October 29, 2020

CMS Releases Fourth Interim Final Rule on the Public Health Emergency

On Wednesday, Oct. 28, the Centers for Medicare and Medicaid Services (CMS) released the fourth Interim Final Rule (IFR) on the COVID-19 public health emergency. This IFR contains provisions related to the coverage and payment of any United States Food and Drug Administration (FDA)-approved COVID-19 vaccine. The rule also includes the following provisions:

  • Creates flexibilities for states maintaining Medicaid enrollment during the COVID‑19 PHE;
  • Establishes enhanced Medicare payments for new COVID-19 treatments;
  • Takes steps to ensure price transparency for COVID-19 tests;
  • Provides an extension of Performance Year 5 for the Comprehensive Care for Joint Replacement (CJR) model; and
  • Creates flexibilities in the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 PHE.

Coverage and Payment of COVID-19 Vaccine

Once the FDA has authorized or approved a COVID-19 vaccine, the vaccine and its administration will be added to the list of preventive vaccines that are covered under Medicare Part B without coinsurance or a deductible.

Within the Medicaid program, the Families First Coronavirus Response Act, provided Medicaid programs with a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). Due to the IFR, in order to receive the temporary FMAP increase, states must cover COVID-19 vaccines and their administration for Medicaid enrollees without cost sharing.

Similarly, the IFR includes a policy for private health plans to provide coverage for an FDA authorized or approved COVID-19 vaccine. The rule will require plans and issuers to cover COVID-19 immunizations that have a recommendation from the United States Preventive Services Task Force or the Advisory Committee on Immunization Practices.

Enhanced COVID-19 Payments

Within the hospital inpatient setting, the Medicare program will provide an enhanced payment for eligible inpatient cases that involve use of certain new products authorized or approved to treat COVID-19. The enhanced payment will be equal to the lesser of:

  • 65% of the operating outlier threshold for the claim; or
  • 65% of the cost of a COVID-19 stay beyond the operating Medicare payment (including the 20% add-on payment under section 3710 of the CARES Act) for eligible cases.

Within the hospital outpatient setting, CMS has excluded FDA-authorized or approved drugs and biologicals, including blood products. This excludes authorized or approved drugs and biologicals 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. CMS will pay for these drugs and biologicals separately throughout the course of the PHE.

Other Provisions

Further, Section 3202(b) of the CARES Act established the requirement for providers to publicize cash prices for COVID-19 diagnostic tests during the PHE. This requires that each provider of a COVID-19 diagnostic test make public the cash price, defined as the charge that applies to an individual who pays cash for a COVID-19 diagnostic test, on the internet. If the provider does not have its own website, the provider must make the cash price available in writing within two business days upon request and through signage, if applicable.

Lastly, in this IFR, certain CJR model policies are being revised and there are technical changes made to accommodate these policy changes. CMS is extending Performance Year (PY) 5 of the model an additional six months, so PY 5 now ends Sept. 30, 2021.

If you have additional questions, please email COVID19@acr.org.