Note: This HHS-approved document has been submitted to …

1 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.

2 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 CMS-1736-FC; CMS-1736-IFC 2.

3 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.

4 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 , , CMS-1736-FC; CMS-1736-IFC 3.

5 , , , , and , 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 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 and , and the Radiation Oncology (RO) Model, instructions 25. through 31 amending 42 CFR , , , , , , and 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 on [Insert date 60 days from date of display in the Federal Register].

6 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): CMS-1736-FC; CMS-1736-IFC 4. 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.

7 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, 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, CMS-1736-FC; CMS-1736-IFC 5.

8 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 ambulatory surgical Center (ASC) Payment System, contact Scott Talaga via email or Mitali Dayal via email ambulatory surgical Center Quality Reporting (ASCQR) Program Administration, Validation, and Reconsideration Issues, contact Anita Bhatia via email at ambulatory surgical Center Quality Reporting (ASCQR) Program Measures, contact Cyra Duncan via email Blood and Blood Products, contact Josh McFeeters via email Cancer hospital Payments, contact Scott Talaga via email CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck Braver via email Composite APCs (Low Dose Brachytherapy and Multiple Imaging), contact Au'Sha Washington via email Comprehensive APCs (C-APCs)

9 , contact Lela Strong-Holloway via email or Mitali Dayal via email CMS-1736-FC; CMS-1736-IFC 6. hospital outpatient Quality Reporting (OQR) Program Administration, Validation, and Reconsideration Issues, contact Shaili Patel via email hospital outpatient Quality Reporting (OQR) Program Measures, contact Nicole P. Crenshaw via email hospital outpatient Visits (Emergency Department Visits and Critical Care Visits), contact Elise Barringer via email hospital Quality Star Rating Methodology, contact Annese Abdullah-Mclaughlin via email Inpatient Only (IPO) Procedures List, contact Au'Sha Washington via email or Allison Bramlett via email or Lela Strong-Holloway via email 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 New Technology Intraocular Lenses (NTIOLs)

10 , contact Scott Talaga via email No Cost/Full Credit and Partial Credit Devices, contact Scott Talaga via email OPPS Brachytherapy, contact Scott Talaga via email 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 or Scott Talaga via email or Josh McFeeters via email at CMS-1736-FC; CMS-1736-IFC 7. OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar Products, contact Josh McFeeters via email at or Gil Ngan via email at or, or Cory Duke via email at OPPS New Technology Procedures/Services, contact the New Technology APC mailbox at OPPS Packaged Items/Services, contact Lela Strong-Holloway via email or Mitali Dayal via email at OPPS Pass-Through Devices, contact the Device Pass-Through mailbox at OPPS Status Indicators (SI) and Comment Indicators (CI), contact Marina Kushnirova via email Partial Hospitalization Program (PHP) and Community Mental Health Center (CMHC).