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Rule2020-191502020-09-02

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

Health and Human Services Department, Centers for Medicare & Medicaid Services

Abstract

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).

Action & Dates

Action
Interim final rule with comment period.
Dates
Effective date: These regulations are effective on September 2, 2020.
Effective Date
2020-09-02

CFR References

Topics

Administrative practice and procedureBiologicsDiseasesDrugsEmergency medical servicesGrant programs-healthHealth facilitiesHealth maintenance organizations (HMO)Health professionsHealth recordsHospitalsLaboratoriesMedicaidMedicareNursing homesNutritionPenaltiesPrivacyPuerto RicoReporting and recordkeeping requirementsRural areasSafetyX-rays

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. 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 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. 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). DATES: Effective date: These regulations are effective on September 2, 2020. Applicability date: These regulations are applicable for the duration of the PHE for COVID-19. Section 488.447 is applicable 1 year beyond the expiration of the PHE for COVID-19. The amendment to § 414.1305 and the expansion of

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Full Document

Citation: 85 FR 54820