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CMS Interim Final Rule Establishes Additional COVID-19 Policies and Regulatory Flexibilities

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The Centers for Medicare & Medicaid Services (CMS) – along with the Departments of Labor and the Treasury – issued its fourth interim final rule with comment period (IFC) on policies and regulatory flexibilities available for the duration of the COVID-19 public health emergency.

The IFC includes a number of policies related to COVID-19 vaccine coverage and payment, enhanced payments for COVID-19 treatments, state Medicaid program requirements, price transparency requirements for COVID-19 diagnostic tests, and an extension of the comprehensive care for joint replacement (CJR) model.  

Specifically, CMS finalizes the following: 

  • COVID-19 Vaccines for Medicare Beneficiaries: Once the Food and Drug Administration (FDA) has authorized or approved a COVID-19 vaccine, the vaccine and its administration will be added to the list of preventive vaccines covered under Medicare Part B without coinsurance or deductible. 
  • COVID-19 Vaccine Coverage Requirements for Private Health Plans: Plans and issuers must cover COVID-19 immunizations that have in effect a recommendation of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices with respect to the individual involved, even if not listed for routine use on the immunization schedules of the CDC. This IFC also requires that during the public health emergency, plans and issuers must cover without cost sharing qualifying COVID-19 preventive services, regardless of whether an in-network or out-of-network provider delivers such services. 
  • COVID-19 Vaccine Coverage for Medicaid Programs: CMS clarifies policies related to COVID-19 vaccine coverage for Medicaid and Children’s Health Insurance Program beneficiaries, including which beneficiaries must be covered under requirements of the Families First Coronavirus Response Act.  
  • Enhanced Medicare Payments for New COVID-19 Treatments: CMS will provide an enhanced payment for eligible inpatient cases that involve the use of certain new products authorized or approved to treat COVID-19. The enhanced payment will be equal to the lesser of: (1) 65% of the operating outlier threshold for the claim; or (2) 65% of the cost of a COVID-19 stay beyond the operating Medicare payment (including the 20% add-on payment authorized by the Coronavirus Aid, Relief, and Economic Security Act) for eligible cases. In the outpatient setting, CMS will exclude FDA-authorized or approved drugs and biologicals (including blood products) authorized or approved to treat or prevent COVID-19 from being packaged into comprehensive ambulatory payment classification (C-APC) payment when these treatments are billed on the same claim as a primary C-APC service. Instead, Medicare will pay for these drugs and biologicals separately throughout the course of the public health emergency. 
  • Price Transparency for COVID-19 Diagnostic Tests: CMS requires that every provider of a COVID-19 diagnostic test make public the cash price, defined as the charge that applies to an individual who pays cash (or cash equivalent or such tests on the internet). 
  • CJR Model Extension: CMS extends performance year (PY) 5 of the model an additional six months to Sept. 30, 2021. CMS also makes additional modifications, including bifurcating PY 5 and performing two reconciliations (one for the first 12 months of PY 5 and one for the remaining nine months of PY 5), extending the extreme and uncontrollable circumstances policy, capping episode payments at the quality adjusted target price for any episode with actual episode payments that include a claim with a COVID-19 diagnosis code, and adding newly finalized Medicare Severity-Diagnosis Related Group 521 and 522 to the model.  

Additional information is available in CMS’ fact sheet on the IFC. CMS will accept comments on the IFC until 2 pm (PT) on Jan. 4, 2021.