Interim Final Rule on COVID-19 Vaccines

Interim Final Rule on COVID-19 Vaccines

During the public health emergency, the CARES Act mandates non-grandfathered health plans cover COVID-19 vaccines without cost sharing within 15 business days of federal authorization of the vaccine.  The Department of Health and Human Services (HHS) recently extended the public health emergency another 90 days to last until mid-January 2021 (it had previously been extended 90 days in mid-April and again in mid-July), so a new vaccine be approved within the next 90 days would be subject to this 15-day requirement.

Federal regulators have announced a 241-page interim final rule (IFR) relating to COVID-19 vaccines, with request for public comment.  Here’s a summary of the vaccine initiatives relevant to employers:

• It “implements a number of measures intended to further the Administration’s commitment to ensure every American has timely access to a COVID-19 vaccine without any out-of-pocket expenses, no matter their source of coverage, or whether they are covered at all.”  A toolkit has been provided to help plans with vaccine coverage compliance.
• At all times, non-grandfathered health plans must cover without cost sharing qualifying coronavirus preventive services within 15 business days of approval/recommendation, “regardless of whether such services are delivered by an in-network or out-of-network provider.” This includes “recommended immunizations for COVID-19 that are qualifying coronavirus preventive services, even if not listed for routine use on the Immunization Schedules of the CDC,” along with the administration of such vaccine “regardless of how the administration is billed.”
  • Ordinarily, recommended preventive care would only have to waive cost-sharing in-network (unless there is inadequate network access for that service), would not be subject to the non-grandfathered preventive care mandates until the plan year beginning on/after the one-year anniversary of a published recommendation, and immunizations would have to be listed for routine use.  So these qualifying coronavirus preventive services mandates have more stipulations to be aware of than usual.
• “Because the vaccine would be intended for administration to healthy people as a prophylactic measure, there must be a higher degree of certainty about the risks and benefits of the product than needed for Emergency Use Authorizations (EUAs) for medical products intended for treatment of sick patients. There are no historical examples in which Medicare has covered vaccines for which an EUA was issued by FDA.”
• Since insurers and self-funded plans might look to how Medicare will process and price these new types of claims, these comments may prove helpful in anticipating how to accommodate several new vaccines coming to market:
  • “The Medicare allowed amount for the COVID-19 vaccine will be 95 percent of the average wholesale price (or reasonable cost, for example under OPPS)…we anticipate establishing a unique administration code for each COVID-19 vaccine product. We believe it is imperative that coding and payment be in place as soon as possible after COVID-19 vaccines become available. We anticipate establishing specific coding and payment rates through technical direction to the MACs, including instructions to make this information available to the public. We also anticipate posting information on coding, payment, and billing for COVID-19 vaccines and vaccine administration on the CMS website. This approach will maintain public transparency while allowing CMS to pay appropriately for particular vaccines and vaccine administration as quickly as practicable once they are authorized or licensed for use by FDA.”

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.