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Regulations on COVID-19 vaccine and testing requirements issued

Benefits Administration and Outsourcing Solutions|Health and Benefits|Total Rewards|Wellbeing
COVID 19 Coronavirus

By Maureen Gammon and Kathleen Rosenow | November 18, 2020

Most group health plans must cover a COVID-19 vaccination with no cost sharing 15 business days after the CDC or USPSTF designates it as preventive.

On October 28, 2020, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued an interim final rule (IFR) to implement the requirement under the Coronavirus Aid, Relief, and Economic Security (CARES) Act for group health plans to cover qualifying COVID-19 preventive services without cost sharing. Non-grandfathered group health plans must begin to cover, without cost sharing, both the COVID-19 vaccination and its administration — by either in-network or out-of-network providers — within 15 business days of receiving a recommendation from the United States Preventive Services Task Force (USPSTF) or the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).

On the same day, the departments also released a press release, fact sheet, frequently asked questions on Medicare billing policies and webpage with COVID-19-related vaccine information.

The IFR also clarifies the requirement under the CARES Act for providers to post the cash price of COVID-19 tests and establishes an enforcement framework for compliance.

The departments will accept comments on the IFR until January 4, 2021.

The IFR is effective November 2, 2020. In general, its provisions will extend until the end of the declared COVID-19 public health emergency (PHE). The PHE declaration was recently extended through January 20, 2021.1 Note that the requirement in the CARES Act for group health plans to cover a COVID-19 vaccine is permanent and will continue even after the PHE expires.

Coverage of COVID-19 vaccine

  • Plans subject to the COVID-19 vaccine mandate.
    The CARES Act requirement to provide first-dollar coverage for COVID-19 preventive services applies to all non-grandfathered private group health plans. It does not apply to grandfathered group health plans; excepted benefits; or short-term, limited-duration insurance.
  • Timing for providing COVID-19 preventive services.
    Under the Affordable Care Act’s (ACA’s) preventive care mandate, a non-grandfathered group health plan typically has at least one year before it must provide first-dollar coverage for a newly issued preventive care requirement or guideline; however, the CARES Act significantly shortens this timing for any qualifying coronavirus preventive service: Non-grandfathered group health plans must cover such a service 15 business days after the USPSTF or ACIP designates it as preventive. The IFR defines qualifying coronavirus preventive services as an item, service or immunization that is intended to prevent or mitigate COVID-19 and that is, with respect to the individual involved, an evidence-based item or service that has in effect a rating of A or B in the current recommendations of the USPSTF, or an immunization that has in effect a recommendation from the ACIP, regardless of whether the immunization is recommended for routine use.
  • Items and services required to be covered.
    The IFR clarifies, as it relates to the ACA’s preventive services requirement, that non-grandfathered group health plans must provide first-dollar coverage for both the COVID-19 vaccine and its administration, regardless of how the administration is billed, and regardless of whether multiple doses are required. The IFR confirms that the cost of administering the vaccine must still be covered when a third party, like the federal government, pays for the cost of the vaccine itself. If the office visit is not billed separately from the COVID-19 vaccination and the primary purpose of the visit is the delivery of the recommended COVID-19 vaccination, then the group health plan may not impose cost-sharing charges for the office visit.
  • COVID-19 vaccines at out-of-network providers.
    Generally, non-grandfathered group health plans are only required to provide first-dollar coverage for in-network preventive services; however, to help ensure that the vaccine is available to as many consumers as possible, the IFR requires that first-dollar coverage be provided for out-of-network services as well.
  • Provider reimbursement of vaccine.
    The IFR does not prohibit providers from balance billing vaccine recipients, but in an effort to discourage this, if the group health plan does not have a negotiated rate with a provider, the plan must reimburse the provider for the qualifying coronavirus preventive service “in an amount that is reasonable, as determined in comparison to the prevailing market rates for such service.” In the IFR’s preamble, the departments indicate that they will consider the amount that would be paid under Medicare for the item or service as being reasonable. Note that providers participating in the CDC’s COVID-19 vaccination program must agree not to seek any reimbursement from the vaccine recipient, including through balance billing.

Clarifications on COVID-19 testing requirements

The IFR provides additional guidance related to the COVID-19 testing requirements for group health plans under the Families First Coronavirus Response Act (FFCRA) and the CARES Act. Group health plans must cover COVID-19 diagnostic testing and related items and services without cost sharing during the COVID-19 PHE. If there is no negotiated rate for the diagnostic test, plans must reimburse the provider for the diagnostic test at the cash price for the service, as listed by the provider on a public internet website. The IFR codifies the requirement for providers to post the cash price for the diagnostic test and provides related details. It also lays out how HHS will enforce the requirement, including imposing civil monetary penalties.

Going forward

Plan sponsors of group health plans should review the guidance and be prepared to comply with the requirements within 15 business days after the USPSTF or ACIP recommends a vaccine.


1 The secretary of HHS may extend the PHE declaration for subsequent 90-day periods for the duration of the PHE as well as terminate it upon determining that the PHE no longer exists.

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Insider November 2020 PDF .4 MB

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