of >500 N,
SpineJack[supreg] provides lift pressure of >500 N whereas BKP and the
PEEK coiled implant do not. The applicant summarized that the
SpineJack[supreg] system is uniquely constructed and utilizes a
different mechanism of action than BKP, which is the gold standard of
treatment for osteoporotic VCFs, and that the construction and
mechanism of action of the SpineJack[supreg] system is further
differentiated when compared with the PEEK coiled implant.
With respect to the newness criterion, the SpineJack[supreg]
Expansion Kit received FDA 510(k) clearance on August 30, 2018, based
on a determination of substantial equivalence to a legally
[[Page 86005]]
marketed predicate device. The applicant explained that although the
SpineJack[supreg] Expansion Kit received FDA 510(k) clearance on August
30, 2018, due to the time required to prepare for supply and
distribution channels, it was not available on the U.S. market until
October 2018. As we discussed previously, the SpineJack[supreg]
Expansion Kit is indicated for use in the reduction of painful
osteoporotic VCFs and is intended to be used in combination with
Stryker VertaPlex and VertaPlex High Viscosity (HV) bone cements. We
received the application for a new device category for transitional
pass-through payment status for the SpineJack[supreg] Expansion Kit on
February 4, 2020, which is within 3 years of the date of the initial
FDA marketing authorization. We solicited public comments on whether
the SpineJack[supreg] Expansion Kit meets the newness criterion.
Comment: The applicant reaffirmed that the SpineJack[supreg] system
meets the newness criteria as it received FDA 510(k) clearance on
August 30, 2018 and was commercially available in the United States on
October 11, 2018.
Response: We appreciate the commenter's input. After consideration
of the public comments we received and based on the fact that the
SpineJack[supreg] Expansion Kit application was received within 3 years
of FDA approval, we have determined that the SpineJack[supreg]
Expansion Kit meets the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the use of the SpineJack[supreg] Expansion
Kit is integral to the service of reducing painful osteoporotic
vertebral compression fractures (VCFs), is used for one patient only,
comes in contact with human skin, and is surgically implanted or
inserted into the patient. Specifically, the applicant explained that
the SpineJack[supreg] system is designed to be implanted into a
collapsed vertebral body (VB) via a percutaneous transpedicular
approach under fluoroscopic guidance. According to the applicant, the
implants remain within the VB with the delivered bone cement. The
applicant also claimed the SpineJack[supreg] Expansion Kit meets the
device eligibility requirements of Sec. 419.66(b)(4) because it is not
an instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service. We solicited public comments on
whether the SpineJack[supreg] Expansion Kit meets the eligibility
criteria at Sec. 419.66(b).
Comment: The applicant stated that the SpineJack[supreg] system
meets each of the device eligibility requirements at Sec. 419.66(b)(3)
for transitional pass-through payment under the OPPS as it is integral
to a service provided, and is not an instrument, apparatus, implement,
or item for which depreciation and financing expenses are recovered nor
is it a material or supply furnished incident to a service.
Response: We appreciate the comment's input. Based on the
information we have received and our review of the application, we have
determined that the SpineJack[supreg] system meets the eligibility
criteria at Sec. 419.66(b)(3) and (4).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. The
applicant describes the SpineJack[supreg] Expansion Kit as an
implantable fracture reduction system used to treat vertebral
compression fractures (VCFs). The applicant reported that it does not
believe that the SpineJack[supreg] Expansion Kit is described by an
existing category and requested category descriptor ``Vertebral body
height restoration device, scissor jack (implantable).'' We identified
one existing pass-through payment categories that may be applicable to
SpineJack[supreg] Expansion Kit. The SpineJack[supreg] Expansion Kit
may be described by HCPCS code C1821 (interspinous process distraction
device (implantable)). We solicited public comments on this issue.
Comment: In response to CMS' comment about whether
SpineJack[supreg] is described by an existing category, the applicant
stated that the SpineJack[supreg] system and implantable interspinous
process distraction devices are vastly different medical devices that
are distinguished by several attributes. According to the applicant,
where the SpineJack[supreg] system involves the insertion of two
bilateral expandable titanium implants into the vertebral body within
the anterior portion of the spinal column, the interspinous spacer uses
a single non-expandable device that is implanted between the spinous
processes of two adjacent veterbral bodies in the posterior portion of
the spinal column. The applicant further noted that the
SpineJack[supreg] system differs from interspinous spacers in terms of
the FDA submission type, the intended use, the mechanism of action, and
whether bone cement is used as a method of fixation. The applicant
reaffirmed their belief that the SpineJack[supreg] system meets the
requirement at Sec. 419.66(c)(1) that the device is not appropriately
described by any of the existing categories or by any category
previously in effect.
Response: We appreciate the additional information provided by the
applicant. After consideration of the public comments we received, we
believe there is no existing pass-through device category that
appropriately describes the SpineJack[supreg] system, due to the many
differences which exist between the predicate device and HCPCS code
C1821--interspinous process distraction device (implantable). Based on
this information, we believe that the SpineJack[supreg] system meets
the eligibility criterion at Sec. 419.66(c)(1).
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. With respect to the substantial
clinical improvement criterion, the applicant submitted 8 studies and
19 other references to support assertions that the treatment of
osteoporotic vertebral compression fracture (VCF) patients with the
SpineJack[supreg] system represents a substantial clinical improvement
over existing technologies because clinical research supports that it
reduces future interventions, hospitalizations, and physician visits
through a decrease in adjacent level fractures (ALFs), which the
applicant stated are clinically significant adverse events associated
with osteoporotic VCF. The applicant also stated that treatment with
the SpineJack[supreg] system greatly reduces pain scores and pain
medication use when compared to BKP, which the applicant stated is the
current gold standard in vertebral augmentation (VA) treatment.
The applicant explained that the SpineJack[supreg] system has been
available for the treatment of patients with osteoporotic VCFs for over
10 years in Europe. The applicant explained that, as
[[Page 86006]]
a result, the SpineJack[supreg] implant has been extensively studied,
and claims from smaller studies are supported by the results from a
recent, larger prospective, randomized study known as the SAKOS
(SpineJack[supreg] versus Kyphoplasty in Osteoporotic Patients) study.
The applicant cited the SAKOS study \41\ in support of multiple
substantial clinical improvement claims: Reduction in adjacent level
fractures, superiority in mid-vertebral body height restoration, and
pain relief. The applicant explained that the SAKOS study was the
pivotal trial conducted in support of the FDA 510(k) clearance for the
SpineJack[supreg] system and that the intent of the study was to
compare the safety and effectiveness of the SpineJack[supreg] system
with the KyphX Xpander Inflatable Bone Tamp (BKP) for treatment of
patients with painful osteoporotic VCFs in order to establish a non-
inferiority finding for use of the SpineJack[supreg] system versus
balloon kyphoplasty procedure (BKP).
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\41\ Noriega, D., et al., ``A prospective, international,
randomized, noninferiority study comparing an implantable titanium
vertebral augmentation device versus balloon kyphoplasty in the
reduction of vertebral compression fractures (SAKOS study),'' The
Spine Journal, 2019, vol. 19(11), pp. 1782-1795.
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The SAKOS study is a prospective, international, randomized, non-
inferiority study comparing a titanium implantable vertebral
augmentation device (TIVAD), the SpineJack[supreg] system, versus BKP
in the reduction of vertebral compression fractures with a 12-month
follow-up. The primary endpoint was a 12-month responder rate based on
a composite of three components: (1) Reduction in VCF fracture-related
pain at 12 months from baseline by >20 mm as measured by a 100-mm
Visual Analog Scale (VAS) measure; (2) maintenance or functional
improvement of the Oswestry Disability Index (ODI) score at 12 months
from baseline; and (3) absence of device-related adverse events or
symptomatic cement extravasation requiring surgical reintervention or
retreatment at the index level. If the primary composite endpoint was
successful, a fourth component (absence of ALF) was added to the three
primary components for further analysis. If the analysis of this
additional composite endpoint was successful, then midline target
height restoration at 6 and 12 months was assessed. According to the
applicant, freedom from ALFs and midline VB height restoration were two
additional superiority measures that were tested. According to the
SAKOS study, secondary clinical outcomes included changes from baseline
in back pain intensity, ODI score, EuroQol 5-domain (EQ-5D) index score
(to evaluate quality of life), EQ-VAS score, ambulatory status,
analgesic consumption, and length of hospital stay. Radiographic
endpoints included restoration of vertebral body height (mm), and Cobb
angle at each follow-up visit. Adverse events (AEs) were recorded
throughout the study period. The applicant explained that researchers
did not blind the treating physicians or patients, so each group was
aware of the treatment allocation prior to the procedure; however, the
three independent radiologists that performed the radiographic reviews
were blinded to the personal data of the patients, study timepoints,
and results of the study.
The SAKOS study recruited patients from 13 hospitals across 5
European countries and randomized 152 patients with osteoporotic
vertebral compression fractures (OVCFs) (1:1) to either
SpineJack[supreg] or BKP procedures. Specifically, patients were
considered eligible for inclusion if they met a number of criteria,
including: (1) At least 50 years of age; (2) had radiographic evidence
of one or two painful VCF between T7 and L4, aged less than 3 months,
due to osteoporosis; (3) fracture(s) that showed loss of height in the
anterior, middle, or posterior third of the VB >=15 percent but <=40
percent; and (4) patient failed conservative medical therapy, defined
as either having a VAS back pain score of >=50 mm at 6 weeks after
initiation of fracture care or a VAS pain score of >=70 percent mm at 2
weeks after initiation of fracture care. Eleven of the originally
recruited patients were subsequently excluded from surgery (9
randomized to SpineJack[supreg] and 2 to BKP). A total of 141 patients
underwent surgery, and 126 patients completed the 12-month follow-up
period (61 TIVAD and 65 BKP). The applicant contended that despite the
SAKOS study being completed outside the U.S., results are applicable to
the Medicare patient population, noting that 82 percent (116 of 141) of
the patients in the SAKOS trial that received treatment
(SpineJack[supreg] system or BKP) were age 65 or older. The applicant
explained further that the FDA evaluated the applicability of the SAKOS
clinical data to the U.S. population and FDA concluded that although
the SAKOS study was performed in Europe, the final study demographics
were very similar to what has been reported in the literature for U.S.-
based studies of BKP. The applicant also explained that FDA determined
that the data was acceptable for the SpineJack[supreg] system 510(k)
clearance, including two clinical superiority claims versus BKP.
The SAKOS study reported that analysis on the intent to treat
population using the observed case method resulted in a 12-month
responder rate of 89.8 percent and 87.3 percent, for SpineJack[supreg]
and BKP respectively (p=0.0016). The additional composite endpoint
analyzed in observed cases resulted in a higher responder rate for
SpineJack[supreg] compared to BKP at both 6 months (88.1 percent vs.
60.9 percent; p<0.0001) and 12 months (79.7 percent vs. 59.3 percent;
p<0.0001). Midline VB height restoration, tested for superiority using
a t test with one-sided 2.5 percent alpha in the ITT population, was
greater with SpineJack[supreg] than BKP at 6 months (1.14
2.61 mm vs 0.31 2.22 mm; p=0.0246) and at 12 months (1.31
2.58 mm vs. 0.10 2.23 mm; p=0.0035), with
similar results in the per protocol (PP) population.
Also, according to the SAKOS study, decrease in pain intensity
versus baseline was more pronounced in the SpineJack[supreg] group
compared to the BKP group at 1 month (p=0.029) and 6 months (p=0.021).
At 12 months, the difference in pain intensity was no longer
statistically significant between the groups, and pain intensity at 5
days post-surgery was not statistically different between the groups.
The SAKOS study publication also reported that at each timepoint, the
percentage of patients with reduction in pain intensity >20 mm was >=90
percent in the SpineJack[supreg] group and >=80 percent in the BKP
group, with a statistically significant difference in favor of
SpineJack[supreg] at 1-month post-procedure (93.8 percent vs 81.4
percent; p=0.03). The study also reported: (1) No statistically
significant difference in disability (ODI score) between groups during
the follow-up period, although there was a numerically greater
improvement in the SpineJack[supreg] group at most time points; (2) at
each time point, the percentage of patients with maintenance or
improvement in functional capacity was at or close to 100 percent; and
(3) in both groups, a clear and progressive improvement in quality of
life was observed throughout the 1-year follow-up period without any
statistically significant between-group differences.
In the SAKOS study, both groups had similar proportions of VCFs
with cement extravasation outside the treated VB (47.3 percent for
TIVAD, 41.0 percent for BKP; p=0.436). No symptoms of cement leakage
were reported. The SAKOS study also reported that the BKP group had a
rate
[[Page 86007]]
of adjacent fractures more than double the SpineJack[supreg] group
(27.3 percent vs. 12.9 percent; p=0.043). The SAKOS study also reported
that the BKP group had a rate of non-adjacent subsequent thoracic
fractures nearly 3 times higher than the SpineJack[supreg] group (21.9
percent vs. 7.4 percent) (a p-value was not reported for this result).
The most common AEs reported over the study period were back pain (11.8
percent with SpineJack[supreg], 9.6 percent with BKP), new lumbar
vertebral fractures (11.8 percent with SpineJack[supreg], 12.3 percent
with BKP), and new thoracic vertebral fractures (7.4 percent with
SpineJack[supreg], 21.9 percent with BKP). The most frequent SAEs were
lumbar vertebral fractures (8.8 percent with SpineJack[supreg]; 6.8
percent with BKP) and thoracic vertebral fractures (5.9 percent with
SpineJack[supreg], 9.6 percent with BKP). We also note that the length
of hospital stay (in days) for osteoporotic VCF patients treated in the
SAKOS trial was 3.8 3.6 days for the SpineJack[supreg]
group and 3.3 2.4 days for the BKP group (p=0.926,
Wilcoxon test).
The applicant also submitted additional studies, which are
described in more detail in this section, related to the applicant's
specific assertions regarding substantial clinical improvement.
As stated previously, the applicant stated that the
SpineJack[supreg] system represents a substantial clinical improvement
over existing technologies because it will reduce future interventions,
hospitalizations, and physician visits through a decrease in ALFs. The
applicant explained that ALFs are considered clinically significant
adverse events associated with osteoporotic VCFs, citing studies by
Lindsay et al.\42\ and Ross et al.\43\ The applicant explained that
these studies reported, respectively, that having one or more VCFs
(irrespective of bone density) led to a 5-fold increase in the
patient's risk of developing another vertebral fracture, and the
presence of two or more VCFs at baseline increased the risk of ALF by
12-fold. The applicant stated that analysis of the additional composite
endpoint in the SAKOS study demonstrated statistical superiority of the
SpineJack[supreg] system over BKP (p<0.0001) for freedom from ALFs at
both 6 months (88.1 percent vs. 60.9 percent) and 12 months (79.7
percent vs. 59.3 percent) post-procedure. The applicant noted that the
results were similar on both the intent to treat and PP patient
populations. In addition, the applicant stated the SpineJack[supreg]
system represents a substantial clinical improvement because in the
SAKOS study, compared to patients treated with the SpineJack[supreg]
system, BKP-treated patients had more than double the rate of ALFs
(27.3 percent vs. 12.9 percent; p=0.043) and almost triple the rate of
non-adjacent thoracic VCFs (21.9 percent vs. 7.4 percent).
---------------------------------------------------------------------------
\42\ Lindsay R. et al., ``Risk of new vertebral fracture in the
year following a fracture,'' Journal of the American Medical
Association, 2001, vol. 285(3), pp. 320-323.
\43\ Ross P. et al., Pre-existing fractures and bone mass
predict vertebral fracture incidence in women. Annals of Internal
Medicine. 1991, vol. 114(11), pp. 919-923.
---------------------------------------------------------------------------
The applicant also stated superiority with respect to mid-vertebral
body height restoration with the SpineJack[supreg] system. The
applicant explained that historical treatments of osteoporotic VCFs
have focused on anterior VB height restoration and kyphotic Cobb angle
correction; however, research indicates that the restoration of middle
VB height may be as important as Cobb angle correction in the
prevention of ALFs.\44\ According to the applicant, the depression of
the mid-vertebral endplate leads to decreased mechanics of the spinal
column by transferring the person's weight to the anterior wall of the
level adjacent to the fracture, and as a result the anterior wall is
the most common location for ALFs. The applicant further stated that by
restoring the entire fracture, including mid-VB height, the vertebral
disc above the superior vertebral endplate is re-pressurized and
transfers the load evenly, preventing ALFs.\45\ The applicant stated
that the SpineJack[supreg] system showed superiority over BKP with
regard to midline VB height restoration at both 6 and 12 months,
pointing to the SAKOS study results in the intent to treat population
at 6 months (1.14 2.61 mm vs 0.31 2.22 mm;
p=0.0246) and 12 months (1.31 2.58 mm vs. 0.10 2.23 mm; p=0.0035) post-procedure. The applicant noted that
similar results were also observed in the PP population (134 patients
in the intent-to-treat population without any major protocol
deviations).
---------------------------------------------------------------------------
\44\ Lin J et al. Better height restoration, greater kyphosis
correction, and fewer refractures of cemented vertebrae by using an
intravertebral reduction device: A 1-year follow-up study. World
Neurosurgery. 2016; 90:391-396.
\45\ Tzermiadianos M., et al., ``Altered disc pressure profile
after an osteoporotic vertebral fracture is a risk factor for
adjacent vertebral body fracture,'' European Spine Journal, 2008,
vol. 17(11), pp. 1522-1530.
---------------------------------------------------------------------------
The applicant also provided two prospective studies, a
retrospective study, and two cadaveric studies in support of its
assertions regarding superior VB height restoration. The applicant
stated that in a prospective comparative study by Noriega D., et
al.,\46\ VB height restoration outcomes utilizing the SpineJack[supreg]
system were durable out to 3 years. This study was a safety and
clinical performance pilot that randomized 30 patients with painful
osteoporotic vertebral compression fractures to SpineJack[supreg]
(n=15) or BKP (n=15).\47\ Twenty-eight patients completed the 3-year
study (14 in each group). The clinical endpoints of analgesic
consumption, back pain intensity, ODI, and quality of life were
recorded preoperatively and through 36-months post-surgery.\48\ Spine
X-rays were also taken 48 hours prior to the procedure and at 5 days,
6, 12, and 36 months post-surgery.\49\ The applicant explained that
over the 3-year follow-up period, VB height restoration and kyphosis
correction was better compared to BKP, specifically that VB height
restoration and kyphotic correction was still evident at 36 months with
a greater mean correction of anterior VB height (10 13
percent vs 2 8 percent for BKP, p=0.007) and midline VB
height (10 11 percent vs 3 7 percent for BKP,
p=0.034), while there was a larger correction of the VB angle (-
4.97[deg] 5.06[deg] vs 0.42[deg] 3.43[deg];
p=0.003) for the SpineJack[supreg] group. The applicant stated that
this study shows superiority with regards to VB height restoration.
---------------------------------------------------------------------------
\46\ Noriega D., et al., ``Long-term safety and clinical
performance of kyphoplasty and SpineJack procedures in the treatment
of osteoporotic vertebral compression fractures: a pilot,
monocentric, investigator-initiated study,'' Osteoporosis
International, 2019, vol. 30, pp. 637-645.
\47\ Ibid.
\48\ Ibid.
\49\ Ibid.
---------------------------------------------------------------------------
The applicant stated that Arabmotlagh M., et al., also supported
superiority with regard to VB height restoration. Arabmotlagh M., et
al. reported an observational case series (with no comparison group) of
SpineJack[supreg]. They enrolled 42 patients with osteoporotic
vertebral compression fracture of the thoracolumbar, who were
considered for kyphoplasty, 31 of whom completed the clinical and
radiological evaluations up to 12 months after the procedure.\50\
According to materials provided by the applicant, the purpose of the
study was to evaluate the efficacy of kyphoplasty with the
SpineJack[supreg] system to correct the kyphotic deformity and to
analyze parameters affecting the restoration and maintenance of spinal
alignment. The
[[Page 86008]]
applicant explained that the mean VB height calculated prior to
fracture was 2.8 cm (standard deviation (SD) of 0.47), which decreased
to 1.5 cm (SD of 0.59) after the fracture. According to the applicant,
following the procedure performed with the SpineJack[supreg] device,
the VB height significantly increased to 1.9 cm (SD of 0.64; p<0.01),
but was reduced to 1.8 cm (SD of 0.61; p<0.01) at 12 months post-
procedure. We note that according to Arabmotlagh M., et al., these
results were specifically for mean anterior VB height. The study does
not appear to report results for midline VB height.\51\ The applicant
also stated that the mean kyphotic angle (KA) calculated prior to
fracture was -1[deg] (SD of 5.8), which increased to 13.4[deg] (SD of
8.1) after the fracture. The applicant also stated that following the
procedure performed with the SpineJack[supreg] device, KA significantly
decreased to 10.8[deg] (SD of 9.1; p<0.01); however, KA correction was
lost at 12 months post-procedure with an increase to 13.3[deg] (SD of
9.5; p<0.01).
---------------------------------------------------------------------------
\50\ Arabmotlagh M., et al., ``Radiological Evaluation of
Kyphoplasty With an Intravertebral Expander After Osteoporotic
Vertebral Fracture,'' Journal of Orthopaedic Research, 2018. Doi:
10.1002.jor.24180.
\51\ Arabmotlagh M., et al., ``Radiological Evaluation of
Kyphoplasty With an Intravertebral Expander After Osteoporotic
Vertebral Fracture,'' Journal of Orthopaedic Research, 2018. Doi:
10.1002.jor.24180.
---------------------------------------------------------------------------
The applicant provided a Lin et al., retrospective study of 75
patients that compared radiologic and clinical outcomes of kyphoplasty
with the SpineJack[supreg] system to vertebroplasty (VP) in treating
osteoporotic vertebral compression fractures to support its assertions
regarding superiority with regard to midline VB height restoration.\52\
The applicant stated that the radiologic outcomes from this study were:
(1) The mean KA and mean KA restoration were more efficient after
SpineJack[supreg] than VP at all time points (up to 1 year), except for
mean KA observed postoperatively at 1 week; and (2) the mean middle VB
heights and mean VB height restoration were more favorable after
SpineJack[supreg] than VP.\53\ We note that this study did not compare
the SpineJack[supreg] system to BKP, which the applicant stated is the
gold-standard in vertebral augmentation.
---------------------------------------------------------------------------
\52\ Lin J., et al., ``Better Height Restoration, Greater
Kyphosis Correction, and Fewer Refractures of Cemented Vertebrae by
Using an Intravertebral Reduction Device: A 1-Year Follow-up
Study,'' World Neurosurg. 2016, vol. 60, pp. 391-396.
\53\ Ibid.
---------------------------------------------------------------------------
In the two cadaveric studies, Kruger A., et al. (2013) and Kruger
A., et al. (2015), wedge compression fractures were created in human
cadaveric vertebrae by a material testing machine and the axial load
was increased until the height of the anterior edge of the VB was
reduced by 40 percent.\54\ The VBs were fixed in a clamp and loaded
with 100 N in a custom made device. In Kruger A., et al. (2013),
vertebral heights were measured at the anterior wall as well as in the
center of the vertebral bodies in the medial sagittal plane in 36 human
cadaveric vertebrae pre- and post-fracture as well as after treatment
and loading in (27 vertebrae were treated with SpineJack[supreg] with
different cement volumes (maximum, intermediate, and no cement), and 9
vertebrae were treated with BKP). In Kruger A., et al. (2015),
anterior, central, and posterior height as well as the Beck index were
measured in 24 vertebral bodies pre-fracture and post-fracture as well
as after treatment (12 treated with SpineJack[supreg] and twelve
treated with BKP). The applicant stated that Kruger A., et al. (2013)
showed superiority on VB height restoration and height maintenance, and
summarized that: (1) Height restoration was significantly better for
the SpineJack[supreg] group compared to BKP; (2) height maintenance was
dependent on the cement volume used; and (3) the group with the
SpineJack[supreg] without cement nevertheless showed better results in
height maintenance, yet the statistical significance could not be
demonstrated.\55\ The applicant stated that Kruger A., et al. (2015)
showed superiority on VB height restoration, because the height
restoration was significantly better in the SpineJack[supreg] group
compared with the BKP group. The applicant explained that the clinical
implications include a better restoration of the sagittal balance of
the spine and a reduction of the kyphotic deformity, which may relate
to clinical outcome and the biological healing process.\56\
---------------------------------------------------------------------------
\54\ Kruger A., et al., ``Height restoration and maintenance
after treating unstable osteoporotic vertebral compression fractures
by cement augmentation is dependent on the cement volume used,''
Clinical Biomechanics, 2013, vol. 28, pp. 725-730; and Kruger A., et
al., ``Height restoration of osteoporotic vertebral compression
fractures using different intervertebral reduction devices: A
cadaveric study,'' The Spine Journal, 2015, vol. 15, pp. 1092-1098.
\55\ Ibid.
\56\ Ibid.
---------------------------------------------------------------------------
The applicant also stated that use of the SpineJack[supreg] system
represents a substantial clinical improvement with respect to pain
relief. According to the applicant, pain is the first and most
prominent symptom associated with osteoporotic VCFs, which drives many
elderly patients to seek hospital treatment and negatively impacts on
their quality of life. The applicant provided the SAKOS randomized
controlled study, a prospective consecutive observational study, and a
retrospective case series to support its assertions regarding pain
relief with the SpineJack[supreg] system. The applicant cited the SAKOS
trial for statistically significant greater pain relief achieved at 1
month and 6 months after surgery with the SpineJack[supreg] system. The
applicant summarized that in the SAKOS trial: (1) Progressive
improvement in pain relief was observed over the follow-up period in
the SpineJack[supreg] system group only; (2) the decrease in pain
intensity versus baseline was more pronounced in the SpineJack[supreg]
system group compared to the BKP group at 1 month (p=0.029) and 6
months (p=0.021); and (3) at each time point, the percentage of
patients with reduced pain intensity >20 mm was >=90 percent in the
SpineJack[supreg] system group and >=80 percent in the BKP group, with
a statistically significant difference in favor of the
SpineJack[supreg] system at 1 month post-procedure (93.8 percent vs.
81.5 percent; p=0.030). The applicant also noted that although
continued pain score improvements were seen out to 1 year for patients
treated with the SpineJack[supreg] system, the difference between the
treatment groups did not meet statistical significance (p=0.061). The
applicant also explained that in the SAKOS study, at 5 days after
surgery, there were significantly fewer patients taking central
analgesic agent medications in the SpineJack[supreg] implant-treated
group as compared to those in the BKP-treated group (SJ 7.4 percent vs.
BKP 21.9 percent, p=0.015). According to the applicant, central
analgesic agents included medications such as non-steroidal anti-
inflammatory drugs (NSAIDS), salicylates, or opioid analgesics.
The applicant also cited a prospective consecutive observational
study by Noriega D., et al. for statistically significant pain relief
immediately after surgery and at both 6 and 12 months. Noriega D., et
al. was a European multicenter, single-arm registry study that aimed to
confirm the safety and clinical performance of the SpineJack[supreg]
system for the treatment of vertebral compression fractures of
traumatic origin (no comparison procedure).\57\ The study enrolled 103
patients (median age: 61.6 years) with 108 VCFs due to trauma (n=81),
or traumatic VCF with associated osteoporosis (n=22) who had a
SpineJack[supreg] procedure. Twenty-three patients withdrew from the
study before
[[Page 86009]]
the 12-month visit. The study reported a significant improvement in
back pain at 48 hours after SpineJack[supreg] procedure, with the mean
VAS pain score decreasing from 6.6 2.6 cm at baseline to
1.4 1.3 cm (mean change: -5.2 2.7 cm;
p<0.001) (median relative decrease in pain intensity of 81.5 percent)
for the total study population. Noriega D., et al. also reported that
the improvement was maintained over the 12-month follow-up period and
similar results were observed with both pure traumatic VCF and
traumatic VCF in patients with osteoporosis. The traumatic VCF with
osteoporosis sub-group had a mean change of -5.5 (SD=1.9) (median
relative change of 81.0 percent) (p<0.001) at 48 hours post-surgery
(n=22), and -5.7 (SD=2.3) mean change (90.3 percent median relative
change) (p<0.001) at 12 months (n=16). The applicant stated that this
study supported a claim of statistically significant pain relief
immediately after surgery and at both 6 and 12 months. The applicant
summarized that (1) pain relief and improvements in pain scores were
statistically significant immediately after treatment (48-72 hours) and
at 6 and 12 months following surgery (p<0.001); and (2) the mean
improvement between baseline and at 48-72 hours after the procedure
(n=31) was -4.6 (2.6) (p<0.001), while the mean improvement between
baseline and at the 12-month follow-up (n=22) was -6.0 (3.4) (p<0.001).
We note that Noriega D., et al. did not report results for 6 months
(although it does include results for 3 months versus baseline) and
does not include the results of mean improvement stated by the
applicant.\58\ It is also unclear if the applicant intended to rely on
the overall results of the study or the subgroup of traumatic VCF with
osteoporosis.
---------------------------------------------------------------------------
\57\ Noriega D., et al., ``Clinical performance and safety of
108 SpineJack implantations: 1-year results of a prospective
multicentre single arm registry study.'' BioMed Research
International. 2015, 173872.
\58\ Ibid.
---------------------------------------------------------------------------
The applicant also cited a retrospective case series, Renaud C., et
al., for statistically significant pain relief after surgery with the
SpineJack[supreg] system. Renaud C., et al., included 77 patients with
a mean age of 60.9 years and 83 VCFs (51 due to trauma and 32 to
osteoporosis) treated with 164 SpineJack[supreg] devices (no comparison
procedure).\59\ The applicant summarized that: (1) Pain relief was
statistically significant (p<0.001), with a pain score decrease from
7.9 pre-operatively to 1.8 at 1 month after the procedure; (2) the pain
score improvement was 77 percent at hospital discharge and gradually
increased to 86 percent after 1 year following surgery; and (3) the
study outcomes demonstrated that the SpineJack[supreg] system provided
both immediate and long-lasting pain relief.
---------------------------------------------------------------------------
\59\ Renaud C., ``Treatment of vertebral compression fractures
with the cranio-caudal expandable implant SpineJack: Technical note
and outcomes in 77 consecutive patients.'' Orthopaedics &
Traumatology: Surgery & Research, 2015, vol. 101, pp. 857-859.
---------------------------------------------------------------------------
As we stated in the CY 2021 OPPS/ASC proposed rule (85 FR 48861),
the results of the SAKOS trial did not appear to have been corroborated
in any other randomized controlled study. Additionally, although the
applicant stated that BKP is the gold standard in VA, there appeared to
be a lack of data comparing the SpineJack[supreg] system to other
existing technology, such as the PEEK coiled implant (Kiva[supreg]
system), particularly since the PEEK coiled system was considered the
predicate device for the SpineJack 510(k). Furthermore, there appeared
to be a lack of data comparing the SpineJack[supreg] system to
conservative medical therapy. We noted that there was an active study
posted on clinicaltrials.gov comparing SpineJack[supreg] system to
conservative orthopedic management consisting of brace and pain
medication in acute stable traumatic vertebral fractures in subjects
aged 18 to 60 years old. The clinicaltrials.gov entry indicated that
findings should be forthcoming in 2020. Additionally, we noted that the
recent systematic reviews of the management of vertebral compression
fracture (Buchbinder et al. for Cochrane (2018), Ebeling et al. (2019)
for the American Society for Bone and Mineral Research (ASBMR)), did
not support vertebral augmentation procedures due to lack of evidence
compared to conservative medical management.\60\ The ASBMR recommended
more rigorous study of treatment options including ``larger sample
sizes, inclusion of a placebo control and more data on serious AEs
(adverse events).''
---------------------------------------------------------------------------
\60\ Buchbinder R., Johnston R.V., Rischin K.J., Homik J., Jones
C.A., Golmohammadi K., Kallmes D.F., ``Percutaneous vertebroplasty
for osteoporotic vertebral compression fracture,'' Cochrane Database
Syst Rev. 2018 Apr 4 and Nov 6. PMID: 29618171; Ebeling P.R.,
Akesson K., Bauer D.C., Buchbinder R., Eastell R., Fink H.A.,
Giangregorio L., Guanabens N., Kado D., Kallmes D., Katzman W.,
Rodriguez A., Wermers R., Wilson H.A., Bouxsein M.L., ``The Efficacy
and Safety of Vertebral Augmentation: A Second ASBMR Task Force
Report.'' J Bone Miner Res., 2019, vol. 34(1), pp. 3-21.
---------------------------------------------------------------------------
We solicited public comment on whether the SpineJack[supreg] system
meets the substantial clinical improvement criterion.
Comment: Many commenters expressed their support for approval of
the SpineJack[supreg] system for device pass-through status. Many of
these commenters shared their academic knowledge of and first-hand
clinical experience with vertebral augmentation procedures, including
claims of familiarity and expertise with the use of the Kiva[supreg]
system, BKP and the SpineJack[supreg] system. According to many of
these commenters, the SpineJack[supreg] system provides a significant
benefit beyond that which is achieved by other vertebral augmentation
technology. Many commenters also indicated that the price compared to
the reimbursement rate has been an impediment to use of the
SpineJack[supreg] system in some cases. Finally, several of these
commenters expressed their belief that the SpineJack[supreg] system may
reduce costs to hospitals and the U.S. health system overall by
preventing the onset of additional adjacent fractures in patients.
The applicant and multiple commenters disagreed with CMS' concern
that recent systematic reviews of the management of vertebral
compression fracture do not support vertebral augmentation procedures
according to the ASBMR, which also suggested more rigorous study of
treatment options. The applicant stated that the latest clinical
evidence and a policy statement from the International Society for the
Advancement of Spine Surgery (ISASS) provide robust support for the use
of vertebral augmentation (VA) over non-surgical management (NSM) in
the treatment of osteoporotic vertebral compression fractures. Another
commenter disagreed with CMS' interpretation of the ASBMR report and
emphasized that the study found kyphoplasty was associated with
significantly more reduction in pain, more reduction in RMDQ scale, and
improvement in quality of life as compared to nonsurgical management;
the commenter concluded that it is not accurate to group kyphoplasty
with vertebroplasty data.
The applicant referenced a systematic review and meta-analysis of
25 prospective studies, which found that patients treated with balloon
kyphoplasty and vertebroplasty had greater pain reduction that those
treated with non-surgical management. Further, the applicant stated
that the most compelling evidence for the use of vertebral augmentation
in the treatment of osteoporotic VCF patients comes from the recently
published Local Coverage Determination (LCD) on Percutaneous Vertebral
Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture by
the seven regional MACs, which currently appear in either a proposed or
final state.
The applicant and commenters also responded to CMS' concern that
the
[[Page 86010]]
SAKOS trial results do not appear to be corroborated in any other
randomized controlled study. Commenters stated it is unfair of CMS to
require results from multiple randomized control trials (RCTs) because
these studies take a large amount of time and resources to conduct,
which is at odds with the characteristics inherent in applicants for
device pass-through payment status given the newness criterion
requiring FDA approval within three years of application. The applicant
stated that multiple RCTs are often not conducted to corroborate level
one evidence that has been published in journals. They added that there
are a minimum of 16 journal articles that highlight the clinical
benefit that the SpineJack[supreg] system provides to patients.
In response to CMS' concern that SpineJack[supreg] was not compared
to the PEEK coiled implant, the applicant and multiple commenters
stated that the PEEK coiled system has not demonstrated clinical
superiority to BKP, which is the gold standard treatment for
osteoporotic VCFs. Commenters added that the PEEK coiled implants are
not widely used in the United States because of the very limited scope
of use, the high price, and the difficulty of use as compared to other
procedures.
In response to CMS' concern that the SpineJack[supreg] system was
not compared to conservative medical therapy, many commenters and the
applicant stated that this comparison would be inappropriate primarily
because of the large body of research showing improvements for patients
who receive treatment for VCFs with VA as opposed to NSM. One commenter
stated that there is a subset of patients who suffer compression
fractures for which no vertebral augmentation is advised but these
patients would not currently receive balloon kyphoplasty nor would they
likely receive treatment with the SpineJack[supreg] system. The
applicant stated that there is clinical evidence showing improved
outcomes for patients with VCFs treated with BKP as compared to NSM.
The applicant concluded that based upon the body of evidence available,
the use of NSM as a comparator treatment to the SpineJack[supreg]
system for a new clinical study would not be in the best interest of
osteoporotic VCF patients, primarily due to the increased risk of
morbidity and mortality that has been reported in this patient
population, particularly among the elderly. Lastly the applicant stated
that the SpineJack[supreg] system is not indicated for use in the
treatment of traumatic vertebral fractures in the United States.
In regard to CMS' statement that a study by Lin et al. did not
compare the SpineJack[supreg] system to BKP, the applicant agreed and
added that the publication provides further support of the claim for
superior mid-vertebral body height restoration with the
SpineJack[supreg] system as compared to other treatment options such as
vertebroplasty, which the applicant asserted continue to be widely
performed in Medicare patients.
In regard to CMS' statement that findings from the Arabmotlagh M.
et al. study did not report results for midline VB height, the
applicant stated that the publication shows that it is possible to
achieve anterior VB height restoration with the SpineJack[supreg]
system in addition to midline VB height restoration demonstrated in the
SAKOS trial.
In response to CMS' assertion that the Noriega et al. article did
not report results for six months and does not include results of mean
improvement as stated by the applicant, the applicant stated that they
would like to correct an error in their application attachment for the
2015 Noriega et al. publication. The data presented in their
application reflects findings from another citation \61\ in which the
overall improvements in visual analog scale back pain scores were
statistically significant at multiple time points.
---------------------------------------------------------------------------
\61\ Noriega D et al. Long-term safety and clinical performance
of kyphoplasty and SpineJack procedures in the treatment of
osteoporotic vertebral compression fractures: A pilot, monocentric,
investigator-initiated study. Osteoporosis International. 2019;
30:637-645.
---------------------------------------------------------------------------
Lastly, the applicant supplied minor corrections regarding the
SAKOS study results. Specifically the applicant stated that for the
midline VB height restoration reported at 12 months post-procedure for
the SpineJack[supreg] system compared to BKP in the SAKOS trial, an
error in the standard deviation value for the BKP data is reported in
the CY 2021 OPPS/ASC proposed rule. The applicant stated that this
value should be revised to 2.34 mm rather than the 2.23 mm reported
previously.
One commenter, a manufacturer of BKP implants, criticized the
evidence the applicant submitted to support its position that the
SpineJack[supreg] system meets the substantial clinical improvement
criterion. The commenter emphasized that although the applicant cited
the SAKOS study as the basis for concluding that the SpineJack[supreg]
system meets the substantial clinical improvement criterion, the SAKOS
study compared the SpineJack[supreg] system to older BKP technology
(KyphX), rather than to the most current BKP technology available at
the time of the study (Xpander II and Express II). According to the
commenter, these newer generation balloons have been available since
2011, generate lift force in excess of 1200 Newtons, and are the only
BKP products indicated for the cement resistance technique, whereby one
bone tamp is left in place during cement injection and curing to
maximize height restoration in a collapsed vertebral body. The
commenter stated that BKP does offer craniocaudal expansion while
creating a void for safer cement fill. Furthermore, with respect to
bilateral load support, according to the commenter, BKP has been
offered since 1998 as a bilateral procedure option to maximize lift
potential and reduce stress exerted on endplates. The commenter went on
to explain that BKP provides bilateral symmetric load support to
fractured endplates by providing a larger surface area when restoring
height. The commenter suggested that if the SAKOS study had compared
the SpineJack[supreg] system to these second-generation BKP implants,
then the SpineJack[supreg] system might not have demonstrated superior
performance on secondary outcome measures.
The commenter also offered several additional criticisms of the
SAKOS study. The commenter pointed out that the SAKOS study design did
not involve an even distribution of the spine levels treated across
study arms, and that it is possible that a difference in the levels
treated could have contributed to the reduction of ALFs in the
SpineJack[supreg] system group. The commenter asserted that the
vertebral levels T11-L1 are commonly known for higher number of
fractures, and that these spinal segments had 14 more levels treated
with BKP than with the SpineJack[supreg] system in the SAKOS study.
According to the commenter, further analysis would be needed to
determine if the location of fractures had an effect on the occurrence
of ALFs between the two study arms in SAKOS. The commenter also pointed
out that it was unclear whether there was any difference in the two
treatment groups' bone density metrics, as this was not disclosed in
the SAKOS study.
The commenter went on to emphasize that the clinical comparison in
the SAKOS study demonstrated the SpineJack[supreg] system was non-
inferior to BKP at the time of the primary endpoint (12 months);
however, there was no significant difference between groups in pain
intensity visual analog scale (VAS) score at the final time point, and
no difference in Oswestry Disability Index (ODI) or the EQ-5D health
status questionnaire at any time point during the study. The commenter
acknowledged that SAKOS
[[Page 86011]]
demonstrated superiority for the SpineJack[supreg] system for mid-
vertebral height restoration, but emphasized that measures of anterior
height, posterior height, and cobb angle showed no difference across
the study arms, within the secondary endpoints. The commenter also
observed that the SAKOS study showed a similar number of adverse events
between study arms, with the SpineJack[supreg] system population seeing
a higher percentage of serious adverse events.
Finally, the commenter disputed the applicant's assertion that
vertebral augmentation treatment with vertebroplasty may alleviate
pain, but cannot restore vertebral body height or correct spinal
deformity. The commenter likewise disputed the applicant's assertion
that BKP attempts to restore vertebral body height, but the temporary
correction obtained cannot be sustained over the long-term. In
countering the applicant's assertions, the commenter referenced three
published articles with empirical evidence regarding the impact of BKP
on kyphotic angle and VB height restoration.62 63 64 Lastly
the commenter stated that any mortality benefits have only been studies
for BKP and vertebroplasty and not for SpineJack[supreg]. According to
the commenter, it is therefore not appropriate to use this information
to demonstrate the mortality benefits from using the SpineJack[supreg]
technology.
---------------------------------------------------------------------------
\62\ Van Meirhaeghe JV, et al. 2013; 38(12): 971-983.
\63\ Dohm M, et al. 2014. (24 Months), Am J Neuroradiol.
2014;35:2227-2236.
\64\ Bozkurt M, et al. 2014. Asian Spine J. 2014; 8(1):27-34.
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Response: We appreciate all the comments we received related to the
SpineJack[supreg] system, and we have taken them into consideration in
making our determination, including the applicant's submission of
additional information to address the concerns presented in the CY 2021
OPPS/ASC proposed rule and the comments expressing concerns with the
design and results of the SAKOS study.
After consideration of the public comments received, we believe
that commenters have addressed our concerns regarding whether the
SpineJack[supreg] system meets the substantial clinical improvement
criterion and that the SpineJack[supreg] system represents a
substantial clinical improvement over existing technologies based on
the data received from commenters. The data provided from the
commenters with clinical experience with vertebral augmentation
procedures and the SpineJack[supreg] system, which included improved
pain, VB height restoration and ALF outcomes for patients with
osteoporotic VCFs when compared with existing treatments, demonstrates
substantial clinical improvement.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that the
SpineJack[supreg] system would be reported with CPT code 22513, which
is assigned to APC 5114 (Level 4 Musculoskeletal Procedures). To meet
the cost criterion for device pass-through payment status, a device
must pass all three tests of the cost criterion for at least one APC.
For our calculations, we used APC 5114, which has a CY 2019 payment
rate of $5,891.95. Beginning in CY 2017, we calculated the device
offset amount at the HCPCS/CPT code level instead of the APC level (81
FR 79657). CPT code 22513 had a device offset amount of $1,127 at the
time the application was received. According to the applicant, the cost
of the SpineJack[supreg] system is $5,623.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $5,622.64 for the SpineJack[supreg] system
is 94 percent of the applicable APC payment amount for the service
related to the category of devices of SpineJack[supreg] system
(($5,622.64/$5,981.28) x 100 = 94 percent). Therefore, we believe the
SpineJack[supreg] system meets the first cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $5,622.64 for
the SpineJack[supreg] system is 499 percent of the cost of the device-
related portion of the APC payment amount for the related service of
$1,126.87(($5,622.64/$1,126.87) x 100 = 499 percent). Therefore, we
believe that the SpineJack[supreg] system meets the second cost
significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $5,622.64 for the SpineJack[supreg] system and the
portion of the APC payment amount for the device of $1,126.87 is 75
percent of the APC payment amount for the related service of $5,987.28
(($5,622.64-$1,126.87)/$5,981.28) = 75.2 percent). Therefore, we
believe that the SpineJack[supreg] Expansion Kit meets the third cost
significance requirement.
We solicited public comment on whether the SpineJack[supreg]
Expansion Kit meets the device pass-through payment criteria discussed
in this section, including the cost criterion.
Comment: The applicant agreed with CMS' conclusion that the
SpineJack[supreg] system meets all three of the cost significance
requirements for establishing a device pass-through category as
described in Sec. 419.66(d).
Response: We appreciate the applicant's input.
After consideration of the public comments we received, we have
determined that the SpineJack[supreg] Expansion Kit qualifies for
device pass-through payment status and we are approving the application
for device pass-through payment status for the SpineJack[supreg]
Expansion Kit beginning in CY 2021.
3. Technical Clarification to the Alternative Pathway to the OPPS
Device Pass-Through Substantial Clinical Improvement Criterion for
Certain Transformative New Devices
As described previously, in the CY 2020 annual rulemaking process,
we finalized an alternative pathway for devices that receive Food and
Drug Administration (FDA) marketing authorization and are granted a
Breakthrough Device designation (84 FR 61295 through 61297). Under this
alternative pathway, devices that are granted an FDA Breakthrough
Device designation are not evaluated in terms of the current
substantial clinical improvement criterion at Sec. 419.66(c)(2) for
purposes of determining device pass-through payment status, but will
need to meet the other requirements for pass-through payment status in
our regulation at Sec. 419.66. Similarly, in the FY 2020 IPPS/LTCH PPS
final rule, we finalized an alternative pathway for new
[[Page 86012]]
technology add-on payments for certain transformative new devices.
Under the existing regulations at Sec. 412.87(c), to be eligible for
approval for IPPS new technology add-on payments under this alternative
pathway, the device must be part of the FDA's Breakthrough Devices
Program and have received FDA marketing authorization.
We have received questions from the public regarding CMS's intent
with respect to the ``marketing authorization'' required for purposes
of approval under the alternative pathway for certain transformative
new devices at Sec. 412.87(c). Some of the public appear to assert
that so long as a technology has received marketing authorization for
any indication, even if that indication differs from the indication for
which the technology was designated by FDA as part of the Breakthrough
Devices Program, the technology would meet the marketing authorization
requirement at Sec. 412.87(c). Because of this potential confusion, we
clarified in the FY 2021 IPPS/LTCH PPS proposed rule that an applicant
cannot combine a marketing authorization for an indication that differs
from the technology's indication under the Breakthrough Device Program,
and for which the applicant is seeking to qualify for the new
technology add-on payment, for purposes of approval under the
alternative pathway for certain transformative devices (85 FR 32692).
We clarified in the CY 2021 OPPS/ASC proposed rule that the same
policy applies for purposes of the OPPS alternative pathway policy.
Specifically, we clarified that under the OPPS, in order to be eligible
for the alternative pathway, the device must receive marketing
authorization for the indication covered by the Breakthrough Devices
Program designation and we are making a conforming change to the
regulations at Sec. 419.66(c)(2). We also noted that the transitional
pass-through payment application for the device must be received within
2 to 3 years of the initial FDA marketing authorization (or a
verifiable market delay) for the device for the indication covered by
the Breakthrough Devices Program designation.
In summary, in the CY 2021 OPPS/ASC proposed rule, we proposed to
amend the regulations in Sec. 419.66(c)(2)(ii) to state that ``A new
medical device is part of the FDA's Breakthrough Devices Program and
has received marketing authorization for the indication covered by the
Breakthrough Device designation.''
We did not receive any comments regarding the technical
clarification outlined in the CY 2021 OPPS/ASC proposed rule that in
order to be eligible for the alternative pathway to the OPPS device
pass-through substantial clinical improvement criterion, the device
must receive marketing authorization for the indication covered by the
Breakthrough Devices Program designation. Therefore we are finalizing
our proposal to amend the regulations in Sec. 419.66(c)(2)(ii) to
provide that ``a new medical device is part of the FDA's Breakthrough
Devices Program and has received marketing authorization for the
indication covered by the Breakthrough Device designation.''
4. Comment Solicitation on Continuing To Provide Separate Payment in
CYs 2022 and Future Years for Devices With OPPS Device Pass-Through
Payment Status During the COVID-19 Public Health Emergency (PHE)
In the CY 2021 OPPS/ASC proposed rule, we solicited comments on
whether we should adjust future payments for devices currently eligible
to receive transitional pass-through payments that may have been
impacted by the PHE, and if so, how we should implement that adjustment
and for how long the adjustment should apply. On January 31, 2020, HHS
Secretary Azar determined that a PHE exists retroactive to January 27,
2020 \65\ under section 319 of the Public Health Service Act (42 U.S.C.
247d) in response to COVID-19, and on April 21, 2020 Secretary Azar
renewed, effective April 26, 2020 and again effective July 25, 2020,
the determination that a PHE exists.\66\ On March 13, 2020, the
President of the United States declared that the COVID-19 outbreak in
the U.S. constitutes a national emergency,\67\ retroactive to March 1,
2020. Due to the PHE, we received multiple inquiries from stakeholders
regarding potential adjustments to the pass-through payment for devices
with OPPS transitional pass-through payment status that may be impacted
by the PHE. According to stakeholders, healthcare resources have been
triaged to assist in the COVID-19 pandemic response effort, which has
reduced utilization for devices receiving transitional pass-through
payment, particularly for devices used in services that could be
considered elective. Stakeholders cited the CMS recommendations issued
on March 18, 2020 to postpone elective surgeries due to the COVID-19
PHE.\68\ Stakeholders claim that devices on pass-through status are
frequently used during such elective procedures, and that CMS's ability
to calculate appropriate payment for services that include these
devices once the devices transition off of pass-through status could be
hindered by a reduction in claims being submitted with these devices
during the PHE.
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\65\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\66\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx.
\67\ https://www.whitehouse.gov/presidentialactions/proclamation-declaring-nationalemergency-concerning-novel-coronavirus-diseasecovid-19-outbreak/.
\68\ https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental.
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Transitional pass-through payment for devices is described in
section 1833(t)(6) of the Act. It is intended as an interim measure to
allow for adequate payment of new innovative technology while we
collect the necessary data to incorporate the costs for these items
into the procedure APC rate (66 FR 55861). As previously stated,
transitional pass-through payments for devices can be made for a period
of at least 2 years, but not more than 3 years, beginning on the first
date on which pass-through payment was made for the device.
In response to stakeholder concerns regarding reduced utilization
of procedures that include pass-through devices during the PHE, we
specifically requested public comment on utilizing our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to provide
separate payment for some period of time after pass-through status ends
for these devices in order to account for the period of time that
utilization for the devices was reduced due to the PHE. Any rulemaking
on this issue in response to this comment solicitation would be
included in the CY 2022 OPPS/ASC proposed rule and would consider the
impact of the PHE on devices with OPPS device pass-through payment
status during the PHE. Note that OPPS device pass-through payment
status generally lasts 3 years, and none of the devices with less than
3 years of pass-through payment status at the start of the PHE have
pass-through payment status set to end before December 31, 2021.
The following is summary of the comments we received and our
responses to those comments.
Comment: Several commenters submitted comments in support of CMS'
comment solicitation on continuing to provide separate payment in CYs
2022 and future years for devices with OPPS device pass-through payment
status during the COVID-19 Public Health Emergency (PHE). All
commenters who supported CMS' comment solicitation stated that the
COVID-19 PHE has
[[Page 86013]]
negatively affected items currently receiving pass-through payment. Two
commenters stated that CMS has the authority to make an equitable
adjustment to provide additional time for items to receive pass-through
payments to account for reduced utilization during the PHE. Multiple
commenters stated that the pass-through payment extension should be
equal to the duration of the PHE with one commenter adding that it
should start immediately after the later of the expiration of the
item's pass-through status or the expiration of the emergency period.
One commenter stated that CMS should provide, specific to each pass-
through item, an adjustment to begin on January 1, 2021, and provide
for a period of continued pass-through payment, rounded up to the
nearest quarter, for which the item's pass-through period coincided
with the PHE. Lastly, one commenter stated that CMS should allow pass-
through periods for devices, drugs or biologicals adversely impacted by
the PHE to be extended, if any extension does not apply to devices,
drugs or biologicals that already had 3 years or more of pass-through
status when the PHE began. One applicant, as well as offering support
for this proposal, added a request that CMS share the operational
details of its policy by the end of CY 2020 rather than waiting for the
CY 2022 rulemaking cycle to facilitate planning.
Response: We appreciate the commenters' support and will take the
information submitted into consideration for future rulemaking.
Comment: Some commenters stated that CMS should not limit the
extension of pass-through payments to devices, but should also extend
pass-through payments for drugs. One commenter stated that drugs should
be subject to this policy because, like pass-through devices, the
commenter believed pass-through drugs likely had reduced utilization
from the PHE. A second commenter stated that there is no principled
reason to limit any COVID-19 related pass-through adjustment to devices
only; adding that it is a basic principle of administrative law that
agencies must treat ``similarly situated'' entities ``similarly'' and
there is no logical basis for treating pass-through devices used in
outpatient settings differently than pass-through drugs used in
outpatient settings. Two commenters stated that CMS should extend the
pass-through period to radiopharmaceuticals in addition to medical
devices, stating that the COVID-19 PHE has negatively affected their
utilization as it has for devices.
One commenter, who supported an extension for pass-through devices,
stated that most drugs, biologicals, and biosimilar biological products
continue to be separately paid after their pass-through period expires
such that prior year claims data do not impact their treatment under
OPPS. For such products, the commenter stated that it would not be
necessary or appropriate to use the equitable adjustment authority to
adjust payment. A second commenter recommended that the products that
received extended pass-through payments under section 1833(t)(6)(G) of
the Act, as added by section 1301(a)(1)(C) of the Consolidated
Appropriations Act of 2018, should not receive an additional extension
of pass-through status due to the PHE as these products have already
had more than the required 3 years of pass-through payments. The
commenter added that extending pass-through payments for these products
would needlessly increase cost to taxpayers and would be contradictory
to the administration's efforts to reduce the cost of prescription
drugs.
Response: We did not solicit comments on extending pass-through
payments for drugs, however, we will consider the commenters' points
for potential future rulemaking.
We thank the commenters for their submissions and will consider
their input when determining whether a change is warranted in response
to the PHE as we develop the 2022 OPPS/ASC proposed rule.
B. Device-Intensive Procedures
1. Background
Under the OPPS, prior to CY 2017, device-intensive status for
procedures was determined at the APC level for APCs with a device
offset percentage greater than 40 percent (79 FR 66795). Beginning in
CY 2017, CMS began determining device-intensive status at the HCPCS
code level. In assigning device-intensive status to an APC prior to CY
2017, the device costs of all the procedures within the APC were
calculated and the geometric mean device offset of all of the
procedures had to exceed 40 percent. Almost all of the procedures
assigned to device-intensive APCs utilized devices, and the device
costs for the associated HCPCS codes exceeded the 40-percent threshold.
The no cost/full credit and partial credit device policy (79 FR 66872
through 66873) applies to device-intensive APCs and is discussed in
detail in section IV.B.4. of the CY 2021 OPPS/ASC proposed rule. A
related device policy was the requirement that certain procedures
assigned to device-intensive APCs require the reporting of a device
code on the claim (80 FR 70422). For further background information on
the device-intensive APC policy, we refer readers to the CY 2016 OPPS/
ASC final rule with comment period (80 FR 70421 through 70426).
a. HCPCS Code-Level Device-Intensive Determination
As stated earlier, prior to CY 2017, the device-intensive
methodology assigned device-intensive status to all procedures
requiring the implantation of a device that were assigned to an APC
with a device offset greater than 40 percent and, beginning in CY 2015,
that met the three criteria listed below. Historically, the device-
intensive designation was at the APC level and applied to the
applicable procedures within that APC. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79658), we changed our methodology to
assign device-intensive status at the individual HCPCS code level
rather than at the APC level. Under this policy, a procedure could be
assigned device-intensive status regardless of its APC assignment, and
device-intensive APCs were no longer applied under the OPPS or the ASC
payment system.
We believe that a HCPCS code-level device offset is, in most cases,
a better representation of a procedure's device cost than an APC-wide
average device offset based on the average device offset of all of the
procedures assigned to an APC. Unlike a device offset calculated at the
APC level, which is a weighted average offset for all devices used in
all of the procedures assigned to an APC, a HCPCS code-level device
offset is calculated using only claims for a single HCPCS code. We
believe that this methodological change results in a more accurate
representation of the cost attributable to implantation of a high-cost
device, which ensures consistent device-intensive designation of
procedures with a significant device cost. Further, we believe a HCPCS
code-level device offset removes inappropriate device-intensive status
for procedures without a significant device cost that are granted such
status because of APC assignment.
Under our existing policy, procedures that meet the criteria listed
in section IV.B.1.b. of the CY 2021 OPPS/ASC proposed rule are
identified as device-intensive procedures and are subject to all the
policies applicable to procedures assigned device-intensive status
under our established methodology, including our policies on device
edits and no cost/full credit and partial credit devices discussed in
sections IV.B.3. and IV.B.4.
[[Page 86014]]
of the CY 2021 OPPS/ASC proposed rule, respectively.
b. Use of the Three Criteria To Designate Device-Intensive Procedures
We clarified our established policy in the CY 2018 OPPS/ASC final
rule with comment period (82 FR 52474), where we explained that device-
intensive procedures require the implantation of a device and
additionally are subject to the following criteria:
All procedures must involve implantable devices that would
be reported if device insertion procedures were performed;
The required devices must be surgically inserted or
implanted devices that remain in the patient's body after the
conclusion of the procedure (at least temporarily); and
The device offset amount must be significant, which is
defined as exceeding 40 percent of the procedure's mean cost.
We changed our policy to apply these three criteria to determine
whether procedures qualify as device-intensive in the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66926), where we stated that we
would apply the no cost/full credit and partial credit device policy--
which includes the three criteria listed previously--to all device-
intensive procedures beginning in CY 2015. We reiterated this position
in the CY 2016 OPPS/ASC final rule with comment period (80 FR 70424),
where we explained that we were finalizing our proposal to continue
using the three criteria established in the CY 2007 OPPS/ASC final rule
with comment period for determining the APCs to which the CY 2016
device intensive policy will apply. Under the policies we adopted in
CYs 2015, 2016, and 2017, all procedures that require the implantation
of a device and meet the previously described criteria are assigned
device-intensive status, regardless of their APC placement.
2. Device-Intensive Procedure Policy for CY 2019 and Subsequent Years
As part of our effort to better capture costs for procedures with
significant device costs, in the CY 2019 OPPS/ASC final rule with
comment period (83 FR 58944 through 58948), for CY 2019, we modified
our criteria for device-intensive procedures. We had heard from
stakeholders that the criteria excluded some procedures that
stakeholders believed should qualify as device-intensive procedures.
Specifically, we were persuaded by stakeholder arguments that
procedures requiring expensive surgically inserted or implanted devices
that are not capital equipment should qualify as device-intensive
procedures, regardless of whether the device remains in the patient's
body after the conclusion of the procedure. We agreed that a broader
definition of device-intensive procedures was warranted, and made two
modifications to the criteria for CY 2019 (83 FR 58948). First, we
allowed procedures that involve surgically inserted or implanted
single-use devices that meet the device offset percentage threshold to
qualify as device-intensive procedures, regardless of whether the
device remains in the patient's body after the conclusion of the
procedure. We established this policy because we no longer believe that
whether a device remains in the patient's body should affect a
procedure's designation as a device-intensive procedure, as such
devices could, nonetheless, comprise a large portion of the cost of the
applicable procedure. Second, we modified our criteria to lower the
device offset percentage threshold from 40 percent to 30 percent, to
allow a greater number of procedures to qualify as device-intensive. We
stated that we believe allowing these additional procedures to qualify
for device-intensive status will help ensure these procedures receive
more appropriate payment in the ASC setting, which will help encourage
the provision of these services in the ASC setting. In addition, we
stated that this change would help to ensure that more procedures
containing relatively high-cost devices are subject to the device
edits, which leads to more correctly coded claims and greater accuracy
in our claims data. Specifically, for CY 2019 and subsequent years, we
finalized that device-intensive procedures will be subject to the
following criteria:
All procedures must involve implantable devices assigned a
CPT or HCPCS code;
The required devices (including single-use devices) must
be surgically inserted or implanted; and
The device offset amount must be significant, which is
defined as exceeding 30 percent of the procedure's mean cost (83 FR
58945).
In addition, to further align the device-intensive policy with the
criteria used for device pass-through payment status, we finalized, for
CY 2019 and subsequent years, that for purposes of satisfying the
device-intensive criteria, a device-intensive procedure must involve a
device that:
Has received FDA marketing authorization, has received an
FDA investigational device exemption (IDE), and has been classified as
a Category B device by FDA in accordance with 42 CFR 405.203 through
405.207 and 405.211 through 405.215, or meets another appropriate FDA
exemption from premarket review;
Is an integral part of the service furnished;
Is used for one patient only;
Comes in contact with human tissue;
Is surgically implanted or inserted (either permanently or
temporarily); and
Is not either of the following:
(a) Equipment, an instrument, apparatus, implement, or item of the
type for which depreciation and financing expenses are recovered as
depreciable assets as defined in Chapter 1 of the Medicare Provider
Reimbursement Manual (CMS Pub. 15-1); or
(b) A material or supply furnished incident to a service (for
example, a suture, customized surgical kit, scalpel, or clip, other
than a radiological site marker) (83 FR 58945).
In addition, for new HCPCS codes describing procedures requiring
the implantation of devices that do not yet have associated claims
data, in the CY 2017 OPPS/ASC final rule with comment period (81 FR
79658), we finalized a policy for CY 2017 to apply device-intensive
status with a default device offset set at 41 percent for new HCPCS
codes describing procedures requiring the implantation or insertion of
a device that did not yet have associated claims data until claims data
are available to establish the HCPCS code-level device offset for the
procedures. This default device offset amount of 41 percent was not
calculated from claims data; instead, it was applied as a default until
claims data were available upon which to calculate an actual device
offset for the new code. The purpose of applying the 41-percent default
device offset to new codes that describe procedures that implant or
insert devices was to ensure ASC access for new procedures until claims
data become available.
As discussed in the CY 2019 OPPS/ASC proposed rule and final rule
with comment period (83 FR 37108 through 37109 and 58945 through 58946,
respectively), in accordance with our policy stated previously to lower
the device offset percentage threshold for procedures to qualify as
device-intensive from greater than 40 percent to greater than 30
percent, for CY 2019 and subsequent years, we modified this policy to
apply a 31-percent default device offset to new HCPCS codes describing
procedures requiring the implantation of a device that do not yet have
associated claims data until claims data are available to establish the
[[Page 86015]]
HCPCS code-level device offset for the procedures. In conjunction with
the policy to lower the default device offset from 41 percent to 31
percent, we continued our current policy of, in certain rare instances
(for example, in the case of a very expensive implantable device),
temporarily assigning a higher offset percentage if warranted by
additional information such as pricing data from a device manufacturer
(81 FR 79658). Once claims data are available for a new procedure
requiring the implantation or insertion of a device, device-intensive
status is applied to the code if the HCPCS code-level device offset is
greater than 30 percent, according to our policy of determining device-
intensive status by calculating the HCPCS code-level device offset.
In addition, in the CY 2019 OPPS/ASC final rule with comment
period, we clarified that since the adoption of our policy in effect as
of CY 2018, the associated claims data used for purposes of determining
whether or not to apply the default device offset are the associated
claims data for either the new HCPCS code or any predecessor code, as
described by CPT coding guidance, for the new HCPCS code. Additionally,
for CY 2019 and subsequent years, in limited instances where a new
HCPCS code does not have a predecessor code as defined by CPT, but
describes a procedure that was previously described by an existing
code, we use clinical discretion to identify HCPCS codes that are
clinically related or similar to the new HCPCS code but are not
officially recognized as a predecessor code by CPT, and to use the
claims data of the clinically related or similar code(s) for purposes
of determining whether or not to apply the default device offset to the
new HCPCS code (83 FR 58946). Clinically related and similar procedures
for purposes of this policy are procedures that have little or no
clinical differences and use the same devices as the new HCPCS code. In
addition, clinically related and similar codes for purposes of this
policy are codes that either currently or previously describe the
procedure described by the new HCPCS code. Under this policy, claims
data from clinically related and similar codes are included as
associated claims data for a new code, and where an existing HCPCS code
is found to be clinically related or similar to a new HCPCS code, we
apply the device offset percentage derived from the existing clinically
related or similar HCPCS code's claims data to the new HCPCS code for
determining the device offset percentage. We stated that we believe
that claims data for HCPCS codes describing procedures that have minor
differences from the procedures described by new HCPCS codes will
provide an accurate depiction of the cost relationship between the
procedure and the device(s) that are used, and will be appropriate to
use to set a new code's device offset percentage, in the same way that
predecessor codes are used. If a new HCPCS code has multiple
predecessor codes, the claims data for the predecessor code that has
the highest individual HCPCS-level device offset percentage is used to
determine whether the new HCPCS code qualifies for device-intensive
status. Similarly, in the event that a new HCPCS code does not have a
predecessor code but has multiple clinically related or similar codes,
the claims data for the clinically related or similar code that has the
highest individual HCPCS level device offset percentage is used to
determine whether the new HCPCS code qualifies for device-intensive
status.
As we indicated in the CY 2019 OPPS/ASC proposed rule and final
rule with comment period, additional information for our consideration
of an offset percentage higher than the default of 31 percent for new
HCPCS codes describing procedures requiring the implantation (or, in
some cases, the insertion) of a device that do not yet have associated
claims data, such as pricing data or invoices from a device
manufacturer, should be directed to the Division of Outpatient Care,
Mail Stop C4-01-26, Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244-1850, or electronically at
[email protected]. Additional information can be submitted
prior to issuance of an OPPS/ASC proposed rule or as a public comment
in response to an issued OPPS/ASC proposed rule. Device offset
percentages will be set in each year's final rule.
In response to stakeholder requests for additional detail on our
device-intensive methodology, we have updated our claims accounting
narrative with a description of our device offset percentage
calculation. Our claims accounting narrative for the CY 2021 OPPS/ASC
final rule can be found under supporting documentation on our website
at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/index.html.
For CY 2021, we did not propose any changes to our device-intensive
policy.
Comment: A number of commenters and the Advisory Panel on Hospital
Outpatient Payment (HOP Panel) recommended that CMS consider lowering
the device-intensive threshold from 30 percent to 25 percent to avoid
excessive payment gaps when device costs do not reach the device-
intensive threshold and thereby do not ``carry over'' device costs from
the hospital outpatient setting to the ASC setting.
Response: We thank the commenters and the HOP Panel for their
recommendation. While payment rates under the ASC payment system for a
particular procedure may be subject to fluctuation if device-intensive
status varies for the procedure on a year-to-year basis, we believe
that the potential payment gaps that commenters note will exist for any
threshold value. Further, as discussed in section XIII.G.2.a. of this
final rule with comment, our established policy under the ASC payment
system is to scale prospective ASC relative payment weights by
comparing total payment using current year ASC scaled relative payment
weights with the total payment using the prospective ASC relative
payment weights, holding ASC utilization, the ASC conversion factor,
and the mix of services constant from the claims year. Lowering the
device-intensive threshold assigns a greater amount of device costs,
which are held constant between the OPPS and ASC payment system, into
the prospective year. This would put additional downward pressure on
the ASC weight scalar and reduce the non-device portion of ASC payment
rates for most surgical procedures. Additionally, a reduction in the
device-intensive threshold to 25 percent would also be accompanied with
a reduction in the default device offset percentage, from 31 percent to
26 percent. A reduction in the default device offset percentage would
reduce the device portion for covered surgical procedures with device
offset amounts established at the existing default offset percentage of
31 percent. In light of these concerns, we are not accepting the
recommendation to lower the device-intensive threshold at this time.
Comment: Some commenters recommended that the device offset
percentage for 0424T (Insertion or replacement of neurostimulator
system for treatment of central sleep apnea; complete system
(transvenous placement of right or left stimulation lead, sensing lead,
implantable pulse generator)) be reevaluated. Commenters contend that a
99.99 percent device offset percentage appears to be erroneous and
would eliminate transitional pass-through device payments for the
associated device C1823 (Generator, neurostimulator (implantable), non-
rechargeable, with transvenous sensing and stimulation leads).
Commenters recommended
[[Page 86016]]
device offset percentages of 37.76 percent which excludes the costs
associated with C1823, or 74.96 percent which includes the costs
associated with C1823.
Response: In reviewing our device cost calculations, we discovered
an oversight related to the cost of certain devices approved for
transitional pass-through payment status. Currently, our ratesetting
process excludes the cost of pass-through devices from being packaged
into the major procedure until those devices no longer have pass-
through status. However, our device cost calculation process in
developing the offsets incorporated the cost of some devices currently
receiving pass-through payment status. Because the costs of these
devices are not included in developing the geometric mean cost of the
procedure and therefore the APC payment rate, the costs associated with
these pass-through devices should not be included in a procedure's
device offset percentage. For this CY 2021 OPPS/ASC final rule with
comment period, we have removed the pass-through device costs at issue
from the calculation of the device offsets. We have also included these
changes in our claims accounting narrative for the CY 2021 OPPS/ASC
final rule which can be found under supporting documentation on our
website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Payment/HospitalOutpatientPPS/index.html.
The change in device cost calculation from the proposed and final
rule only impacted the device offset percentage associated with CPT
code 0424T. Specifically, the updated calculations using final rule
claims data show a device offset percentage of 27.10 percent after
removing the cost of pass-through devices. Therefore, for CY 2021, we
are finalizing a device offset percentage of 27.10 percent for CPT code
0424T.
Comment: Commenters contended that CPT codes 22857 (Total disc
arthroplasty (artificial disc), anterior approach, including discectomy
to prepare interspace (other than for decompression), single
interspace, lumbar), 66174 (Transluminal dilation of aqueous outflow
canal; without retention of device or stent), and 55880 (Ablation of
malignant prostate tissue, transrectal, with high intensity--focused
ultrasound (HIFU), including ultrasound guidance) should be designated
as device-intensive under the OPPS and ASC payment systems.
Response: Using the updated final rule claims data, we have
determined that the device offset percentages for CPT codes 22857 and
66174 are not above the 30-percent device-intensive threshold and,
therefore, these procedures are not eligible to be assigned device-
intensive status. Additionally, while we do not have claims data for
CPT code 55880, we have determined that the device offset percentage of
C9747, the predecessor code to CPT code 55880, is also not above the
30-percent threshold based on CY 2019 claims and, therefore, CPT code
55880 is also not eligible to be assigned device-intensive status.
Comment: Commenters requested that we designate CPT code 50590
(Lithotripsy, extracorporeal shock wave) device-intensive status, or
establish alternative device-intensive criteria so that the costs of
capital equipment, specifically, the lithotripter, associated with CPT
code 50590 would allow this procedure to receive a device-intensive
designation. The commenter suggested alternative criteria that would
include that: (1) The procedure cannot be performed without the
equipment/device; (2) the equipment/device is typically obtained on an
``as-needed'' basis rather than purchased or leased by the entity
providing the care; (3) the fair-market lease or rental cost in an HOPD
or ASC setting is not materially different for either site of service;
(4) the fair-market lease or rental cost of the equipment precludes
performing the service at an appropriate margin in an ASC setting; and
(5) the procedure is most appropriately done on an ambulatory basis for
the majority of patients.
Response: Using the updated claims data for this CY 2021 OPPS/ASC
final rule with comment period, we have determined that the device
offset percentage for CPT code 50590 is not above the 30-percent
threshold and, therefore, this procedure is not eligible to be assigned
device-intensive status.
We also do not believe changes to our device-intensive criteria are
necessary. We believe the existing criteria are adequate to
differentiate implantable and insertable device costs from non-invasive
equipment costs and other procedure-related costs. We also note that
the operating resource costs associated with CPT code 50590 are
captured in the geometric mean cost of the procedure used to develop
the ASC relative weights, as well as the ASC payment rate. While we
acknowledge that the reliance on OPPS scaled relative weights to
develop the ASC payment rate may not necessarily capture the geometric
mean cost of procedures with significant capital equipment costs in the
ASC setting, we are not finalizing any changes to our ASC ratesetting
methodology at this time.
Comment: One commenter requested that we finalize our device-
intensive designation for CPT code 0275T (Percutaneous laminotomy/
laminectomy (interlaminar approach) for decompression of neural
elements, (with or without ligamentous resection, discectomy,
facetectomy and/or foraminotomy), any method, under indirect image
guidance (e.g., fluoroscopic, ct), single or multiple levels,
unilateral or bilateral; lumbar) but only determine the device offset
percentage based on claims with a reported device code.
Response: We appreciate the commenter's recommendation; however, we
do not believe it would be appropriate to exclude claims data that
would otherwise be available from our ratesetting process for the
purposes of modifying the final device offset percentage for 0275T in
particular. We are finalizing our proposal to assign device-intensive
status to CPT code 0275T with a device offset percentage of 34.16
percent, as determined based on the final rule claims data.
Comment: Some commenters recommended that we assign CPT code 0404T
(Transcervical uterine fibroid(s) ablation with ultrasound guidance,
radiofrequency) device-intensive status. Commenters argue that the
device was not commercially available until late 2019, which they
believed explains the lack of claims data and device cost information.
Response: We agree with the commenters. While CPT code 0404T was
established in 2016, which predates our policy of applying a default
device offset percentage for new procedures, we have yet to receive
claims information for this procedure that would allow us to determine
any associated device costs. We also thank the commenters for their
submission of device pricing information. After reviewing the pricing
information provided by commenters, we believe a default device offset
percentage of 31 percent appropriately reflects the device costs for
these procedures for CY 2021.
Comment: One commenter recommended that we assign 0632T
(Percutaneous transcatheter ultrasound ablation of nerves innervating
the pulmonary arteries, including right heart catheterization,
pulmonary artery angiography, and all imaging guidance) device-
intensive status.
Response: As discussed in section III.D of this CY 2021 OPPS/ASC
final rule with comment period, we are finalizing our proposal to
assign SI=E1 ``Not paid by Medicare when submitted on outpatient claims
(any outpatient bill type)'' to CPT code 0632T. This
[[Page 86017]]
procedure is not payable under the OPPS beginning in CY 2021, and
therefore we are not assigning device-intensive status to 0632T at this
time.
Comment: Some commenters suggested that CMS only adjust the non-
device portion of the payment by the wage index, consistent with the
Agency's policy for separately payable drugs and biologicals.
Response: While we did not make such a proposal in this year's
proposed rule, we will take this comment into consideration for future
rulemaking. We note that such a policy would increase payments to
providers with a wage index value of less than 1 and be offset by a
budget neutral decrease in payments to other providers.
As discussed in section IV.A. of this final rule with comment
period, we are approving the BAROSTIM NEOTM system for
transitional pass-through device payment status. The applicant has
stated that the BAROSTIM NEOTM would be reported with CPT
code 0266T (Implantation or replacement of carotid sinus baroreflex
activation device; total system (includes generator placement,
unilateral or bilateral lead placement, intra-operative interrogation,
programming, and repositioning, when performed)). There have been no
device costs reported for CPT code 0266T in CY 2019 claims or in
previous calendar years. Therefore, for purposes of applying a device
offset percentage for transitional pass-through device payments for CPT
code 0266T, we are assigning a device offset percentage to 0266T in CY
2021 based on the clinically-similar procedure 0268T (Implantation or
replacement of carotid sinus baroreflex activation device; pulse
generator only (includes intra-operative interrogation, programming,
and repositioning, when performed)). Based on our review of CY 2019
claims data, CPT code 0268T has a device offset percentage of 95.74
percent. Therefore, for CY 2021, we are assigning device-intensive
status to CPT code 0266T with a device offset percentage of 95.74
percent.
The full listing of the final CY 2021 device-intensive procedures
can be found in Addendum P to the CY 2021 OPPS/ASC final rule with
comment period (which is available via the internet on the CMS
website).
3. Device Edit Policy
In the CY 2015 OPPS/ASC final rule with comment period (79 FR
66795), we finalized a policy and implemented claims processing edits
that require any of the device codes used in the previous device-to-
procedure edits to be present on the claim whenever a procedure code
assigned to any of the APCs listed in Table 5 of the CY 2015 OPPS/ASC
final rule with comment period (the CY 2015 device-dependent APCs) is
reported on the claim. In addition, in the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70422), we modified our previously existing
policy and applied the device coding requirements exclusively to
procedures that require the implantation of a device that are assigned
to a device-intensive APC. In the CY 2016 OPPS/ASC final rule with
comment period, we also finalized our policy that the claims processing
edits are such that any device code, when reported on a claim with a
procedure assigned to a device-intensive APC (listed in Table 42 of the
CY 2016 OPPS/ASC final rule with comment period (80 FR 70422)) will
satisfy the edit.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79658
through 79659), we changed our policy for CY 2017 and subsequent years
to apply the CY 2016 device coding requirements to the newly defined
device-intensive procedures. For CY 2017 and subsequent years, we also
specified that any device code, when reported on a claim with a device-
intensive procedure, will satisfy the edit. In addition, we created
HCPCS code C1889 to recognize devices furnished during a device-
intensive procedure that are not described by a specific Level II HCPCS
Category C-code. Reporting HCPCS code C1889 with a device-intensive
procedure will satisfy the edit requiring a device code to be reported
on a claim with a device-intensive procedure. In the CY 2019 OPPS/ASC
final rule with comment period, we revised the description of HCPCS
code C1889 to remove the specific applicability to device-intensive
procedures (83 FR 58950). For CY 2019 and subsequent years, the
description of HCPCS code C1889 is ``Implantable/insertable device, not
otherwise classified''.
We did not propose any changes to this policy for CY 2021.
Comment: Some commenters requested that CMS restore the device-to-
procedure and procedure-to-device edits.
Response: As we stated in the CY 2015 OPPS/ASC final rule with
comment period (79 FR 66794), we continue to believe that the
elimination of device-to-procedure edits and procedure-to-device edits
is appropriate due to the experience hospitals now have in coding and
reporting these claims fully. More specifically, for the most costly
devices, we believe the C-APCs reliably reflect the cost of the device
if charges for the device are included anywhere on the claim. We note
that, under our current policy, hospitals are still expected to adhere
to the guidelines of correct coding and append the correct device code
to the claim when applicable. We also note that, as with all other
items and services recognized under the OPPS, we expect hospitals to
code and report their costs appropriately, regardless of whether there
are claims processing edits in place.
4. Adjustment to OPPS Payment for No Cost/Full Credit and Partial
Credit Devices
a. Background
To ensure equitable OPPS payment when a hospital receives a device
without cost or with full credit, in CY 2007, we implemented a policy
to reduce the payment for specified device-dependent APCs by the
estimated portion of the APC payment attributable to device costs (that
is, the device offset) when the hospital receives a specified device at
no cost or with full credit (71 FR 68071 through 68077). Hospitals were
instructed to report no cost/full credit device cases on the claim
using the ``FB'' modifier on the line with the procedure code in which
the no cost/full credit device is used. In cases in which the device is
furnished without cost or with full credit, hospitals were instructed
to report a token device charge of less than $1.01. In cases in which
the device being inserted is an upgrade (either of the same type of
device or to a different type of device) with a full credit for the
device being replaced, hospitals were instructed to report as the
device charge the difference between the hospital's usual charge for
the device being implanted and the hospital's usual charge for the
device for which it received full credit. In CY 2008, we expanded this
payment adjustment policy to include cases in which hospitals receive
partial credit of 50 percent or more of the cost of a specified device.
Hospitals were instructed to append the ``FC'' modifier to the
procedure code that reports the service provided to furnish the device
when they receive a partial credit of 50 percent or more of the cost of
the new device. We refer readers to the CY 2008 OPPS/ASC final rule
with comment period for more background information on the ``FB'' and
``FC'' modifiers payment adjustment policies (72 FR 66743 through
66749).
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75005
through 75007), beginning in CY 2014, we modified our policy of
reducing
[[Page 86018]]
OPPS payment for specified APCs when a hospital furnishes a specified
device without cost or with a full or partial credit. For CY 2013 and
prior years, our policy had been to reduce OPPS payment by 100 percent
of the device offset amount when a hospital furnishes a specified
device without cost or with a full credit and by 50 percent of the
device offset amount when the hospital receives partial credit in the
amount of 50 percent or more of the cost for the specified device. For
CY 2014, we reduced OPPS payment, for the applicable APCs, by the full
or partial credit a hospital receives for a replaced device.
Specifically, under this modified policy, hospitals are required to
report on the claim the amount of the credit in the amount portion for
value code ``FD'' (Credit Received from the Manufacturer for a Replaced
Device) when the hospital receives a credit for a replaced device that
is 50 percent or greater than the cost of the device. For CY 2014, we
also limited the OPPS payment deduction for the applicable APCs to the
total amount of the device offset when the ``FD'' value code appears on
a claim. For CY 2015, we continued our policy of reducing OPPS payment
for specified APCs when a hospital furnishes a specified device without
cost or with a full or partial credit and to use the three criteria
established in the CY 2007 OPPS/ASC final rule with comment period (71
FR 68072 through 68077) for determining the APCs to which our CY 2015
policy will apply (79 FR 66872 through 66873). In the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70424), we finalized our policy
to no longer specify a list of devices to which the OPPS payment
adjustment for no cost/full credit and partial credit devices would
apply and instead apply this APC payment adjustment to all replaced
devices furnished in conjunction with a procedure assigned to a device-
intensive APC when the hospital receives a credit for a replaced
specified device that is 50 percent or greater than the cost of the
device.
b. Policy for No Cost/Full Credit and Partial Credit Devices
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79659
through 79660), for CY 2017 and subsequent years, we finalized a policy
to reduce OPPS payment for device-intensive procedures, by the full or
partial credit a provider receives for a replaced device, when a
hospital furnishes a specified device without cost or with a full or
partial credit. Under our current policy, hospitals continue to be
required to report on the claim the amount of the credit in the amount
portion for value code ``FD'' when the hospital receives a credit for a
replaced device that is 50 percent or greater than the cost of the
device.
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75005
through 75007), we adopted a policy of reducing OPPS payment for
specified APCs when a hospital furnishes a specified device without
cost or with a full or partial credit by the lesser of the device
offset amount for the APC or the amount of the credit. Although we
adopted this change in policy in the preamble of the CY 2014 OPPS/ASC
final rule with comment period and discussed it in subregulatory
guidance, including Chapter 4, Section 61.3.6 of the Medicare Claims
Processing Manual, we inadvertently did not make conforming changes to
the regulation text. In particular, we did not change our regulation at
42 CFR 419.45(b)(1) and (2), which describes the amount of the
reduction in the APC payment in situations where the beneficiary
receives an implanted device that is replaced without cost to the
provider or the beneficiary or where the provider receives a full or
partial credit for the cost of a replaced device and which continues to
state that the amount of the reduction is the device offset amount.
Therefore, in the CY 2021 OPPS/ASC proposed rule, we proposed to change
our regulation at Sec. 419.45(b)(1) and (2) to conform with the policy
we adopted in CY 2014. In particular, we proposed revising our
regulations at Sec. 419.45(b)(1) to state that, for situations in
which a beneficiary has received an implanted device that is replaced
without cost to the provider or the beneficiary, or where the provider
receives full credit for the cost of a replaced device, the amount of
reduction to the APC payment is calculated by reducing the APC payment
amount by the lesser of the amount of the credit or the device offset
amount that would otherwise apply if the procedure assigned to the APC
had transitional pass-through status under Sec. 419.66. Additionally,
we proposed to revise our regulation at Sec. 419.45(b)(2) to state
that, for situations in which the provider receives partial credit for
the cost of a replaced device, but only where the amount of the device
credit is greater than or equal to 50 percent of the cost of the
replacement device being implanted, the amount of the reduction to the
APC payment is calculated by reducing the APC payment amount by the
lesser of the amount of the credit or the device offset amount that
would otherwise apply if the procedure assigned to the APC had
transitional-pass through status under Sec. 419.66. The proposed
revisions to Sec. 419.45(b)(1) and (2) appear in section XXVII. of the
CY 2021 OPPS/ASC proposed rule.
We did not receive any comments on our proposal and are finalizing,
without modification, our revisions to Sec. 419.45(b)(1) and (2).
5. Payment Policy for Low-Volume Device-Intensive Procedures
In CY 2016, we used our equitable adjustment authority under
section 1833(t)(2)(E) of the Act and used the median cost (instead of
the geometric mean cost per our standard methodology) to calculate the
payment rate for the implantable miniature telescope procedure
described by CPT code 0308T (Insertion of ocular telescope prosthesis
including removal of crystalline lens or intraocular lens prosthesis),
which is the only code assigned to APC 5494 (Level 4 Intraocular
Procedures) (80 FR 70388). We noted that, as stated in the CY 2017
OPPS/ASC proposed rule (81 FR 45656), we proposed to reassign the
procedure described by CPT code 0308T to APC 5495 (Level 5 Intraocular
Procedures) for CY 2017, but it would be the only procedure code
assigned to APC 5495. The payment rates for a procedure described by
CPT code 0308T (including the predecessor HCPCS code C9732) were
$15,551 in CY 2014, $23,084 in CY 2015, and $17,551 in CY 2016. The
procedure described by CPT code 0308T is a high-cost device-intensive
surgical procedure that has a very low volume of claims (in part
because most of the procedures described by CPT code 0308T are
performed in ASCs). We believe that the median cost is a more
appropriate measure of the central tendency for purposes of calculating
the cost and the payment rate for this procedure because the median
cost is impacted to a lesser degree than the geometric mean cost by
more extreme observations. We stated that, in future rulemaking, we
would consider proposing a general policy for the payment rate
calculation for very low-volume device-intensive APCs (80 FR 70389).
For CY 2017, we proposed and finalized a payment policy for low-
volume device-intensive procedures that is similar to the policy
applied to the procedure described by CPT code 0308T in CY 2016. In the
CY 2017 OPPS/ASC final rule with comment period (81 FR 79660 through
79661), we established our current policy that the payment rate for any
device-intensive procedure that is assigned to a clinical APC with
fewer than 100 total claims for all procedures in the APC be
[[Page 86019]]
calculated using the median cost instead of the geometric mean cost,
for the reasons described previously for the policy applied to the
procedure described by CPT code 0308T in CY 2016. The CY 2018 final
rule geometric mean cost for the procedure described by CPT code 0308T
(based on 19 claims containing the device HCPCS C-code, in accordance
with the device-intensive edit policy) was $21,302, and the median cost
was $19,521. The final CY 2018 payment rate (calculated using the
median cost) was $17,560.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
58951), for CY 2019, we continued with our policy of establishing the
payment rate for any device-intensive procedure that is assigned to a
clinical APC with fewer than 100 total claims for all procedures in the
APC based on calculations using the median cost instead of the
geometric mean cost. For more information on the specific policy for
assignment of low-volume device-intensive procedures for CY 2019, we
refer readers to section III.D.13. of the CY 2019 OPPS/ASC final rule
with comment period (83 FR 58917 through 58918).
For CY 2020, we finalized our policy to continue establishing the
payment rate for any device-intensive procedure that is assigned to a
clinical APC with fewer than 100 total claims for all procedures in the
APC using the median cost instead of the geometric mean cost. In CY
2020, this policy applied to CPT code 0308T which we assigned to APC
5495 (Level 5 Intraocular Procedures) in the CY 2020 OPPS/ASC final
rule with comment period (84 FR 61301).
For CY 2021, we proposed to continue our current policy of
establishing the payment rate for any device-intensive procedure that
is assigned to a clinical APC with fewer than 100 total claims for all
procedures in the APC using the median cost instead of the geometric
mean cost. For CY 2021, this policy would not apply to any procedure.
As discussed in section III.D.3. of the CY 2021 OPPS/ASC proposed rule,
we received no claims data with CPT code 0308T, which we previously
assigned as a low-volume device-intensive procedure for CY 2017 through
CY 2020. As such, we proposed to assign 0308T a payment weight based on
the most recently available data, from the CY 2020 OPPS final rule, and
therefore proposed to assign CPT code 0308T to APC 5495 (Level 5
Intraocular Procedures). Additionally, in the absence of CY 2019 claims
data for the CY 2021 OPPS/ASC proposed rule, we proposed to use the
most recently available data, from the CY 2020 OPPS final rule, to
establish the device offset percentage for 0308T. Therefore, the
proposed CY 2021 device offset percentage for CPT code 0308T was based
on the CY 2020 OPPS final rule device offset percentage of 82.21
percent for CPT code 0308T. For more discussion on the proposed APC
assignment and proposed payment rate for CPT code 0308T, see CY 2021
OPPS/ASC proposed rule (85 FR 48840).
Comment: One commenter supported our proposed device offset
percentage for CPT code 0308T.
Response: We thank the commenter for their support.
After consideration of the public comment we received, we are
finalizing our proposal, without modification, to use the CY 2020
median cost in determining the OPPS and ASC relative payment weights
for 0308T and to assign the CY 2020 OPPS final rule device offset
percentage of 82.21 percent as the CY 2021 device offset for CPT code
0308T. For more discussion on the APC assignment and payment rate for
CPT code 0308T, please see section III.D of this CY 2021 OPPS/ASC final
rule with comment period.
V. OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. OPPS Transitional Pass-Through Payment for Additional Costs of
Drugs, Biologicals, and Radiopharmaceuticals
1. Background
Section 1833(t)(6) of the Act provides for temporary additional
payments or ``transitional pass-through payments'' for certain drugs
and biologicals. Throughout this final rule with comment period, we use
the term ``biological'' because this is the term that appears in
section 1861(t) of the Act. A ``biological'' as used in this final rule
with comment period includes (but is not necessarily limited to) a
``biological product'' or a ``biologic'' as defined under section 351
of the Public Health Service Act. As enacted by the Medicare, Medicaid,
and SCHIP Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-
113), this pass-through payment provision requires the Secretary to
make additional payments to hospitals for: Current orphan drugs for
rare diseases and conditions, as designated under section 526 of the
Federal Food, Drug, and Cosmetic Act; current drugs and biologicals and
brachytherapy sources used in cancer therapy; and current
radiopharmaceutical drugs and biologicals. ``Current'' refers to those
types of drugs or biologicals mentioned above that are hospital
outpatient services under Medicare Part B for which transitional pass-
through payment was made on the first date the hospital OPPS was
implemented.
Transitional pass-through payments also are provided for certain
``new'' drugs and biologicals that were not being paid for as an HOPD
service as of December 31, 1996 and whose cost is ``not insignificant''
in relation to the OPPS payments for the procedures or services
associated with the new drug or biological. For pass-through payment
purposes, radiopharmaceuticals are included as ``drugs.'' As required
by statute, transitional pass-through payments for a drug or biological
described in section 1833(t)(6)(C)(i)(II) of the Act can be made for a
period of at least 2 years, but not more than 3 years, after the
payment was first made for the product as a hospital outpatient service
under Medicare Part B. Proposed CY 2021 pass-through drugs and
biologicals and their designated APCs were assigned status indicator
``G'' in Addenda A and B to the proposed rule (which are available via
the internet on the CMS website).
Section 1833(t)(6)(D)(i) of the Act specifies that the pass-through
payment amount, in the case of a drug or biological, is the amount by
which the amount determined under section 1842(o) of the Act for the
drug or biological exceeds the portion of the otherwise applicable
Medicare OPD fee schedule that the Secretary determines is associated
with the drug or biological. The methodology for determining the pass-
through payment amount is set forth in regulations at 42 CFR 419.64.
These regulations specify that the pass-through payment equals the
amount determined under section 1842(o) of the Act minus the portion of
the APC payment that CMS determines is associated with the drug or
biological.
Section 1847A of the Act establishes the average sales price (ASP)
methodology, which is used for payment for drugs and biologicals
described in section 1842(o)(1)(C) of the Act furnished on or after
January 1, 2005. The ASP methodology, as applied under the OPPS, uses
several sources of data as a basis for payment, including the ASP, the
wholesale acquisition cost (WAC), and the average wholesale price
(AWP). In the proposed rule, the term ``ASP methodology'' and ``ASP-
based'' are inclusive of all data sources and methodologies described
therein. Additional information on the ASP methodology can be found on
our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
The pass-through application and review process for drugs and
biologicals
[[Page 86020]]
is described on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/passthrough_payment.html.
2. Transitional Pass-Through Payment Period for Pass-Through Drugs,
Biologicals, and Radiopharmaceuticals and Quarterly Expiration of Pass-
Through Status
As required by statute, transitional pass-through payments for a
drug or biological described in section 1833(t)(6)(C)(i)(II) of the Act
can be made for a period of at least 2 years, but not more than 3
years, after the payment was first made for the product as a hospital
outpatient service under Medicare Part B. Our current policy is to
accept pass-through applications on a quarterly basis and to begin
pass-through payments for newly approved pass-through drugs and
biologicals on a quarterly basis through the next available OPPS
quarterly update after the approval of a product's pass-through status.
However, prior to CY 2017, we expired pass-through status for drugs and
biologicals on an annual basis through notice-and-comment rulemaking
(74 FR 60480). In the CY 2017 OPPS/ASC final rule with comment period
(81 FR 79662), we finalized a policy change, beginning with pass-
through drugs and biologicals newly approved in CY 2017 and subsequent
calendar years, to allow for a quarterly expiration of pass-through
payment status for drugs, biologicals, and radiopharmaceuticals to
afford a pass-through payment period that is as close to a full 3 years
as possible for all pass-through drugs, biologicals, and
radiopharmaceuticals.
This change eliminated the variability of the pass-through payment
eligibility period, which previously varied based on when a particular
application was initially received. We adopted this change for pass-
through approvals beginning on or after CY 2017, to allow, on a
prospective basis, for the maximum pass-through payment period for each
pass-through drug without exceeding the statutory limit of 3 years.
Notice of drugs whose pass-through payment status is ending during the
calendar year will continue to be included in the quarterly OPPS Change
Request transmittals.
Comment: One commenter commended CMS for continuing the policy to
provide for quarterly expiration of pass-through payment status, which
allows a pass-through period that is as close to a full three years as
possible.
Response: We thank the commenter for their input and support of
this policy change, which was adopted in the CY 2017 OPPS/ASC final
rule (81 FR 79654 through 79655).
3. Drugs and Biologicals With Expiring Pass-Through Payment Status in
CY 2020
There are 29 drugs and biologicals whose pass-through payment
status will expire during CY 2020 as listed in Table 36. Most of these
drugs and biologicals will have received OPPS pass-through payment for
3 years during the period of April 1, 2017 through December 31, 2020.
However, there are two groups of drugs and biologicals included in
Table 36 whose total period of OPPS pass-through payment is greater
than 3 years. The first group are five drugs and biologicals that have
already had 3 years of pass-through payment status but for which pass-
through payment status was extended for an additional 2 years from
October 1, 2018 until September 30, 2020 under section 1833(t)(6)(G) of
the Act, as added by section 1301(a)(1)(C) of the Consolidated
Appropriations Act of 2018 (Pub. L. 115-141). The drugs covered by this
provision include: HCPCS code A9586 (Florbetapir f18, diagnostic, per
study dose, up to 10 millicuries); HCPCS code J1097 (Phenylephrine
10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1
ml); HCPCS code Q4195 (Puraply, per square centimeter); HCPCS code
Q4196 (Puraply am, per square centimeter); and HCPCS code Q9950
(Injection, sulfur hexafluoride lipid microspheres, per ml). The second
group are two diagnostic radiopharmaceuticals: HCPCS code Q9982
(Flutemetamol F18, diagnostic, per study dose, up to 5 millicuries) and
HCPCS code Q9983 (Florbetaben F18, diagnostic, per study dose, up to
8.1 millicuries) whose pass-through payment status was extended for an
additional 9 months from January 1, 2020 to September 30, 2020 under
Division N, Title I, Subtitle A, Section 107(a) of the Further
Consolidated Appropriations Act of 2020, which amended section
1833(t)(6) of the Social Security Act and added a new section
1833(t)(6)(J) to the Act.
In accordance with the policy finalized in CY 2017 and described
earlier, pass-through payment status for drugs and biologicals newly
approved in CY 2017 and subsequent years will expire on a quarterly
basis, with a pass-through payment period as close to 3 years as
possible. With the exception of those groups of drugs and biologicals
that are always packaged when they do not have pass-through payment
status (specifically, anesthesia drugs; drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure (including diagnostic
radiopharmaceuticals, contrast agents, and stress agents); and drugs
and biologicals that function as supplies when used in a surgical
procedure), our standard methodology for providing payment for drugs
and biologicals with expiring pass-through payment status in an
upcoming calendar year is to determine the product's estimated per day
cost and compare it with the OPPS drug packaging threshold for that
calendar year (which was proposed to be $130 for CY 2021), as discussed
further in section V.B.2. of the CY 2021 OPPS/ASC proposed rule. We
proposed that if the estimated per day cost for the drug or biological
is less than or equal to the applicable OPPS drug packaging threshold,
we would package payment for the drug or biological into the payment
for the associated procedure in the upcoming calendar year. If the
estimated per day cost of the drug or biological is greater than the
OPPS drug packaging threshold, we proposed to provide separate payment
at the applicable relative ASP-based payment amount (which was proposed
at ASP+6 percent for non-340B drugs for CY 2021, as discussed further
in section V.B.3. of the CY 2021 OPPS/ASC proposed rule).
We did not receive any public comments regarding our proposals.
Therefore, we are adopting these proposals as final for CY 2021 without
modification. The packaged or separately payable status of each of
these drugs or biologicals is listed in Addendum B of the CY 2021 OPPS/
ASC final rule (which is available via the internet on the CMS
website).
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4. Drugs, Biologicals, and Radiopharmaceuticals With Pass-Through
Payment Status Expiring in CY 2021
We proposed to end pass-through payment status in CY 2021 for 25
drugs and biologicals. These drugs and biologicals, which were approved
for pass-through payment status between April 1, 2018 and January 1,
2019, are listed in Table 37. The APCs and HCPCS codes for these drugs
and biologicals, which have pass-through payment status that will end
by December 31, 2021, are assigned status indicator ``G'' in Addenda A
and B to the CY 2021 OPPS/ASC proposed rule (which are available via
the internet on the CMS website).
Section 1833(t)(6)(D)(i) of the Act sets the amount of pass-through
payment for pass-through drugs and biologicals (the pass-through
payment amount) as the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. For CY 2021, we
[[Page 86023]]
proposed to continue to pay for pass-through drugs and biologicals at
ASP+6 percent, equivalent to the payment rate these drugs and
biologicals would receive in the physician's office setting in CY 2021.
We proposed that a $0 pass-through payment amount would be paid for
pass-through drugs and biologicals under the CY 2021 OPPS because the
difference between the amount authorized under section 1842(o) of the
Act, which was proposed at ASP+6 percent, and the portion of the
otherwise applicable OPD fee schedule that the Secretary determines is
appropriate, which was proposed at ASP+6 percent, is $0.
In the case of policy-packaged drugs (which include the following:
Anesthesia drugs; drugs, biologicals, and radiopharmaceuticals that
function as supplies when used in a diagnostic test or procedure
(including contrast agents, diagnostic radiopharmaceuticals, and stress
agents); and drugs and biologicals that function as supplies when used
in a surgical procedure), we proposed that their pass-through payment
amount would be equal to ASP+6 percent for CY 2021 minus a payment
offset for the portion of the otherwise applicable OPD fee schedule
that the Secretary determines is associated with the drug or biological
as described in section V.A.6. of the CY 2021 OPPS/ASC proposed rule.
We proposed this policy because, if not for the pass-through payment
status of these policy-packaged products, payment for these products
would be packaged into the associated procedure.
We proposed to continue to update pass-through payment rates on a
quarterly basis on the CMS website during CY 2021 if later quarter ASP
submissions (or more recent WAC or AWP information, as applicable)
indicate that adjustments to the payment rates for these pass-through
payment drugs or biologicals are necessary. For a full description of
this policy, we refer readers to the CY 2006 OPPS/ASC final rule with
comment period (70 FR 68632 through 68635).
For CY 2021, consistent with our CY 2020 policy for diagnostic and
therapeutic radiopharmaceuticals, we proposed to provide payment for
both diagnostic and therapeutic radiopharmaceuticals that are granted
pass-through payment status based on the ASP methodology. As stated
earlier, for purposes of pass-through payment, we consider
radiopharmaceuticals to be drugs under the OPPS. Therefore, if a
diagnostic or therapeutic radiopharmaceutical receives pass-through
payment status during CY 2021, we proposed to follow the standard ASP
methodology to determine the pass-through payment rate that drugs
receive under section 1842(o) of the Act, which was proposed at ASP+6
percent. If ASP data are not available for a radiopharmaceutical, we
proposed to provide pass-through payment at WAC+3 percent (consistent
with our proposed policy in section V.B.2.b. of the proposed rule), the
equivalent payment provided to pass-through payment drugs and
biologicals without ASP information. Additional detail on the WAC+3
percent payment policy can be found in section V.B.2.b. of the proposed
rule. If WAC information also is not available, we proposed to provide
payment for the pass-through radiopharmaceutical at 95 percent of its
most recent AWP.
We did not receive any public comments regarding our proposals.
Therefore, we are adopting these proposals as final for CY 2021 without
modification. The drugs and biologicals for which pass-through payment
status will expire between March 31, 2021 and December 31, 2021 are
shown in Table 37.
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5. Drugs, Biologicals, and Radiopharmaceuticals With Pass-Through
Payment Status Continuing in CY 2021
We proposed to continue pass-through payment status in CY 2021 for
46 drugs and note that 22 additional drugs were granted pass-through
status since publication of the proposed rule. Thus, for CY 2021, there
are 68 drugs and biologicals with pass-through status. These drugs and
biologicals, which were approved for pass-through payment status with
effective dates beginning between April 1, 2019 and January 1, 2021,
are listed in Table 38. The APCs and HCPCS codes for these drugs and
biologicals, which have pass-through payment status that will continue
after December 31, 2021, were assigned status indicator ``G'' in
Addenda A and B to the CY 2021 OPPS/ASC proposed rule (which are
available via the internet on the CMS website).
Section 1833(t)(6)(D)(i) of the Act sets the amount of pass-through
payment for pass-through drugs and biologicals (the pass-through
payment amount) as the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. For CY 2021, we proposed to continue to pay for
pass-through drugs and biologicals at ASP+6 percent, equivalent to the
payment rate these drugs and biologicals would receive in the
physician's office setting in CY 2021. We proposed that a $0 pass-
through payment amount would be paid for pass-through drugs and
biologicals under the CY 2021 OPPS because the difference between the
amount authorized under section 1842(o) of the Act, which was proposed
at ASP+6 percent, and the portion of the otherwise applicable OPD fee
schedule that the Secretary determines is appropriate, which was
proposed at ASP+6 percent, is $0.
In the case of policy-packaged drugs (which include the following:
Anesthesia drugs; drugs, biologicals, and radiopharmaceuticals that
function as supplies when used in a diagnostic test or procedure
(including contrast agents, diagnostic radiopharmaceuticals, and stress
agents); and drugs and biologicals that function as supplies when used
in a surgical procedure), we proposed that their pass-through payment
amount would be equal to ASP+6 percent for CY 2021 minus a payment
offset for any predecessor drug products contributing to the pass-
through payment as described in section V.A.6. of the CY 2021 OPPS/ASC
proposed rule. We proposed this policy because, if not for the pass-
through payment status of these policy-packaged products, payment for
these products would be packaged into the associated procedure.
We proposed to continue to update pass-through payment rates on a
quarterly basis on our website during CY 2021 if later quarter ASP
submissions (or more recent WAC or AWP information, as applicable)
indicate that adjustments to the payment rates for these pass-through
payment drugs or biologicals are necessary. For a full description of
this policy, we refer readers to the CY 2006 OPPS/ASC final rule with
comment period (70 FR 68632 through 68635).
For CY 2021, consistent with our CY 2020 policy for diagnostic and
therapeutic radiopharmaceuticals, we proposed to provide payment for
both diagnostic and therapeutic radiopharmaceuticals that are granted
pass-through payment status based on the ASP methodology. As stated
earlier, for purposes of pass-through payment, we consider
radiopharmaceuticals to be drugs under the OPPS. Therefore, if a
diagnostic or therapeutic radiopharmaceutical receives pass-through
payment status during CY 2021, we proposed to follow the standard ASP
methodology to determine the pass-through payment rate that drugs
receive under section 1842(o) of the Act, which was proposed at ASP+6
percent. If ASP data are not available for a radiopharmaceutical, we
proposed to provide pass-through payment at WAC+3 percent (consistent
with our proposed policy in section V.B.2.b. of the proposed rule), the
equivalent payment provided to pass-through payment drugs and
biologicals without ASP information. Additional detail on the WAC+3
percent payment policy can be found in section V.B.2.b. of the proposed
rule. If WAC information also is not available, we proposed to provide
payment for the pass-through radiopharmaceutical at 95 percent of its
most recent AWP.
We did not receive any public comments regarding our proposals.
Therefore, we are adopting these proposals for CY 2021 without
modification. The drugs and biologicals that have pass-through payment
status expire after December 31, 2021 are shown in Table 38.
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6. Provisions for Reducing Transitional Pass-Through Payments for
Policy-Packaged Drugs, Biologicals, and Radiopharmaceuticals To Offset
Costs Packaged into APC Groups
Under the regulations at 42 CFR 419.2(b), nonpass-through drugs,
biologicals, and radiopharmaceuticals that function as supplies when
used in a diagnostic test or procedure are packaged in the OPPS. This
category includes diagnostic radiopharmaceuticals, contrast agents,
stress agents, and other diagnostic drugs. Also under 42 CFR 419.2(b),
nonpass-through drugs and biologicals that function as supplies in a
surgical procedure are packaged in the OPPS. This category includes
skin substitutes and other surgical-supply drugs and biologicals. As
described earlier, section 1833(t)(6)(D)(i) of the Act specifies that
the transitional pass-through payment amount for pass-through drugs and
biologicals is the difference between the amount paid under section
1842(o) of the Act and the otherwise applicable OPD fee schedule
amount. Because a payment offset is necessary in order to provide an
appropriate transitional pass-through payment, we deduct from the pass-
through payment for policy-packaged drugs, biologicals, and
radiopharmaceuticals an amount reflecting the portion of the APC
payment associated with predecessor products in order to ensure no
duplicate payment is made. This amount reflecting the portion of the
APC payment associated with predecessor products is called the payment
offset.
The payment offset policy applies to all policy packaged drugs,
biologicals, and radiopharmaceuticals. For a full description of the
payment offset policy as applied to diagnostic radiopharmaceuticals,
contrast agents, stress agents, and skin substitutes, we
[[Page 86031]]
refer readers to the discussion in the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70430 through 70432). For CY 2021, as we did in
CY 2020, we proposed to continue to apply the same policy packaged
offset policy to payment for pass-through diagnostic
radiopharmaceuticals, pass-through contrast agents, pass-through stress
agents, and pass-through skin substitutes. The proposed APCs to which a
payment offset may be applicable for pass-through diagnostic
radiopharmaceuticals, pass-through contrast agents, pass-through stress
agents, and pass-through skin substitutes are identified in Table 39.
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We proposed to continue to post annually on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files.html a file that contains the
APC offset amounts that will be used for that year for purposes of both
evaluating cost significance for candidate pass-through payment device
categories and drugs and biologicals and establishing any appropriate
APC offset amounts. Specifically, the file will continue to provide the
amounts and percentages of APC payment associated with packaged
implantable devices, policy-packaged drugs, and threshold packaged
drugs and biologicals for every OPPS clinical APC.
Comment: One commenter requested that CMS release a copy of the APC
offset file with future OPPS/ASC proposed rules to enable the public to
[[Page 86032]]
calculate the percentage of APC payment associated with packaged drug
costs using APC offset data for the upcoming calendar year.
Response: We thank the commenter for their suggestion, and we will
consider addressing this request in future rulemaking.
B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals
Without Pass-Through Payment Status
1. Criteria for Packaging Payment for Drugs, Biologicals, and
Radiopharmaceuticals
a. Packaging Threshold
In accordance with section 1833(t)(16)(B) of the Act, the threshold
for establishing separate APCs for payment of drugs and biologicals was
set to $50 per administration during CYs 2005 and 2006. In CY 2007, we
used the four quarter moving average Producer Price Index (PPI) levels
for Pharmaceutical Preparations (Prescription) to trend the $50
threshold forward from the third quarter of CY 2005 (when the Pub. L.
108-173 mandated threshold became effective) to the third quarter of CY
2007. We then rounded the resulting dollar amount to the nearest $5
increment in order to determine the CY 2007 threshold amount of $55.
Using the same methodology as that used in CY 2007 (which is discussed
in more detail in the CY 2007 OPPS/ASC final rule with comment period
(71 FR 68085 through 68086)), we set the packaging threshold for
establishing separate APCs for drugs and biologicals at $130 for CY
2020 (84 FR 61312 through 61313).
Following the CY 2007 methodology, for this CY 2021 OPPS/ASC
proposed rule, we used the most recently available four quarter moving
average PPI levels to trend the $50 threshold forward from the third
quarter of CY 2005 to the third quarter of CY 2021 and rounded the
resulting dollar amount ($130.95) to the nearest $5 increment, which
yielded a figure of $130. In performing this calculation, we used the
most recent forecast of the quarterly index levels for the PPI for
Pharmaceuticals for Human Use (Prescription) (Bureau of Labor
Statistics series code WPUSI07003) from CMS' Office of the Actuary. For
this CY 2021 OPPS/ASC proposed rule, based on these calculations using
the CY 2007 OPPS methodology, we proposed a packaging threshold for CY
2021 of $130.
Comment: One commenter expressed their support for maintaining the
drug packaging threshold for CY 2021 at $130. The commenter believes,
however, that the drug packaging threshold has been increasing faster
than payment increases under the OPPS. The commenter would like us to
research if the drug packaging threshold should be lowered in future
years.
Response: We appreciate the commenter's support of the drug
packaging threshold level of $130. We also thank the commenter for
their suggestion to consider reducing the drug packaging threshold in
future years and will consider it for future rulemaking.
After consideration of the public comment, we are implementing our
proposal without modification to have a drug packaging threshold for CY
2021 of $130.
b. Packaging of Payment for HCPCS Codes That Describe Certain Drugs,
Certain Biologicals, and Therapeutic Radiopharmaceuticals Under the
Cost Threshold (``Threshold-Packaged Drugs'')
To determine the proposed CY 2021 packaging status for all nonpass-
through drugs and biologicals that are not policy packaged, we
calculated, on a HCPCS code-specific basis, the per day cost of all
drugs, biologicals, and therapeutic radiopharmaceuticals (collectively
called ``threshold-packaged'' drugs) that had a HCPCS code in CY 2019
and were paid (via packaged or separate payment) under the OPPS. We
used data from CY 2019 claims processed before January 1, 2020 for this
calculation. However, we did not perform this calculation for those
drugs and biologicals with multiple HCPCS codes that include different
dosages, as described in section V.B.1.d. of the proposed rule, or for
the following policy-packaged items that we proposed to continue to
package in CY 2021: Anesthesia drugs; drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure; and drugs and biologicals that function
as supplies when used in a surgical procedure.
In order to calculate the per day costs for drugs, biologicals, and
therapeutic radiopharmaceuticals to determine their proposed packaging
status in CY 2021, we use the methodology that was described in detail
in the CY 2006 OPPS proposed rule (70 FR 42723 through 42724) and
finalized in the CY 2006 OPPS final rule with comment period (70 FR
68636 through 68638). For each drug and biological HCPCS code, we used
an estimated payment rate of ASP+6 percent (which is the payment rate
we proposed for separately payable drugs and biologicals (other than
340B drugs) for CY 2021, as discussed in more detail in section
V.B.2.b. of the proposed rule) to calculate the CY 2021 proposed rule
per day costs. We used the manufacturer-submitted ASP data from the
fourth quarter of CY 2019 (data that were used for payment purposes in
the physician's office setting, effective April 1, 2020) to determine
the proposed rule per day cost.
As is our standard methodology, for CY 2021, we proposed to use
payment rates based on the ASP data from the fourth quarter of CY 2019
for budget neutrality estimates, packaging determinations, impact
analyses, and completion of Addenda A and B to the proposed rule (which
are available via the internet on the CMS website) because these were
the most recent data available for use at the time of development of
the proposed rule. These data also were the basis for drug payments in
the physician's office setting, effective April 1, 2020. For items that
did not have an ASP-based payment rate, such as some therapeutic
radiopharmaceuticals, we used their mean unit cost derived from the CY
2019 hospital claims data to determine their per day cost.
We proposed to package items with a per day cost less than or equal
to $130, and identify items with a per day cost greater than $130 as
separately payable unless they are policy-packaged. Consistent with our
past practice, we cross-walked historical OPPS claims data from the CY
2019 HCPCS codes that were reported to the CY 2020 HCPCS codes that we
display in Addendum B to the CY 2021 OPPS/ASC proposed rule (which is
available via the internet on the CMS website) for proposed payment in
CY 2021.
Our policy during previous cycles of the OPPS has been to use
updated ASP and claims data to make final determinations of the
packaging status of HCPCS codes for drugs, biologicals, and therapeutic
radiopharmaceuticals for the OPPS/ASC final rule with comment period.
We note that it is also our policy to make an annual packaging
determination for a HCPCS code only when we develop the OPPS/ASC final
rule with comment period for the update year. Only HCPCS codes that are
identified as separately payable in the final rule with comment period
are subject to quarterly updates. For our calculation of per day costs
of HCPCS codes for drugs and biologicals in this CY 2021 OPPS/ASC
proposed rule, we proposed to use ASP data from the fourth quarter of
CY 2019, which is the basis for calculating payment rates for drugs and
biologicals in the physician's office setting using the ASP
methodology, effective April 1, 2020, along with updated hospital
claims data from CY 2019. We note that we also
[[Page 86033]]
proposed to use these data for budget neutrality estimates and impact
analyses for this CY 2021 OPPS/ASC proposed rule.
Payment rates for HCPCS codes for separately payable drugs and
biologicals included in Addenda A and B for this final rule with
comment period will be based on ASP data from the third quarter of CY
2020. These data will be the basis for calculating payment rates for
drugs and biologicals in the physician's office setting using the ASP
methodology, effective October 1, 2020. These payment rates would then
be updated in the January 2021 OPPS update, based on the most recent
ASP data to be used for physicians' office and OPPS payment as of
January 1, 2021. For items that do not currently have an ASP-based
payment rate, we proposed to recalculate their mean unit cost from all
of the CY 2019 claims data and updated cost report information
available for the CY 2021 final rule with comment period to determine
their final per day cost.
Consequently, the packaging status of some HCPCS codes for drugs,
biologicals, and therapeutic radiopharmaceuticals in the proposed rule
may be different from the same drugs' HCPCS codes' packaging status
determined based on the data used for the final rule with comment
period. Under such circumstances, we proposed to continue to follow the
established policies initially adopted for the CY 2005 OPPS (69 FR
65780) in order to more equitably pay for those drugs whose costs
fluctuate relative to the proposed CY 2021 OPPS drug packaging
threshold and the drug's payment status (packaged or separately
payable) in CY 2020. These established policies have not changed for
many years and are the same as described in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70434). Specifically, for CY 2021,
consistent with our historical practice, we proposed to apply the
following policies to these HCPCS codes for drugs, biologicals, and
therapeutic radiopharmaceuticals whose relationship to the drug
packaging threshold changes based on the updated drug packaging
threshold and on the final updated data:
HCPCS codes for drugs and biologicals that were paid
separately in CY 2020 and that are proposed for separate payment in CY
2021, and that then have per day costs equal to or less than the CY
2021 final rule drug packaging threshold, based on the updated ASPs and
hospital claims data used for the CY 2021 final rule, would continue to
receive separate payment in CY 2021.
HCPCS codes for drugs and biologicals that were packaged
in CY 2020 and that are proposed for separate payment in CY 2021, and
that then have per day costs equal to or less than the CY 2021 final
rule drug packaging threshold, based on the updated ASPs and hospital
claims data used for the CY 2021 final rule, would remain packaged in
CY 2021.
HCPCS codes for drugs and biologicals for which we
proposed packaged payment in CY 2021 but that then have per-day costs
greater than the CY 2021 final rule drug packaging threshold, based on
the updated ASPs and hospital claims data used for the CY 2021 final
rule, would receive separate payment in CY 2021.
We did not receive any public comments on our proposal to
recalculate the mean unit cost for items that do not currently have an
ASP-based payment rate from all of the CY 2019 claims data and updated
cost report information available for this CY 2021 final rule with
comment period to determine their final per day cost. We also did not
receive any public comments on our proposal to continue to follow the
established policies, initially adopted for the CY 2005 OPPS (69 FR
65780), when the packaging status of some HCPCS codes for drugs,
biologicals, and therapeutic radiopharmaceuticals in the proposed rule
may be different from the same drug HCPCS code's packaging status
determined based on the data used for the final rule with comment
period. Therefore, for CY 2021, we are finalizing these two proposals
without modification.
c. Policy Packaged Drugs, Biologicals, and Radiopharmaceuticals
As mentioned earlier in this section, under the OPPS, we package
several categories of nonpass-through drugs, biologicals, and
radiopharmaceuticals, regardless of the cost of the products. Because
the products are packaged according to the policies in 42 CFR 419.2(b),
we refer to these packaged drugs, biologicals, and radiopharmaceuticals
as ``policy-packaged'' drugs, biologicals, and radiopharmaceuticals.
These policies are either longstanding or based on longstanding
principles and inherent to the OPPS and are as follows:
Anesthesia, certain drugs, biologicals, and other
pharmaceuticals; medical and surgical supplies and equipment; surgical
dressings; and devices used for external reduction of fractures and
dislocations (Sec. 419.2(b)(4));
Intraoperative items and services (Sec. 419.2(b)(14));
Drugs, biologicals, and radiopharmaceuticals that function
as supplies when used in a diagnostic test or procedure (including, but
not limited to, diagnostic radiopharmaceuticals, contrast agents, and
pharmacologic stress agents) (Sec. 419.2(b)(15)); and
Drugs and biologicals that function as supplies when used
in a surgical procedure (including, but not limited to, skin
substitutes and similar products that aid wound healing and implantable
biologicals) (Sec. 419.2(b)(16)).
The policy at Sec. 419.2(b)(16) is broader than that at Sec.
419.2(b)(14). As we stated in the CY 2015 OPPS/ASC final rule with
comment period: ``We consider all items related to the surgical outcome
and provided during the hospital stay in which the surgery is
performed, including postsurgical pain management drugs, to be part of
the surgery for purposes of our drug and biological surgical supply
packaging policy'' (79 FR 66875). The category described by Sec.
419.2(b)(15) is large and includes diagnostic radiopharmaceuticals,
contrast agents, stress agents, and some other products. The category
described by Sec. 419.2(b)(16) includes skin substitutes and some
other products. We believe it is important to reiterate that cost
consideration is not a factor when determining whether an item is a
surgical supply (79 FR 66875).
Comment: One commenter requested that we develop a policy to
provide separate payment for drugs that are administered at the time of
ophthalmic surgery and have an FDA-approved indication to treat or
prevent post-operative issues.
Response: A surgical procedure episode consists of both pre-
operative and post-operative care in addition to the surgical procedure
itself. If a drug used to address a post-operative concern, such as
pain management, is billed together with a surgical procedure, we
assume that the pain management drug was given as a part of the overall
surgical procedure, and based on our policy, it is required to be
packaged.
Comment: One commenter recommended that CMS continue to apply
radiolabeled product edits to the nuclear medicine procedures to ensure
that all packaged costs are included on nuclear medicine claims in
order to establish appropriate payment rates in the future. The
commenter was concerned that many providers performing nuclear medicine
procedures are not including the cost of diagnostic
radiopharmaceuticals used
[[Page 86034]]
for the procedures in their claims submissions. The commenter believes
this lack of drug cost reporting could be causing the cost of nuclear
medicine procedures to be underreported and therefore request that the
radiolabeled product edits be reinstated.
Response: We appreciated the commenter's feedback; however, we do
not plan to reinstate the radiolabeled product edits to nuclear
medicine procedures, which required a diagnostic radiopharmaceutical to
be present on the same claim as a nuclear medicine procedure for
payment to be made under the OPPS. As previously discussed in the CY
2020 OPPS/ASC final rule with comment period (84 FR 61314), the edits
were in place between CY 2008 and CY 2014 (78 FR 75033). We believe the
period of time in which the edits were in place was sufficient for
hospitals to gain experience reporting procedures involving
radiolabeled products and to become accustomed to ensuring that they
code and report charges so that their claims fully and appropriately
reflect the costs of those radiolabeled products. As with all other
items and services recognized under the OPPS, we expect hospitals to
code and report their costs appropriately, regardless of whether there
are claims processing edits in place.
Comment: The HOP Panel and several commenters requested that
diagnostic radiopharmaceuticals be paid separately in all cases, not
just when the drugs have pass-through payment status. One commenter
suggested payment based upon ASP, WAC, AWP, or mean unit cost data
derived from hospital claims. Some commenters mentioned that pass-
through payment status helps the diffusion of new diagnostic
radiopharmaceuticals into the market, but is not enough to make up for
what the commenters believe is inadequate payment after pass-through
status expires. Commenters opposed incorporating the cost of the drug
into the associated APC, and provided evidence showing procedures in
which diagnostic radiopharmaceuticals are considered to be a surgical
supply, which the commenter believed are often paid at a lower rate
than the payment rate for the diagnostic radiopharmaceutical itself
when the drug had pass-through payment status. Additionally, commenters
proposed alternative payment methodologies such as subjecting
diagnostic radiopharmaceuticals to the drug packaging threshold,
creating separate APC payments for diagnostic radiopharmaceuticals that
cost more than $500, or using ASP, WAC, or AWP to account for packaged
radiopharmaceutical costs.
Response: We thank commenters for their suggestions. Commenters
made many of these suggestions and we addressed them in previous rules,
including the CY 2019 OPPS/ASC final rule (83 FR 58955 through 58966)
and the CY 2020 OPPS/ASC final rule (84 FR 61314 through 61315). We
continue to believe that diagnostic radiopharmaceuticals are an
integral component of many nuclear medicine and imaging procedures and
charges associated with them should be reported on hospital claims to
the extent they are used. Therefore, the payment for the
radiopharmaceuticals is reflected within the payment for the primary
procedure. In response to the comment regarding the proposed cost of
the packaged procedure in CY 2021 being substantially lower than the
payment rate of the radiopharmaceutical when it was on pass-through
payment status plus the payment rate of the procedure associated with
the radiopharmaceutical, we note that rates are established in a manner
that uses the geometric mean of reported costs to furnish the procedure
based on data submitted to CMS from all hospitals paid under the OPPS
to set the payment rate for the service. Accordingly, the costs that
are calculated by Medicare reflect the average costs of items and
services that are packaged into a primary procedure and will not
necessarily equal the sum of the cost of the primary procedure and the
average sales price of the specific items and services used in the
procedure in each case. Furthermore, the costs will be based on the
reported costs submitted to Medicare by the hospitals and not the list
price established by the manufacturer. Claims data that include the
radiopharmaceutical packaged with the associated procedure reflect the
combined cost of the procedure and the radiopharmaceutical used in the
procedure. Additionally, we do not believe it is appropriate to create
a new packaging threshold specifically for diagnostic
radiopharmaceuticals as such a threshold would not align with our
overall packaging policy and commenters have submitted only limited
data to support a specific threshold. With respect to the request that
we create a new APC for each radiopharmaceutical product, we do not
believe it is appropriate to create unique APCs for diagnostic
radiopharmaceuticals. Diagnostic radiopharmaceuticals function as
supplies during a diagnostic test or procedure and following our
longstanding packaging policy, these items are packaged under the OPPS.
Packaging supports our goal of making OPPS payments consistent with
those of a prospective payment system, which packages costs into a
single aggregate payment for a service, encounter, or episode of care.
Furthermore, diagnostic radiopharmaceuticals function as supplies that
enable the provision of an independent service, and are not themselves
the primary therapeutic modality, and therefore, we do not believe they
warrant separate payment through creation of a unique APC at this time.
We welcome ongoing dialogue with stakeholders regarding suggestions for
payment changes for consideration for future rulemaking.
After consideration of the public comments we received, we are
finalizing our proposals without modification regarding products that
are packaged consistent with the policies in 42 CFR 419.2(b).
d. Packaging Determination for HCPCS Codes That Describe the Same Drug
or Biological but Different Dosages
In the CY 2010 OPPS/ASC final rule with comment period (74 FR 60490
through 60491), we finalized a policy to make a single packaging
determination for a drug, rather than an individual HCPCS code, when a
drug has multiple HCPCS codes describing different dosages because we
believe that adopting the standard HCPCS code-specific packaging
determinations for these codes could lead to inappropriate payment
incentives for hospitals to report certain HCPCS codes instead of
others. We continue to believe that making packaging determinations on
a drug-specific basis eliminates payment incentives for hospitals to
report certain HCPCS codes for drugs and allows hospitals flexibility
in choosing to report all HCPCS codes for different dosages of the same
drug or only the lowest dosage HCPCS code. Therefore, we proposed to
continue our policy to make packaging determinations on a drug-specific
basis, rather than a HCPCS code-specific basis, for those HCPCS codes
that describe the same drug or biological but different dosages in CY
2021.
For CY 2021, in order to propose a packaging determination that is
consistent across all HCPCS codes that describe different dosages of
the same drug or biological, we aggregated both our CY 2019 claims data
and our pricing information at ASP+6 percent across all of the HCPCS
codes that describe each distinct drug or biological in order to
determine the mean units per day of the drug or biological in terms of
the HCPCS
[[Page 86035]]
code with the lowest dosage descriptor. The following drugs did not
have pricing information available for the ASP methodology for this CY
2021 OPPS/ASC proposed rule, and as is our current policy for
determining the packaging status of other drugs, we used the mean unit
cost available from the CY 2019 claims data to make the proposed
packaging determinations for these drugs: HCPCS code C9257 (Injection,
bevacizumab, 0.25 mg); HCPCS code J1840 (Injection, kanamycin sulfate,
up to 500 mg); HCPCS code J1850 (Injection, kanamycin sulfate, up to 75
mg); HCPCS code J3472 (Injection, hyaluronidase, ovine, preservative
free, per 1000 usp units); HCPCS code J7100 (Infusion, dextran 40, 500
ml); and HCPCS code J7110 (Infusion, dextran 75, 500 ml).
For all other drugs and biologicals that have HCPCS codes
describing different doses, we then multiplied the proposed weighted
average ASP+6 percent per unit payment amount across all dosage levels
of a specific drug or biological by the estimated units per day for all
HCPCS codes that describe each drug or biological from our claims data
to determine the estimated per day cost of each drug or biological at
less than or equal to the proposed CY 2021 drug packaging threshold of
$130 (so that all HCPCS codes for the same drug or biological would be
packaged) or greater than the proposed CY 2021 drug packaging threshold
of $130 (so that all HCPCS codes for the same drug or biological would
be separately payable). The proposed packaging status of each drug and
biological HCPCS code to which this methodology would apply in CY 2018
was displayed in Table 25 of the CY 2021 OPPS/ASC proposed rule (82 FR
48879).
We did not receive any public comments on this proposal. Therefore,
for CY 2021, we are finalizing our proposal, without modification, to
continue our policy to make packaging determinations on a drug-specific
basis, rather than a HCPCS code-specific basis, for those HCPCS codes
that describe the same drug or biological but different dosages. The
packaging status of each drug and biological HCPCS code to which this
methodology applies in CY 2021 is displayed in Table 40.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
2. Payment for Drugs and Biologicals Without Pass-Through Status That
Are Not Packaged
a. Payment for Specified Covered Outpatient Drugs (SCODs) and Other
Separately Payable Drugs and Biologicals
Section 1833(t)(14) of the Act defines certain separately payable
radiopharmaceuticals, drugs, and biologicals and mandates specific
payments for these items. Under section 1833(t)(14)(B)(i) of the Act, a
``specified covered outpatient drug'' (known as a SCOD) is defined as a
covered outpatient drug, as defined in section 1927(k)(2) of the Act,
for which a separate APC has been established and that either is a
radiopharmaceutical agent or is a drug or biological for which payment
was made on a pass-through basis on or before December 31, 2002.
Under section 1833(t)(14)(B)(ii) of the Act, certain drugs and
biologicals are designated as exceptions and are not included in the
definition of SCODs. These exceptions are--
A drug or biological for which payment is first made on or
after January 1, 2003, under the transitional pass-through payment
provision in section 1833(t)(6) of the Act.
A drug or biological for which a temporary HCPCS code has
not been assigned.
During CYs 2004 and 2005, an orphan drug (as designated by
the Secretary).
Section 1833(t)(14)(A)(iii) of the Act requires that payment for
SCODs in CY 2006 and subsequent years be equal to the average
acquisition cost for the drug for that year as determined by the
Secretary, subject to any adjustment for overhead costs and taking into
account the hospital acquisition cost survey data collected by the
Government Accountability Office (GAO) in CYs 2004 and 2005, and later
periodic surveys conducted by the Secretary as set forth in the
statute. If hospital acquisition cost data are not available, the law
requires that payment be equal to payment rates established under the
methodology described in section 1842(o), section 1847A, or section
1847B of the Act, as calculated and adjusted by the Secretary as
necessary for purposes of paragraph (14). We refer to this alternative
methodology as the ``statutory default.'' Most physician Part B drugs
are paid at ASP+6 percent in accordance with section 1842(o) and
section 1847A of the Act.
Section 1833(t)(14)(E)(ii) of the Act provides for an adjustment in
OPPS payment rates for SCODs to take into account overhead and related
expenses, such as pharmacy services and handling costs. Section
1833(t)(14)(E)(i) of the Act
[[Page 86038]]
required MedPAC to study pharmacy overhead and related expenses and to
make recommendations to the Secretary regarding whether, and if so how,
a payment adjustment should be made to compensate hospitals for
overhead and related expenses. Section 1833(t)(14)(E)(ii) of the Act
authorizes the Secretary to adjust the weights for ambulatory procedure
classifications for SCODs to take into account the findings of the
MedPAC study.\69\
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\69\ Medicare Payment Advisory Committee. June 2005 Report to
the Congress. Chapter 6: Payment for pharmacy handling costs in
hospital outpatient departments. Available at: http://www.medpac.gov/docs/default-source/reports/June05_ch6.pdf?sfvrsn=0.
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It has been our policy since CY 2006 to apply the same treatment to
all separately payable drugs and biologicals, which include SCODs, and
drugs and biologicals that are not SCODs. Therefore, we apply the
payment methodology in section 1833(t)(14)(A)(iii) of the Act to SCODs,
as required by statute, but we also apply it to separately payable
drugs and biologicals that are not SCODs, which is a policy
determination rather than a statutory requirement. In the CY 2021 OPPS/
ASC proposed rule, we proposed to apply section 1833(t)(14)(A)(iii)(II)
of the Act to all separately payable drugs and biologicals, including
SCODs. Although we do not distinguish SCODs in this discussion, we note
that we are required to apply section 1833(t)(14)(A)(iii)(II) of the
Act to SCODs, but we also are applying this provision to other
separately payable drugs and biologicals, consistent with our history
of using the same payment methodology for all separately payable drugs
and biologicals.
For a detailed discussion of our OPPS drug payment policies from CY
2006 to CY 2012, we refer readers to the CY 2013 OPPS/ASC final rule
with comment period (77 FR 68383 through 68385). In the CY 2013 OPPS/
ASC final rule with comment period (77 FR 68386 through 68389), we
first adopted the statutory default policy to pay for separately
payable drugs and biologicals at ASP+6 percent based on section
1833(t)(14)(A)(iii)(II) of the Act. We have continued this policy of
paying for separately payable drugs and biologicals at the statutory
default for CYs 2014 through 2020.
b. Proposed CY 2021 Payment Policy
For CY 2021, we proposed to continue our payment policy that has
been in effect since CY 2013 to pay for separately payable drugs and
biologicals, with the exception of 340B-acquired drugs, at ASP+6
percent in accordance with section 1833(t)(14)(A)(iii)(II) of the Act
(the statutory default). We proposed to pay for separately payable
nonpass-through drugs acquired with a 340B discount at a net rate of
ASP minus 28.7 percent (as described in section V.B.6). We refer
readers to the CY 2018 OPPS/ASC final rule with comment period (82 FR
59353 through 59371), the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58979 through 58981), and the CY 2020 OPPS/ASC final rule
with comment period (84 FR 61321 through 61327) for more information
about our current payment policy for drugs and biologicals acquired
with a 340B discount.
In the case of a drug or biological during an initial sales period
in which data on the prices for sales of the drug or biological are not
sufficiently available from the manufacturer, section 1847A(c)(4) of
the Act permits the Secretary to make payments that are based on WAC.
Under section 1833(t)(14)(A)(iii)(II) of the Act, the amount of payment
for a separately payable drug equals the average price for the drug for
the year established under, among other authorities, section 1847A of
the Act. As explained in greater detail in the CY 2019 PFS final rule,
under section 1847A(c)(4) of the Act, although payments may be based on
WAC, unlike section 1847A(b) of the Act (which specifies that payments
using ASP or WAC must be made with a 6 percent add-on), section
1847A(c)(4) of the Act does not require that a particular add-on amount
be applied to WAC-based pricing for this initial period when ASP data
is not available. Consistent with section 1847A(c)(4) of the Act, in
the CY 2019 PFS final rule (83 FR 59661 to 59666), we finalized a
policy that, effective January 1, 2019, WAC-based payments for Part B
drugs made under section 1847A(c)(4) of the Act will utilize a 3-
percent add-on in place of the 6-percent add-on that was being used
according to our policy in effect as of CY 2018. For the CY 2019 OPPS,
we followed the same policy finalized in the CY 2019 PFS final rule (83
FR 59661 to 59666). In the CY 2020 OPPS/ASC final rule with comment
period, we adopted a policy to utilize a 3-percent add-on instead of a
6-percent add-on for drugs that are paid based on WAC under section
1847A(c)(4) of the Act pursuant to our authority under section
1833(t)(14)(A)(iii)(II) (84 FR 61318). For CY 2021, we proposed to
continue to utilize a 3-percent add-on instead of a 6-percent add-on
for WAC-based drugs pursuant to our authority under section
1833(t)(14)(A)(iii)(II) of the Act, which provides, in part, that the
amount of payment for a SCOD is the average price of the drug in the
year established under section 1847A of the Act. We also proposed to
apply this provision to non-SCOD separately payable drugs. Because we
proposed to establish the average price for a WAC-based drug under
section 1847A of the Act as WAC+3 percent instead of WAC+6 percent, we
believe it is appropriate to price separately payable WAC-based drugs
at the same amount under the OPPS. We proposed that, if finalized, our
proposal to pay for drugs or biologicals at WAC+3 percent, rather than
WAC+6 percent, would apply whenever WAC-based pricing is used for a
drug or biological under 1847A(c)(4). For drugs and biologicals that
would otherwise be subject to a payment reduction because they were
acquired under the 340B Program, the payment amount for these drugs
(proposed as a net rate of WAC minus 28.7 percent) would continue to
apply. We refer readers to the CY 2019 PFS final rule (83 FR 59661 to
59666) for additional background on this policy.
We proposed that payments for separately payable drugs and
biologicals would be included in the budget neutrality adjustments,
under the requirements in section 1833(t)(9)(B) of the Act. We also
propose that the budget neutral weight scalar would not be applied in
determining payments for these separately payable drugs and
biologicals.
We note that separately payable drug and biological payment rates
listed in Addenda A and B to the CY 2021 OPPS/ASC proposed rule
(available via the internet on the CMS website), which illustrate the
proposed CY 2021 payment of ASP+6 percent for separately payable
nonpass-through drugs and biologicals and ASP+6 percent for pass-
through drugs and biologicals, reflect either ASP information that is
the basis for calculating payment rates for drugs and biologicals in
the physician's office setting effective April 1, 2020, or WAC, AWP, or
mean unit cost from CY 2019 claims data and updated cost report
information available for the proposed rule. In general, these
published payment rates are not the same as the actual January 2021
payment rates. This is because payment rates for drugs and biologicals
with ASP information for January 2021 will be determined through the
standard quarterly process where ASP data submitted by manufacturers
for the third quarter of CY 2020 (July 1, 2020 through September 30,
2020) will be used to set the payment rates that are released for
[[Page 86039]]
the quarter beginning in January 2021 near the end of December 2020. In
addition, payment rates for drugs and biologicals in Addenda A and B to
the proposed rule for which there was no ASP information available for
April 2020 are based on mean unit cost in the available CY 2019 claims
data. If ASP information becomes available for payment for the quarter
beginning in January 2021, we will price payment for these drugs and
biologicals based on their newly available ASP information. Finally,
there may be drugs and biologicals that have ASP information available
for the proposed rule (reflecting April 2020 ASP data) that do not have
ASP information available for the quarter beginning in January 2021.
These drugs and biologicals would then be paid based on mean unit cost
data derived from CY 2019 hospital claims. Therefore, the proposed
payment rates listed in Addenda A and B to the proposed rule were not
for January 2021 payment purposes and are only illustrative of the CY
2021 OPPS payment methodology using the most recently available
information at the time of issuance of the proposed rule.
Comment: Multiple commenters expressed their support for paying for
separately payable drugs and biologicals at ASP plus 6 percent. The
commenters believe this policy is consistent with statute and
Congressional intent, and generates more predictable payment for
providers than previous payment methodologies for drugs and
biologicals. The commenters believe the ASP plus 6 percent payment
policy ensures equivalent payment for drugs and biologicals between the
outpatient hospital setting and the physician office, which encourages
Medicare beneficiaries to receive care in the most clinically
appropriate setting.
Response: We appreciate the commenters' support for our policy.
Comment: One commenter requested that an add-on percentage of
greater than 6 percent of ASP be paid for separately payable
radiopharmaceuticals to reflect higher overhead and handling costs for
these products.
Response: The add-on percentage of 6 percent is generally viewed as
reflecting the overhead and handling cost of most drugs,
radiopharmaceuticals, and biologicals that are separately payable in
the OPPS even though the overhead and handling costs for individual
products may be higher or lower than 6 percent of the ASP. It is not
practical to calculate the overhead and handling costs for each drug
and radiopharmaceutical. We believe that the add-on percentage of 6
percent is appropriate for separately payable radiopharmaceuticals.
After considering the public comments we received, we are
finalizing our proposals related to payment for specified covered
outpatient drugs (SCODs) and other separately payable drugs and
biologicals without modification.
c. Biosimilar Biological Products
For CY 2016 and CY 2017, we finalized a policy to pay for
biosimilar biological products based on the payment allowance of the
product as determined under section 1847A of the Act and to subject
nonpass-through biosimilar biological products to our annual threshold-
packaged policy (for CY 2016, 80 FR 70445 through 70446; and for CY
2017, 81 FR 79674). In the CY 2018 OPPS/ASC proposed rule (82 FR
33630), for CY 2018, we proposed to continue this same payment policy
for biosimilar biological products.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59351), we noted that, with respect to comments we received regarding
OPPS payment for biosimilar biological products, in the CY 2018 PFS
final rule, CMS finalized a policy to implement separate HCPCS codes
for biosimilar biological products. Therefore, consistent with our
established OPPS drug, biological, and radiopharmaceutical payment
policy, HCPCS coding for biosimilar biological products is based on the
policy established under the CY 2018 PFS final rule.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59351), after consideration of the public comments we received, we
finalized our proposed payment policy for biosimilar biological
products, with the following technical correction: all biosimilar
biological products are eligible for pass-through payment and not just
the first biosimilar biological product for a reference product. In the
CY 2019 OPPS/ASC proposed rule (83 FR 37123), for CY 2019, we proposed
to continue the policy in place from CY 2018 to make all biosimilar
biological products eligible for pass-through payment and not just the
first biosimilar biological product for a reference product.
In addition, in CY 2018, we adopted a policy that biosimilars
without pass-through payment status that were acquired under the 340B
Program would be paid the ASP of the biosimilar minus 22.5 percent of
the reference product's ASP (82 FR 59367). We adopted this policy in
the CY 2018 OPPS/ASC final rule with comment period because we believe
that biosimilars without pass-through payment status acquired under the
340B Program should be treated in the same manner as other drugs and
biologicals acquired through the 340B Program. As noted earlier,
biosimilars with pass-through payment status are paid their own ASP+6
percent of the reference product's ASP. Separately payable biosimilars
that do not have pass-through payment status and are not acquired under
the 340B Program are also paid their own ASP plus 6 percent of the
reference product's ASP. If a biosimilar does not have ASP pricing, but
instead has WAC pricing, the WAC pricing add-on of either 3 percent or
6 percent is calculated from the biosimilar's WAC and is not calculated
from the WAC price of the reference product.
As noted in the CY 2019 OPPS/ASC proposed rule (83 FR 37123),
several stakeholders raised concerns to us that the payment policy for
biosimilars acquired under the 340B Program could unfairly lower the
OPPS payment for biosimilars not on pass-through payment status because
the payment reduction would be based on the reference product's ASP,
which would generally be expected to be priced higher than the
biosimilar, thus resulting in a more significant reduction in payment
than if the 22.5 percent was calculated based on the biosimilar's ASP.
We agreed with stakeholders that the current payment policy could
unfairly lower the price of biosimilars without pass-through payment
status that are acquired under the 340B Program. In addition, we noted
that we believed that these changes would better reflect the resources
and production costs that biosimilar manufacturers incur. We also
stated that we believe this approach is more consistent with the
payment methodology for 340B-acquired drugs and biologicals, for which
the 22.5 percent reduction is calculated based on the drug or
biological's ASP, rather than the ASP of another product. In addition,
we explained that we believed that paying for biosimilars acquired
under the 340B Program at ASP minus 22.5 percent of the biosimilar's
ASP, rather than 22.5 percent of the reference product's ASP, will more
closely approximate hospitals' acquisition costs for these products.
Accordingly, in the CY 2019 OPPS/ASC proposed rule (83 FR 37123),
we proposed changes to our Medicare Part B drug payment methodology for
biosimilars acquired under the 340B Program. Specifically, for CY 2019
and subsequent years, in accordance with section
1833(t)(14)(A)(iii)(II) of the Act, we proposed to pay nonpass-through
biosimilars acquired under the 340B
[[Page 86040]]
Program at ASP minus 22.5 percent of the biosimilar's ASP instead of
the biosimilar's ASP minus 22.5 percent of the reference product's ASP.
This proposal was finalized without modification in the CY 2019 OPPS/
ASC final rule with comment period (83 FR 58977).
For CY 2021, we proposed to continue our policy to make all
biosimilar biological products eligible for pass-through payment and
not just the first biosimilar biological product for a reference
product. We also proposed to continue our current policy for paying for
nonpass-through biosimilars acquired under the 340B program, except
that we proposed to pay for these biosimilars at the biosimilar's ASP
minus 28.7 percent of the biosimilar's ASP instead of the biosimilar's
ASP minus 28.7 percent of the reference product's ASP, in accordance
with section 1833(t)(14)(A)(iii)(II) of the Act. ASP minus 28.7 percent
reflects the proposed net payment rate. However, in this final rule, as
discussed in section V.B.6, we are not adopting our proposal to pay for
drugs acquired under the 340B program at ASP minus 28.7 percent but
instead are continuing to pay for 340B drugs under the OPPS at ASP
minus 22.5 percent in the OPPS. Accordingly, we are also continuing our
policy to pay for biosimilars acquired through the 340B program at the
biosimilar's ASP minus 22.5 percent of the biosimilar's ASP.
Comment: Multiple commenters supported our proposal to continue our
policy from CY 2018 to make biosimilar biological products eligible for
pass-through payment and not just the first biosimilar biological
product for a reference product.
Response: We appreciate the commenters' support of this established
policy.
Comment: Multiple commenters supported our proposal to pay nonpass-
through biosimilars acquired under the 340B Program at ASP minus 28.7
percent of the biosimilar's ASP in accordance with section
1833(t)(14)(A)(iii)(II) of the Act.
Response: We appreciate the commenters' support. Please see section
V.B.6 of this final rule with comment period for a discussion of
payment for biosimilars acquired under the 340B program. As noted
above, we are not finalizing our proposal to pay for 340B drugs or
biologicals at a net rate of ASP minus 28.7 percent.
Comment: One commenter did not support our proposal to continue our
CY 2018 policy to make all biosimilar biological products eligible for
pass-through payment and not just the first biosimilar biological
product for a reference product. The commenter believes biosimilars are
not new or innovative drugs or biologicals because they believe the
reference product is the only new and innovative product. Therefore,
the commenter stated that biosimilars should not be considered for
pass-through payment status at all. Additionally, the commenter stated
that there should be a ``level playing field'' between biosimilars and
their reference products in order to increase competition and reduce
costs for beneficiaries. The commenter does not believe it is fair for
biosimilars of a reference product to be receiving pass-through payment
of ASP+6 percent of the reference product's ASP. The commenter pointed
out that when the reference product is no longer eligible for pass-
through payment, if it is acquired under the 340B program, hospitals
would be paid for the product at ASP minus 22.5 percent. The commenter
believes that this difference in the payment rates for biosimilars and
their reference products could potentially lead to increased Medicare
spending on biosimilars as providers utilize biosimilars instead of the
biosimilars' reference products because of the higher payment rates for
biosimilars in these circumstances.
Response: As discussed in the CY 2019 OPPS/ASC final rule with
comment period (83 FR 58977), we continue to believe that eligibility
for pass-through payment status reflects the unique, complex nature of
biosimilars and is important as biosimilars become established in the
market, just as it is for all other new drugs and biologicals. In terms
of the potential increased payment for biosimilars under our policy to
allow biosimilars to be eligible for pass-through status, overall
increased competition due to the presence of more biosimilars on the
market as a result of this policy is expected to drive payments down
for both Medicare and for beneficiaries over time, even if there may be
increased spending on biosimilars in the short term.
Comment: Several commenters recommended that CMS provide additional
support for biosimilars in the form of beneficial payment policies.
Some of these recommendations included a delayed effective date for the
340B payment reduction; a smaller reduction in payment for biosimilars
acquired under the 340B program; an add-on based on the reference
product's ASP when the biosimilar is subject to the 340B payment
reduction; increased payment for biosimilars in general; and biosimilar
value-based models.
Response: We thank the commenters for their feedback. However, we
maintain that our proposed payment policy for biosimilars adequately
supports these products by permitting both reference products and their
associated biosimilars to receive the same percentage add-on amount,
which is calculated based on the ASP of the reference product,
regardless of the biosimilar's ASP. Similarly, for products acquired
under the 340B program, we note that CMS pays for nonpass-through
biosimilars acquired under the 340B Program at ASP minus 22.5 percent
of the biosimilar's ASP rather than ASP minus 22.5 percent of the
reference product's ASP. If the payment reduction were based on the
reference product's ASP, which would generally be expected to be priced
higher than the biosimilar, it would result in a more significant
payment decrease than if the 22.5 percent were calculated based on the
biosimilar's ASP. Please see section V.B.6 for a discussion of payment
for biosimilars acquired under 340B. Biosimilars will be treated the
same as other separately payable drugs and cannot be excluded from the
340B discount once their pass-through period has ended. We do not
believe that additional add-on payments for biosimilars obtained under
the 340B program are necessary to encourage their utilization. We note
value-based models are outside of the scope of this rule.
For CY 2021, after consideration of the public comments we
received, we are finalizing our proposed payment policy for biosimilar
products, without modification, to continue the policy established in
CY 2018 to make all biosimilar biological products eligible for pass-
through payment and not just the first biosimilar biological product
for a reference product. We are also finalizing our alternative
proposal to pay nonpass-through biosimilars acquired under the 340B
Program at the biosimilar's ASP minus 22.5 percent of the biosimilar's
ASP, in accordance with section 1833(t)(14)(A)(iii)(II) of the Act. Our
final policy regarding the payment rate for drugs and biologicals that
are acquired under the 340B program is described in section V.B.6 of
this final rule with comment period.
3. Payment Policy for Therapeutic Radiopharmaceuticals
For CY 2021, we proposed to continue the payment policy for
therapeutic radiopharmaceuticals that began in CY 2010. We pay for
separately payable therapeutic radiopharmaceuticals under the ASP
methodology adopted for separately payable drugs and
[[Page 86041]]
biologicals. If ASP information is unavailable for a therapeutic
radiopharmaceutical, we base therapeutic radiopharmaceutical payment on
mean unit cost data derived from hospital claims. We believe that the
rationale outlined in the CY 2010 OPPS/ASC final rule with comment
period (74 FR 60524 through 60525) for applying the principles of
separately payable drug pricing to therapeutic radiopharmaceuticals
continues to be appropriate for nonpass-through, separately payable
therapeutic radiopharmaceuticals in CY 2021. Therefore, we proposed for
CY 2021 to pay all nonpass-through, separately payable therapeutic
radiopharmaceuticals at ASP+6 percent, based on the statutory default
described in section 1833(t)(14)(A)(iii)(II) of the Act. For a full
discussion of ASP-based payment for therapeutic radiopharmaceuticals,
we refer readers to the CY 2010 OPPS/ASC final rule with comment period
(74 FR 60520 through 60521). We also proposed to rely on CY 2019 mean
unit cost data derived from hospital claims data for payment rates for
therapeutic radiopharmaceuticals for which ASP data are unavailable and
to update the payment rates for separately payable therapeutic
radiopharmaceuticals according to our usual process for updating the
payment rates for separately payable drugs and biologicals on a
quarterly basis if updated ASP information is unavailable. For a
complete history of the OPPS payment policy for therapeutic
radiopharmaceuticals, we refer readers to the CY 2005 OPPS final rule
with comment period (69 FR 65811), the CY 2006 OPPS final rule with
comment period (70 FR 68655), and the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60524). The proposed CY 2021 payment rates for
nonpass-through, separately payable therapeutic radiopharmaceuticals
were included in Addenda A and B to the CY 2021 OPPS/ASC proposed rule
(which are available via the internet on the CMS website).
Comment: One commenter supported the continuation of this policy to
provide a predicable payment methodology and avoid the payment swings
that occurred prior to adoption of the statutory default rate.
Response: We thank the commenter for their support.
We did not receive any additional public comments on this proposal.
Therefore, we are finalizing our proposal, without modification, to
continue to pay all nonpass-through, separately payable therapeutic
radiopharmaceuticals at ASP+6 percent. We are also finalizing our
proposal to continue to rely on CY 2019 mean unit cost data derived
from hospital claims data for payment rates for therapeutic
radiopharmaceuticals for which ASP data are unavailable. The CY 2021
final payment rates for nonpass-through separately payable therapeutic
radiopharmaceuticals are included in Addenda A and B to this final rule
with comment period (which are available via the internet on the CMS
website).
4. Payment for Blood Clotting Factors
For CY 2020, we provided payment for blood clotting factors under
the same methodology as other nonpass-through separately payable drugs
and biologicals under the OPPS and continued paying an updated
furnishing fee (83 FR 58979). That is, for CY 2020, we provided payment
for blood clotting factors under the OPPS at ASP+6 percent, plus an
additional payment for the furnishing fee. We note that when blood
clotting factors are provided in physicians' offices under Medicare
Part B and in other Medicare settings, a furnishing fee is also applied
to the payment. The CY 2020 updated furnishing fee was $0.226 per unit.
For CY 2021, we proposed to pay for blood clotting factors at ASP+6
percent, consistent with our proposed payment policy for other nonpass-
through, separately payable drugs and biologicals, and to continue our
policy for payment of the furnishing fee using an updated amount. Our
policy to pay for a furnishing fee for blood clotting factors under the
OPPS is consistent with the methodology applied in the physician's
office and in the inpatient hospital setting. These methodologies were
first articulated in the CY 2006 OPPS final rule with comment period
(70 FR 68661) and later discussed in the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66765). The proposed furnishing fee update
is based on the percentage increase in the Consumer Price Index (CPI)
for medical care for the 12-month period ending with June of the
previous year. Because the Bureau of Labor Statistics releases the
applicable CPI data after the PFS and OPPS/ASC proposed rules are
published, we are not able to include the actual updated furnishing fee
in the proposed rules. Therefore, in accordance with our policy, as
finalized in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66765), we proposed to announce the actual figure for the percent
change in the applicable CPI and the updated furnishing fee calculated
based on that figure through applicable program instructions and
posting on our website at: http://www.cms.gov/Medicare/Medicare-Fee-
for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
We proposed to provide payment for blood clotting factors under the
same methodology as other separately payable drugs and biologicals
under the OPPS and to continue payment of an updated furnishing fee. We
will announce the actual figure of the percent change in the applicable
CPI and the updated furnishing fee calculation based on that figure
through the applicable program instructions and posting on the CMS
website.
We did not receive any public comments on our proposal. Therefore,
we are finalizing our proposal, without modification, to provide
payment for blood clotting factors under the same methodology as other
separately payable drugs and biologicals under the OPPS and to continue
payment of an updated furnishing fee. We will announce the actual
figure of the percent change in the applicable CPI and the updated
furnishing fee calculation based on that figure through the applicable
program instructions and posting on the CMS website.
5. Payment for Nonpass-Through Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes But Without OPPS Hospital Claims
Data
For CY 2021, we proposed to continue to use the same payment policy
as in CY 2020 for nonpass-through drugs, biologicals, and
radiopharmaceuticals with HCPCS codes but without OPPS hospital claims
data, which describes how we determine the payment rate for drugs,
biologicals, or radiopharmaceuticals without an ASP. For a detailed
discussion of the payment policy and methodology, we refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70442
through 70443). The proposed CY 2021 payment status of each of the
nonpass-through drugs, biologicals, and radiopharmaceuticals with HCPCS
codes but without OPPS hospital claims data is listed in Addendum B to
the CY 2021 OPPS/ASC proposed rule, which is available via the internet
on the CMS website.
We did not receive any comments on our proposal. Therefore, we are
finalizing our CY 2021 proposal without modification, including our
proposal to assign drug or biological products status indicator ``K''
and pay for them separately for the remainder of CY 2021 if pricing
information becomes available. The CY 2021 payment status of each of
the nonpass-through drugs, biologicals, and radiopharmaceuticals
[[Page 86042]]
with HCPCS codes but without OPPS hospital claims data is listed in
Addendum B to this final rule with comment period, which is available
via the internet on the CMS website.
6. CY 2021 OPPS Payment Methodology for 340B Purchased Drugs
a. Overview and Background
Section Overview
Under the OPPS, payment rates for drugs are typically based on
their average acquisition cost. This payment is governed by section
1847A of the Act, which generally sets a default rate of average sales
price (ASP) plus 6 percent for certain drugs; however, the Secretary
has statutory authority to adjust that rate under the OPPS. As
described below, beginning in CY 2018, the Secretary adjusted the 340B
drug payment rate to ASP minus 22.5 percent to approximate a minimum
average discount for 340B drugs, which was based on findings of the GAO
and MedPAC that hospitals were acquiring drugs at a significant
discount under HRSA's 340B Drug Pricing Program. As described in the
following sections, in December 2018, the United States District Court
for the District of Columbia (the district court) concluded that the
Secretary lacked the authority to bring the default rate in line with
average acquisition cost unless the Secretary obtained survey data from
hospitals on their acquisition costs. HHS disagreed with that ruling
and appealed the decision. HHS meanwhile gathered the relevant survey
data from 340B hospitals. As described in detail below, those survey
data confirmed that the ASP minus 22.5 percent rate does not underpay
340B hospitals, and the survey data could support an even lower payment
rate. The following sections expand upon the points discussed in this
overview.
Background
In the CY 2018 OPPS/ASC proposed rule (82 FR 33558 through 33724),
we proposed changes to the OPPS payment methodology for drugs and
biologicals (hereinafter referred to collectively as ``drugs'')
acquired under the 340B Program. We proposed these changes to better,
and more accurately, reflect the resources and acquisition costs that
these hospitals incur. We stated our belief that such changes would
allow Medicare beneficiaries (and the Medicare program) to pay a more
appropriate amount when hospitals participating in the 340B Program
furnish drugs to Medicare beneficiaries that are purchased under the
340B Program. Subsequently, in the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59369 through 59370), we finalized our proposal
and adjusted the payment rate for separately payable drugs and
biologicals (other than drugs with pass-through payment status and
vaccines) acquired under the 340B Program from average sales price
(ASP) plus 6 percent to ASP minus 22.5 percent. We stated that our goal
was to make Medicare payment for separately payable drugs more aligned
with the resources expended by hospitals to acquire such drugs, while
recognizing the intent of the 340B Program to allow covered entities,
including eligible hospitals, to stretch scarce resources in ways that
enable hospitals to continue providing access to care for Medicare
beneficiaries and other patients. Critical access hospitals are not
paid under the OPPS, and therefore are not subject to the OPPS payment
policy for 340B-acquired drugs. We also excepted rural sole community
hospitals, children's hospitals, and PPS-exempt cancer hospitals from
the 340B payment adjustment in CY 2018. In addition, as stated in the
CY 2018 OPPS/ASC final rule with comment period, this policy change
does not apply to drugs with pass-through payment status, which are
required to be paid based on the ASP methodology, or vaccines, which
are excluded from the 340B Program.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699
through 79706), we implemented section 603 of the Bipartisan Budget Act
of 2015. As a general matter, applicable items and services furnished
in certain off-campus outpatient departments of a provider on or after
January 1, 2017 are not considered covered outpatient services for
purposes of payment under the OPPS and are paid ``under the applicable
payment system,'' which is generally the Physician Fee Schedule (PFS).
However, consistent with our policy to pay separately payable, covered
outpatient drugs and biologicals acquired under the 340B Program at ASP
minus 22.5 percent, rather than ASP+6 percent, when billed by a
hospital paid under the OPPS that is not excepted from the payment
adjustment, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59015 through 59022), we finalized a policy to pay ASP minus 22.5
percent for 340B-acquired drugs and biologicals furnished in non-
excepted off-campus PBDs paid under the PFS. We adopted this payment
policy effective for CY 2019 and subsequent years.
We clarified in the CY 2019 OPPS/ASC proposed rule (83 FR 37125)
that the 340B payment adjustment applies to drugs that are priced using
either WAC or AWP, and that it has been our policy to subject 340B-
acquired drugs that use these pricing methodologies to the 340B payment
adjustment since the policy was first adopted. The 340B payment
adjustment for WAC-priced drugs is WAC minus 22.5 percent. 340B-
acquired drugs that are priced using AWP are paid an adjusted amount of
69.46 percent of AWP. The 69.46 percent of AWP is calculated by first
reducing the original 95 percent of AWP price by 6 percent to generate
a value that is similar to ASP or WAC with no percentage markup. Then
we apply the 22.5 percent reduction to ASP/WAC-similar AWP value to
obtain the 69.46 percent of AWP, which is similar to either ASP minus
22.5 percent or WAC minus 22.5 percent.
As discussed in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59369 through 59370), to effectuate the payment adjustment for
340B-acquired drugs, we implemented modifier ``JG'', effective January
1, 2018. Hospitals paid under the OPPS, other than a type of hospital
excluded from the OPPS (such as critical access hospitals), or excepted
from the 340B drug payment policy for CY 2018, were required to report
modifier ``JG'' on the same claim line as the drug HCPCS code to
identify a 340B-acquired drug. For CY 2018, rural sole community
hospitals, children's hospitals and PPS-exempt cancer hospitals were
excepted from the 340B payment adjustment. These hospitals were
required to report informational modifier ``TB'' for 340B-acquired
drugs, and continue to be paid ASP+6 percent. We refer readers to the
CY 2018 OPPS/ASC final rule with comment period (82 FR 59353 through
59370) for a full discussion and rationale for the CY 2018 policies and
use of modifiers ``JG'' and ``TB''.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
58981), we continued the Medicare 340B payment policies that were
implemented in CY 2018 and adopted a policy to pay for nonpass-through
340B-acquired biosimilars at ASP minus 22.5 percent of the biosimilar's
ASP, rather than of the reference product's ASP. In the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61321) we continued the 340B
policies that were implemented in CY 2018 and CY 2019.
Our CY 2018 and 2019 OPPS payment policies for 340B-acquired drugs
have been the subject of ongoing litigation. On December 27, 2018, in
the case of American Hospital Association, et al. v. Azar, et al., the
district court concluded in the context of reimbursement requests for
CY 2018 that the Secretary exceeded his statutory authority by
adjusting the Medicare payment rates
[[Page 86043]]
for drugs acquired under the 340B Program to ASP minus 22.5 percent for
that year.\70\ In that same decision, the district court recognized the
```havoc that piecemeal review of OPPS payment could bring about' in
light of the budget neutrality requirement,'' and ordered supplemental
briefing on the appropriate remedy.\71\ On May 6, 2019, after briefing
on remedy, the district court issued an opinion that reiterated that
the 2018 rate reduction exceeded the Secretary's authority, and
declared that the rate reduction for 2019 (which had been finalized
since the Court's initial order was entered) also exceeded his
authority.\72\ Rather than ordering HHS to pay plaintiffs their alleged
underpayments, however, the district court recognized that crafting a
remedy is ``no easy task, given Medicare's complexity,'' \73\ and
initially remanded the issue to HHS to devise an appropriate remedy
while also retaining jurisdiction. The district court acknowledged that
``if the Secretary were to retroactively raise the 2018 and 2019 340B
rates, budget neutrality would require him to retroactively lower the
2018 and 2019 rates for other Medicare Part B products and services.''
\74\ Id. at 19. ``And because HHS has already processed claims under
the previous rates, the Secretary would potentially be required to
recoup certain payments made to providers; an expensive and time-
consuming prospect.'' \75\
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\70\ American Hosp. Ass'n, et al. v. Azar, et al., No. 1:18-cv-
2084 (D.D.C. Dec. 27, 2018).
\71\ Id. at 35 (quoting Amgen, Inc. v. Smith, 357 F.3d 103, 112
(D.C. Cir. 2004) (citations omitted)).
\72\ See May 6, 2019 Memorandum Opinion, Granting in Part
Plaintiffs' Motion for a Permanent Injunction; Remanding the 2018
and 2019 OPPS Rules to HHS at 10-12.
\73\ Id. at 13.
\74\ Id. at 19.
\75\ Id. (citing Declaration of Elizabeth Richter).
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We respectfully disagreed with the district court's understanding
of the scope of the Secretary's adjustment authority. On July 10, 2019,
the district court entered final judgment. The agency appealed to the
United States Court of Appeals for the District of Columbia Circuit,
(hereinafter referred to as ``the D.C. Circuit''), and on July 31, 2020
the court entered an opinion reversing the district court's judgement
in this matter. Nonetheless, before the D.C. Circuit upheld our
authority to pay ASP minus 22.5 percent, we stated in the CY 2020 OPPS/
ASC final rule with comment period that we were taking the steps
necessary to craft an appropriate remedy in the event of an unfavorable
decision on appeal. Notably, after the CY 2020 OPPS/ASC proposed rule
was issued, we announced in the Federal Register (84 FR 51590) our
intent to conduct a 340B hospital survey to collect drug acquisition
cost data for certain quarters in CY 2018 and 2019. We stated that such
survey data may be used in setting the Medicare payment amount for
drugs acquired by 340B hospitals for cost years going forward, and also
may be used to devise a remedy for prior years if the district court's
ruling is upheld on appeal. The district court itself acknowledged that
CMS may base the Medicare payment amount on average acquisition cost
when survey data are available.\76\ No 340B hospital disputed in the
rulemakings for CY 2018 and 2019 that the ASP minus 22.5 percent
formula was a conservative adjustment that represented the minimum
discount that hospitals receive for drugs acquired through the 340B
program, which is significant because 340B hospitals have internal data
regarding their own drug acquisition costs. We stated in the CY 2020
OPPS/ASC final rule with comment period that we thus anticipated that
survey data collected for CY 2018 and 2019 would confirm that the ASP
minus 22.5 percent rate is a conservative amount that overcompensates
covered entity hospitals for drugs acquired under the 340B program. We
also explained that a remedy that relies on such survey data could
avoid the complexities referenced in the district court's opinion.
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\76\ See American Hosp. Assoc. v. Azar, 348 F. Supp. 3d 62, 82
(D.D.C. 2018).
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We noted that under current law, any changes to the OPPS must be
budget neutral, and reversal of the payment adjustment for 340B drugs,
which raised rates for non-drug items and services by an estimated $1.6
billion for 2018 alone, could have a significant economic impact on the
approximately 3,900 facilities that are paid for outpatient items and
services covered under the OPPS. In addition, we stated that any remedy
that increases payments to 340B hospitals could significantly affect
beneficiary cost-sharing. The items and services that could be affected
by the remedy were provided to millions of Medicare beneficiaries, who,
by law, are required to pay cost-sharing for most items and services,
which is usually 20 percent of the total Medicare payment rate.
Accordingly, we solicited comments on how to formulate an appropriate
remedy in the event of an unfavorable decision on appeal. Those
comments are summarized in the CY 2020 OPPS/ASC final rule with comment
period (84 FR 61323 through 61327).
b. Hospital Acquisition Cost Survey for 340B-Acquired Specified Covered
Outpatient Drugs (SCODs)
As discussed in the CY 2020 OPPS/ASC final rule with comment period
(84 FR 61326), we announced in the Federal Register (84 FR 51590) our
intent to conduct a 340B hospital survey to collect drug acquisition
cost data for the fourth quarter of CY 2018 and the first quarter of CY
2019. We noted that the survey data may be used in setting the Medicare
payment amount for drugs acquired by 340B hospitals for cost years
going forward, and also may be used to devise a remedy for prior years
in the event of an adverse decision on appeal in the pending
litigation. We stated that we believed it was prudent to use the
Secretary's existing authority to collect survey data to set OPPS
payment rates for drugs acquired under the 340B Program at rates based
on hospitals' costs to acquire such drugs. We also stated that we
believe it is appropriate for the Medicare program to pay for SCODs
purchased under the 340B program at a rate that approximates what
hospitals actually pay to acquire the drugs, and we believe it is
inappropriate for Medicare to subsidize other programs through Medicare
payments for separately payable drugs. We stated that this approach
would ensure that the Medicare program uses Medicare trust fund dollars
prudently, while maintaining beneficiary access to these drugs and
allowing beneficiary cost-sharing to be based on the amounts hospitals
actually pay to acquire the drugs.
Section 1833(t)(14)(D)(i)(I) of the Act required the Comptroller
General of the United States to conduct a survey in each of 2004 and
2005 to determine the hospital acquisition cost for each SCOD and, not
later than April 1, 2005, to furnish data from such surveys to the
Secretary for purposes of setting payment rates under the OPPS for
SCODs for 2006. The Comptroller General was then required to make
recommendations to the Secretary under section 1833(t)(14)(D)(i)(II) of
the Act regarding the frequency and methodology of subsequent surveys
to be conducted by the Secretary under clause (ii). Clause (ii) of
section 1833(t)(14)(D) of the Act provides that the Secretary, taking
into account such recommendations, shall conduct periodic subsequent
surveys to determine the hospital acquisition cost for SCODs for use in
setting payment rates under subparagraph (A) of section 1833(t)(14).
[[Page 86044]]
In response to the requirements at section 1833(t)(14)(D)(i)(I) and
(II) of the Act, the Government Accountability Office (GAO) surveyed
hospitals and prepared a report that included its recommendations for
the Secretary regarding the frequency and methodology for subsequent
surveys.\77\ While GAO recognized that collecting accurate and current
drug price data was important to ensure the agency does not pay too
much or too little for drugs, GAO's 2006 report recommended that CMS
conduct a streamlined hospital survey once or twice per decade because
of the significant operational difficulties and burden that such a
survey would place on hospitals and CMS.\78\ In response to questions
about whether the data undercounted rebates, GAO acknowledged that
their data did not include drug rebates or 340B rebates as part of its
calculation.\79\ In the CY 2006 OPPS final rule, we explained that the
data collected by the GAO was ultimately not used to set payment rates,
in part because the data did not fully account for rebates from
manufacturers or other price concessions or payments from group
purchasing organizations made to hospitals (70 FR 68640). Instead, we
adopted a policy to pay hospitals at ASP+6 percent because we believed
ASP+6 percent was a reasonable level of payment for both the hospital
acquisition and pharmacy overhead cost of drugs and biologicals (70 FR
68642).
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\77\ https://www.gao.gov/new.items/d06372.pdf.
\78\ Id. at 18.
\79\ https://www.gao.gov/new.items/d06372.pdf (Appendix I:
Purchase Price for Drug SCODs).
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Between 2006 and 2017, we have generally paid for separately
payable drugs for which ASP data is available at ASP plus 6 percent.
Beginning in 2018, we adopted the current policy to pay for 340B-
acquired drugs at ASP minus 22.5 percent to better align Medicare
payment with acquisition costs for 340B-acquired drugs. The Medicare
Payment Advisory Commission (MedPAC) has consistently stated that
Medicare should institute policies that improve the program's value to
beneficiaries and taxpayers. For example, in its March 2019 Report to
the Congress, MedPAC noted that outpatient payments increased in part
due to rapid growth in Part B drug spending. MedPAC stated this rapid
growth in OPPS specifically, was ``largely driven by the substantial
margins for drugs obtained through the 340B Drug Pricing Program.''
\80\ While we continue to believe that ASP plus 6 percent represents a
reasonable proxy for Part B drug acquisition costs for most hospitals,
we do not believe the same is true for hospitals that acquire Part B
drugs under the 340B program since such hospitals are able to purchase
drugs at deeply discounted 340B ceiling prices, or at even lower ``sub-
ceiling'' prices. For this reason, we concluded that it was appropriate
to survey 340B hospitals to gather drug acquisition cost data for drugs
acquired under the 340B program to allow us to pay hospitals for these
drugs at amounts that approximate the hospitals' acquisition costs.
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\80\ http://www.medpac.gov/docs/default-source/reports/mar19_medpac_entirereport_sec.pdf?sfvrsn=0.
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Population of Surveyed Hospitals
Because of our longstanding belief that ASP plus 6 percent is a
reasonable proxy for hospital acquisition costs and overhead for
separately payable drugs, we did not believe it was necessary or
appropriate to burden hospitals that are not eligible to acquire drugs
under the 340B program with a drug acquisition cost survey where we
have a proxy for hospital acquisition costs for those drugs. ASP data
does not, however, include 340B drug prices. (CY 2011 OPPS/ASC final
rule with comment period (75 FR 71800, 71960)). When GAO surveyed
hospitals in 2005, it found that the survey ``created a considerable
burden for hospitals as the data suppliers and considerable costs for
GAO as the data collector,'' and recommended that CMS survey hospitals
only once or twice per decade to ``occasionally validat[e] CMS's proxy
for SCODs' average acquisition costs--the [ASP] data that manufacturers
report.'' GAO Report to Congress: Survey Shows Price Variation and
Highlights Data Collection Lessons and Outpatient Rate-Setting
Challenges for CMS, 4 (April 2006). Section 1833(t)(14)(D)(ii) requires
the Secretary, in conducting periodic subsequent surveys, to take into
account GAO's recommendations on the frequency and methodology of
subsequent surveys. We considered GAO's conclusion that the 2005 survey
created ``considerable burden'' for hospitals and, thus, only surveyed
340B hospitals given our belief that the current payment rate for non-
340B hospitals continues to be an appropriate rate. For the same
reason, we also limited the data we requested from 340B hospitals to
acquisition costs for 340B-acquired drugs, rather than for drugs
purchased outside the 340B program for 340B participating hospitals. We
note that section 1833(t)(14)(D)(ii) refers to use of surveys conducted
by the Secretary to determine the hospital acquisition costs for SCODs
in setting payment rates under subparagraph (A). Therefore, we stated
that we believed it is appropriate to read the two provisions together
to permit the Secretary to survey 340B hospitals only, and formulate a
340B payment policy for this hospital group that is distinct from the
payment policy for non-340B hospitals.
Survey Methodology
Under the authority at section 1833(t)(14)(D)(ii) to conduct
periodic subsequent surveys to determine hospital acquisition costs, we
administered the survey to 1,422 340B covered entity hospitals between
April 24 and May 15, 2020. We requested that all hospitals that
participated in the 340B program, including rural sole community
hospitals (SCHs), children's hospitals, and PPS-exempt cancer hospitals
(which are currently exempt from the Medicare 340B payment rate
adjustment), supply their average acquisition cost for each SCOD
purchased under the 340B program during the last quarter of CY 2018
(October 1, 2018 through December 31, 2018) and/or the first quarter of
2019 (January 1, 2019 through March 31, 2019), which could be the 340B
ceiling price, a 340B sub-ceiling price, or another amount, depending
on the discounts the hospital received when it acquired a particular
drug. The ceiling price is the maximum amount covered entities may
permissibly be required to pay for a drug under section 340B(a)(1) of
the Public Health Service Act, so we would not expect any 340B hospital
to have acquisition costs for any 340B-acquired drug that are greater
than the ceiling price. For this reason, where the acquisition price
for a particular drug was not available or not submitted in response to
the survey, we stated that we would use the 340B ceiling price for that
drug as a proxy for the hospitals' acquisition cost in order to produce
the most conservative drug discount when data was missing or not
submitted.
We incorporated valuable input from stakeholders on the development
and construction of the 340B acquisition cost survey. We collected the
stakeholders' input in two rounds of public comment through the survey
Paperwork Reduction Act (PRA) submission process. We published the
initial 340B drug hospital acquisition cost survey proposal in the
Federal Register (84 FR 51590) for a 60-day public comment period that
began September 30, 2019 and ended November 29, 2019. After
incorporating comments from the 60-day public comment period, we
released a revised 340B acquisition cost survey proposal in the Federal
Register (85 FR 7306) for a
[[Page 86045]]
30-day public comment period from February 7, 2020 to March 9, 2020.
After incorporating the stakeholders' comments and suggestions from
the second public comment period, OMB approved CMS' survey design (OMB
control number 0938-1374, expires 10/31/2021), and CMS released the
340B acquisition cost survey to the relevant 340B hospitals under the
OPPS. As mentioned earlier in this section, the survey was open from
April 24, 2020, to May 15, 2020. The survey sample was 100 percent of
the potential respondent universe, or all hospitals that acquired drugs
under the 340B Program and were paid under OPPS in the fourth quarter
of 2018 and/or the first quarter of 2019. We provided respondents with
two options to complete the survey: The Detailed Survey and the Quick
Survey.
Respondents that selected the Detailed Survey provided acquisition
costs for each individual SCOD. We requested that these respondents
report the net acquisition cost for each SCOD that they acquired under
the 340B program (that is, the sub-ceiling price after all applicable
discounts). We stated that if the acquisition cost for the SCOD was
unknown, the respondent may leave the field blank and we would use the
340B ceiling price as a proxy for the acquisition cost for that drug.
In the survey instructions, we stated that acquisition cost for
purposes of the survey meant the price that the hospitals paid upon
receiving the product, including, but not limited to, prices paid for
340B drugs purchased via a replenishment model under the 340B program,
or under penny pricing. We explained that applicable discounts are any
discounts below the discounted ceiling price. We also made clear that
for purposes of the survey the 340B drug acquisition cost should be
reported regardless of whether the drug was dispensed at all, or
whether the drug was dispensed in multiple settings. We only requested
the acquisition cost of the drugs acquired under the 340B program
during the specified timeframes: The fourth quarter of 2018 and/or the
first quarter of 2019. We also stated that acquisition costs for drugs
acquired by 340B hospitals outside of the 340B program should not be
submitted in response to the survey.
The Quick Survey option allowed the hospital to indicate that it
preferred that CMS utilize the 340B ceiling prices obtained from (HRSA)
as reflective of their hospital acquisition costs. Additionally, we
stated that in instances where the acquisition price for a particular
drug is not available or submitted in response to the survey, we would
use the 340B ceiling price for that drug as a proxy for the hospitals'
acquisition cost because the price for a drug acquired under the 340B
program cannot be higher than the 340B ceiling price by statute.
Finally, we noted that where a hospital did not affirmatively respond
to the Detailed or Quick Survey within the open period of response, we
would use the 340B ceiling prices in lieu of their responses because
the ceiling price represents the highest possible price that a 340B
hospital could permissibly be required to pay for a 340B-acquired drug.
c. Analysis of Hospital Acquisition Cost Survey Data for 340B Drugs
The results of the survey, which closed on May 15, 2020 were as
follows: Seven percent (n=100) of surveyed hospitals affirmatively
responded via the Detailed Survey option; 55 percent (n=780) of
surveyed hospitals affirmatively responded via the Quick Survey option;
and the remaining 38 percent (n=542) of surveyed hospitals did not
respond affirmatively to either survey option. As previously noted, we
applied 340B ceiling prices for hospitals that did not affirmatively
respond to the survey; such action may skew the survey results towards
the minimum average discount (that is, the ceiling price) that a 340B
hospital would receive on a drug.
We also examined the hospital characteristics of those hospitals
that submitted either a Detailed or Quick Survey to the general 340B
survey population. The characteristics we analyzed included hospital
bed count, teaching hospital status, hospital type, and geographic
classification as a rural or urban hospital. Our findings showed that
the hospital survey respondents, including respondents to both the
Quick and Detailed surveys, were generally similar to the hospital
characteristics of the aggregate 340B survey population.
d. Proposed Payment Policy for Drugs Acquired Under the 340B Program
for CY 2021
(1) Grouping Hospitals by 340B Covered Entity Status
Section 1833(t)(14)(A)(iii)(I) authorizes the Secretary to set the
amount of payment for SCODs at an amount equal to the average
acquisition cost for the drug for that year (which, at the option of
the Secretary, may vary by hospital group (as defined by the Secretary
based on volume of covered OPD services or other relevant
characteristics)), as determined by the Secretary taking into account
the hospital acquisition cost survey data under subparagraph (D). In
the CY 2021 OPPS/ASC proposed rule, we stated that we were exercising
the authority to vary the amount of payment for the group of hospitals
that is enrolled in the 340B program because their drug acquisition
costs vary significantly from those not enrolled in that program.
Section 1833(t)(14)(A)(iii) of the Act allows the Secretary to exercise
discretion to vary payment by hospital group, ``as defined by the
Secretary based on the volume of covered OPD services or other relevant
characteristics.'' We stated that we believe that it is within the
Secretary's authority to distinguish between hospital groups based on
whether or not they are covered entities under section 340B(a)(4) of
the PHSA that are eligible to receive drugs and biologicals at
discounted rates under the 340B program. We also stated that we believe
that the significant drug acquisition cost discounts that 340B covered
entity hospitals receive enable these hospitals to acquire drugs at
much lower costs than non-340B hospitals incur for the same drugs.
Accordingly, we explained that we believe it is appropriate to use 340B
covered entity status as a relevant characteristic to group hospitals
for purposes of payment based on average acquisition cost under section
1833(t)(14)(A)(iii)(I).
(2) Applying a Single Reduction Amount to ASP for 340B-Acquired Drugs
Section 1833(t)(14)(A)(iii)(I) provides that the payment amount for
a SCOD for a year is equal to the average acquisition cost for the drug
``as determined by the Secretary taking into account'' the survey data
collected under subparagraph (D). As we explained in the CY 2021 OPPS/
ASC proposed rule (85 FR 48886), we interpret the reference to
acquisition costs being ``determined'' by the Secretary, ``taking into
account'' survey data, to give us discretion to determine the
appropriate payment rate based on data collected from the hospital
acquisition cost survey for 340B drugs. We proposed to apply a single
discount factor to ASP for drugs acquired by 340B hospitals in lieu of
calculating individual acquisition cost amounts for 340B-acquired
drugs. We note that 340B ceiling prices are protected from disclosure
both because the prices themselves are sensitive, and because they
could potentially be used to reverse-engineer average manufacturer
prices, which are protected under section 1927(b)(3)(D) of the Act. We
also pledged confidentiality of individual responses regarding
acquisition prices for each SCOD to the extent required by law. Given
that the survey data is heavily weighted towards
[[Page 86046]]
340B ceiling prices (because 340B ceiling prices were used for any
SCODs within the Detailed Survey for which a hospital did not provide
responses, for hospitals that selected the Quick Survey option, and for
hospitals that did not affirmatively respond), and since ceiling prices
are protected by law from public disclosure, we instead proposed to
establish one aggregate discount amount relative to ASP for SCODs
acquired under the 340B program rather than proposing drug-specific
prices, which could reveal sensitive or protected pricing information.
(3) Methodology To Calculate ASP Reduction Amount Based on Survey Data
As we explained in the CY 2021 OPPS/ASC proposed rule and as
described in detail in the following sections, we analyzed the survey
results and applied various statistical methodologies to determine an
appropriate average or typical amount by which to reduce ASP that would
approximate hospital acquisition costs for 340B drugs and biologicals.
In fairness to hospitals, we generally chose methodologies that yield
the most conservative reduction to ASP when establishing the payment
rate, and thus would be most generous to hospitals. This includes the
use of 340B ceiling prices, which must be kept confidential, where
applicable in the survey results. Based on our analysis of the
available information, we estimated that the typical acquisition cost
for 340B drugs for hospitals paid under the OPPS is ASP minus 34.7
percent.
We explained in the proposed rule that we determined the average
discount of 34.7 percent by assessing a number of factors including:
Multiple measures of central tendencies (arithmetic mean, median,
geometric mean); the effect of including penny priced drugs; mapping of
multi-source NDCs to a single HCPCS code; weighting values by volume/
utilization; and applying trimming methodologies to remove anomalous or
outlier data. The analysis of each of these variables is discussed in
the next section.
(a) Selecting an Averaging Methodology
When determining the appropriate average reduction amount relative
to ASP for 340B drugs, we assessed multiple measures of central
tendencies, including the arithmetic mean, median, and geometric mean,
on the typical 340B discount based on drug acquisition cost survey
data. Based upon the cumulative data from the Detailed Survey option,
the Quick Survey option, and imputed responses for hospitals that did
not affirmatively respond, we analyzed the effects of each averaging
method, combining the data from all three sources in both survey
quarters (fourth quarter 2018 and first quarter 2019). Using the raw
data without accounting for outliers, we explained in the proposed rule
that we determined that the arithmetic mean would result in an average
discount from ASP of approximately 66.3 percent; the median would
result in an average discount from ASP of approximately 70.4 percent,
and the geometric mean would result in an average discount from ASP of
approximately 58.3 percent.
Under the OPPS, we generally calculate resource costs for a given
service using the geometric mean. The geometric mean minimizes the
effects of the outliers without ignoring them. Minimizing outliers is
consistent with our methodology to estimate an average or typical 340B
discount that is representative across all 340B SCODs. Therefore, we
proposed to utilize the geometric mean discount to ASP from both survey
quarters--2018 Q4 and 2019 Q1--as a component of our overall analysis
of the survey data. Without any further adjustments, we explained that
applying the geometric mean to the survey results would result in an
average drug acquisition cost estimate of ASP minus 58.3 percent for
340B-acquired drugs.
(b) Volume Weighting Survey Data
While we realize the geometric mean minimizes the effects of some
outliers, it does not take into consideration several other important
factors. Notably, we explained in the proposed rule that we believe
that in calculating the average discount that 340B drugs receive
relative to ASP, we should take into account how often those drugs were
billed by all hospitals under the OPPS for 2018 and 2019, to give a
better reflection of each drug's overall utilization under the OPPS.
Therefore, we volume-weighted the drug discounts determined from the
survey to mirror the drug utilization in the OPPS. That is, drugs that
were commonly used were assigned a higher weight while those less
commonly used were assigned a lower weight. We explained that we
incorporated volume weighting into our analysis by assessing the
utilization rate of each individual drug (using its HCPCS code) under
the OPPS for CY 2018 and CY 2019. Specifically, we calculated the
average discount by taking the utilization of each drug under the OPPS
into account to arrive at a case-weighted average for each HCPCS code.
For example, a highly utilized HCPCS code for an oncology drug would be
weighted higher than a drug for snake anti-venom that has relatively
low utilization in the OPPS. In the proposed rule, we stated that the
data for CY 2018 Q4 was volume weighted based upon OPPS utilization
during CY 2018 as determined using OPPS claims data. The data for CY
2019 Q1 was volume weighted based upon OPPS utilization during CY 2019
as determined using OPPS claims data. As we explained in the proposed
rule, this resulted in a change in the geometric mean to an average
discount of 58.0 percent from 58.3 percent non-weighted.
(c) Addressing HCPCS Codes With Multiple NDCs
In addition, we stated in the proposed rule that a small portion of
the SCODs that were subject to the 340B drug acquisition cost survey
contain multiple NDCs that map to a single HCPCS code. This is because
these drugs are multiple source drugs, meaning that they were
manufactured by different entities and have varying package sizes or
strengths, and thus, multiple different NDCs for the same drug. For
payment purposes under the OPPS, we pay for drug products based on the
drug's HCPCS code, regardless of which NDC is used. Hospitals that
completed the Detailed Survey option were instructed to report their
average acquisition costs for each drug during the surveyed quarters
per HCPCS code. However, for those hospitals that opted for the Quick
Survey option or that did not affirmatively respond, we were unable to
determine which combination of NDCs mapped to the HCPCS codes these
entities would have used during the given quarters. Therefore, we
analyzed the effects of averaging all of the NDCs' acquisition costs
for a given HCPCS code when determining the average discount, as well
as selecting the NDC with the highest acquisition cost for a given
HCPCS code and using that NDC's acquisition cost amount to determine
the average discount. When we calculated the average discount using an
average of the acquisition costs for all of the NDCs assigned to the
HCPCS code, the average volume weighted geometric mean discount off of
ASP is 58.0 percent. The 58.0 percent was calculated by taking all of
the various NDCs (across various manufacturers, package sizes, and
strengths) for the same drug and averaging the unit costs together in
order to arrive at a single amount for each HCPCS code for a drug. When
we calculated the average discount using the highest acquisition cost
NDC for each HCPCS code for a
[[Page 86047]]
drug, the average volume weighted geometric mean discount from ASP is
47.0 percent. This was achieved by analyzing all of the various NDCs
(across various manufacturers, package sizes, and strengths) assigned
to the HCPCS code for the same drug and selecting the NDC that has the
highest unit cost in order to arrive at a single cost for each HCPCS
code. Consistent with the general principle of choosing the
methodological approach that is most generous to hospitals, we proposed
to use the highest acquisition cost NDC for each HCPCS code for a drug
to determine the average 340B discount.
(d) Addressing Penny Pricing in the Survey Data
As part of our analysis of the survey data, we examined the effect
of including ``penny priced'' drugs on the average discount off of ASP.
The 340B ceiling price is statutorily defined as the Average
Manufacturer Price (AMP) reduced by the rebate percentage, which is
commonly referred to as the Unit Rebate Amount (URA).\81\ The
calculation of the 340B ceiling price is defined in section 340B(a)(1)
of the PHSA. Penny pricing occurs when, under section 1927(c)(2)(A) of
the Social Security Act, the AMP increases at a rate faster than
inflation, in which case the manufacturer is required to pay an
additional rebate amount, which is reflected in an increased URA and
could result in a 340B ceiling price of zero. However, as HRSA noted in
the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil
Monetary Penalties Regulation Final Rule (82 FR 1210), although
infrequent, there are instances when the 340B ceiling price is zero.
HRSA did not believe that it is consistent with the statutory scheme to
set the price at zero. In this circumstance, HRSA required that
manufacturers charge $0.01 for the drug, which they believed best
effectuates the statutory scheme by requiring a payment.\82\ We
proposed to exclude penny priced drugs to remove outliers that may
distort the average discount in order to provide the most conservative
estimate of the average 340B discount from ASP.
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\81\ https://www.hrsa.gov/opa/updates/2015/may.html.
\82\ https://www.govinfo.gov/content/pkg/FR-2017-01-05/pdf/2016-31935.pdf.
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In the proposed rule, we acknowledged that penny pricing of drugs
is not intended to be permanent and, by its very nature, is dynamic,
meaning the select group of drugs to which penny pricing applies could
vary from quarter to quarter. We analyzed the inclusion and exclusion
of penny pricing on the overall average discount of 340B drugs compared
to ASP. As expected, we found that excluding penny pricing provides a
much more conservative estimate of the average 340B discount from ASP
relative to including penny pricing. When we excluded penny pricing,
the geometric mean volume weighted average discount, using the highest
NDC for a drug's HCPCS code, decreased to 40.9 percent from 47.0
percent. We observed penny pricing in less than 10 percent of the drugs
surveyed. Because penny pricing is dynamic and the drugs to which it
applies may vary from quarter to quarter, we believe it is appropriate
to exclude penny pricing from our survey analysis, although we
acknowledge that penny pricing, when it does apply, represents the
acquisition cost for the drug to which it applies.
We stated in the proposed rule that we were concerned that
including a discount of a penny priced drug from the two quarters
surveyed may inappropriately increase the average discount, where the
drug may not have been priced based on penny pricing in following or
preceding quarters. However, it also is the case that a drug could have
penny pricing for any given quarter and it could be appropriate to
include penny priced drugs in the calculation of the average
acquisition cost because in such cases, penny prices do represent the
maximum (ceiling) price the 340B hospital would pay for that drug.
Nonetheless, in order to provide for a more conservative discount
estimate, we proposed to exclude penny priced drugs from our analysis,
but solicited public comment on whether such a policy accurately
represents 340B drug acquisition costs.
(e) Addressing Outliers
In response to the Detailed Survey, hospitals provided some drug
acquisition cost data that exceeded 340B ceiling prices, and in some
cases even exceeded the ASP or ASP+6 percent payment rate for certain
drugs. As previously noted, covered entities cannot be required to pay
more than the ceiling price to acquire a drug under the 340B program.
Therefore, we attributed any Detailed Survey acquisition cost data
greater than the ceiling price to potential data entry error; for
instance, miscalculation or incorrect decimal point placement. However,
because hospitals may have been overcharged for their drug acquisition
costs and could have accurately reported acquisition costs greater than
the HRSA ceiling price, we did not eliminate these data from our
calculations. Instead, consistent with our standard methodology for
processing extreme outliers under the OPPS, we excluded responses for
any SCODs that were three standard deviations from the geometric mean.
We believe applying a three standard deviation limit to the reported
acquisition data is appropriate because it removes outliers from both
the high and low reported values. In addition, applying a three
standard deviations limit may be more representative of the
respondents' acquisition cost, even though it may not eliminate some
data values that are above the ceiling price. While this approach means
that some values above the ceiling price will be included in our data
analysis, we did not propose to trim them because we proposed to apply
a standard trimming methodology. The cumulative application of this
trimming methodology, along with other methodologies applied to the
survey data described above, results in an average acquisition cost for
drugs that hospitals acquire under the 340B program of ASP minus 34.7
percent. For the reasons previously discussed, we proposed to exclude
survey data from the Detailed Survey that is more than three standard
deviations from the mean. We note that we also explored capping any
survey submissions received at the 340B ceiling price, as no covered
entity can be required to pay more than the ceiling price. This
approach, holding all other methodological approaches constant, would
have resulted in an average acquisition cost of ASP minus 41.5 percent
for drugs acquired under the 340B program.
Table 41, Aggregate 340B Drug Program Cost Savings Percentage
Relative to ASP, shows the aggregate 340B drug program discount
percentage relative to ASP using several different statistical
measures. In this table, we outlined some additional figures following
a similar path as described above. For example, we arrived at the 33.8
percent figure in Table 41 under median, and penny pricing excluded, by
initially choosing the median as the averaging methodology, and then
performing trimming methodologies as described above, which include
volume weighting by HCPCS code, using the highest NDC per HCPCS code,
and using only data within three standard deviations of the median.
This would have resulted in a final proposed discount of 33.8 percent.
While this final discount appears more generous to hospitals than our
proposal, we do not believe it would be appropriate. Specifically, we
believe using the
[[Page 86048]]
geometric mean as outlined in the methodology above is the most
generous methodology for establishing a final discount amount that also
maintains accuracy and consistency with past OPPS practices. As
described previously, under the OPPS, we generally calculate resource
costs for a given service using the geometric mean. The geometric mean
minimizes the effects of the outliers without ignoring them. As an
additional example, under the arithmetic mean methodology with penny
pricing included in Table 41, the final discount was determined to be
23.1 percent. We arrived at this figure of 23.1 percent by initially
choosing the arithmetic mean as the averaging methodology, and then
performing trimming methodologies as described above, with the
exception of including penny prices in this figure. Similar to the
discussion above regarding the use of the median, we do not think
utilizing the arithmetic mean would be appropriate or consistent with
the averaging methodologies historically used under the OPPS. The
arithmetic mean could easily skew towards outlier data and anomalous
data not captured by previously described trimming methodologies.
Additionally, with this 23.1 percent figure, while penny pricing is a
valid maximum (that is, ceiling) price for drugs to which it applies,
as noted above we believed it was appropriate to exclude penny priced
drugs for purposes of our proposal.
We explained in the CY 2021 OPPS/ASC proposed rule that we believe
the manner in which we arrived at the proposed payment amount of ASP
minus 34.7 percent for 340B-acquired drugs is an appropriate and
accurate method of determining the average discount or typical
discount. We also noted that we believe it is reflective of
stakeholder's actual acquisition costs, and is as generous as possible
without compromising accuracy. We explained that we believe the
geometric mean is the most appropriate averaging methodology as it
mitigates the effects of outliers relative to the arithmetic mean and
median and is consistent with OPPS payment methodologies. Although
ceiling prices are protected by statute and the respondents to the
survey were given a pledge of confidentiality, we also emphasized that
we were exploring and previously sought comment on the possibility of
providing microdata to qualified researchers through their restricted
access infrastructure, in accordance with best practices for
transparency.
[GRAPHIC] [TIFF OMITTED] TR29DE20.063
(4) Determining an Add-on Payment for 340B Drugs
Under the OPPS, Medicare pays for separately payable drugs at rates
that approximate their acquisition costs, such as at ASP or WAC. These
drugs typically also receive an add-on payment. Under the OPPS, section
1833(t)(14)(E) authorizes, but does not require, the Secretary to make
an adjustment to payment rates for SCODs to take into account overhead
and related expenses, such as pharmacy services and handling costs.
In the MedPAC report from 2005,\83\ MedPAC recommended that the
Secretary:
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\83\ http://medpac.gov/docs/default-source/reports/June05_ch6.pdf?sfvrsn=0.
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Establish separate, budget neutral payments to cover the
costs that hospitals incur for handling separately paid drugs,
biologicals, and radiopharmaceuticals;
define a set of handling fee APCs that group drugs,
biologicals, and radiopharmaceuticals based on attributes of the
products that affect handling costs;
instruct hospitals to submit charges for those APCs; and
base payment rates for the handling fee APCs on submitted
charges, reduced to costs.
Because we took a conservative approach in estimating the average
acquisition costs for 340B-acquired drugs, we stated in the proposed
rule that we did not believe that it was imperative to establish an
add-on for overhead and handling as we believe that such a conservative
estimate may already account for the costs of overhead and handling. In
addition, our current 340B drug payment policy under the OPPS pays
separately payable drugs at ASP minus 22.5 percent with no add-on
payment because this payment rate represents the minimum average
discount that a 340B entity would receive on a drug. We emphasized that
we believe hospitals receive a significant margin on 340B drugs under
our current policy, so an additional add-on payment is not necessary.
Nonetheless, under the methodology in section 1847A, we explained that
the Part B payments for separately payable drugs and biologicals
furnished by practitioners and certain suppliers generally include an
add-on set at 6 percent of the ASP for the specific drug. As discussed
in the CY 2019 Physician Fee Schedule final rule with comment period
(83 FR 59661-59662), the 6 percent add-on is widely believed to include
services associated with drug acquisition that are not separately paid
for, such as handling, storage, and other overhead. We noted
[[Page 86049]]
that we realize that the acquisition costs for drugs acquired under the
340B program are significantly lower than for those drugs purchased
outside of the 340B program, so we did not find it appropriate to base
the add-on for 340B drugs on the 340B acquisition cost as previously
discussed. However, we explained that we believe that it is reasonable
to assume that a given drug will have similar overhead and other
administrative costs regardless of whether the drug was purchased under
the 340B Program or a by non-340B entity. Additionally, we stated that
utilizing a drug add-on will ensure a level of payment parity with the
add-on that applies to Part B drugs outside of the 340B program.
Therefore, for CY 2021 and subsequent years, we proposed to pay for
drugs acquired under the 340B program at ASP minus 34.7 percent, plus
an add-on of 6 percent of the product's ASP, for a net payment rate of
ASP minus 28.7 percent. Under this payment methodology, we explained
that each drug would receive the same add-on payment regardless of
whether it is paid at the 340B rate or at the traditional ASP rate for
drugs not purchased under the 340B program. We noted that this add-on
percentage would be more generous to hospitals than adding 6 percent of
the reduced 340B rate. As an example, assuming a non-340B drug is paid
its ASP of $1,000 and $60 for the 6 percent add-on, the 340B rate would
be $653 ($1,000--$347) plus $60 or $713 total, instead of $653 plus
$39.18 (6 percent of the reduced rate of $653) which would equal $39.18
or $692.18 total. We proposed that this payment methodology would be
our Medicare payment policy for 340B-acquired drugs going forward for
CY 2021 and subsequent years.
(5) 340B Payment Policy for Drugs for Which ASP Is Unavailable
As we clarified in the CY 2019 OPPS/ASC proposed rule, the 340B
payment adjustment applies to drugs that are priced using either WAC or
AWP, and it has been our policy to subject 340B-acquired drugs that use
these pricing methodologies to the 340B payment adjustment since the
policy was first adopted. We proposed the 340B payment adjustment for
WAC-priced drugs would mirror that of ASP payment with payment being
WAC minus 34.7 percent plus 6 percent of the drug's WAC, except for
when WAC plus 3 percent policy applies under 1847A(c)(4) and as
discussed in V.B.2.b., for which we would propose a payment rate of WAC
minus 34.7 percent plus 3 percent of the drug's WAC. Previously, AWP-
priced drugs have had a payment rate of 69.46 percent of AWP when the
340B payment adjustment is applied. The 69.46 percent of AWP was
calculated by first reducing the original 95 percent of AWP price by 6
percent to generate a value that is similar to ASP or WAC with no
percentage markup. Then we applied the 22.5 percent reduction to ASP/
WAC-similar AWP value to obtain the 69.46 percent of AWP, which is
similar to either ASP minus 22.5 percent or WAC minus 22.5 percent.
Similarly, for CY 2021, we proposed to pay for drugs paid at AWP under
the 340B program at 95 percent AWP first reduced by 6 percent to
generate a value that is similar to ASP or WAC with no percentage mark
up. Then we proposed to apply the net 28.7 percent reduction resulting
in a payment rate of 63.90 percent of AWP.
(6) 340B Payment Policy Exemptions
In the CY 2018 OPPS/ASC proposed rule, we sought public comment on
whether, due to access to care issues, certain groups of hospitals,
such as those with special adjustments under the OPPS (for example,
children's hospitals or PPS-exempt cancer hospitals) should be excepted
from a policy to adjust OPPS payments for drugs acquired under the 340B
program. Specifically, in accordance with section 1833(t)(7)(D)(ii) of
the Act, we make transitional outpatient payments (TOPs) to both
children's and PPS-exempt cancer hospitals. This means that these
hospitals are permanently held harmless to their ``pre-BBA amount,''
and they receive hold harmless payments to ensure that they do not
receive a payment that is lower in amount under the OPPS than the
payment amount they would have received before implementation of the
OPPS. Accordingly, if we were to reduce drug payments to these
hospitals on a per claim basis, it is very likely that the reduction in
payment would be paid back to these hospitals at cost report
settlement, given the TOPs structure. We believed further study on the
effect of the 340B drug payment policy was warranted for classes of
hospitals that receive statutory payment adjustments under the OPPS.
Accordingly, we stated that we continued to believe it is appropriate
to exempt children's and PPS-exempt cancer hospitals from the
alternative 340B drug payment methodology.
In addition to the children's and PPS-exempt cancer hospitals,
Medicare has long recognized the particularly unique needs of rural
communities and the financial challenges rural hospital providers face.
Across the various Medicare payment systems, CMS has established a
number of special payment provisions for rural providers to maintain
access to care and to deliver high quality care to beneficiaries in
rural areas. With respect to the OPPS, section 1833(t)(13) of the Act
gave the Secretary the authority to make an adjustment to OPPS payments
for rural hospitals, effective January 1, 2006, if justified by a study
of the difference in costs by APC between hospitals in rural areas and
hospitals in urban areas. Our analysis showed a difference in costs for
rural SCHs. Therefore, for the CY 2006 OPPS, we finalized a payment
adjustment for rural SCHs of 7.1 percent for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, brachytherapy sources, and devices paid under the pass-
through payment policy, in accordance with section 1833(t)(13)(B) of
the Act. We have continued this 7.1 percent payment adjustment since
2006.
For CY 2021 and subsequent years, similar to previous years, we
proposed that rural sole community hospitals (as described under the
regulations at 42 CFR 412.92 and designated as rural for Medicare
purposes), children's hospitals, and PPS-exempt cancer hospitals would
be excepted from the 340B payment adjustment and that these hospitals
continue to report informational modifier ``TB'' for 340B-acquired
drugs, and continue to be paid ASP+6 percent. We may revisit our policy
to exempt rural SCHs, as well as other the hospital types that are
exempt from the 340B drug payment reduction, in future rulemaking.
As discussed in section V.B.2.c. of the CY 2019 OPPS/ASC proposed
rule, we proposed to pay nonpass-through biosimilars acquired under the
340B Program at the biosimilar's ASP minus 22.5 percent of the
biosimilar's ASP. Similarly, for CY 2021, we proposed to pay nonpass-
through biosimilars acquired under the 340B Program at the biosimlar's
ASP minus the net payment discount reduction, 34.7 percent plus an add-
on of 6 percent, of the biosimilar's ASP, for a net payment rate of the
biosimilar's ASP minus 28.7 percent of the biosimilar's ASP.
Summary of Proposed Policy
In summary, we proposed for CY 2021 and subsequent years to pay for
drugs acquired under the 340B program at ASP minus 34.7 percent, plus
an add-on of 6 percent of the product's ASP, for a net payment rate of
ASP minus 28.7 percent using the authority under section
1833(t)(14)(A)(iii)(I) of the Act.
[[Page 86050]]
This proposal included our previously discussed methodology used to
arrive at the 34.7 percent average discount that we proposed to apply
to all drugs acquired under the 340B program. This methodology included
using the geometric mean of the survey data, volume weighting the
average based upon utilization of the drug in the OPPS, using the
highest priced NDC when multiple NDCs are available for a single HCPCS
code, eliminating penny pricing from the average, and eliminating any
data outside of 3 standard deviations from the mean when calculating
the average discount of 34.7 percent. We explained in the proposed rule
that our intent was that, if finalized, this payment methodology would
apply beginning on January 1, 2021 and any changes to this permanent
payment policy would be required to be adopted through notice and
comment rulemaking. We also proposed that Rural SCHs, PPS-exempt cancer
hospitals and children's hospitals would be exempted from the 340B
payment policy for CY 2021 and subsequent years. Finally, we proposed
in the alternative to continue our current policy of paying ASP minus
22.5 percent for 340B-acquired drugs as we prevailed on appeal to the
D.C. Circuit in the litigation.
For the reasons discussed below, we are finalizing our alternative
proposal to continue our current policy of paying ASP minus 22.5
percent for 340B-acquired drugs. However, we also summarize and respond
below to the comments we received on our proposal to pay for 340B-
acquired drugs at a net rate of ASP minus 28.7 percent based on survey
data.
Comments Regarding 340B Survey Methodology and Implementation
Comment: Several commenters contended that CMS' plan to collect
acquisition cost data from 340B hospitals only, and not from other
providers that are paid under the OPPS, but that do not participate in
the 340B program, violates section 1833(t)(14)(D)(iii) of the Act.
Specifically, they stated that although the Medicare statute allows for
a survey of hospitals based on drug acquisition costs, the statute does
not allow the Secretary to use subclause (I) of section
1833(t)(14)(A)(iii) to target a subset of hospitals for the survey and
subclause (II) of section 1833(t)(14)(A)(iii) for other non-340B
hospitals. While commenters agreed that the Secretary has authority
under section 1833(t)(14)(A)(iii)(I) to set payment rates that vary by
hospital group based on relevant hospital characteristics such as
volume of outpatient services, they maintained that the Secretary is
not permitted to survey only one group of hospitals for acquisition
costs for purposes of setting the payment rates under the OPPS.
Furthermore, commenters stated that section 1833(t)(14)(D)(iii)
requires that surveys conducted by the Secretary ``shall have a large
sample of hospitals that is sufficient to generate a statistically
significant estimate of the average hospital acquisition cost for each
specified covered outpatient drug (SCODs).'' Commenters continued to
state that because the survey had what they contended was a low
response rate, they believed CMS was unable to gain enough data to
yield a statistically significant estimate of average hospital
acquisition cost for each specified covered outpatient drug.
Additionally, some of these commenters contended that the acquisition
data collected in response to the survey only included data from the
fourth quarter of 2018 and the first quarter of 2019, and that this was
an inadequate sample due to yearly fluctuations in drug pricing.
Response: We disagree with the commenters' assertion that the
manner in which we collected drug and biological acquisition cost data
from 340B hospitals is inconsistent with the statute, as well as the
commenters' interpretation of section 1833(t)(14)(D)(iii) that the
survey of hospital acquisition costs for SCODs must be administered to
all hospitals or all hospital types. Section 1833(t)(14)(D)(iii) does
not require the Secretary to survey all hospitals, it requires Medicare
to have a large sample of hospitals that is sufficient to generate a
statistically significant estimate of the average hospital acquisition
cost for each SCOD. The statute does not prescribe how we develop the
sampling methodology. Surveying 340B hospitals, for which average sales
price (ASP) data does not serve as a reliable proxy for their
acquisition costs, is necessary to accurately determine payment amounts
for drugs acquired under the 340B program. However, we do not believe
it is necessary to survey non-340B hospitals because our ASP data
includes drug acquisition costs from these hospitals, which are an
adequate proxy of the average drug acquisition costs of such providers.
Surveying non-340B hospitals would unnecessarily burden such hospitals,
for which we already have an adequate proxy for drug acquisition costs.
Unlike the reasonable proxy that exists for average acquisition
drug costs for non-340B enrolled hospitals (that is, ASP data), the
significant drug acquisition cost discounts that 340B participating
hospitals receive are much greater than those received by hospitals not
participating in the 340B program; accordingly, 340B enrollment status
is a relevant characteristic for drug acquisition costs. The statutory
provision at issue--section 1833(t)(14)(A)(iii)(I)--explicitly states
that the average acquisition cost for a drug for a year ``at the option
of the Secretary, may vary by hospital group (as defined by the
Secretary based on volume of covered OPD services or other relevant
characteristics).'' We believe it is within the Secretary's discretion
under section 1833(t)(14)(A)(iii)(I) to choose to distinguish between
hospital groups based on whether or not they are covered entities
eligible to receive drugs and biologicals at discounted rates under the
340B program. We also note that section 1833(t)(14)(D)(ii) refers to
use of the hospital acquisition costs for SCODs in setting payment
rates under subparagraph (A) of section 1833(t)(14), and therefore, we
believe it is appropriate to read the two provisions together to permit
the Secretary to survey 340B hospitals only. Conversely, no provision
compels the Secretary to impose an unnecessary survey burden on non-
340B hospitals, for which we have an adequate proxy for average
acquisition drug costs. As previously stated, we believe the sampling
timeframe is appropriate due to the numerous factors taken into
consideration to provide a conservative estimate as well as the
proposed application of the ASP reduction, which was proposed as a
single reduction amount applied to each drug's ASP.
Comment: Some commenters had concerns with the survey response
rate. Commenters stated that only providing approximately 3 weeks to
complete the survey during the initial stages of the PHE was
concerning. Commenters believed this was why CMS received what they
contended was a low response rate of 62 percent (7 percent Detailed
Surveys and 55 percent Quick Surveys). Several commenters who completed
the Quick Survey noted in their comments that they chose this method
due to it being the least burdensome option, and that ceiling prices
were not necessarily reflective of their acquisition costs. For these
reasons, commenters felt it would be inappropriate for CMS to base OPPS
payment for 340B drugs on these survey results.
Response: We thank commenters for their feedback. We respectfully
disagree with commenters' assertion that CMS received an inadequate
response rate on
[[Page 86051]]
which to base OPPS payment for 340B-acquired drugs. As commenters
noted, a combined 62 percent of the 340B participating providers
responded to the survey through a Detailed or Quick Survey submission.
For the remaining 38 percent of non-affirmative responders, we noted in
the survey instructions that we would utilize 340B ceiling prices as
proxies for the hospitals' highest possible acquisition costs. We
believe the 340B ceiling price is a fair proxy for the hospitals'
acquisition costs because hospitals cannot be required to pay more than
the 340B ceiling price (and, in fact, often pay much less) for a 340B
drug. Therefore, we explained in the proposed rule that we believed
using the 340B ceiling price was the most conservative, and yet
appropriate, way to calculate the discount for the 38 percent of non-
affirmative responders.
Comment: Commenters were generally supportive of CMS' application
of a 6 percent add-on based upon the product's ASP as part of our
proposal to pay for 340B-acquired drugs under the OPPS based on survey
data. Commenters did not find it appropriate to base payment on ASP
minus 34.7 percent, which would not include a 6 percent add-on, and
instead supported a payment amount of ASP minus 28.7 percent, which
includes the 6 percent add-on. Commenters believed this add-on was
necessary, and they felt it would be appropriate for the same drug to
receive the same add-on payment regardless of whether it was purchased
through the 340B program or at the current policy of ASP minus 22.5
percent.
Response: We thank the commenters for their support on this
proposal. We still do not believe that it is imperative to establish an
add-on for overhead and handling, as we believe that our conservative
estimate of average acquisition costs may already account for the costs
of overhead and handling. However, as explained further below, we are
not finalizing our proposal to pay for 340B-acquired drugs based on
hospital survey data at ASP minus 28.7 percent, which we proposed would
include a 6 percent add-on. Nonetheless, we will consider this
information for potential future rulemaking.
Comment: Commenters generally did not agree that our proposed
methodology, including our use of 340B ceiling prices for Quick Survey
respondents and as a proxy for non-affirmative responses, together with
a 6 percent add-on, as well as the manner in which we calculated the
proposed discount, yielded a conservative estimate of hospitals' costs
to acquire 340B drugs. Commenters often stated that CMS should also
take into consideration the costs that 340B entities incur to maintain
their status and comply with 340B program requirements. Commenters
contended that 340B program compliance costs are quite considerable and
that CMS should consider these administrative costs in determining an
OPPS payment rate for 340B-acquired drugs.
Response: As outlined in the section above, Methodology to
Calculate ASP Reduction Amount Based on Survey Data, CMS considered
numerous factors in order to calculate what we believe was a
conservative discount amount. Section 1833(t)(14)(A)(iii)(I) authorizes
the Secretary to set the amount of payment for SCODs at an amount equal
to the average acquisition cost for the drug for that year, but the
statute does not mention covering 340B program compliance cost.
Accordingly, we do not believe it is necessary to provide additional
payment for costs that commenters state they must pay in order to
remain compliant with the 340B program. We reiterate that we do not
believe CMS payment is required for these costs as Medicare payments
for drugs are not intended to cross-subsidize other programs.
Nonetheless, we believe that such a conservative estimate and the add-
on of 6 percent of the product's ASP would already allow for a
significant margin to offset these costs.
Comment: Commenters stated that not every entity is able to
purchase all drugs at the 340B ceiling price and that some drugs must
be purchased under WAC-based pricing. Furthermore, stakeholders
contended that their systems are limited in determining which drugs
were purchased at the 340B price and thus were limited in their ability
to assign the ``JG'' modifier. Therefore, commenters stated they
applied the ``JG'' modifier to all of their purchased drugs, even if
the drug was purchased under WAC-based pricing. Commenters stated that
WAC-based pricing is significantly higher than 340B pricing; 30 to 90
percent greater according to one stakeholder. Additionally, commenters
believed using ceiling prices as proxies was a flawed methodology as
these data do not come directly from those being surveyed, even if they
are the highest prices hospitals can pay to acquire these drugs.
Response: The ceiling price is the maximum amount covered entities
may permissibly be required to pay for a drug under section 340B(a)(1)
of the Public Health Service Act, so we would not expect a 340B
hospital to have acquisition costs for any drug that is acquired
through the 340B program that are greater than the ceiling price. For
this reason, where the acquisition price for a particular drug was not
available or submitted in response to the survey, we stated that we
would use the 340B ceiling price for that drug as a proxy for the
hospital's acquisition cost in order to produce a conservative drug
discount estimate when data was missing or not submitted. We believed
using ceiling prices as proxies was the most appropriate option when
drug acquisition cost information was not available, because this price
represents the most conservative discount that a 340B entity could have
received. In addition, while some commenters expressed generalized
disagreement with our proposed approach, we did not receive any
comments demonstrating that 340B hospitals pay more than the ceiling
price for a particular drug, or that 340B hospitals pay more than ASP
minus 28.7 for a particular drug when acquired under the 340B program
at their negotiated 340B price. Thus, similar to our policy of paying
ASP minus 22.5 percent, this proposed approach of paying ASP minus 28.7
percent appears to be in line with hospital acquisition costs for such
drugs, which is reinforced by the fact that we did not receive public
comments demonstrating that 340B hospitals pay more for particular
drugs acquired under the 340B program. However, because we are not
finalizing our proposal to pay for 340B drugs based on hospital survey
data for CY 2021, we will take these comments into account for
potential future rulemaking.
Additionally, the payment rate of ASP minus 22.5 percent only
applies to drugs acquired under the 340B program and therefore, the
``JG'' modifier should only be appended to claim lines for these drugs.
Hospitals should not append the ``JG'' modifier for drugs for which the
hospital paid an amount based on WAC where the drug was not acquired
under the 340B program.
Comment: Commenters generally did not make specific recommendations
about CMS' methodology for calculating the reduction that would be
applied to ASP for 340B-acquired drugs. Rather, most commenters
expressed opposition to the policy in general. However, several
commenters expressed support for CMS' exclusion of penny pricing in our
calculation of the proposed payment rate. Additionally, several
commenters encouraged CMS to eliminate any drugs with inflationary
penalties, as the commenters believed these penalties are unevenly
distributed among drugs and
[[Page 86052]]
among hospitals and may skew our data if included. Additionally, some
commenters were not supportive of CMS' volume weighting methodology.
Commenters stated that taking into account how often those drugs were
billed by all hospitals under the OPPS for 2018 and 2019 was
inappropriate as 340B utilization may differ from all OPPS hospital
utilization.
Response: We thank commenters for their input on our proposal. We
believe the methodology for developing the proposed payment adjustment
appropriately provided for a conservative estimate for the ASP
reduction. At this time, we do not believe it would be appropriate to
eliminate all drugs with inflationary penalties; however, we will take
this point into consideration for future potential rulemaking.
Additionally, as outlined in our summary above, our volume weighting
methodology took into account how often drugs were billed by all
hospitals under the OPPS for 2018 and 2019, to better reflect each
drug's overall utilization under the OPPS. We calculated the average
discount by taking the utilization of each drug under the OPPS into
account to arrive at a case-weighted average for each HCPCS code.
Therefore, we volume-weighted the drug discounts determined from the
survey to mirror the drug utilization in the OPPS. We note that the
340B hospitals drug utilization pattern did not vary significantly from
the overall OPPS utilization. Therefore, drugs that were commonly used
were assigned a higher weight while those less commonly used were
assigned a lower weight. For example, a highly utilized HCPCS code for
an oncology drug would be weighted higher than that of a drug for snake
anti-venom that has a relative low utilization in the OPPS. We
incorporated volume weighting into our analysis by assessing the
utilization rate of each individual drug (using its HCPCS code) under
the OPPS for CY 2018 and CY 2019. For the purposes of creating an
average discount, we believe this is the most appropriate methodology.
Nonetheless, we will consider these comments for potential future
rulemaking.
Comment: Several commenters asked for the release of data that CMS
used in order to calculate the 340B payment reduction. Commenters
expressed a desire to replicate CMS' calculations based on the data
submitted in response to the 340B Drug Acquisition Cost Survey.
Response: We do not intend to release an individual hospitals' SCOD
acquisition cost data to the public. During the Paperwork Reduction Act
process for the 340B survey, we pledged to maintain the confidentiality
of individual responses that include acquisition prices for each SCOD
to the extent required by law. However, we stated we would make average
acquisition prices reported for SCODs across all hospitals surveyed
public. We believe the confidentiality of drug prices applies to
individual drugs purchased by individual hospitals, which we have no
intent to make public. Additionally, this confidentiality extends to
the ceiling prices used in the survey. Therefore, we are unable to
publicly disclose the ceiling prices for the same reason. As we stated
in the proposed rule, we are exploring the possibility of providing
microdata to qualified researchers through their restricted access
infrastructure, in accordance with best practices for transparency. We
will continue to explore if there is an appropriate method in which to
release microdata to qualified researchers.
e. Alternative Proposal To Continue Policy To Pay ASP Minus 22.5
Percent
Previously, we adopted the OPPS 340B payment policy based on the
average minimum discount for 340B-acquired drugs being approximately
ASP minus 22.5 percent. The estimated discount was based on a MedPAC
analysis identifying 22.5 percent as a conservative minimum discount
that 340B entities receive when they purchase drugs under the 340B
program, which we discussed in the CY 2018 OPPS/ASC final rule with
comment period (82 FR 52496). We continue to believe that ASP minus
22.5 percent is an appropriate payment rate for 340B-acquired drugs
under the authority of 1833(t)(14)(A)(iii)(II) for the reasons we
stated when we adopted this policy in CY 2018 (82 FR 59216). On July
31, 2020, the D.C. Circuit reversed the decision of the district court,
holding that this interpretation of the statute was reasonable.
Therefore, we also proposed in the alternative that the agency could
continue the current Medicare payment policy for CY 2021. If adopted,
we stated that this proposed policy would continue the current Medicare
payment policy for CY 2021.
Based on feedback from stakeholders, we believe maintaining the
current payment policy of paying ASP minus 22.5 percent for 340B drugs
is appropriate in order to maintain consistent and reliable payment for
these drugs both for the remainder of the PHE and after its conclusion
to give hospitals some certainty as to payments for these drugs.
Continuing our current policy also gives us more time to conduct
further analysis of hospital survey data for potential future use for
340B drug payment. We note that any changes to the current 340B payment
policy would be adopted through public notice and comment rulemaking.
While we believe our methods to conduct the 340B Drug Acquisition
Cost Survey, as well as the methodology we used to calculate the
proposed average or typical discount received by 340B entities on 340B
drugs, are valid, we nonetheless recognize stakeholders' concerns. As
described above, the utilization of the survey data is complex, and we
wish to continue to evaluate how to balance and weigh the use of the
survey data, the necessary adjustments to the data, and the weighting
and incorporation of ceiling prices--all to determine how best to take
the relevant factors into account for potentially using the survey to
set Medicare OPPS drug payment policy. We appreciate the feedback from
commenters and will continue to assess it as we explore whether survey
data should be considered hospital acquisition cost data for purposes
of paying for drugs acquired under section 1833(t)(14)(A)(iii)(I) in
future years.
Comments on Maintaining Current 340B Payment Reduction of ASP Minus
22.5 Percent
Comment: A few commenters voiced their support for the current OPPS
payment policy for 340B-acquired drugs. These commenters generally
believed that approximating payment based on acquisition costs is
appropriate; however, they also recommended reform to the 340B program
itself.
Response: We thank the commenters for their support of our 340B
payment policies. We note that comments related to reform of the 340B
program are out of scope for purposes of this final rule, and we also
note that the 340B program is administered by the Health Resources and
Services Administration, not CMS; however, we thank commenters for
their input.
Comment: Many commenters did not support CMS finalizing the
proposal to pay a net payment rate of ASP minus 28.7 percent for 340B-
acquired drugs. These commenters stated that they opposed any reduction
in payment for 340B drugs in general, but preferred the proposal to
maintain ASP minus 22.5 percent if CMS continued to adjust payment for
340B drugs. Commenters stated that the profits derived from
participation in the 340B program allowed them to deliver charity or
uncompensated care to their patients. Commenters detailed a wide
variety of programs that they fund with profits
[[Page 86053]]
from the 340B program, and stated they may not be able to continue
these programs without profits from Medicare payments for 340B-acquired
drugs. Many commenters stated that the current 340B payment rate has
hurt hospitals financially and undermined hospitals' ability to provide
safety-net care to their low-income patients, thereby threatening the
patients' access to care. They stated that any policy proposal to
reduce payment for 340B-acquired drugs was contrary to the
congressional intent for the 340B program. Commenters asserted that CMS
should pay hospitals participating in the 340B program the statutory
default payment amount of ASP plus 6 percent.
Response: We note that we have not seen evidence that the current
OPPS 340B drug payment policy has limited patient access to 340B drugs.
Further, Medicare payments for drugs are not intended to cross-
subsidize other programs. As noted in the CY 2018 OPPS/ASC final rule
with comment period, we continue to believe that ASP minus 22.5 percent
for drugs acquired through the 340B Program represents the average
minimum discount that 340B enrolled hospitals receive. Additionally, as
discussed throughout this section, the proposed payment reduction based
on the survey data was calculated in a conservative manner. We disagree
with commenters that the OPPS 340B payment policy has had a negative
impact on Medicare patients and are not aware of any access issues
related to the implementation of this policy. Further, we note that
under the current policy, Medicare patients who receive 340B drugs for
which the Medicare program paid ASP minus 22.5 percent have much lower
cost sharing than if these beneficiaries received 340B drugs for which
the Medicare program paid ASP+6 percent. As a result, we continue to
believe that ASP minus 22.5 percent is a reasonable payment rate for
these drugs. We note that the 340B drug payment policy is consistent
with our authority under the statute, as confirmed by the D.C.
Circuit's decision. As explained further below, we are finalizing our
proposal to continue our current policy of generally paying under the
OPPS for 340B-acquired drugs at ASP minus 22.5 percent.
Comment: We received several comments regarding OPPS payment for
biosimilars acquired under the 340B program. Commenters suggested a
variety of modified payment methodologies for biosimilars. Some
commenters believed biosimilars should be excluded from the adjustment
for 340B-acquired drugs altogether, and some commenters stated if CMS
moves forward with the net reduction of ASP minus 28.7 percent, the
agency should maintain the reduction for biosimilars at ASP minus 22.5
percent. Additionally, several commenters suggested the add-on payment
of 6 percent should be based on the reference product's ASP when
calculating the net payment rate for biosimilars under the survey
methodology. Finally, some commenters had concerns that new biosimilars
on pass-through status would have a competitive advantage over its
reference product.
Response: We are finalizing our alternate proposal to continue
paying for 340B-acquired drugs under the OPPS at a rate of ASP - 22.5
percent, and thus we do not believe any changes to our biosimilar
policy are necessary for CY 2021. We believe the continuation of our
current biosimilar policy will allow for appropriate payment and access
to these important treatments. Regarding comments related to
biosimilars and the perceived competitive advantage, we do not believe
that the temporary payments provided by pass-through status will create
the substantial competitive advantage that commenters described. We
also note we are continuing the policy from previous years regarding
biosimilars and 340B payment, under which we will pay ASP minus 22.5
percent of the biosimilar's ASP. We thank the commenters for the
comments regarding biosimilar add-on payment under the survey
methodology (ASP minus a net 28.7 percent), and we will take these
comments into consideration for potential future rulemaking. Please see
section V.B.2.C. for additional discussion regarding biosimilars and
section V.A.1. for additional discussion on drug pass-through payments.
Comment: Many commenters opposed both the CY 2021 proposal to pay
for drugs acquired under the 340B program at the net payment rate of
ASP minus 28.7 percent, as well as the alternative proposal of
continuing the current 340B program payment reduction of ASP minus 22.5
percent. These commenters urged CMS to withdraw its proposed policy and
contended that the policy was an unlawful application of the CMS'
authority.
Commenters also stated that reducing payment for drugs acquired
through the 340B Program does not help reduce high drug costs. Many
commenters opposed the current 340B policy and argued that it takes
away resources designated for safety net hospitals to subsidize non-
340B hospitals because the payment reduction is budget neutral. The
commenters requested that CMS end its policy of paying for drugs
obtained through the 340B program at ASP minus 22.5 percent and restore
the statutory default payment rate of ASP plus 6 percent.
Response: We respectfully disagree with the commenters' assertions
that our 340B drug payment policy is illegal or an unlawful application
of the law. It is also beyond the scope of the CY 2021 rulemaking, nor
is it the intent of the 340B payment policy to address all aspects of a
larger drug pricing issue. We disagree with commenters that the OPPS
340B payment policy has taken away resources designated for safety net
hospitals, and we are not aware of any access to care issues related to
the implementation of this policy. As discussed in this section of the
CY 2021 final rule with comment period, the D.C. Circuit has confirmed
that our 340B drug payment policy is within our authority in section
1833(t)(14) of the Act. Thus, we are finalizing our alternate proposal,
without modification, to continue to pay ASP minus 22.5 percent for
340B-acquired drugs, including when furnished in nonexcepted off-campus
PBDs paid under the PFS. Our final policy continues the 340B Program
policies that were implemented in CY 2018 with the exception of the way
we are calculating payment for 340B-acquired biosimilars, which is
discussed in section V.B.2.c. of the CY 2019 OPPS/ASC final rule with
comment period, and continues the policy we finalized in CY 2019 to pay
ASP minus 22.5 percent for 340B-acquired drugs and biologicals
furnished in nonexcepted off-campus PBDs paid under the PFS.
Furthermore, although we are finalizing our alternate proposal,
without modification, to pay ASP minus 22.5 percent for 340B-acquired
drugs, we believe our proposal to pay for 340B-acquired drugs at ASP
minus 34.7 percent based on hospital survey data, plus an add-on of 6
percent of the product's ASP, for a net payment rate of ASP minus 28.7
percent could be within the Secretary's authority under section
1833(t)(14). The 340B payment rate proposal of ASP minus 28.7 percent
was based on drug acquisition cost data derived from the CMS 2020
Hospital Acquisition Cost Survey for 340B-Acquired SCODs, authorized
under subclause 1833(t)(14)(D). Specifically, we applied the statutory
authority under section 1833(t)(14)(A)(iii)(I) to collect 340B drug
acquisition cost data and limited our survey to the 340B hospital
groups. A more detailed discussion of the CMS 2020 Hospital Acquisition
Cost Survey methodology is included earlier in this section. Although
we are continuing the current 340B payment
[[Page 86054]]
policy, we will continue to consider the 340B drug payment rate of
under the ASP minus 34.7 percent, plus an add-on of 6 percent of the
product's ASP, for a net payment rate of ASP minus 28.7 percent in
potential future rulemaking.
Comment: Several commenters stated that CMS has not provided
sufficient analysis for the continuation of the 340B payment policy,
believing that CMS has not considered changes in utilization and volume
for hospitals that are actively participating in the 340B program since
the policy was initially proposed in 2017. They further noted that CMS
has not analyzed the impact of the prior year reimbursement changes for
drugs acquired under the 340B program for the affected hospitals. They
also contended that CMS has not provided evidence that the payment
policy remains budget neutral by recalculating the policy's impact to
make sure the conversion factor is properly adjusted.
Response: In the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59369 through 59370), we implemented the 340B drug payment
policy and adjusted the payment rate for separately payable drugs and
biologicals (other than drugs with pass-through payment status and
vaccines) acquired under the 340B Program. This adjustment changed the
payment rate from average sales price (ASP) plus 6 percent to ASP minus
22.5 percent for drugs subject to this policy. In that rule, we stated
that our goal was to make Medicare payment for separately payable drugs
more aligned with the resources expended by hospitals to acquire such
drugs. We believe the current 340B drug payment policy reflects the
average minimum discount that 340B participating hospitals receive for
drugs acquired under the 340B Program and we believe it is
inappropriate for Medicare to subsidize other programs through Medicare
payments for separately payable drugs. While commenters remarked on the
continuation of this policy since CY 2018, the commenters did not
provide us with any evidence that ASP minus 22.5 percent is no longer a
conservative estimate of their drug acquisition costs. Moreover, we
note that the data collected in our 2020 Hospital Acquisition Cost
Survey for 340B-acquired SCODs found the average 340B program drug
discount to be 34.7 percent. Additionally, in the CY 2021 OPPS/ASC
proposed rule (85 FR 48890), we proposed that we could continue the
current Medicare 340B payment policy of ASP minus 22.5 percent as an
alternative, as the D.C. Circuit concluded that this policy was a
reasonable application of the Secretary's statutory authority under
1833(t)(14)(A)(iii)(II) of the Act.
With respect to OPPS budget neutrality and the conversion factor,
OPPS budget neutrality is generally developed on a prospective basis by
isolating the effect of any changes in payment policy or data under the
prospective OPPS with all other factors held constant. We note that
since the CY 2018 implementation of the 340B drug payment policy in
which we developed a budget neutrality adjustment for the policy, the
adjusted percentage payment has remained at ASP minus 22.5 percent. As
a result, while some of the claims may change based on drug payment and
billing, as indicated by the ``JG'' modifier, these drugs, including
their utilization and expected payments, would be included as part of
the broader budget neutrality adjustments, but collectively they would
not have a separate budget neutrality adjustment specifically for the
340B drug payment policy. We note that in rulemaking where we proposed
to establish or modify the adjustment, we have included in the impact
analysis the estimated effects on different categories of providers
based on the policy. Finally, we note that we monitor the payment and
utilization patterns associated with this adjustment and for drug
spending more broadly, and will continue to do so.
Comment: Several commenters expressed confusion as to whether our
proposed policy would affect drugs purchased at their retail pharmacies
or whether this payment reduction applied to Federally Qualified Health
Centers (FQHCs).
Response: The 340B payment policy originally adopted in the CY 2018
OPPS/ASC final rule with comment period and continued in subsequent
years applies to certain hospitals paid under the OPPS. 340B payment
policy exceptions under the OPPS include rural sole community
hospitals, children's hospitals, and PPS-exempt cancer hospitals. FQHCs
and retail pharmacies are not paid under the OPPS, and therefore are
not affected by this policy.
Comment: As previously discussed, several commenters recommended
CMS avoid any further action on a 340B payment reduction until the
issue is settled in the courts. Commenters noted that although CMS
prevailed in the D.C. Circuit, a petition for a rehearing was filed on
September 14, 2020. Commenters believed CMS should wait until this
decision has been finalized by the courts before moving forward with a
continuation of the 340B payment reduction.
Response: On October 16, 2020, the D.C. Circuit denied the
appellees' petition for rehearing en banc. We believe our 340B drug
payment policy is within the Secretary's statutory authority at
1833(t)(14)(A)(iii)(II) of the Act, which was confirmed by the D.C.
Circuit. Thus, we are finalizing our alternate proposal, without
modification, to continue our current policy of paying ASP minus 22.5
percent for 340B-acquired drugs.
Comment: Several commenters requested that we make our 340B policy
exemptions permanent. Additionally, commenters asked CMS to extend the
exemption to urban SCHs, Medicare Dependent Hospitals, and Rural
Referral Centers.
Response: We thank commenters for their recommendations. At this
time, we do not believe it is appropriate to revise our policy on 340B
policy exemptions and we believe we should maintain our current policy.
Nonetheless, we will take these comments into consideration for future
rulemaking.
Summary of Finalized Policy
We are finalizing our alternate proposal, without modification, to
continue our current policy of paying ASP minus 22.5 percent for 340B-
acquired drugs and biologicals, including when furnished in nonexcepted
off-campus PBDs paid under the PFS. Our finalized policy continues the
340B Program policies that were implemented in CY 2018 with the
exception of the way we are calculating payment for 340B-acquired
biosimilars, which is discussed in section V.B.2.c. of the CY 2019
OPPS/ASC final rule with comment period, and would continue the policy
we finalized in CY 2019 to pay ASP minus 22.5 percent for 340B-acquired
drugs and biologicals furnished in nonexcepted off-campus PBDs paid
under the PFS. We are also continuing the 340B payment adjustment for
WAC-priced drugs, which is WAC minus 22.5 percent. 340B-acquired drugs
that are priced using AWP will continue to be paid an adjusted amount
of 69.46 percent of AWP.
Additionally, we are finalizing our proposal to continue to exempt
rural sole community hospitals (as described under the regulations at
42 CFR 412.92 and designated as rural for Medicare purposes),
children's hospitals, and PPS-exempt cancer hospitals from the 340B
payment adjustment. These hospitals must continue to report
informational modifier ``TB'' for 340B-acquired drugs, and will
continue to be paid ASP plus 6 percent. We may revisit our policy to
exempt rural SCHs, as well
[[Page 86055]]
as other hospital types, from the 340B drug payment reduction in future
rulemaking. Finally, we are continuing to require hospitals to use of
modifiers to identify 340B-acquired drugs. We refer readers to the CY
2018 OPPS/ASC final rule with comment period (82 FR 59353 through
59370) for a full discussion and rationale for the CY 2018 policies and
the requirements for use of modifiers ``JG'' and ``TB''. We note that
any future changes to our policy regarding payment for 340B drugs will
be adopted through notice and comment rulemaking.
7. High Cost/Low Cost Threshold for Packaged Skin Substitutes
a. Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR
74938), we unconditionally packaged skin substitute products into their
associated surgical procedures as part of a broader policy to package
all drugs and biologicals that function as supplies when used in a
surgical procedure. As part of the policy to package skin substitutes,
we also finalized a methodology that divides the skin substitutes into
a high cost group and a low cost group, in order to ensure adequate
resource homogeneity among APC assignments for the skin substitute
application procedures (78 FR 74933).
Skin substitutes assigned to the high cost group are described by
HCPCS codes 15271 through 15278. Skin substitutes assigned to the low
cost group are described by HCPCS codes C5271 through C5278. Geometric
mean costs for the various procedures are calculated using only claims
for the skin substitutes that are assigned to each group. Specifically,
claims billed with HCPCS code 15271, 15273, 15275, or 15277 are used to
calculate the geometric mean costs for procedures assigned to the high
cost group, and claims billed with HCPCS code C5271, C5273, C5275, or
C5277 are used to calculate the geometric mean costs for procedures
assigned to the low cost group (78 FR 74935).
Each of the HCPCS codes described earlier are assigned to one of
the following three skin procedure APCs according to the geometric mean
cost for the code: APC 5053 (Level 3 Skin Procedures): HCPCS codes
C5271, C5275, and C5277); APC 5054 (Level 4 Skin Procedures): HCPCS
codes C5273, 15271, 15275, and 15277); or APC 5055 (Level 5 Skin
Procedures): HCPCS code 15273). In CY 2020, the payment rate for APC
5053 (Level 3 Skin Procedures) was $497.02, the payment rate for APC
5054 (Level 4 Skin Procedures) was $1,622.74, and the payment rate for
APC 5055 (Level 5 Skin Procedures) was $2,766.13. This information also
is available in Addenda A and B of the CY 2020 OPPS/ASC final rule with
comment period, correction notice (which is available via the internet
on the CMS website).
We have continued the high cost/low cost categories policy since CY
2014, and we proposed to continue it for CY 2021. Under this current
policy, skin substitutes in the high cost category are reported with
the skin substitute application CPT codes, and skin substitutes in the
low cost category are reported with the analogous skin substitute HCPCS
C-codes. For a discussion of the CY 2014 and CY 2015 methodologies for
assigning skin substitutes to either the high cost group or the low
cost group, we refer readers to the CY 2014 OPPS/ASC final rule with
comment period (78 FR 74932 through 74935) and the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66882 through 66885).
For a discussion of the high cost/low cost methodology that was
adopted in CY 2016 and has been in effect since then, we refer readers
to the CY 2016 OPPS/ASC final rule with comment period (80 FR 70434
through 70435). Beginning in CY 2016 and in subsequent years, we
adopted a policy where we determined the high cost/low cost status for
each skin substitute product based on either a product's geometric mean
unit cost (MUC) exceeding the geometric MUC threshold or the product's
per day cost (PDC) (the total units of a skin substitute multiplied by
the mean unit cost and divided by the total number of days) exceeding
the PDC threshold. We assigned each skin substitute that exceeded
either the MUC threshold or the PDC threshold to the high cost group.
In addition, we assigned any skin substitute with a MUC or a PDC that
does not exceed either the MUC threshold or the PDC threshold to the
low cost group (84 FR 61327 through 61328).
However, some skin substitute manufacturers have raised concerns
about significant fluctuation in both the MUC threshold and the PDC
threshold from year to year using the methodology developed in CY 2016.
The fluctuation in the thresholds may result in the reassignment of
several skin substitutes from the high cost group to the low cost group
which, under current payment rates, can be a difference of
approximately $1,000 in the payment amount for the same procedure. In
addition, these stakeholders were concerned that the inclusion of cost
data from skin substitutes with pass-through payment status in the MUC
and PDC calculations would artificially inflate the thresholds. Skin
substitute stakeholders requested that CMS consider alternatives to the
current methodology used to calculate the MUC and PDC thresholds and
also requested that CMS consider whether it might be appropriate to
establish a new cost group in between the low cost group and the high
cost group to allow for assignment of moderately priced skin
substitutes to a newly created middle group.
We share the goal of promoting payment stability for skin
substitute products and their related procedures as price stability
allows hospitals using such products to more easily anticipate future
payments associated with these products. We have attempted to limit
year-to-year shifts for skin substitute products between the high cost
and low cost groups through multiple initiatives implemented since CY
2014, including: Establishing separate skin substitute application
procedure codes for low-cost skin substitutes (78 FR 74935); using a
skin substitute's MUC calculated from outpatient hospital claims data
instead of an average of ASP+6 percent as the primary methodology to
assign products to the high cost or low cost group (79 FR 66883); and
establishing the PDC threshold as an alternate methodology to assign a
skin substitute to the high cost group (80 FR 70434 through 70435).
To allow additional time to evaluate concerns and suggestions from
stakeholders about the volatility of the MUC and PDC thresholds, in the
CY 2018 OPPS/ASC proposed rule (82 FR 33627), we proposed that a skin
substitute that was assigned to the high cost group for CY 2017 would
be assigned to the high cost group for CY 2018, even if it does not
exceed the CY 2018 MUC or PDC thresholds. We finalized this policy in
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59347). We
stated in the CY 2018 OPPS/ASC proposed rule that the goal of our
proposal to retain the same skin substitute cost group assignments in
CY 2018 as in CY 2017 was to maintain similar levels of payment for
skin substitute products for CY 2018 while we study our skin substitute
payment methodology to determine whether refinements to the existing
policies are consistent with our policy goal of providing payment
stability for skin substitutes.
We stated in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59347) that we would continue to study issues related to the
payment of skin
[[Page 86056]]
substitutes and take these comments into consideration for future
rulemaking. We received many responses to our request for comments in
the CY 2018 OPPS/ASC proposed rule about possible refinements to the
existing payment methodology for skin substitutes that would be
consistent with our policy goal of providing payment stability for
these products. In addition, several stakeholders have made us aware of
additional concerns and recommendations since the release of the CY
2018 OPPS/ASC final rule with comment period. As discussed in the CY
2019 OPPS/ASC final rule with comment period (83 FR 58967 through
58968), we identified four potential methodologies that have been
raised to us that we encouraged the public to review and provide
comments on. We stated in the CY 2019 OPPS/ASC final rule with comment
period that we were especially interested in any specific feedback on
policy concerns with any of the options presented as they relate to
skin substitutes with differing per day or per episode costs and sizes
and other factors that may differ among the dozens of skin substitutes
currently on the market.
For CY 2020, we sought more extensive comments on the two policy
ideas that generated the most comment from the CY 2019 comment
solicitation. One of the ideas was to establish a payment episode
between 4 to 12 weeks where a lump-sum payment would be made to cover
all of the care services needed to treat the wound. There would be
options for either a complexity adjustment or outlier payments for
wounds that require a large amount of resources to treat. The other
policy idea would be to eliminate the high cost and low cost categories
for skin substitutes and have only one payment category and set of
procedure codes for the application of all graft skin substitute
products.
b. Discussion of CY 2019 and CY 2020 Comment Solicitations for Episode-
Based Payment for Graft Skin Substitute Procedures
The methodology that commenters discussed most in response to our
comment solicitation in CY 2019 and that stakeholders raised in
subsequent meetings we have had with the wound care community has been
a lump-sum ``episode-based'' payment for a wound care episode.
Commenters that supported an episode-based payment believe that it
would allow health care professionals to choose the best skin
substitute to treat a patient's wound and would give providers
flexibility with the treatments they administer. These commenters also
believe an episode-based payment helps to reduce incentives for
providers to use excessive applications of skin substitute products or
use higher cost products to generate more payment for the services they
furnish. In addition, they believe that episode-based payment could
help with innovations with skin substitutes by encouraging the
development of products that require fewer applications. These
commenters noted that episode-based payment would make wound care
payment more predictable for hospitals and provide incentives to manage
the cost of care that they furnish. Finally, commenters that supported
an episode-based payment believe that workable quality metrics can be
developed to monitor the quality of care administered under the payment
methodology and limit excessive applications of skin substitutes.
However, many commenters opposed establishing an episode-based
payment. One of the main concerns of commenters who opposed episode-
based payment was that wound care is too complex and variable to be
covered through such a payment methodology. These commenters stated
that every patient and every wound is different; therefore, it would be
very challenging to establish a standard episode length for coverage.
They noted that it would be too difficult to risk-stratify and
specialty-adjust an episode-based payment, given the diversity of
patients receiving wound care and their providers who administer
treatment, as well as the variety of pathologies covered in treatment.
Also, these commenters questioned how episodes would be defined for
patients when they are having multiple wounds treated at one time or
have another wound develop while the original wound was receiving
treatment. These commenters expressed concerns that episode-based
payment would be burdensome both operationally and administratively for
providers. They believe that CMS will need to create a large number of
new APCs and HCPCS codes to account for all of the patient situations
that would be covered with an episode-based payment, which would
increase provider burden. Finally, these commenters had concerns about
the impact of episode-based payment on the usage of higher cost skin
substitute products. They believe that a single payment could
discourage the use of higher-cost products because of the large
variability in the cost of skin substitute products, which could limit
innovations for skin substitute products.
The wide array of views on episode-based payment for skin
substitute products and the unforeseen issues that may arise from the
implementation of such a policy encouraged us to continue to study the
issues associated with episode-based payment. Therefore, we sought
further comments from stakeholders and other interested parties
regarding skin substitute payment policies that could be applied in
future years to address concerns about excessive utilization and
spending on skin substitute products, while avoiding administrative
issues such as establishing additional HCPCS codes to describe
different treatment situations.
One possible policy construct that we sought comments on was
whether to establish a payment period for skin substitute application
services (CPT codes 15271 through 15278 and HCPCS codes C5271 through
C5278) between 4 weeks and 12 weeks. Under this option, we could also
assign CPT codes 15271, 15273, 15275, and 15277, and HCPCS codes C5271,
C5273, C5275, and C5277 to comprehensive APCs with the option for a
complexity adjustment that would allow for an increase in the standard
APC payment for more resource-intensive cases. Our research has found
that most wound care episodes require one to three skin substitute
applications. Those cases would likely receive the standard APC payment
for the comprehensive procedure. Then the complexity adjustment could
be applied for the relatively small number of cases that require more
intensive treatments.
Several commenters were in favor of establishing a comprehensive
APC with either an option for a complexity adjustment or outlier
payments to pay for higher cost skin substitute application procedures.
The commenters supported the idea of having a traditional comprehensive
APC payment for standard wound care cases with a complexity adjustment
or outlier payment to handle complicated or costly cases. However, they
also expressed concerns about how many payment levels would be
available in the skin substitute procedures APC group since a
complexity adjustment can only be used if there is an existing higher-
paying APC to which the service receiving the complexity adjustment may
be assigned. A couple of commenters wanted more opportunities for
services to receive a complexity adjustment through using clusters of
procedure codes that reflect the full range of wound care services a
beneficiary receives instead of using code pairs to determine if a
complexity adjustment should apply. Other commenters suggested that
episodic
[[Page 86057]]
payments be risk-adjusted to account for clinical conditions and co-
morbidities of beneficiaries with outlier payments and that complexity
adjustments be linked to beneficiaries with more comorbidities.
Some commenters opposed the idea of a complexity adjustment for
skin substitute application procedures. The commenters stated there was
not enough detail in the comment solicitation to understand how a
complexity adjustment would work with an episodic payment arrangement.
Commenters also expressed concerns that payment rates for comprehensive
APCs may not be representative of the wound care services that would be
paid within those APCs. One commenter stated that payment policy is not
the right way to resolve issues with the over-utilization and
inappropriate use of skin substitutes because they are concerned that
major changes in payment methodology, such as episodic payment, could
lead to serious issues with the care beneficiaries receive. In recent
meetings, stakeholders have expressed concerns that establishing a
comprehensive APC for graft skin substitute procedures could lead to
other unrelated wound care services such as hyperbaric oxygen
treatments being bundled into those procedures. Some stakeholders have
provided suggestions to provide additional payment for the treatment of
complicated wounds, similar to a complexity adjustment, without
bundling unrelated wound care services.
The additional comments we received in CY 2020 related to including
a complexity adjustment with an episode-based payment, along with the
comments we received on episode-based payment in general from the CY
2019 comment solicitation, show that there are many issues that
continue to require study for this payment methodology. In addition, we
also need more time to assess the benefits and drawbacks of episode-
based payment compared to other possible options to change the payment
methodology for graft skin substitute procedures. Therefore, in the CY
2021 OPPS/ASC proposed rule, we stated that will continue our review of
the feasibility of using episode-based payment for graft skin
substitute procedures, and we did not propose any episode-based payment
for these procedures.
Comment: Several commenters expressed either their support for or
their concerns about establishing episode-based payment for graft skin
substitute procedures. Commenters made many suggestions about how a
payment episode should be constructed and which services should be
included or excluded from a payment episode.
Response: We appreciate the feedback we received from the
commenters. We will continue to study issues related to changing the
methodology for paying for skin substitute products and procedures for
possible future rulemaking.
c. Discussion of CY 2019 and CY 2020 Comment Solicitations To Have a
Single Payment Category for Graft Skin Substitute Procedures
Another policy option on which we solicited comments in CY 2019 and
CY 2020 was to eliminate the high cost and low cost categories for skin
substitutes and have only one payment category and set of procedure
codes for the application of all graft skin substitute products. Under
this option, the only available procedure codes to bill for graft skin
substitute procedures would be CPT codes 15271 through 15278. HCPCS
codes C5271 through C5278 would be eliminated. Providers would bill CPT
codes 15271 through 15278 without having to consider either the MUC or
PDC of the graft skin substitute product used in the procedure. There
would be only one APC for the graft skin substitute application
procedures described by CPT codes 15271 (Skin sub graft trnk/arm/leg),
15273 (Skin sub grft t/arm/lg child), 15275 (Skin sub graft face/nk/hf/
g), and 15277 (Skin sub grft f/n/hf/g child). The payment rate would be
based on the geometric mean cost of all graft skin substitute
procedures for a given CPT code that are paid through the OPPS. For
example, under the current skin substitute payment policy, there are
two procedure codes (CPT code 15271 and HCPCS code C5271) that are
reported for the procedure described as ``application of skin
substitute graft to trunk, arms, legs, total wound surface area up to
100 sq cm; first 25 sq cm or less wound surface area''.
Commenters who supported this option believed it would remove the
incentives for manufacturers to develop and providers to use high cost
skin substitute products and would lead to the use of lower cost,
quality products. Commenters noted that lower Medicare payments for
graft skin substitute procedures would lead to lower copayments for
beneficiaries. In addition, commenters believe a single payment
category would reduce incentives to apply skin substitute products in
excessive amounts. Commenters and stakeholders also believe a single
payment category is clinically justified because they stated that many
studies have shown that no one skin substitute product is superior to
another. Supporters of a single payment category believed it would
simplify coding for providers and reduce administrative burden.
Finally, some stakeholders believed that a single payment category
policy could serve as a transitional payment policy for graft skin
substitute products while we continue to study the feasibility of
establishing an episode-based payment for skin substitutes.
Most commenters and stakeholders were opposed to a single payment
category for skin substitute products. Commenters and stakeholders
stated that the large difference in resource costs between higher cost
and lower cost skin substitute products would provide an incentive for
hospitals to use the most inexpensive products, which would hurt both
product innovation and the quality of care beneficiaries receive.
Commenters and stakeholders were concerned that a single payment
category would encourage providers to choose financial benefit over
clinical efficacy when determining which skin substitute products to
use.
These commenters and stakeholders also stated that a single payment
category would increase incentives for providers to use cheaper
products that require more applications to generate more revenue and
emphasize volume over value. A couple of commenters believed that
overall Medicare spending on skin substitutes would be higher with a
single payment category than under the current payment methodology,
which has separate payment for higher cost and lower cost skin
substitutes. The reason spending would increase according to the
commenters is that overpayment for low cost skin substitutes by
Medicare would exceed the savings Medicare would receive on reduced
payments for higher cost skin substitutes.
Further, commenters and stakeholders stated that a single payment
rate would lead to too much heterogeneity in the products receiving
payment through the skin substitute application procedures. That is,
the same payment rate would apply to skin substitute products whether
they cost less than $10 per cm\2\ or over $200 per cm\2\ and regardless
of the type of wound they treat. Commenters and stakeholders would
prefer to have multiple payment categories where the payment rate is
more reflective of the cost of the product. Commenters and stakeholders
believe that a single payment category would discourage providers from
treating more complicated wounds and wounds larger than 100 cm\2\.
[[Page 86058]]
The responses to the comment solicitation indicated that a single
payment category could potentially reduce the cost of wound care
services for graft skin substitute procedures for both beneficiaries
and Medicare. In addition, a single payment category may help reduce
administrative burden for providers. Conversely, we are cognizant of
other commenters' concerns that a single payment category may hinder
innovation of new graft skin substitute products and cause some
products that are currently well-utilized to leave the market.
Nonetheless, we are persuaded that a single payment category could
potentially provide a more equitable payment for many products used
with graft skin substitute procedures, while recognizing that
procedures performed with expensive skin substitute products would
likely receive substantially lower payment.
We believe some of the concerns that commenters who oppose a single
payment category for skin substitute products raised might be mitigated
if stakeholders have a period of time to adjust to the changes inherent
in establishing a single payment category. Accordingly in CY 2020, we
solicited public comments that provide additional information about how
commenters believe we should transition from the current low cost/high
cost payment methodology to a single payment category.
Such suggestions to facilitate the payment transition from a low
cost/high cost payment methodology to a single payment category
methodology included--
Delaying implementation of a single category payment for 1
or 2 years after the payment methodology is adopted; and
Gradually lowering the MUC and PDC thresholds over 2 or
more years to add more graft skin substitute procedures into the
current high cost group until all graft skin substitute procedures are
assigned to the high cost group and it becomes a single payment
category.
Those commenters in favor of a single payment category did not see
a need for a transition period or wanted only a one-year transition
period. Conversely, those commenters opposed to a single payment
category either mentioned the idea of a transition period or wanted it
to last multiple years, with one commenter suggesting a transition
period of four years. In the end, having a transition period before
establishing a single payment category did not affect the views of
commenters who were initially opposed to establishing a single payment
category, as they continued to oppose this policy option.
Based on the comments received regarding establishing a single
payment category for graft skin substitute procedures, we stated that
we need more time to consider the trade-offs between the potential
benefits of a single category against the potential substantial
drawbacks. We also need to consider the merits of this policy option
compared to episode-based payment for graft skin substitute procedures.
Therefore, we did not propose a single payment category for graft skin
substitute procedures for CY 2021 in the CY 2021 OPPS/ASC proposed
rule.
Comment: Several commenters expressed either their support or their
concerns about a single payment category for graft skin substitute
procedures. Commenters provided their views on whether a single payment
category encourages value and cost savings for graft skin substitute
procedures, or if a single payment category would discourage providers
from using higher-cost skin substitute products that may have better
clinical results for patients.
Response: We appreciate the feedback we received from the
commenters. We will continue to study issues related to changing the
methodology for paying for skin substitute products.
d. Packaged Skin Substitutes for CY 2021
For CY 2021, consistent with our policy since CY 2016, we proposed
to continue to determine the high cost/low cost status for each skin
substitute product based on either a product's geometric mean unit cost
(MUC) exceeding the geometric MUC threshold or the product's per day
cost (PDC) (the total units of a skin substitute multiplied by the mean
unit cost and divided by the total number of days) exceeding the PDC
threshold. Consistent with the methodology as established in the CY
2014 through CY 2018 final rules with comment period, we analyzed CY
2019 claims data to calculate the MUC threshold (a weighted average of
all skin substitutes' MUCs) and the PDC threshold (a weighted average
of all skin substitutes' PDCs). The final CY 2021 MUC threshold is $48
per cm\2\ (rounded to the nearest $1) (proposed at $47 per cm\2\) and
the final CY 2021 PDC threshold is $949 (rounded to the nearest $1)
(proposed at $936). We also proposed to clarify that our definition of
skin substitutes includes synthetic skin substitute products in
addition to biological skin substitute products, as described in
section V.B.7.d. of the CY 2021 OPPS/ASC proposed rule. We also want to
clarify that the availability of a HCPCS code for a particular human
cell, tissue, or cellular or tissue-based product (HCT/P) does not mean
that that product is appropriately regulated solely under section 361
of the PHS Act and the FDA regulations in 21 CFR part 1271.
Manufacturers of HCT/Ps should consult with the FDA Tissue Reference
Group (TRG) or obtain a determination through a Request for Designation
(RFD) on whether their HCT/Ps are appropriately regulated solely under
section 361 of the PHS Act and the regulations in 21 CFR part 1271.
For CY 2021, as we did for CY 2020, we proposed to assign each skin
substitute that exceeds either the MUC threshold or the PDC threshold
to the high cost group. In addition, we proposed to assign any skin
substitute with a MUC or a PDC that does not exceed either the MUC
threshold or the PDC threshold to the low cost group. For CY 2021, we
proposed that any skin substitute product that was assigned to the high
cost group in CY 2020 would be assigned to the high cost group for CY
2021, regardless of whether it exceeds or falls below the CY 2021 MUC
or PDC threshold. This policy was established in the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59346 through 59348).
For CY 2021, we proposed to continue to assign skin substitutes
with pass-through payment status to the high cost category. We proposed
to assign skin substitutes with pricing information but without claims
data to calculate a geometric MUC or PDC to either the high cost or low
cost category based on the product's ASP+6 percent payment rate as
compared to the MUC threshold. If ASP is not available, we proposed to
use WAC+3 percent to assign a product to either the high cost or low
cost category. Finally, if neither ASP nor WAC is available, we
proposed to use 95 percent of AWP to assign a skin substitute to either
the high cost or low cost category. We proposed to continue to use
WAC+3 percent instead of WAC+6 percent to conform to our proposed
policy described in section V.B.2.b. of the CY 2021 OPPS/ASC proposed
rule to establish a payment rate of WAC+3 percent for separately
payable drugs and biologicals that do not have ASP data available. New
skin substitutes without pricing information would be assigned to the
low cost category until pricing information is available to compare to
the CY 2021 MUC and PDC thresholds. For a discussion of our existing
policy under which we assign skin substitutes without pricing
information to the low cost category until pricing information
[[Page 86059]]
is available, we refer readers to the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70436). Table 42 displays the final CY 2021 cost
category assignment for each skin substitute product.
Comment: One commenter did not support our proposal to assign graft
skin substitute products to a high cost or a low cost group based on if
the MUC or PDC of a product exceeds a weighted average of either the
MUC or PDC of all graft skin substitute products. The commenter
believes the current two-tier system provides incentives for providers
to use higher-cost graft skin substitute products instead of lower-cost
products that have similar efficacy to the higher-cost products.
Response: As we explained in the CY 2014 OPPS/ASC final rule (78 FR
74933), the graft skin substitute procedures described by CPT codes
15271 through 15278 are clinically homogeneous, but there is a large
amount of resource heterogeneity between different skin substitute
products with the cost per cm\2\ ranging from under $10 per cm\2\ to
over $200 per cm\2\. We believe establishing high cost and low cost
groups for skin substitutes makes the payment for these products more
homogeneous and reduces the risk of excessive overpayment or
underpayment to a provider when a skin substitute product is used.
Comment: Multiple commenters supported our proposal to continue to
assign skin substitutes to the low cost or high cost group. Commenters
also supported our proposal that any skin substitute product that was
assigned to the high cost group in CY 2020 would be assigned to the
high cost group for CY 2021, regardless of whether it exceeds or falls
below the CY 2021 MUC or PDC threshold.
Response: We appreciate the support of the commenters for our
proposals.
Comment: One commenter requested that CMS be more transparent when
presenting the data regarding whether individual graft skin substitute
products are assigned to either the high cost or low cost group. The
commenter requested that we share more of the process details for
determining high cost and low cost assignments and provide the
calculation processes and formulas used to make the determinations.
Response: We already provide the information that the commenter
seeks. In the CY 2021 OPPS/ASC final rule (85 FR 48891) and in previous
OPPS proposed and final rules, we discuss in detail how both the MUC
and PDC thresholds are calculated and which pricing data are used to
determine if a graft skin substitute product is assigned to the high
cost or low cost group. We provide drug cost statistics data on our
website, which include cost data for all the graft skin substitute
products that are used to calculate the overall MUC and PDC cost group
thresholds. Links to the drug cost statistics data may be found on the
same web page that has links to the OPPS preamble, OPPS claims
accounting narrative, OPPS addenda, and other data related to the OPPS/
ASC final rule.
Comment: One commenter requested that HCPCS code Q4235 (Amniorepair
or altiply, per square centimeter) be assigned to the high cost skin
substitute group based on either WAC plus 3 percent or 95 percent of
AWP pricing data, which the commenter believed would demonstrate that
the cost of these products exceeds the MUC threshold.
Response: The commenter did not provide the required information to
make a determination on assignment to the high cost skin substitute
group in time. Therefore, HCPCS code Q4235 will continue to be assigned
to the low cost skin substitute group in this final rule.
Comment: Individual commenters have requested that the HCPCS codes
Q4205 (Membrane graft or membrane wrap, per square centimeter), Q4222
(Progenamatrix, per square centimeter), Q4226 (MyOwn skin, includes
harvesting and preparation procedures, per square centimeter), Q4227
(Amniocore, per square centimeter), and Q4232 (Corplex, per square
centimeter) be assigned to the high cost skin substitute group based on
either WAC plus 3 percent or 95 percent of AWP pricing data, which the
commenters believed would demonstrate that the cost of these products
exceeds the MUC threshold.
Response: HCPCS codes Q4205 and Q4226 were assigned to the high
cost group starting in October 2020. We also note that we are assigning
HCPCS codes Q4222, Q4227, and Q4232 to the high cost group starting on
January 1, 2021.
Comment: Individual commenters have requested that HCPCS codes
Q4206 (Fluid flow or fluid gf, 1 cc) and Q4231 (Corplex p, per cc) be
assigned to the high cost skin substitute group based on either WAC
plus 3 percent or 95 percent of AWP pricing data, which the commenters
believed would demonstrate that the cost of these products exceeds the
MUC threshold.
Response: HCPCS codes Q4206 and Q4231 are not graft skin substitute
products. Therefore, these products cannot be assigned to either the
high cost or low cost skin substitute group.
Comment: One commenter, the manufacturer, has requested that HCPCS
codes Q4122 (Dermacell, per square centimeter) and Q4150 (Allowrap ds
or dry, per square centimeter) continue to be assigned to the high-cost
skin substitute group.
Response: HCPCS codes Q4122 and Q4150 were both assigned to the
high-cost group in CY 2020 and also were proposed to be assigned to the
high-cost group for CY 2021. Per our proposal, a skin substitute that
has been proposed in the high-cost group in a proposed rule will remain
in the high-cost group in the final rule. Also, any skin substitute
assigned to the high-cost group in CY 2020 will continue to be assigned
to the high-cost group in CY 2021 even if the MUC and PDC for the skin
substitute product is below the overall MUC and PDC thresholds for all
skin substitute products. Accordingly, we are finalizing our proposal
to assign HCPCS codes Q4122 and Q4150 to the high-cost group in CY
2021.
After consideration of the public comments we received, we are
finalizing our proposal to assign a skin substitute with a MUC or a PDC
that does not exceed either the MUC threshold or the PDC threshold to
the low cost group, unless the product was assigned to the high cost
group in CY 2020, in which case we would assign the product to the high
cost group for CY 2021, regardless of whether it exceeds the CY 2021
MUC or PDC threshold. We are also finalizing our proposal to assign to
the high cost group any skin substitute product that exceeds the CY
2021 MUC or PDC thresholds and assign to the low cost group any skin
substitute product that does not exceed the CY 2021 MUC or PDC
thresholds and was not assigned to the high cost group in CY 2020. We
are finalizing our proposal to continue to use payment methodologies,
including ASP+6 percent and 95 percent of AWP, for skin substitute
products that have pricing information but do not have claims data to
determine if their costs exceed the CY 2021 MUC. In addition, we are
finalizing our proposal to continue to use WAC+3 percent instead of
WAC+6 percent for skin substitute products that do not have ASP pricing
information or claims data to determine if those products' costs exceed
the CY 2021 MUC. We also are finalizing our proposal to retain our
established policy to assign new skin substitute products with pricing
information to the low cost group. Table 42 below includes the final CY
2021 cost category assignment for each skin substitute product.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
e. Synthetic Skin Graft Sheet Products To Be Reported With Graft Skin
Substitute Procedure Codes
The CY 2014 OPPS/ASC final rule with comment period describes skin
substitute products as ``. . . a category of products that are most
commonly used in outpatient settings for the treatment of diabetic foot
ulcers and venous leg ulcers . . . [T]hese products do not actually
function like human skin that is grafted onto a wound; they are not a
substitute for a skin graft. Instead, these products are applied to
wounds to aid wound healing and through various mechanisms of action
that stimulate the host to regenerate lost tissue.'' (78 FR 74930
through 74931) The CY 2014 final rule also described skin substitutes
as ``. . . a class of products that we treat as biologicals . . .'' and
mentioned that prior to CY 2014, skin substitutes were separately paid
in the OPPS as if they were biologicals according to the ASP
methodology (78 FR 74930 through 74931).
The 2014 rule did not specifically mention whether synthetic
products could be considered to be skin substitute products in the same
manner as biological products, because there were no synthetic products
at that time that were identified as skin substitute products. Then in
2018, a manufacturer made a request that an entirely synthetic product
that it claimed is used in the same manner as biological skin
substitutes, receive a HCPCS code that would allow the product to be
billed with graft skin substitute procedure codes, including CPT codes
15271 through 15278 and C5271 through C5278, starting in 2019.
Initially, the
[[Page 86065]]
synthetic product was not described as a graft skin substitute product.
However, we now believe that both biological and synthetic products
could be considered to be skin substitutes for Medicare payment
purposes.
This view is supported by a paper referenced in a report we cited
in the CY 2014 OPPS/ASC final rule with comment period titled ``Skin
Substitutes for Treating Chronic Wounds Technology Assessment Report at
ES-2'', which is available on the AHRQ website at: https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf. That paper, titled ``Regenerative
medicine in dermatology: biomaterials, tissue engineering, stem cells,
gene transfer and beyond'' by Dieckmann et al.,\84\ states that skin
substitutes should be divided into two broad categories: biomaterial
and cellular. The paper explains that ``. . . biomaterial skin
substitutes do not contain cells (acellular) and are derived from
natural or synthetic sources . . .'' \85\ The paper continues by
describing biomaterial skin substitutes further: ``Synthetic sources
include various degradable polymers such as polylactide and
polyglycolide. Whether natural or synthetic, the biomaterial provides
an extracellular matrix that allows for infiltration of surrounding
cells.'' \86\ The paper by Dieckmann et al. indicates that skin
substitute products may be synthetic products as well as biological
products.
---------------------------------------------------------------------------
\84\ Dieckmann C, Renner R, Milkova L, et al. Regenerative
medicine in dermatology: Biomaterials, tissue engineering, stem
cells, gene transfer and beyond. Exp Dermatol 2010 Aug;19(8):697-
706.
\85\ Ibid, Dieckmann C, Renner R, Milkova L, et al.
\86\ Ibid, Dieckmann C, Renner R, Milkova L, et al.
---------------------------------------------------------------------------
Therefore, for CY 2021 we proposed to include synthetic products in
addition to biological products in our description of skin substitutes.
Our new description would define skin substitutes as a category of
biological and synthetic products that are most commonly used in
outpatient settings for the treatment of diabetic foot ulcers and
venous leg ulcers. We also proposed to retain the additional
description of skin substitute products from the CY 2014 OPPS final
rule which states ``. . . that skin substitute products do not actually
function like human skin that is grafted onto a wound; they are not a
substitute for a skin graft. Instead, these products are applied to
wounds to aid wound healing and through various mechanisms of action
they stimulate the host to regenerate lost tissue . . .'' (78 FR 74930
through 74931).
Comment: Two commenters requested that CMS no longer use the term
``skin substitutes'' to describe products that do not function like
human skin that is grafted onto a wound and are not substitutes for
skin grafts, but do aid in wound healing by stimulating the patient to
regenerate lost tissue. Instead, the commenters request that we use the
term ``cellular and/or tissue based products for skin wounds'' that is
abbreviated ``CTPs''. The commenters believe the term ``skin
substitute'' is a misleading and clinically incorrect term that does
not accurately describe all of the products that are considered to be
cellular and tissue based products to treat skin wounds. Also, one of
the commenters notes that the FDA discourages the use of the term
``skin substitute'' and that an international standards organization,
the American Society for Testing and Materials (ASTM), has adopted the
``CTPs'' terminology as well. Finally, the commenter claims the
``CTPs'' terminology is used by physicians and clinicians throughout
the wound care community.
Response: We appreciate the suggestion by the commenters, but we do
not believe it is appropriate at this time to end our use of the term
``skin substitute.'' Notably, the CPT and HCPCS codes used to report
graft procedures using cellular and tissue based products to heal skin
wounds, CPT codes 15271 through 15278 and HCPCS codes C5271 through
C5278, use the term ``skin substitute'' in the descriptor. We feel that
we should use terminology that reflects the service descriptors that
are reported in the OPPS. Also, the term ``skin substitute'' is well-
understood by providers and industry stakeholders, even if it is not
the most precise terminology to describe cellular and tissue based
products to heal skin wounds. Finally, we did not propose to change the
terminology used to describe products that do not function like human
skin that is grafted onto a wound and are not substitutes for skin
grafts, but do aid in wound healing by stimulating the patient to
regenerate lost tissue. While we are not changing the use of the term
``skin substitute'', we appreciate the information from commenters.
Comment: A commenter expressed concern about our proposed
definition of synthetic skin substitutes. The commenter believes it is
possible under our proposal that bandages and standard dressings could
be defined as skin substitutes. The commenter does support Medicare
coverage of synthetic skin substitutes, but would like us to modify our
proposal to prevent products that would normally be described as
medical supplies to be defined as skin substitutes.
Response: The descriptor for HCPCS code C1849 (Skin substitute,
synthetic, resorbable, per square centimeter) includes the term
``resorbable'', which means the graft skin substitute product must be
able to be absorbed by the body. Bandages and standard dressings are
not resorbable products and are removed and replaced on a regular basis
while treating a wound. We find it highly unlikely that a bandage or
standard dressing would be used for a graft skin substitute procedure.
However to make it clear, we will modify our definition of a synthetic
graft skin substitute product to exclude bandages and standard
dressings.
Comment: Multiple commenters agreed with CMS that synthetic graft
skin substitute products should receive payment under the OPPS, even if
the commenters did not support our methodology for the payment of graft
skin substitute products.
Response: We appreciate commenters' support for our proposal to pay
for synthetic graft skin substitute products under the OPPS.
Comment: Several commenters requested that we establish product-
specific HCPCS codes for synthetic graft skin substitute products. Most
of the same commenters also requested that we delete HCPCS code C1849,
but there was one commenter who supported both product-specific HCPCS
codes and continuing to have HCPCS code C1849 be packaged in the OPPS.
The primary reason commenters want product-specific codes for synthetic
graft skin substitute is they feel that synthetic products should be
assigned to either the high cost or low cost skin substitute group
based on the cost of each individual product in a similar manner to
biological skin substitute products. Commenters feel that because
multiple synthetic graft skin substitute products can be assigned to
HCPCS code C1849, there may be some synthetic products that should be
in the low cost skin substitute group that will receive payment in the
high cost skin substitute group if HCPCS code C1849 is assigned to the
high cost group. Commenters also are concerned about the opposite
situation, in which high cost synthetic products would potentially be
underpaid if HCPCS code C1849 is assigned to the low cost skin
substitute group. Commenters believed the only resolution to these
issues with HCPCS code C1849 is to delete the code so there are not
cases of synthetic products being either overpaid or underpaid.
[[Page 86066]]
Commenters also expressed concerns about using a C-code to report
synthetic graft skin substitute codes in Medicare. One commenter noted
that the use of a C-code meant that synthetic graft skin substitute
products would only be in a payable status under the OPPS, and cannot
be reported for graft skin substitute application services provided in
the physician office setting. Two commenters thought that a C-code
might confuse providers by unintentionally implying that HCPCS code
C1849 has pass-through status under the OPPS, even though HCPCS code
C1849 does not have pass-through status. Another commenter had concerns
that there would be a less rigorous process to determine that a graft
skin substitute product can be reported with HCPCS code C1849 than the
process CMS uses to assign biological skin substitute products to
product-specific HCPCS codes. Finally, two commenters asked for more
transparency from CMS regarding the reasons for the creation of HCPCS
code C1849.
Response: HCPCS code C1849 was established in response to the need
to pay for graft skin substitute application services performed with
synthetic graft skin substitute products in the OPPS in a manner
comparable to how we pay for graft skin substitute application services
performed with biological graft skin substitute products. As mentioned
earlier in this section, when we established our policy in the CY 2014
OPPS final rule to package graft skin substitute products into their
associated application procedures (78 FR 74930 through 74931), we did
not specifically mention whether synthetic products could be considered
skin substitute products in the same manner as biological products. The
reason for this was that there were no synthetic products at that time
that were identified as skin substitute products.
We note that unless a graft skin substitute product has pass-
through status, graft skin substitute products are not paid separately
under unique HCPCS or CPT codes in OPPS. However, in CY 2018, a
manufacturer requested that CMS develop methodologies to allow
synthetic graft skin substitute products to receive payment in the
outpatient hospital setting and in the physician office setting. After
extensive review, we decided against establishing a product-specific
HCPCS code for the synthetic graft skin substitute product. Instead,
CMS decided to assign the synthetic product in CY 2019 to HCPCS codes
A6460 and A6461, which were newly created HCPCS codes to report
synthetic, resorbable wound dressings. HCPCS codes A6460 and A6461 are
packaged under the OPPS and cannot be assigned to either the high cost
or low cost skin substitute group. This meant that graft skin
substitute products could not be billed with CPT codes 15271 through
15278 or HCPCS codes C5271 through C5278, even though synthetic graft
skin substitute products and biological graft skin substitute products
perform the same function and have similar efficacy.
Because all skin substitutes, except those with pass-through
status, are packaged under the OPPS, we explored solutions that would
permit synthetic skin substitute products to be billed with either CPT
codes 15271 through 15278 or HCPCS codes C5271 though C5278. We decided
to create HCPCS code C1849 to describe any synthetic graft skin
substitute product, and we revised the payment logic for the graft skin
substitute application procedure codes to allow HCPCS code C1849 to be
billed with those procedures. So far, we have identified one synthetic
graft skin substitute product that is described by HCPCS code C1849.
Even though there are no OPPS claims data for the synthetic product,
the manufacturer of the product was able to produce pricing data for
the product. Using our alternative methodology to assign products to
the high cost skin substitute group through WAC or AWP pricing that
exceeds the MUC threshold, the data showed that the synthetic product
would be assigned to the high cost group. As more synthetic graft skin
substitute products are identified as being described by HCPCS code
C1849, we will average the pricing data from the various products to
determine an amount for the products described by HCPCS code C1849 to
compare against the MUC threshold. This comparison will determine if
HCPCS code C1849 should be assigned to the high cost or low cost skin
substitute category.
Regarding other comments about HCPCS code C1849, it is correct that
HCPCS C-codes are only payable under the OPPS and not under the PFS. We
also note that while the process may be different to receive payment
for synthetic graft skin substitute products reporting HCPCS code C1849
than for a new product-specific HCPCS code for a biological skin
substitute product, synthetic graft skin substitute products must be
described by C1849 to be eligible for payment in the OPPS. Like any
other claim paid in the OPPS, claims reporting C1849 also are subject
to medical review to ensure that providers are appropriately billing
for synthetic, resorbable graft skin substitute products. Finally, we
disagree with the commenters who feel that assigning a HCPCS C-code to
report synthetic graft skin substitute products may confuse providers
who may think synthetic products are receiving pass-through payment. We
note that for several years a biological graft skin substitute product,
Integra meshed bilayer wound matrix, has been assigned to HCPCS code
C9363, and providers are well aware the product is packaged under the
OPPS and does not have pass-through status.
Comment: Several commenters stated that if HCPCS code C1849 is not
either modified or deleted, then the HCPCS code should be assigned to
the low cost skin substitute group by default, similar to how we pay
for HCPCS code Q4100 (Skin substitute, not otherwise specified), which
is used to report multiple biological skin substitute products that do
not have product-specific HCPCS codes. Commenters are concerned that
synthetic graft skin substitute products that should receive payment
through the low cost skin substitute group would instead receive
payment in the high cost skin substitute group and increase overall
graft skin substitute costs for Medicare. In addition, two commenters
expressed concern about the assignment of HCPCS code C1849 to the high
cost skin substitute group because the commenters believed it was an
automatic assignment that was not based on OPPS claims data or product
pricing data.
Response: We are currently aware of one synthetic graft skin
substitute product that is described by HCPCS code C1849. As we
mentioned earlier, the manufacturer provided pricing data that showed
the cost of the product is above the MUC threshold for graft skin
substitute products and therefore HCPCS code C1849 should be assigned
to the high cost skin substitute group. We note that we used pricing
data to assign HCPCS code C1849 to the high cost group, and the
assignment of HCPCS code C1849 to the high cost skin substitute group
was not automatic. As more synthetic graft skin substitute products are
identified, we will use their pricing data to calculate an average
price for the products described by HCPCS code C1849 and compare that
average price to the overall MUC threshold to determine whether HCPCS
code C1849 should be assigned to the high cost or low cost skin
substitute group. We are not in favor of a default assignment of HCPCS
code C1849 to the low cost skin substitute group. Instead, we want to
rely on pricing data and, when available, claims data to determine the
appropriate skin
[[Page 86067]]
substitute cost group for HCPCS code C1849. If most of the products
described by HCPCS code C1849 have pricing or cost that qualify the
products to be assigned to the high cost group, then the HCPCS code
should be assigned to the high cost skin substitute group as that group
best reflects the costs of the products described by HCPCS code C1849.
Comment: One commenter was concerned that the establishment of a
single HCPCS code to describe all synthetic graft skin substitute
products is a substantial step towards the establishment of a single
category payment system for both synthetic and biological graft skin
substitute products.
Response: The creation of HCPCS code C1849 and the scope of its
descriptor was not an attempt to promote one of the several payment
methodologies discussed in the CY 2019 and CY 2020 comment
solicitations regarding alternative payment methodologies for graft
skin substitute products over the other payment methodologies. This is
made clear by the fact that there are over 100 biological graft skin
substitute products with their own product-specific HCPCS codes as
compared to one identified synthetic graft skin substitute product. As
explained previously, HCPCS code C1849 was created to provide a way for
synthetic skin substitute products that have similar function and
efficacy to biological skin substitute products to receive comparable
payment under the OPPS.
Comment: Multiple commenters expressed their support for our
proposal without any suggested changes.
Response: We appreciate the commenters' support for our proposal.
After reviewing the public comments, we have decided to implement our
proposal for CY 2021 with modification to include synthetic products,
in addition to biological products, in our description of skin
substitutes. Our new description defines skin substitutes as a category
of biological and synthetic products that are most commonly used in
outpatient settings for the treatment of diabetic foot ulcers and
venous leg ulcers. We will retain the additional description of skin
substitute products from the CY 2014 OPPS final rule which states that
``skin substitute products do not actually function like human skin
that is grafted onto a wound; they are not a substitute for a skin
graft. Instead, these products are applied to wounds to aid wound
healing and through various mechanisms of action they stimulate the
host to regenerate lost tissue'' (78 FR 74930 through 74931). Finally,
we note that our definition of skin substitutes does not include
bandages or standard dressings and therefore, these items cannot be
assigned to either the high cost or low cost skin substitute groups or
be reported with either CPT codes 15271 through 15278 or HCPCS codes
C5271 through C5278.
VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
Section 1833(t)(6)(E) of the Act limits the total projected amount
of transitional pass-through payments for drugs, biologicals,
radiopharmaceuticals, and categories of devices for a given year to an
``applicable percentage,'' currently not to exceed 2.0 percent of total
program payments estimated to be made for all covered services under
the OPPS furnished for that year. If we estimate before the beginning
of the calendar year that the total amount of pass-through payments in
that year would exceed the applicable percentage, section
1833(t)(6)(E)(iii) of the Act requires a uniform prospective reduction
in the amount of each of the transitional pass-through payments made in
that year to ensure that the limit is not exceeded. We estimate the
pass-through spending to determine whether payments exceed the
applicable percentage and the appropriate pro rata reduction to the
conversion factor for the projected level of pass-through spending in
the following year to ensure that total estimated pass-through spending
for the prospective payment year is budget neutral, as required by
section 1833(t)(6)(E) of the Act.
For devices, developing a proposed estimate of pass-through
spending in CY 2021 entails estimating spending for two groups of
items. The first group of items consists of device categories that are
currently eligible for pass-through payment and that will continue to
be eligible for pass-through payment in CY 2021. The CY 2008 OPPS/ASC
final rule with comment period (72 FR 66778) describes the methodology
we have used in previous years to develop the pass-through spending
estimate for known device categories continuing into the applicable
update year. The second group of items consists of items that we know
are newly eligible, or project may be newly eligible, for device pass-
through payment in the remaining quarters of CY 2020 or beginning in CY
2021. The sum of the proposed CY 2021 pass-through spending estimates
for these two groups of device categories equaled the proposed total CY
2021 pass-through spending estimate for device categories with pass-
through payment status. We based the device pass-through estimated
payments for each device category on the amount of payment as
established in section 1833(t)(6)(D)(ii) of the Act, and as outlined in
previous rules, including the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75034 through 75036). We note that, beginning in CY 2010,
the pass-through evaluation process and pass-through payment
methodology for implantable biologicals newly approved for pass-through
payment beginning on or after January 1, 2010, that are surgically
inserted or implanted (through a surgical incision or a natural
orifice) use the device pass-through process and payment methodology
(74 FR 60476). As has been our past practice (76 FR 74335), in the
proposed rule, we proposed to include an estimate of any implantable
biologicals eligible for pass-through payment in our estimate of pass-
through spending for devices. Similarly, we finalized a policy in CY
2015 that applications for pass-through payment for skin substitutes
and similar products be evaluated using the medical device pass-through
process and payment methodology (76 FR 66885 through 66888). Therefore,
as we did beginning in CY 2015, for CY 2021, we also proposed to
include an estimate of any skin substitutes and similar products in our
estimate of pass-through spending for devices.
For drugs and biologicals eligible for pass-through payment,
section 1833(t)(6)(D)(i) of the Act establishes the pass-through
payment amount as the amount by which the amount authorized under
section 1842(o) of the Act (or, if the drug or biological is covered
under a competitive acquisition contract under section 1847B of the
Act, an amount determined by the Secretary equal to the average price
for the drug or biological for all competitive acquisition areas and
year established under such section as calculated and adjusted by the
Secretary) exceeds the portion of the otherwise applicable fee schedule
amount that the Secretary determines is associated with the drug or
biological. Our estimate of drug and biological pass-through payment
for CY 2021 for this group of items was $473.4 million, as discussed
below, because we proposed that most non pass-through separately
payable drugs and biologicals would be paid under the CY 2021 OPPS at
ASP+6 percent with the exception of 340B-acquired separately payable
drugs, which are paid at ASP minus 22.5
[[Page 86068]]
percent, but for which we proposed to pay a net rate of ASP minus 28.7
percent, and because we proposed to pay for CY 2021 pass-through
payment drugs and biologicals at ASP+6 percent, as we discussed in
section V.A. of this CY 2021 OPPS/ASC proposed rule.
Furthermore, payment for certain drugs, specifically diagnostic
radiopharmaceuticals and contrast agents without pass-through payment
status, is packaged into payment for the associated procedures, and
these products will not be separately paid. In addition, we policy-
package all non pass-through drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure and drugs and biologicals that function as
supplies when used in a surgical procedure, as discussed in section
V.B.1.c. of this CY 2021 OPPS/ASC proposed rule. We proposed that all
of these policy-packaged drugs and biologicals with pass-through
payment status would be paid at ASP+6 percent, like other pass-through
drugs and biologicals, for CY 2020. Therefore, our estimate of pass-
through payment for policy-packaged drugs and biologicals with pass-
through payment status approved prior to CY 2021 was not $0, as
discussed below. In section V.A.6. of the CY 2021 OPPS/ASC proposed
rule, we discussed our policy to determine if the costs of certain
policy-packaged drugs or biologicals are already packaged into the
existing APC structure. If we determine that a policy-packaged drug or
biological approved for pass-through payment resembles predecessor
drugs or biologicals already included in the costs of the APCs that are
associated with the drug receiving pass-through payment, we proposed to
offset the amount of pass-through payment for the policy-packaged drug
or biological. For these drugs or biologicals, the APC offset amount is
the portion of the APC payment for the specific procedure performed
with the pass-through drug or biological, which we refer to as the
policy-packaged drug APC offset amount. If we determine that an offset
is appropriate for a specific policy-packaged drug or biological
receiving pass-through payment, we proposed to reduce our estimate of
pass-through payments for these drugs or biologicals by this amount.
Similar to pass-through spending estimates for devices, the first
group of drugs and biologicals requiring a pass-through payment
estimate consists of those products that were recently made eligible
for pass-through payment and that will continue to be eligible for
pass-through payment in CY 2021. The second group contains drugs and
biologicals that we know are newly eligible, or project will be newly
eligible, in the remaining quarters of CY 2020 or beginning in CY 2021.
The sum of the CY 2021 pass-through spending estimates for these two
groups of drugs and biologicals equals the total CY 2021 pass-through
spending estimate for drugs and biologicals with pass-through payment
status.
B. Estimate of Pass-Through Spending
In the CY 2021 OPPS/ASC proposed rule, we proposed to set the
applicable pass-through payment percentage limit at 2.0 percent of the
total projected OPPS payments for CY 2021, consistent with section
1833(t)(6)(E)(ii)(II) of the Act and our OPPS policy from CY 2004
through CY 2020 (84 FR 61336 through 61337).
For the first group, consisting of device categories that are
currently eligible for pass-through payment and will continue to be
eligible for pass-through payment in CY 2021, there are four active
categories for CY 2021. The active categories are described by HCPCS
codes C1734, C1824, C1982, and C2596. Based on the information from the
device manufacturers, we proposed estimates that C1824 will cost $46
million in pass-through expenditures in CY 2021, C1982 will cost $116.3
million in pass-through expenditures in CY 2021, C2596 will cost $11.3
million in pass-through expenditures in CY 2021, and C1734 will cost
$37.2 million in pass-through expenditures in CY 2021. Therefore, we
proposed an estimate for the first group of devices of $210.8 million.
We did not receive any public comments on the proposal. Therefore, we
are finalizing the proposed estimate for the first group of devices of
$210.8 million for CY 2021.
In estimating our proposed CY 2021 pass-through spending for device
categories in the second group, we included: Device categories that we
knew at the time of the development of the proposed rule will be newly
eligible for pass-through payment in CY 2021; additional device
categories that we estimated could be approved for pass-through status
after the development of the proposed rule and before January 1, 2021;
and contingent projections for new device categories established in the
second through fourth quarters of CY 2021. For CY 2021, we proposed to
use the general methodology described in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66778), while also taking into account
recent OPPS experience in approving new pass-through device categories.
The proposed estimate of CY 2021 pass-through spending for this second
group of device categories is $99 million.
We did not receive any public comments on this proposal. As stated
earlier in this final rule with comment period, we are approving five
devices for pass-through payment status in the CY 2021 rulemaking
cycle: Barostim NEO[supreg] System, Hemospray[supreg] Endoscopic
Hemostat, EXALTTM Model D Single-Use Duodenoscope, The
SpineJack[supreg] Expansion Kit, and Customflex[supreg] Artificial
Iris. The manufacturers of these systems provided utilization and cost
data that indicate the spending for the devices would be approximately
$4 million for Barostim NEO[supreg] System, $40 million for
Hemospray[supreg] Endoscopic Hemostat, $40 million for
EXALTTM Model D Single-Use Duodenoscope, $14 million for
SpineJack[supreg] Expansion Kit, and $600 thousand for
Customflex[supreg] Artificial Iris. Therefore, we are finalizing an
estimate of $99 million for this second group of devices for CY 2021.
To estimate proposed CY 2021 pass-through spending for drugs and
biologicals in the first group, specifically those drugs and
biologicals recently made eligible for pass-through payment and
continuing on pass-through payment status for at least one quarter in
CY 2021, we proposed to use the most recent Medicare hospital
outpatient claims data regarding their utilization, information
provided in the respective pass-through applications, historical
hospital claims data, pharmaceutical industry information, and clinical
information regarding those drugs or biologicals to project the CY 2021
OPPS utilization of the products.
For the known drugs and biologicals (excluding policy-packaged
diagnostic radiopharmaceuticals, contrast agents, drugs, biologicals,
and radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure, and drugs and biologicals that function
as supplies when used in a surgical procedure) that will be continuing
on pass-through payment status in CY 2021, we estimate the pass-through
payment amount as the difference between ASP+6 percent and the payment
rate for non pass-through drugs and biologicals that will be separately
paid. Separately payable drugs are paid at a rate of ASP+6 percent with
the exception of 340B-acquired drugs, for which we currently pay ASP
minus 22.5 percent but for which we proposed to pay a net rate of ASP
minus 28.7 percent or in the alternative, to continue our current
policy of paying ASP minus 22.5 percent. Therefore, the payment rate
difference between the pass-through
[[Page 86069]]
payment amount and the non pass-through payment amount is $473.4
million for this group of drugs. Because payment for policy-packaged
drugs and biologicals is packaged if the product was not paid
separately due to its pass-through payment status, we proposed to
include in the CY 2021 pass-through estimate the difference between
payment for the policy-packaged drug or biological at ASP+6 percent (or
WAC+6 percent, or 95 percent of AWP, if ASP or WAC information is not
available) and the policy-packaged drug APC offset amount, if we
determine that the policy-packaged drug or biological approved for
pass-through payment resembles a predecessor drug or biological already
included in the costs of the APCs that are associated with the drug
receiving pass-through payment, which we estimate for CY 2021 for the
first group of policy-packaged drugs to be $0 since there are currently
no policy-packaged drugs for which we have cost data that will be on
pass-through in CY 2021.
We did not receive any public comments on our proposal. Using our
methodology for this final rule with comment period, we calculated a CY
2021 spending estimate for this first group of drugs and biologicals of
approximately $449.5 million based on our decision to finalize our
alternative proposal to maintain our current policy of paying ASP minus
22.5 percent for 340B-acquired drugs.
To estimate proposed CY 2021 pass-through spending for drugs and
biologicals in the second group (that is, drugs and biologicals that we
knew at the time of development of the final rule were newly eligible
for pass-through payment in CY 2021, additional drugs and biologicals
that we estimated could be approved for pass-through status subsequent
to the development of the final rule and before January 1, 2021 and
projections for new drugs and biologicals that could be initially
eligible for pass-through payment in the second through fourth quarters
of CY 2021), we proposed to use utilization estimates from pass-through
applicants, pharmaceutical industry data, clinical information, recent
trends in the per unit ASPs of hospital outpatient drugs, and projected
annual changes in service volume and intensity as our basis for making
the CY 2021 pass-through payment estimate. We also proposed to consider
the most recent OPPS experience in approving new pass-through drugs and
biologicals. Using our proposed methodology for estimating CY 2021
pass-through payments for this second group of drugs, we calculate a
proposed spending estimate for this second group of drugs and
biologicals of approximately $10 million.
We did not receive any public comments on our proposal. Therefore,
for CY 2021, we are continuing to use the general methodology described
above. For this final rule with comment period, we calculated a CY 2021
spending estimate for this second group of drugs and biologicals of
approximately $10 million.
We estimate that total pass-through spending for the device
categories and the drugs and biologicals that are continuing to receive
pass-through payment in CY 2021 and those device categories, drugs, and
biologicals that first become eligible for pass-through payment during
CY 2021 would be approximately $769.3 million (approximately $309.8
million for device categories and approximately $459.5 million for
drugs and biologicals) which represents 0.92 percent of total projected
OPPS payments for CY 2021 (approximately $84 billion). Therefore, we
estimate that pass-through spending in CY 2021 will not amount to 2.0
percent of total projected OPPS CY 2021 program spending.
VII. OPPS Payment for Hospital Outpatient Visits and Critical Care
Services
For CY 2021, we proposed to continue with our current clinic and
emergency department (ED) hospital outpatient visits payment policies.
For a description of the current clinic and ED hospital outpatient
visits policies, we refer readers to the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70448). We also proposed to continue our
payment policy for critical care services for CY 2020. For a
description of the current payment policy for critical care services,
we refer readers to the CY 2016 OPPS/ASC final rule with comment period
(80 FR 70449), and for the history of the payment policy for critical
care services, we refer readers to the CY 2014 OPPS/ASC final rule with
comment period (78 FR 75043). In the CY 2021 OPPS/ASC proposed rule, we
solicited public comment on any changes to these codes that we should
consider for future rulemaking cycles. We encouraged commenters to
provide the data and analysis necessary to justify any suggested
changes.
The following is a summary of the comments we received and our
responses to those comments.
Comment: We received comments suggesting that CMS develop a set of
national guidelines for coding hospital emergency department (ED)
visits. One commenter cited the June 2019 Medicare Payment Advisory
Commission (MedPAC) ``Report to the Congress: Medicare and the Health
Care Delivery System,'' which recommended that the Secretary develop
and implement a set of national guidelines for coding hospital ED
visits under the OPPS by 2022. In this report, MedPAC indicated that
national guidelines are necessary in order to improve the accuracy of
Medicare payments for ED visits and to regain a distribution of coding
frequency that is approximately normal, meaning Level 3 ED visits being
the most frequently coded level and Levels 1 and 5 the least frequently
coded. MedPAC found that hospitals' coding of ED visits has steadily
shifted from the lower levels to the higher levels, and they estimated
that 20 to 25 percent of the growth in Medicare spending on ED visits
was due to these visits being coded to higher levels. Commenters felt
that ``standardized, national guidelines are necessary in order to
ensure coding consistency and data comparability across hospitals and
to improve payment accuracy.'' Another commenter stated that absent
such standards, payers are creating their own criteria and are
downgrading higher-level ED evaluation and management services,
resulting in a loss of resources and increased administrative burden.
Response: We thank the commenters for their suggestions. As we
noted in the CY 2008 OPPS/ASC final rule (72 FR 66579) we understand
the interest in promulgating national guidelines but we continue to
believe that it is unlikely that national guidelines could apply to the
reporting of all ED visits. We may revisit this topic in the future as
necessary.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59004
through 59015), we adopted a method to control unnecessary increases in
the volume of covered outpatient department services under section
1833(t)(2)(F) of the Act by utilizing a Medicare Physician Fee Schedule
(PFS)-equivalent payment rate for the hospital outpatient clinic visit
(HCPCS code G0463) when it is furnished by excepted off-campus
provider-based departments (PBDs). As discussed in section X.D of that
proposed rule and the CY 2019 OPPS/ASC final rule with comment period
(83 FR 58818 through 59179), CY 2020 was the second year of the 2-year
transition for this policy and, beginning in CY 2020, these departments
are paid the site-specific PFS rate for the clinic visit service. We
note that on September 1, 2019, the United States District Court for
the District of Columbia (the district court) entered an order vacating
the portion of the CY 2019 OPPS/ASC final
[[Page 86070]]
rule with comment period that adopted the volume control method for
clinic visit services furnished by nonexcepted off-campus PBDs and
remanded the matter to the Secretary for further proceedings consistent
with the district court's opinion.\87\ In the CY 2020 OPPS/ASC final
rule with comment period, we acknowledged that the district court
vacated the volume control policy for CY 2019 and we stated that we
were working to ensure affected 2019 claims for clinic visits were paid
consistent with the court's order. We also stated that we did not
believe it was appropriate at that time to make a change to the second
year of the 2-year phase-in of the clinic visit policy. We explained
that we still had appeal rights, and were evaluating the rulings and
considering whether to appeal from the final judgment. On July 17,
2020, the United States Court of Appeals for the District of Columbia
Circuit (D.C. Circuit) ruled in favor of CMS, holding that our
regulation was a reasonable interpretation of the statutory authority
to adopt a method to control for unnecessary increases in the volume of
the relevant service. For a full discussion of this policy, we refer
readers to the CY 2020 OPPS/ASC final rule with comment period (84 FR
61142).
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\87\ American Hospital Ass'n, et al. v. Azar, No. 1:18-cv-02841-
RMC (D.D.C. Sept. 17, 2019).
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As detailed later in this section, after consideration of public
comments, we are continuing the clinic visit payment policy as adopted
in CY 2019 rulemaking. We will continue to take information submitted
by the commenters into consideration for future analysis.
The following is a summary of the comments we received and our
responses to those comments.
Comment: We received comments supporting CMS' efforts to continue
implementing its method to control for unnecessary increases in the
volume of outpatient services. Commenters expressed their support for
site-neutral payment policies in excepted and non-excepted off-campus
PBDs that promote greater payment alignment between physicians and
hospitals. One commenter noted, ``Over the last decade, our nation has
seen a trend of formerly independent physician practices becoming
affiliated with major hospital systems.\88\ This movement is part of a
larger trend of consolidation among health systems and physicians where
health systems are able to use their market power to leverage higher
prices for all consumers.\89\ The purchasing of physician practices by
hospital systems has resulted in costs shifting to outpatient
facilities where the costs of care are substantially higher. The drive
toward higher-cost hospital-based outpatient services has had a direct
negative financial impact on Medicare beneficiaries and overall
Medicare expenditures. Medicare beneficiaries pay higher copays at
hospital outpatient departments (HOPDs) than they do in physician
offices, and HOPDs are paid more than twice as much as physicians are
paid under the Medicare physician fee schedule for the same service,
thereby contributing to excess Medicare expenditures.'' One commenter
recommended CMS continue implementing site-neutral payments not just
for off-campus PBDs but also for on-campus PBDs, and freestanding and
non-freestanding emergency departments.
---------------------------------------------------------------------------
\88\ Jeff Lagasse, ``Hospitals acquired 5,000 physician
practices in a single year,'' Healthcare Finance, March 15, 2018,
https://www.healthcarefinancenews.com/news/hospitals-acquired-5000-physician-practices-single-year.
\89\ Bela Gorman, Don Gorman, Jennifer Smagula, John D.
Freedman, Gabriella Lockhart, Rik Ganguly, Alyssa Ursillo, Paul
Crespi, and David Kadish, Why Are Hospital Prices Different? An
Examination of New York Hospital Reimbursement, New York: New York
State Health Foundation, December 2016, https://nyshealthfoundation.org/wp-content/uploads/2017/11/an-examination-of-new-york-hospital-reimbursement-dec-2016.pdf.
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Response: We appreciate the commenters' support. As we noted in the
CY 2019 OPPS/ASC proposed rule (83 FR 37138 through 37143), ``[a] large
source of growth in spending on services furnished in hospital
outpatient departments (HOPDs) appears to be the result of the shift of
services from (lower cost) physician offices to (higher cost) HOPDs.''
We continue to believe that these shifts in the sites of service are
unnecessary if the beneficiary can safely receive the same services in
a lower cost setting but instead receives care in a higher cost setting
due to payment incentives. In addition to the concern that the
difference in payment is leading to unnecessary increases in the volume
of covered outpatient department services, we remain concerned that
this shift in care setting increases beneficiary cost-sharing liability
because Medicare payment rates for the same or similar services are
generally higher in hospital outpatient departments than in physician
offices. We continue to believe that our method will address the
concerns as described in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59005).
Comment: We received numerous comments outlining concerns we
contemplated in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59005) and in the CY 2020 OPPS/ASC (84 FR 61142) final rule with
comment period. Commenters' expressed that the payment cut for hospital
outpatient clinic visits threatens access to care, especially in rural
and other vulnerable communities, and that CMS has undermined the clear
congressional intent of Section 603 of the Bipartisan Budget Act of
2015 and exceeded its legal authority.
Many commenters asserted that the clinic visit policy is an
``adjustment'' subject to budget neutrality. Commenters expressed
concern that we did not create sufficient data analytics to support our
policy rationales. Commenters stated that there are several factors in
the Medicare program (and outside of hospital control) that could
influence more services moving to the hospital outpatient setting,
including the hospital readmissions reduction program, hospital value-
based purchasing, and the 2-midnight rule. Commenters further stated
that care provided at PBDs is held to higher quality standards and thus
cannot be directly compared to care provided at physician offices.
Commenters reiterated their comments from the CY 2019 OPPS/ASC
final rule with comment period (83 FR 59005) that, relative to patients
seen in physician offices, patients seen in HOPDs:
Have more severe chronic conditions;
Have higher prior utilization of hospitals and EDs;
Are more likely to live in low-income areas;
Are 1.8 times more likely to be dually eligible for
Medicare and Medicaid;
Are 1.4 times more likely to be nonwhite;
Are 1.6 times more likely to be under age 65 and disabled;
and
Are 1.1 times more likely to be over 85 years old.
Response: We continue to believe that section 1833(t)(2)(F) of the
Act gives the Secretary authority to develop a method for controlling
unnecessary increases in the volume of covered OPD services, including
a method that controls unnecessary volume increases by removing a
payment differential that is driving a site-of-service decision, and as
a result, is unnecessarily increasing service volume.\90\ We also
continue to believe shifts in the sites of service described in CY 2019
OPPS/ASC final rule with comment period (83 FR
[[Page 86071]]
59011) are inherently unnecessary if the beneficiary can safely receive
the same services in a lower cost setting but instead receives care in
a higher cost setting due to the payment incentives created by the
difference in payment amounts. While HOPDs may serve unique patient
populations and provide services to medically complex beneficiaries, we
have not received data from commenters that demonstrates the need for
higher payment for clinic visits furnished in excepted off-campus PBDs.
As we asserted in the 2019 OPPS/ASC final rule with comment period (83
FR 59011), the fact that the commenters did not supply new or
additional data supporting these assertions suggests that the payment
differential is likely the main driver for unnecessary volume increases
in outpatient department services, particularly clinic visits.
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\90\ Available at: https://www.ssa.gov/OP_Home/ssact/title18/1833.htm.
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As we noted in the CY 2019 OPPS/ASC final rule comment period (83
FR 59013), we maintain that while section 1833(t)(9)(B) of the Act does
require that certain changes made under the OPPS be made in a budget
neutral manner, this provision does not apply to the volume control
method under section 1833(t)(2)(F) of the Act. Further, as we stated in
the CY 2019 OPPS/ASC proposed rule (83 FR 37138 through 37143), we
believe that implementing a volume control method in a budget neutral
manner would not appropriately reduce the overall unnecessary volume of
covered OPD services, and instead would simply shift the volume within
the OPPS system in the aggregate.
On July 17, 2020, the D.C. Circuit ruled in favor of CMS, holding
that our regulation was a reasonable interpretation of the statutory
authority to adopt a method to control for unnecessary increases in the
volume of the relevant service.\91\ The D.C. Circuit concluded that CMS
reasonably read subparagraph (2)(F) to allow a service-specific, non-
budget-neutral payment reduction in the circumstances presented in the
CY 2019 OPPS/ASC final rule with comment period (83 FR 59013).\92\ On
October 16, 2020, appellees' petition for panel rehearing and petition
for rehearing en banc were denied.
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\91\ Am. Hosp. Ass'n v. Azar, 964 F.3d 1230, 1244-45 (D.C. Cir.
July 17, 2020).
\92\ Id.
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Comment: We received comments asserting that our site-neutral
policies are based on the flawed assumption that Medicare PFS payment
rates are sustainable rates for physicians.
Response: As we noted in the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61142), Medicare payment rates under the PFS for
services furnished by physicians and other suppliers are determined as
required by the PFS statute, and the rates for individual services are
determined based on the resources involved in furnishing these services
relative to other services paid under the PFS. To the extent that
commenters believe that the PFS rate for a particular service is
misvalued relative to other PFS services, we encourage commenters to
nominate the service for review as a potentially misvalued service
under the PFS.
Comment: Many commenters referenced the ongoing litigation
(described earlier in this section). They noted that the American
Hospital Association (AHA) is seeking a rehearing by the full D.C.
Circuit of the recent decision overturning the district court's ruling
in favor of AHA. Several commenters stated that while this issue
remains under consideration by the D.C. Circuit, CMS should delay
continuing the policy in CY 2021. Some commenters requested that CMS
restore the higher payment rates for off-campus HOPDs. Commenters also
requested that CMS make remedial payments to hospitals for
underpayments in 2019 and 2020. One commenter stated that CMS should
not seek recoupment of previously adjusted claims, given hospitals'
current financial situations as a result of the ongoing COVID-19
pandemic. They noted that CMS and HHS have sought opportunities to
support hospitals throughout the pandemic and one simple way to do so
would be to refrain from recouping prior repayments made to hospitals
in response to the district court's decision.
Response: As noted earlier in this section, on July 17, 2020, the
D.C. Circuit ruled in favor of CMS, holding that our regulation was a
reasonable interpretation of the statutory authority to adopt a method
to control for unnecessary increases in the volume of the relevant
service. On October 16, 2020, the D.C. Circuit denied the appellees'
petitions for a panel rehearing or a rehearing en banc. The appellees
have 90 days from the date of the orders denying their petitions to ask
the United States Supreme Court to review the case. We are still
considering how we may address any over or underpayments for 2019
claims.
Comment: Many commenters characterized the reductions to hospital
payments for clinic visits as excessive and harmful, especially during
the COVID-19 PHE. One commenter noted that ``Continuing to impose a 60%
cut on clinic visit services in 2021, on top of the dire financial
impacts on U.S. hospitals and health systems due to COVID-19, would
greatly endanger the critical role that HOPDs play in their
communities, including providing convenient access to care for the most
vulnerable and medically complex beneficiaries.'' Another commenter
asked CMS to reconsider its current policy and exempt Medicare-
Dependent Hospitals, Small Rural Hospitals, Sole Community Hospitals
(urban and rural) and Rural Referral Centers from all applications of
the PFS relativity adjuster.
Response: We share commenter's concerns about the financial
difficulties brought on by the COVID-19 PHE. We have taken a variety of
actions to support hospitals so they can more effectively respond to
the COVID-19 PHE, including waiving the provider-based rules and
permitting on-campus and excepted off-campus provider-based departments
to temporarily relocate and continue to be paid under the OPPS if they
submit a temporary extraordinary relocation exception request to their
Regional Office. Additionally, we provided for a 2-year phase-in of
this policy to help to mitigate the immediate financial impact on
providers.
We share the commenters' concerns about access to care, especially
in rural areas where access issues may be more pronounced than in other
areas of the country. Medicare has long recognized the unique needs of
rural communities and the financial challenges rural providers face.
Across the various Medicare payment systems, CMS has implemented a
number of special payment provisions for rural providers to maintain
access and ensure beneficiaries in rural areas receive high quality
care. Under the OPPS, section 1833(t)(13) of the Act gives the
Secretary authority to make an adjustment to OPPS payments for rural
hospitals, effective January 1, 2006, if justified by a study of the
difference in costs by APC between hospitals in rural areas and
hospitals in urban areas. Our analysis showed a difference in costs for
rural sole community hospitals. Therefore, for the CY 2006 OPPS, we
finalized a payment adjustment for rural sole community hospitals of
7.1 percent for all services and procedures paid under the OPPS,
excluding separately payable drugs and biologicals, brachytherapy
sources, and devices paid under the pass-through payment policy, in
accordance with section 1833(t)(13)(B) of the Act. We have continued
this 7.1 percent payment adjustment since 2006. We will continue to
monitor trends for any access to care issues and may consider
exemptions from the clinic visit policy for future rulemaking.
[[Page 86072]]
After consideration of public comments we received, we are
continuing the clinic visit payment policy for CY 2021 and beyond. We
will continue to utilize a PFS-equivalent payment rate for the hospital
outpatient clinic visit service described by HCPCS code G0463 when it
is furnished by excepted off-campus provider-based departments. The
PFS-equivalent rate for CY 2021 is 40 percent of the proposed OPPS
payment (that is, 60 percent less than the proposed OPPS rate). Under
this policy, these departments will be paid approximately 40 percent of
the OPPS rate (100 percent of the OPPS rate minus the 60-percent
payment reduction that is applied in CY 2021) for the clinic visit
service in CY 2021. Considering the effects of estimated changes in
enrollment, utilization, and case-mix, this policy results in an
estimated CY 2021 savings of approximately $430 million, with
approximately $340 million of the savings accruing to Medicare, and
approximately $90 million saved by Medicare beneficiaries in the form
of reduced copayments, when compared to estimated expenditures if the
policy were not applied. We will continue to monitor the effect of this
change in Medicare payment policy, including the volume of these types
of OPD services. We also will continue to evaluate this policy as
necessary in response to the ongoing litigation.
VIII. Payment for Partial Hospitalization Services
A. Background
A partial hospitalization program (PHP) is an intensive outpatient
program of psychiatric services provided as an alternative to inpatient
psychiatric care for individuals who have an acute mental illness,
which includes, but is not limited to, conditions such as depression,
schizophrenia, and substance use disorders. Section 1861(ff)(1) of the
Act defines partial hospitalization services as the items and services
described in paragraph (2) prescribed by a physician and provided under
a program described in paragraph (3) under the supervision of a
physician pursuant to an individualized, written plan of treatment
established and periodically reviewed by a physician (in consultation
with appropriate staff participating in such program), which sets forth
the physician's diagnosis, the type, amount, frequency, and duration of
the items and services provided under the plan, and the goals for
treatment under the plan. Section 1861(ff)(2) of the Act describes the
items and services included in partial hospitalization services.
Section 1861(ff)(3)(A) of the Act specifies that a PHP is a program
furnished by a hospital to its outpatients or by a community mental
health center (CMHC), as a distinct and organized intensive ambulatory
treatment service, offering less than 24-hour-daily care, in a location
other than an individual's home or inpatient or residential setting.
Section 1861(ff)(3)(B) of the Act defines a CMHC for purposes of this
benefit. We refer readers to sections 1833(t)(1)(B)(i), 1833(t)(2)(B),
1833(t)(2)(C), and 1833(t)(9)(A) of the Act and 42 CFR 419.21, for
additional guidance regarding PHP.
In CY 2008, we began efforts to strengthen the PHP benefit through
extensive data analysis, along with policy and payment changes by
implementing two refinements to the methodology for computing the PHP
median. For a detailed discussion on these policies, we refer readers
to the CY 2008 OPPS/ASC final rule with comment period (72 FR 66670
through 66676). In CY 2009, we implemented several regulatory, policy,
and payment changes. For a detailed discussion on these policies, we
refer readers to the CY 2009 OPPS/ASC final rule (73 FR 68688 through
68697). In CY 2010, we retained the two-tier payment approach for
partial hospitalization services and used only hospital-based PHP data
in computing the PHP APC per diem costs, upon which PHP APC per diem
payment rates are based (74 FR 60556 through 60559). In CY 2011, (75 FR
71994), we established four separate PHP APC per diem payment rates:
two for CMHCs (APC 0172 and APC 0173) and two for hospital-based PHPs
(APC 0175 and APC 0176) and instituted a 2-year transition period for
CMHCs to the CMHC APC per diem payment rates. For a detailed
discussion, we refer readers to section X.B. of the CY 2011 OPPS/ASC
final rule with comment period (75 FR 71991 through 71994). In CY 2012,
we determined the relative payment weights for partial hospitalization
services provided by CMHCs based on data derived solely from CMHCs and
the relative payment weights for partial hospitalization services
provided by hospital-based PHPs based exclusively on hospital data (76
FR 74348 through 74352). In the CY 2013 OPPS/ASC final rule with
comment period, we finalized our proposal to base the relative payment
weights that underpin the OPPS APCs, including the four PHP APCs (APCs
0172, 0173, 0175, and 0176), on geometric mean costs rather than on the
median costs. For a detailed discussion on this policy, we refer
readers to the CY 2013 OPPS/ASC final rule with comment period (77 FR
68406 through 68412).
In the CY 2014 OPPS/ASC proposed rule (78 FR 43621 through 43622)
and CY 2015 OPPS/ASC final rule with comment period (79 FR 66902
through 66908), we continued to apply our established policies to
calculate the four PHP APC per diem payment rates based on geometric
mean per diem costs using the most recent claims data for each provider
type. For a detailed discussion on this policy, we refer readers to the
CY 2014 OPPS/ASC final rule with comment period (78 FR 75047 through
75050). In the CY 2016, we described our extensive analysis of the
claims and cost data and ratesetting methodology, corrected a cost
inversion that occurred in the final rule data with respect to
hospital-based PHP providers and renumbered the PHP APCs. In CY 2017
OPPS/ASC final rule with comment period (81 FR 79687 through 79691), we
continued to apply our established policies to calculate the PHP APC
per diem payment rates based on geometric mean per diem costs and
finalized a policy to combine the Level 1 and Level 2 PHP APCs for
CMHCs and for hospital-based PHPs. We also implemented an eight-percent
outlier cap for CMHCs to mitigate potential outlier billing
vulnerabilities. For a comprehensive description of PHP payment policy,
including a detailed methodology for determining PHP per diem amounts,
we refer readers to the CY 2016 and CY 2017 OPPS/ASC final rules with
comment period (80 FR 70453 through 70455 and 81 FR 79678 through
79680).
In the CYs 2018 and 2019 OPPS/ASC final rules with comment period
(82 FR 59373 through 59381, and 83 FR 58983 through 58998,
respectively), we continued to apply our established policies to
calculate the PHP APC per diem payment rates based on geometric mean
per diem costs, designated a portion of the estimated 1.0 percent
hospital outpatient outlier threshold specifically for CMHCs, and
proposed updates to the PHP allowable HCPCS codes. We finalized these
proposals in the CY 2020 OPPS/ASC final rule with comment period (84 FR
61352). We refer readers to section VIII.D. of the CY 2021 OPPS/ASC
proposed rule for a discussion of the proposed updates and the
applicability for CY 2021.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61339
through 61350), we finalized our proposal to use the calculated CY 2020
CMHC geometric mean per diem cost and the calculated CY 2020 hospital-
[[Page 86073]]
based PHP geometric mean per diem cost, but with a cost floor equal to
the CY 2019 final geometric mean per diem costs as the basis for
developing the CY 2020 PHP APC per diem rates. Also, we continued to
designate a portion of the estimated 1.0 percent hospital outpatient
outlier threshold specifically for CMHCs, consistent with the
percentage of projected payments to CMHCs under the OPPS, excluding
outlier payments.
In the April 30, 2020 interim final rule with comment (85 FR 27562
through 27566), effective as of March 1, 2020 and for the duration of
the COVID-19 Public Health Emergency (PHE), hospital and CMHC staff are
permitted to furnish certain outpatient therapy, counseling, and
educational services (including certain PHP services), incident to a
physician's services, to beneficiaries in temporary expansion
locations, including the beneficiary's home, so long as the location
meets all conditions of participation to the extent not waived. A
hospital or CMHC can furnish such services using telecommunications
technology to a beneficiary in a temporary expansion location if that
beneficiary is registered as an outpatient. These provisions apply only
for the duration of the COVID-19 PHE.
B. PHP APC Update for CY 2021
1. PHP APC Geometric Mean Per Diem Costs
In summary, for CY 2021, we are finalizing our proposal to use the
CY 2021 CMHC geometric mean per diem cost calculated in accordance with
our existing methodology, using the most recent updated claims and cost
data, as the basis for developing the CY 2021 CMHC APC per diem rate.
We are also finalizing our proposal for CY 2021 to use the CY 2021
hospital-based geometric mean per diem cost calculated in accordance
with our existing methodology, using the most recent updated claims and
cost data.
In the CY 2021 OPPS/ASC proposed rule, we proposed to use geometric
mean per diem cost for CMHCs and hospital-based PHPs, calculated in
accordance with our existing methodology as the basis for calculating
the APC per diem rates for CMHCs and hospital-based PHPs respectively,
but with a cost floor applicable for each APC. We proposed to use the
cost floors calculated last year for CY 2020 ratesetting; that is, a
cost floor of $121.62 for CMHCs and a cost floor of $222.76 for
hospital-based PHPs. Following this methodology, we proposed to use a
cost floor value of $121.62 for CMHCs as the basis for developing the
CY 2021 CMHC APC per diem rate. We proposed to use the CY 2021
hospital-based PHP geometric mean per diem cost of $243.94, calculated
in accordance with our existing methodology for hospital-based PHPs, as
the basis for developing the CY 2021 hospital-based APC per diem rate.
Using the most recent updated claims and cost data as proposed, the
final CMHC geometric mean per diem cost is $136.14 and the final
hospital-based PHP geometric mean per diem cost is $253.76. The final
calculated geometric mean per diem costs for both CMHCs and hospital-
based PHPs are significantly higher than each proposed floor, therefore
a floor is not necessary at this time and we are not finalizing the
proposed cost floors in this CY 2021 OPPS/ASC final rule with comment
period at this time.
Lastly, we are finalizing our proposal to continue to use CMHC APC
5853 (Partial Hospitalization (three or More Services Per Day)) and
hospital-based PHP APC 5863 (Partial Hospitalization (three or More
Services Per Day)). These policies are discussed in more detail below.
2. Development of the PHP APC Geometric Mean Per Diem Costs
In preparation for CY 2021, we followed the PHP ratesetting
methodology described in section VIII.B.2. of the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70462 through 70466) to calculate
the PHP APCs' geometric mean per diem costs and payment rates for APCs
5853 and 5863, incorporating the modifications made in the CY 2017
OPPS/ASC final rule with comment period. As discussed in section
VIII.B.1. of the CY 2017 OPPS/ASC final rule with comment period (81 FR
79680 through 79687), the geometric mean per diem cost for hospital-
based PHP APC 5863 is based upon actual hospital-based PHP claims and
costs for PHP service days providing three or more services. Similarly,
the geometric mean per diem cost for CMHC APC 5853 is based upon actual
CMHC claims and costs for CMHC service days providing three or more
services. The CMHC or hospital-based PHP APC per diem costs are the
provider-type specific costs derived from the most recent claims and
cost data. The CMHC or hospital-based PHP APC per diem payment rates
are the national unadjusted payment rates calculated from the CMHC or
hospital-based PHP APC geometric mean per diem costs, after applying
the OPPS budget neutrality adjustments described in section XX of this
CY 2021 OPPS/ASC final rule with comment period.
a. CMHC Data Preparation: Data Trims, Exclusions, and CCR Adjustments
For this CY 2021 OPPS/ASC final rule, prior to calculating the
proposed geometric mean per diem cost for CMHC APC 5853, we prepared
the data by first applying trims and data exclusions, and assessing
CCRs as described in the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70463 through 70465), so that ratesetting was not skewed
by providers with extreme data. Before any trims or exclusions were
applied, there were 40 CMHCs in the PHP claims data file. Under the
2 standard deviation trim policy, we excluded any data from
a CMHC for ratesetting purposes when the CMHC's geometric mean cost per
day was more than 2 standard deviations from the geometric
mean cost per day for all CMHCs. In applying this trim for CY 2021
ratesetting, 2 CMHCs had geometric mean costs per day below the trim's
lower limit of $33.81 or had geometric mean costs per day above the
trim's upper limit of $519.84. Therefore, we excluded these 2 CMHCs
from ratesetting because of the 2 standard deviation trim.
In accordance with our PHP ratesetting methodology (80 FR 70465),
we also removed service days with no wage index values, because we used
the wage index data to remove the effects of geographic variation in
costs prior to APC geometric mean per diem cost calculation. For this
CY 2021 OPPS/ASC final rule ratesetting, no CMHC was missing wage index
data for all of its service days and, therefore, no CMHC was excluded.
We also excluded providers without any days containing 3 or more units
of PHP-allowable services. One provider was excluded from ratesetting
because it had no days containing 3 or more units of PHP-allowable
services. In addition to our trims and data exclusions, before
calculating the PHP APC geometric mean per diem costs, we also assess
CCRs (80 FR 70463). Our longstanding PHP OPPS ratesetting methodology
defaults any CMHC CCR greater than one to the statewide hospital CCR
(80 FR 70457). For this CY 2021 OPPS/ASC final rule ratesetting, there
were no CMHCs that showed CCRs greater than one. Therefore, it was not
necessary to default any CMHC to its statewide hospital CCR for
ratesetting.
In summary, these data preparation steps did not adjust the CCR for
any CMHCs with a CCR greater than one during our ratesetting process.
We excluded one CMHC because it had no
[[Page 86074]]
days containing 3 or more services and 2 CMHCs for failing the 2 standard deviation trim, resulting in the inclusion of 37
CMHCs. We did not exclude any other CMHCs for any other trims or
exclusions or for other missing data. There were 439 CMHC claims
removed during data preparation steps due to the 2 standard
deviation trim or because they either had no PHP-allowable codes or had
zero payment days, leaving 10,495 CMHC claims in our CY 2021 final rule
ratesetting modeling. After applying all of the previously listed
trims, exclusions, and adjustments, we followed the methodology
described in the CY 2016 OPPS/ASC final rule with comment period (80 FR
70464 through 70465) and modified in the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79687 through 79688, and 79691) to calculate
a CMHC APC geometric mean per diem cost.\93\ The calculated CY 2021
geometric mean per diem cost for all CMHCs for providing three or more
services per day (CMHC APC 5853) is $136.14, an increase from $121.62
calculated last year for CY 2020 ratesetting (84 FR 61347).
---------------------------------------------------------------------------
\93\ Each revenue code on the CMHC claim must have a HCPCS code
and charge associated with it. We multiply each claim service line's
charges by the CMHC's overall CCR from the OPSF (or statewide CCR,
where the overall CCR was greater than 1) to estimate CMHC costs.
Only the claims service lines containing PHP allowable HCPCS codes
and PHP allowable revenue codes from the CMHC claims remaining after
trimming are retained for CMHC cost determination. The costs,
payments, and service units for all service lines occurring on the
same service date, by the same provider, and for the same
beneficiary are summed. CMHC service days must have three or more
services provided to be assigned to CMHC APC 5853. The final
geometric mean per diem cost for CMHC APC 5853 is calculated by
taking the nth root of the product of n numbers, for days where
three or more services were provided. CMHC service days with costs
3 standard deviations from the geometric mean costs
within APC 5853 are deleted and removed from modeling. The remaining
PHP service days are used to calculate the final geometric mean per
diem cost for each PHP APC by taking the nth root of the product of
n numbers for days where three or more services were provided.
---------------------------------------------------------------------------
In the CY 2021 proposed rule (85 FR 48902) the CY 2021 calculated
CMHC APC was $104.00, which we were concerned would not support ongoing
access to PHPs in CMHCs. Therefore, we proposed to extend for CY 2021
and subsequent years the cost floor established in the prior year (84
FR 61339 through 61344). Because the final calculated CMHC geometric
mean per diem cost for this final rule with comment period is
substantially higher than the cost floor, we believe that the final
calculated geometric mean per diem cost for CMHCs will effectively
support access to partial hospitalization services and PHPs, and
therefore the data no longer supports the need to finalize a cost floor
at this time.
The CMHC APC 5853 is described as providing three or more partial
hospitalization services per day (81 FR 79680), and 85.7 percent of
CMHC paid days in CY 2019 were for providing four or more services per
day. To be eligible for a PHP, a patient must need at least 20 hours of
therapeutic services per week, as evidenced in the patient's plan of
care (42 CFR 410.43(c)(1)). To meet those patient needs, most PHP
provider paid days are for providing four or more services per day (we
refer readers to Table 45--Percentage of PHP Days by Service Unit
Frequency of this final rule with comment period). Therefore, the
higher calculated geometric mean per diem cost of $136.14 is in line
with our expectations, since the CMHC APC 5853 is actually heavily
weighted to the cost of providing four or more services. For context,
the per diem costs for CMHC APC 5853 have been calculated as $124.92,
$143.22, and $121.62 for CY 2017 (81 FR 79691), CY 2018 (82 FR 59378),
and CY 2019 (83 FR 58991), respectively.
In our analysis for the CY 2021 proposed rule, we found that six
providers, collectively representing 39.7 percent of all CMHC days,
reported lower costs per day than those reported for the CY 2020 final
rule ratesetting. These six providers heavily influenced the calculated
geometric mean per diem cost for CY 2021. Because these providers had a
high number of paid PHP days, and because the CMHC data set was so
small (n=38), these providers had a significant influence on the
calculated CY 2021 CMHC APC geometric mean per diem cost. Based on
updated cost and claims data for this final rule, the geometric mean
costs for three of these six providers (collectively representing 15.7
percent of all CMHC days) increased substantially along with the
geometric mean costs of a fourth provider, such that the final
calculated geometric mean per diem cost for all CMHCs increased to
$136.14.
For the CY 2021 OPPS/ASC proposed rule, in crafting our proposal,
we also considered a 3-year collective PHP geometric mean per diem cost
for each provider type calculated using the cost data from the three
most recent years, that is the final cost data from CY 2017 and CY
2018, along with the latest available cost data from CY 2019. We also
considered a 4-year collective PHP geometric mean per diem cost for
each provider type calculated using the cost data from the four most
recent years, which is the final cost data from CY 2016, CY 2017, and
CY 2018, along with the latest available cost data from CY 2019. We did
not ultimately propose either of these methodologies, and we did not
receive any comments on these methodologies. Further discussion of
these alternatives that we considered is found in the CY 2021 OPPS/ASC
proposed rule (85 FR 48904).
In summary, we are finalizing our proposal to use the current
year's CMHC APC geometric mean per diem cost (in this case, the CY 2021
CMHC APC geometric mean per diem cost), calculated in accordance with
our existing methodology. Since the final calculated CMHC geometric
mean per diem cost for this final rule with comment period is
substantially higher than the cost floor, we believe that the final
calculated geometric mean per diem cost for CMHCs will effectively
support access to partial hospitalization services and PHPs, and
therefore the data no longer supports the need to finalize a cost floor
at this time. We refer readers to section XXIV. of this CY 2021 OPPS/
ASC final rule with comment period for payment impacts, which are
budget neutral.
We received 8 comments that addressed CMHC ratesetting, which are
summarized as follows:
Comment: Nearly all commenters supported our proposed increase to
the CMHC payment rate and the efforts by CMS to mitigate fluctuations
in CMHC payments and help protect beneficiary access to PHP services.
However, several commenters expressed concern that despite the modest,
occasional rate increases proposed and finalized in recent years, the
results of the proposed PHP ratesetting methodology are contrary to
CMS's efforts to protect access. One commenter suggested that CMS
consider incorporating an annual adjustment to the cost floor in order
to ensure that it reflects updated cost information and continues to
help minimize the impact of significant changes in the median costs.
Five commenters stated that the current payment methodology has
resulted in reductions in provider access rather than protection of
access. Several commenters expressed concern about the decline in the
number of CMHCs and the effect that further declines would have on
beneficiary access to care. These commenters suggested that declining
PHP payment rates have been the cause of the decline in the number of
CMHCs. One commenter stated that decreased access to CMHC PHP services
could force beneficiaries to use more costly hospital-based PHPs, with
higher beneficiary co-payments, or lead to increased use of inpatient
psychiatric resources. This commenter stated that the data used for
CMHC ratesetting are
[[Page 86075]]
skewed, the calculations are incorrect, and the proposed low payment
rates would result in the remaining CMHCs closing. This commenter noted
that setting CMHCs' payment rates based on a small number of CMHCs does
not reflect the actual cost of providing these services and expressed
concern that by using the mean or median costs, more CMHCs would close.
Response: We thank the commenters for their support, and we also
share the commenters' concerns about the decline in the number of PHPs,
particularly at CMHCs, and the effect on access. However, it does not
directly follow that declining per diem payment rates alone have caused
the decline in the number of PHPs. As we have noted in prior rulemaking
(76 FR 74350 and 79 FR 66906), the closure of PHPs may be due to a
number of reasons, such as business management or marketing decisions,
competition, oversaturation of certain geographic areas, and federal
and state fraud and abuse efforts, among others. Our goal is to ensure
accurate and reasonable payment rates for PHP services that protect
access to both provider types, so beneficiaries have choices regarding
where to receive treatment. We want to ensure that CMHCs remain a
viable option as providers of mental health care in the beneficiary's
own community. Also, beneficiaries receiving care at a CMHC instead of
a hospital-based PHP may incur lower beneficiary copayments. However,
we disagree with the assertion that the CMHC data are skewed and that
the calculations are incorrect. In the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70456 to 70459), we implemented a 2
standard deviation trim on CMHC costs per day to remove aberrant data
that could skew costs up or down inappropriately. We recognize that
with a small number of providers, such as the 37 CMHCs used for this
final rule rate setting, the calculations can be influenced by large
providers, however it is important to note that the influence these
providers have is appropriate and proportional to their share of PHP
days furnished. In this CY 2021 final rule ratesetting, as discussed
previously in this section, updated data from three large providers
reflected a significant increase in geometric mean per diem costs. Due
to the large share of PHP days that these providers furnished, their
increased per diem costs influenced the overall CMHC geometric mean per
diem cost calculation.
We also recognize that as the number of providers decreases, the
ratesetting calculations can be more strongly influenced by the costs
of large providers. We are regularly evaluating our rate setting
methodology to ensure that it is as accurate as possible, and captures
provider cost data fully. However, our rate setting methodology must
comply with requirements at sections 1833(t)(2) and 1833(t)(9) of the
Act, and depends heavily on provider-reported costs. We strongly
encourage CMHCs to review cost reporting instructions to be sure they
are reporting their costs correctly. These instructions are available
in chapter 45 of the Provider Reimbursement Manual, Part 2, available
on the CMS website at https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/PaperBased-Manuals.html. We want to reiterate that it
is a requirement for CMHCs, unless they are approved as a low-
utilization or no-utilization provider in accordance with PRM-1,
chapter 1, section 110 (42 CFR 413.24(g) and (h)), to file full cost
reports, to help us capture accurate CMHC costs in rate setting. We
furthermore encourage those CMHCs that do not file full cost reports to
consider doing so.
We are confident that the per diem costs we calculate follow the
methodology discussed in the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70462 to 70466) and in the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79691). Those costs are geometric mean per
diem costs, rather than arithmetic mean or median per diem costs; in
the CY 2013 OPPS final rule (77 FR 68409), we discussed the advantages
of using geometric means rather than medians to calculate PHP costs,
and noted that the geometric mean more accurately captures the full
range of service costs (including outliers) than the median cost and
promotes more stability in the payment system. In summary, we believe
that providing payment that is based upon actual provider-reported
costs supports access to PHP services and does not lead to provider
closures; however, as we noted above, we rely on providers to
accurately report their costs in a timely and complete manner.
For CY 2021, after reviewing comments and updated cost and claims
data, we are finalizing the CY 2021 CMHC geometric mean per diem cost
as $136.14, which is above the proposed cost floor amount and based on
updated cost and claims data. We believe this calculated geometric mean
per diem cost will support access to PHP services. Therefore at this
time, we are not finalizing our proposal to extend the cost floor for
CY 2021 or subsequent years. Given the higher than expected calculated
CMHC geometric mean per diem cost due to updated data, we do not
believe our proposal for a cost floor is necessary for CY 2021 and do
not believe it is appropriate to apply this cost floor for subsequent
years; in response to the concerns raised by several commenters, we
will continue to evaluate the effects of our policies and analyze the
latest available cost and claims data to look for ways to further
mitigate payment fluctuations and protect beneficiary access to PHP
services. We appreciate the commenters' suggestions, and will take them
into consideration as we explore future policies. We also refer readers
to section VII.B.2.b of this final rule with comment period for a
similar comment and response related to hospital-based PHPs.
Comment: Three commenters highlighted the importance of PHP
services in the current environment and noted that the need for mental
health services in general has increased.
Response: We appreciate the work PHPs do to care for a particularly
vulnerable population with serious mental illnesses, and we recognize
the particular importance of these programs in the current environment.
We believe it is crucial to ensure that providers receive accurate
payment in order to provide these necessary services to the PHP
population. Based on the latest data, the geometric mean per diem cost
for CMHCs is significantly higher than the cost floor that we proposed
for CY 2021, and therefore the data does not support finalizing floor
at this time in this CY 2021 OPPS/ASC final rule. As noted above, we
will continue to look for ways to further mitigate payment fluctuations
and protect beneficiary access to PHP services.
Comment: One commenter requested that CMS take into account for
future rulemaking the effects that the COVID-19 PHE and the subsequent
conversion to virtual care may have on PHP services and the payment
methodology for such services.
Response: We appreciate the commenter's suggestion and will take
this into consideration as we explore policy options for appropriately
strengthening the PHP benefit and increasing access to the valuable
services provided by CMHCs as well as by hospital-based PHPs. As part
of that process, we regularly review our methodology to ensure that it
is appropriately capturing the cost of care reported by providers and
will give particular attention to effects of the ongoing COVID-19 PHE.
Comment: One commenter stated that CMHCs incur extra costs to meet
the CMHC conditions of participation (CoPs) and have experienced an
increase in bad debt expense.
[[Page 86076]]
Response: Most (if not all) of the costs associated with adhering
to CoPs should be captured in the cost report data used in ratesetting
and, therefore, are accounted for when computing the geometric mean per
diem costs. Finally, the statutory reduction to bad debt reimbursement
was a result of provisions of section 3201 of the Middle Class Tax
Relief and Job Creation Act of 2012 (Pub. L. 112-96). The reduction to
bad debt reimbursement impacted all providers eligible to receive bad
debt reimbursement, as discussed in the CY 2013 End-Stage Renal Disease
final rule (77 FR 67518). Medicare currently reimburses bad debt for
eligible providers at 65 percent of such debt. Because this percentage
was enacted by Congress, CMS does not have the authority to change the
percentage. In contrast to the Medicare bad debt reimbursement policy,
private sector insurers typically do not reimburse providers for any
amounts of enrollees' unpaid deductibles or coinsurance. In light of
budgetary constraints and the steady increase in bad debt claims over
the years, a reduction in bad debt reimbursement is necessary to
protect the Medicare Trust Fund and preserve beneficiary access to care
without imposing an undue burden on hospitals.
Comment: One commenter recommended that CMS pay CMHCs the same rate
as hospital-based PHPs, since these two provider types provide the same
services and have the same qualified clinical staff. This commenter
objected to CMS' continuing use of the single-tier payment system for
CMHCs, stating that it adversely affects the quality and intensity of
PHP services.
Response: The OPPS pays for outpatient services, including partial
hospitalization services, based on the costs of providing services
using provider data from claims and cost reports, in accordance with
statute. Section 1833(t)(2)(B) of the Act provides that the Secretary
may establish groups of covered OPD services, within a classification
system developed by the Secretary for covered OPD services, so that
services classified within each group are comparable clinically and
with respect to the use of resources. In addition, by statute at
Section 1833(t)(2)(C) of the Act, we are required to use data on claims
and most recent available cost reports to establish relative payment
weights for covered OPD services. Therefore, we calculate a CMHC APC
rate based on costs, which providers supply on their cost reports.
While CMHCs and hospital-based CMHCs provide the same clinical
services, their resource use differs, because these two provider types
have different cost structures. In this final rule and in prior
rulemaking, commenters and CMS have noted that hospitals tend to have
higher costs than CMHCs, particularly higher overhead (83 FR 58986, 82
FR 59377, and 81 FR 79686 to 79687). We see this difference in cost
structures reflected when we calculate the geometric mean cost per day
for CMHCs versus for hospital-based PHPs, where CMHC costs per day are
consistently lower than hospital-based PHP costs per day. For example,
for this CY 2021 OPPS/ASC final rule with comment, the calculated
geometric mean costs for providing PHP services were $136.14 per day
for CMHCs, but were $253.76 per day for hospital-based PHPs. Therefore,
we do not believe it is appropriate to pay CMHCs the same APC rate as
hospital-based PHPs. We strongly encourage CMHCs to review cost
reporting instructions to be sure they are reporting their costs
correctly. These instructions are available in chapter 45 of the
Provider Reimbursement Manual, Part 2, available on the CMS website at
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/PaperBased-Manuals.html.
We believe our policy to replace the existing Level 1 and Level 2
PHP APCs for both provider types with a single PHP APC, by provider
type, is supported by the statute and regulations and will continue to
pay for partial hospitalization services appropriately based upon
actual provider costs (81 FR 79683). Regarding the commenter's concern
about the small number of providers and the use of a single-tier
payment system, we refer the commenter to the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79682 through 79685), where we
discussed our rationale for implementing the single-tier payment system
for CMHCs. A key reason behind implementing the single tier for CMHCs
was to reduce cost fluctuations and bring more stability to CMHC APC
rates, especially given the small number of providers (81 FR 79683). We
also noted that the costs of providing a Level 1 CMHC day were nearly
the same as the cost of providing a Level 2 CMHC day (81 FR 79684). In
accordance with the regulations at 42 CFR 419.31, we could not justify
continuing to separate these services into two APCs, but combined
clinically similar services with similar resource use into a single APC
(81 FR 79683 to 79684).
We do not believe the intensity of PHP services provided in
hospitals and in CMHCs has been affected by using a single-tier payment
system. Based on the utilization data found in Table 45 of this final
rule with comment period, the percentage of paid PHP days which have
only three services has been relatively stable over time and has
remained consistent for hospital-based PHPs. Even though we identified
an increase in 3-service days for CMHCs in 2019, as we note in section
VIII.B.3.b of this final rule with comment period, we also identified a
noticeable increase in days with 5 or more services. We will continue
to monitor the percentage of 3-service days and will also monitor the
provision of 20 hours per week of PHP services, to ensure there are no
unintended consequences of a single-tier payment system on PHP
intensity. We are unable to determine the effects of the single-tier
payment on CMHC quality, because there are no quality measures for
CMHCs, nor is quality reporting required of CMHCs. However, we do not
believe that a single-tier payment system would affect the quality of
care provided in a CMHC.
Comment: One commenter suggested that CMS use value-based
purchasing for paying CMHCs instead of a cost-based system stating that
rewarding providers for higher-quality care, as measured by selected
standards is a better way to improve the quality of any service. Other
commenters recommended that CMS reconsider its policy positions on PHP
services and look for ways to rebuild these services, suggesting that
CMS base PHP reimbursement on incentives determined by documented
productivity results. These commenters suggested we consider
Measurement-based Care and Patient Satisfaction.
Response: We believe ``measurement-based care'' that the commenters
cited refers to administering a standardized instrument to measure some
aspect of patient symptoms when he or she begins and ends receiving PHP
services. This type of measure could inform clinical decision-making
and quality improvement activities at minimum, but results could
theoretically be used to adjust payment. We also believe that the
commenters are asking if CMS could administer patient satisfaction
surveys and then reward high-performing PHPs. We responded to a similar
public comment in the CY 2016 OPPS/ASC final rule with comment period
(80 FR 70462) and refer readers to a summary of that comment and our
response. Currently, there is no statutory language authorizing
incentive payment methodology based on productivity results, patient
satisfaction, or value-based purchasing for CMHCs or for outpatient
hospital-based PHPs. To reiterate, sections 1833(t)(2) and 1833(t)(9)
of the Act set forth the
[[Page 86077]]
requirements for establishing and adjusting OPPS payment rates, which
are based on costs, and which include PHP payment rates. We note that
section 1833(t)(17) of the Act authorizes the Hospital Outpatient
Quality Reporting (OQR) Program, which applies a payment reduction to
subsection (d) hospitals that fail to meet program requirements. In the
CY 2015 OPPS/ASC proposed rule (79 FR 41040), we considered future
inclusion of, and requested comments on, the following quality measures
addressing PHP issues that would apply in the hospital outpatient
setting: (1) 30-Day Readmission; (2) Group Therapy; and (3) No
Individual Therapy. We refer readers to the CY 2015 OPPS/ASC final rule
with comment period (79 FR 66957 through 66958) for a more detailed
discussion of PHP measures considered for inclusion in the Hospital OQR
Program in future years, and of the comments received as a result of
the solicitation. CMS also adopted the OAS CAHPS survey in the Hospital
OQR Program, beginning with CY 2020 payment determination (2018 data
collection) (82 FR 52572 through 52573); however, implementation was
delayed until further action in future rulemaking to ensure that the
survey measures appropriately account for patient response rates, both
aggregate and by survey administration method; reaffirm the reliability
of national implementation of OAS CAHPS Survey data; and appropriately
account for the burden associated with administering the survey in the
outpatient setting of care.
However, the Hospital OQR Program does not apply to CMHCs, and
there are no quality measures applied to CMHCs.
After careful consideration of the comments and updated data, we
are finalizing our proposal to use the CY 2021 CMHC APC geometric mean
per diem cost calculated in accordance with our existing methodology.
Because the final calculated CMHC geometric mean per diem cost for this
final rule with comment period is substantially higher than the cost
floor, we believe that the final calculated geometric mean per diem
cost for CMHCs will effectively support access to partial
hospitalization services and PHPs. Therefore, the data no longer
supports the need to finalize a cost floor at this time. In response to
the concerns raised by several commenters, we will continue to look for
ways to further mitigate payment fluctuations and protect beneficiary
access to PHP services. The final CY 2021 CMHC geometric mean per diem
cost is $136.14.
b. Hospital-Based PHP Data Preparation: Data Trims and Exclusions
For this CY 2021 final rule, we prepared data consistent with our
policies as described in the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70463 through 70465) for hospital-based PHP providers,
which is similar to that used for CMHCs. The CY 2019 PHP claims
included data for 449 hospital-based PHP providers for our calculations
in this CY 2021 OPPS/ASC proposed rule.
Consistent with our policies as stated in the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70463 through 70465), we prepared
the data by applying trims and data exclusions. We applied a trim on
hospital service days for hospital-based PHP providers with a CCR
greater than 5 at the cost center level. To be clear, the CCR greater
than 5 trim is a service day-level trim in contrast to the CMHC 2 standard deviation trim, which is a provider-level trim.
Applying this CCR greater than 5 trim removed affected service days
from one hospital-based PHP provider from our final ratesetting.
However, 100 percent of the service days for this hospital-based PHP
provider had at least one service associated with a CCR greater than 5,
so the trim removed this provider entirely from our final ratesetting.
In addition, 68 hospital-based PHPs were removed for having no days
with PHP payment. Two hospital-based PHPs were removed because none of
their days included PHP-allowable HCPCS codes. No hospital-based PHPs
were removed for missing wage index data, and a single hospital-based
PHP was removed by the OPPS 3 standard deviation trim on
costs per day. (We refer readers to the OPPS Claims Accounting
Document, available online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1717-P-2020-OPPS-Claims-Accounting.pdf.
Overall, we removed 72 hospital-based PHP providers [(1 with all
service days having a CCR greater than 5) + (68 with no PHP payment) +
(2 with no PHP-allowable HCPCS codes) + (1 provider with geometric mean
costs per day outside the 3 SD limits)], resulting in 377
(449 total - 72 excluded) hospital-based PHP providers in the data used
for calculating ratesetting. In addition, 6 hospital-based PHP
providers were defaulted to their overall hospital ancillary CCRs due
to outlier cost center CCR values.
After completing these data preparation steps, we calculated the
final CY 2021 geometric mean per diem cost for hospital-based PHP APC
5863 for hospital-based partial hospitalization services by following
the methodology described in the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70464 through 70465) and modified in the CY 2017
OPPS/ASC final rule with comment period (81 FR 79687 and 79691).\94\
The calculated CY 2021 hospital-based PHP APC geometric mean per diem
cost for hospital-based PHP providers that provide three or more
services per service day (hospital-based PHP APC 5863) is $253.76,
which is an increase of 8.7 percent from $233.52 calculated last year
for CY 2020 ratesetting (84 FR 61344 through 61348). We believe that a
hospital-based PHP APC geometric mean per diem cost of $253.76 best
supports ongoing access to hospital-based PHPs.
---------------------------------------------------------------------------
\94\ Each revenue code on the hospital-based PHP claim must have
a HCPCS code and charge associated with it. We multiply each claim
service line's charges by the hospital's department-level CCR; in CY
2020 and subsequent years, that CCR is determined by using the PHP-
only revenue-code-to-cost-center crosswalk. Only the claims service
lines containing PHP-allowable HCPCS codes and PHP-allowable revenue
codes from the hospital-based PHP claims remaining after trimming
are retained for hospital-based PHP cost determination. The costs,
payments, and service units for all service lines occurring on the
same service date, by the same provider, and for the same
beneficiary are summed. Hospital-based PHP service days must have
three or more services provided to be assigned to hospital-based PHP
APC 5863. The final geometric mean per diem cost for hospital-based
PHP APC 5863 is calculated by taking the nth root of the product of
n numbers, for days where three or more services were provided.
Hospital-based PHP service days with costs 3 standard
deviations from the geometric mean costs within APC 5863 are deleted
and removed from modeling. The remaining hospital-based PHP service
days are used to calculate the final geometric mean per diem cost
for hospital-based PHP APC 5863.
---------------------------------------------------------------------------
In the proposed rule (85 FR 48902) we stated that we believe access
is better supported when the geometric mean per diem cost does not
fluctuate greatly. In addition, while the hospital-based PHP APC 5863
is described as providing payment for the cost of three or more
services per day (81 FR 79680), 89.1 percent of hospital-based PHP paid
service days in CY 2019 were for providing four or more services per
day. To be eligible for a PHP, a patient must need at least 20 hours of
therapeutic services per week, as evidenced in the patient's plan of
care (42 CFR 410.43(c)(1)). To meet those patient needs, most PHP paid
service days provide four or more services (we refer readers to Table
45--Percentage of PHP Days by Service Unit Frequency in this final
rule). Therefore, the hospital-based PHP APC 5863 is actually heavily
weighted to the cost of providing four or more services. The per diem
costs for hospital-based PHP APC 5863 have been
[[Page 86078]]
calculated as $213.14, $208.09, and $222.76 for CY 2017 (81 FR 79691),
CY 2018 (82 FR 59378), and CY 2019 (83 FR 58991), respectively.
As we noted for CMHCs above, we likewise do not believe that it is
likely that the cost of providing hospital-based PHP services would
suddenly decline when costs generally increase over time. In order to
address concerns about potential fluctuations, which we believed could
be influenced by data from a small number of providers with low service
costs per day, we proposed to use the CY 2021 hospital-based PHP APC
geometric mean per diem cost, calculated in accordance with our
existing methodology, but with a cost floor equal to the floor for
hospital-based providers of $222.76 calculated last year for CY 2020
ratesetting (84 FR 61344 through 61345), as the basis for developing
the CY 2021 hospital-based PHP APC per diem rate. As part of this
proposal, we proposed that we would use the most recent updated claims
and cost data to calculate CY 2021 geometric mean per diem costs, just
as we did for CMHCs. We further proposed that the established hospital-
based geometric mean per diem cost floor of $222.76 be extended to CY
2021 and subsequent years and that if the calculated geometric mean per
diem cost for a given year is below the floor, then the geometric mean
per diem cost that would be used for ratesetting in that year would be
equal to the geometric mean per diem cost floor of $222.76. We stated
we believed using the CY 2020 hospital-based PHP per diem cost floor as
the floor for CY 2021 is appropriate because it is based on very recent
hospital-based PHP claims and cost data and would help to protect
provider access by preventing wide fluctuation in the per diem costs
for hospital-based APC 5863.
While the proposed cost floor would protect hospital-based PHPs if
the CY 2021 calculated hospital-based PHP APC geometric mean per diem
cost were less than $222.76, the calculated hospital-based PHP
geometric mean per diem cost of $243.94 was greater than the floor, and
therefore, we proposed this calculated CY 2021 cost for hospital-based
PHPs.
For the CY 2021 proposed rule, we also considered a 3-year
collective PHP geometric mean per diem cost for each provider type
calculated using the cost data from the three most recent years, that
is, the final cost data from CY 2017 and CY 2018, along with the latest
available cost data from CY 2019. We also considered a 4-year
collective PHP geometric mean per diem cost for each provider type
calculated using the cost data from the four most recent years, which
is the final cost data from CY 2016, CY 2017, and CY 2018, along with
the latest available cost data from CY 2019. We did not ultimately
propose either of these methodologies, and we did not receive any
comments on these methodologies. Further discussion of these
alternatives is found in the CY 2021 OPPS proposed rule (85 FR 48904).
In summary, we are finalizing our proposal to use the most recent
updated claims and cost data to calculate CY 2021 geometric mean per
diem costs, just as we are for CMHCs in the section above. Because the
final calculated CY 2021 hospital-based PHP APC geometric mean per diem
cost is significantly higher than the proposed floor, we believe that
the final calculated geometric mean per diem cost for hospital-based
PHPs will effectively support access to partial hospitalization
services. The data no longer supports the need to finalize a cost floor
at this time, and therefore, we are not finalizing our proposal to
extend the established hospital-based geometric mean per diem cost
floor of $222.76 to CY 2021 and subsequent years. The final CY 2021
hospital-based PHP geometric mean per diem cost is $253.76. We refer
readers to section XXIV of this CY 2021 OPPS/ASC final rule with
comment period for a discussion of payment impacts and the budget
neutrality adjustment for OPPS rates.
We received 8 comments that addressed hospital-based PHP
ratesetting, which are summarized as follows:
Comment: Nearly all commenters supported our proposed increase to
the hospital-based PHP payment rate and the efforts by CMS to mitigate
fluctuations in hospital-based PHP payments and help protect
beneficiary access to PHP services. However, several commenters
expressed concern that despite the modest, occasional rate increases
proposed and finalized in recent years, the results of the proposed PHP
ratesetting methodology are contrary to CMS's efforts to protect
access. Several commenters expressed concern about the decline in the
number of hospital-based PHPs and the effect that further declines
would have on beneficiary access to care. Five of these commenters
stated that the current payment methodology has resulted in reductions
in provider access rather than protection of access. One commenter
suggested that CMS consider incorporating an annual adjustment to the
cost floor in order to ensure that it reflects updated cost information
and continues to help minimize the impact of significant changes in the
median costs.
Response: We thank the commenters for their support, and we also
share the commenters' concerns about the decline in the number of PHPs
and the effect on access. However, as we stated above, it does not
directly follow that declining per diem payment rates alone have caused
the decline in the number of PHPs. As we have noted in prior rulemaking
(76 FR 74350 and 79 FR 66906), the closure of PHPs may be due to a
number of reasons, such as business management or marketing decisions,
competition, oversaturation of certain geographic areas, and federal
and state fraud and abuse efforts, among others. Our goal is to ensure
accurate and reasonable payment rates for PHP services that protect
access to both provider types, so beneficiaries have choices regarding
where to receive treatment. After reviewing comments and updated costs,
for CY 2021, we are finalizing the CY 2021 hospital-based PHP geometric
mean per diem cost as $253.76, which is above the cost floor amount and
based on updated cost and claims data. We believe this calculated
geometric mean per diem cost will support access to hospital-based PHP
services. At this time we are not finalizing our proposal to extend the
cost floor for CY 2021 or subsequent years. Given the hospital-based
PHP geometric mean per diem cost is $253.76, which is above the cost
floor, we do not believe our proposal for a cost floor is necessary for
CY 2021 and do not believe it is appropriate to apply this cost floor
for subsequent years; in response to the concerns raised by several
commenters, we will continue evaluate the effects of our policies and
analyze the latest available cost and claims data to look for ways to
further mitigate payment fluctuations and protect beneficiary access to
PHP services. We appreciate the commenters' suggestions, and will take
them into consideration as we explore future policies.
We also recognize that as the number of providers decreases, the
relative share of PHP days furnished by large providers can increase,
such that large providers' costs more strongly influence the
ratesetting calculations. We are regularly evaluating our rate setting
methodology to ensure that it is as accurate as possible, that it
captures provider cost data fully, and that it protects access to PHP
services. However, our rate setting methodology must comply with
requirements at sections 1833(t)(2) and 1833(t)(9) of the Act, and
depends heavily on provider-
[[Page 86079]]
reported costs. We strongly encourage hospitals to review cost
reporting instructions to be sure they are reporting their costs
correctly. These instructions are available in chapter 40 of the
Provider Reimbursement Manual, Part 2, available on the CMS website at
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/PaperBased-Manuals.html. We also refer readers to section VIII.B.2.a.
for a similar comment and response related to CMHCs.
Comment: Three commenters highlighted the importance of PHP
services in the current environment and noted that the need for mental
health services in general has increased.
Response: We appreciate the work PHPs do to care for a particularly
vulnerable population with serious mental illnesses and believe that
having PHPs available to beneficiaries helps prevent patient recidivism
and inpatient psychiatric admissions, and we recognize the particular
importance of these programs in the current environment. We believe it
is crucial to ensure that providers receive accurate payment in order
to provide these necessary services to the PHP population. Based on the
latest data, the geometric mean per diem cost for hospital-based PHPs
is significantly higher than the cost floor that we proposed for CY
2021, and therefore the data does not support finalizing floor at this
time in this CY 2021 OPPS/ASC final rule.
Comment: One commenter requested that CMS to take into account for
future rulemaking the effects that the COVID-19 PHE and the subsequent
conversion to virtual care may have on PHP services and the payment
methodology for such services.
Response: As mentioned earlier, we will continue to explore policy
options for strengthening the PHP benefit and increasing access to the
valuable services provided by CMHCs as well as by hospital-based PHPs
with particular attention to effects of this PHE. As part of that
process, we regularly review our methodology to ensure that it is
appropriately capturing the cost of care reported by providers.
Comment: One commenter suggested that CMS use value-based
purchasing for paying hospital-based PHPs instead of a cost-based
system stating that rewarding providers for higher-quality care, as
measured by selected standards is a better way to improve the quality
of any service. Other commenters recommended that CMS reconsider its
policy positions on PHP services and look for ways to rebuild these
services, suggesting that CMS base PHP reimbursement on incentives
determined by documented productivity results. These commenters
suggested we consider Measurement-based Care and Patient Satisfaction.
Response: We believe ``measurement-based care'' that the commenters
cited refers to administering a standardized instrument to measure some
aspect of patient symptoms when he or she begins and ends receiving PHP
services. This type of measure could inform clinical decision-making
and quality improvement activities at minimum, but results could
theoretically be used to adjust payment. We also believe that the
commenters are asking if CMS could administer patient satisfaction
surveys and then reward high-performing PHPs. We responded to a similar
public comment in the CY 2016 OPPS/ASC final rule with comment period
(80 FR 70462) and refer readers to a summary of that comment and our
response. Currently, there is no statutory language authorizing
incentive payment methodology based on productivity results, patient
satisfaction, or value-based purchasing for CMHCs or for outpatient
hospital-based PHPs. To reiterate, sections 1833(t)(2) and 1833(t)(9)
of the Act set forth the requirements for establishing and adjusting
OPPS payment rates, which are based on costs, and which include PHP
payment rates. We note that section 1833(t)(17) of the Act authorizes
the Hospital OQR Program, which applies a payment reduction to
subsection (d) hospitals that fail to meet program requirements. In the
CY 2015 OPPS/ASC proposed rule (79 FR 41040), we considered future
inclusion of, and requested comments on, the following quality measures
addressing PHP issues that would apply in the hospital outpatient
setting: (1) 30-Day Readmission; (2) Group Therapy; and (3) No
Individual Therapy. We refer readers to the CY 2015 OPPS/ASC final rule
with comment period (79 FR 66957 through 66958) for a more detailed
discussion of PHP measures considered for inclusion in the Hospital OQR
Program in future years, and of the comments received as a result of
the solicitation. CMS also adopted the OAS CAHPS survey in the Hospital
OQR Program, beginning with CY 2020 payment determination (2018 data
collection) (82 FR 52572 through 52573); however, implementation was
delayed until further action in future rulemaking to ensure that the
survey measures appropriately account for patient response rates, both
aggregate and by survey administration method; reaffirm the reliability
of national implementation of OAS CAHPS Survey data; and appropriately
account for the burden associated with administering the survey in the
outpatient setting of care.
After careful consideration of all the comments on the proposed
rule and updated data, we used the most recent updated claims and cost
data to calculate CY 2021 geometric mean per diem costs in this CY 2021
OPPS/ASC final rule with comment period. The final calculated geometric
mean per diem costs for CY 2021 are substantially higher than the
proposed cost floors for both CMHCs and hospital-based PHPs. We believe
that the final calculated geometric mean per diem costs for CMHCs and
hospital-based PHPs will effectively protect access to partial
hospitalization services. Therefore, the data no longer supports the
need to finalize either the proposed CMHC or hospital-based PHP cost
floor at this time. In response to the concerns raised by several
commenters, we will continue to look for ways to further mitigate
payment fluctuations and protect beneficiary access to PHP services.
The final CY 2021 hospital-based PHP geometric mean per diem cost is
$253.76.
The final CY 2021 PHP geometric mean per diem costs are shown in
Table 43 and are used to derive the final CY 2021 PHP APC per diem
rates for CMHCs and hospital-based PHPs. The final CY 2021 PHP APC per
diem rates are included in Addendum A to the CY 2021 OPPS/ASC proposed
rule (which is available on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html).\95\
---------------------------------------------------------------------------
\95\ As discussed in section XX. of this CY 2021 OPPS/ASC final
rule, OPPS APC geometric mean per diem costs (including PHP APC
geometric mean per diem costs) are divided by the geometric mean per
diem costs for APC 5012 (Clinic Visits and Related Services) to
calculate each PHP APC's unscaled relative payment weight. An
unscaled relative payment weight is one that is not yet adjusted for
budget neutrality. Budget neutrality is required under section
1833(t)(9)(B) of the Act, and ensures that the estimated aggregate
weight under the OPPS for a calendar year is neither greater than
nor less than the estimated aggregate weight that would have been
made without the changes. To adjust for budget neutrality (that is,
to scale the weights), we compare the estimated aggregated weight
using the scaled relative payment weights from the previous calendar
year at issue. We refer readers to the ratesetting procedures
described in Part 2 of the OPPS Claims Accounting narrative and in
section II. of the CY 2021 OPPS/ASC proposed rule for more
information on scaling the weights, and for details on the final
steps of the process that leads to final PHP APC per diem payment
rates. The OPPS Claims Accounting narrative is available on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.
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[[Page 86080]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.069
3. PHP Service Utilization Updates
a. Provision of Individual Therapy
In the CY 2016 OPPS/ASC final rule with comment period (81 FR 79684
through 79685), we expressed concern over the low frequency of
individual therapy provided to beneficiaries. The CY 2019 claims data
used for the CY 2021 OPPS/ASC proposed rule revealed some changes in
the provision of individual therapy compared to CY 2015, CY 2016, CY
2017, and CY 2018 claims data as shown in the Table 44.
[GRAPHIC] [TIFF OMITTED] TR29DE20.070
As shown in Table 44, the CY 2019 claims show that CMHCs have
slightly increased the provision of individual therapy on days with
four or more services, compared to CY 2018 claims. However, on CMHC
days with three services, the provision of individual therapy decreased
sharply from the prior year CY 2018. This appears to follow a downward
trend which started in CY 2016 and has continued through CY 2019. In
comparing CY 2018 to CY 2019, we see that for CMHCs the provision of 3-
service days also sharply increased (this increase is shown in Table 45
in subsection b). The net effect of these two changes is that for all
CMHC days with three or more services, the provision of individual
therapy decreased from 4.4 percent in CY 2018 to 4.2 percent in CY
2019. We are concerned by this decrease in the provision of individual
therapy among CMHCs from CY 2018, and will continue to monitor this
trend. As we stated in the CY 2017 final rule with comment period (81
FR 79684 through 79685), the PHP is intensive in nature, and we believe
that appropriate treatment for PHP patients includes individual
therapy. We continue to encourage providers to examine their provision
of individual therapy to PHP patients to ensure that patients are
receiving all of the services that they may need.
For hospital-based providers, the CY 2019 claims show that the
provision of individual therapy has slightly decreased on days with
only 3 services and remained the same on days with four or more
services. These very small decreases correspond with a modest increase
of less than one tenth of one percent in the provision of individual
therapy on all days with three or more services, comparable with
fluctuations in prior years.
b. Provision of 3-Service Days
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59378), we stated that we are aware that our single-tier payment policy
may influence a change in service provision because providers are able
to obtain payment that is heavily weighted to the cost of providing
four or more services when they provide only 3 services. We indicated
that we are interested in ensuring that providers furnish an
appropriate number of services to beneficiaries enrolled in PHPs.
Therefore, with the CY 2017 implementation of CMHC APC 5853 and
hospital-based PHP APC 5863 for
[[Page 86081]]
providing 3 or more PHP services per day, we are continuing to monitor
utilization of days with only 3 PHP services.
For the CY 2021 OPPS/ASC proposed rule, we used the CY 2019 claims
data. Table 45 shows the utilization findings based on the 2019 claims
data.
[GRAPHIC] [TIFF OMITTED] TR29DE20.071
As shown in Table 45, the CY 2019 claims data used for proposed
rule show that for CMHCs, utilization of 3 service days is increasing
compared to the 3 prior claim years, whereas it is decreasing for
hospital-based providers. Compared to CY 2018, in CY 2019 hospital-
based PHPs provided fewer days with three services only, more days with
four services only, and fewer days with five or more services. Compared
to CY 2018, in CY 2019 CMHCs provided substantially more days with
three services, fewer days with four services, and more days with five
or more services.
The CY 2017 data were the first year of claims data to reflect the
change to the single-tier PHP APCs. Since that time, we have observed a
steady increase in the percentage of CMHC days with three services
only. We are concerned by this increase, because as noted below, the
intent of the PHP is for three-service days to be the exception, rather
than the norm. As we noted in the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79685), we will continue to monitor the provision
of days with only three services, particularly now that the single-tier
PHP APCs 5853 and 5863 are established for providing three or more
services per day for CMHCs and hospital-based PHPs, respectively.
It is important to reiterate our expectation that days with only
three services are meant to be an exception and not the typical PHP
day. In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68694), we clearly stated that we consider the acceptable minimum units
of PHP services required in a PHP day to be 3 and explained that it was
never our intention that three units of service represent the number of
services to be provided in a typical PHP day. PHP is furnished in lieu
of inpatient psychiatric hospitalization and is intended to be more
intensive than a half-day program. We further indicated that a typical
PHP day should generally consist of 5 to 6 units of service (73 FR
68689). We explained that days with only three units of services may be
appropriate to bill in certain limited circumstances, such as when a
patient might need to leave early for a medical appointment and,
therefore, would be unable to complete a full day of PHP treatment. At
that time, we noted that if a PHP were to only provide days with three
services, it would be difficult for patients to meet the eligibility
requirement in 42 CFR 410.43(c)(1) that patients must require a minimum
of 20 hours per week of therapeutic services as evidenced in their plan
of care (73 FR 68689).
The following is summary of the comments we received and our
responses to those comments.
Comment: Four commenters noted that the data in Table 45 (Table 30
of the CY 2021 OPPS/ASC proposed rule) demonstrate commitment by PHPs
to comply with and exceed the 20-hour rule. These commenters noted that
the vast majority of claim days for CMHCs and hospital-based PHPs have
4 or more services provided. The commenters noted that PHPs are
voluntary, and that they cannot force patients to attend every day.
They also noted that the typical patient profile includes behaviors
that work against attendance and full daily participation. In addition,
the commenters wrote that there are other challenges to providing 20
hours of services per week that are beyond providers' control, such as
holidays, weather, and other medical appointments.
Response: We appreciate that most PHP days include 4 or more
services being provided. The updated data for this final rule with
comment period showed an uptick in the percentage of 3-service days
among CMHCs, but we also note that there is an increase in the
percentage of days with 5 or more services. We will continue to monitor
the data over time. The ``20-hour rule'' the commenters mentioned is
from our regulations at 42 CFR 410.43(c) (discussed at 73 FR 68694 to
68695), which require that eligible PHP patients need at least 20 hours
of therapeutic services per week, as evidenced in their plan of care.
PHPs are intended to be intensive programs that are provided in lieu of
inpatient hospitalization. We appreciate the efforts providers have
[[Page 86082]]
made to increase beneficiary attendance, and also recognize the
provider concerns about circumstances beyond their control which can
affect the number of hours of services provided each week. We did not
make any proposals related to the 20-hour requirement, and are
continuing to monitor the claims data regarding the hours per week of
services provided, sending providers informational messaging without
affecting payment.
C. Outlier Policy for CMHCs
For CY 2021, we proposed to continue to calculate the CMHC outlier
percentage, cutoff point and percentage payment amount, outlier
reconciliation, outlier payment cap, and fixed-dollar threshold
according to previously established policies. These topics are
discussed in more detail. We refer readers to section II.G.1 of this CY
2021 OPPS/ASC final rule with comment period for our general policies
for hospital outpatient outlier payments.
We did not receive any public comments on our proposal, and are
finalizing it as proposed.
1. Background
As discussed in the CY 2004 OPPS final rule with comment period (68
FR 63469 through 63470), we noted a significant difference in the
amount of outlier payments made to hospitals and CMHCs for PHP
services. Given the difference in PHP charges between hospitals and
CMHCs, we did not believe it was appropriate to make outlier payments
to CMHCs using the outlier percentage target amount and threshold
established for hospitals. Therefore, beginning in CY 2004, we created
a separate outlier policy specific to the estimated costs and OPPS
payments provided to CMHCs. We designated a portion of the estimated
OPPS outlier threshold specifically for CMHCs, consistent with the
percentage of projected payments to CMHCs under the OPPS each year,
excluding outlier payments, and established a separate outlier
threshold for CMHCs. This separate outlier threshold for CMHCs resulted
in $1.8 million in outlier payments to CMHCs in CY 2004 and $0.5
million in outlier payments to CMHCs in CY 2005 (82 FR 59381). In
contrast, in CY 2003, more than $30 million was paid to CMHCs in
outlier payments (82 FR 59381).
2. CMHC Outlier Percentage
In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59267
through 59268), we described the current outlier policy for hospital
outpatient payments and CMHCs. We note that we also discussed our
outlier policy for CMHCs in more detail in section VIII.C. of that same
final rule (82 FR 59381). We set our projected target for all OPPS
aggregate outlier payments at 1.0 percent of the estimated aggregate
total payments under the OPPS (82 FR 59267). This same policy was also
reiterated in the CY 2019 OPPS/ASC final rule with comment period (83
FR 58996). We estimate CMHC per diem payments and outlier payments by
using the most recent available utilization and charges from CMHC
claims, updated CCRs, and the updated payment rate for APC 5853. For
increased transparency, we are providing a more detailed explanation of
the existing calculation process for determining the CMHC outlier
percentages. We proposed to continue to calculate the CMHC outlier
percentage according to previously established policies, and we did not
propose any changes to our current methodology for calculating the CMHC
outlier percentage for CY 2021. To calculate the CMHC outlier
percentage, we followed three steps:
Step 1: We multiplied the OPPS outlier threshold, which is
1.0 percent, by the total estimated OPPS Medicare payments (before
outliers) for the prospective year to calculate the estimated total
OPPS outlier payments: (0.01 x Estimated Total OPPS Payments) =
Estimated Total OPPS Outlier Payments.
Step 2: We estimated CMHC outlier payments by taking each
provider's estimated costs (based on their allowable charges multiplied
by the provider's CCR) minus each provider's estimated CMHC outlier
multiplier threshold (we refer readers to section VIII.C.3. of the CY
2021 OPPS/ASC proposed rule). That threshold is determined by
multiplying the provider's estimated paid days by 3.4 times the CMHC
PHP APC payment rate. If the provider's costs exceeded the threshold,
we multiplied that excess by 50 percent, as described in section
VIII.C.3. of the CY 2021 OPPS/ASC proposed rule, to determine the
estimated outlier payments for that provider. CMHC outlier payments are
capped at 8 percent of the provider's estimated total per diem payments
(including the beneficiary's copayment), as described in section
VIII.C.5. of the CY 2021 OPPS/ASC proposed rule, so any provider's
costs that exceed the CMHC outlier cap will have its payments adjusted
downward. After accounting for the CMHC outlier cap, we summed all of
the estimated outlier payments to determine the estimated total CMHC
outlier payments.
(Each Provider's Estimated Costs--Each Provider's Estimated
Multiplier Threshold) = A. If A is greater than 0, then (A x 0.50) =
Estimated CMHC Outlier Payment (before cap) = B. If B is greater than
(0.08 x Provider's Total Estimated Per Diem Payments), then cap-
adjusted B = (0.08 x Provider's Total Estimated Per Diem Payments);
otherwise, B = B. Sum (B or cap-adjusted B) for Each Provider = Total
CMHC Outlier Payments.
Step 3: We determined the percentage of all OPPS outlier
payments that CMHCs represent by dividing the estimated CMHC outlier
payments from Step 2 by the total OPPS outlier payments from Step 1:
(Estimated CMHC Outlier Payments/Total OPPS Outlier Payments).
In CY 2019, we designated approximately 0.01 percent of that
estimated 1.0 percent hospital outpatient outlier threshold for CMHCs
(83 FR 58996), based on this methodology. For CY 2021, we proposed to
continue to use the same methodology as CY 2020. Therefore, based on
our CY 2021 payment estimates, CMHCs are projected to receive 0.02
percent of total hospital outpatient payments in CY 2021, excluding
outlier payments. We proposed to designate approximately less than 0.01
percent of the estimated 1.0 percent hospital outpatient outlier
threshold for CMHCs. This percentage is based upon the formula given in
Step 3.
We did not receive any public comments on this proposal, and are
finalizing our proposal as proposed.
3. Cutoff Point and Percentage Payment Amount
As described in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59381), our policy has been to pay CMHCs for outliers if the
estimated cost of the day exceeds a cutoff point. In CY 2006, we set
the cutoff point for outlier payments at 3.4 times the highest CMHC PHP
APC payment rate implemented for that calendar year (70 FR 68551). For
CY 2018, the highest CMHC PHP APC payment rate is the payment rate for
CMHC PHP APC 5853. In addition, in CY 2002, the final OPPS outlier
payment percentage for costs above the multiplier threshold was set at
50 percent (66 FR 59889). In CY 2018, we continued to apply the same 50
percent outlier payment percentage that applies to hospitals to CMHCs
and continued to use the existing cutoff point (82 FR 59381).
Therefore, for CY 2018, we continued to pay for partial hospitalization
services that exceeded 3.4 times the CMHC PHP APC payment rate at 50
percent of the amount of
[[Page 86083]]
CMHC PHP APC geometric mean per diem costs over the cutoff point. For
example, for CY 2018, if a CMHC's cost for partial hospitalization
services paid under CMHC PHP APC 5853 exceeds 3.4 times the CY 2018
payment rate for CMHC PHP APC 5853, the outlier payment would be
calculated as 50 percent of the amount by which the cost exceeds 3.4
times the CY 2018 payment rate for CMHC PHP APC 5853 [0.50 x (CMHC Cost
- (3.4 x APC 5853 rate))]. This same policy was also reiterated in the
CY 2019 OPPS/ASC final rule with comment period (83 FR 58996 through
58997) and the CY 2020 OPPS/ASC final rule with comment period (84 FR
61351). For CY 2021, we proposed to continue to pay for partial
hospitalization services that exceed 3.4 times the proposed CMHC PHP
APC payment rate at 50 percent of the CMHC PHP APC geometric mean per
diem costs over the cutoff point. That is, for CY 2021, if a CMHC's
cost for partial hospitalization services paid under CMHC PHP APC 5853
exceeds 3.4 times the payment rate for CMHC APC 5853, the outlier
payment will be calculated as [0.50 x (CMHC Cost - (3.4 x APC 5853
rate))].
We did not receive any public comments on this proposal, and are
finalizing our proposal as proposed.
4. Outlier Reconciliation
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68594
through 68599), we established an outlier reconciliation policy to
address charging aberrations related to OPPS outlier payments. We
addressed vulnerabilities in the OPPS outlier payment system that lead
to differences between billed charges and charges included in the
overall CCR, which are used to estimate cost and would apply to all
hospitals and CMHCs paid under the OPPS. We initiated steps to ensure
that outlier payments appropriately account for the financial risk when
providing an extraordinarily costly and complex service, but are only
being made for services that legitimately qualify for the additional
payment.
For a comprehensive description of outlier reconciliation, we refer
readers to the CY 2019 OPPS/ASC final rules with comment period (83 FR
58874 through 58875 and 81 FR 79678 through 79680).
We proposed to continue these policies for partial hospitalization
services provided through PHPs for CY 2021. The current outlier
reconciliation policy requires that providers whose outlier payments
meet a specified threshold (currently $500,000 for hospitals and any
outlier payments for CMHCs) and whose overall ancillary CCRs change by
plus or minus 10 percentage points or more, are subject to outlier
reconciliation, pending approval of the CMS Central Office and Regional
Office (73 FR 68596 through 68599). The policy also includes provisions
related to CCRs and to calculating the time value of money for
reconciled outlier payments due to or due from Medicare, as detailed in
the CY 2009 OPPS/ASC final rule with comment period and in the Medicare
Claims Processing Manual (73 FR 68595 through 68599 and Medicare Claims
Processing internet Only Manual, Chapter 4, Section 10.7.2 and its
subsections, available online at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf).
We did not receive any public comments on this proposal, and are
finalizing our proposal as proposed.
5. Outlier Payment Cap
In the CY 2017 OPPS/ASC final rule with comment period, we
implemented a CMHC outlier payment cap to be applied at the provider
level, such that in any given year, an individual CMHC will receive no
more than a set percentage of its CMHC total per diem payments in
outlier payments (81 FR 79692 through 79695). We finalized the CMHC
outlier payment cap to be set at 8 percent of the CMHC's total per diem
payments (81 FR 79694 through 79695). This outlier payment cap only
affects CMHCs, it does not affect other provider types (that is,
hospital-based PHPs), and is in addition to and separate from the
current outlier policy and reconciliation policy in effect. In the CY
2020 OPPS/ASC final rule with comment period (84 FR 61351), we
finalized a proposal to continue this policy in CY 2020 and subsequent
years.
For CY 2021, we proposed to continue to apply the 8 percent CMHC
outlier payment cap to the CMHC's total per diem payments. We did not
receive any public comments on this proposal, and are finalizing our
proposal as proposed.
6. Fixed-Dollar Threshold
In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59267
through 59268), for the hospital outpatient outlier payment policy, we
set a fixed-dollar threshold in addition to an APC multiplier
threshold. Fixed-dollar thresholds are typically used to drive outlier
payments for very costly items or services, such as cardiac pacemaker
insertions. CMHC PHP APC 5853 is the only APC for which CMHCs may
receive payment under the OPPS, and is for providing a defined set of
services that are relatively low cost when compared to other OPPS
services. Because of the relatively low cost of CMHC services that are
used to comprise the structure of CMHC PHP APC 5853, it is not
necessary to also impose a fixed-dollar threshold on CMHCs. Therefore,
in the CY 2018 OPPS/ASC final rule with comment period, we did not set
a fixed-dollar threshold for CMHC outlier payments (82 FR 59381). This
same policy was also reiterated in the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61351). We proposed to continue this policy for
CY 2021. We did not receive any public comments on this proposal, and
are finalizing our proposal as proposed.
IX. Services That Will Be Paid Only as Inpatient Services
A. Background
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74352 through 74353) for a full discussion of our
longstanding policies for identifying services that are typically
provided only in an inpatient setting (referred to as the inpatient
only (IPO) list) and, therefore, that will not be paid by Medicare
under the OPPS, as well as the criteria we use to review the IPO list
each year to determine whether or not any services should be removed
from the list. The complete list of codes that describe services that
will be paid by Medicare in CY 2021 as inpatient only services is
included as Addendum E to this CY 2021 OPPS/ASC proposed rule, which is
available via the internet on the CMS website.\96\
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\96\ Note, the IPO list is proposed to be eliminated beginning
in CY 2021, with all services being removed from the list over the
course of a three-year transition period. The CY 2020 IPO List can
be found here: Hospital Outpatient PPS, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.
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B. Proposed Changes to the Inpatient Only (IPO) List
1. Methodology for Identifying Appropriate Changes to IPO List
Currently, there are approximately 1,740 services on the IPO list.
Under our current policy, we annually review the IPO list to identify
any services that should be removed from or added to the list based on
the most recent data and medical evidence available. We have
established five criteria to determine whether a procedure should be
removed from the IPO list (65 FR 18455). As noted in the CY 2012 OPPS/
ASC final rule with comment period (76 FR 74353), we utilize these
criteria when reviewing services to determine whether
[[Page 86084]]
or not they should be removed from the IPO list and assigned to an APC
group for payment under the OPPS when provided in the hospital
outpatient setting. We note that a procedure is not required to meet
all of the established criteria to be removed from the IPO list. The
criteria include the following:
Most outpatient departments are equipped to provide the
services to the Medicare population.
The simplest procedure described by the code may be
furnished in most outpatient departments.
The procedure is related to codes that we have already
removed from the IPO list.
A determination is made that the procedure is being
furnished in numerous hospitals on an outpatient basis.
A determination is made that the procedure can be
appropriately and safely furnished in an ASC and is on the list of
approved ASC services or has been proposed by us for addition to the
ASC list.
2. CY 2021 Proposal To Eliminate the IPO List
The IPO List was established with the implementation of the OPPS in
the CY 2000 OPPS/ASC final rule with comment period (65 FR 18455).
Using the authority under section 1833(t)(1)(B)(i) of the Act, the IPO
List was created to identify services that require inpatient care
because of the invasive nature of the procedure, the need for at least
24 hours of postoperative recovery time, or the underlying physical
condition of the patient who would require the surgery and, therefore,
the service would not be paid by Medicare under the OPPS. For example,
the list includes certain surgically invasive services on the brain,
heart, and abdomen, such as craniotomies, coronary-artery bypass
grafting, and laparotomies.
Since the IPO list was established in 2000, we have stated that
regardless of how a procedure is classified for purposes of payment, we
expect that in every case the surgeon and the hospital will assess the
risk of a procedure or service to the individual patient, taking site
of service into account, and will act in that patient's best interests
(65 FR 18456). We have reiterated this sentiment in rulemaking several
times over the years, including in our discussion of the removal of
total knee arthroplasty (TKA) from the IPO list in the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59383) and most recently when we
discussed removing total hip arthroplasty (THA) from the IPO List in
the CY 2020 OPPS/ASC final rule with comment period, where we stated
that the decision regarding the most appropriate care setting for a
given surgical procedure is a complex medical judgment made by the
physician based on the beneficiary's individual clinical needs and
preferences and on the general coverage rules requiring that any
procedure be reasonable and necessary (84 FR 61354).
In previous years, we received several comments from stakeholders
who believe that we should eliminate the IPO list entirely and instead
defer to the clinical judgment of physicians for decisions regarding
site of service. For example, in the CY 2000 final rule with comment
period, in response to the establishment of the IPO list, commenters
stated that they believed CMS was making decisions, such as the
appropriate site of service for a particular medical procedure, that
should be left to the discretion of surgeons and their patients (65 FR
18455, 18442). In the CY 2012 OPPS/ASC final rule with comment period,
a number of commenters suggested that regulations should not supersede
the physician's level of knowledge and assessment of the patient's
condition, and that the physician can appropriately determine whether a
procedure can be performed in a hospital outpatient setting (76 FR
74354). In the CY 2014 rulemaking, we again noted that some commenters
requested that the IPO list be eliminated in its entirety (78 FR
75055). Stakeholders have also commented that the exclusion of services
from payment under the OPPS is unnecessary and could have an adverse
effect on advances in surgical care (65 FR 18442). Furthermore, some
stakeholders have suggested that when a service is removed from the IPO
list, it creates an expectation among hospitals that the service must
be furnished in the outpatient setting, regardless of the clinical
judgment of the physician or needs of the patient.
Other stakeholders have supported maintaining the IPO list and
consider it an important tool to indicate which services are
appropriate to furnish in the outpatient setting and to ensure that
Medicare beneficiaries receive quality care. They have agreed that many
of the procedures that we designated as ``inpatient only'' are
currently performed appropriately and safely only in the inpatient
setting (65 FR 18442). Commenters have expressed concerns that without
the IPO list, patient safety and care quality could decline, and have
noted the potential for surgical complications in response to allowing
specific procedures to be paid under the OPPS when performed in the
outpatient setting for the Medicare population, such as TKA and THA.
Stakeholders have also supported the use of the IPO list because
services included on the IPO list are an exception to the 2-midnight
rule and as such are considered appropriate for inpatient hospital
admission and payment under Medicare Part A regardless of the expected
length of stay and therefore are not subject to medical review by
Beneficiary and Family- Centered Care-Quality Improvement Organizations
(BFCC-QIOs) for ``patient status'' (that is, site-of-service). We note
that in the CY 2020 OPPS/ASC final rule with comment period, we
finalized a policy to exempt procedures that have been removed from the
IPO list from certain medical review activities for 2 calendar years
following their removal from the IPO list. For CY 2021 and subsequent
years, we proposed to continue this 2-year exemption from site-of-
service claim denials, BFCC-QIO referrals to Recovery Audit Contractors
(RACs), and RAC reviews for ``patient status'' for procedures that are
removed from the IPO list under the OPPS beginning on January 1, 2021.
We also sought comment on whether a 2-year exemption continues to be
appropriate, or if a longer or shorter period may be more warranted.
For more information on these policies please refer to section X.B of
the CY 2021 OPPS/ASC proposed rule.
While we agreed with commenters in previous rulemakings that the
IPO list was necessary, we stated there are many surgical procedures
that cannot be safely performed on a typical Medicare beneficiary in
the hospital outpatient setting, and that it would be inappropriate for
us to establish payment rates for those services under the OPPS (78 FR
75055). However, recently we have reconsidered the various stakeholder
comments requesting that we eliminate the IPO list and reevaluated the
need for CMS to restrict payment for certain procedures in the hospital
outpatient setting. For the proposed rule, we concluded that we no
longer believed there was a need for the IPO list in order to identify
services that require inpatient care. Instead, we agreed with past
commenters that the physician should use his or her clinical knowledge
and judgment, together with consideration of the beneficiary's specific
needs, to determine whether a procedure can be performed appropriately
in a hospital outpatient setting or whether inpatient care is required
for the beneficiary, subject to the general coverage rules requiring
that any procedure be reasonable and necessary. We believed
[[Page 86085]]
that this change would ensure maximum availability of services to
beneficiaries in the outpatient setting.
We also believed that since the IPO list was established, there
have been significant developments in the practice of medicine that
have allowed numerous services to be provided safely and effectively in
the outpatient setting. We acknowledged in the CY 2000 OPPS/ASC final
rule with comment period that we believed that emerging new
technologies and innovative medical practice were blurring the
difference between the need for inpatient care and the sufficiency of
outpatient care for many services (65 FR 18456). We also stated in the
CY 2001 OPPS/ASC interim final rule with comment period that, over
time, given advances in technology and surgical technique, many of the
procedures that were on the IPO list at the time may eventually be
performed safely in a hospital outpatient setting and that we would
continue to evaluate services to determine whether they should be
removed from the IPO list (65 FR 67826). Specifically, we stated that
insofar as advances in medical practice mitigate concerns about these
services being furnished on an outpatient basis, we would be prepared
to remove them from the IPO list and provide for payment under the OPPS
(65 FR 67826). Since that time, there have been many new technologies
and advances in surgical techniques and surgical care protocols,
including the use of minimally invasive surgical procedures such as
laparoscopy, improved perioperative anesthesia, expedited
rehabilitation protocols, as well as significant enhancements to
postoperative processes, such as improvements in pain management, that
have reduced the inpatient length of stay and the need for
postoperative care following a surgical service. In consideration of
these advancements, we have removed services from the IPO list that
were previously considered to require inpatient care, including TKA in
CY 2018 (82 FR 59385) and THA in CY 2020 (84 FR 61355). As medical
practice continues to develop, we believed that the difference between
the need for inpatient care and the appropriateness of outpatient care
has become less distinct for many services. Therefore, we believed that
the IPO list was no longer necessary to identify services that require
inpatient care.
In the CY 2021 OPPS/ASC proposed rule, we acknowledged the
seriousness of the concerns regarding patient safety and quality of
care that various stakeholders have expressed regarding removing
procedures from the IPO list or eliminating the IPO list altogether.
However, we stated that we believe that the evolving nature of the
practice of medicine, which has allowed more procedures to be performed
on an outpatient basis with a shorter recovery time, in addition to
physician judgment, state and local licensure requirements,
accreditation requirements, hospital conditions of participation
(CoPs), medical malpractice laws, and CMS quality and monitoring
initiatives and programs will continue to ensure the safety of
beneficiaries in both the inpatient and outpatient settings, even in
the absence of the IPO list. In the past, we stated that although
hospitals must meet minimum safety standards through accreditation or
state survey and certification of compliance with the CoPs that ensure
a hospital is generally safe and an appropriate environment for
providing care, we were concerned that those measures did not determine
whether a particular service could be safely provided in the outpatient
setting to beneficiaries (76 FR 74355). However, the CoPs are
regulations that are focused on protecting the health and safety of all
patients receiving services from Medicare enrolled providers. The CoPs
are the baseline health and safety requirements for Medicare
certification. Accrediting organizations and states and localities,
through their licensure authorities, may have more specific and
stringent requirements. Often professional organizations or other
nonprofit organizations give additional guidance to health care
providers to improve patient safety and quality of care. We note that
the CoPs already require hospitals to be in compliance with applicable
Federal laws related to the health and safety of patients (42 CFR
482.11) Additionally, there are numerous provisions in the hospital
CoPs at 42 CFR part 482 that provide extensive patient safeguards and
that provide enough flexibility to ensure that hospitals can follow
nationally recognized standards of practice and of care, where they are
applicable, and can adapt if those standards change over time through
innovative new practices.
Additionally, as indicated in the 2020 Quality Strategy,\97\ CMS
has also continued to develop safety measures and tools, like the
Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare
Providers and Systems Survey and the CMS' case management system, to
help determine the safety and quality of the performance of procedures
in the outpatient setting and to address concerns about the safety and
quality of more varied, complex procedures performed in the outpatient
setting. We stated in the CY 2021 OPPS/ASC proposed rule that we
believe that the aforementioned federally established CoPs, the CMS
Quality Strategy and state and local safety requirements help ensure
important patient safeguards for all patients, including Medicare
beneficiaries. Further, although we believe it was important to pause
certain medical contractor reviews for patient status to allow
providers time to adjust to the proposed changes to the IPO list, we
note that the BFCC-QIO program's beneficiary case review contractors
routinely address, and will continue to address any beneficiary quality
of care complaints that include concerns about treatment as a hospital
inpatient or outpatient, not receiving expected services, early
discharge, and discharge planning. CMS' case management system
currently allows QIOs and CMS to monitor the frequency and status of
beneficiary quality of care complaints and other beneficiary appeals by
topic, provider type, and geographic area. These numbers are compiled
by the BFCC-QIO national coordinating and oversight review contractor
and reported to the QIOs and CMS leadership on a weekly basis for
monitoring purposes. As previously noted, although we proposed to
continue a 2-year exemption from site-of-service claim denials, BFCC-
QIO referrals to Recovery Audit Contractors (RACs), and RAC reviews for
``patient status'' for procedures that are removed from the IPO list
under the OPPS beginning on January 1, 2021, BFCC-QIOs will continue to
conduct initial medical reviews for both the medical necessity of the
services, the medical necessity of the site of service, and will also
continue to be permitted and expected to deny claims if the service
itself is determined not to be reasonable and medically necessary as
noted in the CY 2020 OPPS/ASC final rule (84 FR 61365). Therefore,
given CMS' increasing ability to measure the safety of procedures
performed in the outpatient setting and to monitor the quality of care,
in addition to the other safeguards detailed above, we stated that we
believe that quality of care was unlikely to be negatively affected by
the elimination of the IPO list. However, we also requested that
commenters submit evidence on what effect, if any, they believe
eliminating the IPO list would have on the quality of care.
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\97\ Speech: Remarks by CMS Administrator Seema Verma at the
2020 CMS Quality Conference, https://www.cms.gov/newsroom/press-releases/speech-remarks-cms-administrator-seema-verma-2020-cms-quality-conference.
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[[Page 86086]]
Furthermore, we explained that some stakeholders had previously
shared concerns with us that removing procedures from the IPO list and
allowing them to be paid under the OPPS when performed in the
outpatient setting might result in an increased financial burden for
beneficiaries for certain complex services. Under current law, the OPPS
cost-sharing for a service is capped at the applicable Part A hospital
inpatient deductible amount for that year for each service. However,
this cap applies to individual services, so if a Medicare beneficiary
receives multiple separately payable OPPS services, it is possible that
the aggregate cost-sharing for a beneficiary may be higher for services
provided in the outpatient setting than it would be had the services
been furnished during an inpatient stay. We emphasized in the CY 2021
OPPS/ASC proposed rule that services included on the IPO list tend to
be surgical procedures that would typically be the focus of the
hospital outpatient stay and would likely be assigned to a
comprehensive APC (C-APC) when they are removed from the IPO list. As
such, these services would likely be considered a single episode of
care with one payment rate and one copayment amount instead of multiple
copayments for each individual service. In most instances, we expect
that beneficiaries will not be responsible for multiple copayments for
individual ancillary services associated with services removed from the
IPO list, since because of their assignment to C-APCs, the inpatient
deductible cap will apply to the entire hospital claim which is paid as
a comprehensive service or procedure. In the event there are separately
payable OPPS services included on a claim with a service assigned to a
C-APC, our previously mentioned policy remains applicable, which is
that the OPPS cost-sharing for an individual service is capped at the
applicable Part A hospital inpatient deductible amount for that year
for each service. For further information regarding beneficiary
copayments, please refer to section II.I.1. of the CY 2021 OPPS/ASC
proposed rule.
After careful consideration of the need for the IPO list and taking
into account the feedback that we have received since the OPPS was
implemented, we stated in the CY 2021 OPPS/ASC proposed rule that we
believe that instead of maintaining a list of services that typically
require inpatient care and are not paid under the OPPS, physicians
should continue to use their clinical knowledge and judgment to
appropriately determine whether a procedure can be performed in a
hospital outpatient setting or whether inpatient care is required for
the beneficiary based on the beneficiary's specific needs and
preferences, subject to the general coverage rules requiring that any
procedure be reasonable and necessary, and that payment should be made
pursuant to the otherwise applicable payment policies. We also stated
that we believe that developments in surgical technique and
technological advances in the delivery of services may obviate the need
for the IPO list. Finally, we also stated that we believe physician
judgment, state and local regulations, accreditation requirements,
hospital conditions of participation (CoPs), medical malpractice laws,
and other CMS quality and monitoring initiatives would continue to
ensure the safety of beneficiaries in both the inpatient and outpatient
settings in the absence of the IPO list. Therefore, we proposed to
eliminate the IPO list over a transitional period beginning in CY 2021.
We also stated that while we believe that the list could be eliminated
in its entirety at this point, as explained in further detail below, we
proposed a transitional period.
Given the significant number of services on the list and that they
would be newly priced under the OPPS, we recognized that stakeholders
may need time to adjust to the removal of procedures from the list.
Providers may need time to prepare, update their billing systems, and
gain experience with newly removed procedures eligible to be paid under
either the inpatient prospective payment system or outpatient
prospective payment system. Therefore, we proposed to transition
services off the IPO list over a 3-year period, with the list
completely eliminated by 2024. In accordance with this proposal, we
proposed to amend 42 CFR 419.22(n) to state that effective beginning on
January 1, 2021, the Secretary shall eliminate the list of services and
procedures designated as requiring inpatient care through a 3-year
transition, with the full list eliminated in its entirety by January 1,
2024.
For CY 2021, we proposed that musculoskeletal services would be the
first group of services that would be removed from the IPO list. We
stated that we believe it is appropriate to remove this group of
services first for several reasons. In recent years, due to new
technologies and advances in surgical care protocols, expedited
rehabilitation protocols, and significant enhancements to postoperative
processes we have removed TKA and THA, which are both musculoskeletal
services, from the IPO list. During the process of proposing and
finalizing removing TKA and THA from the IPO list, stakeholders have
continuously requested that CMS remove other musculoskeletal services
from the IPO list as well, citing shortened length of stay times,
advancements in technologies and surgical techniques, and improved
postoperative processes. Additionally, we noted that, more often than
not, stakeholders' historical requests for removals were for
musculoskeletal services. We also recognized that there is already a
set of comprehensive APCs for musculoskeletal services for payment in
the outpatient setting, which facilitates the removal of these types of
services for CY 2021. Specifically, because we have previously removed
codes from the IPO list that are similar clinically and in terms of
resource cost and assigned them to these comprehensive APCs, these APCs
generally describe appropriate ranges and placements for these
musculoskeletal codes being proposed for removal in CY 2021, which will
allow for appropriate payment. We identified 266 musculoskeletal
services that we proposed to remove from the IPO list for CY 2021.
Comment: Numerous commenters, including some medical specialty
societies, health systems, and individual physicians, supported our
proposal to eliminate the IPO list and defer to physicians' judgment on
site of service decisions. These commenters stated that CMS' efforts to
remove regulatory barriers would provide patients with more choices for
where to receive affordable care. The commenters also believed the
proposed change could potentially decrease overall healthcare costs and
improve clinical outcomes for patients. These commenters stated that
there is no clinical difference between a surgery performed in an
inpatient setting and an outpatient setting, and that eliminating the
IPO list would create more flexibility for physicians and
beneficiaries.
Response: We thank the commenters for their support.
Comment: Many commenters, including hospital associations, health
systems, medical specialty societies and professional organizations,
and advocacy groups opposed the elimination of the IPO list due to
patient safety concerns, stating that the IPO list serves as an
important programmatic safeguard and maintains a common standard in the
Medicare program. These commenters stated that the high-risk, invasive
procedures that require post-operative monitoring that are currently
included on the IPO list
[[Page 86087]]
would not be safe to perform on Medicare beneficiaries in the
outpatient setting. These commenters also stated that CMS should retain
its current process for evaluating and removing procedures from the IPO
list through rulemaking. Alternatively, several commenters requested
that instead of eliminating the IPO list, CMS maintain the list
specifically for a smaller number of procedures that are complex,
surgically invasive, and should never be performed in the outpatient
setting. Other commenters requested that specific CPT codes proposed to
be removed from the IPO list for CY 2021 remain payable in the
inpatient setting only, including CPT codes 27280 (Arthrodesis, open,
sacroiliac joint, including obtaining bone graft, including
instrumentation, when performed) and 22857 (Total disc arthroplasty
(artificial disc), anterior approach, including discectomy to prepare
interspace (other than for decompression), single interspace, lumbar).
Response: We acknowledge the commenters' important concerns
regarding the elimination of the IPO list and the potential for safety
risks for Medicare beneficiaries. We continue to believe that
physicians can and should use their clinical knowledge and judgment to
appropriately determine whether a procedure can be performed in a
hospital outpatient setting or whether inpatient care is required for
the beneficiary based on the beneficiary's specific needs and
preferences, subject to the general coverage rules requiring that any
procedure be reasonable and necessary, and that payment should be made
pursuant to the otherwise applicable payment policies. We believe that
patient safety and quality of care will be safeguarded by the
physician's assessment of the risk of a procedure or service to the
individual beneficiary and their selection of the most appropriate
setting of care based on this risk in addition to state and local
licensure requirements, accreditation requirements, hospital conditions
of participation (CoPs), medical malpractice laws, and CMS quality and
monitoring initiatives and programs. In addition, as we have stated in
previous rulemaking, the removal of a service from the IPO list does
not require the service to be performed only on an outpatient basis.
Rather, it allows for payment under the OPPS when the service is
performed on a registered hospital outpatient (82 FR 59384; 84 FR
61354). Services that are removed from the IPO list can and are
performed on individuals who are admitted as inpatients (as well as
individuals who are registered hospital outpatients). We also continue
to believe that there have been significant developments in the
practice of medicine that have allowed numerous services to now be
provided safely and effectively in the outpatient setting. Therefore,
at this time, we do not believe it is necessary for CMS to maintain a
list of services that typically require inpatient care and are not paid
under the OPPS nor do we currently believe that it is necessary to
require specific HCPCS codes to remain payable only when furnished in
the inpatient setting.
Comment: We received comments from physicians and medical specialty
societies who stated that, while they agreed that physicians should be
the primary arbiters regarding the clinically appropriate site of
service for a procedure, a physician's medical judgment is not always
paramount in this decision-making. These commenters noted that when
procedures are removed from the IPO list, many hospitals and commercial
payors make rules establishing outpatient status as the assumed
baseline site of service for these procedures, regardless of patient
characteristics or the physician's clinical assessment. Commenters
noted various reasons for this action on the part of hospitals and
commercial payors, including concerns regarding the application of the
2-midnight benchmark to services that are removed from the IPO list and
the potential for claim denials if this benchmark is not met and/or
excessive administrative burden to support the case-by-case exception
to the 2-midnight rule, misinterpretation of CMS' rulemaking guidance,
or the desire to have the procedure performed in a lower cost setting.
According to commenters, physicians must, at times, convince a hospital
or payor that a particular patient should receive a given procedure in
an inpatient setting due to patient safety concerns. Commenters
requested that CMS issue clear guidance that encourages consideration
of and deference to the judgment of the physician, professional
societies, and hospital associations regarding the procedures that are
appropriate to be performed in the HOPD.
Response: CMS has repeatedly recognized that the decision regarding
the most appropriate care setting for a given surgical procedure is a
complex medical judgment made by the physician based on the
beneficiary's individual clinical needs and on the general coverage
rules requiring that any procedure be reasonable and necessary. We
continue to believe that deference should be given to physicians and
medical professionals in these determinations. In accordance with
section 1801 of the Act, CMS does not control or supervise the practice
of medicine or the manner in which medical services are provided. We
also reiterate that we do not require services that are no longer
included on the IPO list to be performed solely in the outpatient
setting and that following elimination of the IPO list, services that
were previously identified as inpatient-only can continue to be
performed in the inpatient setting. It is not CMS' policy to require
services that are removed from the IPO list to only be performed in the
outpatient setting. Instead, we aim to offer providers enhanced
flexibility and choice in determining the safest, most efficient
setting of care for Medicare beneficiaries, whether that is the
inpatient or outpatient setting. It is a misinterpretation of CMS
payment policy for providers to create policies or guidelines that
establish the outpatient setting as the baseline or default site of
service for a procedure based on its removal from the IPO list or the
elimination of the IPO list. As stated in previous rulemaking, services
that are no longer included on the IPO list are payable in either the
inpatient or outpatient setting subject to the general coverage rules
requiring that any procedure be reasonable and necessary, and payment
should be made pursuant to the otherwise applicable payment policies
(84 FR 61354; 82 FR 59384; 81 FR 79697).
As discussed in detail in previous rulemaking (84 FR 61363 through
61365) as well as in section X.B. of this final rule with comment
period, the 2-midnight benchmark, which provides that an inpatient
admission is considered reasonable and necessary for purposes of
Medicare Part A payment when the physician expects the patient to
require hospital care that crosses at least 2 midnights and admits the
patient to the hospital based upon that expectation, is applicable to
services that have been removed from the IPO list. Additionally, as we
have detailed in previous rulemaking (80 FR 70538 through 70549), we
allow for case-by-case exceptions to the 2-midnight benchmark, whereby
Medicare Part A payment may be made for inpatient admissions where the
admitting physician does not expect the patient to require hospital
care spanning 2 midnights, if the documentation in the medical record
supports the physician's
[[Page 86088]]
determination that the patient nonetheless requires inpatient hospital
care. We acknowledge commenters' concerns regarding the application of
the 2-midnight benchmark to services that are removed from the IPO
list. While services removed from the IPO list are no longer subject to
the blanket IPO list exception from the 2-midnight rule at 42 CFR
412.3(d)(2), such services may be payable under Part A pursuant to
either the 2-midnight benchmark at Sec. 412.3(d)(1) or the case-by-
case exception at Sec. 412.3(d)(3). In addition, beginning in CY 2020,
we have allowed an exemption from certain medical review activities
related to the 2-midnight rule for procedures that have been recently
removed from the IPO list. Specifically, while inpatient claims for
procedures that have been removed from the IPO list may be reviewed by
the BFCC-QIOs for purposes of providing education to practitioners and
providers on compliance with the 2-midnight rule, those claims
identified as noncompliant will not be denied for such noncompliance
within the first 2 calendar years of their removal from the IPO list.
Additionally, these procedures are not considered by the BFCC-QIOs in
determining whether a provider exhibits persistent noncompliance with
the 2-midnight rule for purposes of referral to the RAC nor are these
procedures reviewed by RACs for ``patient status.'' As discussed
further in section X.B of this final rule, for CY 2021, we are
finalizing a proposal to extend the medical review exemption period
indefinitely for a service newly removed from the IPO list beginning in
CY 2021, until there is data indicating that the procedure removed is
more commonly performed in the outpatient setting than in the inpatient
setting. We believe this exemption from certain medical review
activities in combination with the fact that many inpatient admissions
for procedures formerly on the IPO list are likely to meet either the
2-midnight benchmark or the case-by-case exception to that benchmark
mitigates the concerns regarding denial of payment under Medicare Part
A for procedures no longer included on the IPO list. Lastly, with
regard to the behavior of commercial insurance providers and site
selection for outpatient services, while we believe that these comments
are outside the scope of the proposed rule, we note that commercial
providers establish their own rules regarding payment for services.
Comment: Several commenters requested that if the proposal to
eliminate the IPO list is finalized, CMS provide baseline criteria or
guidance for providers to consider when determining which services
would be appropriate to furnish in the outpatient setting based upon
peer-reviewed evidence, patient factors including age, co-morbidities,
social determinants, and other factors relevant to positive patient
outcomes. Commenters urged CMS to develop national guidelines outlining
beneficiaries who are appropriate candidates for the inpatient vs
outpatient setting, particularly for services that generally have a
short length of stay (i.e. do not meet the 2-midnight benchmark).
Response: We again emphasize that the decision about the most
appropriate care setting for a given surgical procedure is a complex
medical judgment and we believe this decision should be based on the
beneficiary's individual clinical needs and on the general coverage
rules requiring that any procedure be reasonable and necessary.
However, we understand that with over 1,700 services currently included
on the IPO list, the elimination of the list over the three-year period
will vastly increase the number of services that are newly payable in
the outpatient setting. It will take time for clinical staff and
providers to gain experience furnishing these services to the
appropriate Medicare beneficiaries in the HOPD in order to develop
comprehensive patient selection criteria and other protocols to
identify whether a beneficiary can safely have these procedures
performed in the outpatient setting. We agree with the commenters that,
in the near term, in light of the elimination of the IPO list over a
three-year period, physicians and providers could benefit from having
access to general considerations for physicians regarding the types of
services that may continue to be more appropriately performed in the
inpatient setting for Medicare beneficiaries. Therefore, in the future,
we plan to provide information on appropriate site of service selection
to support physicians' decision-making. We note that these
considerations will be for informational or educational purposes only
and will not supersede physicians' medical judgment about whether a
procedure should be performed in the inpatient or outpatient hospital
setting.
Comment: Some commenters also noted the potential for negative
financial impacts for both providers and beneficiaries with the
elimination of the IPO list. Commenters stated that beneficiaries who
require more than one outpatient hospital procedure delivered in
separate episodes of care could be subject to multiple co-payments that
may, when combined, exceed the inpatient deductible. Other commenters,
particularly hospital associations and health systems, stated that a
shift in site of service from the inpatient setting to the outpatient
setting for numerous procedures could be financially disadvantageous
for providers because the patients who would continue to receive these
services as inpatients would likely be the more complex cases and more
costly to treat. These commenters stated that this financial impact
would be particularly significant in light of the COVID-19 pandemic.
Response: As stated in the CY 2021 OPPS/ASC proposed rule (85 FR
48911), services included on the IPO list tend to be surgical
procedures that, if performed on an outpatient basis, would typically
be the focus of the hospital outpatient stay and would likely be
assigned to a comprehensive APC (C-APC) when they are removed from the
IPO list. As such, these services would likely be considered a single
episode of care with one payment rate and one copayment amount. In most
instances, we expect that beneficiaries will not be responsible for
multiple copayments for individual ancillary services associated with
services removed from the IPO list, because the primary service will be
assigned to a C-APC and the inpatient deductible cap will apply to the
entire hospital claim, which is paid as a comprehensive service. All
298 services that are being removed from the IPO list beginning in CY
2021 are assigned status indicator ``J1'' and will receive payment
through C-APCs, except for 34 services that are assigned status
indicator ``N'', which indicates that payment for the service is
packaged into payment for other services and there is no separate APC
payment, and two services assigned status indicator ``Q1'' which
indicates conditionally packaged payment. CPT code 44314 (Revision of
ileostomy; complicated (reconstruction in-depth) (separate procedure)),
is the only code to be removed from the IPO list that is assigned
status indicator ``T'', indicating that it is a separately paid
procedure. The vast majority of the procedures being removed from the
IPO list for CY 2021 are assigned to C-APCs or packaged into payment
for other services, which will result in beneficiaries paying one
copayment amount. Therefore, we do not believe that beneficiaries will
be significantly impacted through increased cost sharing for services
that were on the IPO list and are furnished in the hospital outpatient
department setting.
In the event there are separately payable OPPS services included on
a claim with a service assigned to a C-APC, our previously mentioned
policy
[[Page 86089]]
remains applicable; that is, the OPPS cost-sharing for an individual
service is capped at the applicable Part A hospital inpatient
deductible amount for that year for each service. For further
information regarding beneficiary copayments, please refer to section
II.I.1. of this final rule.
With regard to stakeholder concerns about providers experiencing
negative financial effects because of services transitioning from the
inpatient setting to the lower cost outpatient setting, we understand
the numerous challenges that providers are facing due to the COVID-19
public health emergency. We reiterate that providers retain the
flexibility to provide services that are no longer included on the IPO
list in the inpatient setting and that these services will remain
payable under Medicare Part A when appropriate in accordance with the
2-midnight rule and general coverage rules. We also refer readers to
the discussion of exemption from certain medical review activities for
services removed from the IPO list in section X.B. of this final rule
with comment period. Similar to other services that have been removed
from the IPO list in previous years, we expect that the volume of
services currently being performed in the inpatient setting that can be
appropriately performed in the outpatient setting will gradually shift
as physicians and providers gain experience furnishing these services
to the appropriate Medicare beneficiaries in the HOPD. Therefore, we do
not expect that providers will experience a significant financial
impact due to the elimination of the IPO list.
Comment: Commenters expressed concerns regarding the proposed APC
assignments for procedures proposed to be removed from the IPO list and
stated that CMS did not provide sufficient detail as to how the
proposed APC placements were determined. Some commenters also believed
that the proposed APC payments did not adequately reflect the costs
associated with providing the procedure in the outpatient setting and
that there was a significant differential between MS-DRG payment and
APC payment for some procedures. One commenter also disagreed with the
proposed APC assignment of APC 5115 (Level 5 Musculoskeletal
Procedures) for the following HCPCS codes: 27702 (Arthroplasty, ankle;
with implant (total ankle)), 27703 (Arthroplasty; revision, total
ankle), 23472 (Arthroplasty, glenohumeral joint; total shoulder
(glenoid and proximal humeral replacement (e.g., total shoulder))) and
23473 (Revision of total shoulder arthroplasty, including allograft
when performed; humeral or glenoid component), stating that the
geometric mean costs of these procedures is more similar to the
geometric mean costs of procedures assigned to APC 5116 (Level 6
Musculoskeletal Procedures). The commenter noted the assignment of
HCPCS code 27702 to APC 5115 would have created a 2 times rule
violation within this APC based on geometric mean costs; however, the
procedure did not have enough claims volume to be considered a
significant procedure and therefore was not considered in the
evaluation of 2 times rule violations. The commenter requested that all
these procedures be assigned to C-APC 5116 for CY 2021.
Response: We assign services payable under the OPPS, including
services removed from the IPO list, to APCs based on their similarity
to other codes within the APC in terms of clinical characteristics and
resource use. Based on the claims data currently available for
procedures removed from the IPO list and the clinical characteristics
of the procedures, we believe that the 266 musculoskeletal procedures
being removed from the IPO list for CY 2021, including HCPCS codes
27702, 27703, 23472, and 23473, are appropriately assigned to the C-
APCs identified in Table 48--Services Removed from the Inpatient Only
(IPO) List for CY 2021. We will continue to monitor these procedures
and claims data as they become available to determine if assignment to
other APCs is appropriate. We refer readers to Section III.D.17 of this
final rule with comment period for a discussion of the musculoskeletal
procedure APC series (APCs 5111 through 5116).
Comment: Commenters raised concerns about the effect of the
elimination of the IPO list on the target pricing of payment models
administered by the Center for Medicare and Medicaid Innovation (CMS
Innovation Center), such as the Bundled Payments for Care Initiatives,
the Bundled Payments for Care Initiatives (BPCI) Advanced Model, and
the Comprehensive Care for Joint Replacement Model and requested that
CMS ensure that any changes to the IPO list do not unfairly penalize
model participants.
Response: As we have stated in previous rulemaking (82 FR 59384 and
84 FR 61355) when commenters raised similar concerns when total knee
arthroplasty and total hip arthroplasty were removed from the IPO list,
the CMS Innovation Center will monitor the overall volume and
complexity of cases performed in hospital outpatient departments to
determine whether any future refinements to the CJR, BPCI, and BPCI
Advanced Models are warranted. The Innovation Center may consider
making future changes to these models to address the elimination of the
IPO list and subsequent performance of procedures previously identified
as inpatient-only in the outpatient hospital setting.
Comment: Commenters also raised concerns about the impact of this
policy on the 3-day stay requirement for skilled nursing facility care.
By statute, beneficiaries must have a prior inpatient hospital stay of
no fewer than three consecutive days to be eligible for Medicare
coverage of inpatient SNF care. Specifically, commenters stated that
the elimination of the IPO list may have a significant impact on
Medicare beneficiaries' ability to obtain a three day inpatient stay to
qualify for SNF care.
Response: We reiterate that removal of procedures from the IPO list
does not require the procedures to be performed only on an outpatient
basis. Removal of procedures from the IPO list allows for payment of
the procedure in either the inpatient setting or the outpatient
setting. A prior 3-day inpatient hospital stay remains a statutory
requirement for SNF coverage. However, as stated in the CY 2018 final
rule with comment period (82 FR 59384), in our discussion of the
removal of TKA from the IPO list, we would expect that Medicare
beneficiaries who are identified as appropriate candidates to receive a
surgical procedure in the outpatient setting instead of being admitted
as an inpatient, would not be expected to require SNF care following
surgery. Instead, we expect that many of these beneficiaries would be
appropriate for discharge to home (with outpatient therapy) or home
health care.
Comment: Commenters noted that there are anesthesia codes related
to some of the musculoskeletal procedures proposed to be removed from
the IPO list for CY 2021 that were not proposed to be removed from the
list. These commenters requested that these related anesthesia services
also be removed from the IPO list for CY 2021. In addition to these
requests, at the August 31, 2020 meeting, the Advisory Panel on
Hospital Outpatient Payment (HOP Panel) recommended that we remove the
16 additional procedures in Table 47 from the IPO list and assign these
procedures to C-APCs.
Response: We appreciate the comments. We reviewed the IPO list for
CPT codes describing anesthesia services that are related to the
musculoskeletal procedures that we have proposed to remove from the IPO
[[Page 86090]]
list beginning in CY 2021. After our analysis, we agree with the
commenters that the anesthesia codes that are billed with services that
were proposed to be removed from the IPO list for CY 2021 should also
be removed from the IPO list for CY 2021. Therefore, we are removing
the 16 anesthesia codes from the IPO list for CY 2021.
We also accept the HOP panel recommendation to remove 16 additional
procedures from the IPO list. The anesthesia services are included in
Table 46 below. The CPT codes recommended for removal from the IPO list
by the HOP panel are included in Table 47 below. We refer readers to
Table 48 for the final list of all procedures we are removing from the
IPO list for CY 2021.
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3. Comment Solicitation on Order of Removal of Additional Clinical
Families From the IPO List During the Transition To Complete
Elimination of the IPO List
As stated above, we proposed to eliminate the current IPO list of
1,740 services, starting with the 266 musculoskeletal-related services,
which were listed in Table 31 of the CY 2021 OPPS/ASC proposed rule (85
FR 48912). We requested comments from the public on whether three years
was an appropriate time frame for the transition, whether there are
other services that would be ideal candidates for removal from the IPO
list in the near term given known technological advancements and other
advances in care, and the order of removal of additional clinical
families and/or specific services for each of the CY 2022 and CY 2023
rulemakings until the IPO list is completely eliminated. Additionally,
we sought comment on whether we should restructure or create any new
APCs to allow for OPPS payment for services that are removed from the
IPO list. We also solicited public comments on whether any of the
musculoskeletal codes proposed for removal from the IPO list for CY
2021 may meet the criteria to be added to the ASC Covered Procedures
List. We refer readers to section XIII.C.1.c. of the CY 2021 OPPS/ASC
proposed rule for a complete discussion of the ASC Covered Procedures
List.
Comment: Several commenters, including several hospital
associations, medical specialty societies, and MedPAC requested we
delay the elimination of the IPO list until a comprehensive evaluation
of the procedures on the list has occurred. They felt a more thorough
review of the services proposed for removal is appropriate due to the
large number of services on the IPO list across a range of medical
specialties. Commenters suggested various time frames for eliminating
the IPO list that ranged from three years to seven years. Several
hospital associations recommended we delay eliminating the list until
we address patient safety concerns and provide national guidelines
outlining patients who are appropriate candidates for care in the
inpatient hospital versus outpatient hospital setting. One commenter
suggested that we remove the proposed musculoskeletal services from the
IPO list, and then monitor the transition of those services to the
outpatient hospital setting and the effect on beneficiary outcomes for
a period of time before removing any additional procedures. Some
hospital systems also requested a delay, noting that the timing of the
proposed change is particularly difficult in light of the COVID-19
pandemic.
Response: We thank commenters for their feedback. However, we do
not believe it is necessary to delay eliminating the IPO list over the
course of a three-year transition beginning in CY 2021. We are
finalizing a three-year transition for removing procedures from the IPO
list and enabling them to be paid under the OPPS, with the list
eliminated in its entirety by 2024. In the CY 2021 OPPS/ASC proposed
rule (85 FR 48911), we proposed to eliminate the IPO list over 3 years
to provide a gradual transition that gives the public the opportunity
to comment on the sequence in which services should be removed from the
IPO list. In addition, as we previously discussed in the CY 2021 OPPS/
ASC proposed rule (85 FR 48911), we recognized that stakeholders would
need time to adjust to the significant number of services removed from
the IPO list and newly priced under the OPPS. We believe that longer
transition periods would prevent providers who are ready to perform
services in the outpatient department from doing so, and it is equally
important to note that providers are not required to perform services
in the outpatient department as services are eliminated from the IPO
list if they are not ready. While we still believe that 3 years will
offer providers an adequate time period to prepare, update their
billing systems, and gain experience with newly removed procedures
eligible to be paid when furnished in both the inpatient hospital and
outpatient hospital settings, we also realize that providers will have
varying time frames for completing the transition.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48909 through 48912)
we discussed patient safety concerns stakeholders expressed regarding
removing procedures from the IPO list or eliminating the IPO list. We
continue to believe that the evolving nature of the practice of
medicine, which has allowed more procedures to be performed on an
outpatient basis with a shorter recovery time, in addition to physician
judgment, state and local licensure requirements, accreditation
requirements, hospital conditions of participation (CoPs), medical
malpractice laws, and CMS quality and monitoring initiatives and
programs will continue to ensure the safety of beneficiaries in both
the inpatient and outpatient settings, even in the absence of the IPO
list (85 FR 48910). In prior rulemaking, we have
[[Page 86093]]
stated that regardless of how a procedure is classified for purposes of
payment, we expect that in every case the surgeon and the hospital will
assess the risk of a procedure or service to the individual patient,
taking site of service into account, and will act in that patient's
best interests (65 FR 18456). As we transition procedures off of the
IPO list, we will continue to actively monitor for impacts on patient
safety and quality through analyzing claims and other relevant data;
throughout this transition, CMS will take necessary steps to address
any changes in patient safety or quality that may emerge.
Comment: Two medical specialty societies recommended that
cardiothoracic procedures and spine-related procedures be the last
procedures removed from the IPO list due to clinical and resource
intensity these procedures require.
Response: We appreciate the commenter's feedback. We will consider
these comments for future rulemaking.
Comment: A few commenters suggested that procedures removed from
the IPO list receive an interim assignment to a new technology APC to
help collect claims data and subsequently assign the procedures to
clinical APCs. These commenters suggested that we assign a default 31
percent device offset for procedures removed from the IPO list that are
low-volume and are assigned to a device-intensive APC. They felt that
current APCs may need to be restructured due to the lack of appropriate
comparison procedures to those procedures being removed from the IPO
list. In addition, the commenter argued that we did not provide an
analysis to support our proposal to assign a given HCPCS/CPT code to a
proposed APC or C-APC from the perspective of clinical or resource use
similarity. They stated that in Table 31 of the proposed rule, we
referenced related services for the musculoskeletal services proposed
for removal from the IPO list for 2021; however, we proposed to assign
these codes to different APCs than the APCs to which the comparator
services are assigned. The commenter also stated that we did not
provide information on proposed device offset amounts or how complexity
adjustments were considered for procedures proposed for IPO List
removal.
Response: As specified in our regulation at 42 CFR 419.31(a)(1),
CMS classifies outpatient services and procedures that are comparable
clinically and in terms of resource use into APC groups. As we stated
in the CY 2012 OPPS/ASC final rule (76 FR 74224), the OPPS is a
prospective payment system that provides payment for groups of services
that share clinical and resource use characteristics. It should be
noted that for all codes newly paid under the OPPS, including codes
removed from the IPO list, our policy has been to assign the service or
procedure to an APC based on feedback from a variety of sources,
including but not limited to, review of the clinical similarity of the
service to existing procedures; advice from CMS medical advisors;
information from interested specialty societies; and review of all
other information available to us, including information provided to us
by the public, whether through meetings with stakeholders or additional
information that is mailed or otherwise communicated to us (84 FR
61229). Therefore, we believe assigning procedures removed from the IPO
list to existing clinical APCs that are similar in clinical
characteristics and resource costs is appropriate. We note that
procedures assigned to new technology APCs do not fit into existing APC
groups, unlike the procedures transitioning from the IPO list. For
further information on new technology APCs, we refer readers to Section
III.C. We note that we will reevaluate the APC assignments for
procedures removed from the IPO list once we have hospital outpatient
claims data and, if appropriate, reassign and/or restructure APC
assignments. For procedures that we are removing from the IPO list in
CY 2021, we will apply offset calculations and assessment in
determining device intensive status at the HCPCS/CPT code level (81 FR
79657). We refer readers to Section IV.B for more information on
device-intensive assignments for procedures.
In summary, after consideration of the public comments, we are
finalizing our proposal with modification to eliminate the IPO list
over the course of the next 3 years, starting with the proposed removal
of 266 musculoskeletal-related services and 16 HOP Panel recommended
services and related anesthesia codes, for a total of 298 services, as
provided in Table 48 in CY 2021. We plan to provide considerations for
physicians and other health care providers when determining whether a
service may be more appropriately performed in the inpatient or
outpatient setting for a beneficiary, but again we emphasize that
decisions regarding appropriate care setting are complex medical
judgments. We are also finalizing our proposal, without modification,
to amend 42 CFR 419.22(n) to state that effective beginning on January
1, 2021, the Secretary shall eliminate the list of services and
procedures designated as requiring inpatient care through a 3-year
transition, with the full list eliminated in its entirety by January 1,
2024. We believe that the developments in surgical technique and
technological advances in the practice of medicine, as well as the
various safeguards discussed above, including, but not limited to,
physician clinical judgment, state and local regulations, accreditation
requirements, medical malpractice laws, hospital conditions of
participation, and other CMS initiatives will ensure that procedures
removed from the IPO list and provided in the outpatient setting will
be done so safely.
Table 48 lists the final procedures, including long descriptors and
CPT/HCPCS codes and status indicators (if applicable) that are removed
from the IPO list for CY 2021. These services are included in Addendum
B to the CY 2021 OPPS/ASC final rule as well.
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BILLING CODE 4120-01-C
X. Nonrecurring Policy Changes
A. Changes in the Level of Supervision of Outpatient Therapeutic
Services in Hospitals and Critical Access Hospitals (CAHs)
In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61359
through 61363), we implemented a policy for CY 2020 and subsequent
years to change the generally applicable minimum required level of
supervision for most hospital outpatient therapeutic services from
direct supervision to general supervision for services furnished by all
hospitals and CAHs. However, some groups of services were not subject
to the change in the required supervision level and those services
continue to have a minimum default level of supervision that is higher
than general supervision.
On January 31, 2020, Health and Human Services Secretary Alex M.
Azar II determined that a PHE exists retroactive to January 27, 2020
\98\ under section 319 of the Public Health Service Act (42 U.S.C.
247d), in response to COVID-19, and on April 21, 2020, Secretary Azar
renewed, effective April 26, 2020, and again effective July 25, 2020,
the determination that a PHE exists.\99\ On March 13, 2020, the
President of the U.S. declared the COVID-19 outbreak in the U.S.
constitutes a national emergency,\100\ beginning March 1, 2020. On
March 31, 2020, we issued an interim final rule with comment period
(IFC) to give individuals and entities that provide services to
Medicare beneficiaries needed flexibilities to respond effectively to
the serious public health threats posed by the spread of COVID-19. The
goal of the IFC issued on March 31, 2020, was to provide the necessary
flexibility for Medicare beneficiaries to be able to receive medically
necessary services without jeopardizing their health or the health of
those who are providing those services, while minimizing the overall
risk to public health (85 FR 19232).
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\98\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCo.V.aspx.
\99\ https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx.
\100\ https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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In the IFC issued March 31, 2020, we adopted a policy to reduce, on
an interim basis for the duration of the PHE, the minimum default level
of supervision for non-surgical extended duration therapeutic services
(NSEDTS) to general supervision for the entire service, including the
initiation portion of the service, for which we had previously required
direct supervision. We also specified in the IFC issued March 31, 2020,
that, for the duration of the PHE for the COVID-19 pandemic, the
requirement for direct physician supervision of pulmonary
rehabilitation, cardiac rehabilitation, and intensive cardiac
rehabilitation services includes virtual presence of the physician
through audio/video real-time communications technology when use of
such technology is indicated to reduce exposure risks for the
beneficiary or health care provider.
These policies were adopted on an interim final basis for the
duration of the PHE. However, in the CY 2021 OPPS/ASC proposed rule, we
stated that we believed these policies are appropriate outside of the
PHE and should apply permanently. Therefore, we proposed to adopt these
policies for CY 2021 and beyond as described in more detail below.
1. General Supervision of Outpatient Hospital Therapeutic Services
Currently Assigned to the Non-Surgical Extended Duration Therapeutic
Services (NSEDTS) Level of Supervision
NSEDTS describe services that have a significant monitoring
component that can extend for a lengthy period of time, that are not
surgical, and that typically have a low risk of complications after the
assessment at the beginning of the service. The minimum default
supervision level of NSEDTS was established in the CY 2011 OPPS/ASC
final rule with comment period (75 FR 72003 through 72013) as being
direct supervision during the initiation of the service, which may be
followed by general supervision at the discretion of the supervising
physician or the appropriate nonphysician practitioner (Sec.
410.27(a)(1)(iv)(E)). In this case, initiation means the beginning
portion of the NSEDTS, which ends when the patient is stable and the
supervising physician or the appropriate nonphysician practitioner
determines that the remainder of the service can be delivered safely
under general supervision. We originally established general
supervision as the appropriate level of supervision after the
initiation of the service because it is challenging for hospitals to
ensure direct supervision for services with an extended duration and a
significant monitoring component, particularly for CAHs and small rural
hospitals.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61359
through 61363), we changed the generally applicable minimum required
level of supervision for most hospital outpatient therapeutic services
from direct supervision to general supervision for hospitals and CAHs.
We made this change because we believe it is critical that hospitals
have the flexibility to provide the services Medicare beneficiaries
need while minimizing provider burden. In the IFC issued March 31, 2020
(85 FR 19266), we assigned, on an interim basis, a minimum required
supervision level of general supervision for NSEDTS services, including
during the initiation portion of the service, during the PHE. Changing
the minimum level of supervision to general supervision during the PHE
gives providers additional flexibility to handle the burdens created by
the COVID-19 PHE.
We believe changing the level of supervision for NSEDTS permanently
for the duration of the service would be beneficial to patients and
outpatient hospital providers as it would allow greater flexibility in
providing these services and reduce provider burden, and thus, improve
access to these
[[Page 86111]]
services in cases where the direct supervision requirement may have
otherwise prevented some services from being furnished due to lack of
availability of the supervising physician or nonphysician practitioner.
In addition, as we explained in the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61360), our experience indicates that Medicare
providers will provide a similar quality of hospital outpatient
therapeutic services, including NSEDTS, regardless of whether the
minimum level of supervision required under the Medicare program is
direct or general. We note that the requirement for general supervision
for an entire NSEDTS does not preclude these hospitals from providing
direct supervision for any part of a NSEDTS when the practitioners
administering the medical procedures decide that it is appropriate to
do so. Many outpatient therapeutic services, including NSEDTS, may
involve a level of complexity and risk such that direct supervision
would be warranted even though only general supervision is required.
In addition, CAHs and hospitals in general continue to be subject
to conditions of participation (CoPs) that complement the general
supervision requirements for hospital outpatient therapeutic services,
including NSEDTS, to ensure that the medical services Medicare patients
receive are properly supervised. CoPs for hospitals require Medicare
patients to be under the care of a physician (42 CFR 482.12(c)(4)), and
for the hospital to ``have an organized medical staff that operates
under bylaws approved by the governing body, and which is responsible
for the quality of medical care provided to patients by the hospital''
(42 CFR 482.22). The CoPs for CAHs (42 CFR 485.631(b)(1)(i)) require
physicians to provide medical direction for the CAHs' health care
activities, consultation for, and medical supervision of the health
care staff. The physicians' responsibilities in hospitals and CAHs
include supervision of all services performed at those facilities. In
addition, physicians must also follow state laws regarding scope of
practice.
Therefore, we proposed to establish general supervision as the
minimum required supervision level for all NSEDTS that are furnished on
or after January 1, 2021. This would be consistent with the minimum
required level of general supervision that currently applies for most
outpatient hospital therapeutic services. General supervision, as
defined in our regulation at Sec. 410.32(b)(3)(i), means that the
procedure is furnished under the physician's overall direction and
control, but that the physician's presence is not required during the
performance of the procedure; and as provided under Sec.
410.27(a)(1)(iv)(C), certain non-physician practitioners can provide
the required supervision of services that they can personally furnish
in accordance with state law and all other applicable requirements.
Because we proposed a minimum required level of general supervision for
NSEDTS, including during the initiation of the service, we proposed to
delete paragraph (a)(1)(iv)(E) from the regulations at Sec. 410.27. We
sought public comment on this proposal.
Comment: All commenters supported our proposal to change the
minimum required level of supervision to general supervision for all
NSEDTS that are furnished on or after January 1, 2021. Several
commenters appreciated the additional flexibility to deliver care while
acknowledging that practitioners administering individual medical
procedures continue to have the discretion to increase the level of
supervision when necessary. Commenters similarly acknowledged that CoPs
for hospitals and CAHs and state scope of practice requirements also
might lead to higher level of supervision for a part or all of an
NSEDTS. One commenter, MedPAC, supported our proposal, but encouraged
CMS to be diligent in monitoring NSEDTS performed under general
supervision, especially services that involve risk of serious
complications.
Response: We appreciate the support for our proposal from the
commenters. We will monitor NSEDTS for safety or service quality issues
that may arise from the change to general supervision as the minimum
default level of supervision for the initiation period of these
services.
After reviewing the public comments we received, we are finalizing
our proposal without modification to establish general supervision as
the minimum required supervision level for all NSEDTS that are
furnished on or after January 1, 2021. In addition, we are finalizing
our proposal to delete paragraph (a)(1)(iv)(E) from the regulations at
Sec. 410.27, which will reflect that, starting in CY 2021, the
entirety of NSEDTS has a minimum required supervision level of general
supervision.
2. Direct Supervision of Pulmonary Rehabilitation Services, Cardiac
Rehabilitation Services, and Intensive Cardiac Rehabilitation Services
Using Interactive Telecommunications Technology
Direct physician supervision was the standard set forth in the
April 7, 2000 OPPS final rule with comment period (68 FR 18524 through
18526) for supervision of hospital outpatient therapeutic services
covered and paid by Medicare in hospitals and provider-based
departments of hospitals, including for cardiac rehabilitation,
intensive cardiac rehabilitation, and pulmonary rehabilitation services
provided to hospital outpatients. As we explained in the CY 2011 OPPS/
ASC final rule with comment period, the statutory language of sections
1861(eee)(2)(B) and (eee)(4)(A) and section 1861(fff)(1) of the Act (as
added by section 144(a)(1) of Pub. L. 110-275) defines cardiac
rehabilitation, intensive cardiac rehabilitation, and pulmonary
rehabilitation programs as ``physician supervised.'' More specifically,
section 1861(eee)(2)(B) of the Act establishes that, for cardiac
rehabilitation, intensive cardiac rehabilitation, and pulmonary
rehabilitation programs, ``a physician is immediately available and
accessible for consultation and medical emergencies at all times items
and services are being furnished under the program, except that, in the
case of items and services furnished under such a program in a
hospital, such availability shall be presumed.'' As we explained in the
CY 2009 OPPS/ASC proposed rule and final rule with comment period (73
FR 41518 through 41519 and 73 FR 68702 through 68704, referencing the
April 7, 2000 OPPS final rule (65 FR 18525)), the ``presumption'' or
``assumption'' of direct supervision means that direct physician
supervision is the standard for all hospital outpatient therapeutic
services. We have assumed this requirement is met on hospital premises
because staff physicians would always be nearby in the hospital. In
other words, the requirement is not negated by a presumption that the
requirement is being met. Recently, some stakeholders suggested we have
the authority to change the default minimum level of supervision for
pulmonary rehabilitation services, cardiac rehabilitation services, and
intensive cardiac rehabilitation services to general supervision
because of the policy we adopted in CY 2020 to change the generally
applicable minimum required level of supervision for most other
hospital outpatient therapeutic services from direct supervision to
[[Page 86112]]
general supervision (84 FR 61359 through 61363). For the reasons
explained above, we disagree that we can change the default level of
supervision for these services to general supervision under current
law.
In the IFC issued March 31, 2020 (85 FR 19246), we implemented a
policy for the duration of the PHE that allows the direct supervision
requirement for cardiac rehabilitation, intensive cardiac
rehabilitation, and pulmonary rehabilitation services to be met by the
virtual presence of the supervising physician through audio/video real-
time communications technology when use of such technology is indicated
to reduce exposure risks to COVID-19 for the beneficiary or health care
provider. While we adopted this policy to help improve the availability
of rehabilitation services during the PHE and reduce the burden for
providers, we also believed the policy to allow direct supervision
provided by the virtual presence of the physician could continue to
improve access for patients and reduce burden for providers after the
end of the PHE. In some cases, depending upon the circumstances of
individual patients and supervising physicians, we believed that
telecommunications technology could be used in a manner that would
facilitate the physician's immediate availability to furnish assistance
and direction without necessarily requiring the physician's physical
presence in the location where the service is being furnished. For
example, use of real-time audio and video telecommunications technology
could allow a supervising physician to observe the patient during
treatment as they interact with or respond to the in-person clinical
staff. Thus, the supervising physician's immediate availability to
furnish assistance and direction during the service could be met
virtually without requiring the physician's physical presence in that
location.
Therefore for pulmonary rehabilitation, cardiac rehabilitation, and
intensive cardiac rehabilitation services, we proposed to change our
regulation at Sec. 410.27(a)(1)(iv)(D) to specify that, beginning on
or after January 1, 2021, direct supervision for these services
includes virtual presence of the physician through audio/video real-
time communications technology subject to the clinical judgment of the
supervising physician. We clarify that the virtual presence required
for direct supervision using audio/video real-time communications
technology would not be limited to mere availability of the physician,
but rather real-time presence via interactive audio and video
technology throughout the performance of the procedure. We sought
public comment on this proposal.
Comment: Many commenters wanted more clarity on our proposal to
meet the direct supervision requirement for pulmonary rehabilitation,
cardiac rehabilitation, and intensive cardiac rehabilitation services
through virtual presence. Commenters were unsure what the phrase
``real-time presence via interactive audio and video technology
throughout the performance of the procedure'' meant. Some commenters
were concerned that our proposal would require the supervising
practitioner to observe a rehabilitation service during the entire time
the service is being administered, which would be comparable to
personal supervision. That type of standard, according to the
commenters, would actually be more burdensome than the current direct
supervision requirement through physical presence.
Other commenters stated that, while they were generally in favor of
permitting direct physician supervision through virtual presence for
pulmonary rehabilitation, cardiac rehabilitation, and intensive cardiac
rehabilitation services, they would prefer that we require the
supervising practitioner simply be ``immediately available'' through
audio/visual real-time communications technology, and not be required
to provide real-time presence or observation of the service via
interactive audio and video technology throughout the performance of
the procedure. A few commenters also encouraged us to align our
proposal on direct supervision through virtual presence with what had
been proposed in the CY 2021 PFS proposed rule (85 FR 50115 through
50116), which discussed requiring only immediate availability to engage
using audio/visual technology to provide direct supervision.
Response: We believe the commenters have made some important points
about our proposal. CMS continues to work to reduce burden on providers
under the Medicare program, and we want to ensure that while expanding
access to medical care and promoting patient safety, we do not
implement policies that increase provider burden. In this case, our
proposal appears to have required a higher level of participation by
the physician providing direct supervision of pulmonary rehabilitation,
cardiac rehabilitation, and intensive cardiac rehabilitation services
through virtual presence than would be required if they were providing
direct supervision of the services in person. In addition, our proposal
was not aligned with the proposal in the CY 2021 PFS proposed rule to
permit direct supervision requirements to be met through virtual
presence through the later of the end of the year in which the PHE ends
or December 31, 2021; and to specify that the direct supervision
requirement could be met by the supervising practitioner being
immediately available to engage via interactive real-time audio/video
communications technology, without requiring real-time presence or
observation of the service via interactive audio/video technology
throughout the performance of the procedure. This lack of alignment
could lead to additional burden for providers having to accommodate
different levels of virtual engagement depending on whether a
rehabilitation service is furnished as an outpatient hospital service
or a physicians' service.
Comment: A few commenters either opposed the proposal or wanted to
place substantial limits on when direct supervision through virtual
presence could be used to furnish pulmonary rehabilitation, cardiac
rehabilitation, and intensive cardiac rehabilitation services. One
commenter, MedPAC, opposed the proposal because they believe it is
unclear whether telehealth is beneficial or harmful to the quality of
care received for pulmonary rehabilitation, cardiac rehabilitation, and
intensive cardiac rehabilitation services. MedPAC encouraged us to
study the policy further before implementing our proposal. Another
commenter expressed support for permitting the direct supervision of
rehabilitation services through virtual presence, but only if the
supervising practitioner has first seen both the patient and the site
of service in person, initiated the treatment, and provides subsequent
services that show active participation in, and management of, the
course of treatment. A third commenter did not explicitly state that
they were against allowing direct supervision of pulmonary
rehabilitation, cardiac rehabilitation, and intensive cardiac
rehabilitation services through virtual presence, and the commenter
expressed support for permitting direct supervision through virtual
presence during the current PHE to avoid the risks associated with
COVID-19. However, the commenter believes that the policy to allow
direct supervision through virtual presence should end for all medical
services including pulmonary rehabilitation, cardiac rehabilitation,
and intensive cardiac rehabilitation services at the end of the PHE.
The commenter felt that practitioners cannot adequately
[[Page 86113]]
supervise procedures, especially complex and high-risk procedures, and
meet all of a patient's clinical needs, unless they are physically
available to participate in the administration of the medical service.
Furthermore, the commenter suggested that we adopt limits on the number
of clinical staff members a supervising practitioner may engage with
simultaneously through audio and visual technology, and limits on a
supervising practitioner's incident to relationships with outpatient
hospital providers that are fulfilled primarily through the use of
audio and visual technology before allowing direct supervision through
virtual presence after the end of the PHE. This request was for all
outpatient hospital services, and not just for pulmonary
rehabilitation, cardiac rehabilitation, and intensive cardiac
rehabilitation services.
Response: We appreciate the concerns expressed by some commenters
about the potential risks of allowing direct supervision using virtual
presence. We note that, during the PHE, virtual presence of the
supervising physician using interactive audio/video real-time
communications technology is an available option for direct
supervision, but it is not a requirement. Providers and physicians are
free to use their own judgment to determine whether direct supervision
through virtual presence is appropriate for the rehabilitation services
being administered, or if the supervising physician should provide
direct supervision in person. Also, providers will need to meet
conditions of participation and state scope of work requirements in the
location where the service is administered. Finally, we will monitor
the use of interactive audio/video real-time communications technology
to meet the direct supervision requirement to determine whether there
is a negative impact on the quality of pulmonary rehabilitation,
cardiac rehabilitation, and intensive cardiac rehabilitation services.
Comment: Several commenters supported our proposal to allow the use
of virtual presence to meet the direct physician supervision
requirements for pulmonary rehabilitation, cardiac rehabilitation, and
intensive cardiac rehabilitation services as proposed and they did not
request modifications to our proposal.
Response: We thank the commenters for their support of our
proposal.
After consideration of the public comments received for our
proposal, we have decided to modify the proposal in the CY 2021 OPPS/
ASC proposed rule. We believe we need to continue to explore the
appropriateness of permitting direct supervision through virtual
presence before extending this policy permanently beyond the end of the
PHE. The public comments we received, along with feedback we have
received since the implementation of the policy in IFC-1 allowing for
direct supervision through virtual presence (85 FR 19246) have
convinced us that we need more information on the issues involved with
direct supervision through virtual presence before implementing this
policy permanently. Therefore, we are finalizing our proposed policy to
permit direct supervision of these services using virtual presence only
until the later of the end of the calendar year in which the PHE ends
or December 31, 2021. Specifically, the required direct physician
supervision can be provided through virtual presence using audio/video
real-time communications technology (excluding audio-only) subject to
the clinical judgement of the supervising practitioner, as discussed in
IFC-1 (85 FR 19246).
When the policy to permit direct supervision through virtual
presence ends, we will resume our current policy to require direct
physician supervision of pulmonary rehabilitation, cardiac
rehabilitation, and intensive cardiac rehabilitation services, and that
the supervising practitioner must be present in the office suite and
immediately available to furnish assistance and direction throughout
the performance of the procedure. This does not mean that the
supervising practitioner must be present in the room when the procedure
is performed.
In response to questions received since we issued our interim
policy for the PHE, we are clarifying that, to the extent our policy
allows direct supervision through virtual presence using audio/video
real-time communications technology during the PHE, the requirement
could be met by the supervising practitioner being immediately
available to engage via audio/video technology (excluding audio-only),
and would not require real-time presence or observation of the service
via interactive audio and video technology throughout the performance
of the procedure. We intend our policy to permit direct physician
supervision of pulmonary rehabilitation, cardiac rehabilitation, and
intensive cardiac rehabilitation services to be consistent with the
policy to permit direct supervision through virtual presence in section
II.D.9. of the CY 2021 PFS final rule, which we cross reference here.
We also are revising the regulatory text in 42 CFR 410.27(a)(1)(iv)(D)
to reflect our revised policy, and to align the regulation with similar
language describing direct supervision through virtual presence in the
physician office setting in 42 CFR 410.32(b)(3)(ii).
B. Medical Review of Certain Inpatient Hospital Admissions Under
Medicare Part A for CY 2021 and Subsequent Years
1. Background on the 2-Midnight Rule
In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50913 through
50954), we clarified our policy regarding when an inpatient admission
is considered reasonable and necessary for purposes of Medicare Part A
payment. Under this policy, we established a benchmark providing that
surgical procedures, diagnostic tests, and other treatments would be
generally considered appropriate for inpatient hospital admission and
payment under Medicare Part A when the physician expects the patient to
require a stay that crosses at least 2 midnights and admits the patient
to the hospital based upon that expectation. Conversely, when a
beneficiary enters a hospital for a surgical procedure not designated
as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n),
a diagnostic test, or any other treatment, and the physician expects to
keep the beneficiary in the hospital for only a limited period of time
that does not cross 2 midnights, the services would be generally
inappropriate for payment under Medicare Part A, regardless of the hour
that the beneficiary came to the hospital or whether the beneficiary
used a bed. With respect to services designated under the OPPS as IPO
procedures, we explained that because of the intrinsic risks, recovery
impacts, or complexities associated with such services, these
procedures would continue to be appropriate for inpatient hospital
admission and payment under Medicare Part A regardless of the expected
length of stay. We also indicated that there might be further ``rare
and unusual'' exceptions to the application of the benchmark, which
would be detailed in subregulatory guidance.
In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50913 through
50954), we also finalized the 2-Midnight presumption, which is related
to the 2-Midnight benchmark but is a separate medical review policy.
The 2-Midnight benchmark represents guidance to reviewers to identify
when an inpatient admission is generally reasonable and necessary for
purposes of Medicare Part A payment, while the 2-Midnight presumption
relates to instructions to medical reviewers regarding the
[[Page 86114]]
selection of claims for medical review. Specifically, under the 2-
Midnight presumption, inpatient hospital claims with lengths of stay
greater than 2 midnights after the formal admission following the order
are presumed to be appropriate for Medicare Part A payment and are not
the focus of medical review efforts, absent evidence of systematic
gaming, abuse, or delays in the provision of care in an attempt to
qualify for the 2-Midnight presumption. Thus, for purposes of the 2-
Midnight presumption, the ``clock'' starts at the point of admission as
an inpatient.
With respect to the 2-Midnight benchmark, however, the starting
point is when the beneficiary begins receiving hospital care either as
a registered outpatient or after inpatient admission. That is, for
purposes of determining whether the 2-Midnight benchmark is met and,
therefore, whether an inpatient admission is appropriate for Medicare
Part A payment, we consider the physician's expectation including the
total time spent receiving hospital care--not only the expected
duration of care after inpatient admission, but also any time the
beneficiary has spent (before inpatient admission) receiving outpatient
services, such as observation services, treatments in the emergency
department, and procedures provided in the operating room or other
treatment area. From the medical review perspective, while the time the
beneficiary spent as an outpatient before the admission order is
written is not considered inpatient time, it is considered during the
medical review process for purposes of determining whether the 2-
Midnight benchmark was met and, therefore, whether payment is
appropriate under Medicare Part A. For beneficiaries who do not arrive
through the emergency department or are directly receiving inpatient
services (for example, inpatient admission order written prior to
admission for an elective admission), the starting point for medical
review purposes is when the beneficiary starts receiving medically
responsive services following arrival at the hospital. For Medicare
payment purposes, both the decision to keep the patient at the hospital
and the expectation of needed duration of the stay must be supported by
documentation in the medical record based on factors such as
beneficiary medical history and comorbidities, the severity of signs
and symptoms, current medical needs, and the risk of an adverse event
during hospitalization.
With respect to inpatient stays spanning less than 2 midnights
after admission, we instructed contractors that, although such claims
would not be subject to the presumption, the admission may still be
appropriate for Medicare Part A payment because time spent as an
outpatient should be considered in determining whether there was a
reasonable expectation that the hospital care would span 2 or more
midnights. In other words, even if an inpatient admission was for only
1 Medicare utilization day, medical reviewers are instructed to
consider the total duration of hospital care, both pre- and post-
inpatient admission, as well as the reasonable expectations of the
admitting physician regarding duration of hospital care, when making
the determination of whether the inpatient stay was reasonable and
necessary for purposes of Medicare Part A payment.
We continue to believe that use of the 2-Midnight benchmark gives
appropriate consideration to the medical judgment of physicians and
furthers the goal of clearly identifying when an inpatient admission is
appropriate for payment under Medicare Part A. More specifically, as we
described in the FY 2014 IPPS/LTCH PPS final rule (78 FR 50943 through
50954), factors such as the procedures being performed and the
beneficiary's condition and comorbidities apply when the physician
formulates his or her expectation regarding the need for hospital care,
while the determination of whether an admission is appropriately billed
and paid under Medicare Part A or Part B is generally based upon the
physician's medical judgment regarding the beneficiary's expected
length of stay. We have not identified any circumstances where the 2-
Midnight benchmark restricts the physician to a specific pattern of
care, because the 2-Midnight benchmark does not prevent the physician
from ordering or providing any service at any hospital, regardless of
the expected duration of the service. Rather, this policy provides
guidance on when the hospitalized beneficiary's care is appropriate for
coverage and payment under Medicare Part A as an inpatient, and when
the beneficiary's care is reasonable and necessary for payment under
Medicare Part B as an outpatient.
2. Current Policy for Medical Review of Inpatient Hospital Admissions
Under Medicare Part A
As mentioned previously, in the FY 2014 IPPS/LTCH PPS final rule
(78 FR 50943 through 50954), we provided guidance for payment purposes
that specified that, generally, a hospital inpatient admission is
considered reasonable and necessary if a physician or other qualified
practitioner (collectively, ``physician'') orders such admission based
on the expectation that the beneficiary's length of stay will exceed 2
midnights or if the beneficiary requires a procedure specified as
inpatient-only under Sec. 419.22 of the regulations. We finalized at
Sec. 412.3 of the regulations that services designated under the OPPS
as inpatient only procedures would continue to be appropriate for
inpatient hospital admission and payment under Medicare Part A. In
addition, we finalized a benchmark providing that surgical procedures,
diagnostic tests, and other treatments would be generally considered
appropriate for inpatient hospital admission and payment under Medicare
Part A when the physician expects the patient to require a stay that
crosses at least 2 midnights and admits the patient to the hospital
based upon that expectation.
In the CY 2016 OPPS/ASC final rule with comment period (80 FR 70538
through 70549), we revisited the previous rare and unusual exceptions
policy and finalized a proposal to allow for case-by-case exceptions to
the 2-Midnight benchmark, whereby Medicare Part A payment may be made
for inpatient admissions where the admitting physician does not expect
the patient to require hospital care spanning 2 midnights, if the
documentation in the medical record supports the physician's
determination that the patient nonetheless requires inpatient hospital
care.
We note that, in the CY 2016 OPPS/ASC final rule with comment
period, we reiterated our position that the 2-Midnight benchmark
provides clear guidance on when a hospital inpatient admission is
appropriate for Medicare Part A payment, while respecting the role of
physician judgment. We stated that the following criteria will be
relevant to determining whether an inpatient admission with an expected
length of stay of less than 2 midnights is nonetheless appropriate for
Medicare Part A payment:
Complex medical factors such as history and comorbidities;
The severity of signs and symptoms;
Current medical needs; and
The risk of an adverse event.
In other words, for purposes of Medicare payment, an inpatient
admission is payable under Part A if the documentation in the medical
record supports either the admitting physician's reasonable expectation
that the patient will require hospital care spanning at least 2
midnights, or the physician's determination based on factors such as
those identified previously that the patient nonetheless
[[Page 86115]]
requires care on an inpatient basis. The exceptions for procedures on
the IPO list and for ``rare and unusual'' circumstances designated by
CMS as national exceptions were unchanged by the CY 2016 OPPS/ASC final
rule with comment period.
As we stated in the CY 2016 OPPS/ASC final rule with comment
period, the decision to formally admit a patient to the hospital is
subject to medical review. For instance, for cases where the medical
record does not support a reasonable expectation of the need for
hospital care crossing at least 2 midnights, and for inpatient
admissions not related to a surgical procedure specified by Medicare as
an IPO procedure under 42 CFR 419.22(n) or for which there was not a
national exception, payment of the claim under Medicare Part A is
subject to the clinical judgment of the medical reviewer. The medical
reviewer's clinical judgment involves the synthesis of all submitted
medical record information (for example, progress notes, diagnostic
findings, medications, nursing notes, and other supporting
documentation) to make a medical review determination on whether the
clinical requirements in the relevant policy have been met. In
addition, Medicare review contractors must abide by CMS' policies in
conducting payment determinations, but are permitted to take into
account evidence-based guidelines or commercial utilization tools that
may aid such a decision. While Medicare review contractors may continue
to use commercial screening tools to help evaluate the inpatient
admission decision for purposes of payment under Medicare Part A, such
tools are not binding on the hospital, CMS, or its review contractors.
This type of information also may be appropriately considered by the
physician as part of the complex medical judgment that guides their
decision to keep a beneficiary in the hospital and formulation of the
expected length of stay.
In the CY 2020 OPPS/ASC final rule with comment period we finalized
a policy to exempt procedures that have been removed from the IPO list
from certain medical review activities to assess compliance with the 2-
Midnight rule within the 2-calendar years following their removal from
the IPO list. We stated that these procedures will not be considered by
the Beneficiary and Family-Centered Care Quality Improvement
Organizations (BFCC-QIOs) in determining whether a provider exhibits
persistent noncompliance with the 2-Midnight rule for purposes of
referral to the RAC nor will these procedures be reviewed by RACs for
``patient status.'' We explained that during this 2-year period, BFCC-
QIOs will have the opportunity to review such claims in order to
provide education for practitioners and providers regarding compliance
with the 2-Midnight rule, but claims identified as noncompliant will
not be denied with respect to the site-of-service under Medicare Part
A.
3. Medical Review of Certain Inpatient Hospital Admissions Under
Medicare Part A for CY 2021 and Subsequent Years
As stated earlier in this section, services on the IPO list are not
subject to the 2-Midnight rule for purposes of determining whether
payment is appropriate under Medicare Part A. However, the 2-Midnight
rule is applicable once services have been removed from the IPO list.
Outside of the exemption period discussed above, services that have
been removed from the IPO list are subject to initial medical reviews
of claims for short-stay inpatient admissions conducted by BFCC-QIOs.
BFCC-QIOs may also refer providers to the RACs for further medical
review due to exhibiting persistent noncompliance with Medicare payment
policies, including, but not limited to:
Having high denial rates;
Consistently failing to adhere to the 2-Midnight rule; or
Failing to improve their performance after QIO educational
intervention.
However, as finalized in the CY 2020 OPPS/ASC final rule with
comment period, procedures that have been removed from the IPO list are
exempt from claim denial by the BFCC-QIOs based on site-of-service and
from eligibility for referral to RACs for noncompliance with the 2-
Midnight rule within the 2-calendar years following their removal from
the IPO list.
As stated in section IX. of this final rule with comment period, we
are finalizing our policy to eliminate the IPO list in CY 2021 with a
transitional period of 3 years. For CY 2021, we are finalizing our
proposal to remove all musculoskeletal procedures from the IPO list.
The elimination of the IPO list will mean that procedures currently on
the IPO list will be subject to the 2-Midnight rule (both the 2-
Midnight benchmark and 2-Midnight presumption).
We believe that with the elimination of the IPO list, the 2-
Midnight benchmark will remain an important metric to help guide when
Part A payment for inpatient hospital admissions is appropriate. With
more services available to be paid in the hospital outpatient setting,
it will be increasingly important for physicians to exercise their
clinical judgment in determining the generally appropriate clinical
setting for their patient to receive a procedure, whether that be as an
inpatient or on an outpatient basis. Importantly, removal of a service
from the IPO list has never meant that a beneficiary cannot receive the
service as a hospital inpatient--as always, the physician should use
his or her complex medical judgment to determine the appropriate
setting on a case by case basis.
As stated previously, our current policy regarding IPO list
procedures is that they are appropriate for inpatient hospital
admission and payment under Medicare Part A regardless of the expected
length of stay. With the elimination of the IPO list, this policy will
no longer be applicable. Instead, just as for services removed from the
IPO list, the elimination of the IPO list will mean that any service
that was once on the IPO list will be subject to the 2-Midnight
benchmark and 2-Midnight presumption. This means that for services
removed from the IPO list, under the 2-Midnight presumption, inpatient
hospital claims with lengths of stay greater than 2 midnights after
admission will be presumed to be appropriate for Medicare Part A
payment and would not be the focus of medical review efforts, absent
evidence of systematic gaming, abuse, or delays in the provision of
care in an attempt to qualify for the 2-Midnight presumption.
Additionally, under the 2-Midnight benchmark, services formerly on the
IPO list will be generally considered appropriate for inpatient
hospital admission and payment under Medicare Part A when the physician
expects the patient to require a stay that crosses at least 2 midnights
and admits the patient to the hospital based upon that expectation.
As finalized in the CY 2020 OPPS/ASC final rule with comment
period, procedures that have been removed from the IPO list are exempt
from certain medical review activities to assess compliance with the 2-
Midnight rule within the first 2 calendar years of their removal from
the IPO list. These procedures are not considered by the BFCC-QIOs in
determining whether a provider exhibits persistent noncompliance with
the 2-midnight rule for purposes of referral to the RAC nor will claims
for these procedures be reviewed by RACs for ``patient status.'' During
the 2-year period, BFCC-QIOs
[[Page 86116]]
have the opportunity to review such claims in order to provide
education for practitioners and providers regarding compliance with the
2-Midnight rule, but claims identified as noncompliant are not denied
with respect to the site-of-service under Medicare Part A. Again,
information gathered by the BFCC-QIO when reviewing procedures as they
are newly removed from the IPO list can be used for educational
purposes and does not result in a claim denial during the 2-year
exemption period.
We explained in the CY 2021 OPPS/ASC proposed rule that, based on
the information available to us as the time, we continued to believe
that in order to facilitate compliance with our payment policy for
inpatient admissions, the 2-year exemption from certain medical review
activities by the BFCC-QIOs for services removed from the IPO list
under the OPPS in CY 2021 and subsequent years was appropriate.
Accordingly, we proposed to retain the existing 2-year exemption even
in the event that we finalized the proposal to eliminate the IPO list.
However, given that a large number of services would be removed from
the IPO list at once during the proposed transition to eliminate the
list, we sought comment on whether this 2-year period was appropriate
or whether a longer or shorter period would be more appropriate in
order for providers to gain experience with applying the 2-Midnight
rule to these services.
We also explained that we continued to believe that a 2-year
exemption from BFCC-QIO referral to RACs and RAC ``patient status''
review of the setting for procedures removed from the IPO list under
the OPPS and performed in the inpatient setting would be an adequate
amount of time to allow providers to gain experience with application
of the 2-Midnight rule to these procedures and the documentation
necessary for Part A payment for those patients for which the admitting
physician determines that the procedures should be furnished in an
inpatient setting. Furthermore, it was our belief that the 2-year
exemption from referrals to RACs, RAC patient status review, and claims
denials would be sufficient to allow providers time to update their
billing systems and gain experience with respect to newly removed
procedures eligible to be paid under either the IPPS or the OPPS, while
avoiding potential adverse site-of-service determinations. Nonetheless,
we solicited public comments regarding the appropriate period of time
for this exemption. Commenters could indicate whether and why they
believed the 2-year period was appropriate, or whether they believed a
longer or shorter exemption period would be more appropriate.
In summary, for CY 2021 and subsequent years, we proposed to
continue the 2-year exemption from site-of-service claim denials, BFCC-
QIO referrals to RACs, and RAC reviews for ``patient status'' (that is,
site-of-service) for procedures that are removed from the IPO list
under the OPPS beginning on January 1, 2021. We encouraged BFCC-QIOs to
review these cases for medical necessity in order to educate themselves
and the provider community on appropriate documentation for Part A
payment when the admitting physician determines that it is medically
reasonable and necessary to conduct these procedures on an inpatient
basis. We noted that we would monitor changes in site-of-service to
determine whether changes may be necessary to certain CMS Innovation
Center models. Finally, while we proposed to retain the current 2-year
exemption period, given that a large number of services would be
removed from the IPO as part of the transition towards the elimination
of the list, we sought comment on whether that time period remained
appropriate, or if a longer or shorter period may be more warranted.
Many commenters offered suggestions on the appropriate length of
time for exemptions from site-of-service claim denials, BFCC-QIO
referrals to RACs, and RAC reviews for ``patient status'' (that is,
site-of-service) for procedures that are removed from the IPO list
under the OPPS beginning on January 1, 2021. These comments are
summarized below.
Comment: Numerous stakeholders including medical professional
societies, health systems, and hospital associations supported the
proposal to continue the 2-year exemption from site-of-service claim
denials under Medicare Part A, eligibility for BFCC-QIO referrals to
RACs for noncompliance with the 2-Midnight rule, and RAC reviews for
``patient status'' (that is, site-of-service) for procedures that are
removed from the IPO list under the OPPS beginning on January 1, 2021.
While these commenters expressed their support for continuing the 2-
year exemption, they further stated that a longer exemption period
would be more appropriate. Some commenters suggested that anywhere
between 3 to 6 years or indefinitely would be appropriate. Commenters
felt that increasing the length of the exemption would be necessary to
allow hospitals and practitioners sufficient time to adjust their
billing and clinical systems, as well as processes used to determine
the appropriate setting of care. One commenter noted that because
providers have no experience assessing procedures on the IPO list
against the 2-Midnight benchmark, they will require time to update
their processes to make appropriate decisions about whether to admit
patients for the large numbers of procedures being removed from the IPO
list. Commenters stressed that providers need time without the fear of
audits to update their procedures so they can make appropriate
decisions about admitting patients based on their specific conditions
and recovery needs. They further noted that having an extension of the
exemption period would provide stability to the healthcare systems and
ensure that clinician judgment, shared decision-making with the
patient, and a focus on high quality outcomes drive the selection of
the appropriate site-of-service for care.
Response: We thank these commenters for their support of our
proposal to continue the 2-year exemption from site-of-service claim
denials under Medicare Part A, eligibility for BFCC-QIO referrals to
RACs for noncompliance with the 2-Midnight rule, and RAC reviews for
``patient status'' (that is, site-of-service) for procedures that are
removed from the IPO list under the OPPS beginning on January 1, 2021.
We understand that the 2-year exemption might not be sufficient given
the magnitude of the change for providers. We agree that additional
time would be more appropriate for hospitals and practitioners to
adjust their billing and clinical systems, as well as develop their own
internal processes to determine the appropriate setting of care for
their patients. We recognize that providers may not be experienced with
assessing procedures on the IPO list against the 2-Midnight benchmark
and that a longer exemption would allow them ample time to update their
processes to make appropriate decisions about whether to admit patients
for the large numbers of procedures being removed from the IPO list. We
are mindful of the important role medical review plays in maintaining
the integrity of the Medicare program but understand why providers
might be anxious about balancing a new landscape for services with
their concerns about claim denials or RAC referrals. Accordingly, as
discussed more fully below, we are finalizing an indefinite exemption
period rather than the 2-year period proposed.
Comment: We heard from many commenters that the two-year
[[Page 86117]]
exemption was appropriate when CMS was removing a smaller volume of
procedures from the IPO list. However, commenters felt that the
unprecedented volume of procedures becoming subject to the 2-Midnight
rule would necessitate a longer exemption period. Many commenters
believe that the extra time would allow for the education of hospital
staff and physician/non-physician practitioners and operational
processes to be established and refined.
Response: We agree that the two-year exemption was appropriate when
CMS was removing a smaller, more targeted population of procedures from
the IPO. We also agree that since the agency is changing the landscape
in where procedures can be performed that a longer exemption would be
more appropriate. Accordingly, as discussed more fully below, we are
finalizing an indefinite exemption period for procedures removed from
the IPO list due to the elimination of that list.
Comment: A large contingent of commenters felt that CMS should
extend the exemption indefinitely. Some expressed that 2 years is not
enough time for adequate evidence and research to be conducted to
demonstrate that procedures removed from the IPO list can be performed
safely for Medicare beneficiaries in hospital outpatient settings. As
such, they commented that CMS should extend the medical review
exemption period until such evidence is widely available and there is
data indicating that the procedure removed from the IPO list is more
commonly performed on an outpatient basis. One commenter specified that
procedures that have an average length of stay of 2 days or more or are
performed on an inpatient basis more than a threshold percentage of the
time (for example, 70 or more percent) should be exempted from the
medical review activities outlined earlier in this section. Another
commenter noted that procedures should be removed from exemption from
medical review under the 2-Midnight rule as medical technology practice
changes, inpatient length of stay declines, and procedures become more
commonly performed on an outpatient basis. Another commenter suggested
that CMS should use claims data from several payers (that is, Medicare,
commercial payers, Veterans Affairs hospitals, etc.) in order to
determine when procedures removed from the IPO list are routinely and
safely performed in the outpatient setting and no longer require an
indefinite exemption.
Most commenters that suggested the indefinite exemption stressed it
was appropriate because even with the elimination of the IPO list it
will still be medically necessary for a large number of these
procedures to be performed in the inpatient setting. A commenter stated
that applying the 2-Midnight rule to some of these procedures was not
practical, as they are either exclusively performed on an inpatient
basis or have an average length of stay of two days or longer. Another
commenter noted that complex medical decisions are not always
straightforward, and while CMS claims its intent is to defer to
physician judgement on the appropriate site-of-service, this deference
is not always incentivized during medical reviews and thus reflected in
the RAC's review practices. Many commenters were concerned about the
compliance burden on hospitals and health care providers as they seek
to navigate providing care in the appropriate setting while balancing
2-Midnight enforcement.
Response: We agree with the commenters' suggestions that an
indefinite exemption period is appropriate. Further, we are convinced
that the medical review exemption should apply until evidence is widely
available and there is data indicating that the procedure removed from
the IPO list is more commonly performed on an outpatient basis.
Accordingly, we are finalizing an indefinite exemption from the
specified medical review activities for procedures removed from the IPO
list as a result of the elimination of that list. This exemption will
apply to each procedure until such time as the procedure is more
commonly performed on an outpatient basis. We will use Medicare claims
data to determine when a procedure is more commonly performed on an
outpatient basis. We will compare on a yearly basis the number of times
a given procedure is performed inpatient versus outpatient. We will
define ``more commonly performed'' as being done more than fifty
percent of the time in the outpatient setting. As with the 2-Midnight
presumption, we will still maintain the ability to conduct medical
reviews where there is evidence of systemic fraud or abuse.
We would like to emphasize that the 2-Midnight rule does not
prohibit procedures from being performed or billed on an inpatient
basis. Whether a procedure has an exemption or not, does not change
what site-of-service is medically necessary or appropriate for an
individual beneficiary. Providers are still expected to bill in
compliance with the 2-Midnight rule. The exemption is not from the 2-
Midnight rule but from certain medical review procedures and certain
site-of-service claim denials. We do not believe that there will be any
significant additional burden in complying with the 2-Midnight rule. It
is standard practice for providers to sufficiently document medically
necessity in medical records. Providers are expected to do this whether
the 2-Midnight rule or any associated exemption applies or not.
Comment: Commenters suggested that CMS could reevaluate the
exemption once there is sufficient data indicating that the procedure
is being more commonly performed in the outpatient setting. One
commenter recommended that CMS only remove the exemption once
sufficient evidence exists that the procedure is being performed
routinely and safely in the outpatient setting, which they believed is
unlikely to develop within two years. They added that without an
extension of the exemption period providers might not receive payment
for care for inpatient settings even when it is the appropriate site of
care. Many commenters stated that ending the exemption too early could
create pressure on providers to perform a medical service in the
outpatient setting despite medical judgement suggesting otherwise.
Response: We agree with commenters and will be finalizing a policy
that indefinitely extends the exemption for all procedures removed from
the IPO list after January 1, 2021. We will consider removing the
exemption for a procedure once we have claims data that indicates it is
being performed more in the outpatient setting than the inpatient
setting. We do not agree with commenters that the exemption, whether it
be indefinite, shorter or longer would create any hindrance to
providers receiving the appropriate payment for care in the inpatient
setting when the documentation in the medical record supports the
inpatient setting as the appropriate site of care. In such a scenario,
the claim would generally be payable under Part A pursuant to either
the 2-Midnight rule at 42 CFR. 412.3(d)(1) or the case-by-case
exception at Sec. 412.3(d)(3). We also believe it is important for CMS
to be able to continue to conduct medical reviews in situations in
which there is evidence of systemic fraud or abuse.
Comment: We received comments suggesting that CMS establish a list
of procedures that would be exempt from medical review under the 2-
Midnight rule permanently. One commenter suggested that CMS provide an
explicit exception to the 2-Midnight rule for procedures that are
removed from the IPO list where the beneficiary is at higher risk as
identified by factors such as age, dual-eligible status, presence of
certain comorbidities, social factors,
[[Page 86118]]
environmental factors, and patient body mass index. Another commenter
stated that certain procedures with high average length of stay, such
as organ transplants, are likely to never be performed outpatient
absent significant improvements in technology. They added that, based
on criteria similar to that of the current IPO list, CMS could use
average length of stay information and site-of-service patterns to
determine whether the exemption would continue for a given procedure
and deference provided to the physician.
Response: We thank the commenters for their suggestions and will
consider additional metrics for determining whether a procedure
requires a 2-Midnight medical review exemption in the future.
Comment: We received many comments suggesting that if the
elimination of the IPO list is being driven by the belief that the
physician should determine the correct level of care based upon
individual patient needs and comorbidities and the physician certifies
this need, these level of care audits should be discontinued. Many
commenters felt that physicians should be able to select the
appropriate site-of-service without having that decision questioned by
subjecting the procedure to medical review for site-of-service under
the 2-Midnight rule. Some commenters expressed that site-of-service
claim denials, BFCC-QIO referrals to RACs, and RAC reviews for
``patient status'' (that is, site-of-service) constituted a barrier to
payment for procedures performed in the inpatient setting. Moreover, if
site-of-service determinations are based on a physician's clinical
judgment regarding the care setting that is best suited to meet a given
patient's medical needs that decision should not be subject to any
review.
Response: As stated earlier in this section, we continue to believe
that use of the 2-Midnight benchmark gives appropriate consideration to
the medical judgment of physicians and furthers the goal of clearly
identifying when an inpatient admission is appropriate for payment
under Medicare Part A. More specifically, as we described in the FY
2014 IPPS/LTCH PPS final rule (78 FR 50943 through 50954), factors such
as the procedures being performed and the beneficiary's condition and
comorbidities apply when the physician formulates his or her
expectation regarding the need for hospital care, while the
determination of whether an admission is appropriately billed and paid
under Medicare Part A or Part B is generally based upon the physician's
medical judgment regarding the beneficiary's expected length of stay.
We have not identified any circumstances where the 2-Midnight benchmark
restricts the physician to a specific pattern of care, because the 2-
Midnight benchmark does not prevent the physician from ordering or
providing any service at any hospital, regardless of the expected
duration of the service. Rather, this policy provides guidance on when
the hospitalized beneficiary's care is appropriate for coverage and
payment under Medicare Part A as an inpatient, and when the
beneficiary's care is reasonable and necessary for payment under
Medicare Part B as an outpatient. Further, as we stated in the CY 2016
OPPS/ASC final rule with comment period (80 FR 70545), section
1154(a)(1) of the Act authorizes BFCC-QIOs to review whether services
and items billed under Medicare are reasonable and medically necessary
and whether services that are provided on an inpatient basis could be
appropriately and effectively provided on an outpatient basis.
BFCC-QIOs will continue to conduct initial medical reviews for both
the medical necessity of the services, and the medical necessity of the
site-of-service. BFCC-QIOs will continue to be permitted and expected
to deny claims if the service itself is determined not to be reasonable
and medically necessary. For procedures removed from the IPO list on or
after January 1, 2021, BFCC-QIOs will not make referrals to RACs for
noncompliance with the 2-Midnight rule for such procedures until the
procedure is no longer subject to the medical review exemption because
it is more commonly performed in the outpatient setting then the
inpatient setting. RACs will not conduct reviews for ``patient status''
(that is, site-of-service) for procedures that are removed from the IPO
list until they are no longer subject to the medical review exemption,
and claims for procedures that are removed from the IPO list that are
identified as noncompliant with the 2-Midnight rule will not be denied
with respect to the site-of-service under Medicare Part A until they
are no longer subject to the medical review exemption. Providers are
still expected to bill in compliance with the 2-Midnight rule even if
the procedure is exempt from medical review activities. The BFCC-QIOs
will continue to review claims and provide education when providers
submit noncompliant claims, despite the fact that they will not be
denying such claims during the exemption period. CMS may also still
conduct medical review where there is evidence of systemic fraud or
abuse.
We continue to believe that the 2-Midnight rule plays a useful role
in providing clarity to hospitals and physicians while addressing the
program integrity concerns surrounding appropriate inpatient
admissions. We believe that extending the exemption while providing
education to providers when they submit noncompliant claims will
alleviate providers' concerns about adjusting to new procedures being
subject to the 2-Midnight rule.
Comment: Some commenters approached the policy concerns more
broadly and implored CMS to reevaluate the meaningfulness of the 2-
Midnight rule considering the agency's shift toward site-neutrality. A
few commenters went as far to suggest that CMS rescind the 2-Midnight
rule in its entirety.
Response: We thank the commenters for their suggestions, but note
that they are outside the scope of the proposed rule. Moreover, we
believe that with more choices in site-of-service the 2-Midnight rule
continues to be meaningful and necessary. It continues to be important
to determine whether an inpatient admission is appropriate for Medicare
Part A payment. We refer readers to the FY 2014 IPPS/LTCH PPS final
rule (78 FR 50913 through 50954), in which we clarified our policy
regarding when an inpatient admission is considered reasonable and
necessary for purposes of Medicare Part A payment. Eliminating the IPO
list does not change the agency's stance on the 2-Midnight rule.
Comment: Some commenters expressed concern that the elimination of
the IPO list along with the continued application of the 2-Midnight
rule would increase paperwork and administrative burden. Commenters
were particularly concerned about the documentation required when a
patient is admitted for a short stay to undergo a procedure that should
only be performed on an inpatient basis. Many commenters were concerned
that the burden will fall on physicians to provide appropriate
documentation for Part A payment when the physician determines that it
is medically reasonable and necessary to conduct these procedures on an
inpatient basis. Commenters stressed that subjecting these procedures
to the 2-Midnight rule would significantly increase provider
documentation burden, which is counter to CMS' recent stated efforts to
reduce physicians' administrative burden. Many commenters felt that
subjecting additional procedures to the 2-Midnight rule would result in
increased documentation and audit
[[Page 86119]]
burden, both of which would increase the administrative cost of
procedures.
Response: The decision to eliminate the IPO list is based upon
CMS's determination that it is no longer appropriate to categorically
specify that Medicare only pays for certain procedures when they are
performed in an inpatient hospital setting. Instead, as with other
procedures, the determination of the appropriate site-of-service is a
complex medical decision to be made on a case-by-case basis. We
continue to expect providers and physicians to document the medical
necessity of any inpatient admission.
We believe that exempting procedures that are removed from the IPO
list from site-of-service claim denials under Medicare Part A,
eligibility for BFCC-QIO referrals to RACs for noncompliance with the
2-Midnight rule, and RAC reviews for ``patient status'' (that is, site-
of-service) until the procedure is more commonly performed in the
outpatient setting then the inpatient setting will give providers the
requisite time to adjust to any additional changes associated with the
elimination of the IPO list. As we indicated in the CY 2016 OPPS/ASC
Final Rule (80 FR 70543), we believe that the documentation
requirements for admitting physicians are not overly burdensome because
they are consistent with Medicare's longstanding documentation
requirements, which predate the adoption of the 2-Midnight rule.
Comment: We heard from many commenters that CMS has an essential
role to play in the education of stakeholders on the 2-Midnight rule,
its exceptions, and outpatient selection criteria. Some commenters felt
that not enough providers are aware that CMS policy allows for case-by-
case exceptions to the 2-Midnight rule based on patient history, co-
morbidities and risk of adverse events. Many commenters requested that
CMS provide additional education on the case-by-case exceptions to the
2-Midnight rule. One commenter felt that such education would help
ensure that concerns about audits are not unduly influencing the
selection of an outpatient setting unless it is medically appropriate.
One commenter specifically requested that CMS issue educational
guidance to providers and Medicare contractors, similar to MLN Matters
articles, reinforcing that surgeons determine whether a particular
procedure should be performed on an inpatient or outpatient basis, and
there is no presumption that procedures should be performed on an
outpatient basis. Other commenters felt that providing hospitals and
clinicians with clear and consistent standards against which they can
perform will alleviate some of the administrative and financial burden
otherwise associated with this kind of substantial policy overhaul.
Response: We understand the importance of education and guidance
when implementing policy changes. Therefore, in the future, we plan to
provide considerations for the selection of site-of-service for a
procedure to support physicians' decision-making. We note that these
guidelines will be for informational or educational purposes only and
will not be intended to prohibit payment of procedures that were
previously included on the IPO list in the outpatient setting.
CMS is finalizing a policy to exempt procedures removed from the
IPO list as part of its elimination from certain medical review
activities associated with the 2-Midnight rule. As noted previously,
however, these procedures are not an exception to the 2-Midnight rule.
Providers are still expected to comply with the 2-Midnight rule even if
the procedure is exempt from medical review activities. The BFCC-QIOs
will continue to review claims and provide education when providers
submit noncompliant claims, despite the fact that they will not be
denying such claims during the exemption period. This is different from
the case-by-case exceptions to the 2-Midnight benchmark, whereby
Medicare Part A payment may be made for inpatient admissions where the
admitting physician does not expect the patient to require hospital
care spanning 2-Midnights, if the documentation in the medical record
supports the physician's determination that the patient nonetheless
requires inpatient hospital care.
Comment: Numerous commenters were concerned about how the
Beneficiary and Family-Centered Care Quality Improvement Organizations
(BFCC-QIOs) and Recovery Audit Contractors (RACs) would handle the
rapid influx of procedures now subject to review. Many commenters felt
that it was essential for CMS to begin outreach to the BFCC-QIOs to
ensure that best practices for audits and education to providers
regarding compliance with short-stay admission policies are universally
adopted and communicated prior to the start of CY 2021. Commenters
further asserted that this will help mitigate some of the
administrative burden for outpatient hospitals and surgeons performing
services previously flagged as inpatient-only procedures. One commenter
noted that BFCC-QIOs contract awards are being delayed by vendor
protests. They were concerned that few hospitals have actually had the
opportunity to engage with the BFCC-QIOs to review cases recently
removed from the IPO list, such as TKAs and THAs. They felt it will be
important to ensure that these discussion sessions can occur so that
the exemption can serve its intended purpose.
Response: We understand commenters' concerns and will work with the
BFCC-QIOs as appropriate to address any issues as they arise. The BFCC-
QIOs will continue to review claims even while procedures are exempt
from denial based on site-of-service in order to provide education for
practitioners and providers regarding compliance with the 2-Midnight
rule.
We appreciate the stakeholders' feedback regarding the appropriate
period of time for this exemption. After considering the concerns,
suggestions, and recommendations from commenters, we have decided to
finalize our proposal with modifications. Instead of the 2-year
exemption, procedures removed from the IPO list on or after January 1,
2021 will be indefinitely exempted from site-of-service claim denials
under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for
noncompliance with the 2-Midnight rule, and RAC reviews for ``patient
status'' (that is, site-of-service) indefinitely, until the procedure
is more commonly performed in the outpatient setting then the inpatient
setting. As a result, in order for the exemption to end for a specific
procedure, we will require claims data for the service indicating that
the procedure is performed more commonly on an outpatient rather than
inpatient basis in a given year. Thus, for the exemption to end for a
specific procedure, in a single calendar year we would need to have
Medicare claims data indicating that procedure was performed more than
50 percent of the time in the outpatient setting. We will revisit in
rulemaking whether and when an exemption for a procedure should be
ended. Thus, for each procedure removed from the IPO list on or after
January 1, 2021, the exemption will continue until terminated in future
rulemaking. We may consider additional metrics in the future that could
assist us in determining when the exemption period should end for a
procedure. This will only apply to procedures removed from the IPO list
beginning in CY 2021. We may revisit procedures that were removed from
the IPO list prior to January 1, 2021 and extend their exemption if we
deem it necessary. Conversely, we may shorten
[[Page 86120]]
the exemption period for a procedure if necessary. In the future, we
may examine the exemption status of any procedure that was formerly on
the IPO list and lengthen, shorten or end their exemption.
As we stated earlier, procedures removed from the IPO list in prior
years were targeted and selected in small numbers. In those cases, 2-
years was an appropriate time frame to allow providers to become more
comfortable with how to comply with the 2-Midnight rule. Eliminating
the IPO list is a larger scale change that creates brand new
considerations in determining site-of-service for providers and
beneficiaries. This is a significant change, and based upon feedback
from commenters, we have reevaluated our stance on the exemption period
for procedures removed from the IPO list. We now feel that the
magnitude of this change calls for an indefinite exemption, with CMS
reevaluating that exemption once procedures are more commonly performed
in the outpatient setting.
We agree with the commenters who suggested that an indefinite
exemption period from certain medical review activities for procedures
removed from the IPO list would be necessary to allow providers to
become more familiar with how to comply with the 2-Midnight rule. The
indefinite exemption will help hospitals and clinicians become used to
the availability of payment under both the hospital inpatient and
outpatient setting for procedures removed from the IPO list. Further,
we are persuaded by the comments asserting that an indefinite exemption
period will allow providers time to gather information on procedures
newly removed from the IPO list to help inform education and guidance
for the broader provider community, develop patient selection criteria
to identify which patients are, and are not, appropriate candidates for
outpatient procedures, and to develop related policy protocols. We also
believe that an extended exemption period will further facilitate
compliance with our payment policy for inpatient admissions.
We believe that extending the exemption period until procedures are
more commonly performed in the outpatient setting than the inpatient
setting will let providers comfortably gain experience with the
application of the 2-Midnight rule to these procedures. While these
procedures will be exempt from certain medical review activities
related to the 2-Midnight rule, providers are not excepted from
compliance with the 2-Midnight rule. That is an important distinction.
As we stated earlier, providers are still expected to bill in
compliance with the 2-Midnight rule. It is standard practice that the
factors supporting the determination that inpatient care is required
will be documented in the medical records. The BFCC-QIOs will still
have the opportunity to review claims for exempt procedures in order to
provide education for practitioners and providers regarding compliance
with the 2-Midnight rule, but claims identified as noncompliant will
not be denied with respect to the site-of-service under Medicare Part A
until the procedure is no longer subject to the exemption. We believe
that the longer exemption from the medical review for procedures
removed from the IPO list will give providers and BFCC-QIOs time to
understand the documentation necessary to support Part A payment for
those patients for which the admitting physician determines that the
procedures should be furnished in an inpatient setting.
Additionally, CMS may still conduct medical review in cases in
which there is evidence of systemic fraud or abuse occurring. Finally,
we are amending 42 CFR 412.3 to clarify when a procedure removed from
the IPO is exempt from certain medical review activities. For those
services and procedures removed between January 1 and December 31,
2020, this exemption will last for 2 years from the date of such
removal. For those services and procedures removed on or after January
1, 2021, this exemption will last until the Secretary determines that
the service or procedure is more commonly performed in the outpatient
setting.
XI. CY 2021 OPPS Payment Status and Comment Indicators
A. CY 2021 OPPS Payment Status Indicator Definitions
Payment status indicators (SIs) that we assign to HCPCS codes and
APCs serve an important role in determining payment for services under
the OPPS. They indicate whether a service represented by a HCPCS code
is payable under the OPPS or another payment system, and also whether
particular OPPS policies apply to the code.
For CY 2021, we did not propose to make any changes to the existing
definitions of status indicators that were listed in Addendum D1 to the
CY 2020 OPPS/ASC final rule with comment period available on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
We did not receive any public comments on the proposed definitions
of the OPPS status indicators for CY 2021. We believe that the existing
definitions of the OPPS status indicators will continue to be
appropriate for CY 2021. Therefore, we are finalizing our proposed
policy without modifications.
The complete list of the payment status indicators and their
definitions that would apply for CY 2021 is displayed in Addendum D1 to
the CY 2021 OPPS/ASC final rule with comment period, which is available
on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
CY 2021 payment status indicator assignments for APCs and HCPCS
codes are shown in Addendum A and Addendum B, respectively, to the CY
2021 OPPS/ASC final rule with comment period, which are available on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
B. CY 2021 OPPS Comment Indicator Definitions
In the CY 2021 OPPS/ASC proposed rule, we proposed to use four
comment indicators for the CY 2021 OPPS. These comment indicators,
``CH'', ``NC'', ``NI'', and ``NP'', are in effect for CY 2020 and we
proposed to continue their use in CY 2021. The CY 2021 OPPS comment
indicators are as follows:
``CH''--Active HCPCS code in current and next calendar
year, status indicator and/or APC assignment has changed; or active
HCPCS code that will be discontinued at the end of the current calendar
year.
``NC''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year for which we
requested comments in the proposed rule, final APC assignment; comments
will not be accepted on the final APC assignment for the new code.
``NI''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year, interim APC
assignment; comments will be accepted on the interim APC assignment for
the new code.
``NP''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year, proposed APC
assignment; comments
[[Page 86121]]
will be accepted on the proposed APC assignment for the new code.
The definitions of the OPPS comment indicators for CY 2021 are
listed in Addendum D2 to the CY 2021 OPPS/ASC final rule with comment
period, which is available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
We did not receive any public comments on the proposed definitions
of the OPPS comment indicators for CY 2021.
We believe that the existing CY 2020 definitions of the OPPS
comment indicators continue to be appropriate for CY 2021. Therefore,
we are using those definitions without modification for CY 2021.
XII. MedPAC Recommendations
The Medicare Payment Advisory Commission (MedPAC) was established
under section 1805 of the Act in large part to advise the U.S. Congress
on issues affecting the Medicare program. As required under the
statute, MedPAC submits reports to the Congress no later than March and
June of each year that present its Medicare payment policy
recommendations. The March report typically provides discussion of
Medicare payment policy across different payment systems and the June
report typically discusses selected Medicare issues. We are including
this section to make stakeholders aware of certain MedPAC
recommendations for the OPPS and ASC payment systems as discussed in
its March 2020 report.
A. OPPS Payment Rates Update
The March 2020 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' recommended that Congress update Medicare OPPS payment rates
by 2 percent, with the difference between this and the update amount
specified in current law to be used to increase payments in a new
suggested Medicare quality program, the ``Hospital Value Incentive
Program (HVIP).'' We refer readers to the March 2020 report for a
complete discussion of these recommendations.\101\ We appreciate
MedPAC's recommendations, but as MedPAC acknowledged in its March 2020
report, the Congress would need to change current law to enable us to
implement its recommendations. Comments received from MedPAC for other
OPPS policies are discussed in the applicable sections of this rule.
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\101\ Medicare Payment Advisory Committee. March 2020 Report to
the Congress. Chapter 5: Ambulatory surgical center services, pp.94-
95. Available at: http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0.
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B. ASC Conversion Factor Update
In the March 2020 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' MedPAC found that, based on its analysis of indicators of
payment adequacy, the number of ASCs had increased, beneficiaries' use
of ASCs had increased, and ASC access to capital has been
adequate.\102\ As a result, for CY 2021, MedPAC stated that payments to
ASCs are adequate and recommended that in the absence of cost report
data no payment update should be given for CY 2021 (that is, the update
factor would be zero percent).
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\102\ Medicare Payment Advisory Committee. March 2020 Report to
the Congress. Chapter 5: Ambulatory surgical center services, p.147.
Available at: http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0.
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In the CY 2019 OPPS/ASC final rule with comment period (83 FR
59079), we adopted a policy, which we codified at 42 CFR 416.171(a)(2),
to apply the MFP-adjusted hospital market basket update to ASC payment
system rates for an interim period of 5 years. We refer readers to the
CY 2019 OPPS/ASC final rule with comment period for complete details
regarding our policy to use the MFP-adjusted hospital market basket
update for the ASC payment system for CY 2019 through CY 2023.
Therefore, consistent with our policy for the ASC payment system, as
discussed in section XIII.G. of the CY 2021 OPPS/ASC proposed rule, we
proposed to apply the MFP-adjusted hospital market basket update factor
to the CY 2020 ASC conversion factor for ASCs meeting the quality
reporting requirements to determine the CY 2021 ASC payment amounts.
C. ASC Cost Data
In the March 2020 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' MedPAC recommended that Congress require ASCs to report cost
data to enable the Commission to examine the growth of ASCs' costs over
time and analyze Medicare payments relative to the costs of efficient
providers, and that CMS could use ASC cost data to examine whether an
existing Medicare price index is an appropriate proxy for ASC costs or
an ASC specific market basket should be developed. Further, MedPAC
suggested that CMS could limit the scope of the cost reporting system
to minimize administrative burden on ASCs and the program.\103\
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\103\ Medicare Payment Advisory Committee. March 2020 Report to
the Congress. Chapter 5: Ambulatory surgical center services.
Available at: http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0.
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We recognize that the submission of cost data could place
additional administrative burden on most ASCs. We are interested in
methods that would mitigate the burden of reporting costs on ASCs while
also collecting enough data to reliably use such data in the
determination of ASC costs. We did not propose any cost reporting
requirements for ASCs in the CY 2021 OPPS/ASC proposed rule.
Comments received from MedPAC for other ASC payment system policies
are discussed in the applicable sections of this rule. The full March
2020 MedPAC Report to Congress can be downloaded from MedPAC's website
at: http://www.medpac.gov.
XIII. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
1. Legislative History, Statutory Authority, and Prior Rulemaking for
the ASC Payment System
For a detailed discussion of the legislative history and statutory
authority related to payments to ASCs under Medicare, we refer readers
to the CY 2012 OPPS/ASC final rule with comment period (76 FR 74377
through 74378) and the June 12, 1998 proposed rule (63 FR 32291 through
32292). For a discussion of prior rulemaking on the ASC payment system,
we refer readers to the CYs 2012, 2013, 2014, 2015, 2016, 2017, 2018,
2019 and 2020 OPPS/ASC final rules with comment period (76 FR 74378
through 74379; 77 FR 68434 through 68467; 78 FR 75064 through 75090; 79
FR 66915 through 66940; 80 FR 70474 through 70502; 81 FR 79732 through
79753; 82 FR 59401 through 59424; 83 FR 59028 through 59080, and 84 FR
61370 through 61410, respectively).
2. Policies Governing Changes to the Lists of Codes and Payment Rates
for ASC Covered Surgical Procedures and Covered Ancillary Services
Under 42 CFR 416.2 and 416.166 of the Medicare regulations, subject
to certain exclusions, covered surgical procedures in an ASC are
surgical procedures that are separately paid under the OPPS, that would
not be expected to pose a significant risk to beneficiary safety when
performed in an ASC, and for which standard medical practice dictates
that the beneficiary would not typically be expected to require active
medical monitoring and care at midnight following the
[[Page 86122]]
procedure (``overnight stay''). We adopted this standard for defining
which surgical procedures are covered under the ASC payment system as
an indicator of the complexity of the procedure and its appropriateness
for Medicare payment in ASCs. We use this standard only for purposes of
evaluating procedures to determine whether or not they are appropriate
to be furnished to Medicare beneficiaries in ASCs. As discussed in
detail in Section XIII.C.1.d of this final rule with comment period, we
are finalizing changes to the way procedures are added to the CPL.
Historically, we have defined surgical procedures as those
described by Category I CPT codes in the surgical range from 10000
through 69999 as well as those Category III CPT codes and Level II
HCPCS codes that directly crosswalk or are clinically similar to
procedures in the CPT surgical range that we have determined do not
pose a significant safety risk, that we would not expect to require an
overnight stay when performed in ASCs, and that are separately paid
under the OPPS (72 FR 42478).
In the August 2, 2007 final rule (72 FR 42495), we also established
our policy to make separate ASC payments for the following ancillary
items and services when they are provided integral to ASC covered
surgical procedures: (1) Brachytherapy sources; (2) certain implantable
items that have pass-through payment status under the OPPS; (3) certain
items and services that we designate as contractor-priced, including,
but not limited to, procurement of corneal tissue; (4) certain drugs
and biologicals for which separate payment is allowed under the OPPS;
and (5) certain radiology services for which separate payment is
allowed under the OPPS. In the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66932 through 66934), we expanded the scope of ASC
covered ancillary services to include certain diagnostic tests within
the medicine range of Current Procedural Terminology (CPT) codes for
which separate payment is allowed under the OPPS when they are provided
integral to an ASC covered surgical procedure. Covered ancillary
services are specified in 42 CFR 416.164(b) and, as stated previously,
are eligible for separate ASC payment. Payment for ancillary items and
services that are not paid separately under the ASC payment system is
packaged into the ASC payment for the covered surgical procedure.
We update the lists of, and payment rates for, covered surgical
procedures and covered ancillary services in ASCs in conjunction with
the annual proposed and final rulemaking process to update the OPPS and
the ASC payment system (42 CFR 416.173; 72 FR 42535). We base ASC
payment and policies for most covered surgical procedures, drugs,
biologicals, and certain other covered ancillary services on the OPPS
payment policies, and we use quarterly change requests (CRs) to update
services covered under the OPPS. We also provide quarterly update CRs
for ASC covered surgical procedures and covered ancillary services
throughout the year (January, April, July, and October). We release new
and revised Level II HCPCS codes and recognize the release of new and
revised CPT codes by the American Medical Association (AMA) and make
these codes effective (that is, the codes are recognized on Medicare
claims) via these ASC quarterly update CRs. We recognize the release of
new and revised Category III CPT codes in the July and January CRs.
These updates implement newly created and revised Level II HCPCS and
Category III CPT codes for ASC payments and update the payment rates
for separately paid drugs and biologicals based on the most recently
submitted ASP data. New and revised Category I CPT codes, except
vaccine codes, are released only once a year, and are implemented only
through the January quarterly CR update. New and revised Category I CPT
vaccine codes are released twice a year and are implemented through the
January and July quarterly CR updates. We refer readers to Table 41 in
the CY 2012 OPPS/ASC proposed rule for an example of how this process
is used to update HCPCS and CPT codes, which we finalized in the CY
2012 OPPS/ASC final rule with comment period (76 FR 42291; 76 FR 74380
through 74384).
In our annual updates to the ASC list of, and payment rates for,
covered surgical procedures and covered ancillary services, we
undertake a review of excluded surgical procedures, new codes, and
codes with revised descriptors, to identify any that we believe meet
the criteria for designation as ASC covered surgical procedures or
covered ancillary services. Updating the lists of ASC covered surgical
procedures and covered ancillary services, as well as their payment
rates, in association with the annual OPPS rulemaking cycle is
particularly important because the OPPS relative payment weights and,
in some cases, payment rates, are used as the basis for the payment of
many covered surgical procedures and covered ancillary services under
the revised ASC payment system. This joint update process ensures that
the ASC updates occur in a regular, predictable, and timely manner.
3. Definition of ASC Covered Surgical Procedures
Since the implementation of the ASC prospective payment system, we
have historically defined a ``surgical'' procedure under the payment
system as any procedure described within the range of Category I CPT
codes that the CPT Editorial Panel of the AMA defines as ``surgery''
(CPT codes 10000 through 69999) (72 FR 42478). We also have included as
``surgical,'' procedures that are described by Level II HCPCS codes or
by Category III CPT codes that directly crosswalk or are clinically
similar to procedures in the CPT surgical range that we have determined
do not pose a significant safety risk, would not expect to require an
overnight stay when performed in an ASC, and that are separately paid
under the OPPS (72 FR 42478).
As we noted in the August 7, 2007 final rule that implemented the
revised ASC payment system, using this definition of surgery would
exclude from ASC payment certain invasive, ``surgery-like'' procedures,
such as cardiac catheterization or certain radiation treatment services
that are assigned codes outside the CPT surgical range (72 FR 42477).
We stated in that final rule that we believed continuing to rely on the
CPT definition of surgery is administratively straightforward, is
logically related to the categorization of services by physician
experts who both establish the codes and perform the procedures, and is
consistent with a policy to allow ASC payment for all outpatient
surgical procedures.
However, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59029 through 59030), after consideration of public comments
received in response to the CY 2019 OPPS/ASC proposed rule and earlier
OPPS/ASC rulemaking cycles, we revised our definition of a surgical
procedure under the ASC payment system. We now define a surgical
procedure under the ASC payment system as any procedure described
within the range of Category I CPT codes that the CPT Editorial Panel
of the AMA defines as ``surgery'' (CPT codes 10000 through 69999) (72
FR 42476), as well as procedures that are described by Level II HCPCS
codes or by Category I CPT codes or by Category III CPT codes that
directly crosswalk or are clinically similar to procedures in the CPT
surgical range that we have determined are not expected to pose a
significant risk to beneficiary safety when performed in an ASC, for
which
[[Page 86123]]
standard medical practice dictates that the beneficiary would not
typically be expected to require an overnight stay following the
procedure, and are separately paid under the OPPS.
B. ASC Treatment of New and Revised Codes
1. Background on Current Process for Recognizing New and Revised HCPCS
Codes
Payment for ASC procedures, services, and items are generally based
on medical billing codes, specifically, HCPCS codes, that are reported
on ASC claims. The HCPCS is divided into two principal subsystems,
referred to as Level I and Level II of the HCPCS. Level I is comprised
of CPT (Current Procedural Terminology) codes, a numeric and
alphanumeric coding system maintained by the American Medical
Association (AMA), and includes Category I, II, and III CPT codes.
Level II of the HCPCS, which is maintained by CMS, is a standardized
coding system that is used primarily to identify products, supplies,
and services not included in the CPT codes. Together, Level I and II
HCPCS codes are used to report procedures, services, items, and
supplies under the ASC payment system. Specifically, we recognize the
following codes on ASC claims:
Category I CPT codes, which describe surgical procedures,
diagnostic and therapeutic services, and vaccine codes;
Category III CPT codes, which describe new and emerging
technologies, services, and procedures; and
Level II HCPCS codes (also known as alpha-numeric codes),
which are used primarily to identify drugs, devices, supplies,
temporary procedures, and services not described by CPT codes.
We finalized a policy in the August 2, 2007 final rule (72 FR 42533
through 42535) to evaluate each year all new and revised Category I and
Category III CPT codes and Level II HCPCS codes that describe surgical
procedures, and to make preliminary determinations during the annual
OPPS/ASC rulemaking process regarding whether or not they meet the
criteria for payment in the ASC setting as covered surgical procedures
and, if so, whether or not they are office-based procedures. In
addition, we identify new and revised codes as ASC covered ancillary
services based upon the final payment policies of the revised ASC
payment system. In prior rulemakings, we refer to this process as
recognizing new codes. However, this process has always involved the
recognition of new and revised codes. We consider revised codes to be
new when they have substantial revision to their code descriptors that
necessitate a change in the current ASC payment indicator. To clarify,
we refer to these codes as new and revised in this CY 2021 OPPS/ASC
proposed rule.
We have separated our discussion below based on when the codes are
released and whether we proposed to solicit public comments in the CY
2021 OPPS/ASC proposed rule (and respond to those comments in this
final rule with comment period) or whether we are soliciting public
comments in this final rule with comment period (and responding to
those comments in the CY 2022 OPPS/ASC final rule with comment period).
We note that we sought public comments in the CY 2020 OPPS/ASC
final rule with comment period (84 FR 62375) on the new and revised
Level II HCPCS codes effective October 1, 2019 or January 1, 2020.
These new and revised codes were flagged with comment indicator ``NI''
in Addenda AA and BB to the CY 2020 OPPS/ASC final rule with comment
period to indicate that we were assigning them an interim payment
status and payment rate, if applicable, which were subject to public
comment following publication of the CY 2020 OPPS/ASC final rule with
comment period. In the CY 2021 OPPS/ASC proposed rule, we stated that
we will finalize the treatment of these codes under the ASC payment
system in this CY 2021 OPPS/ASC final rule with comment period.
2. April 2020 HCPCS Codes for Which We Solicited Public Comments in the
Proposed Rule
For the April 2020 update, there were no new CPT codes, however,
there were several new Level II HCPCS codes. In the April 2020 ASC
quarterly update (Transmittal 10046, CR 11694, dated April 13, 2020),
we added four new Level II HCPCS codes to the list of covered ancillary
services. Table 32 of the CY 2021 OPPS/ASC proposed rule displayed the
new Level II HCPCS codes that were implemented on April 1, 2020, along
with their proposed payment indicators for CY 2021.
We invited public comments on the proposed payment indicators and
payment rates for the new HCPCS codes that were recognized as ASC
ancillary services in April 2020 through the quarterly update CRs, as
listed in Table 32 of the CY 2021 OPPS/ASC proposed rule. We proposed
to finalize their payment indicators in this CY 2021 OPPS/ASC final
rule with comment period.
We did not receive any public comments on the proposed ASC payment
indicator assignments for the new Level II HCPCS codes implemented in
April 2020. Therefore, we are finalizing the proposed ASC payment
indicator assignments for these codes, as indicated in Table 49 below.
We note that several of the temporary drug HCPCS C-codes have been
replaced with permanent drug HCPCS J-codes, effective January 1, 2021.
Their replacement codes are also listed in Table 49. The final payment
rates for these codes can be found in Addendum BB to this final rule
with comment period (which is available via the internet on the CMS
website). In addition, the status indicator meanings can be found in
Addendum DD1 to this final rule with comment period (which is available
via the internet on the CMS website).
[[Page 86124]]
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3. July 2020 HCPCS Codes for Which We Solicited Public Comments in the
Proposed Rule
In the July 2020 ASC quarterly update (Transmittal 10188, Change
Request 11842, dated June 19, 2020), we added several separately
payable Category III CPT and Level II HCPCS codes to the list of
covered surgical procedures and ancillary services. Table 33 of the CY
2020 OPPS/ASC proposed rule displayed the new HCPCS codes that were
effective July 1, 2020.
In addition, through the July 2020 quarterly update CR, we also
implemented ASC payments for two new Category III CPT codes as ASC
covered ancillary services, effective July 1, 2020. These codes were
listed in Table 34 of the CY 2020 OPPS/ASC proposed rule, along with
the proposed comment indicator and payment indicator.
We invited public comments on these proposed payment indicators for
the new Category III CPT code and Level II HCPCS codes newly recognized
as ASC covered surgical procedures or covered ancillary services in
July 2020 through the quarterly update CRs, as listed in Tables 32, 33,
and 34 of the proposed rule.
We did not receive any public comments on the proposed ASC payment
indicator assignments for the new Category III CPT codes or Level II
HCPCS codes implemented in July 2020. Therefore, we are finalizing the
proposed ASC payment indicator assignments for these codes, as
indicated in Table 50 and 51 below. We note that several of the HCPCS
C-codes have been replaced with HCPCS J-codes, effective January 1,
2021. Their replacement codes are listed in Table 50. The final payment
rates for these codes can be found in Addendum AA and BB to this final
rule with comment period (which is available via the internet on the
CMS website). In addition, the status indicator meanings can be found
in Addendum DD1 to this final rule with comment period (which is
available via the internet on the CMS website).
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4. October 2020 HCPCS Codes for Which We Are Soliciting Public Comments
in This Final Rule With Comment Period
In the past, we released new and revised HCPCS codes that are
effective October 1 through the October OPPS quarterly update CRs and
incorporated these new codes in the final rule with comment period.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48947), for CY 2021,
consistent with our established policy, we proposed that the Level II
HCPCS codes that will be effective October 1, 2020 would be flagged
with comment indicator ``NI'' in Addendum BB to the CY 2021 OPPS/ASC
final rule with comment period to indicate that we have assigned the
codes an interim ASC payment indicator for CY 2021. We did not receive
any public comments on our proposal. As we stated in the CY 2021 OPPS/
ASC proposed rule, we are inviting public comments in this CY 2021
OPPS/ASC final rule with comment period on the interim ASC payment
indicator for these codes that we intend to finalize in the CY 2022
OPPS/ASC final rule with comment period.
5. January 2021 HCPCS Codes
a. Level II HCPCS Codes for Which We Are Soliciting Public Comments in
This Final Rule With Comment Period
Consistent with past practice, we are soliciting comments on the
new Level II HCPCS codes that are effective January 1, 2021 in the CY
2021 OPPS/ASC final rule with comment period, thereby updating the ASC
payment system for the calendar year. These codes are released to the
public via the CMS HCPCS website, and also through the January OPPS
quarterly update CRs. We note that unlike the CPT codes that are
effective January 1 and are included in the OPPS/ASC proposed rules,
and except for the G-codes listed in Addendum O to the CY 2021 OPPS/ASC
proposed rule, most Level II HCPCS codes are not released until
November to be effective January 1. Because these codes are not
available until November, we are unable to include them in the OPPS/ASC
proposed rules. Therefore, we stated in the CY 2021 OPPS/ASC proposed
rule with comment period that the Level II HCPCS codes that will be
effective January 1, 2021 would be released to the public through this
CY 2021 OPPS/ASC final rule with comment period, January 2021 ASC
Update CR, and the CMS HCPCS website (85 FR 48948).
In addition, for CY 2021, we proposed to continue our established
policy of assigning comment indicator ``NI'' in Addendum AA and
Addendum BB to the CY 2021 OPPS/ASC final rule with comment period to
the new Level II HCPCS codes that will be effective January 1, 2021 to
indicate that we are assigning them an interim payment indicator, which
is subject to public comment. We are inviting public comments in this
CY 2021 OPPS/ASC final rule with comment period on the payment
indicator assignments, which would then be finalized in the CY 2022
OPPS/ASC final rule with comment period.
b. CPT Codes for Which We Solicited Public Comments in the Proposed
Rule
In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66841
through 66844), we finalized a revised process of assigning APC and
status indicators for new and revised Category I and III CPT codes that
would be effective January 1. Specifically, for the new/revised CPT
codes that we receive in a timely manner from the AMA's CPT Editorial
Panel, we finalized our proposal to include the codes that would be
effective January 1 in the OPPS/ASC proposed rules, along with proposed
APC and status indicator assignments for them, and to finalize the APC
and status indicator assignments in the OPPS/ASC final rules beginning
with the CY 2016 OPPS/ASC final rule. For those new/revised CPT codes
that were received too late for inclusion in the OPPS/ASC proposed
rule, we finalized our proposal to establish and use HCPCS G-codes that
mirror the predecessor CPT codes and retain the current APC and status
indicator assignments for a year until we can propose APC and status
indicator assignments in the following year's rulemaking cycle. We note
that even if we find that we need to create HCPCS G-codes in place of
certain CPT codes for the PFS proposed rule, we do not anticipate that
these HCPCS G-codes will always be necessary for OPPS purposes. We will
make every effort to include proposed APC and status indicator
assignments for all new and revised CPT codes that the AMA makes
publicly available in time for us to include them in the proposed rule,
and to avoid the resort to HCPCS G-codes and the resulting delay in
utilization of the most current CPT codes. Also, we finalized our
proposal to make interim APC and status indicator assignments for CPT
codes that are not available in time for the proposed rule and that
describe wholly new services (such as new technologies or new surgical
procedures), solicit public comments, and finalize the specific APC and
status indicator assignments for those codes in the following year's
final rule.
[[Page 86130]]
For the CY 2021 OPPS update, we received the CPT codes that will be
effective January 1, 2021 from AMA in time to be included in the
proposed rule. The new, revised, and deleted CPT codes were listed in
Addendum AA and Addendum BB to the CY 2021 OPPS/ASC proposed rule. The
new and revised CPT codes were assigned to comment indicator ``NP'' in
Addendum AA and Addendum BB of the CY 2021 OPPS/ASC proposed rule to
indicate that the code is new for the next calendar year or the code is
an existing code with substantial revision to its code descriptor in
the next calendar year as compared to the current calendar year, along
with a proposed ASC payment indicator assignment, and that comments
would be accepted on the proposed ASC payment indicator.
Further, we note that the CPT code descriptors that appeared in
Addendum AA and BB to the CY 2021 OPPS/ASC proposed rule were short
descriptors and did not fully describe the complete procedure, service,
or item described by the CPT code. Therefore, we included the 5-digit
placeholder codes and the long descriptors for the new and revised CY
2021 CPT codes in Addendum O to the proposed rule so that the public
could adequately comment on the proposed ASC payment indicator
assignments. The 5-digit placeholder codes were listed in Addendum O,
specifically under the column labeled ``CY 2021 OPPS/ASC Proposed Rule
5-Digit AMA Placeholder Code''. The final CPT code numbers are included
in this CY 2021 OPPS/ASC final rule with comment period, and can be
found in Addendum AA, Addendum BB, and Addendum O.
For new and revised CPT codes effective January 1, 2021 that were
received in time to be included in the CY 2021 OPPS/ASC proposed rule,
we proposed the appropriate payment indicator assignments, and
solicited public comments on the payment assignments. We stated we
would accept comments and finalize the payment indicators in this CY
2021 OPPS/ASC final rule with comment period. We received comments on
the ASC payment indicators for certain new CPT codes that will be
effective January 1, 2021. These comments, and our responses, can be
found in section XIII.C. (Update to the List of ASC Covered Surgical
Procedures and Covered Ancillary Services) of this final rule with
comment period.
Also, we note that we inadvertently omitted four new HCPCS codes,
specifically, CPT codes 0627T, 0628T, 0629T, and 0630T, effective
January 1, 2021 from Addendum AA of the CY 2021 OPPS/ASC proposed rule.
The procedures described by the four new HCPCS codes are displayed in
Addendum AA of this CY 2021 OPPS/ASC final rule with comment period
with comment indicator ``NI'' to indicate that we are assigning them an
interim payment indicator, which is subject to public comment. We are
inviting public comments on the ASC payment indicators for CPT codes
0627T, 0628T, 0629T, and 0630T, which will be finalized in the CY 2022
OPPS/ASC final rule with comment period.
Finally, shown in Table 35 of the CY 2021 OPPS/ASC proposed rule
(85 FR 48949) and reprinted in Table 52 below, we summarize our process
for updating codes through our ASC quarterly update CRs, seeking public
comments, and finalizing the treatment of these new codes under the ASC
payment system.
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C. Update to the List of ASC Covered Surgical Procedures and Covered
Ancillary Services
1. Covered Surgical Procedures
a. Covered Surgical Procedures Designated as Office-Based
(1) Background
In the August 2, 2007 ASC final rule, we finalized our policy to
designate as ``office-based'' those procedures that are added to the
ASC Covered Procedures List (CPL) in CY 2008 or later years that we
determine are furnished predominantly (more than 50 percent of the
time) in physicians' offices based on consideration of the most recent
available volume and utilization data for each individual procedure
code and/or, if appropriate, the clinical characteristics, utilization,
and volume of related codes. In that rule, we also finalized our policy
to exempt all procedures on the CY 2007 ASC list from application of
the office-based classification (72 FR 42512). The procedures that were
added to the ASC CPL beginning in CY 2008 that we determined were
office-based were identified in Addendum AA to that rule by payment
indicator ``P2'' (Office-based surgical procedure added to ASC list in
CY 2008 or later with MPFS nonfacility PE RVUs; payment based on OPPS
relative payment weight); ``P3'' (Office-based surgical procedures
added to ASC list in CY 2008 or later with MPFS nonfacility PE RVUs;
payment based on MPFS nonfacility PE RVUs); or ``R2'' (Office-based
surgical procedure added to ASC list in CY 2008 or later without MPFS
nonfacility PE RVUs; payment based on OPPS relative payment weight),
depending on whether we estimated the procedure would be paid according
to the standard ASC payment methodology based on its OPPS relative
payment weight or at the MPFS nonfacility PE RVU-based amount.
Consistent with our final policy to annually review and update the
ASC CPL to include all covered surgical procedures eligible for payment
in ASCs, each year we identify covered surgical procedures as either
temporarily office-based (these are new procedure codes with little or
no utilization data that we have determined are clinically similar to
other procedures that are permanently office-based), permanently
office-based, or non office-based, after taking into account updated
volume and utilization data.
(2) Changes for CY 2021 to Covered Surgical Procedures Designated as
Office-Based
In developing the CY 2021 OPPS/ASC proposed rule (85 FR 48949
through 48953), we followed our policy to annually review and update
the covered surgical procedures for which ASC payment is made and to
identify new procedures that may be appropriate for ASC payment
(described in detail in section XIII.C.1.d), including their potential
designation as office-based. We reviewed the most recent claims volume
and utilization data (CY 2019 claims) and the clinical characteristics
for all covered surgical procedures that are currently assigned a
payment indicator in CY 2020 of ``G2'' (Non office-based surgical
procedure added in CY 2008 or later; payment based on OPPS relative
payment weight), as well as for those procedures assigned one of the
temporary office-based payment
[[Page 86132]]
indicators, specifically ``P2'', ``P3'', or ``R2'' in the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61376 through 61380).
Our review of the CY 2019 volume and utilization data of covered
surgical procedures currently assigned a payment indicator of ``G2''
(Non office-based surgical procedure added in CY 2008 or later; payment
based on OPPS relative payment weight) resulted in our identification
of six covered surgical procedures that we believe met the criteria for
designation as permanently office-based. The data indicated that these
procedures are performed more than 50 percent of the time in
physicians' offices, and we believe that the services were of a level
of complexity consistent with other procedures performed routinely in
physicians' offices. The CPT codes that we proposed to permanently
designate as office-based for CY 2021 are listed as Table 53.
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We also reviewed CY 2019 volume and utilization data and other
information for 18 procedures designated as temporarily office-based
and temporarily assigned one of the office-based payment indicators,
specifically ``P2,'' ``P3'' or ``R2,'' as shown in Table 56 and Table
57 in the CY 2020 OPPS/ASC final rule with comment period (84 FR 61380
through 61383). These procedures were surgical procedures that were
designated as temporarily office-based in the CY 2019 OPPS/ASC final
rule with comment period or were new CPT codes for CY 2020 that were
designated as temporarily office-based. Of these 18 procedures, for
each procedure, there were fewer than 50 claims in our data and no
claims data for 11 of the 18 procedures described by CPT codes 64454,
64624, 65785, 67229, 0402T, 0512T, 0551T, 0566T, 0588T, 93985 and
93986. Therefore, we proposed to continue to designate these
procedures, shown in Table 54, as temporarily office-based for CY 2021.
The procedures for which the proposed office-based designation for CY
2021 is temporary are indicated by an asterisk in Addendum AA to the CY
2021 OPPS/ASC proposed rule with comment period (which is available via
the internet on the CMS website).
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For the remaining seven procedures of the 18 procedures designated
as temporarily office-based as shown in Table 56 and Table 57 in the CY
2020 OPPS/ASC final rule with comment period (84 FR 61380 through
61383), we proposed to permanently assign an office-based designation
for five of the procedures, represented by CPT codes 10007, 10011,
11102, 11104, and 11106. After reviewing CY 2019 volume and utilization
data for these five procedures, the claims data were sufficient to
indicate that these covered surgical procedures are performed
predominantly in physicians' offices (greater than 50 percent of the
time) and, therefore, we proposed to permanently assign one of the
office-based payment indicators, specifically ``P2,'' ``P3'' or
``R2,''--to these codes for CY 2021 as shown in Table 55. For the two
remaining procedures that had temporary office-based designations for
CY 2020, described by CPT codes 10005 (Fine needle aspiration biopsy,
including ultrasound guidance; first lesion) and 10009 (Fine needle
aspiration biopsy, including ct guidance; first lesion), utilization
data are sufficient to indicate that these covered surgical procedures
are not performed predominantly in physician's offices (performed in
physician's offices less than 50 percent of the time) and, therefore,
we proposed to assign a non office-based payment indicator--``G2''--to
these codes for CY 2021 as shown in Table 55.
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As discussed in the August 2, 2007 revised ASC payment system final
rule (72 FR 42533 through 42535), we finalized our policy to designate
certain new surgical procedures temporarily as office-based until
adequate claims data are available to assess their predominant sites of
service, whereupon if we confirm their office-based nature, the
procedures would be permanently assigned to the list of office-based
procedures. In the absence of claims data, we stated we would use other
available information, including our clinical advisors' judgment,
predecessor CPT and Level II HCPCS codes, information submitted by
representatives of specialty societies and professional associations,
and information submitted by commenters during the public comment
period.
For CY 2021 we proposed to designate two new CY 2021 CPT codes for
ASC covered surgical procedures as temporarily office-based. After
reviewing the clinical characteristics, utilization, and volume of
related procedure codes, we determined that the procedures in Table 56
would be predominantly performed in physicians' offices. We believe the
procedures described by CPT codes 0596T (Temporary female intraurethral
valve-pump (that is, voiding prosthesis); initial insertion, including
urethral measurement) and 0597T (Temporary female intraurethral valve-
pump (that is, voiding prosthesis); replacement) are similar to CPT
code 55285 (Cystourethroscopy for treatment of the female urethral
syndrome with any or all of the following: urethral meatotomy, urethral
dilation, internal urethrotomy, lysis of urethrovaginal septal
fibrosis, lateral incisions of the bladder neck, and fulguration of
polyp(s) of urethra, bladder neck, and/or trigone) which is currently
on the list of covered surgical procedures and assigned a proposed
payment indicator ``A2''--Surgical procedure on ASC list in CY 2007;
payment based on OPPS relative payment weight.--for CY 2021. While CPT
code 52285 is not subject to office-based determinations as it is
assigned an ``A2'' payment indicator, we note that this procedure is
predominantly performed in a physician office setting (52 percent based
on CY 2019 claims). As such, we proposed to add CPT codes 0596T and
0597T in Table 56 to the list of temporarily office-based covered
surgical procedures.
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Comment: Some commenters supported our proposed temporary office-
based designations as well as the removal of temporary office-based
designations for CPT codes 10005 (Fine needle aspiration biopsy,
including ultrasound guidance; first lesion) and 10009 (Fine needle
aspiration biopsy, including ct guidance; first lesion). Many
commenters did not support our proposed temporary office-based
designation for CPT code 64624 (Destruction by neurolytic agent,
genicular nerve branches including imaging guidance, when performed).
Commenters argued that the office setting does not represent the
predominant site of care where this procedure is furnished, noting that
this procedure is more likely to be performed in a hospital outpatient
department or ASC setting. Commenters note that CY 2020 claims and
utilization data support this position.
Response: We thank commenters for the support of our proposed
temporary office-based designations. For the first two quarters of CY
2020, we reviewed over 5,000 claims submitted for CPT code 64624. We
observed that this procedure was performed 23.9 percent of the time in
an office setting for the first two quarters of CY 2020, significantly
less than the 50 percent threshold for a permanent office-based
designation. Therefore, we agree with commenters that removing the
temporary office-based designation for CPT code 64624 is appropriate.
For CY 2021, we are finalizing a payment indicator of ``G2''--(Non
office-based surgical procedure added in CY 2008 or later; payment
based on OPPS relative payment weight)--for CPT code 64624.
After consideration of the public comments we received, we are
finalizing our proposal, without modifications, to remove the temporary
office-based designation for CPT codes 10005 and 10009. Additionally,
we are finalizing our proposal, with modifications, to designate the
procedures shown in Table 57 as temporarily office-based for CY 2021.
Further, after consideration of the public comments we received, we are
finalizing our proposal, without modifications, to designate the
procedures shown in Table 58 as permanently office-based beginning CY
2021.
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BILLING CODE 4120-01-C
(3) Comment Solicitation on Office-Based Exemption for Dialysis
Vascular Access Procedures
As we stated in the CY 2019 OPPS/ASC final rule with comment period
(83 FR 59036), the office-based utilization for CPT codes 36902 and
36905 (dialysis vascular access procedures) was greater than 50
percent. However, we did not designate CPT codes 36902 and 36905 as
office-based procedures for CY 2019. These codes became effective
January 1, 2017 and CY 2017 was the first year we had claims volume and
utilization data for CPT codes 36902 and 36905. We shared commenters'
concerns that the available data were not adequate to make a
determination that these procedures should be office-based, and
believed it was premature to assign office-based payment status to
those procedures for CY 2019. For CY 2019, CPT codes 36902 and 36905
were assigned payment indicators of ``G2''--Non office-based surgical
procedure added in CY 2008 or later; payment based on OPPS relative
weight.
As we stated in the CY 2020 OPPS/ASC final rule with comment period
(84 FR 61378), volume and utilization data for CPT code 36902 for CY
2018 showed the procedure was performed more than 50 percent of the
time in physicians' offices. However, the office-based utilization for
CPT code 36902 had fallen from 62 percent based on 2017 data to 52
percent based on 2018 data. In addition, there was a sizeable increase
in claims for this service in ASCs--from approximately 14,000 in 2017
to 38,000 in 2018. In light of these changes in utilization and due to
the high utilization of this procedure in all settings (over 125,000
claims in 2018), we believed it may have been premature to assign
office-based payment status to CPT code 36902 for CY 2020. Therefore,
for CY 2020, we finalized our proposal to not designate CPT code 36902
as an office-based procedure, but to continue to assign CPT code 36902
a payment indicator of ``G2''--non office-based surgical procedure paid
based on OPPS relative weights. Additionally, CY 2018 volume and
utilization data for CPT code 36905 showed the procedure was not
performed more than 50 percent of the time in physicians' offices and
we finalized our proposal to retain its payment indicator of ``G2''--
non office-based surgical procedure based on OPPS relative weights for
CY 2020.
For the CY 2021 OPPS/ASC proposed rule, we reviewed CY 2019 volume
and utilization data for CPT code 36902 and determined that this
procedure was performed less than 50 percent of the time in physicians'
offices. We note that the office-based utilization for CPT code 36902
has fallen from 52 percent in 2018 to 41 percent in 2019. Similarly,
[[Page 86140]]
CY 2019 volume and utilization data for CPT code 36905 continues to
show that this procedure was performed less than 50 percent of the time
in physician's offices. Therefore, we did not propose to designate CPT
codes 36902 and 36905 as office-based procedures for CY 2021.
In past rulemaking, commenters have requested we permanently exempt
dialysis vascular access procedures from office-based designations
similar to our exemption for radiology services that involve certain
nuclear medicine procedures and radiology services that involve
contrast agents (42 CFR 416.171(d)(1) and (2)) (83 FR 59036).
Commenters contended that an office-based designation for dialysis
vascular access procedures (in particular CPT codes 36902 and 36905)
would result in a lower ASC payment rate if frequently used additional
services, which are often packaged under the ASC payment system but
separately payable under the Physician Fee Schedule, are factored into
the analysis. Therefore, an office-based designation and payment at
Physician Fee Schedule amounts under the ASC payment system may provide
an inappropriate and lower global payment, after factoring in
additional surgical procedures and/or ancillary items and services,
when compared to the Physician Fee Schedule. Further, commenters have
noted that ASCs are generally able to provide a wider array of dialysis
vascular access procedures than are typically available in the
physician office setting and at a lower Medicare payment rate than the
hospital outpatient department setting. Providing an office-based ASC
payment rate using PFS non facility PE RVUs for dialysis vascular
access procedures may reduce the number of ASCs willing to perform such
services and, subsequently, reduce beneficiary access for dialysis
vascular access procedures in an ASC setting. Such an outcome may
inadvertently encourage migration of dialysis vascular access
procedures-related services to the more expensive hospital outpatient
department setting.
While current volume and utilization data shows that dialysis
vascular access procedures are not predominantly performed in a
physician's office setting, future data for office-based designations
may illustrate a different result. ASC rates established at PFS non
facility PE RVU values may reduce the number of ASCs performing these
procedures and inadvertently encourage greater utilization in the
hospital outpatient department setting. While we did not propose an
exemption from payment at physician fee schedule non-facility PE RVU
amounts as characterized by payment indicator ``P3'' for CY 2021, we
contemplated implementing such an exemption in the future if necessary
and sought comment on whether we might be justified in establishing a
permanent exemption from Physician Fee Schedule non facility PE RVU
amounts for dialysis vascular access procedures under Sec. 416.171(d)
in future rulemaking.
Comment: Some commenters supported a permanent exemption from
Physician Fee Schedule non facility PE RVU amounts for dialysis
vascular access procedures under Sec. 416.171(d) in future rulemaking.
However, other commenters, while supportive, did not believe an
exemption was necessary as office utilization for such procedures was
unlikely to rise above the 50 percent threshold.
Response: We appreciate the commenters' feedback regarding a
potential exemption from Physician Fee Schedule non facility PE RVU
amounts for dialysis vascular access procedures under Sec. 416.171(d).
We agree with commenters that such an exemption is not necessary at
this time; however, we may consider such a proposal for future
rulemaking.
b. ASC Covered Surgical Procedures To Be Designated as Device-Intensive
(1) Background
We refer readers to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59040 through 59041), for a summary of our existing
policies regarding ASC covered surgical procedures that are designated
as device-intensive.
(2) Changes to List of ASC Covered Surgical Procedures Designated as
Device-Intensive for CY 2021
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
590401 through 59043), for CY 2019, we modified our criteria for
device-intensive procedures to better capture costs for procedures with
significant device costs. We adopted a policy to allow procedures that
involve surgically inserted or implanted, high-cost, single-use devices
to qualify as device-intensive procedures. In addition, we modified our
criteria to lower the device offset percentage threshold from 40
percent to 30 percent. Specifically, for CY 2019 and subsequent years,
we adopted a policy that device-intensive procedures would be subject
to the following criteria:
All procedures must involve implantable devices assigned a
CPT or HCPCS code;
The required devices (including single-use devices) must
be surgically inserted or implanted; and
The device offset amount must be significant, which is
defined as exceeding 30 percent of the procedure's mean cost.
Corresponding to this change in the cost criterion we adopted a policy
that the default device offset for new codes that describe procedures
that involve the implantation of medical devices will be 31 percent
beginning in CY 2019. For new codes describing procedures that are
payable when furnished in an ASC and involve the implantation of a
medical device, we adopted a policy that the default device offset
would be applied in the same manner as the policy we adopted in section
IV.B.2. of the CY 2019 OPPS/ASC final rule with comment period (83 FR
58944 through 58948). We amended Sec. 416.171(b)(2) of the regulations
to reflect these new device criteria.
In addition, as also adopted in section IV.B.2. of CY 2019 OPPS/ASC
final rule with comment period, to further align the device-intensive
policy with the criteria used for device pass-through status, we
specified, for CY 2019 and subsequent years, that for purposes of
satisfying the device-intensive criteria, a device-intensive procedure
must involve a device that:
Has received Food and Drug Administration (FDA) marketing
authorization, has received an FDA investigational device exemption
(IDE) and has been classified as a Category B device by the FDA in
accordance with 42 CFR 405.203 through 405.207 and 405.211 through
405.215, or meets another appropriate FDA exemption from premarket
review;
Is an integral part of the service furnished;
Is used for one patient only;
Comes in contact with human tissue;
Is surgically implanted or inserted (either permanently or
temporarily); and
Is not any of the following:
++ Equipment, an instrument, apparatus, implement, or item of this
type for which depreciation and financing expenses are recovered as
depreciable assets as defined in Chapter 1 of the Medicare Provider
Reimbursement Manual (CMS Pub. 15-1); or
++ A material or supply furnished incident to a service (for
example, a suture, customized surgical kit, scalpel, or clip, other
than a radiological site marker).
Based on our modified device-intensive criteria, for CY 2021, we
proposed to update the ASC CPL to indicate procedures that are eligible
for payment according to our device-intensive procedure payment
methodology, based on the proposed
[[Page 86141]]
individual HCPCS code device-offset percentages using the CY 2018 OPPS
claims and cost report data available for the CY 2020 OPP/ASC proposed
rule.
The ASC covered surgical procedures that we proposed to designate
as device-intensive, and therefore subject to the device-intensive
procedure payment methodology for CY 2021, are assigned payment
indicator ``J8'' and are included in ASC Addendum AA to the CY 2021
OPPS/ASC proposed rule (which is available via the internet on the CMS
website). The CPT code, the CPT code short descriptor, and the proposed
CY 2021 ASC payment indicator, and an indication of whether the full
credit/partial credit (FB/FC) device adjustment policy would apply
because the procedure is designated as device-intensive are also
included in Addendum AA to the proposed rule (which is available via
the internet on the CMS website).
Under current policy, the payment rate under the ASC payment system
for device-intensive procedures furnished with an implantable or
inserted medical device are calculated by applying the device offset
percentage based on the standard OPPS APC ratesetting methodology to
the OPPS national unadjusted payment based on the standard ratesetting
methodology to determine the device cost included in the OPPS payment
rate for a device-intensive ASC covered surgical procedure, which we
then set as equal to the device portion of the national unadjusted ASC
payment rate for the procedure. We calculate the service portion of the
ASC payment for device intensive procedures by applying the uniform ASC
conversion factor to the service (non-device) portion of the OPPS
relative payment weight for the device-intensive procedure. Finally, we
sum the ASC device portion and ASC service portion to establish the
full payment for the device-intensive procedure under the ASC payment
system (82 FR 59409).
As discussed in section IV.A. of this final rule with comment
period, we are approving the BAROSTIM NEOTM system for
transitional pass-through device payment status. The applicant has
stated that the BAROSTIM NEOTM would be reported with CPT
code 0266T (Implantation or replacement of carotid sinus baroreflex
activation device; total system (includes generator placement,
unilateral or bilateral lead placement, intra-operative interrogation,
programming, and repositioning, when performed)). There have been no
device costs reported for CPT code 0266T in CY 2019 claims or in
previous calendar years. Therefore, we are assigning a device offset
percentage to 0266T in CY 2021 based on the clinically-similar
procedure 0268T (Implantation or replacement of carotid sinus
baroreflex activation device; pulse generator only (includes intra-
operative interrogation, programming, and repositioning, when
performed)). Based on our review of CY 2019 claims data, CPT code 0268T
has a device offset percentage of 96.04 percent. Therefore, for CY
2021, we are assigning device-intensive status to CPT code 0266T with a
device offset percentage of 96.04 percent.
Comment: Some commenters requested that device-intensive
designations for procedures under the ASC payment system be based
solely on device-intensive designations under the OPPS.
Response: We are not accepting the commenters' recommendation. As
we have stated in past rulemaking (79 FR 66924), under 42 CFR 416.167
and 416.171, most ASC payment rates are based on the OPPS relative
payment weights, and our ASC policy with respect to device-intensive
procedures is designed to be consistent with the OPPS. As such, a
``device-intensive'' designation identifies those procedures with
significant device costs and applies to services that are performed
both in the hospital outpatient department and the ASC setting. We
believe that the device-intensive methodology for ASCs should align
with the device-intensive policies for OPPS, and, therefore, procedures
should not be device intensive in the ASC setting if they are not
device intensive in the hospital outpatient setting. Accordingly, to be
assigned device-intensive status in the ASC setting, the procedure must
be identified as device-intensive in the hospital outpatient setting
and have a device offset percentage that exceeds the 30 percent
threshold as calculated using our standard ratesetting methodology as
stated in 42 CFR 416.171(b)(2).
Comment: Several commenters requested that we restore the device-
intensive status for CPT code 0200T (Percutaneous sacral augmentation
(sacroplasty), unilateral injection(s), including the use of a balloon
or mechanical device, when used, 1 or more needles, includes imaging
guidance and bone biopsy, when performed), noting that we proposed
device-intensive status for this procedure under the OPPS.
Response: Based on updated claims data for this final rule with
comment period, CPT code 0200T has a device offset percentage of 20.39
percent based on the standard ratesetting methodology. Therefore, CPT
code 0200T is ineligible for device-intensive status under the ASC
payment system and we are finalizing a payment indicator of ``G2'' CPT
code 0200T for CY 2021.
Comment: One commenter recommended that we assign device-intensive
status to CPT code 66174 (Transluminal dilation of aqueous outflow
canal; without retention of device or stent).
Response: Based on updated claims data for this final rule with
comment period, CPT code 66174 has a device offset percentage of 24.70
percent. Therefore, CPT code 66174 is ineligible for device-intensive
status under the ASC payment system. We are finalizing a payment
indicator of ``A2''--Surgical procedure on ASC list in CY 2007; payment
based on OPPS relative payment weight--for CPT code 66174 for CY 2021.
Comment: Some commenters supported the Advisory Panel on Hospital
Outpatient Payment (HOP Panel) recommendation that CMS consider
lowering the ASC device-intensive threshold from 30 percent to 25
percent to better capture device costs in the ASC setting.
Response: Our established policy under the ASC payment system, as
discussed at greater length in section XIII.G. of this final rule, is
to scale prospective ASC relative payment weights by comparing total
payment using current year ASC scaled relative payment weights with the
total payment using the prospective ASC relative payment weights,
holding ASC utilization, the ASC conversion factor, and the mix of
services constant from the claims year. Lowering the device-intensive
threshold would have the effect of assigning a greater amount of device
costs, and increasing estimated ASC expenditures for the prospective
year. The increase in prospective year expenditures can be attributable
to portions of ASC non-device costs, which are otherwise calculated
using an ASC conversion factor that is lower than the OPPS conversion
factor, being replaced with device costs which are calculated using the
higher OPPS conversion factor so that device costs are held constant
between the OPPS and ASC payment system. The increase in estimated
prospective year expenditures would put additional downward pressure on
the ASC weight scalar and otherwise reduce ASC payment rates for most
surgical procedures. Accordingly, we do not believe it would be
appropriate to lower the ASC device-intensive threshold at this time.
Comment: One commenter requested that we reevaluate our device cost
calculations with respect to the device
[[Page 86142]]
offset percentage difference between CPT codes 64910 (Nerve repair;
with synthetic conduit or vein allograft (e.g., nerve tube), each
nerve) and 64912 (Nerve repair; with nerve allograft, each nerve, first
strand (cable)). The commenter noted that the device offset percentage
for CPT code 64912 has historically been greater than the device offset
percentage for CPT code 64910.
Response: We appreciate the commenters' recommendation. We note
that CPT codes 64910 and 64912 each had less than 50 claims for this CY
2021 OPPS/ASC final rule with comment period. For relatively lower
volume procedures such as these, the limited sample sizes may cause
greater fluctuation in device cost statistics for these procedures on a
year-to-year basis. The amount of packaged costs submitted on a claim,
the hospital charges reported on the claim, as well as the cost-to-
charge ratios for the hospitals that submitted these claims, can have a
substantial impact on our device cost calculations for relatively lower
volume procedures. However, we believe continuing to use our device-
intensive methodology results in the most accurate and reliable device
cost statistics for capturing changes in device costs over time and for
purposes of determining device-intensive status and device offset
percentages.
After consideration of the public comments we received, we are
designating the ASC covered surgical procedures displayed in Addendum
AA with payment indicator ``J8'' as device-intensive and subject to the
device-intensive procedure payment methodology for CY 2021.
c. Adjustment to ASC Payments for No Cost/Full Credit and Partial
Credit Devices
Our ASC payment policy for costly devices implanted or inserted in
ASCs at no cost/full credit or partial credit is set forth in Sec.
416.179 of our regulations, and is consistent with the OPPS policy that
was in effect until CY 2014. We refer readers to the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66845 through 66848) for a full
discussion of the ASC payment adjustment policy for no cost/full credit
and partial credit devices.) ASC payment is reduced by 100 percent of
the device offset amount when a hospital furnishes a specified device
without cost or with a full credit and by 50 percent of the device
offset amount when the hospital receives partial credit in the amount
of 50 percent or more of the cost for the specified device.
Effective CY 2014, under the OPPS, we finalized our proposal to
reduce OPPS payment for applicable APCs by the full or partial credit a
provider receives for a device, capped at the device offset amount.
Although we finalized our proposal to modify the policy of reducing
payments when a hospital furnishes a specified device without cost or
with full or partial credit under the OPPS, in the CY 2014 OPPS/ASC
final rule with comment period (78 FR 75076 through 75080), we
finalized our proposal to maintain our ASC policy for reducing payments
to ASCs for specified device-intensive procedures when the ASC
furnishes a device without cost or with full or partial credit. Unlike
the OPPS, there is currently no mechanism within the ASC claims
processing system for ASCs to submit to CMS the actual credit received
when furnishing a specified device at full or partial credit.
Therefore, under the ASC payment system, we finalized our proposal for
CY 2014 to continue to reduce ASC payments by 100 percent or 50 percent
of the device offset amount when an ASC furnishes a device without cost
or with full or partial credit, respectively.
Under current ASC policy, all ASC device-intensive covered surgical
procedures are subject to the no cost/full credit and partial credit
device adjustment policy. Specifically, when a device-intensive
procedure is performed to implant or insert a device that is furnished
at no cost or with full credit from the manufacturer, the ASC would
append the HCPCS ``FB'' modifier on the line in the claim with the
procedure to implant or insert the device. The contractor would reduce
payment to the ASC by the device offset amount that we estimate
represents the cost of the device when the necessary device is
furnished without cost or with full credit to the ASC. We continue to
believe that the reduction of ASC payment in these circumstances is
necessary to pay appropriately for the covered surgical procedure
furnished by the ASC.
Effective in CY 2019 (83 FR 59043 through 59044), for partial
credit, we adopted a policy to reduce the payment for a device-
intensive procedure for which the ASC receives partial credit by one-
half of the device offset amount that would be applied if a device was
provided at no cost or with full credit, if the credit to the ASC is 50
percent or more (but less than 100 percent) of the cost of the new
device. The ASC will append the HCPCS ``FC'' modifier to the HCPCS code
for the device-intensive surgical procedure when the facility receives
a partial credit of 50 percent or more (but less than 100 percent) of
the cost of a device. To report that the ASC received a partial credit
of 50 percent or more (but less than 100 percent) of the cost of a new
device, ASCs have the option of either: (1) Submitting the claim for
the device-intensive procedure to their Medicare contractor after the
procedure's performance, but prior to manufacturer acknowledgment of
credit for the device, and subsequently contacting the contractor
regarding a claim adjustment, once the credit determination is made; or
(2) holding the claim for the device implantation or insertion
procedure until a determination is made by the manufacturer on the
partial credit and submitting the claim with the ``FC'' modifier
appended to the implantation procedure HCPCS code if the partial credit
is 50 percent or more (but less than 100 percent) of the cost of the
device. Beneficiary coinsurance would be based on the reduced payment
amount. As finalized in the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66926), to ensure our policy covers any situation
involving a device-intensive procedure where an ASC may receive a
device at no cost or receive full credit or partial credit for the
device, we apply our ``FB''/''FC'' modifier policy to all device-
intensive procedures.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043
through 59044) we stated we would reduce the payment for a device-
intensive procedure for which the ASC receives partial credit by one-
half of the device offset amount that would be applied if a device was
provided at no cost or with full credit, if the credit to the ASC is 50
percent or more (but less than 100 percent) of the cost of the device.
In the CY 2020 OPPS/ASC final rule with comment period, we finalized
continuing our existing policies for CY 2020. We note that we
inadvertently omitted language that this policy would apply not just in
CY 2019 but also in subsequent calendar years. We intended to apply
this policy in CY 2019 and subsequent calendar years. Therefore, we
proposed to apply our policy for partial credits specified in the CY
2019 OPPS/ASC final rule with comment period (83 FR 59043 through
59044) in CY 2021 and subsequent calendar years. Specifically, for CY
2021 and subsequent calendar years, we would reduce the payment for a
device-intensive procedure for which the ASC receives partial credit by
one-half of the device offset amount that would be applied if a device
was provided at no cost or with full credit, if the credit to the ASC
is 50 percent or more (but less than 100 percent) of the cost of the
[[Page 86143]]
device. To report that the ASC received a partial credit of 50 percent
or more (but less than 100 percent) of the cost of a device, ASCs have
the option of either: (1) Submitting the claim for the device intensive
procedure to their Medicare contractor after the procedure's
performance, but prior to manufacturer acknowledgment of credit for the
device, and subsequently contacting the contractor regarding a claim
adjustment, once the credit determination is made; or (2) holding the
claim for the device implantation or insertion procedure until a
determination is made by the manufacturer on the partial credit and
submitting the claim with the ``FC'' modifier appended to the
implantation procedure HCPCS code if the partial credit is 50 percent
or more (but less than 100 percent) of the cost of the device.
Beneficiary coinsurance would be based on the reduced payment amount.
We did not propose any other changes to our policies related to no/cost
full credit or partial credit devices.
In the CY 2021 OPPS/ASC proposed rule, we did not propose any
changes to these policies and we did not receive any comments on our
policies related to no/cost full credit or partial credit devices.
Therefore, we are finalizing continuing our existing policies for CY
2021 and subsequent years.
d. Additions to the List of ASC Covered Surgical Procedures
Section 1833(i)(1) of the Act requires us, in part, to specify, in
consultation with appropriate medical organizations, surgical
procedures that are appropriately performed on an inpatient basis in a
hospital but that can be safely performed in an ASC, a CAH, or an HOPD
and to review and update the list of ASC procedures at least every 2
years. We evaluate the ASC covered procedures list (ASC CPL) each year
to determine whether procedures should be added to or removed from the
list, and changes to the list are often made in response to specific
concerns raised by stakeholders.
Under our current regulations at 42 CFR 416.2 and 416.166, covered
surgical procedures furnished on or after January 1, 2008 are surgical
procedures that meet the general standards specified in 42 CFR
416.166(b) and are not excluded under the general exclusion criteria
specified in 42 CFR 416.166(c). Specifically, under 42 CFR 416.166(b),
the general standards provide that covered surgical procedures are
surgical procedures specified by the Secretary and published in the
Federal Register and/or via the internet on the CMS website that are
separately paid under the OPPS, that would not be expected to pose a
significant safety risk to a Medicare beneficiary when performed in an
ASC, and for which standard medical practice dictates that the
beneficiary would not typically be expected to require active medical
monitoring and care at midnight following the procedure. Section 42 CFR
416.166(c) sets out the general exclusion criteria used under the ASC
payment system to evaluate the safety of procedures for performance in
an ASC. The general exclusion criteria provide that covered surgical
procedures do not include those surgical procedures that: (1) Generally
result in extensive blood loss; (2) require major or prolonged invasion
of body cavities; (3) directly involve major blood vessels; (4) are
generally emergent or life threatening in nature; (5) commonly require
systemic thrombolytic therapy; (6) are designated as requiring
inpatient care under 42 CFR 419.22(n); (7) can only be reported using a
CPT unlisted surgical procedure code; or (8) are otherwise excluded
under 42 CFR 411.15.
For purposes of identifying procedures eligible to be added to the
covered surgical procedure list, we define surgical procedures as those
procedures described by Category I CPT codes in the surgical range from
10000 through 69999 as well as those Category I and III CPT codes and
Level II HCPCS codes that directly crosswalk or are clinically similar
to procedures in the CPT surgical range (83 FR 59044 through 59045),
that we have determined do not pose a significant safety risk, would
not be expected to require an overnight stay when performed in an ASC,
and are separately paid under the OPPS. We proposed to continue to
apply the revised definition of ``surgery'' we adopted in the CY 2019
OPPS/ASC final rule with comment period (83 FR 59029 through 59030),
which includes certain ``surgery-like'' procedures that are assigned
codes outside the CPT surgical range, for CY 2021 and subsequent years.
As discussed above, section 1833(i)(1) of the Act requires the
Secretary to specify, in consultation with appropriate medical
organizations, surgical procedures that are appropriately performed on
an inpatient basis in a hospital but that can be safely performed on an
ambulatory basis in an ASC, a CAH, or an HOPD and to review and update
the list of ASC procedures at least every 2 years. The report
accompanying the legislation establishing section 1833(i)(1) of the Act
explained that Congress intended procedures routinely performed on an
ambulatory basis in a physician's office that do not generally require
the more elaborate facilities of an ASC not to be included in the list
of ASC covered procedures (H.R. Rep. No. 96-1167, at 390-91, reprinted
in 1980 U.S.C.C.A.N. 5526, 5753-54).
In consideration of the statutory requirements and legislative
history, in the implementing regulations of the current ASC system
(effective in 2008), which we adopted in the August 2, 2007 final ASC
rule (72 FR 42487), we excluded procedures that would otherwise pose a
significant safety risk to the typical Medicare beneficiary if
performed in the ASC setting. However, we agreed with stakeholders who
have noted that ASCs are increasingly able to safely provide a greater
range of services as medical practice continues to evolve and advance.
We also believe that physicians play an important role and should be
able to exercise their clinical judgment in making site-of-service
determinations. Accordingly, CMS has continued to reexamine the process
of how we determine which procedures are payable under Medicare when
furnished in the ASC setting, keeping in mind the statutory requirement
in section 1833(i)(1)(A) of the Act that the Secretary must specify
those surgical procedures that are appropriately performed on an
inpatient basis in a hospital but which also can be performed safely on
an ambulatory basis in an ASC, CAH or HOPD as part of reviewing and
updating the list of procedures.
In the CY 2020 OPPS/ASC final rule with comment period, we added
total knee arthroplasty and several coronary intervention procedures to
the ASC CPL (84 FR 61386 through 61397). Although the coronary
intervention procedures involved blood vessels that could be considered
major, based on our policy to consider the involvement of major blood
vessels in the context of the clinical characteristics of the
individual procedures and to maintain logical and clinical consistency
in excluding procedures from the ASC CPL (72 FR 42481), as well as our
review of the clinical characteristics of the procedures and their
similarity to other procedures that were included on the ASC CPL, we
believed these procedures could be safely performed in the ASC setting
for appropriate beneficiaries. In the CY 2019 OPPS/ASC final rule with
comment period, we also noted that in light of our conditions of
coverage for ASCs, including 42 CFR 416.42, which require surgical
procedures to be performed in a safe manner by qualified physicians who
have been granted clinical privileges by the governing body of the ASC
in accordance with approved policies and procedures of the
[[Page 86144]]
ASC, we believe that the CfCs provide further assurance that services
furnished in the ASC setting are held to a high standard of safety.
While we acknowledged in the CY 2019 OPPS/ASC final rule with comment
period that it could be more appropriate for certain beneficiaries to
receive the coronary intervention procedures we were adding to the ASC
CPL in a hospital-level setting, which typically has a higher level of
emergency staff and equipment available, including onsite cardiac
surgery backup, when compared to an ASC setting, we also noted that
many beneficiaries could be ideal candidates to receive these services
in an ASC setting and that beneficiaries and their physicians should be
able to choose an appropriate site of service for surgeries based on
the clinical characteristics of the patient and other factors (83 FR
59046). We continue to believe that relatively healthy and less complex
patients would benefit from the shorter length of stay and reduced
cost-sharing that would be expected in an ASC setting.
In the August 2, 2007 final rule with comment period establishing
the revised ASC payment system, we discussed criteria for excluding
procedures from the ASC CPL (72 FR 42478 through 42484). In that same
final rule, we adopted the current general standards and general
exclusion criteria described above. One of the general exclusion
criteria we established for the revised ASC payment system, at Sec.
416.166(c)(6), excludes any procedure on the OPPS Inpatient Only (IPO)
list, which is a list of procedures for which we do not make payment
under the OPPS and that are typically performed in the hospital
inpatient setting because of the nature of the procedure, the need for
at least 24 hours of postoperative recovery time or monitoring before
the patient can be safely discharged, and the underlying physical
condition of the patient (65 FR 18456). We also stated that we believed
that any procedures for which we did not allow payment in the hospital
outpatient setting due to safety concerns would not be safe to perform
in an ASC (72 FR 42478). We stated that we were committed to revising
the ASC CPL so that it excludes only those surgical procedures that
pose significant safety risks to beneficiaries or that are expected to
require an overnight stay (72 FR 42479).
Also in the August 2, 2007 final rule with comment period, we
discussed the exclusion of procedures involving major blood vessels,
but we noted that it was important to maintain flexibility in our
review of procedures for safe performance in the ASC setting,
consistent with our past practice regarding this criterion (72 FR
42481). We discussed that there were some procedures already on the ASC
list being safely performed in ASCs that involve blood vessels that
would generally be defined as major. We did not agree with commenters
that it would be logical or clinically consistent for us to adopt a
specific definition of major blood vessels to evaluate procedures for
exclusion from ASC payment (72 FR 42481). We noted the involvement of
major blood vessels is best considered in the context of the clinical
characteristics of individual procedures.
We noted that we proposed to exclude surgical procedures that were
expected to involve major blood vessels, major or prolonged invasion of
body cavities, extensive blood loss, or that are emergent or life-
threatening in nature from ASC payment, based on evaluation by our
medical advisors (72 FR 42478 through 42479). We also noted that most
of the procedures that our medical advisors identified as involving any
of the characteristics listed in 42 CFR 416.65(b)(3) also require
overnight or inpatient stays, reinforcing our belief that they should
be excluded from ASC payment (72 FR 42478 through 42479). We also
disagreed, at that time, that all procedures performed in HOPDs were
appropriate for performance in ASCs. This was due in part to the fact
that we believed that HOPDs were able to provide much higher acuity
care, and because hospitals were subject to more stringent infection
prevention, documentation, and patient assessment requirements than
ASCs. As discussed in the August 2, 2007 final rule with comment
period, ASCs were not required to meet patient safety standards
consistent with those in place for hospitals (that is, hospital
conditions of participation), and ASCs were not required, and are not
currently required, to have the trained staff and equipment needed to
provide the breadth and intensity of care that hospitals are required
to maintain (72 FR 42479).
Many of these concerns have been addressed with the passage of
time. We believe that our approach needs to evolve away from the
criteria we established in 2008, in order to reflect the significant
advances in medical practice and ASC capabilities over the last 12
years. In particular, we believe that significant advancements in
medical practice, surgical techniques, medical technology, and other
factors have allowed certain ASCs to safely perform procedures that
were once too complex, including those involving major blood vessels
and other general exclusion criteria. We acknowledge that ASCs and
hospitals have different health and safety requirements. Despite this
fact, ASCs often undergo accreditation as a condition of state
licensure and share some similar licensure and compliance requirements
with hospitals as well as meet Medicare conditions for coverage (see 42
CFR 416.40 through 416.54).
As mentioned above, in recent years, we have added procedures to
the ASC CPL that were largely considered hospital inpatient procedures
in the past, such as total knee arthroplasty (TKA) and certain coronary
intervention procedures. As the practice of medicine has evolved,
hospital lengths of stay have become shorter for many surgical
procedures. Many services that used to be predominantly performed in
the hospital inpatient setting are now routinely performed in the
hospital outpatient setting on an ambulatory basis. Further, many
procedures that are currently only payable as hospital outpatient
services under Medicare fee-for-service are safely performed in the ASC
setting for other payors. While we recognize that non-Medicare patients
tend to be younger and have fewer comorbidities than the Medicare
population, we note that careful patient selection can identify
Medicare beneficiaries who are suitable candidates for these services
in the ASC setting. Further, Medicare Advantage plans are not obligated
to adopt the ASC CPL as it exists in Medicare fee-for-service and,
based on Medicare Advantage encounter data, many MA enrollees have had
services performed in the ASC setting that are not currently payable
under Medicare fee-for-service.
In addition, the COVID-19 pandemic has highlighted the need for
more healthcare access points throughout the country. Many ASCs
temporarily closed or significantly scaled back their operations based
on state and federal recommendations to delay elective procedures
during the public health emergency associated with COVID-19 while some
ASCs opted to temporarily enroll as hospitals. Looking ahead to after
the pandemic, it will be more important than ever to ensure that the
health care system has as many access points and patient choices for
all Medicare beneficiaries as possible. Because the pandemic has forced
many ASCs to close, thereby decreasing Medicare beneficiary access to
care in that setting, we believe allowing greater flexibility for
physicians and patients to choose ASCs as the site of care,
particularly during the pandemic, would help to alleviate both access
to care concerns for elective procedures as well as access to emergency
care
[[Page 86145]]
concerns for hospital outpatient departments.
(1) Changes to the List of ASC Covered Surgical Procedures for CY 2021
Historically, we have reviewed the clinical characteristics of
procedures and consulted with stakeholders and our clinical advisors to
determine if those procedures would meet our existing regulatory
criteria under 42 CFR 416.2 and 416.166. Our regulation at 416.166(b)
specifies the general standard criteria for covered surgical
procedures, and requires that covered surgical procedures be surgical
procedures: (1) That are separately paid under OPPS, (2) that would not
be expected to pose a significant safety risk to a Medicare beneficiary
when performed in an ASC, and (3) for which standard medical practice
dictates that the beneficiary would not typically be expected to
require active medical monitoring and care at midnight following the
procedure. Additionally, 42 CFR 416.166(b) requires that a procedure
not meet our exclusion criteria set forth in 42 CFR 416.166(c).
For CY 2021, we proposed to continue to apply our current policies
and criteria set forth in 42 CFR 416.2 and 416.166 for updating the ASC
CPL. In addition, we proposed two alternative options for modifying our
approach to adding surgical procedures to the ASC CPL--(1) a nomination
process for adding new procedures to the ASC CPL, and (2) a broader
approach under which we would revise our regulatory criteria at 42 CFR
416.166 to evaluate potential additions to the ASC CPL. Under our first
alternative proposal, a proposed nomination process along with
modifications to certain regulatory criteria, we would accept and
consider nominations submitted by March 1st, 2021 in our rulemaking for
CY 2022. Under our second alternative proposal, we proposed to revise
our regulatory criteria by removing certain general exclusions at 42
CFR 416.166(c) and under the revised criteria, we proposed to add
certain surgical procedures to the ASC CPL beginning in CY 2021. We
expected either of these options would have the effect of expanding the
ASC CPL, while maintaining the balance between safety and access for
Medicare beneficiaries.
A. Standard ASC CPL Review Process for CY 2021
For CY 2021, consistent with our current policy for reviewing the
ASC CPL, we conducted a review of HCPCS codes that currently are paid
under the OPPS, but not included on the ASC CPL, and that meet the
definition of surgery to determine if changes in technology and/or
medical practice affected the clinical appropriateness of these
procedures for the ASC setting. Based on this review, and as explained
in more detail below, we proposed to update the list of ASC covered
surgical procedures by adding eleven procedures to the list for CY 2021
as shown in Table 40 of the CY 2021 OPPS/ASC proposed rule. Procedures
that we proposed to add to the ASC CPL for CY 2021 include total hip
arthroplasty (THA), vaginal colpopexy, transcervical uterine fibroid
ablation, and intravascular lithotripsy procedures, among others. After
reviewing the clinical characteristics of these eleven procedures and
consulting with our clinical advisors, we determined that these
procedures are separately paid under the OPPS, would not be expected to
pose a significant risk to beneficiary safety when performed in an ASC,
and would not be expected to require active medical monitoring and care
of the beneficiary at midnight following the procedure. We have
assessed each of the proposed procedures against the regulatory safety
criteria in the regulation at 42 CFR 416.166(c) and believe that none
of the procedures meet the general exclusion criteria.
Of the eleven procedures we proposed to add, we believed that the
THA procedure merited additional discussion in the CY 2021 OPPS/ASC
proposed rule, given prior discussion of the procedure in past
rulemaking, to explain our belief that the procedure meets existing
safety criteria for purposes of adding this procedure to the ASC CPL.
In the CY 2018 OPPS/ASC proposed rule, we solicited public comments on
whether the THA procedure, CPT code 27130 (Arthroplasty, acetabular and
proximal femoral prosthetic replacement (total hip arthroplasty), with
or without autograft or allograft), met the criteria to be added to the
ASC CPL. In the CY 2018 OPPS/ASC final rule with comment period, we
noted that some commenters argued many ASCs are equipped to perform
this procedure and orthopedic surgeons in ASCs are increasingly
performing this procedure safely and effectively on non-Medicare
patients and appropriate Medicare patients (82 FR 59412). Commenters
also stated that adding THA to the ASC CPL would allow for greater
choices in care settings for Medicare patients, would provide a more
patient-centered approach to joint arthroplasty procedures, and would
potentially be safer in some cases when performed in an outpatient
setting to prevent certain hospital-acquired infections (82 FR 59412).
However, other commenters recommended that ASCs obtain enhanced
certification from a national accrediting organization that certifies
an ASC meets higher quality standards and can safely perform joint
arthroplasty procedures (82 FR 59412). Some commenters opposed adding
THA to the ASC CPL, as they believed the vast majority of ASCs are not
equipped to safely perform these procedures on patients and the vast
majority of Medicare patients are not suitable candidates to receive
``overnight'' joint arthroplasty procedures in an ASC setting (82 FR
59412). For CY 2018, we did not finalize adding THA to the ASC CPL, but
noted that we would take commenters' suggestions and recommendations
into consideration for future rulemaking.
In the CY 2021 OPPS/ASC proposed rule, we sought to continue to
promote site neutrality, where possible, between the hospital
outpatient department and ASC settings, and expand the ASC CPL to
include as many procedures that can be performed in the HOPD as
reasonably possible to advance that goal. Further, we believed that
there are at least a subset of Medicare beneficiaries who may be
suitable candidates to receive THA procedures in an ASC setting based
on the beneficiaries' clinical characteristics. We believe physicians
should continue to play an important role in exercising their clinical
judgment when making site-of-service determinations, including for THA.
We believe THA would meet our existing regulatory requirements
established under 42 CFR 416.2 and 416.166(b) and (c) for covered
surgical procedures in the ASC setting. In light of this information
and the public comments submitted in support of adding THA to the ASC
CPL in response to our CY 2018 public comment solicitation, we proposed
to add THA to the ASC CPL in CY 2021, as shown in Table 40 of the CY
2021 OPPS/ASC proposed rule.
We proposed to add a total of eleven procedures, displayed in Table
40 of the CY 2021 OPPS/ASC proposed rule, with their HCPCS code long
descriptors, to the list of ASC covered surgical procedures for CY
2021. We sought public comment on our proposal, including any medical
evidence or literature to support the commenters' views on whether or
not we should add any of these procedures to the ASC CPL for CY 2021.
In addition, we also sought comment on the two alternative proposals
described below. Note that under both alternative proposals, we still
proposed to add the eleven
[[Page 86146]]
procedures proposed under this section for CY 2021.
Comment: Multiple commenters supported adding the eleven procedures
we proposed to add to the ASC CPL under the established process for
assessing procedures for inclusion on the ASC CPL. They noted that
orthopedic surgeons in ASCs are increasingly performing these eleven
procedures safely and effectively on non-Medicare-fee-for-service
patients and appropriate Medicare patients. Two of these procedures,
total hip arthroplasty (THA) and autologous chondrocyte knee
implantation, received significant support from commenters. Commenters
noted that due to advancements in clinical practice, less invasive
techniques, patient selection, improved perioperative anesthesia,
alternative postoperative pain management and expedited rehabilitation
protocols, these procedures can be safely and effectively performed for
Medicare beneficiaries in the ASC setting. These commenters observed
that patients are typically not expected to require active medical
monitoring and care at midnight following these procedures.
Several commenters opposed the addition of THA to the CPL due to
the risk of jeopardizing patient safety as well as expanded beneficiary
coinsurance obligations. These commenters also recommended CMS ensure
beneficiaries are informed in advance that, unlike under the OPPS, ASC
cost-sharing is not capped at the inpatient deductible and could exceed
cost sharing in the hospital outpatient setting for the same procedure.
One commenter stated that CMS should delay adding THA to the ASC CPL
until there is more robust outcomes data available.
Response: We thank commenters for providing public comments on the
appropriateness of adding THA and other procedures to the ASC CPL and
recognize their concerns for ensuring patient health and quality care.
As we have noted in the CY 2019 OPPS/ASC final rule (83 FR 59046) and
the CY 2020 OPPS/ASC final rule (84 FR 61354), we continue to believe
that the appropriate site of service for any surgical procedure,
including THA, should be based on the physician's assessment of the
patient and tailored to the individual patient's needs. We believe
there are a number of less medically complex Medicare beneficiaries
that could appropriately receive THA in an ASC setting. For these
beneficiaries, physicians should continue to play an important role in
exercising their clinical judgment when making site-of-service
determinations.
We are aware that beneficiaries may incur greater cost-sharing for
THA procedures in an ASC setting under our proposal, but note that this
is not an occurrence that is unique to THA. As we stated in the CY 2018
OPPS/ASC final rule with comment period (82 FR 59389), section 4011 of
the 21st Century Cures Act (Pub. L. 114-255) amended section 1834 of
the Act by adding a new subsection (t), which requires the Secretary to
make available to the public via a searchable website, with respect to
an appropriate number of items and services, the estimated payment
amount for the item or service under the OPPS and ASC payment system
and the estimated beneficiary liability applicable to the item or
service. We implemented this provision by providing our Outpatient
Procedure Price Lookup tool available via the internet at https://www.medicare.gov/procedure-price-lookup. This web page allows
beneficiaries to compare their potential cost-sharing liability for
procedures performed in the hospital outpatient setting versus the ASC
setting. We believe this tool helps inform beneficiaries of potential
cost-sharing amounts for receiving a service in the ASC setting
compared to the outpatient setting, and note that this tool would
include a comparison of cost-sharing liability for THA in the
outpatient hospital and ASC settings in the future. Given these
reasons, we do not believe a delay in the implementation of our
proposed additions to the ASC CPL is warranted based on concerns
relating to beneficiary safety or the potential for greater cost
sharing expenses for beneficiaries.
We assessed each of the eleven procedures we proposed to add to the
ASC CPL using the existing regulatory safety criteria and determined
that these procedures meet each of the criteria. Based on our review of
the clinical characteristics of the procedures and their similarity to
other procedures that are currently included on the ASC CPL, we believe
the eleven procedures (CPT codes 0266T, 0268T, 0404T, 21365, 27130,
27412, 57282, 57283, 57425, C9764, and C9766) can be safely performed
in the ASC setting and note that the physician should determine whether
a particular beneficiary would be a good candidate to undergo a
procedure in the ASC setting rather than the hospital setting based on
the clinical assessment of the patient. We agree with commenters who
stated that advancements in clinical practice, less invasive
techniques, patient selection, improved perioperative anesthesia,
alternative postoperative pain management and expedited rehabilitation
protocols have allowed these procedures to safely be performed in an
ASC setting.
Therefore, in this final rule with comment period, we are
finalizing our proposal without modification to add these eleven
procedures to the ASC CPL. These procedures, listed in Table 59 of this
CY 2021 OPPS/ASC final rule, are:
CPT code 0266T (Implantation or replacement of carotid
sinus baroreflex activation device; total system (includes generator
placement, unilateral or bilateral lead placement, intra-operative
interrogation, programming, and repositioning, when performed)),
CPT code 0268T (Implantation or replacement of carotid
sinus baroreflex activation device; pulse generator only (includes
intra-operative interrogation, programming, and repositioning, when
performed),
CPT code 0404T (Transcervical uterine fibroid(s) ablation
with ultrasound guidance, radiofrequency),
CPT code 21365 (Open treatment of complicated (eg,
comminuted or involving cranial nerve foramina) fracture(s) of malar
area, including zygomatic arch and malar tripod; with internal fixation
and multiple surgical approaches,
CPT code 27130 (Arthroplasty, acetabular and proximal
femoral prosthetic replacement (total hip arthroplasty), with or
without autograft or allograft
CPT code 27412 (Autologous chondrocyte implantation, knee)
CPT code 57282 (Colpopexy, vaginal; extra-peritoneal
approach (sacrospinous, iliococcygeus))
CPT code 57283 (Colpopexy, vaginal; intra-peritoneal
approach (uterosacral, levator myorrhaphy)
CPT code 57425 (Laparoscopy, surgical, colpopexy
(suspension of vaginal apex))
CPT code C9764 (Revascularization, endovascular, open or
percutaneous, lower extremity artery (ies), except tibial/peroneal;
with intravascular lithotripsy, includes angioplasty within the same
vessel (s), when performed
CPT code C9766 (Revascularization, endovascular, open or
percutaneous, lower extremity artery (ies), except tibial/peroneal;
with intravascular lithotripsy and atherectomy, includes angioplasty
within the same vessel (s), when performed.
[[Page 86147]]
(1) Proposed Changes to General Exclusion Criterion for Procedures
Requiring Inpatient Care To Conform to Proposed Changes to the
Underlying Requirements Under the OPPS
As described in section IX.B. of the CY 2021 OPPS/ASC proposed
rule, CMS proposed to eliminate the OPPS IPO list and amend 42 CFR
419.22(n) to state that effective beginning on January 1, 2021, the
Secretary shall eliminate the list of services and procedures
designated as requiring inpatient care through a 3-year transition,
with the full list eliminated in its entirety by January 1, 2024. We
believed that retaining Sec. 416.166(c)(6) would ensure that
procedures that are largely performed on an inpatient basis and cannot
be safely performed on an ambulatory basis will not be added to the CPL
prematurely. As a result, we proposed to revise the regulatory language
and modify this standard to exclude procedures designated as requiring
inpatient care under Sec. 419.22(n) as of December 31, 2020.
Comment: Commenters had concerns about modifying the general
exclusion criteria at Sec. 416.166(c)(6) to exclude procedures
designated as requiring inpatient care.
Several commenters supported retaining the exclusion of procedures
designated as requiring inpatient care, due to patient safety and
quality of care concerns. These commenters urged caution in how CMS
modifies criteria and adds procedures to the CPL, with one noting that
they do not believe there is currently enough information to determine
if these procedures would be clinically appropriate to perform in an
outpatient or ASC setting.
Other commenters opposed this modification and believed this
exclusionary criterion should be removed. These commenters urged CMS
not to finalize this proposal, as they believe it is counter to CMS'
intention to expand physician and patient choice.
Response: We thank commenters for their suggestions. As we discuss
in more detail later in this section, we believe that retaining
regulatory text similar to Sec. 416.166(c)(6) in CY 2021 will ensure
that procedures that cannot be safely performed on an ambulatory basis
will not be added to the CPL. As a result, we are modifying this
standard for CY 2021 and future years to exclude procedures designated
as requiring inpatient care under Sec. 419.22(n) as of December 31,
2020. We are revising the regulatory language at Sec. 416.166(c)(6) to
reflect this change at Sec. 416.166(b)(2)(i)(A).
(2) Alternative Proposals Under Consideration for CY 2021
In the CY 2021 OPPS/ASC proposed rule (85 FR 48958), we stated
that, for CY 2021, we are continuing to build on our efforts to
maximize patient and physician choice and access to care by exploring
broader approaches to adding procedures to the ASC CPL in order to
further increase the availability of ASCs as an alternative site of
care for Medicare beneficiaries, often at a lower cost than other
options. In light of the current national Public Health Emergency
related to COVID-19 and its anticipated lasting effects on the health
care system, we noted that we also believe a broader approach for
adding procedures to the ASC CPL would allow for a more efficient use
of healthcare resources and infrastructure. An expansion of the ASC CPL
would maximize the ability of ASCs to divert patients that can be
safely treated in an ASC setting away from the hospital setting, which
would preserve the capacity of hospitals to treat more acute patients.
We explained that expanding the procedures placed on the ASC CPL would
also build on the policy changes we have made in recent years to
further site neutrality between the HOPD and ASC settings. In light of
these objectives, we proposed two alternatives to our existing policy
of adding procedures to the ASC CPL, each of which we believed would
further support these goals.
a. Alternative Proposal To Create a Nomination Process
Under the first approach, we proposed a nomination process for
adding new procedures to the ASC CPL. We explained that this process
would involve soliciting recommendations from external stakeholders,
like medical specialty societies and other members of the public, for
procedures that may be suitable candidates to add to the ASC CPL. As
discussed in greater detail below, under this approach, we proposed to
provide parameters as guidelines that we would strongly encourage
stakeholders to consider in nominating procedures for the ASC CPL. We
noted that we anticipated stakeholders, such as specialty societies
that specialize in and have a deep understanding of the complexities
involved in providing certain procedures, would be able to provide
valuable suggestions as to which additional procedures may reasonably
and safely be provided in an ASC.
While members of the public may already suggest procedures to be
added to the CPL through meetings with CMS or through public comments
to the proposed rule, we stated in the proposed rule that we believe it
may be beneficial to adopt a streamlined process under which the
public, particularly specialty societies that are very familiar with
procedures in their specialty, can nominate procedures based on the
latest evidence available as well as input from their memberships. We
noted that we believe this revised process could increase transparency
in how we are assessing procedures to add to the ASC list and also help
ensure that we are assessing the list in a more streamlined fashion.
We proposed that the nomination process would be conducted through
annual notice and comment rulemaking and the final determinations
regarding nominated procedures would be decided in the final rule.
Specifically, for the OPPS/ASC rulemaking for a calendar year, we would
request stakeholder nominations by March 1 of the previous calendar
year, with all nominations received by that date considered in the next
applicable rulemaking cycle, likely the rulemaking for the following
calendar year. Any nominations received after that date, including
those received through comments as part of the rulemaking cycle, would
generally be addressed in rulemaking the following year. CMS would
evaluate procedures nominated by stakeholders based on the applicable
statutory and regulatory requirements for ASC covered surgical
procedures and the additional parameters specified in detail below. We
proposed to establish the nomination process in the CY 2021 final rule
to begin in CY 2021, for surgical procedures that could be added to the
ASC CPL beginning in CY 2022. We proposed a process under which
nominated procedures would be included in the proposed rule for that
calendar year, along with a summary of the policy and factual
justification for adding or not adding each procedure, which would
allow members of the public to assess and provide comment on nominated
procedures during the public comment period. We indicated that, after
reviewing comments provided during the public comment period, CMS would
finalize adding the procedures that meet the requisite criteria to the
ASC CPL in the final rule. In the event that CMS disagreed with any
procedures nominated, we would provide a specific rationale in the
final rule. We stated that, in certain cases, CMS may need to defer a
final determination regarding a nominated procedure to future
rulemaking in order to provide sufficient time to evaluate and make the
[[Page 86148]]
most appropriate decision about the nominated procedure.
Under this alternative proposal, we proposed to update the ASC CPL
by considering whether nominated procedures meet the requirements for
covered surgical procedures under 42 CFR 416.166(b), which sets out the
general standards for covered surgical procedures, requiring that
surgical procedures be separately paid under the OPPS, not be expected
to pose a significant safety risk to a Medicare beneficiary when
performed in an ASC, and for which standard medical practice dictates
that the beneficiary would not typically be expected to require active
medical monitoring and care at midnight following the procedure. We
also proposed to eliminate the general exclusion criteria in 42 CFR
416.166(c)(1) through (5) such that nominated procedures would not have
to meet those criteria. Further, we proposed to modify Sec.
416.166(c)(6) to align the regulatory text with the proposed
elimination of the IPO list. Finally, we proposed that nominated
procedures would need to meet the general exclusions at 42 CFR
416.166(c)(7) and (8).
With respect to the existing general exclusion at 42 CFR
416.166(c)(6), which excludes procedures designated as requiring
inpatient care under 42 CFR 419.22(n) from classification as covered
surgical procedures, we noted that this alternative proposal would
modify this standard since the IPO list is being proposed to be
eliminated beginning in CY 2021, as described in section IX.B of the CY
2021 OPPS/ASC proposed rule. Therefore, we proposed to modify this
criterion to exclude procedures designated as requiring inpatient care
under Sec. 419.22(n) as of December 31, 2020. In other words, we would
not accept any nominations for procedures to add to the ASC CPL if the
procedure is on the CY 2020 IPO list. We proposed to retain the
criteria at Sec. 416.166(c)(6) through (8) and eliminate the five
exclusions currently at Sec. 416.166(c)(1) through (5) because we
believed that the general standards at Sec. 416.166(b) provide
sufficient guardrails to ensure, along with appropriate patient
selection and the complex medical judgment of the physician, that
procedures can be performed safely on an ambulatory basis, including
certain procedures that may involve these five exclusions. We explained
that we believed this alternative proposal could balance the goals of
increasing physician and patient choice and expanding site neutral
options with patient safety considerations.
Additionally, we also proposed parameters for stakeholders to
consider and specifically address in nominating procedures to add to
the ASC CPL. These parameters would be general guidelines, not
requirements, and we sought public comment on these suggested
parameters including language changes, recommendations for additional
parameters, potential unintended implications of the parameters we
proposed, and whether we should finalize these parameters if this
alternative proposal is finalized in the CY 2021 final rule.
We stated that we believe a nomination process will take time to
develop and stakeholders will need time to consider and evaluate
potential nominations. We proposed to implement this process for CY
2021 in order to accept nominations for procedures to be added to the
ASC CPL beginning in CY 2022.
b. Alternative Proposal To Revise Criteria and Add Codes to the ASC-CPL
In the CY 2021 OPPS/ASC proposed rule (85 FR 4896), we also
considered another alternative approach that would allow for more
immediate changes to the ASC CPL for CY 2021 and beyond. Specifically,
under this alternative proposal, we proposed to keep the existing
general standards under 42 CFR 416.166(b) that currently require
covered surgical procedures to be surgical procedures specified by the
Secretary and published in the Federal Register and/or via the internet
on the CMS website, separately paid under the OPPS, not be expected to
pose a significant safety risk to a Medicare beneficiary when performed
in an ASC, and for which standard medical practice dictates that the
beneficiary would not typically be expected to require active medical
monitoring and care at midnight following the procedure. However, under
this alternative proposal, we proposed to eliminate five of the current
general exclusion criteria at 42 CFR 416.166(c)(1) through (5). We
considered whether these five exclusionary criteria may no longer be
necessary to determine what procedures can be safely added to the ASC
CPL because many ASCs are currently able to safely provide services
with these characteristics based on prior stakeholder feedback and
public comments we have received.
We explored whether it is appropriate to remove the general
exclusion criteria, which we explained would allow physicians
practicing in the ASC setting, who have the greatest familiarity and
insight into the needs of individual beneficiaries, to use their
complex medical judgment to determine whether they can safely perform a
procedure in the ASC, given the entirety of the circumstances,
including the clinical profile of the patient, the surgical back-up
available at the ASC, and the ability to safely and timely respond to
unexpected complications. Under this alternative proposal, we stated
that we would keep the remaining three general exclusion criteria at 42
CFR 416.166(c)(6) through (8), as the original reasons we adopted them
in CY 2008 continue to exist, subject to the proposed modifications to
Sec. 416.166(c)(6). These criteria would continue to prohibit the
addition of certain procedures to the ASC CPL, namely those that are:
designated as requiring inpatient care under 42 CFR 419.22(n) as of
December 31, 2020; can only be reported using a CPT unlisted surgical
procedure code; or otherwise excluded under 42 CFR 411.15. We proposed
to retain these criteria and eliminate the previous five criteria
because we believe that the general standards alone are sufficient
guardrails to ensure, along with appropriate patient selection and
complex medical judgment of the physician, that the procedure can be
performed safely on an ambulatory basis, including procedures that
involve these five characteristics.
We noted that, with respect to the existing general exclusion at 42
CFR 416.166(c)(6), which excludes procedures designated as requiring
inpatient care under 42 CFR 419.22(n) from classification as covered
surgical procedures, the alternative proposal would modify this
standard since the IPO list was proposed to be eliminated beginning in
CY 2021, as described in section IX.B of the CY 2021 OPPS/ASC proposed
rule. Therefore, we proposed to modify this criterion to exclude
procedures designated as requiring inpatient care under 419.22(n) as of
December 31, 2020. In other words, not all procedures on the current
(that is, CY 2020) IPO list would necessarily meet the remaining
revised criteria to be added to the ASC CPL. However, because any
procedure not on the IPO can be performed safely on an ambulatory basis
in the hospital outpatient setting, we believe that the remaining
criteria in 42 CFR 416.166, most notably the exclusion of services that
are on the current IPO list, could sufficiently limit the expansion of
the ASC CPL to those services that can be safely performed on an
ambulatory basis. As previously mentioned, we proposed to retain the
criteria in Sec. 416.166(c)(6) through (8) and
[[Page 86149]]
eliminate the five criteria currently at Sec. 416.166(c)(1) through
(5) because we believe that the general standards at Sec. 416.166(b)
provide sufficient guardrails to ensure, along with appropriate patient
selection and the complex medical judgment of the physician, that
procedures can be performed safely on an ambulatory basis, including
certain procedures that may involve these five characteristics. We
explained that we believed this alternative proposal could balance the
goals of increasing physician and patient choice and expanding site
neutral options with patient safety considerations.
We identified approximately 270 potential surgery or surgery-like
codes that we believed would meet the proposed revised criteria for
being added to the ASC CPL under 42 CFR 416.166. That is, we reviewed
these procedures and found that they would meet the proposed revised
regulatory requirements that would be in effect if we were to adopt
this alternative proposal. Specifically, the identified procedures
under this alternative proposal were surgical procedures that are
separately paid under the OPPS, that would not be expected to pose a
significant safety risk to a Medicare beneficiary when performed in an
ASC, and for which standard medical practice dictates that the
beneficiary would not typically be expected to require active medical
monitoring and care of the beneficiary at midnight following the
procedure, that have not been designated as requiring inpatient care
under Sec. 419.22(n) as of December 31, 2020, that can be reported
without using a CPT unlisted surgical procedure code, and are not
otherwise excluded under 42 CFR 411.15.
Additionally, we noted that, while several of the identified
procedures may typically require active medical monitoring and care at
midnight following the procedure, we expect that an appropriately
selected patient population in the ASC setting would be healthier and
less complex and would likely not require active monitoring or medical
care at midnight following the procedure. We believed that these
procedures are safe to perform in an ASC setting because all procedures
identified are already payable in the HOPD setting and, therefore, are
already safely performed on an ambulatory basis, consistent with the
statutory requirement under section 1833(i)(1) of the Act. We proposed
to retain the general standard criteria, as we believe these criteria
are sufficient to ensure that procedures meet the statutory
requirements and can be safely performed in ASCs. We sought public
comment on whether any of these procedures would typically require care
after midnight, and, therefore, should not be added to the ASC CPL.
We stated that we believed this alternative proposal could have
beneficial effects for Medicare beneficiaries and healthcare
professionals. For beneficiaries, expansion of the ASC CPL would
increase access to procedures in ambulatory surgery settings, often at
a lower cost. ASCs and healthcare professionals would also benefit from
this proposal as this expansion would better utilize the potential of
existing healthcare resources and expand the capacity of the healthcare
system. Further, under this alternative, physicians would have greater
flexibility to divert patients who can be safely treated in the ASC
setting away from hospitals and preserve hospital capacity for more
acute patients.
We acknowledged that this approach was a departure from the
existing criteria that we established effective beginning in 2008.
However, we believed that this approach would expand and build upon our
2008 policy intent. In the August 2, 2007 final rule with comment
period, we discussed criteria for procedures excluded from the ASC CPL
under the revised ASC payment system (72 FR 42478 through 42484).
However, although there are differences, much of the underlying
rationale we used to develop the August 2, 2007 final rule revised
criteria remains true under the broader CY 2021 proposal. For example,
in the August 2, 2007 final rule with comment period, we indicated that
we believed that any procedure for which we did not allow payment in
the hospital outpatient setting due to safety concerns would not be
safe to perform in an ASC (72 FR 42478). Much like we are considering
now, we excluded from the ASC list any procedure on the IPO list, and
committed to excluding surgical procedures that pose significant safety
risks to beneficiaries or that are expected to require an overnight
stay (72 FR 42478 through 42479). Although there are some differences
when comparing our CY 2008 criteria and the proposed CY 2021 criteria,
such as removing several of the original general exclusion criteria,
permitting the addition of procedures to the ASC CPL that would have
been prohibited by those criteria, and the different accreditation
requirements and conditions of participation requirements between HOPDS
and ASCs, these concerns have largely been addressed by the progress in
medical practice and ASC capabilities in the twelve years since the
criteria were developed as previously noted. We noted that, in
particular, given advances in the practice of medicine and the evolving
nature of ASCs, we believe ASCs are now better equipped to safely
perform procedures that were once too complex or risky to be performed
safely on Medicare beneficiaries in the ASC setting. As previously
mentioned, although ASCs and hospitals have different health and safety
requirements, many ASCs often undergo accreditation as a condition of
state licensure and share some similar licensure and compliance
requirements with hospitals. We recognized that each of these
requirements provides additional safeguards for the health and safety
of Medicare beneficiaries receiving surgical procedures in an ASC.
(3) Comment Solicitation on Potential Revisions to the ASC Conditions
for Coverage if Alternative 2 Is Adopted
In the proposed rule (85 FR 48962), we stated that we were
considering allowing more invasive and lengthy surgical procedures to
be performed in ASCs. We were seeking public input regarding what
revisions to the ASC CfCs would be needed, if any, to ensure patient
safety in response to the additional range of complex services that
would be added to the ASC-CPL and noted that we might adopt such
revisions as final in the CY 2021 final rule.
We also solicited comments on specific examples contained within
the current ASC CfCs. We noted that we were especially interested in
public comments about some specific CfCs and whether they should be
more prescriptive and require additional elements. Those items included
expanded risk evaluations, additional nursing personnel, requiring
staff be trained in Advanced Cardiac Life Support, and the requirement
that ASCs identify certain patient conditions or more complex
procedures that require a medical history and physical examination
prior to surgery.
(3) Summary of Proposals
For CY 2021, we proposed to add eleven procedures using the
standard ASC CPL review process under our current regulations. In
addition, we included two alternative proposals that we noted that we
might finalize for CY 2021. One alternative was to establish a
nomination process for CY 2021, which would allow us to propose to add
nominated procedures beginning in CY 2022. Under this proposal,
external stakeholders, such as professional
[[Page 86150]]
specialty societies, would nominate procedures that can be safely
performed in the ASC setting based on the requirements in the ASC
regulations, revised as described in the CY 2021 OPPS/ASC proposed rule
(that is, retaining the general standard criteria and eliminating five
of the general exclusion criteria), along with suggested parameters and
all other regulatory standards. CMS would review and finalize
procedures through annual rulemaking.
Alternatively, we proposed to revise the ASC CPL criteria under 42
CFR 416.166, retaining the general standard criteria and eliminating
five of the general exclusion criteria. Using these revised criteria,
we proposed to add approximately 270 potential surgery or surgery-like
codes to the CPL that are not on the CY 2020 IPO list. We proposed to
finalize only one of these alternative proposals, and we welcomed
public comment as to which policy should be adopted in the final rule.
After consideration of the issues discussed earlier in this
section, we noted that we believed that these proposed policies struck
an appropriate balance between flexibility for physicians to exercise
their complex medical judgment in factoring in patient safety
considerations and flexibility for patients to choose from more
settings of care in which to receive surgical procedures.
Comment: Many commenters were concerned that the alternative
proposal to revise the general exclusion criteria at 42 CFR 416.166(c)
and add 267 potential surgery or surgery-like procedures that are not
on the current IPO list to the ASC-CPL list would not give adequate
consideration to patient safety or stakeholder input. One commenter
urged CMS not to finalize this alternative proposal, which the
commenter believed would eliminate several safety ``guardrails.''
Another commenter stated that CMS should not remove the proposed
exclusion criteria for the ASC CPL at 42 CFR 416.166(c) in light of
what the commenter believed were oversight, quality, and safety
concerns. Specifically, the commenter felt that procedures excluded by
these safeguards were major and potentially life-threatening procedures
that were appropriately excluded from ASCs, ASCs are not generally
equipped to handle extensive blood loss or emergent and life-
threatening procedures, the time waiting for emergency transport to a
hospital would potentially place beneficiary life in jeopardy, and that
these risks may occur even if a physician believes that the individual
beneficiary's clinical condition would allow these procedures to be
performed in an ASC.
Several commenters supported the alternative proposal to revise the
general exclusion criteria at 42 CFR 416.166(c) and add 267 potential
surgery or surgery-like procedures not on the current IPO list to the
ASC CPL. They believed that medical research and technological advances
have allowed for similar outcomes and a comparable quality of care for
patients in both the outpatient hospital and ASC settings. One
commenter supported this alternative proposal because they believed
expanding the ASC CPL would increase the availability of ASCs as
alternative care sites and preserve inpatient hospital capacity for
higher acuity patients. The commenter agreed with CMS that significant
advancements in medical practice, surgical techniques, and technology
have allowed certain ASCs to perform procedures that were once too
complex to be safely performed in an ASC.
Some commenters urged CMS not to treat ASCs as the equivalent of
hospital outpatient departments because, as the commenter explained,
they are not regulated as hospitals and do not have the necessary
resources on site to provide the higher level of care necessary to
perform many of the surgical procedures we would add to the ASC CPL if
our proposal is finalized.
One commenter supported removing the five exclusionary criteria at
42 CFR 416.166(c)(1) through (5), stating that physicians are best
equipped to make decisions about site of service for their patients.
Response: Under Sec. 416.166, covered surgical procedures are
those surgical procedures that meet the general standards specified in
Sec. 416.166(b) and are not excluded under the general exclusion
criteria specified in Sec. 416.166(c). Both of our alternatives
included a proposal to eliminate the exclusion criteria at Sec.
416.166(c)(1) through (5), which currently require that covered
surgical procedures do not include procedures that: (1) Generally
result in extensive blood loss; (2) require major or prolonged invasion
of body cavities; (3) directly involve major blood vessels; (4) are
generally emergent or life threatening in nature; or (5) commonly
require systemic thrombolytic therapy. While these are important
considerations in determining whether a surgical procedure may be
safely performed in an ASC, we considered that it may no longer be
necessary for CMS to apply these five exclusionary criteria because, as
we have heard from many stakeholders, ASCs are currently and
increasingly able to safely provide services with these
characteristics.
We have previously recognized the importance of increasing
flexibility in our review of procedures for safe performance in the ASC
setting, and we have been able to add surgical procedures to the ASC
CPL that were once considered hospital inpatient procedures, including,
for example, total knee arthroplasty and certain coronary intervention
procedures involving major blood vessels. We believe it important that
we adapt the ASC CPL in light of the significant advances in medical
practice, surgical techniques, and ASC capabilities that have enabled
some ASCs to safely perform procedures that were once too complex for
the ASC setting, including those involving major blood vessels and
other general exclusion criteria. Indeed, as we noted earlier, many
procedures that are currently only payable as hospital outpatient
services under Medicare are safely performed in the ASC setting for
other payors. We acknowledge that non-Medicare patients tend to be
younger and have fewer comorbidities than the Medicare population, but
careful patient selection can identify Medicare beneficiaries who are
suitable candidates to receive these services in the ASC setting. We
have long recognized the importance of ensuring that the health care
system has as many access points and patient choices for all Medicare
beneficiaries as possible, and we believe it is important that we
continue to support greater flexibility for physicians and patients to
choose ASCs as the site of care in supporting those important goals.
We agree with commenters who support our proposal to revise the
general exclusion criteria at Sec. 416.166(c), to eliminate Sec.
416.166(c)(1) through (5), because medical advances and careful patient
selection have allowed procedures that were once too complex for the
ASC setting to now be safely performed in ASCs. Importantly, physicians
have always played a critically significant role in determining the
appropriate site of care for their patients, and we believe it is
appropriate that patient choice and physician judgement determine
whether a surgical procedure may be safely performed in the ASC setting
for each individual patient. Therefore, we are finalizing our proposal
for CMS to no longer apply the exclusion criteria at Sec.
416.166(c)(1) through (5) beginning on January 1, 2021. However, while
CMS will no longer apply those five criteria in determining whether a
procedure is a covered surgical procedure, we believe they are
important safety factors that
[[Page 86151]]
physicians consider in making site-of-service determinations for their
specific beneficiaries. Accordingly, general exclusions one through
five will continue to be displayed under a new paragraph (d) titled
``Physician considerations beginning January 1, 2021,'' at Sec.
416.166(d) for physicians to consider in selecting the most appropriate
site of service for their patients.
Consistent with our recognition of the primary importance of the
role physicians play in exercising their clinical judgment for each
specific patient to assess whether a covered surgical procedure can be
safely performed in the ASC setting, for all the same reasons we
identify above, we are also recognizing that physicians are better-
positioned than CMS to determine that a surgical procedure is not
expected to pose a significant safety risk for a specific beneficiary
and is one for which standard medical practice for the specific
beneficiary dictates the beneficiary would not typically be expected to
require active medical monitoring and care at midnight following the
procedure. While these two considerations, currently reflected in Sec.
416.166(b), are ones that CMS has made to date in determining whether a
surgical procedure is a covered surgical procedure, we are also
shifting the responsibility for these two considerations from CMS to
physicians, as now reflected in Sec. 416.166(d)(1) and (2).
CMS will continue to designate procedures as covered surgical
procedures. That is, we will continue to determine that surgical
procedures can be covered surgical procedures if, under current Sec.
416.166(b), they are separately paid under the OPPS, and, under current
Sec. 416.166(c)(6) through (8), are not designated as requiring
inpatient care under 42 CFR 419.22(n), are not only able to be reported
using a CPT unlisted surgical procedure code, or are not otherwise
excluded under 42 CFR 411.15. We are revising Sec. 416.166(b) to
reflect these requirements for procedures to be designated by CMS as
covered surgical procedures. With regard to the criterion at current
Sec. 416.166(c)(6), that is, covered surgical procedures are those not
designated as requiring inpatient care under 42 CFR 419.22(n), as
described in section IX.B. of the CY 2021 OPPS/ASC proposed rule, CMS
is eliminating the OPPS IPO list and amending 42 CFR 419.22(n) to state
that effective beginning on January 1, 2021, the Secretary shall
eliminate the list of services and procedures designated as requiring
inpatient care through a three-year transition, with the IPO list
eliminated in its entirety by January 1, 2024. Therefore, we are
specifying in revised Sec. 416.166(b) that covered surgical procedures
may not include those surgical procedures that are designated as
requiring inpatient care under 42 CFR 419.22(n) as of December 31,
2020. If CMS determines that a surgical procedure meets the four
requirements at revised Sec. 416.166(b), CMS will designate the
procedure a covered surgical procedure and place it on the ASC CPL.
Physicians then have the opportunity to assess whether their specific
patients can or cannot safely receive such covered surgical procedure
in the ASC setting based on the considerations now reflected in Sec.
416.166(d).
We disagree with the commenters who believe that expansion of the
ASC CPL would negatively affect beneficiary safety or quality of care.
We believe the policy we are finalizing to allow patients and
physicians to determine the most appropriate site of care for an
individual patient will continue to ensure patient safety. As we
discuss above, physicians and patients are best-positioned to make
patient-specific site-of-service determinations for their individual
patients. Physicians have the greatest familiarity with and
understanding of the needs of their individual patients and will use
their complex medical judgment to determine whether a procedure can be
safely performed in the ASC, given their patients' clinical profiles,
available surgical back-up at the ASC, and the ability to safely and
timely respond to unexpected complications, among other important
considerations.
We believe there are numerous other safety considerations that will
affect a physician's decision to perform a particular service in the
ASC setting, separate from the inclusion of the procedure on the ASC
CPL and the physician's medical judgment. These include the Medicare
Conditions for Coverage (CfCs), Medicare's ASC quality rating program
(ASCQR), public and private accreditations and certifications,
malpractice insurance premiums, and the pressures of market
competition, all of which could be negatively impacted if an ASC does
not appropriately take patient safety concerns into account when
deciding to perform a particular procedure in the ASC setting. We are
confident that all of these factors will help to ensure facilities and
providers carefully assess each patient and determine the most
appropriate site of service for procedures on the ASC CPL.
In accordance with our final policy that CMS will apply the four
criteria at new Sec. 416.166(b)(2), we are adding the 267 surgery and
surgery-like codes to the ASC CPL we proposed to add under the second
alternative because they meet the requirements at new Sec.
416.166(b)(2). This policy is in keeping with our policy changes made
in recent years to further site neutrality between the HOPD and ASC
settings. With this addition of procedures to the ASC CPL, CMS is
making available a broader range of surgical procedures that Medicare
will pay for when performed in the ASC setting, which will further
increase the availability of ASCs as an alternative site of care for
Medicare beneficiaries, while also ensuring patient safety through
CMS's and physicians' respective roles in determining that procedures
can be safely performed in an ASC.
Physicians are not required to maintain new documentation of their
determination that procedures meet the revised CPL regulatory criteria,
beyond what they are already required by Medicare. At this time, we
believe that additional documentation and compliance activities
associated with the revision of the CPL criteria are not necessary, as
we noted earlier there remain many factors that encourage ASCs and
physicians to appropriately consider patient safety in making site-of-
service determinations for individual beneficiaries.
Comment: The majority of commenters supported the alternative
proposal to establish a process for the public to nominate procedures
for addition to the ASC CPL. These commenters generally supported this
proposal because they believed it would better address beneficiary
safety concerns than the alternative proposal to remove the general
exclusion criteria at Sec. 416.166(c)(1) through (5). Several
commenters noted that this alternative proposal would formalize the
review process that occurs currently, provide transparency, and
increase opportunity for engagement with providers and external
stakeholders. One commenter believed that establishing a formal
nomination process would streamline the process for specialty societies
to suggest procedures that can be safely performed in ASCs. Several
commenters believed a nomination process would avoid the potential
patient safety risks associated with adding 267 procedures to the ASC
CPL before stakeholders are able to review the procedures and analyze
whether they are appropriate to furnish in an ASC. One commenter
believed that CMS should formalize a stakeholder nomination process for
future years with greater transparency and standardization. Another
commenter recommended that CMS
[[Page 86152]]
give greater consideration to nominations from professional specialty
societies, which include physicians who have clinical expertise
regarding procedures that can be performed in an ASC.
A number of commenters, largely hospitals and hospital
associations, opposed both alternatives and raised safety concerns
about expanding the ASC CPL. These commenters stated that both
proposals would ``substantially weaken the agency's process'' and
explained that Medicare beneficiary safety and quality of care could be
negatively affected if Medicare pays for these higher risk surgical
procedures when performed in an ASC. A few commenters believed we
should finalize both alternative proposals, which they viewed as
complementary and not mutually exclusive. Another commenter felt that
finalizing both proposals would remove a barrier to physicians
exercising their clinical judgment as to the appropriate setting of
care for a particular patient.
Response: In the CY 2021 OPPS/ASC proposed rule (85 FR 48959), we
proposed a nomination process that would involve CMS updating the ASC
CPL if we determined that a nominated procedure met the requirements
for covered surgical procedures under the regulations at 42 CFR
416.166, as we proposed to amend them. We proposed that the nomination
process would be conducted through annual notice and comment rulemaking
such that stakeholders would nominate surgical procedures they believed
should be added to the ASC CPL by March 1, and CMS would propose and
potentially finalize those nominated procedures for addition to the ASC
CPL in the next applicable rulemaking cycle. We explained in the
proposed rule that we believed a nomination process would provide
external stakeholders, including specialty societies and physicians, a
formalized process for notifying CMS of procedures that should be added
to the ASC CPL. As with our other alternative proposal, we also
proposed that we would revise the general exclusion criteria at Sec.
416.166(c) by eliminating Sec. 416.166(c)(1) through (5).
With regard to the proposal to eliminate the general exclusions at
Sec. 416.166(c), which as we noted was a common feature of both
alternative proposals, we discussed previously in this section that we
are finalizing this proposal beginning January 1, 2021. We believe
physicians may consider each of those five safety factors at current
Sec. 416.166(c)(1) through (5) in making site-of-service
determinations for their specific beneficiaries. In addition, we
explained that physicians will now consider whether a surgical
procedure is not expected to pose a significant safety risk for
specific beneficiaries and is one for which standard medical practice
dictates the beneficiary would not typically be expected to require
active medical monitoring and care at midnight following the
procedure--criteria at Sec. 416.166(b) that have until now been part
of CMS's process for adding procedures to the ASC CPL. While CMS will
still designate surgical procedures as covered surgical procedures and
add them to the ASC CPL, we will apply only the following four
criteria. The procedure is: (1) Separately paid under the OPPS; (2) not
designated as requiring inpatient care under Sec. 419.22(n) as of
December 31, 2020; (3) not only able to be reported using a CPT
unlisted surgical procedure code; or (4) not otherwise excluded under
Sec. 411.15.
In light of the policies we are finalizing, we believe it is still
appropriate for us to adopt a process whereby stakeholders notify CMS
of procedures to be added to the ASC CPL, but a slightly different and
simpler process than the nomination process alternative we proposed. We
agree with commenters that a formalized process whereby the public
notifies CMS of procedures to be added to the ASC CPL would provide
more transparency and increase opportunities for CMS to engage with
providers and external stakeholders in adding procedures to the ASC
CPL. However, because CMS will now be applying only the four criteria
listed in new Sec. 416.166(b)(2) to determine whether a surgical
procedure is a covered surgical procedure, and given that CMS's role
will be more limited than it was when it applied the more subjective
safety criteria, CMS will be able to more expeditiously determine
whether a surgical procedure meets the regulatory requirements for
inclusion on the ASC CPL, and therefore, we do not believe a full
nomination process is necessary.
CMS will add surgical procedures to the ASC CPL as we become aware
of new surgical procedures that meet the four requirements at new Sec.
416.166(b)(2), but we expect the industry may become aware of other
procedures that CMS may not know about, and has therefore not
considered for inclusion on the ASC CPL. In that case, a member of the
public may notify CMS of a surgical procedure any time they believe a
surgical procedure meets the requirements at new Sec. 416.166(b)(2).
CMS will confirm whether the procedure does in fact meet those
requirements and will add it to the ASC CPL if it does. In accordance
with the new regulations we are finalizing at new Sec. 416.166(d),
physicians will then assess whether their specific patients can or
cannot safely receive such covered surgical procedure in the ASC
setting based on the patient-specific considerations reflected in new
Sec. 416.166(d). The process we are finalizing is not a nominations
process so much as a notification process, which we are adding at new
Sec. 416.166(e), titled ``Additions to the list of ASC covered
surgical procedures beginning January 1, 2021,'' to provide that we
will add surgical procedures to the ASC CPL as follows: (1) CMS
identifies a surgical procedure that meets the requirements at
paragraph (b)(2) of this section. (2) CMS is notified of a surgical
procedure that could meet the requirements at paragraph (b)(2) of this
section and CMS confirms that such surgical procedure meets those
requirements.
Comment: In the CY 2021 OPPS/ASC proposed rule (85 FR 48959 through
48960), we suggested parameters for stakeholders to use when evaluating
procedures for nomination. Two commenters agreed that the parameters
were appropriate and would be essential considerations during the
proposed nomination process but recommended modifications, such as
removing the fourth parameter on nearby facilities or adding an
additional parameter evaluating whether data are available to inform
the appropriate clinical support and monitoring for patients in an ASC
setting. Another commenter noted that the parameters were a useful
baseline for adding procedures and could be refined with exceptions or
counterexamples in future years.
Response: We thank the commenters for their feedback. We proposed
that stakeholders would consider the parameters we described in the
proposed rule and address them in a nomination process. As we have
indicated, we are not adopting the nomination process described in the
proposed rule. Rather, we are adopting a simpler approach whereby
entities may notify CMS of procedures they believe meet the four
requirements at new Sec. 416.166(b)(2). If CMS confirms a procedure
does meet those four requirements, CMS will add it to the ASC CPL. At
that point, it will be up to physicians to determine whether a
procedure on the ASC CPL is safe for their specific patients to receive
in an ASC. We are not adopting the parameters we discussed in the
proposed rule because we are not adopting the more formal nomination
process we described in that rule. However, in keeping with our final
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policies, which emphasize the importance of physicians' safety
determinations for their specific patients in deciding whether to
perform a covered surgical procedure in an ASC, physicians should find
the parameters useful in deciding whether to perform a covered surgical
procedure on a particular ASC patient.
Comment: We received a few comments that specifically addressed the
requested information regarding the expansion of the existing ASC CfCs.
Commenters that supported adopting the alternative proposal to revise
the criteria and add additional procedures to the ASC CPL did not
believe it would be necessary to change the ASC CfCs if the alternative
proposal is finalized. Commenters that did not support the proposed
changes to the ASC CPL process and criteria suggested that CMS expand
the ASC CfCs if either of the alternative proposals is finalized. One
commenter also suggested that CMS reinstate the CFCs that were removed
in the 2019 Regulatory Provisions to Promote Program Efficiency,
Transparency, and Burden Reduction final rule (84 FR 51732, 51737
through 52739). Other commenters recommended we work with clinical
experts and other stakeholders to make appropriate changes to the CfCs.
Response: We thank the commenters for their helpful responses to
the RFI. In keeping with our efforts to reduce provider burden and our
stated objectives of prioritizing patient choice and physician
judgement in determining the most appropriate site of service for a
beneficiary, we are declining to modify the ASC CfCs at this time. We
believe there are numerous considerations which effectively incentivize
careful patient selection in ASCs, including accreditation
requirements, insurer and provider privileges, state licensure
requirements, and competitive market forces, to name only a few.
Additionally, we will continue all measures described in our current
CfCs and in Appendix L of the State Operations Manual. We may revisit
modifying the ASC CfCs in the future should the need arise.
After consideration of the public comments we received, we are
finalizing our proposal to add eleven procedures using the standard ASC
CPL review process under our current regulations. In addition, we are
revising the definition of covered surgical procedures at Sec.
416.166(a) to conform to the changes we are making to the requirements
for covered surgical procedures at Sec. 416.166(b)(1) and (2) and (c),
whereby CMS will determine whether the four specified criteria are met
as the basis for adding surgical procedures to the ASC CPL. CMS will
add 267 procedures to the ASC CPL, based upon these changes to the
regulatory criteria. We also recognize that physicians may consider
certain safety factors when determining the most appropriate site of
care for a specific patient. We are adding a new Sec. 416.166(d) to
reflect these considerations. Finally, we are adding new Sec.
416.166(e), which describes how CMS will add a surgical procedure to
the ASC CPL, either on its own initiative or based on a notification
from the public that a procedure not currently on the ASC CPL meets the
criteria for addition to the ASC CPL.
New CPT and HCPCS codes for covered procedures and their final
payment indicators for CY 2021 can be found in section XIII.B of this
CY 2021 OPPS/ASC Final Rule. All ASC covered procedures and their final
payment indicators for CY 2021 are also included in Addendum BB to this
CY 2021 OPPS/ASC final rule (which is available via the internet on the
CMS website).
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2. Covered Ancillary Services
This section was inadvertently omitted from the CY 2021 OPPS/ASC
Proposed Rule. We are finalizing the continuation of our existing
policies relating to covered ancillary services without change. In the
CY 2019 OPPS/ASC final rule (83 FR 59062 through 59063), consistent
with the established ASC payment system policy (72 FR 42497), we
finalized the policy to update the ASC list of covered ancillary
services to reflect the payment status for the services under the CY
2019 OPPS final rule. As discussed in prior rulemaking, maintaining
consistency with the OPPS may result in changes to ASC payment
indicators for some covered ancillary services because of changes that
are being finalized under the OPPS for CY 2021. For example, if a
covered ancillary service was separately paid under the ASC payment
system in CY 2020, but will be packaged under the CY 2021 OPPS, to
maintain consistency with the OPPS, we would also package the ancillary
service under the ASC payment system for CY 2021. In the CY 2019 OPPS/
ASC final rule, we finalized the policy to continue this reconciliation
of packaged status for subsequent calendar years. Comment indicator
``CH'', which is discussed in section XIII.F. of the CY 2021 OPPS/ASC
proposed rule, is used in Addendum BB to this CY 2021 OPPS/ASC final
rule (which is available via the internet on the CMS website) to
indicate covered ancillary services for which we are finalizing a
change in the ASC payment indicator to reflect a finalized change in
the OPPS treatment of the service for CY 2021.
Comment: One commenter requested that we add CPT code 91040
(Esophageal balloon distension study, diagnostic, with provocation when
performed) to our list of covered ancillary services. Commenter stated
that esophageal balloon distension studies are often performed in
conjunction with esophagogastroduodenoscopy procedures. The commenter
noted that not adding this procedure sets a standard that an ancillary
service must be performed 100 percent of the time with the surgical
procedure in order for it to be considered integral, which results in a
smaller subset of ancillary procedures being eligible for payment in
the ASC setting.
Response: Services included in our list of covered ancillary
services must be integral to the performance of a covered surgical
procedure. However, based on the description of the procedure, we do
not believe this service is integral to the performance of the surgical
procedures identified by the commenter, specifically CPT codes 43235
(Esophagogastroduodenoscopy, flexible, transoral; diagnostic, including
collection of specimen(s) by brushing or washing, when performed
(separate procedure)), 43236 (Esophagogastroduodenoscopy, flexible,
transoral; with directed submucosal injection(s), any substance), or
43239 (Esophagogastroduodenoscopy, flexible, transoral; with biopsy,
single or multiple), or other surgical procedures. Therefore, we are
not adding CPT code 91040 to the list of ASC covered ancillary services
for CY 2021.
New CPT and HCPCS codes for covered ancillary services and their
final payment indicators for CY 2021 can be found in section XIII.B of
this CY 2021 OPPS/ASC Final Rule. All ASC covered ancillary services
and their
[[Page 86167]]
final payment indicators for CY 2021 are also included in Addendum BB
to this CY 2021 OPPS/ASC final rule (which is available via the
internet on the CMS website).
D. Update and Payment for ASC Covered Surgical Procedures and Covered
Ancillary Services
1. ASC Payment for Covered Surgical Procedures
a. Background
Our ASC payment policies for covered surgical procedures under the
revised ASC payment system are described in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66828 through 66831). Under our
established policy, we use the ASC standard ratesetting methodology of
multiplying the ASC relative payment weight for the procedure by the
ASC conversion factor for that same year to calculate the national
unadjusted payment rates for procedures with payment indicators ``G2''
and ``A2''. Payment indicator ``A2'' was developed to identify
procedures that were included on the list of ASC covered surgical
procedures in CY 2007 and, therefore, were subject to transitional
payment prior to CY 2011. Although the 4-year transitional period has
ended and payment indicator ``A2'' is no longer required to identify
surgical procedures subject to transitional payment, we retained
payment indicator ``A2'' because it is used to identify procedures that
are exempted from the application of the office-based designation.
The rate calculation established for device-intensive procedures
(payment indicator ``J8'') is structured so only the service portion of
the rate is subject to the ASC conversion factor. In the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61397 through 61400), we
updated the CY 2019 ASC payment rates for ASC covered surgical
procedures with payment indicators of ``A2'', ``G2'', and ``J8'' using
CY 2018 data, consistent with the CY 2020 OPPS update. We also updated
payment rates for device-intensive procedures to incorporate the CY
2020 OPPS device offset percentages calculated under the standard APC
ratesetting methodology, as discussed earlier in this section.
Payment rates for office-based procedures (payment indicators
``P2'', ``P3'', and ``R2'') are the lower of the PFS nonfacility PE
RVU-based amount or the amount calculated using the ASC standard rate
setting methodology for the procedure. In the CY 2020 OPPS/ASC final
rule with comment period, we updated the payment amounts for office-
based procedures (payment indicators ``P2'', ``P3'', and ``R2'') using
the most recent available MPFS and OPPS data. We compared the estimated
CY 2020 rate for each of the office-based procedures, calculated
according to the ASC standard rate setting methodology, to the PFS
nonfacility PE RVU-based amount to determine which was lower and,
therefore, would be the CY 2020 payment rate for the procedure under
our final policy for the revised ASC payment system (Sec. 416.171(d)).
In the CY 2014 OPPS/ASC final rule with comment period (78 FR
75081), we finalized our proposal to calculate the CY 2014 payment
rates for ASC covered surgical procedures according to our established
methodologies, with the exception of device removal procedures. For CY
2014, we finalized a policy to conditionally package payment for device
removal procedures under the OPPS. Under the OPPS, a conditionally
packaged procedure (status indicators ``Q1'' and ``Q2'') describes a
HCPCS code where the payment is packaged when it is provided with a
significant procedure but is separately paid when the service appears
on the claim without a significant procedure. Because ASC services
always include a covered surgical procedure, HCPCS codes that are
conditionally packaged under the OPPS are always packaged (payment
indicator ``N1'') under the ASC payment system. Under the OPPS, device
removal procedures are conditionally packaged and, therefore, would be
packaged under the ASC payment system. There would be no Medicare
payment made when a device removal procedure is performed in an ASC
without another surgical procedure included on the claim; therefore, no
Medicare payment would be made if a device was removed but not
replaced. To ensure that the ASC payment system provides separate
payment for surgical procedures that only involve device removal--
conditionally packaged in the OPPS (status indicator ``Q2'')--we
continued to provide separate payment since CY 2014 and assigned the
current ASC payment indicators associated with these procedures.
b. Update to ASC Covered Surgical Procedure Payment Rates for CY 2021
We proposed to update ASC payment rates for CY 2021 and subsequent
years using the established rate calculation methodologies under Sec.
416.171 and using our definition of device-intensive procedures, as
discussed in section XII.C.1.b. of this CY 2021 OPPS/ASC proposed rule.
Because the proposed OPPS relative payment weights are generally based
on geometric mean costs, the ASC system would generally use the
geometric mean to determine proposed relative payment weights under the
ASC standard methodology. We proposed to continue to use the amount
calculated under the ASC standard ratesetting methodology for
procedures assigned payment indicators ``A2'' and ``G2''.
We proposed to calculate payment rates for office-based procedures
(payment indicators ``P2'', ``P3'', and ``R2'') and device-intensive
procedures (payment indicator ``J8'') according to our established
policies and, for device-intensive procedures, using our modified
definition of device-intensive procedures, as discussed in section
XII.C.1.b. of the CY 2021 OPPS/ASC proposed rule. Therefore, we
proposed to update the payment amount for the service portion of the
device-intensive procedures using the standard ASC rate setting
methodology and the payment amount for the device portion based on the
proposed CY 2021 device offset percentages that have been calculated
using the standard OPPS APC ratesetting methodology. Payment for
office-based procedures would be at the lesser of the proposed CY 2021
MPFS nonfacility PE RVU-based amount or the proposed CY 2021 ASC
payment amount calculated according to the ASC standard ratesetting
methodology.
As we did for CYs 2014 through 2020, for CY 2021 we proposed to
continue our policy for device removal procedures, such that device
removal procedures that are conditionally packaged in the OPPS (status
indicators ``Q1'' and ``Q2'') would be assigned the current ASC payment
indicators associated with those procedures and would continue to be
paid separately under the ASC payment system. A summary of the comments
received and our responses to those comments are set forth below.
Comment: One commenter disagreed with the proposed CY 2021 ASC
payment rates for the surgical procedures described by the following
CPT/HCPCS codes, requesting that CMS increase payment in the ASC
setting for the following codes:
CPT 22869 (Insertion of interlaminar/interspinous process
stabilization/distraction device, without open decompression or fusion,
including image guidance when performed, lumbar; single level)
CPT 62287 (Decompression procedure, percutaneous, of
nucleus pulposus of intervertebral disc, any method utilizing needle
based technique to remove disc material under fluoroscopic imaging or
other form of indirect visualization, with discography
[[Page 86168]]
and/or epidural injection(s) at the treated level(s), when performed,
single or multiple levels, lumbar)
CPT 64575 (Incision for implantation of neurostimulator
electrode array; peripheral nerve (excludes sacral nerve))
CPT 64454 (Injection(s), anesthetic agent(s) and/or
steroid; genicular nerve branches, including imaging guidance, when
performed)
CPT 64624 (Destruction by neurolytic agent, genicular
nerve branches including imaging guidance, when performed)
Response: We update the data on which we establish payment rates
each year through rulemaking and note that ASC rates are derived from
OPPS payment rates, which are required to be reviewed and updated at
least annually under section 1833(t)(9) of the Act. Based on our
analysis of the latest hospital OPPS and ASC claims data used for this
final rule with comment period, we are updating ASC payment rates for
CY 2021 using the established rate calculation methodologies under
Sec. [thinsp]416.171 of the regulations and our definition of device-
intensive procedures, as discussed in section XII.C.1.b. of this CY
2021 OPPS/ASC final rule with comment period. We do not generally make
additional payment adjustments to specific procedures. Therefore, we
are finalizing the payment indicators for the HCPCS codes 22869, 62287,
64575, 64454, and 64624 as proposed.
Comment: Two commenters recommended that CMS eliminate the
prohibition against ASC billing for services using an unlisted CPT
surgical procedure code.
Response: Under Sec. [thinsp]416.166(c)(7), covered surgical
procedures do not include procedures that can only be reported using a
CPT unlisted surgical procedure code. As discussed in the August 2,
2007 final rule (72 FR 42485), it is not possible to know what specific
procedure would be represented by an unlisted code, and therefore, it
is not possible to evaluate procedures reported by unlisted CPT codes
according to applicable regulatory criteria at Sec. 416.166.
Therefore, we are not accepting this recommendation.
After consideration of the public comments we received, we are
finalizing our proposed policies without modification to calculate the
CY 2021 payment rates for ASC covered surgical procedures according to
our established rate calculation methodologies under Sec. 416.171 and
using the modified definition of device-intensive procedures as
discussed in section XIII.C.1.b. of this CY 2021 OPPS/ASC final rule.
For covered office-based surgical procedures, the payment rate is the
lower of the final CY 2021 MPFS nonfacility PE RVU-based amount or the
final CY 2021 ASC payment amount calculated according to the ASC
standard ratesetting methodology. The final payment indicators and
rates set forth in this final rule with comment period are based on a
comparison using the PFS PE RVUs and the conversion factor effective
January 1, 2021. For a discussion of the PFS rates, we refer readers to
the CY 2021 PFS final rule with comment period, which is available on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Limit on ASC Payment Rates for Low-Volume Device-Intensive
Procedures
As stated in section XIII.D.1.b. of this CY 2021 OPPS/ASC proposed
rule, the ASC payment system generally uses OPPS geometric mean costs
under the standard methodology to determine proposed relative payment
weights under the standard ASC ratesetting methodology. However, for
low-volume device-intensive procedures, the proposed relative payment
weights are based on median costs, rather than geometric mean costs, as
discussed in section IV.B.5. of this CY 2021 OPPS/ASC proposed rule.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR
61400), we finalized our policy to limit the ASC payment rate for low-
volume device-intensive procedures to a payment rate equal to the OPPS
payment rate for that procedure. Under our new policy, where the ASC
payment rate based on the standard ASC ratesetting methodology for low
volume device-intensive procedures would exceed the rate paid under the
OPPS for the same procedure, we establish an ASC payment rate for such
procedures equal to the OPPS payment rate for the same procedure. For
CY 2020, this policy only affected HCPCS code 0308T, which had very low
claims volume (7 claims from CY 2018 used for CY 2020 ratesetting in
the OPPS). Additionally, we amended Sec. 416.171(b) of the regulations
to reflect the new limit on ASC payment rates for low-volume device-
intensive procedures. CMS' existing regulation at Sec. 416.171(b)(2)
requires the payment for the device portion of a device-intensive
procedure to be set at an amount derived from the payment rate for the
equivalent item under the OPPS using our standard ratesetting
methodology. We added paragraph (b)(4) to Sec. 416.171 to require
that, notwithstanding paragraph (b)(2), low volume device-intensive
procedures where the otherwise applicable payment rate calculated based
on the standard methodology for device-intensive procedures would
exceed the payment rate for the equivalent procedure set under the
OPPS, the payment rate for the procedure under the ASC payment system
would be equal to the payment rate for the same procedure under the
OPPS.
Based on our review of CY 2019 claims using our standard
ratesetting methodology, there are no low volume device-intensive
procedures that would exceed the rate paid under the OPPS for the same
procedure. However, there was a single claim containing CPT code 0308T
that was unable to be used for the CY 2021 OPPS/ASC proposed rule
ratesetting process as it was packaged into a comprehensive APC. As a
result, there was no available cost data from CY 2019 claims data to
construct relative payment weights for CPT code 0308T. As discussed in
section III.D.2., under the OPPS, we proposed to establish the payment
weight for the CY 2021 OPPS for CPT code 0308T using the CY 2020 OPPS
final rule median cost of $20,229.78 and relative payment weight as
reflecting the most recent claims and cost data. Similarly, as there
were no usable claims with CPT code 0308T from CY 2019, which we would
normally use for the CY 2021 OPPS/ASC proposed rule under our standard
ratesetting methodology to establish an appropriate payment rate in CY
2021 for CPT code 0308T using the most recent claims and cost data, we
proposed to establish the payment rate under the ASC payment system for
CY 2021 using the CY 2020 final rule OPPS median cost and relative
payment weight as reflecting the most recent available claims and cost
data.
However, CPT code 0308T was designated as a low volume device-
intensive procedure in CY 2020. For CY 2020, under the low-volume
procedure payment policies in effect through CY 2019, the available
claims data would have resulted in a payment rate of approximately
$111,019.30 for CPT code 0308T when performed in the ASC setting, which
would have been several times greater than the OPPS payment rate.
Therefore, for CY 2020 we finalized our policy to limit the ASC payment
rate for low-volume device intensive procedures to a payment rate equal
to the OPPS payment rate for the procedures. This policy had the effect
of limiting the ASC payment rate for CPT code 0308T to the applicable
payment rate under the OPPS (which was
[[Page 86169]]
$20,675.62 in CY 2020). Therefore, for the CY 2021 OPPS/ASC proposed
rule, we proposed to apply a payment rate under the ASC payment system
equal to the OPPS payment rate for CPT code 0308T, which is $20,994.57
in the CY 2021 OPPS/ASC proposed rule. Further, in the absence of
claims data for the CY 2021 OPPS/ASC proposed rule, we also proposed in
this CY 2021 OPPS/ASC proposed rule to continue the CY 2020 final rule
device offset percentage of 90.18 percent for CPT code 0308T.
Comment: Commenters supported our proposal to apply a payment rate
under the ASC payment system equal to the OPPS payment rate for CPT
code 0308T and to continue the CY 2020 final rule device offset
percentage of 90.18 percent for CPT code 0308T.
Response: We thank the commenters for their support. After
consideration of the public comments we received, for CY 2021, we are
finalizing our policy to limit the ASC payment rate for low-volume
device intensive procedures to a payment rate equal to the OPPS payment
rate for the procedures. Based on our review of CY 2019 claims using
our standard ratesetting methodology for this final rule with comment
period, there are no low volume device-intensive procedures that would
exceed the rate paid under the OPPS for the same procedure. However,
claims data show two claims containing CPT code 0308T that are unable
to be used for this CY 2021 OPPS/ASC final rule with comment period
ratesetting process. Under the low-volume device intensive procedure
policy that we are adopting in this final rule with comment period, the
ASC payment rate for CPT code 0308T is limited to the applicable
payment rate under the OPPS (which is $20,766.56 in CY 2021). Further,
in the absence of claims data for this final rule with comment period,
we are finalizing our proposal to continue to use the CY 2020 final
rule device offset percentage of 90.18 percent for CPT code 0308T in CY
2021.
2. Payment for Covered Ancillary Services
a. Background
Our payment policies under the ASC payment system for covered
ancillary services generally vary according to the particular type of
service and its payment policy under the OPPS. Our overall policy
provides separate ASC payment for certain ancillary items and services
integrally related to the provision of ASC covered surgical procedures
that are paid separately under the OPPS and provides packaged ASC
payment for other ancillary items and services that are packaged or
conditionally packaged (status indicators ``N'', ``Q1'', and ``Q2'')
under the OPPS. In the CY 2013 OPPS/ASC rulemaking (77 FR 45169 and 77
FR 68457 through 68458), we further clarified our policy regarding the
payment indicator assignment of procedures that are conditionally
packaged in the OPPS (status indicators ``Q1'' and ``Q2''). Under the
OPPS, a conditionally packaged procedure describes a HCPCS code where
the payment is packaged when it is provided with a significant
procedure but is separately paid when the service appears on the claim
without a significant procedure. Because ASC services always include a
surgical procedure, HCPCS codes that are conditionally packaged under
the OPPS are generally packaged (payment indictor ``N1'') under the ASC
payment system (except for device removal procedures, as discussed in
section IV. of this CY 2021 OPPS/ASC proposed rule). Thus, our policy
generally aligns ASC payment bundles with those under the OPPS (72 FR
42495). In all cases, in order for those ancillary services also to be
paid, ancillary items and services must be provided integral to the
performance of ASC covered surgical procedures for which the ASC bills
Medicare.
Our ASC payment policies generally provide separate payment for
drugs and biologicals that are separately paid under the OPPS at the
OPPS rates and package payment for drugs and biologicals for which
payment is packaged under the OPPS. However, as discussed in section
XIII.D.3. of the CY 2021 OPPS/ASC proposed rule, for CY 2019, we
finalized a policy to unpackage and pay separately at ASP + 6 percent
for the cost of non-opioid pain management drugs that function as
surgical supplies when furnished in the ASC setting, even though
payment for these drugs continues to be packaged under the OPPS. We
generally pay for separately payable radiology services at the lower of
the PFS nonfacility PE RVU-based (or technical component) amount or the
rate calculated according to the ASC standard ratesetting methodology
(72 FR 42497). However, as finalized in the CY 2011 OPPS/ASC final rule
with comment period (75 FR 72050), payment indicators for all nuclear
medicine procedures (defined as CPT codes in the range of 78000 through
78999) that are designated as radiology services that are paid
separately when provided integral to a surgical procedure on the ASC
list are set to ``Z2'' so that payment is made based on the ASC
standard ratesetting methodology rather than the MPFS nonfacility PE
RVU amount (``Z3''), regardless of which is lower (Sec.
416.171(d)(1)).
Similarly, we also finalized our policy to set the payment
indicator to ``Z2'' for radiology services that use contrast agents so
that payment for these procedures will be based on the OPPS relative
payment weight using the ASC standard ratesetting methodology and,
therefore, will include the cost for the contrast agent (Sec.
416.171(d)(2)).
ASC payment policy for brachytherapy sources mirrors the payment
policy under the OPPS. ASCs are paid for brachytherapy sources provided
integral to ASC covered surgical procedures at prospective rates
adopted under the OPPS or, if OPPS rates are unavailable, at
contractor-priced rates (72 FR 42499). Since December 31, 2009, ASCs
have been paid for brachytherapy sources provided integral to ASC
covered surgical procedures at prospective rates adopted under the
OPPS.
Our ASC policies also provide separate payment for: (1) Certain
items and services that CMS designates as contractor-priced, including,
but not limited to, the procurement of corneal tissue; and (2) certain
implantable items that have pass-through payment status under the OPPS.
These categories do not have prospectively established ASC payment
rates according to ASC payment system policies (72 FR 42502 and 42508
through 42509; Sec. 416.164(b)). Under the ASC payment system, we have
designated corneal tissue acquisition and hepatitis B vaccines as
contractor-priced. Corneal tissue acquisition is contractor-priced
based on the invoiced costs for acquiring the corneal tissue for
transplantation. Hepatitis B vaccines are contractor-priced based on
invoiced costs for the vaccine.
Devices that are eligible for pass-through payment under the OPPS
are separately paid under the ASC payment system and are contractor-
priced. Under the revised ASC payment system (72 FR 42502), payment for
the surgical procedure associated with the pass-through device is made
according to our standard methodology for the ASC payment system, based
on only the service (non-device) portion of the procedure's OPPS
relative payment weight if the APC weight for the procedure includes
other packaged device costs. We also refer to this methodology as
applying a ``device offset'' to the ASC payment for the associated
surgical procedure. This ensures that duplicate payment is not
[[Page 86170]]
provided for any portion of an implanted device with OPPS pass-through
payment status.
In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66933
through 66934), we finalized that, beginning in CY 2015, certain
diagnostic tests within the medicine range of CPT codes for which
separate payment is allowed under the OPPS are covered ancillary
services when they are integral to an ASC covered surgical procedure.
We finalized that diagnostic tests within the medicine range of CPT
codes include all Category I CPT codes in the medicine range
established by CPT, from 90000 to 99999, and Category III CPT codes and
Level II HCPCS codes that describe diagnostic tests that crosswalk or
are clinically similar to procedures in the medicine range established
by CPT. In the CY 2015 OPPS/ASC final rule with comment period, we also
finalized our policy to pay for these tests at the lower of the PFS
nonfacility PE RVU-based (or technical component) amount or the rate
calculated according to the ASC standard ratesetting methodology (79 FR
66933 through 66934). We finalized that the diagnostic tests for which
the payment is based on the ASC standard ratesetting methodology be
assigned to payment indicator ``Z2'' and revised the definition of
payment indicator ``Z2'' to include a reference to diagnostic services
and those for which the payment is based on the PFS nonfacility PE RVU-
based amount be assigned payment indicator ``Z3,'' and revised the
definition of payment indicator ``Z3'' to include a reference to
diagnostic services.
Comment: One commenter recommended that CMS solicit comments from
stakeholders regarding development of a more transparent and consistent
policy regarding valuation of pass-through devices implanted in the ASC
setting. The commenter further notes that CMS has published its method
for valuing pass-through devices implanted in the hospital outpatient
setting clearly in the Federal Register, and that, in the ASC setting,
payment for a qualifying procedure and the associated pass-through
device should be separate. However, the commenter disagreed with CMS's
approach to valuation of pass-through devices implanted in the ASC
setting as contractor-priced.
Response: We thank the commenter for their recommendation. We will
take the commenters' concerns into consideration in determining if
additional instructions or future guidance for the MACs are warranted.
b. Payment for Covered Ancillary Services for CY 2021
We proposed to update the ASC payment rates and to make changes to
ASC payment indicators, as necessary, to maintain consistency between
the OPPS and ASC payment system regarding the packaged or separately
payable status of services and the proposed CY 2021 OPPS and ASC
payment rates and subsequent year payment rates. We also proposed to
continue to set the CY 2021 ASC payment rates and subsequent year
payment rates for brachytherapy sources and separately payable drugs
and biologicals equal to the OPPS payment rates for CY 2021 and
subsequent year payment rates.
Covered ancillary services and their final payment indicators for
CY 2021 are listed in Addendum BB of this CY 2021 OPPS/ASC final rule
with comment period (which is available via the internet on the CMS
website). For those covered ancillary services where the payment rate
is the lower of the proposed rates under the ASC standard rate setting
methodology and the PFS final rates, the final payment indicators and
rates set forth in the proposed rule are based on a comparison using
the proposed PFS rates effective January 1, 2021. For a discussion of
the PFS rates, we refer readers to the CY 2021 PFS final rule, which is
available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
3. CY 2021 ASC Packaging Policy for Non-Opioid Pain Management
Treatments
Section 6082 of the ``Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities
Act,'' also referred to as the ``SUPPORT for Patients and Communities
Act'' (SUPPORT Act) (Pub. L. 115-271) was enacted on October 24, 2018.
Section 6082(a) of the SUPPORT Act requires in part that the Secretary:
``(i) shall, as soon as practicable, conduct a review (part of which
may include a request for information) of payments for opioids and
evidence-based non-opioid alternatives for pain management (including
drugs and devices, nerve blocks, surgical injections, and
neuromodulation) with a goal of ensuring that there are not financial
incentives to use opioids instead of non-opioid alternatives; (ii) may,
as the Secretary determines appropriate, conduct subsequent reviews of
such payments; and (iii) shall consider the extent to which revisions
under this subsection to such payments (such as the creation of
additional groups of covered OPD services to classify separately those
procedures that utilize opioids and non-opioid alternatives for pain
management) would reduce payment incentives to use opioids instead of
non-opioid alternatives for pain management.'' Section 6082(b) of the
SUPPORT Act requires that the Secretary conduct a similar type of
review in ambulatory surgical centers.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59066
through 59072), we finalized the policy to unpackage and pay separately
at ASP+6 percent for the cost of non-opioid pain management drugs that
function as surgical supplies when they are furnished in the ASC
setting for CY 2019. We also finalized conforming changes to Sec.
416.164(a)(4) to exclude non-opioid pain management drugs that function
as a supply when used in a surgical procedure from our policy to
package payment for drugs and biologicals for which separate payment is
not allowed under the OPPS into the ASC payment for the covered
surgical procedure. We added a new Sec. 416.164(b)(6) to include non-
opioid pain management drugs that function as a supply when used in a
surgical procedure as covered ancillary services that are integral to a
covered surgical procedure. Finally, we finalized a change to Sec.
416.171(b)(1) to exclude non-opioid pain management drugs that function
as a supply when used in a surgical procedure from our policy to pay
for ASC covered ancillary services an amount derived from the payment
rate for the equivalent item or service set under the OPPS.
For the CY 2020 OPPS/ASC proposed rule (84 FR 39424 through 39427),
we reviewed payments under the ASC for opioids and evidence-based non-
opioid alternatives for pain management (including drugs and devices,
nerve blocks, surgical injections, and neuromodulation) with a goal of
ensuring that there are not financial incentives to use opioids instead
of non-opioid alternatives. We used available data to analyze the
payment and utilization patterns associated with specific non-opioid
alternatives to determine whether our packaging policies reduced the
use of non-opioid alternatives. For the CY 2020 OPPS/ASC proposed rule
(84 FR 39426), we proposed to continue our policy to pay separately at
ASP+6 percent for the cost of non-opioid pain management drugs that
function as surgical supplies in the performance of surgical procedures
when they are furnished in the ASC
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setting for CY 2020. In the CY 2020 OPPS/ASC final rule with comment
period (84 FR 61177), after reviewing data from stakeholders and
Medicare claims data, we did not find compelling evidence to suggest
that revisions to our OPPS payment policies for non-opioid pain
management alternatives were necessary for CY 2020. We finalized our
proposal to continue to unpackage and pay separately at ASP+6 percent
for the cost of non-opioid pain management drugs that function as
surgical supplies when furnished in the ASC setting for CY 2020. Under
this policy, the only FDA-approved drug that met these criteria was
Exparel.
We conducted an evaluation to determine whether there are payment
incentives for using opioids instead of non-opioid alternatives in the
CY 2020 OPPS/ASC final rule with comment period (84 FR 61176 to 61180).
The results of our review and evaluation of our claims data did not
provide evidence to indicate that the OPPS packaging policy had the
unintended consequence of discouraging the use of non-opioid treatments
for postsurgical pain management in the hospital outpatient department.
Our updated review of claims data for the CY 2020 proposed rule showed
a continued decline in the utilization of Exparel[supreg] in the ASC
setting, which supported our proposal to continue paying separately for
Exparel[supreg] in the ASC setting.
4. Evaluation and CY 2021 Payment for Non-Opioid Alternatives
Over the last 2 years, we have conducted detailed evaluations of
our payment policies regarding the use of opioids and non-opioid
alternatives. We have reviewed multiple years of Medicare claims data,
all public comments received on this topic, and studies and data from
external stakeholders. Each of these reviews have led to the consistent
conclusion that CMS's packaging policies are not discouraging the use
of non-opioid alternatives or impeding access to these products, with
the exception of Exparel, which was the only non-opioid pain management
drug that functions as a surgical supply when furnished in the ASC
setting.
Section 6082(a) of the SUPPORT Act also provides that after an
initial review, the Secretary can conduct subsequent reviews of covered
payments as the Secretary deems appropriate. In light of the fact that
CMS has conducted a thorough review of payments for opioids and
evidence-based non-opioid alternatives for pain management to ensure
that there are not financial incentives to use opioids instead of non-
opioid alternatives, we did not believe that conducting a similar
review for CY2021 would be a fruitful effort. After careful
consideration, we concluded we had fulfilled the statutory requirement
to review payments for opioids and evidence-based non-opioid
alternatives for pain management to ensure that there are not financial
incentives to use opioids instead of non-opioid alternatives, as
described in the CY 2020 OPPS/ASC rulemaking. We are committed to
evaluating our current policies to adjust payment methodologies, if
necessary, in order to ensure appropriate access for beneficiaries amid
the current opioid epidemic. However, we did not believe conducting a
similar CY 2021 review would yield significantly different outcomes or
new evidence that would prompt us to change our payment policies under
the OPPS or ASC payment system.
Current claims data suggest that CMS' current policies are not
providing a disincentive for the utilization of non-opioid
alternatives, including Exparel, in the hospital outpatient department
or ASC. A preliminary claims analysis showed that the total units of
Exparel employed in the ASC setting has increased over the last year.
From CY 2015 to CY 2018, we saw an annual decline in the total units of
Exparel furnished in the ASC setting, with 244,756 total units provided
in CY 2015 dropping to 60,125 total units provided in CY 2018. In CY
2019, ASCs furnished a total of 1,379,286 units of Exparel. Due to this
positive trend that reflects the increased use of non-opioid treatment
for pain, we did not believe that further changes are necessary under
the ASC payment system for non-opioid pain management drugs that
function as a surgical supply in the ASC setting. Therefore, for CY
2021, we proposed to continue our policy to unpackage and pay
separately at ASP+6 percent for the cost of non-opioid pain management
drugs that function as surgical supplies in the performance of surgical
procedures furnished in the ASC setting and to continue to package
payment for non-opioid pain management drugs that function as surgical
supplies in the performance of surgical procedures in the hospital
outpatient department setting for CY 2021.
The comments we received and our responses to those comments are
set forth below.
Comment: Multiple commenters, including individual stakeholders,
hospital and physician groups, national medical associations, device
manufacturers, and groups representing the pharmaceutical industry,
supported the proposal to continue to unpackage and pay separately for
the cost of non-opioid pain management drugs that function as surgical
supplies when furnished in the ASC setting, such as Exparel, for CY
2021. These commenters believed that packaged payment for non-opioid
alternatives presents a barrier to access to non-opioid pain management
drugs and that separate payment for non-opioid pain management drugs
would be an appropriate response to the opioid drug abuse epidemic.
Several commenters suggested that CMS expand this policy, including
commenters who asked that CMS develop a policy that pays separately for
drugs that are administered at the time of ophthalmic surgery and have
an FDA-approved indication to treat or prevent postoperative pain.
Response: We appreciate these comments. After reviewing the
information provided by the commenters, we continue to believe that
separate payment is appropriate for non-opioid pain management drugs
that function as surgical supplies when furnished in the ASC setting
for CY 2021. Therefore, as discussed in greater detail below, we are
finalizing our proposal to continue to unpackage and pay separately for
the cost of non-opioid pain management drugs that function as surgical
supplies when they are furnished in the ASC setting without
modification.
Comment: Several commenters requested that the drug Omidria, CPT
J1097, (phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic
irrigation solution, 1 ml), be excluded from the ASC payment system
packaging policy once its pass-through status expires on September 30,
2020, because they believe it is a non-opioid pain management drug that
functions as a surgical supply when furnished in the ASC setting.
Omidria is indicated for maintaining pupil size by preventing
intraoperative miosis and reducing postoperative ocular pain in
cataract or intraocular surgeries. The commenters stated that extensive
clinical evidence has been published in medical literature
demonstrating that Omidria reduces dependence on opioids for patients
undergoing cataract surgery and postoperative prescription opioids. The
commenters noted that OMIDRIA is FDA-approved for intraocular use in
cataract procedures, a pain management drug, a non-opioid, and
functions, and was previously packaged, as a surgical supply during
cataract surgery according to CMS' definition of a surgical supply.
Commenters asserted that the use of Omidria decreases
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patients' need for fentanyl during surgeries and provided an
unpublished manuscript that has been submitted, but not approved, for
publication in a peer-reviewed journal, which suggested that Omidria
reduces opioid use after surgery based on pill counts.
Response: We thank commenters for their feedback on Omidria.
Omidria received pass-through status for a 3-year period from 2015 to
2017. After expiration of its pass-through status, it was packaged
under both the OPPS and the ASC payment system. Subsequently, Omidria's
pass-through status under the OPPS was reinstated in October 1, 2018
through September 30, 2020 as required by section 1833(t)(6)(G) of the
Act, as added by section 1301(a)(1)(C) of the Consolidated
Appropriations Act of 2018 (Pub. L. 115-141), which means that Omidria
continued to be paid separately under the ASC payment system through
September 30, 2020. We note that our previous review of the clinical
evidence submitted by commenters during CY 2020 rulemaking concluded
that the studies the commenter submitted were not sufficiently
compelling to revise our payment policy for Omidria. Moreover, the
results of a CMS analysis of cataract procedures performed on Medicare
beneficiaries in the OPPS between January 2015 and July 2019 comparing
procedures performed with Omidria to procedures performed without
Omidria did not demonstrate a significant decrease in fentanyl
utilization during the cataract surgeries in the OPPS when Omidria was
used. Our findings also did not suggest any decrease in opioid
utilization post-surgery for procedures involving Omidria.
However, we continue to believe the separate payment is appropriate
for non-opioid pain management drugs that function as surgical supplies
when furnished in the ASC setting for CY 2021. After careful
consideration of the commenters' assertion that Omidria meets this
definition, we believe that Omidria qualifies as a non-opioid pain
management drug that functions as a surgical supply when furnished in
the ASC setting and will therefore exclude Omidria from packaging under
the ASC payment system beginning October 1, 2020, and in CY 2021, in
accordance with this policy.
Comment: Two commenters briefly mentioned the drug IV
acetaminophen, CPT code J0131, which they believe may reduce opioid
usage if CMS paid separately for the drug. These commenters believed
CPT code J0131 is a highly effective medication that also decreases use
of post-operative opioids.
Response: We thank commenters for their comments. We do not find it
appropriate to pay separately for IV acetaminophen as suggested by
these commenters due to our drug packaging threshold policies, which
are discussed in section V.B.1.a to this final rule with comment
period. In accordance with section 1833(t)(16)(B) of the Act, we
finalized our proposal to set the drug packaging threshold for CY 2021
to $130. To the extent that the items and services mentioned by the
commenters are effective alternatives to opioid prescriptions, we
encourage providers to use them when medically necessary.
Comment: Commenters suggested modified payment for ``pain block''
CPT codes 64415, 64416, 64417, 64445, 64446, 64447, 64448, and 64450.
Two commenters stated that providers use these pain blocks to mitigate
the post-operative pain that is otherwise typically addressed with
short-term opioid use. Additionally, a few commenters noted that CPT
code J1096 (Dexamethasone, lacrimal ophthalmic insert, 0.1 mg) used for
treatment of ocular inflammation and pain following ophthalmic surgery
is administered through CPT code 0356T (Insertion of drug-eluting
implant (including punctal dilation and implant removal when performed)
into lacrimal canaliculus, each). These commenters felt CPT code 0356T,
which commenters state describes the administration of CPT code J1096,
should also receive separate or additional payment due to the alleged
clinical benefits of the drug, including treatment of pain.
Response: We thank the commenters for their suggestions. The ``pain
block'' procedure codes and drug administration code discussed above do
not qualify as non-opioid pain management drugs that function as
surgical supplies, and therefore, do not qualify for separate payment
when furnished in the ASC setting. At this time, we have not found
compelling evidence to revise our policies to provide separate payment
for the non-opioid pain management alternatives described above under
the OPPS or ASC payment systems for CY 2021. To the extent that the
items and services mentioned by the commenters are effective
alternatives to opioid prescriptions, we encourage providers to use
them when medically appropriate. For a greater discussion on CPT code
0356T, please see section III. D. (Administration of Lacrimal
Ophthalmic Insert Into Lacrimal Canaliculus (APC 5692)) of this final
rule with comment period.
Comment: Some commenters encouraged CMS to establish permanent
separate payment for drugs that are currently on drug pass-through
status in the OPPS and ASC settings, such as Dexycu (HCPCS code J1095).
Regarding Dexycu specifically, one commenter stated that permanent
separate payment for ophthalmic drugs is appropriate due to growing
evidence that these drugs reduce reliance on opioids used in
association with cataract surgeries. They noted that they were
conducting a new, comprehensive study of a longitudinal claim dataset
that will provide deeper insights into the association between cataract
surgery and opioid utilization, as well as the role of Dexycu in
reducing the prescribing of opioids.
Response: We refer readers to section V.A., ``OPPS Transitional
Pass-Through Payment for Additional Costs of Drugs, Biologicals, and
Radiopharmaceuticals'' of this final rule with comment period regarding
pass-through payments under the OPPS. Once a drug's pass-through status
expires, we determine whether that drug is eligible for separate
payment under our policy for non-opioid pain management drugs that
function as surgical supplies when furnished in the ASC setting. We
thank commenters for conducting studies regarding their specific
products and look forward to reviewing the results.
Comment: Commenters requested separate payment for various non-drug
pain management treatments that they believe are viable alternatives to
opioids, such as ERAS[supreg] protocols or spinal cord stimulators
(SCS), that they believe decrease the number of opioid prescriptions
beneficiaries receive during and following an outpatient visit or
procedure. For SCS, several commenters noted that this therapy may lead
to a reduction in the use of opioids for chronic pain patients. They
noted that neurostimulation is a key alternative to opioid prescription
for the management and recommended that CMS increase access to SCS.
Response: We appreciate the responses from commenters on this
topic. At this time, we have not found compelling evidence that our
current payment policies discourage use of the various non-drug
alternatives for non-opioid pain management commenters described, such
that separate payment would be warranted under the OPPS or ASC payment
systems for CY 2021. We do not find it appropriate to revise our
policies at this time based on these comments; however, we plan to take
these comments and suggestions into consideration for future
rulemaking. We agree that providing incentives to avoid or reduce
opioid prescriptions may be one of several strategies for addressing
the opioid epidemic. To the extent that
[[Page 86173]]
the items and services mentioned by the commenters are effective
alternatives to opioid drugs, we encourage providers to use them when
medically appropriate. We look forward to working with stakeholders as
we further consider suggested refinements to the OPPS and the ASC
payment system to encourage use of non-opioid pain management
treatments.
After consideration of the public comments that we received, we are
finalizing the policy to continue to unpackage and pay separately at
ASP[thinsp]+[thinsp]6 percent for the cost of non-opioid pain
management drugs that function as surgical supplies when they are
furnished in the ASC setting for CY 2021 as proposed. We will continue
to analyze the issue of access to other non-opioid alternatives for
pain management in the OPPS and ASC settings. This policy is also
discussed in section II.A.3.b. of this final rule with comment period.
E. New Technology Intraocular Lenses (NTIOLs)
New Technology Intraocular Lenses (NTIOLs) are intraocular lenses
that replace a patient's natural lens that has been removed in cataract
surgery and that also meet the requirements listed in Sec. 416.195.
1. NTIOL Application Cycle
Our process for reviewing applications to establish new classes of
NTIOLs is as follows:
Applicants submit their NTIOL requests for review to CMS
by the annual deadline. For a request to be considered complete, we
require submission of the information that is found in the guidance
document entitled ``Application Process and Information Requirements
for Requests for a New Class of New Technology Intraocular Lenses
(NTIOLs) or Inclusion of an IOL in an Existing NTIOL Class'' posted on
the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-
Service-Payment/ASCPayment/NTIOLs.html.
We announce annually, in the proposed rule updating the
ASC and OPPS payment rates for the following calendar year, a list of
all requests to establish new NTIOL classes accepted for review during
the calendar year in which the proposal is published. In accordance
with section 141(b)(3) of Public Law 103-432 and our regulations at
Sec. 416.185(b), the deadline for receipt of public comments is 30
days following publication of the list of requests in the proposed
rule.
In the final rule updating the ASC and OPPS payment rates
for the following calendar year, we--
++ Provide a list of determinations made as a result of our review
of all new NTIOL class requests and public comments.
++ When a new NTIOL class is created, identify the predominant
characteristic of NTIOLs in that class that sets them apart from other
IOLs (including those previously approved as members of other expired
or active NTIOL classes) and that is associated with an improved
clinical outcome.
++ Set the date of implementation of a payment adjustment in the
case of approval of an IOL as a member of a new NTIOL class
prospectively as of 30 days after publication of the ASC payment update
final rule, consistent with the statutory requirement.
++ Announce the deadline for submitting requests for review of an
application for a new NTIOL class for the following calendar year.
2. Requests To Establish New NTIOL Classes for CY 2021
We did not receive any requests for review to establish a new NTIOL
class for CY 2021.
3. Payment Adjustment
The current payment adjustment for a 5-year period from the
implementation date of a new NTIOL class is $50 per lens. Since
implementation of the process for adjustment of payment amounts for
NTIOLs in 1999, we have not revised the payment adjustment amount, and
we did not propose to revise the payment adjustment amount for CY 2021.
The comments and our responses to the comments are set forth below.
Comment: One commenter requested that we re-evaluate our payment
adjustment for new NTIOL class. Commenters noted that our $50 payment
adjustment has not been adjusted since CY 1999 and that the stagnant
payment adjustment has been a barrier to intraocular lens innovation.
The commenter requested that the $50 be inflated to 2021 dollars and
updated by inflation in subsequent years.
Response: We thank the commenter for their recommendation. We did
not propose revising the payment adjustment amount for CY 2021.
However, we will take the commenter's recommendations into
consideration in future rulemaking.
4. Announcement of CY 2022 Deadline for Submitting Requests for CMS
Review of Applications for a New Class of NTIOLS
In accordance with Sec. 416.185(a) of our regulations, CMS
announces that in order to be considered for payment effective
beginning in CY 2022, requests for review of applications for a new
class of new technology IOLs must be received by 5:00 p.m. EST, on
March 1, 2021. Send requests via email to [email protected] or
by mail to ASC/NTIOL, Division of Outpatient Care, Mailstop C4-05-17,
Centers for Medicare and Medicaid Services, 7500 Security Boulevard,
Baltimore, MD 21244-1850. To be considered, requests for NTIOL reviews
must include the information requested on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/NTIOLs.
F. ASC Payment and Comment Indicators
1. Background
In addition to the payment indicators that we introduced in the
August 2, 2007 final rule, we created final comment indicators for the
ASC payment system in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66855). We created Addendum DD1 to define ASC payment
indicators that we use in Addenda AA and BB to provide payment
information regarding covered surgical procedures and covered ancillary
services, respectively, under the revised ASC payment system. The ASC
payment indicators in Addendum DD1 are intended to capture policy-
relevant characteristics of HCPCS codes that may receive packaged or
separate payment in ASCs, such as whether they were on the ASC CPL
prior to CY 2008; payment designation, such as device-intensive or
office-based, and the corresponding ASC payment methodology; and their
classification as separately payable ancillary services, including
radiology services, brachytherapy sources, OPPS pass-through devices,
corneal tissue acquisition services, drugs or biologicals, or NTIOLs.
We also created Addendum DD2 that lists the ASC comment indicators.
The ASC comment indicators included in Addenda AA and BB to the
proposed rules and final rules with comment period serve to identify,
for the revised ASC payment system, the status of a specific HCPCS code
and its payment indicator with respect to the timeframe when comments
will be accepted. The comment indicator ``NI'' is used in the OPPS/ASC
final rule to indicate new
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codes for the next calendar year for which the interim payment
indicator assigned is subject to comment. The comment indicator ``NI''
also is assigned to existing codes with substantial revisions to their
descriptors such that we consider them to be describing new services,
and the interim payment indicator assigned is subject to comment, as
discussed in the CY 2010 OPPS/ASC final rule with comment period (74 FR
60622).
The comment indicator ``NP'' is used in the OPPS/ASC proposed rule
to indicate new codes for the next calendar year for which the proposed
payment indicator assigned is subject to comment. The comment indicator
``NP'' also is assigned to existing codes with substantial revisions to
their descriptors, such that we consider them to be describing new
services, and the proposed payment indicator assigned is subject to
comment, as discussed in the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70497).
The ``CH'' comment indicator is used in Addenda AA and BB to the
proposed rule (which are available via the internet on the CMS website)
to indicate that the payment indicator assignment has changed for an
active HCPCS code in the current year and the next calendar year, for
example if an active HCPCS code is newly recognized as payable in ASCs;
or an active HCPCS code is discontinued at the end of the current
calendar year. The ``CH'' comment indicators that are published in the
final rule with comment period are provided to alert readers that a
change has been made from one calendar year to the next, but do not
indicate that the change is subject to comment.
2. ASC Payment and Comment Indicators for CY 2021
For CY 2021, we proposed new and revised Category I and III CPT
codes as well as new and revised Level II HCPCS codes. Therefore,
proposed Category I and III CPT codes that are new and revised for CY
2021 and any new and existing Level II HCPCS codes with substantial
revisions to the code descriptors for CY 2021 compared to the CY 2020
descriptors are included in ASC Addenda AA and BB to the CY 2021 OPPS/
ASC proposed rule were labeled with proposed comment indicator ``NP''
to indicate that these CPT and Level II HCPCS codes were open for
comment as part of the proposed rule. Proposed comment indicator ``NP''
meant a new code for the next calendar year or an existing code with
substantial revision to its code descriptor in the next calendar year,
as compared to current calendar year; and denoted that comments would
be accepted on the proposed ASC payment indicator for the new code.
For the CY 2021 update, we proposed to add ASC payment indicator
``K5''--Items, Codes, and Services for which pricing information and
claims data are not available. No payment made.--to ASC Addendum DD1 to
the CY 2021 OPPS/ASC proposed rule (which is available via the internet
on the CMS website). New drug HCPCS codes that do not have claims data
or payment rate information are currently assigned to OPPS status
indicator ``E2''--Not paid by Medicare when submitted on outpatient
claims (any outpatient bill type). These codes are categorized and
included in the ASC payment system as nonpayable codes and are
currently assigned an ASC payment indicator ``Y5''--Non-surgical
procedure/item not valid for Medicare purposes because of coverage,
regulation and/or statute; no payment made--because that is the ASC
payment indicator that currently best describes the status of these
HCPCS codes. However, ``Y5'' assignments include both drug codes that
would not be integral to the performance of a surgical procedure and
are therefore not payable in the ASC payment system and codes that may
become separately payable in the ASC payment system. Since there is not
a separate payment indicator that describes the subset of drug codes
that will become payable when claims data or payment information is
available, the existing ASC payment indicators cannot currently
communicate the distinction between these two classes of drugs.
Therefore, for CY 2021 and subsequent calendar years, we proposed to
add ASC payment indicator ``K5''--Items, Codes, and Services for which
pricing information and claims data are not available. No payment
made.--to ASC Addendum DD1 to the CY 2021 OPPS/ASC proposed rule (which
is available via the internet on the CMS website) to indicate those
services and procedures that CMS anticipates will become payable when
claims data or payment information becomes available.
In the CY 2021 OPPS/ASC proposed rule, we stated we would respond
to public comments on ASC payment and comment indicators and finalize
their ASC assignment in the CY 2021 OPPS/ASC final rule with comment
period. We refer readers to Addenda DD1 and DD2 of the CY 2021 OPPS/ASC
proposed rule (which are available via the internet on the CMS website)
for the complete list of ASC payment and comment indicators proposed
for the CY 2021 update.
We did not receive any public comments on the proposed ASC payment
and comment indicators. Therefore, we are finalizing their use as
proposed without modification. Addenda DD1 and DD2 to this CY 2021
OPPS/ASC final rule (which are available via the internet on the CMS
website) contain the complete list of ASC payment and comment
indicators for CY 2021.
G. Calculation of the ASC Payment Rates and the ASC Conversion Factor
1. Background
In the August 2, 2007 final rule (72 FR 42493), we established our
policy to base ASC relative payment weights and payment rates under the
revised ASC payment system on APC groups and the OPPS relative payment
weights. Consistent with that policy and the requirement at section
1833(i)(2)(D)(ii) of the Act that the revised payment system be
implemented so that it would be budget neutral, the initial ASC
conversion factor (CY 2008) was calculated so that estimated total
Medicare payments under the revised ASC payment system in the first
year would be budget neutral to estimated total Medicare payments under
the prior (CY 2007) ASC payment system (the ASC conversion factor is
multiplied by the relative payment weights calculated for many ASC
services in order to establish payment rates). That is, application of
the ASC conversion factor was designed to result in aggregate Medicare
expenditures under the revised ASC payment system in CY 2008 being
equal to aggregate Medicare expenditures that would have occurred in CY
2008 in the absence of the revised system, taking into consideration
the cap on ASC payments in CY 2007, as required under section
1833(i)(2)(E) of the Act (72 FR 42522). We adopted a policy to make the
system budget neutral in subsequent calendar years (72 FR 42532 through
42533; Sec. 416.171(e)).
We note that we consider the term ``expenditures'' in the context
of the budget neutrality requirement under section 1833(i)(2)(D)(ii) of
the Act to mean expenditures from the Medicare Part B Trust Fund. We do
not consider expenditures to include beneficiary coinsurance and
copayments. This distinction was important for the CY 2008 ASC budget
neutrality model that considered payments across the OPPS, ASC, and
MPFS payment systems. However, because coinsurance is almost always 20
percent for ASC services, this interpretation of expenditures has
minimal impact for subsequent budget
[[Page 86175]]
neutrality adjustments calculated within the revised ASC payment
system.
In the CY 2008 OPPS/ASC final rule with comment period (72 FR 66857
through 66858), we set out a step-by-step illustration of the final
budget neutrality adjustment calculation based on the methodology
finalized in the August 2, 2007 final rule (72 FR 42521 through 42531)
and as applied to updated data available for the CY 2008 OPPS/ASC final
rule with comment period. The application of that methodology to the
data available for the CY 2008 OPPS/ASC final rule with comment period
resulted in a budget neutrality adjustment of 0.65.
For CY 2008, we adopted the OPPS relative payment weights as the
ASC relative payment weights for most services and, consistent with the
final policy, we calculated the CY 2008 ASC payment rates by
multiplying the ASC relative payment weights by the final CY 2008 ASC
conversion factor of $41.401. For covered office-based surgical
procedures, covered ancillary radiology services (excluding covered
ancillary radiology services involving certain nuclear medicine
procedures or involving the use of contrast agents, as discussed in
section XII.D.2. of this CY 2021 OPPS/ASC proposed rule), and certain
diagnostic tests within the medicine range that are covered ancillary
services, the established policy is to set the payment rate at the
lower of the MPFS unadjusted nonfacility PE RVU-based amount or the
amount calculated using the ASC standard ratesetting methodology.
Further, as discussed in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66841 through 66843), we also adopted alternative
ratesetting methodologies for specific types of services (for example,
device-intensive procedures).
As discussed in the August 2, 2007 final rule (72 FR 42517 through
42518) and as codified at Sec. 416.172(c) of the regulations, the
revised ASC payment system accounts for geographic wage variation when
calculating individual ASC payments by applying the pre-floor and pre-
reclassified IPPS hospital wage indexes to the labor-related share,
which is 50 percent of the ASC payment amount based on a GAO report of
ASC costs using 2004 survey data. Beginning in CY 2008, CMS accounted
for geographic wage variation in labor costs when calculating
individual ASC payments by applying the pre-floor and pre-reclassified
hospital wage index values that CMS calculates for payment under the
IPPS, using updated Core Based Statistical Areas (CBSAs) issued by OMB
in June 2003.
The reclassification provision in section 1886(d)(10) of the Act is
specific to hospitals. We believe that using the most recently
available pre-floor and pre-reclassified IPPS hospital wage indexes
results in the most appropriate adjustment to the labor portion of ASC
costs. We continue to believe that the unadjusted hospital wage
indexes, which are updated yearly and are used by many other Medicare
payment systems, appropriately account for geographic variation in
labor costs for ASCs. Therefore, the wage index for an ASC is the pre-
floor and pre-reclassified hospital wage index under the IPPS of the
CBSA that maps to the CBSA where the ASC is located.
Generally, OMB issues major revisions to statistical areas every 10
years, based on the results of the decennial census. On February 28,
2013, OMB issued OMB Bulletin No. 13-01, which provides the
delineations of all Metropolitan Statistical Areas, Metropolitan
Divisions, Micropolitan Statistical Areas, Combined Statistical Areas,
and New England City and Town Areas in the United States and Puerto
Rico based on the standards published on June 28, 2010 in the Federal
Register (75 FR 37246 through 37252) and 2010 Census Bureau data. (A
copy of this bulletin may be obtained at: https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2013/b13-01.pdf). In the FY
2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963), we
implemented the use of the CBSA delineations issued by OMB in OMB
Bulletin 13-01 for the IPPS hospital wage index beginning in FY 2015.
OMB occasionally issues minor updates and revisions to statistical
areas in the years between the decennial censuses. On July 15, 2015,
OMB issued OMB Bulletin No. 15-01, which provides updates to and
supersedes OMB Bulletin No. 13-01 that was issued on February 28, 2013.
OMB Bulletin No. 15-01 made changes that are relevant to the IPPS and
ASC wage index. We refer readers to the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79750) for a discussion of these changes and
our implementation of these revisions. (A copy of this bulletin may be
obtained at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2015/15-01.pdf).
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. We refer readers to the CY 2019 OPPS/ASC final
rule with comment period (83 FR 58864 through 58865) for a discussion
of these changes and our implementation of these revisions. (A copy of
this bulletin may be obtained at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf).
For CY 2021, the proposed CY 2021 ASC wage indexes fully reflect
the OMB labor market area delineations (including the revisions to the
OMB labor market delineations discussed above, as set forth in OMB
Bulletin Nos. 15-01 and 17-01).
We note that, in certain instances, there might be urban or rural
areas for which there is no IPPS hospital that has wage index data that
could be used to set the wage index for that area. For these areas, our
policy has been to use the average of the wage indexes for CBSAs (or
metropolitan divisions as applicable) that are contiguous to the area
that has no wage index (where ``contiguous'' is defined as sharing a
border). For example, for CY 2014, we applied a proxy wage index based
on this methodology to ASCs located in CBSA 25980 (Hinesville-Fort
Stewart, GA) and CBSA 08 (Rural Delaware).
When all of the areas contiguous to the urban CBSA of interest are
rural and there is no IPPS hospital that has wage index data that could
be used to set the wage index for that area, we determine the ASC wage
index by calculating the average of all wage indexes for urban areas in
the state (75 FR 72058 through 72059). (In other situations, where
there are no IPPS hospitals located in a relevant labor market area, we
continue our current policy of calculating an urban or rural area's
wage index by calculating the average of the wage indexes for CBSAs (or
metropolitan divisions where applicable) that are contiguous to the
area with no wage index.)
2. Calculation of the ASC Payment Rates
a. Updating the ASC Relative Payment Weights for CY 2021 and Future
Years
We update the ASC relative payment weights each year using the
national OPPS relative payment weights (and PFS nonfacility PE RVU-
based amounts, as applicable) for that same calendar year and uniformly
scale the ASC relative payment weights for each update year to make
them budget neutral (72 FR 42533). The OPPS relative payment weights
are scaled to maintain budget neutrality for the OPPS. We then scale
the OPPS relative payment weights again to establish the ASC relative
payment weights. To accomplish this we hold estimated total ASC payment
levels constant between
[[Page 86176]]
calendar years for purposes of maintaining budget neutrality in the ASC
payment system. That is, we apply the weight scalar to ensure that
projected expenditures from the updated ASC payment weights in the ASC
payment system equal to what would be the current expenditures based on
the scaled ASC payment weights. In this way we ensure budget neutrality
and that the only changes to total payments to ASCs result from
increases or decreases in the ASC payment update factor.
Where the estimated ASC expenditures for an upcoming year are
higher than the estimated ASC expenditures for the current year, the
ASC weight scalar is reduced, in order to bring the estimated ASC
expenditures in line with the expenditures for the baseline year. This
frequently results in ASC relative payment weights for surgical
procedures that are lower than the OPPS relative payment weights for
the same procedures for the upcoming year. Therefore, over time, even
if procedures performed in the HOPD and ASC receive the same update
factor under the OPPS and ASC payment system, payment rates under the
ASC payment system would increase at a lower rate than payment for the
same procedures performed in the HOPD as a result of applying the ASC
weight scalar to ensure budget neutrality.
Consistent with our established policy, we proposed to scale the CY
2021 relative payment weights for ASCs according to the following
method. Holding ASC utilization, the ASC conversion factor, and the mix
of services constant from CY 2019, we proposed to compare the total
payment using the CY 2020 ASC relative payment weights with the total
payment using the CY 2021 ASC relative payment weights to take into
account the changes in the OPPS relative payment weights between CY
2020 and CY 2021. We proposed to use the ratio of CY 2020 to CY 2021
total payments (the weight scalar) to scale the ASC relative payment
weights for CY 2021. The proposed CY 2021 ASC weight scalar was 0.8494.
Consistent with historical practice, we would scale the ASC relative
payment weights of covered surgical procedures, covered ancillary
radiology services, and certain diagnostic tests within the medicine
range of CPT codes, which are covered ancillary services for which the
ASC payment rates are based on OPPS relative payment weights.
Scaling would not apply in the case of ASC payment for separately
payable covered ancillary services that have a predetermined national
payment amount (that is, their national ASC payment amounts are not
based on OPPS relative payment weights), such as drugs and biologicals
that are separately paid or services that are contractor-priced or paid
at reasonable cost in ASCs. Any service with a predetermined national
payment amount would be included in the ASC budget neutrality
comparison, but scaling of the ASC relative payment weights would not
apply to those services. The ASC payment weights for those services
without predetermined national payment amounts (that is, those services
with national payment amounts that would be based on OPPS relative
payment weights) would be scaled to eliminate any difference in the
total payment between the current year and the update year.
For any given year's ratesetting, we typically use the most recent
full calendar year of claims data to model budget neutrality
adjustments. At the time of the CY 2021 OPPS/ASC proposed rule, we had
90 percent of CY 2019 ASC claims data available.
A summary of the comments we received and our responses to those
comments are set forth below.
Comment: Many commenters believe that CMS needs to reduce the
disparity in payments between ASCs and HOPDs. Commenters stated that
ASC payment rates are less than 50 percent of the HOPD payment rates
for some high volume procedures. Many of these same commenters support
the discontinuation of the ASC weight scalar, which they believe is the
cause of the payment gap between ASCs and HOPDs. Commenters suggested
that the ASC weight scalar as currently applied may make it
economically infeasible for ASC facilities to continue to perform
Medicare cases, hurting beneficiaries by limiting their access to high-
quality outpatient surgical care. One commenter highlighted this
concern and suggested that while expansion of the ASC Covered
Procedures List would allow more procedures to be performed in the ASC,
these additional procedures will not be performed in the ASC if ASC
payment rates are lowered to unsustainable levels over time. Multiple
commenters suggested that eliminating the secondary rescaling of the
ASC relative payment weights, and instead applying the OPPS relative
payment weights to ASC services, would allow ASCs to continue to
provide quality surgical care for Medicare patients. They provided
that, while they understand the additional scaling factor that CMS
applies to the ASC relative payment weights maintains budget neutrality
within the ASC payment system, this scaling contributes to the large
payment differentials for similar services between the ASC and HOPD
systems.
Response: We thank commenters for flagging this important issue. As
we stated in the CY 2018 OPPS/ASC final rule with comment period (82 FR
59421) we share commenters' concerns about the effects of payment
disparities between the OPPS and ASC payment systems. We note that
applying the weight scalar in calculation of ASC payment rates, which
is 0.8591 for this final rule with comment period, ensures that the ASC
payment system remains budget neutral. We understand the commenters do
not believe it is necessary to calculate a weight scalar under the ASC
payment system. The commenters contend that application of the weight
scalar to ASC payment rates has led to increasingly large differences
in the amount of payment for similar services between the OPPS and the
ASC payment system. We understand commenters' concerns, however, we are
unable to calculate a single weight scalar for both the OPPS and the
ASC payment system without rescaling OPPS payment weights in a non-
budget neutral manner. We will take the points that the commenters
raised into consideration as part of our efforts to improve choice and
competition in the Medicare program. However, as noted in previous
rulemaking (83 FR 59076), we do not believe that the ASC cost structure
is identical to the hospital cost structure. Further, we do not collect
cost data from ASCs, and therefore we lack the necessary data to assess
the actual differences in costs between the hospital outpatient
department and ASC settings.
To create an analytic file to support calculation of the weight
scalar and budget neutrality adjustment for the wage index (discussed
below), we summarized available CY 2019 ASC claims by ASC and by HCPCS
code. We used the National Provider Identifier for the purpose of
identifying unique ASCs within the CY 2019 claims data. We used the
supplier zip code reported on the claim to associate State, county, and
CBSA with each ASC. This file is available to the public as a
supporting data file for the CY 2021 OPPS/ASC proposed rule and is
posted on the CMS website at: http://http://www.cms.gov/Research-
Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/
ASCPaymentSystem.html.
Comment: One commenter noted that our CY 2021 NPRM ASC Supplier
Specific file incorrectly assigned certain ASCs in the previous CBSA of
16974 (Chicago-Naperville-Arlington Heights, IL) to the default CBSA 14
(Illinois)
[[Page 86177]]
rather than the new CBSA of 16984 (Chicago-Naperville-Evanston, IL)
applicable to their location.
Response: We appreciate the commenter's observation and agree that
ASCs in the previous CBSA of 16974 were erroneously assigned to default
CBSA 14 rather than the new CBSA of 16984. We have corrected the CBSA
assignment for these ASCs for this final rule with comment period.
b. Updating the ASC Conversion Factor
Under the OPPS, we typically apply a budget neutrality adjustment
for provider level changes, most notably a change in the wage index
values for the upcoming year, to the conversion factor. Consistent with
our final ASC payment policy, for the CY 2017 ASC payment system and
subsequent years, in the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79751 through 79753), we finalized our policy to
calculate and apply a budget neutrality adjustment to the ASC
conversion factor for supplier level changes in wage index values for
the upcoming year, just as the OPPS wage index budget neutrality
adjustment is calculated and applied to the OPPS conversion factor. For
CY 2021, we calculated the proposed adjustment for the ASC payment
system by using the most recent CY 2019 claims data available and
estimating the difference in total payment that would be created by
introducing the proposed CY 2021 ASC wage indexes. Specifically,
holding CY 2019 ASC utilization, service-mix, and the proposed CY 2021
national payment rates after application of the weight scalar constant,
we calculated the total adjusted payment using the CY 2020 ASC wage
indexes and the total adjusted payment using the proposed CY 2021 ASC
wage indexes. We used the 50-percent labor-related share for both total
adjusted payment calculations. We then compared the total adjusted
payment calculated with the CY 2020 ASC wage indexes to the total
adjusted payment calculated with the proposed CY 2021 ASC wage indexes
and applied the resulting ratio of 0.9999 (the proposed CY 2021 ASC
wage index budget neutrality adjustment) to the CY 2020 ASC conversion
factor to calculate the proposed CY 2021 ASC conversion factor.
Section 1833(i)(2)(C)(i) of the Act requires that, if the Secretary
has not updated amounts established under the revised ASC payment
system in a calendar year, the payment amounts shall be increased by
the percentage increase in the Consumer Price Index for all urban
consumers (CPI-U), U.S. city average, as estimated by the Secretary for
the 12-month period ending with the midpoint of the year involved. The
statute does not mandate the adoption of any particular update
mechanism, but it requires the payment amounts to be increased by the
CPI-U in the absence of any update. Because the Secretary updates the
ASC payment amounts annually, we adopted a policy, which we codified at
Sec. 416.171(a)(2)(ii)), to update the ASC conversion factor using the
CPI-U for CY 2010 and subsequent calendar years.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59075
through 59080), we finalized our proposal to apply the MFP-adjusted
hospital market basket update to ASC payment system rates for an
interim period of 5 years (CY 2019 through CY 2023), during which we
will assess whether there is a migration of the performance of
procedures from the hospital setting to the ASC setting as a result of
the use of a MFP-adjusted hospital market basket update, as well as
whether there are any unintended consequences, such as less than
expected migration of the performance of procedures from the hospital
setting to the ASC setting. In addition, we finalized our proposal to
revise our regulations under Sec. 416.171(a)(2), which address the
annual update to the ASC conversion factor. During this 5-year period,
we intend to assess the feasibility of collaborating with stakeholders
to collect ASC cost data in a minimally burdensome manner and could
propose a plan to collect such information. We refer readers to that
final rule for a detailed discussion of the rationale for these
policies.
As stated in the CY 2021 OPPS/ASC proposed rule, the hospital
market basket update for CY 2021 was projected to be 3.0 percent, as
published in the FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32738),
based on IHS Global Inc.'s (IGI's) 2019 fourth quarter forecast with
historical data through the third quarter of 2019.
We finalized the methodology for calculating the MFP adjustment in
the CY 2011 PFS final rule with comment period (75 FR 73394 through
73396) and revised it in the CY 2012 PFS final rule with comment period
(76 FR 73300 through 73301) and the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70500 through 70501). As stated in the CY 2021
OPPS/ASC proposed rule (85 FR 32739), the proposed MFP adjustment for
CY 2021 was projected to be 0.4 percentage point, as published in the
FY 2021 IPPS/LTCH PPS proposed rule (85 FR 32739) based on IGI's 2019
fourth quarter forecast.
For CY 2021, we proposed to utilize the hospital market basket
update of 3.0 percent minus the MFP adjustment of 0.4 percentage point,
resulting in an MFP-adjusted hospital market basket update factor of
2.6 percent for ASCs meeting the quality reporting requirements.
Therefore, we proposed to apply a 2.6 percent MFP-adjusted hospital
market basket update factor to the CY 2020 ASC conversion factor for
ASCs meeting the quality reporting requirements to determine the CY
2021 ASC payment amounts. The ASCQR Program affected payment rates
beginning in CY 2014 and, under this program, there is a 2.0 percentage
point reduction to the update factor for ASCs that fail to meet the
ASCQR Program requirements. We refer readers to section XIV.E. of the
CY 2019 OPPS/ASC final rule with comment period (83 FR 59138 through
59139) and section XIV.E. of this CY 2021 OPPS/ASC proposed rule for a
detailed discussion of our policies regarding payment reduction for
ASCs that fail to meet ASCQR Program requirements. We proposed to
utilize the hospital market basket update of 3.0 percent reduced by 2.0
percentage points for ASCs that do not meet the quality reporting
requirements and then subtract the 0.4 percentage point MFP adjustment.
Therefore, we proposed to apply a 0.6 percent MFP-adjusted hospital
market basket update factor to the CY 2020 ASC conversion factor for
ASCs not meeting the quality reporting requirements. We also proposed
that if more recent data are subsequently available (for example, a
more recent estimate of the hospital market basket update or MFP
adjustment), we would use such data, if appropriate, to determine the
CY 2021 ASC update for the CY 2021 OPPS/ASC final rule with comment
period.
For CY 2021, we proposed to adjust the CY 2020 ASC conversion
factor ($47.747) by the proposed wage index budget neutrality factor of
0.9999 in addition to the MFP-adjusted hospital market basket update of
2.6 percent discussed above, which resulted in a proposed CY 2021 ASC
conversion factor of $48.984 for ASCs meeting the quality reporting
requirements. For ASCs not meeting the quality reporting requirements,
we proposed to adjust the CY 2020 ASC conversion factor ($47.747) by
the proposed wage index budget neutrality factor of 0.9999 in addition
to the quality reporting/MFP-adjusted hospital market basket update of
0.6 percent discussed above, which resulted in a proposed CY 2021 ASC
conversion factor of $48.029.
The comments we received on our proposals for updating the CY 2021
ASC
[[Page 86178]]
conversion factor and our responses are set forth below.
Comment: The majority of commenters supported continued use of the
hospital market basket for updating ASC payments on an annual basis.
Some commenters suggested that maintaining alignment in the update
factor used in the OPPS and ASC payment system will encourage the
migration of care to the lower cost ASC setting and ensure that ASCs
remain a viable high quality and lower cost option for patients. Other
commenters supported this approach as it would promote site-neutrality
between the two settings of care through more comparable payment. Other
commenters supported the continued use of the hospital market basket to
update ASC payment rates, but believed that the migration of services
to ASCs would be limited due to the ASC budget neutrality adjustments.
Specifically, commenters stated that CMS' current approach to
maintaining budget neutrality in the ASC payment system caused
increasingly large differences in the amount of payment for similar
services provided in the ASC and HOPD settings, and there was no
evidence of corresponding changes in capital and operating costs
between the ASC and HOPD settings to support this growing payment
differential. Commenters suggested that widening the gap in payment
amounts for similar services provided in the ASC and hospital
outpatient department settings could make it economically infeasible
for ASCs to perform certain procedures for Medicare beneficiaries,
causing financial hardships for ASCs, discouraging them from furnishing
those procedures, and thereby discouraging the migration of services
from the HOPD to the ASC setting.
Response: We appreciate the commenters' support. We believe using
the same update factor to calculate payments to ASC and hospital
outpatient departments encourages the migration of services from the
hospital setting to the ASC setting, and could potentially increase the
presence of ASCs in health care markets or geographic areas where
previously there were none or few. The migration of services from the
higher cost hospital outpatient setting to the ASC setting is likely to
result in savings to beneficiaries and the Medicare program. This
policy will also further our goal of giving both physicians and
beneficiaries a greater choice in selecting the care setting that best
suits their needs.
Comment: Several commenters provided input on collecting cost data
from ASCs. They suggested that if CMS chooses to collect cost data from
ASCs, for instance to develop a market basket, the agency should
consider establishing a market basket that can be applied to both the
ASC and hospital outpatient setting. They believed this would ensure
that payments using the same relative weights and update factor would
remain aligned over time, noting that HOPDs and ASCs incur similar
types of costs.
These commenters offered to work with CMS in developing a survey or
other low burden data collection activity. They suggested an initial
effort to identify and calculate expense categories as a percentage of
total expenses to help determine the appropriate weights and price
proxies for the ASC setting. These commenters also urged CMS to
recognize the variability among ASCs and recognize that cost experience
can differ depending on factors such as specialties served, facility
size, and geographic location. Commenters also requested that CMS keep
in mind the administrative burdens placed on ASC staff in meeting
current regulatory requirements and that requiring any formal cost
reports from ASCs may run counter to the agency's desire to establish
policies that allow ASCs to deliver services to Medicare beneficiaries
efficiently.
Response: We thank the commenters for their input and we will take
these suggestions into consideration in future policy development. As
discussed in the CY 2019 OPPS/ASC final rule with comment period, we
will continue to assess the feasibility of collaborating with
stakeholders to collect ASC cost data in a minimally burdensome manner
and potentially propose a plan to collect such information during the
5-year period in which CMS has updated the ASC payment methodology to
rely upon the hospital market basket as the update factor (83 FR
59077). We will continue to assess the feasibility of collaborating
with stakeholders to collect ASC cost data in a minimally burdensome
manner for future policy development.
After consideration of the public comments we received, consistent
with our proposal that if more recent data are subsequently available
(for example, a more recent estimate of the hospital market basket
update and MFP), we would use such data, if appropriate, to determine
the CY 2021 ASC update for the CY 2021 OPPS/ASC final rule with comment
period, we are incorporating more recent data to determine the final CY
2021 ASC update.
For this CY 2021 OPPS/ASC final rule with comment period, the 10-
year moving average growth of the MFP for FY 2021 is projected to be -
0.1 percentage point, based on IGI's June 2020 macroeconomic forecast,
as published in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58797).
However, under section 1833(i)(2)(D)(v) of the Act, the Secretary is
required to reduce (not increase) the annual update factor by changes
in economy-wide productivity. Accordingly, we are applying a final MFP
adjustment of 0.0 percentage point for CY 2021.
Therefore, for this CY 2021 OPPS/ASC final rule with comment
period, the hospital market basket update for CY 2021 is 2.4 percent,
as published in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58796-7),
based on IGI's 2020 second quarter forecast with historical data
through the first quarter of 2020. The MFP adjustment for this CY 2020
OPPS/ASC final rule with comment period is 0.0 percentage point, as
published in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58797).
For CY 2021, we are finalizing the hospital market basket update of
2.4 percent minus the MFP adjustment of 0.0 percentage point, resulting
in an MFP-adjusted hospital market basket update factor of 2.4 percent
for ASCs meeting the quality reporting requirements. Therefore, we
apply a 2.4 percent MFP-adjusted hospital market basket update factor
to the CY 2020 ASC conversion factor for ASCs meeting the quality
reporting requirements to determine the CY 2021 ASC payment rates. We
are finalizing the hospital market basket update of 2.4 percent reduced
by 2.0 percentage points for ASCs that do not meet the quality
reporting requirements and then subtract the 0.0 percentage point MFP
adjustment. Therefore, we apply a 0.4 percent MFP-adjusted hospital
market basket update factor to the CY 2020 ASC conversion factor for
ASCs not meeting the quality reporting requirements.
For CY 2021, we are adjusting the CY 2020 ASC conversion factor
($47.747) by a wage index budget neutrality factor of 1.0012 in
addition to the MFP-adjusted hospital market basket update of 2.4
percent, discussed above, which results in a final CY 2021 ASC
conversion factor of $48.952 for ASCs meeting the quality reporting
requirements. For ASCs not meeting the quality reporting requirements,
we are adjusting the CY 2020 ASC conversion factor ($47.747) by the
wage index budget neutrality factor of 1.0012 in addition to the
quality reporting/MFP-adjusted hospital market basket update of 0.4
percent discussed above, which results in a final CY 2021 ASC
conversion factor of $47.996.
[[Page 86179]]
3. Display of Final CY 2021 ASC Payment Rates
Addenda AA and BB to this CY 2021 OPPS/ASC final rule (which are
available on the CMS website) display the final ASC payment rates for
CY 2021 for covered surgical procedures and covered ancillary services,
respectively. For those covered surgical procedures and covered
ancillary services where the payment rate is the lower of the proposed
rates under the ASC standard ratesetting methodology and the MPFS final
rates, the final payment indicators and rates set forth in this CY 2021
OPPS/ASC final rule are based on a comparison using the PFS rates that
would be effective January 1, 2021. For a discussion of the PFS rates,
we refer readers to the CY 2021 PFS proposed rule that is available on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The final payment rates included in addenda AA and BB to this CY
2021 OPPS/ASC final rule reflect the full ASC payment update and not
the reduced payment update used to calculate payment rates for ASCs not
meeting the quality reporting requirements under the ASCQR Program.
These addenda contain several types of information related to the final
CY 2021 payment rates. Specifically, in Addendum AA, a ``Y'' in the
column titled ``To be Subject to Multiple Procedure Discounting''
indicates that the surgical procedure would be subject to the multiple
procedure payment reduction policy. As discussed in the CY 2008 OPPS/
ASC final rule with comment period (72 FR 66829 through 66830), most
covered surgical procedures are subject to a 50-percent reduction in
the ASC payment for the lower-paying procedure when more than one
procedure is performed in a single operative session.
Display of the comment indicator ``CH'' in the column titled
``Comment Indicator'' indicates a change in payment policy for the item
or service, including identifying discontinued HCPCS codes, designating
items or services newly payable under the ASC payment system, and
identifying items or services with changes in the ASC payment indicator
for CY 2021. Display of the comment indicator ``NI'' in the column
titled ``Comment Indicator'' indicates that the code is new (or
substantially revised) and that comments will be accepted on the
interim payment indicator for the new code. Display of the comment
indicator ``NP'' in the column titled ``Comment Indicator'' indicates
that the code is new (or substantially revised) and that comments will
be accepted on the ASC payment indicator for the new code.
For CY 2021, we proposed to add a new column to ASC Addendum BB
titled ``Drug Pass-Through Expiration during Calendar Year'' where we
would flag through the use of an asterisk each drug for which pass-
through payment is expiring during the calendar year (that is, on a
date other than December 31st).
The values displayed in the column titled ``Final CY 2021 Payment
Weight'' are the final relative payment weights for each of the listed
services for CY 2021. The final relative payment weights for all
covered surgical procedures and covered ancillary services where the
ASC payment rates are based on OPPS relative payment weights were
scaled for budget neutrality. Therefore, scaling was not applied to the
device portion of the device-intensive procedures, services that are
paid at the MPFS nonfacility PE RVU-based amount, separately payable
covered ancillary services that have a predetermined national payment
amount, such as drugs and biologicals and brachytherapy sources that
are separately paid under the OPPS, or services that are contractor-
priced or paid at reasonable cost in ASCs. This includes separate
payment for non-opioid pain management drugs.
To derive the final CY 2021 payment rate displayed in the ``Final
CY 2021 Payment Rate'' column, each ASC payment weight in the ``Final
CY 2021 Payment Weight'' column was multiplied by final CY 2021
conversion factor of $48.952. The conversion factor includes a budget
neutrality adjustment for changes in the wage index values and the
annual update factor as reduced by the productivity adjustment. The
final CY 2021 ASC conversion factor uses the CY 2021 MFP-adjusted
hospital market basket update factor of 2.4 percent (which is equal to
the projected hospital market basket update of 2.4 percent minus a
projected MFP adjustment of 0.0 percentage point).
In Addendum BB, there are no relative payment weights displayed in
the ``Final CY 2021 Payment Weight'' column for items and services with
predetermined national payment amounts, such as separately payable
drugs and biologicals. The ``Final CY 2021 Payment'' column displays
the final CY 2021 national unadjusted ASC payment rates for all items
and services. The final CY 2021 ASC payment rates listed in Addendum BB
for separately payable drugs and biologicals are based on ASP data used
for payment in physicians' offices in 2020.
Addendum EE provides the HCPCS codes and short descriptors for
surgical procedures that are proposed to be excluded from payment in
ASCs for CY 2021.
XIV. Requirements for the Hospital Outpatient Quality Reporting (OQR)
Program
A. Background
1. Overview
CMS seeks to promote higher quality and more efficient healthcare
for Medicare beneficiaries. Consistent with these goals, CMS has
implemented quality reporting programs for multiple care settings
including the quality reporting program for hospital outpatient care,
known as the Hospital Outpatient Quality Reporting (OQR) Program,
formerly known as the Hospital Outpatient Quality Data Reporting
Program (HOP QDRP). The Hospital OQR Program is generally aligned with
the quality reporting program for hospital inpatient services known as
the Hospital Inpatient Quality Reporting (IQR) Program.
2. Statutory History of the Hospital OQR Program
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72064 through 72065) for a detailed discussion of the
statutory history of the Hospital OQR Program.
3. Regulatory History of the Hospital OQR Program
We refer readers to the CY 2008 through 2019 OPPS/ASC final rules
with comment period (72 FR 66860 through 66875; 73 FR 68758 through
68779; 74 FR 60629 through 60656; 75 FR 72064 through 72110; 76 FR
74451 through 74492; 77 FR 68467 through 68492; 78 FR 75090 through
75120; 79 FR 66940 through 66966; 80 FR 70502 through 70526; 81 FR
79753 through 79797; 82 FR 59424 through 59445; 83 FR 59080 through
59110; and 84 FR 61410 through 61420) for the regulatory history of the
Hospital OQR Program. We have codified certain requirements under the
Hospital OQR Program at Sec. 419.46.
4. Codify Statutory Authority for Hospital OQR Program
The Hospital OQR Program regulations are codified at Sec. 419.46.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48984), we proposed to
update the regulations to include a reference to the statutory
authority for the Hospital OQR Program. Section 1833(t)(17)(A) of the
Social Security Act (the Act) states that subsection (d) hospitals (as
defined
[[Page 86180]]
under section 1886(d)(1)(B) of the Act) that do not submit data
required for measures selected with respect to such a year, in the form
and manner required by the Secretary, will incur a 2.0 percentage point
reduction to their annual Outpatient Department (OPD) fee schedule
increase factor. We proposed to redesignate the existing paragraphs (a)
through (h) as paragraphs (b) through (i) and codify the Hospital OQR
Program's statutory authority at new Sec. 419.46(a). Because of the
proposed redesignations, the cross-references throughout Sec. 419.46
were also proposed to be updated. Table 61 shows the correlation
between the proposed cross-references.
[GRAPHIC] [TIFF OMITTED] TR29DE20.120
We requested public comment on this proposal.
We refer readers to section XIV.E. of the CY 2021 OPPS/ASC proposed
rule for a detailed discussion of the payment reduction for hospitals
that fail to meet Hospital OQR Program requirements for the CY 2023
payment determination (85 FR 48772).
The following is a summary of the comment we received and our
response that comment.
Comment: A commenter supported our proposal to codify the statutory
authority for the Hospital OQR Program.
Response: We thank the commenter for their support.
After consideration of the public comments received, we are
finalizing our proposals as proposed.
B. Hospital OQR Program Quality Measures
1. Considerations in Selecting Hospital OQR Program Quality Measures
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74458 through 74460) for a detailed discussion of the
priorities we consider for the Hospital OQR Program quality measure
selection. We did not propose any changes to these policies.
2. Retention of Hospital OQR Program Measures Adopted in Previous
Payment Determinations
We previously adopted a policy to retain measures from a previous
year's Hospital OQR Program measure set for subsequent years' measure
sets in the CY 2013 OPPS/ASC final rule with comment period (77 FR
68471). For more information regarding this policy, we refer readers to
that final rule with comment period. We codified this policy at Sec.
419.46(h)(1) in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59082). We did not propose any changes to these policies.
3. Removal of Quality Measures From the Hospital OQR Program Measure
Set
a. Immediate Removal
In the CY 2010 OPPS/ASC final rule with comment period (74 FR 60634
through 60635), we finalized a process for removal of Hospital OQR
Program measures, based on evidence that the continued use of the
measure as specified raises patient safety concerns.\104\ We codified
this policy at Sec. 419.46(h)(2) in the CY 2019 OPPS/ASC final rule
with comment period (83 FR 59082). In the case of suspension or removal
due to patient safety concerns, action would need to be taken quickly
and may not coincide with rulemaking cycles (77 FR 68472). In this
case, we would promptly remove the measure and notify hospitals of its
removal, and confirm the removal of the measure in the next rulemaking
cycle. We did not propose any changes to these policies.
---------------------------------------------------------------------------
\104\ We refer readers to the CY 2013 OPPS/ASC final rule with
comment period (77 FR 68472 through 68473) for a discussion of our
reasons for changing the term ``retirement'' to ``removal'' in the
Hospital OQR Program.
---------------------------------------------------------------------------
b. Consideration Factors for Removing Measures
In the CY 2010 OPPS/ASC final rule with comment period (74 FR
60635), we finalized to use the regular rulemaking process to remove a
measure for circumstances for which we do not believe that continued
use of a measure raises specific patient safety concerns.\105\ We
codified this policy at Sec. 419.46(h)(3) in the CY 2019 OPPS/ASC
final rule with comment period (83 FR 59082). In the CY 2019 OPPS/ASC
final rule with comment period (83 FR 59083 through 59085), we
clarified, finalized, and codified at Sec. 419.46(h)(3) an updated set
of factors \106\ and policies for determining whether to remove
measures from the Hospital OQR Program. We refer readers to that final
rule with comment period for a detailed discussion of our policies
regarding measure removal factors. We did not propose any changes to
these policies.
---------------------------------------------------------------------------
\105\ We initially referred to this process as ``retirement'' of
a measure in the 2010 OPPS/ASC proposed rule, but later changed it
to ``removal'' during final rulemaking.
\106\ We note that we previously referred to these factors as
``criteria'' (for example, 77 FR 68472 through 68473); we now use
the term ``factors'' in order to align the Hospital OQR Program
terminology with the terminology we use in other CMS quality
reporting and pay-for-performance (value-based purchasing) programs.
---------------------------------------------------------------------------
4. Summary of Hospital OQR Program Measure Set for the CY 2023 Payment
Determination and Subsequent Years
We refer readers to the CY 2020 OPPS/ASC final rule with comment
period (84 FR 61410 through 61420) for a summary of the previously
adopted Hospital OQR Program measure set for the CY 2022 payment
determination and subsequent years.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48985), we did not
propose any changes to the previously adopted measure set. Table 62
summarizes the previously finalized Hospital OQR Program measure set
for the CY 2023
[[Page 86181]]
payment determination and subsequent years.
[GRAPHIC] [TIFF OMITTED] TR29DE20.121
The following is a summary of the comments we received and our
response those comments.
Comment: A few commenters supported retaining the current Hospital
OQR Program measure set.
Response: We thank commenters for their support.
5. Maintenance of Technical Specifications for Quality Measures
CMS maintains technical specifications for previously adopted
Hospital OQR Program measures. These specifications are updated as we
modify the Hospital OQR Program measure set. The manuals that contain
specifications for the previously adopted measures can be found on the
QualityNet website at: https://www.qualitynet.org/dcs/ContentServer?c=Page&pagename=QnetPublic%2FPage%2FQnetTier2&cid=1196289981244. We refer readers to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59104 through 59105), where we changed the frequency of
the Hospital OQR Program Specifications Manual release beginning with
CY 2019 and subsequent years, such that we will release a manual once
every 12 months and release addenda as necessary. We did not propose
any changes to these policies.
6. Public Display of Quality Measures
We refer readers to the CY 2009, CY 2014, and CY 2017 OPPS/ASC
final rules with comment period (73 FR 68777 through 68779, 78 FR
75092, and 81 FR 79791, respectively) for our previously finalized
policies regarding public display of quality measures.
a. Codification
In the 2009 OPPS/ASC final rule with comment period (73 FR 68778),
we finalized that hospitals sharing the same CMS Certification Number
(CCN) must combine data collection and submission across their multiple
campuses for all clinical measures for public reporting purposes. While
we previously finalized this policy, it was not codified. In the CY
2021 OPPS/ASC proposed rule (85 FR 48987, we proposed to codify this
policy by adding language at the
[[Page 86182]]
redesignated paragraph (d)(1). The newly redesignated paragraph (d)(1)
would specify that ``Hospitals sharing the same CCN must combine data
collection and submission across their multiple campuses for all
clinical measures for public reporting purposes.'' We solicited public
comment on our proposal. The following is a summary of the comment we
received and our response that comment.
Comment: One commenter expressed concern with the proposal to
codify this previously finalized policy to combine Hospital OQR Program
data for multiple hospitals under the same CCN. The commenter believes
that CMS should publicly report data for individual facilities (that
is, campuses and locations), not by CCN.
Response: We disagree with the commenter; we believe data should be
reported by CCN, because it is difficult to identify cases by
facilities since billing is done under CCNs. Under our current policy,
we publish quality data by the corresponding hospital CCN and indicate
instances where data from two or more hospitals are combined to form
the publicly reported measures on the Hospital Compare website and the
successor Care Compare website. In the CY 2014 OPPS/ASC proposed rule
(78 FR 43645), we noted that in a situation in which a larger hospital
has taken over ownership of a smaller hospital, the smaller hospital's
CCN is replaced by the larger hospital's CCN (the principal CCN). For
data display purposes, we only display data received under the
principal CCN. If both hospitals submit data, those data are not
distinguishable in the warehouse \107\ and are calculated together as
one hospital.
---------------------------------------------------------------------------
\107\ The data reviewed are maintained in the CMS Integrated
Data Repository (IDR). The IDR is a high volume data warehouse
integrating Medicare Parts A, B, C, and D, and DME claims,
beneficiary and provider data sources, along with ancillary data
such as contract information and risk scores. Additional information
is available at https://www.cms.gov/Research-Statistics-Data-andSystems/Computer-Data-and-Systems/IDR/index.html.
---------------------------------------------------------------------------
After consideration of the public comments received, we are
finalizing our proposal as proposed.
b. Overall Hospital Quality Star Rating
In the CY 2021 OPPS/ASC proposed rule (85 FR 48987), we proposed a
methodology to calculate the Overall Hospital Quality Star Rating
(Overall Star Rating). The Overall Star Rating would utilize data
collected on hospital inpatient and outpatient measures that are
publicly reported on a CMS website, including data from the Hospital
OQR Program. We refer readers to section XVI. ``Overall Hospital
Quality Star Rating Methodology for Public Release in CY 2021 and
Subsequent Years'' of the CY 2021 OPPS/ASC final rule with comment
period for details.
C. Administrative Requirements
1. QualityNet Account and Security Administrator/Security Official
The previously finalized QualityNet security administrator
requirements, including setting up a QualityNet account and the
associated timelines, are described in the CY 2014 OPPS/ASC final rule
with comment period (78 FR 75108 through 75109). We codified these
procedural requirements at Sec. 419.46(a) in that final rule with
comment period.
In the CY 2021 OPPS/ASC proposed rule (85 FR 48772), we proposed to
use the term ``security official'' instead of ``security
administrator'' to denote the exercise of authority invested in the
role. The term ``security official'' would refer to ``the
individual(s)'' who have responsibilities for security and account
management requirements for a hospital's QualityNet account. To be
clear, this proposed update in terminology would not change the
individual's responsibilities or add burden. We proposed to revise
existing Sec. 419.46(a)(2) and redesignate Sec. 419.46(b)(2), by
replacing the term ``security administrator'' with the term ``security
official.'' The redesignated paragraph (b)(2) would read: ``Identify
and register a QualityNet security official as part of the registration
process under paragraph (b)(1) of this section.''
We invited public comment on our proposal. However, we did not
receive any comments on this proposal. We are finalizing our proposal
as proposed.
2. Requirements Regarding Participation Status
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75108 through 75109), the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70519) and the CY 2019 OPPS/ASC final rule
with comment period (83 FR 59103 through 59104) for requirements for
participation and withdrawal from the Hospital OQR Program. We codified
these procedural requirements regarding participation status at Sec.
419.46(a) and (b).
In the CY 2021 OPPS/ASC proposed rule (85 FR 48772), we proposed to
revise existing Sec. 419.46(b), redesignated Sec. 419.46(c), by
removing the phrase ``submit a new participation form'' to align with
previously finalized policy. In the CY 2019 OPPS/ASC final rule with
comment period (83 FR 59103through 83 FR 59104), we removed submission
of Notice of Participation (NoP) form as a program requirement. We also
proposed to update internal cross-references as a result of the
redesignations discussed under section XIV.A.4. of the CY 2021 OPPS/ASC
proposed rule. The proposed redesignated Sec. 419.46(c) would specify
that a withdrawn hospital will not be able to later sign up to
participate in that payment update, is subject to a reduced annual
payment update as specified under Sec. 419.46(i), and is required to
renew participation as specified in Sec. 419.46(b) in order to
participate in any future year of the Hospital OQR Program. Our
proposal also included updated cross-referenced provisions in the
redesignated Sec. 419.46(c).
We solicited public comment on our proposal. However, we did not
receive any comments on this proposal. We are finalizing our proposal
as proposed.
D. Form, Manner, and Timing of Data Submitted for the Hospital OQR
Program
1. Hospital OQR Program Annual Submission Deadlines
We refer readers to the CYs 2014, 2016, and 2018 OPPS/ASC final
rules with comment period (78 FR 75110 through 75111; 80 FR 70519
through 70520; and 82 FR 59439) where we finalized our policies for
data submission deadlines. We codified these submission requirements at
Sec. 419.46(c). The submission deadlines for the CY 2023 payment
determination and subsequent years are illustrated in Table 63.
[[Page 86183]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.122
In the CY 2021 OPPS/ASC proposed rule (85 FR 48772), we proposed a
change to our submission deadlines to align with statute. We proposed
that all deadlines falling on a nonwork day be moved forward consistent
with section 216(j) of the Act, 42 U.S.C. 416(j), ``Periods of
Limitation Ending on Nonwork Days,'' beginning with the effective date
of this rule. Section 1872 of the Act, incorporates section 216(j) of
the Act, to apply to Title XVIII, the Medicare program to which the
Hospital OQR Program is administered. We proposed that all deadlines
occurring on a Saturday, Sunday, legal holiday, or on any other day all
or part of which is declared to be a nonwork day for federal employees
by statute or Executive order, would be extended to the first day
thereafter which is not a Saturday, Sunday, legal holiday, or any other
day all or part of which is declared to be a nonwork day for federal
employees by statute or Executive order.
We proposed to revise our policy regarding submission deadlines at
existing Sec. 419.46(c)(2), redesignated Sec. 419.46(d)(2). The newly
redesignated paragraph (d)(2) would specify that all deadlines
occurring on a Saturday, Sunday, or legal holiday, or on any other day
all or part of which is declared to be a nonwork day for Federal
employees by statute or Executive order are extended to the first day
thereafter which is not a Saturday, Sunday or legal holiday or any
other day all or part of which is declared to be a nonwork day for
Federal employees by statute or Executive order. We invited public
comment on our proposal. The following is a summary of the comments we
received and our responses to those comments.
Comment: A few commenters supported our proposal to codify in order
to make it consistent with section 216(j) of the Act. One commenter
also stated that it would reduce the need for employees to work on
holidays or weekends in order to submit Hospital OQR Program measures.
Response: We thank the commenters for their support. We agree with
commenters that this policy change would lessen the need for employees
to work on holidays or weekends.
After consideration of public comments, we are finalizing our
proposal as proposed.
2. Requirements for Chart-Abstracted Measures Where Patient-Level Data
Are Submitted Directly to CMS for the CY 2023 Payment Determination and
Subsequent Years
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68481 through 68484) for a discussion of the form,
manner, and timing for data submission requirements of chart-abstracted
measures for the CY 2014 payment determination and subsequent years. We
did not propose any changes to these policies.
The following previously finalized Hospital OQR Program chart-
abstracted measures will require patient-level data to be submitted for
the CY 2022 payment determination and subsequent years:
OP-2: Fibrinolytic Therapy Received Within 30 Minutes of
ED Arrival (NQF #0288);
OP-3: Median Time to Transfer to Another Facility for
Acute Coronary Intervention (NQF #0290);
OP-18: Median Time from ED Arrival to ED Departure for
Discharged ED Patients (NQF #0496); and
OP-23: Head CT Scan Results for Acute Ischemic Stroke or
Hemorrhagic Stroke Patients who Received Head CT Scan Interpretation
Within 45 Minutes of ED Arrival (NQF #0661).
3. Claims-Based Measure Data Requirements for the CY 2023 Payment
Determination and Subsequent Years
Currently, the following previously finalized Hospital OQR Program
claims-based measures are required for the CY 2022 payment
determination and subsequent years:
OP-8: MRI Lumbar Spine for Low Back Pain (NQF #0514);
OP-10: Abdomen CT--Use of Contrast Material;
OP-13: Cardiac Imaging for Preoperative Risk Assessment
for Non-Cardiac, Low Risk Surgery (NQF #0669);
OP-32: Facility 7-Day Risk-Standardized Hospital Visit
Rate after Outpatient Colonoscopy (NQF #2539);
OP-35: Admissions and Emergency Department Visits for
Patients Receiving Outpatient Chemotherapy; and
OP-36: Hospital Visits after Hospital Outpatient Surgery
(NQF #2687).
We refer readers to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59106 through 59107), where we established a 3-year
reporting period for OP-32: Facility 7-Day Risk-Standardized Hospital
Visit Rate after Outpatient Colonoscopy beginning with the CY 2020
payment determination and for subsequent years. In that final rule with
comment period (83 FR 59136 through 59138), we established a similar
policy under the ASCQR Program. We did not propose any changes to these
policies.
4. Data Submission Requirements for the OP-37a-e: Outpatient and
Ambulatory Surgery Consumer Assessment of Healthcare Providers and
Systems (OAS CAHPS) Survey-Based Measures for the CY 2023 Payment
Determination and Subsequent Years
We refer readers to the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79792 through 79794) for a discussion of the previously
finalized requirements related to survey administration and vendors for
the OAS CAHPS Survey-based measures. In addition, we refer readers to
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59432
through 59433), where we finalized a policy to delay implementation of
the OP-37a-e OAS CAHPS Survey-based measures beginning with the CY 2020
payment determination (2018 reporting period) until further action in
future rulemaking. We did not propose any changes to the previously
finalized requirements related to survey administration and vendors for
the OAS CAHPS Survey-based measures.
[[Page 86184]]
5. Data Submission Requirements for Measures for Data Submitted via a
Web-based Tool for the CY 2022 Payment Determination and Subsequent
Years
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75112 through 75115), the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70521), and the CMS QualityNet website
(www.qualitynet.org for a discussion of the requirements for measure
data submitted via the CMS QualityNet Secure Portal (also referred to
as the HQR system secure portal) for the CY 2017 payment determination
and subsequent years. In addition, we refer readers to the CY 2014
OPPS/ASC final rule with comment period (78 FR 75097 through 75100) for
a discussion of the requirements for measure data submitted via the CDC
NHSN website. We did not propose any changes to these policies.
The following previously adopted quality measures will require data
to be submitted via a CMS web-based tool for the CY 2023 payment
determination and subsequent years with the exception of OP-31:
Cataracts: Improvement in Patient's Visual Function within 90 Days
Following Cataract Surgery (NQF #1536) for which data submission
remains voluntary:
OP-22: Left Without Being Seen (NQF #0499);
OP-29: Endoscopy/Polyp Surveillance: Appropriate Follow-up
Interval for Normal Colonoscopy in Average Risk Patients (NQF #0658);
and
OP-31: Cataracts: Improvement in Patient's Visual Function
within 90 Days Following Cataract Surgery (NQF #1536).
6. Population and Sampling Data Requirements for the CY 2021 Payment
Determination and Subsequent Years
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72100 through 72103) and the CY 2012 OPPS/ASC final rule
with comment period (76 FR 74482 through 74483) for discussions of our
population and sampling requirements. We did not propose any changes to
these policies.
7. Review and Corrections Period for Measure Data Submitted to the
Hospital OQR Program
a. Chart-Abstracted Measures
We refer readers to the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66964 and 67014) where we formalized a review and
corrections period for chart-abstracted measures in the Hospital OQR
Program. Per the previously finalized policy, the Hospital OQR Program
implemented a 4-month review and corrections period for chart-
abstracted measure data, which runs concurrently with the data
submission period. During the review and corrections period for chart-
abstracted data, hospitals can enter, review, and correct data
submitted directly to CMS for the chart-abstracted measures.
b. Web-Based Measures
In the CY 2021 OPPS/ASC proposed rule (85 FR 48772), we proposed to
expand our review and corrections policy to apply to measure data
submitted via the CMS web-based tool beginning with data submitted for
the CY 2023 payment determination and subsequent years. Hospitals would
have a review and corrections period for web-based measures, which
would run concurrently with the data submission period. The review and
corrections period for web-based measures is from the time the
submission period opens to the submission deadline. During this review
and corrections period, hospitals can enter, review, and correct data
submitted directly to CMS. However, after the submission deadline,
hospitals would not be allowed to change these data. The expansion of
the existing policy for chart-abstracted measures to data submitted via
the CMS web-based tool would accommodate a growing diversity of measure
types in the Hospital OQR Program. We solicited public comment on our
proposal. The following is a summary of the comments we received and
our responses to those comments.
Comment: A few commenters supported our proposal to expand the
review and corrections policy for chart-abstracted measures to apply to
measure data submitted via the CMS web-based tool. The commenters
stated that it is appropriate for hospitals to have an opportunity to
review and correct data submitted on any existing and future measures
using a web-based tool.
Response: We thank the commenters for their support. As the
diversity of measure types continues to increase, we agree that
hospitals should have an opportunity to enter, review and correct data
submitted to our web-based tool. This begins with data submitted during
CY 2022 for the CY 2023 payment determination.
After consideration of public comments, we are finalizing our
proposal as proposed.
c. Codification of the Review and Corrections Periods for Measure Data
Submitted to the Hospital OQR Program
We note that the previously finalized policy relating to the review
and corrections period for chart-abstracted measures has not yet been
codified. Therefore, in the CY 2021 OPPS/ASC proposed rule (85 FR
48772), we proposed to codify the review and corrections period policy
for measure data submitted to the Hospital OQR Program for chart-
abstracted measure data, as well as for the proposed policy for measure
data submitted directly to CMS via the CMS web-based tool.
Specifically, we proposed to add a new paragraph (c)(4) to Sec.
419.46, redesignated Sec. 419.46(d). The new paragraph (d)(4) would
provide that for both chart-abstracted and web-based measures,
hospitals have a review and corrections period, which runs concurrently
with the data submission period. During this timeframe, hospitals can
enter, review, and correct data submitted. However, after the
submission deadline, this data cannot be changed. We solicited public
comment on our proposal. The following is a summary of the comment we
received and our response to that comment.
Comment: One commenter supported our proposed updates to codify the
review and corrections period policy for chart-abstracted measure data
submitted to the Hospital OQR Program, as well as the proposed policy
for measure data submitted directly to CMS via the CMS web-based tool.
Response: We thank the commenter for their support.
After consideration of public comments, we are finalizing our
proposal as proposed.
7. Hospital OQR Program Validation Requirements
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72105 through 72106), the CY 2013 OPPS/ASC final rule
with comment period (77 FR 68484 through 68487), the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66964 through 66965), the CY 2016
OPPS/ASC final rule with comment period (80 FR 70524), and the CY 2018
OPPS/ASC final rule with comment period (82 FR 59441 through 59443),
and Sec. 419.46(e) for our policies regarding validation. In the CY
2021 OPPS/ASC proposed rule (85 FR 48772), while we did not propose
changes to our validation policies, we proposed to codify certain
previously finalized policies. These policies are discussed in detail
in section XIV.D.8.b of the proposed rule.
[[Page 86185]]
a. Educational Review Process and Score Review and Correction Period
for Chart-Abstracted Measures
(1) Background
In the CY 2018 final rule (82 FR 59441 through 59443), we finalized
a policy to formalize the Educational Review Process for Chart-
Abstracted Measures, including Validation Score Review and Correction.
Under the informal process, hospitals that were selected and received a
score for validation may request an educational review to better
understand the results. A hospital has 30 calendar days from the date
the validation results are made available via the QualityNet Secure
Portal (also referred to as the HQR System) to contact the CMS
designated contractor, currently known as the Validation Support
Contractor (VSC), to request an educational review (82 FR 59442). In
response to a request, the VSC obtains and reviews medical records
directly from the Clinical Data Abstraction Center (CDAC) and provides
feedback (82 FR 59442). CMS, or its contractor, generally provides
educational review results and responses via a secure file transfer to
the hospital (82 FR 59442). In the CY 2018 final rule (82 FR 59441
through 59443), we (1) formalized this process; and (2) specified that
if the results of an educational review indicate that we incorrectly
scored a hospital's medical records selected for validation, the
corrected quarterly validation score would be used to compute the
hospital's final validation score at the end of the calendar year. We
did not propose any changes to this finalized policy.
(2) Codification of Educational Review Process and Score Review and
Correction Period for Chart-Abstracted Measures
The previously finalized policy to formalize the Educational Review
Process for Chart-Abstracted Measures, including Validation Score
Review and Correction finalized in the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59441 through 59442), has not yet been codified
at Sec. 419.46. In the CY 2021 OPPS/ASC proposed rule (85 FR 48772),
we proposed to codify those policies by adding a new paragraph (e)(4)
to Sec. 419.46, redesignated Sec. 419.46(f). The new paragraph (f)(4)
would specify that hospitals that are selected and receive a score for
validation of chart-abstracted measures may request an educational
review in order to better understand the results within 30 calendar
days from the date the validation results are made available. If the
results of an educational review indicate that a hospital's medical
records selected for validation for chart-abstracted measures was
incorrectly scored, the corrected quarterly validation score will be
used to compute the hospital's final validation score at the end of the
calendar year.
We invited public comment on this proposal. We did not receive any
comments on this proposal. We are finalizing our proposal as proposed.
8. Extraordinary Circumstances Exception (ECE) Process for the CY 2021
Payment Determination and Subsequent Years
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68489), the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75119 through 75120), the CY 2015 OPPS/ASC final rule
with comment period (79 FR 66966), the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70524), the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79795), the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59444), and 42 CFR 419.46(d) for a complete
discussion of our extraordinary circumstances exception (ECE) process
under the Hospital OQR Program. We did not propose any changes to these
policies.
9. Hospital OQR Program Reconsideration and Appeals Procedures for the
CY 2021 Payment Determination and Subsequent Years
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68487 through 68489), the CY 2014 OPPS/ASC final rule
with comment period (78 FR 75118 through 75119), the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70524), the CY 2017 OPPS/ASC
final rule with comment period (81 FR 79795), and Sec. 419.46(f) for
our reconsideration and appeals procedures.
In alignment with our proposal to change submission deadlines, in
section XIV.D.1. of the CY 2021 OPPS/ASC proposed rule (85 FR 48772),
we proposed a change to our reconsideration deadlines. We proposed that
all deadlines falling on a nonwork day be moved forward consistent with
section 216(j) of the Act, 42 U.S.C. 416(j), ``Periods of Limitation
Ending on Nonwork Days,'' beginning with the effective date of this
rule. Section 1872 of the Act, incorporates section 216(j) of the Act,
to apply to Title XVIII, the Medicare program to which the Hospital OQR
Program is administered. Under this proposal, all deadlines occurring
on a Saturday, Sunday, legal holiday, or on any other day all or part
of which is declared to be a nonwork day for federal employees by
statute or Executive order, would be extended to the first day
thereafter which is not a Saturday, Sunday, legal holiday or any other
day all or part of which is declared to be a nonwork day for federal
employees by statute or Executive order. Specifically, we proposed to
remove ``the first business day on or after'' from existing Sec.
419.46(f)(1), redesignated Sec. 419.46(g)(1), to ensure consistency
with section 216(j) of the Act. The redesignated paragraph (g)(1) would
provide that a hospital may request reconsideration of a decision by
CMS that the hospital has not met the requirements of the Hospital OQR
Program for a particular calendar year. Except as provided in paragraph
(e), a hospital must submit a reconsideration request to CMS via the
QualityNet website, no later than March 17, or if March 17 falls on a
nonwork day, on the first day after March 17 which is not a nonwork day
as defined in Sec. 419.46(d)(2), of the affected payment year as
determined using the date the request was mailed or submitted to CMS.
We invited public comment on our proposal. However, we did not
receive any comments on this proposal. We are finalizing our proposal
as proposed.
E. Payment Reduction for Hospitals That Fail To Meet the Hospital OQR
Program Requirements for the CY 2021 Payment Determination
1. Background
Section 1833(t)(17) of the Act, which applies to subsection (d)
hospitals (as defined under section 1886(d)(1)(B) of the Act), states
that hospitals that fail to report data required to be submitted on
measures selected by the Secretary, in the form and manner, and at a
time, specified by the Secretary will incur a 2.0 percentage point
reduction to their Outpatient Department (OPD) fee schedule increase
factor; that is, the annual payment update factor. Section
1833(t)(17)(A)(ii) of the Act specifies that any reduction applies only
to the payment year involved and will not be taken into account in
computing the applicable OPD fee schedule increase factor for a
subsequent year.
The application of a reduced OPD fee schedule increase factor
results in reduced national unadjusted payment rates that apply to
certain outpatient items and services provided by hospitals that are
required to report outpatient quality data in order to receive the full
payment update factor and that fail to meet the Hospital OQR Program
requirements. Hospitals that meet the reporting requirements receive
[[Page 86186]]
the full OPPS payment update without the reduction. For a more detailed
discussion of how this payment reduction was initially implemented, we
refer readers to the CY 2009 OPPS/ASC final rule with comment period
(73 FR 68769 through 68772).
The national unadjusted payment rates for many services paid under
the OPPS equal the product of the OPPS conversion factor and the scaled
relative payment weight for the APC to which the service is assigned.
The OPPS conversion factor, which is updated annually by the OPD fee
schedule increase factor, is used to calculate the OPPS payment rate
for services with the following status indicators (listed in Addendum B
to the proposed rule, which is available via the internet on the CMS
website): ``J1'', ``J2'', ``P'', ``Q1'', ``Q2'', ``Q3'', ``R'', ``S'',
``T'', ``V'', or ``U''. In the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79796), we clarified that the reporting ratio does not
apply to codes with status indicator ``Q4'' because services and
procedures coded with status indicator ``Q4'' are either packaged or
paid through the Clinical Laboratory Fee Schedule and are never paid
separately through the OPPS. Payment for all services assigned to these
status indicators will be subject to the reduction of the national
unadjusted payment rates for hospitals that fail to meet Hospital OQR
Program requirements, with the exception of services assigned to New
Technology APCs with assigned status indicator ``S'' or ``T''. We refer
readers to the CY 2009 OPPS/ASC final rule with comment period (73 FR
68770 through 68771) for a discussion of this policy.
The OPD fee schedule increase factor is an input into the OPPS
conversion factor, which is used to calculate OPPS payment rates. To
reduce the OPD fee schedule increase factor for hospitals that fail to
meet reporting requirements, we calculate two conversion factors--a
full market basket conversion factor (that is, the full conversion
factor), and a reduced market basket conversion factor (that is, the
reduced conversion factor). We then calculate a reduction ratio by
dividing the reduced conversion factor by the full conversion factor.
We refer to this reduction ratio as the ``reporting ratio'' to indicate
that it applies to payment for hospitals that fail to meet their
reporting requirements. Applying this reporting ratio to the OPPS
payment amounts results in reduced national unadjusted payment rates
that are mathematically equivalent to the reduced national unadjusted
payment rates that would result if we multiplied the scaled OPPS
relative payment weights by the reduced conversion factor. For example,
to determine the reduced national unadjusted payment rates that applied
to hospitals that failed to meet their quality reporting requirements
for the CY 2010 OPPS, we multiplied the final full national unadjusted
payment rate found in Addendum B of the CY 2010 OPPS/ASC final rule
with comment period by the CY 2010 OPPS final reporting ratio of 0.980
(74 FR 60642).
We note that the only difference in the calculation for the full
conversion factor and the calculation for the reduced conversion factor
is that the full conversion factor uses the full OPD update and the
reduced conversion factor uses the reduced OPD update. The baseline
OPPS conversion factor calculation is the same since all other
adjustments would be applied to both conversion factor calculations.
Therefore, our standard approach of calculating the reporting ratio as
described earlier in this section is equivalent to dividing the reduced
OPD update factor by that of the full OPD update factor. In other
words:
Full Conversion Factor = Baseline OPPS conversion factor * (1 + OPD
update factor)
Reduced Conversion Factor = Baseline OPPS conversion factor * (1 + OPD
update factor - 0.02)
Reporting Ratio = Reduced Conversion Factor/Full Conversion Factor
Which is equivalent to:
Reporting Ratio = (1 + OPD Update factor - 0.02)/(1 + OPD update
factor)
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68771
through 68772), we established a policy that the Medicare beneficiary's
minimum unadjusted copayment and national unadjusted copayment for a
service to which a reduced national unadjusted payment rate applies
would each equal the product of the reporting ratio and the national
unadjusted copayment or the minimum unadjusted copayment, as
applicable, for the service. Under this policy, we apply the reporting
ratio to both the minimum unadjusted copayment and national unadjusted
copayment for services provided by hospitals that receive the payment
reduction for failure to meet the Hospital OQR Program reporting
requirements. This application of the reporting ratio to the national
unadjusted and minimum unadjusted copayments is calculated according to
Sec. 419.41 of our regulations, prior to any adjustment for a
hospital's failure to meet the quality reporting standards according to
Sec. 419.43(h). Beneficiaries and secondary payers thereby share in
the reduction of payments to these hospitals.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68772), we established the policy that all other applicable adjustments
to the OPPS national unadjusted payment rates apply when the OPD fee
schedule increase factor is reduced for hospitals that fail to meet the
requirements of the Hospital OQR Program. For example, the following
standard adjustments apply to the reduced national unadjusted payment
rates: The wage index adjustment, the multiple procedure adjustment,
the interrupted procedure adjustment, the rural sole community hospital
adjustment, and the adjustment for devices furnished with full or
partial credit or without cost. Similarly, OPPS outlier payments made
for high cost and complex procedures will continue to be made when
outlier criteria are met. For hospitals that fail to meet the quality
data reporting requirements, the hospitals' costs are compared to the
reduced payments for purposes of outlier eligibility and payment
calculation. We established this policy in the OPPS beginning in the CY
2010 OPPS/ASC final rule with comment period (74 FR 60642). For a
complete discussion of the OPPS outlier calculation and eligibility
criteria, we refer readers to section II.G. of the CY 2021 OPPS/ASC
proposed rule.
2. Reporting Ratio Application and Associated Adjustment Policy for CY
2021
We proposed to continue our established policy of applying the
reduction of the OPD fee schedule increase factor through the use of a
reporting ratio for those hospitals that fail to meet the Hospital OQR
Program requirements for the full CY 2021 annual payment update factor.
For the CY 2021 OPPS/ASC proposed rule, the proposed reporting ratio
was 0.9805, which when multiplied by the proposed full conversion
factor of $83.697 equaled a proposed conversion factor for hospitals
that fail to meet the requirements of the Hospital OQR Program (that
is, the reduced conversion factor) of $82.016. We proposed to continue
to apply the reporting ratio to all services calculated using the OPPS
conversion factor. For the CY 2021 OPPS/ASC proposed rule, we proposed
to continue to apply the reporting ratio, when applicable, to all HCPCS
codes to which we have proposed status indicator assignments of ``J1'',
``J2'', ``P'', ``Q1'', ``Q2'', ``Q3'', ``R'', ``S'', ``T'', ``V'', and
``U'' (other than new technology APCs to which we have proposed status
[[Page 86187]]
indicator assignment of ``S'' and ``T''). We proposed to continue to
exclude services paid under New Technology APCs. We proposed to
continue to apply the reporting ratio to the national unadjusted
payment rates and the minimum unadjusted and national unadjusted
copayment rates of all applicable services for those hospitals that
fail to meet the Hospital OQR Program reporting requirements. We also
proposed to continue to apply all other applicable standard adjustments
to the OPPS national unadjusted payment rates for hospitals that fail
to meet the requirements of the Hospital OQR Program. Similarly, we
proposed to continue to calculate OPPS outlier eligibility and outlier
payment based on the reduced payment rates for those hospitals that
fail to meet the reporting requirements. In addition to our proposal to
implement the policy through the use of a reporting ratio, we also
proposed to calculate the reporting ratio to four decimals (rather than
the previously used three decimals) to more precisely calculate the
reduced adjusted payment and copayment rates.
For the CY 2021 OPPS/ASC final rule with comment period, the final
reporting ratio is 0.9805, which when multiplied by the final full
conversion factor of 82.797 equals a final conversion factor for
hospitals that fail to meet the requirements of the Hospital OQR
Program (that is, the reduced conversion factor) of 81.183. We are
finalizing our proposal to continue to calculate OPPS outlier
eligibility and outlier payment based on the reduced payment rates for
those hospitals that fail to meet the reporting requirements. We are
also finalizing our proposals to implement the policy through the use
of a reporting ratio, and to calculate the reporting ratio to four
decimals (rather than the previously used three decimals) to more
precisely calculate the reduced adjusted payment and copayment rates
for hospitals that fail to meet the Hospital OQR Program requirements
for CY 2021 payment.
XV. Requirements for the Ambulatory Surgical Center Quality Reporting
(ASCQR) Program
A. Background
1. Overview
We refer readers to section XIV.A.1. of the CY 2020 final rule with
comment period (84 FR 61410) for a general overview of our quality
reporting programs and to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58820 through 58822) where we previously discussed our
Meaningful Measures Initiative and our approach for evaluating quality
program measures.
2. Statutory History of the ASCQR Program
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74492 through 74494) for a detailed discussion of the
statutory history of the ASCQR Program.
3. Regulatory History of the ASCQR Program
We refer readers to the CYs 2014 through 2020 OPPS/ASC final rules
with comment period (78 FR 75122; 79 FR 66966 through 66987; 80 FR
70526 through 70538; 81 FR 79797 through 79826; 82 FR 59445 through
59476; 83 FR 59110 through 59139; and 84 FR 61420 through 61434,
respectively) for an overview of the regulatory history of the ASCQR
Program. We have codified certain requirements under the ASCQR Program
at 42 CFR, part 16, subpart H (42 CFR 416.300 through 416.330). In the
CY 2021 OPPS/ASC proposed rule (85 FR 48993), we proposed to update
certain currently codified program policies and propose a review and
corrections period as well as other administrative changes. We discuss
these proposals and applicable public comments in more detail below in
sections XV.C. and XV.D.
B. ASCQR Program Quality Measures
1. Considerations in the Selection of ASCQR Program Quality Measures
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68493 through 68494) for a detailed discussion of the
priorities we consider for the ASCQR Program quality measure selection.
We did not propose any changes to these policies.
2. Policies for Retention and Removal of Quality Measures From the
ASCQR Program
a. Retention of Previously Adopted ASCQR Program Measures
We previously finalized a policy that quality measures adopted for
an ASCQR Program measure set for a previous payment determination year
be retained in the ASCQR Program for measure sets for subsequent
payment determination years except when such measures are removed,
suspended, or replaced as indicated (76 FR 74494 and 74504; 77 FR 68494
through 68495; 78 FR 75122; and 79 FR 66967 through 66969). We did not
propose any changes to this policy.
b. Removal Factors for ASCQR Program Measures
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59111
through 59115), we clarified, finalized, and codified at 42 CFR 416.320
an updated set of factors \108\ and the process for removing measures
from the ASCQR Program. We refer readers to the CY 2019 OPPS/ASC final
rule with comment period (83 FR 59111 through 59115) for a detailed
discussion of our process regarding measure removal. We did not propose
any changes to this policy.
---------------------------------------------------------------------------
\108\ We note that we previously referred to these factors as
``criteria'' (for example, 79 FR 66967 through 66969); we now use
the term ``factors'' to align the ASCQR Program terminology with the
terminology used in other CMS quality reporting and pay-for-
performance (value-based purchasing) programs.
---------------------------------------------------------------------------
3. Summary of ASCQR Program Quality Measure Set Previously Finalized
for the CY 2024 Payment Determination and for Subsequent Years
In the CY 2021 OPPS/ASC proposed rule (85 FR 48992), we did not
propose to remove any existing measures or to adopt any new measures
for the CY 2023 payment determination. Table 64 summarizes the
previously finalized ASCQR Program measure set for the CY 2024 payment
determination and subsequent years.
[[Page 86188]]
[GRAPHIC] [TIFF OMITTED] TR29DE20.123
The following is a summary of the comment we received and our
response that comment.
Comment: A few commenters supported retaining the current measure
set.
Response: We thank commenters for their support; we agree that at
this time no changes to the ASCQR Program measure set are necessary.
4. Maintenance of Technical Specifications for Quality Measures
We refer readers to the CYs 2012 through 2016 OPPS/ASC final rules
with comment period (76 FR 74513 through 74514; 77 FR 68496 through
68497; 78 FR 75131; 79 FR 66981; and 80 FR 70531, respectively) for
detailed discussion of our policies regarding the maintenance of
technical specifications for the ASCQR Program which are codified at 42
CFR 416.325. We did not propose any changes to these policies.
5. Public Reporting of ASCQR Program Data
We refer readers to the CYs 2012, 2016, 2017 and 2018 OPPS/ASC
final rules with comment period (76 FR 74514 through 74515; 80 FR 70531
through 70533; 81 FR 79819 through 79820; and 82 FR 59455 through
59470, respectively) for detailed discussion of our policies regarding
the public reporting of ASCQR Program data which are codified at 42 CFR
416.315 (80 FR 70533). We did not propose any changes to these
policies.
6. ASCQR Program Measures and Topics for Future Considerations
We seek to develop a comprehensive set of quality measures to be
available for widespread use for informed decision-making regarding
care and quality improvement in the ASC setting. We also seek measures
that would facilitate meaningful comparisons between ASCs and hospitals
providing comparable services. Therefore, we invited public comment on
new measures for our consideration that address care quality in the ASC
settings as well as on additional measures that could facilitate
comparison of care provided in ASCs and hospitals.
The following is a summary of the comments we received and our
responses to those comments.
Comment: Several commenters provided recommendations regarding both
new quality measures for CMS to consider as well as measures to
facilitate the comparison of care provided in ASCs and hospitals. One
commenter requested that we require measures for surgical procedures
that occur in both the ASC and outpatient hospital settings be
reflected in the measure sets of both programs. For example, currently
the Hospital OQR Program contains measures of surgical procedures that
[[Page 86189]]
also occur in ASCs, but there is no comparable measure in the ASCQR
Program. The commenter recommended that such measures be specified so
that for in common surgical procedures analysis for both settings was
possible.
Response: We thank the commenters for their recommendations
regarding measures to facilitate the comparison of care provided in
ASCs and hospitals and the request for measures of surgical procedures
that occur in both settings to be reflected in the measure sets of both
programs. We understand the commenters concern that such measures be
specified to allow for an analysis of both settings for common surgical
procedures. We agree that there are surgical procedures that occur in
both ASC and outpatient hospital settings that may not be currently
reflected in both programs' measure sets. We will evaluate the
feasibility of the commenters' recommendations and take them into
consideration as we determine future updates to the ASCQR Program
measure set.
Comment: A few commenters recommended we adopt measures related to
patient and caregiver engagement, experience, and safety. Commenters
suggested these measures to ensure providers deliver equitable,
patient-centered care and provide patients and their caregivers a
standardized way to compare providers and organizations. A few
commenters also suggested CMS broaden the focus on safety to include
workforce safety measures as a way to examine workforce burnout and
turnover. One of these commenters requested that CMS employ an annual
web-based workforce engagement survey to allow quality performance to
be factored into payment and performance-based incentives.
Response: We thank the commenters for their recommendations
regarding the adoption of measures related to patient and caregiver
engagement, experience, and workforce safety. We refer readers to the
CY 2017 OPPS/ASC final rule with comment period where we adopted ASC-
15a-e (81 FR 79803 through 79817), and finalized data collection and
data submission timelines (81 FR 79822 through 79824). These measures
assess patients' experience with care following a procedure or surgery
in an ASC by rating patient experience as a means for empowering
patients and improving the quality of their care. In the CY 2018 OPPS/
ASC final rule with comment period (82 FR 59450 through 59451), we
finalized a delay in the implementation of the Outpatient and
Ambulatory Surgery Consumer Assessment of Healthcare Providers and
Systems (OAS CAHPS) Survey-based Measures (ASC-15a-e) beginning with
the CY 2020 payment determination (CY 2018 data collection) until
further action in future rulemaking. We will investigate the
feasibility of the commenters' recommendation to focus on workforce
safety measures for consideration toward future updates to the ASCQR
Program measure set.
Comment: Several commenters had specific suggestions of measures
for future consideration. These measures include: Normothermia (ASC-
13), Unplanned Anterior Vitrectomy (ASC-14), Toxic Anterior Segment
Syndrome (TASS) (ASC-16), Hospital-level Risk-standardized Complication
Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA)
and/or Total Knee Arthroplasty (TKA) (NQF #1550), and Ambulatory Breast
Procedure Surgical Site Infection (SSI) Outcome (NQF #3025).
Response: We note that in the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79801 through 79803), the Normothermia (ASC-13)
and Unplanned Anterior Vitrectomy (ASC-14) were adopted into the ASCQR
Program for the CY 2020 payment determination and subsequent years; we
thank the commenter for their support of these measures. While we
proposed the adoption of Toxic Anterior Segment Syndrome (TASS) (ASC-
16) for the ASCQR Program (82 FR 52594), we did not finalize the
adoption of this measure due to concerns that the burden of the measure
would outweigh the benefits. We will consider the suggested measures
not currently included in the ASCQR Program as well as reconsider the
Toxic Anterior Segment Syndrome (TASS) (ASC-16) measure as we develop
and refine the ASCQR Program measure set.
C. Administrative Requirements
1. Requirements Regarding QualityNet Account and Security Administrator
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75132 through 75133) for a detailed discussion of the
QualityNet security administrator requirements, including setting up a
QualityNet account and the associated timelines for the CY 2014 payment
determination and subsequent years. In the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70533), we codified the administrative
requirements regarding the maintenance of a QualityNet account and
security administrator for the ASCQR Program at Sec. 416.310(c)(1)(i).
In the CY 2021 OPPS/ASC proposed rule with comment period (85 FR
48993), we proposed to use the term ``security official'' instead of
``security administrator'' to denote the exercise of authority invested
in the role. The term ``security official'' refers to ``the
individual(s)'' who have responsibilities for security and account
management requirements for a facility's QualityNet account. To be
clear, this proposed update in terminology would not change the
individual's responsibilities or add burden. We also proposed to revise
Sec. 416.310(c)(1)(i) by replacing the term ``security administrator''
with the term ``security official''. The new sentence would read ``A
QualityNet security official is necessary to set up such an account for
the purpose of submitting this information.'' We invited public comment
on our proposals.
The following is a summary of the comment we received and our
response that comment.
Comment: One commenter expressed concern with the terminology
change of ``security administrator'' to ``security official,'' despite
no changes in responsibility of the individual(s). The commenter
suggested that the current term is sufficient and any changes to the
title may cause undue confusion.
Response: We thank the commenter for their input and acknowledge
the commenter's concern about potential confusion. However, we believe
the term ``security official'' more clearly conveys the exercise of
authority invested in the role and want to ensure adequate recognition.
While an administrator is a person who performs official duties in a
sphere, an official is a person having official duties, specifically as
a representative of an organization. Thus, the term ``security
official'' more aptly describes this role as a representative one.
After consideration of the comment received, we are finalizing our
proposal as proposed.
2. Requirements Regarding Participation Status
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75133 through 75135) for a complete discussion of the
participation status requirements for the CY 2014 payment determination
and subsequent years. In the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70533 through 70534), we codified these requirements
regarding participation status for the ASCQR Program at 42 CFR 416.305.
We did not propose any changes to these policies.
[[Page 86190]]
D. Form, Manner, and Timing of Data Submitted for the ASCQR Program
1. Data Collection and Submission
a. Update of Language Generally
We previously codified our existing policies regarding data
collection and submission under the ASCQR Program at 42 CFR 416.310. We
currently use the phrases ``data collection period'' and ``data
collection time period'' interchangeably in Sec. 416.310(a) through
(c). We believe that using one, consistent phrase will streamline and
simplify the section and our policies to help avoid potential
confusion. As such, we proposed to remove the phrase ``data collection
time period'' in all instances where it appears in Sec. 416.310, and
replace it with the phrase ``data collection period''--specifically at
Sec. 416.310(a)(2), (b), (c)(1)(ii), and (c)(2), as well as replacing
the phrase ``time period'' with ``period'' in Sec. 416.310(c)(1)(ii)
for language consistency. We invited comment on our proposal.
The following is a summary of the comment we received and our
response that comment.
Comment: One commenter supported the proposal to remove the phrase
``data collection time period'' in all instances where it appears in
Sec. 416.310 and replace it with the phrase ``data collection
period''. The commenter agreed that using one consistent phrase will
help avoid potential confusion.
Response: We thank the commenter for their support. We agree that
the change will reduce confusion and believe that using one consistent
phrase will streamline the language across policies.
After consideration of the public comment received, we are
finalizing our proposals as proposed.
b. Requirements Regarding Data Processing and Collection Periods for
Claims-Based Measures Using Quality Data Codes (QDCs)
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75135) for a complete summary of the data processing and
collection periods for the claims-based measures using QDCs for the CY
2014 payment determination and subsequent years. In the CY 2016 OPPS/
ASC final rule with comment period (80 FR 70534), we codified the
requirements regarding data processing and collection periods for
claims-based measures using QDCs for the ASCQR Program at 42 CFR
416.310(a)(1) and (2).
We did not propose any changes to these requirements. We note that
data submission for the following claims-based measures using QDCs was
suspended as finalized in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59117 through 59123 and 83 FR 59134 through 59135) until
further action in rulemaking:
ASC-1: Patient Burn;