Regulatory Resources
Updated 11/3/20
On Wednesday, March 18, 2020 the President of the United States signed the Families First Coronavirus Response Act. This is brief summary of the FFCRA requirements for mandatory coverage of testing for Covid-19 by group health plans and insurers.
A group health plan (this includes self-funded ERISA and fully insured ERISA plans), and a health insurance insurer offering group or individual health insurance coverage (including a grandfathered health plan) must provide coverage, and must not impose any cost sharing (including deductibles, copayments, and coinsurance) requirements or prior authorization or other medical management requirements, for the following items and services furnished during any portion of the declared emergency period1:
- In vitro diagnostic products2 for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 that are approved, cleared, or authorized under section 510(k), 513, 515 or 564 of the Federal Food, Drug, and Cosmetic Act, and the administration of such in vitro diagnostic products.
- Items and services furnished to an individual during health care provider office visits (includes in-person visits and telehealth visits), urgent care center visits, and emergency room visits that result in an order for or administration of an in vitro diagnostic product described in paragraph (1), but only to the extent such items and services relate to the furnishing or administration of such product or to the evaluation of such individual for purposes of determining the need of such individual for such product.
This Act, and the requirements under this Act, takes effect April 2, 2020. The mandatory coverage of testing for COVID-19 without cost share will be effective for as long as the Secretary of HHS declares the public health emergency.
The Secretary of Health and Human Services, Secretary of Labor, and Secretary of the Treasury may promulgate future guidance.
1 The emergency period ends upon termination of the applicable public health emergency.
2 (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.
2 (a) In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.