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Agencies Issue Regulations on Coverage of COVID-19 Vaccines


· 5 minute read


· 5 minute read

Interim Final Rule: Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, 26 CFR Part 54; 29 CFR Part 2590; 31 CFR Part 33; 42 CFR Parts 410, 411, 414, 417, 433, and 510; 45 CFR Parts 147, 155, and 182; 85 Fed. Reg. ____ (Nov. 6, 2020)

Interim Final Rule

HHS Fact Sheet

HHS News Release

The IRS, DOL, and HHS have issued interim final regulations addressing (among other things) group health plan coverage of COVID-19 vaccines and testing. The regulations are effective immediately and will sunset at the end of the COVID-19 public health emergency (see our Checkpoint article). The agencies have requested comments on certain aspects of the regulations by January 4, 2021. Here are highlights of the provisions affecting group health plans:

  • Qualifying Coronavirus Preventive Services. The regulations implement the CARES Act requirement that most group health plans cover, without cost-sharing, qualifying coronavirus preventive services, including immunizations, that receive specified recommendations from the CDC (see our Checkpoint article). Coverage must be provided within 15 days after the CDC’s recommendation, regardless of whether the service or immunization is recommended for routine use and whether it is provided by an in-network or out-of-network provider. (In contrast, the general Affordable Care Act rules for preventive services allow plans at least a year after the CDC recommendation to begin coverage, and coverage is only required for services and immunizations approved for routine use and provided by in-network providers, with limited exceptions.) Plans must cover the cost of a vaccine’s administration, even if the cost of the vaccine itself is paid by a third party such as the federal government. Plans may impose cost-sharing for office visits that are billed separately, but office visits not billed separately must be covered without cost-sharing if the primary purpose of the visit is for the administration of the vaccine. Although grandfathered plans and plans providing excepted benefits or short-term, limited-duration coverage are not required to comply with the rules regarding qualifying coronavirus preventive services, an accompanying toolkit makes clear that they are encouraged to do so.
  • COVID-19 Testing. The CARES Act requires group health plans (including grandfathered plans but not those providing excepted benefits or short-term, limited-duration insurance) to cover a broad range of COVID-19-related diagnostic items and services and reimburse any provider of diagnostic tests (in-network or out-of-network) the cash price listed by the provider on a public website or a lower negotiated rate (see our Checkpoint article). To address plan concerns about providers failing to post cash prices, the regulations provide further posting instructions and details about how the requirement will be enforced. The agencies seek comments on related issues, including whether the posting requirement should be expanded to include providers that perform additional services related to the performance of a COVID-19 test (such as specimen collection or transportation). The agencies also note that COVID-19 testing efforts have been hampered by challenges such as delays in obtaining results, test accuracy, and supply shortages. Plans are encouraged to explore using pay-for-performance arrangements that create incentives for providers to reduce the time it takes to report test results while still maintaining accuracy.

EBIA Comment: The agencies have issued a wealth of guidance regarding required coverage of COVID-19 testing and vaccines, and this will likely not be the last. Although a COVID-19 vaccine is not yet publicly available, plans should prepare now to provide coverage without cost-sharing within 15 days after the CDC recommendation. For more information, see EBIA’s Group Health Plan Mandates manual at Sections XVI.C (“Mandated Coverage of Diagnostic and Preventive Services”) and XIV (“Coverage of Preventive Health Services”). See also EBIA’s Health Care Reform manual at Section XII.C (“Coverage of Preventive Health Services”).

Contributing Editors: EBIA Staff.

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