DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

1 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. [Billing Code: 4120-01-P] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid SERVICES 42 CFR Parts 410, 413, 414, 422, 423, 482, 483, 485, 488 and 493 [CMS-3401-IFC] RIN 0938-AU33 Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public HEALTH Emergency AGENCY: Centers for Medicare & Medicaid SERVICES (CMS), HHS.

2 ACTION: Interim final rule with comment period. SUMMARY: This interim final rule with comment period (IFC) revises regulations to strengthen CMS ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public HEALTH officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results 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 This IFC updates the extraordinary circumstances exceptions granted for the ESRD Quality Incentive Program (QIP), Hospital Acquired Condition (HAC) Reduction Program, Hospital Readmissions Reduction Program CMS-3401-IFC AB/GB 08/24/20 A 2 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. (HRRP), and Hospital VBP Program for the PHE for COVID-19, and revises the FY 2022 performance period under the Skilled Nursing Facility (SNF) VBP as a result of the PHE for COVID-19.

4 This IFC also announces that with respect to the Hospital VBP Program, HRRP, HAC Reduction Program, SNF VBP Program and the ESRD QIP, if, as a result of a decision to grant a new nationwide ECE without request or a decision to grant a substantial number of individual ECE requests, we do not have enough data to reliably compare national performance on measures, we may propose to not score facilities, hospitals, or SNFs based on such limited data or make the associated payment adjustments for the affected program year. In addition, this IFC announces that CMS will not enforce certain procedural volume requirements for four national coverage determinations, revises the previous policy outlined in the May 8th COVID-19 IFC by establishing that one single COVID-19 diagnostic test and one of each other applicable related tests without an order from a treating physician or other practitioner is reasonable and necessary.

5 Establishes a policy whereby the orders of pharmacists and other practitioners that are allowed to order laboratory tests in accordance with state scope of practice and other pertinent laws can fulfill the requirements related to orders for covered COVID-19 and related tests for Medicare patients, specifies how temporary premium credits for individual and small group HEALTH insurance coverage are treated for purposes of the risk adjustment and medical loss ratio programs, modifies the application of the extreme and uncontrollable circumstances policy for calculation of the 2022 Part C and D Star ratings to address the effects of the PHE for COVID-19, includes in the Merit-Based Incentive Payment System (MIPS) beneficiary assignment methodology for the CMS Web Interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey for performance year 2020 and any subsequent performance year that starts during the PHE for COVID-19 certain Current Procedural Terminology (CPT) CMS-3401-IFC AB/GB 08/24/20 A 3 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.

6 It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. and Healthcare Common Procedure Coding System (HCPCS) code additions, and modifies IA_ERP_3. DATES: Effective date: These regulations are effective on [Insert the date of publication at the Office of the Federal Register]. Applicability date: These regulations are applicable for the duration of the PHE for COVID-19. Section is applicable 1 year beyond the expiration of the PHE for COVID-19. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 on [Insert date 60 days after date of publication in the Federal Register.]

7 ] ADDRESSES: In commenting, please refer to file code CMS-3401-IFC. Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to Follow the "Submit a comment" instructions. 2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid SERVICES , DEPARTMENT of HEALTH and HUMAN SERVICES , Attention: CMS-3401-IFC, Box 8016, Baltimore, MD 21244-8016. Please allow sufficient time for mailed comments to be received before the close of the comment period. CMS-3401-IFC AB/GB 08/24/20 A 4 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.

8 It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. 3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid SERVICES , DEPARTMENT of HEALTH and HUMAN SERVICES , Attention: CMS-3401-IFC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850 For information on viewing public comments, see the beginning of the "SUPPLEMENTARY INFORMATION" section. FOR FURTHER INFORMATION CONTACT: Debra Lyons, (410) 786-6780, for information on the LTC enforcement regulation at 42 CFR part 488.

9 CAPT Scott Cooper, USPHS, (410) 786-9465, for the hospital and CAH COVID-19 reporting requirements. Sarah Bennett, (410) 786-3354, for laboratory reporting information. Julia Venanzi, (410) 786-1471, for provisions related to the Hospital Value-Based Purchasing Program. Erin Patton, (410) 786-2437, for provisions related to the Hospital Readmissions Reduction Program. Lang Le, (410)786-5693, for provisions related to the Skilled-Nursing Facility Value-Based Purchasing Program and the Hospital-Acquired Condition Reduction Program. Delia Houseal, (410) 786-2724, for provisions related to the End-Stage Renal Disease CMS-3401-IFC AB/GB 08/24/20 A 5 INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed and may be privileged and confidential.

10 It is for internal government use only and must not be disseminated, distributed, or copied to persons not authorized to receive the information. Unauthorized disclosure may result in prosecution to the full extent of the law. Quality Incentive Program. Kimberly Long, (410) 786-5702, or for provisions related to NCD Procedural Volumes for Facilities and Practitioners to Maintain Medicare Coverage. Jennifer Dupee, (410) 786-6537, for provisions related to order requirements for COVID-19 and related testing. Jaya Ghildiyal, (301) 492-5149, for PPACA risk adjustment requirements. Christina Whitefield, (301) 492-4172, for PPACA medical loss ratio requirements. Elizabeth Goldstein, (410) 786-6665, or for the modifications to the calculation of the 2022 Part C and D Star ratings .