CMS Issues Interim Final Rule on Future COVID-19 Vaccine

This week, the U.S. Centers for Medicare and Medicaid Services (CMS), along with the Departments of Labor and Treasury, issued an interim final rule with comment period (IFC) to remove administrative barriers to eliminate potential delays to patient access to a COVID-19 vaccine once available among Medicare and Medicaid beneficiaries, as well as those with employer-sponsored or other private health coverage.

Upon FDA approval of a COVID-19 vaccine, CMS is expected to announce coding and payment information through program memoranda. The IFC was taken to ensure that a COVID-19 vaccine authorized by FDA under an emergency use authorization (EUA) will be covered by Medicare and Medicaid. Without this action, a vaccine authorized under the EUA would not be treated the same way, creating cost sharing and reimbursement barriers to care. The IFC additionally implements a Congressional CARES Act requirement that private insurers cover vaccines authorized for emergency use as long as the COVID-19 public health emergency exists.  

The IFC additionally:

  • Creates flexibilities for states maintaining Medicaid enrollment during the COVID-19 public health emergency;
  • 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 flexibility in the public notice requirements and post-award public participation requirements of a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 public health emergency

Additional information on the interim final rule is available here.