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Note: This HHS-approved document has been submitted to the Office of the Federal Register (OFR) for publication and has not yet been placed on public display or published in the Federal Register. The document may vary slightly from the published document if minor editorial changes have been made during the OFR review process. The document published in the Federal Register is the official HHS-approved document

[Billing Code: 4120-01-P] 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), HHS. ACTION: Final rule with comment period and interim final rule with comment period. 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

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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: The provisions of the final rule with comment are effective

January 1, 2021. The regulations in the interim final rule with comment period are effective on

January 1, 2021, except for instructions 25 through 31 amending 42 CFR 512.205, 512.210,

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512.217, 512.220, 512.245, 512.255, and 512.285, which are effective on [Insert date of display

in the Federal Register].

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 [Insert date 30

days from date of display in the Federal Register].

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 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 [Insert date 60 days from date of display

in the Federal Register].

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):

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1. Electronically. You may (and we encourage you to) submit electronic comments on

this regulation to . 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,

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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 APCPanel@cms..

Ambulatory Surgical Center (ASC) Payment System, contact Scott Talaga via email

Scott.Talaga@cms. or Mitali Dayal via email Mitali.Dayal2@cms..

Ambulatory Surgical Center Quality Reporting (ASCQR) Program Administration,

Validation, and Reconsideration Issues, contact Anita Bhatia via email at

Anita.Bhatia@cms..

Ambulatory Surgical Center Quality Reporting (ASCQR) Program Measures, contact

Cyra Duncan via email Cyra.Duncan@cms..

Blood and Blood Products, contact Josh McFeeters via email

Joshua.McFeeters@cms..

Cancer Hospital Payments, contact Scott Talaga via email Scott.Talaga@cms..

CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck Braver via email

Chuck.Braver@cms..

Composite APCs (Low Dose Brachytherapy and Multiple Imaging), contact Au'Sha

Washington via email AuSha.Washington@cms..

Comprehensive APCs (C-APCs), contact Lela Strong-Holloway via email

Lela.Strong@cms., or Mitali Dayal via email Mitali.Dayal2@cms..

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