Biden Administration Guidance:
No Out-of-Pocket Costs for COVID Testing,
No Cost Sharing for Colonoscopy following Positive Test
On January 10, 2022, the Biden Administration released the Affordable Care Act Implementation Frequently Asked Questions Part 51, which includes guidance that reaffirms no out-of-pocket costs for COVID-19 testing and no cost-sharing for colonoscopies following a positive non-invasive colorectal cancer screening test. Excerpts from the document are included below.
Q1. Under section 6001 of the FFCRA, are plans and issuers required to cover over-the-counter (OTC) COVID-19 tests available without an order or individualized clinical assessment by a health care provider?
Yes. Plans and issuers must cover OTC COVID-19 tests that meet the statutory criteria under section 6001(a)(1) of the FFCRA,12 including tests obtained without the involvement of a healthcare provider. Consistent with section 6001 of the FFCRA, this coverage must be provided without imposing any cost-sharing requirements, prior authorization, or other medical management requirements.
[…] plans and issuers are strongly encouraged to provide direct coverage for
OTC COVID-19 tests to participants, beneficiaries, and enrollees by reimbursing sellers directly without requiring participants, beneficiaries, or enrollees to provide upfront payment and seek reimbursement.
This FAQ modifies guidance previously provided by the Departments such that the requirement to cover COVID-19 tests under section 6001 of the FFCRA with respect to OTC COVID-19 tests is no longer limited only to situations in which the individual has an order or individualized clinical assessment from a health care provider. This updated guidance requires coverage, without an order or individualized clinical assessment from a health care provider, only with respect to OTC COVID-19 tests that do not require a health care provider’s order under the applicable FDA authorization, clearance, or approval. This FAQ does not modify
previous guidance addressing coverage for purposes not primarily intended for individualized diagnosis or treatment of COVID-19 […]
Q6. When must plans and issuers begin providing coverage without cost-sharing, prior authorization, or other medical management requirements for OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider?
Plans and issuers must provide coverage without cost-sharing requirements, prior authorization, or other medical management requirements in accordance with the requirements under section 6001 of the FFCRA with respect to OTC COVID-19 tests available without an order or individualized clinical assessment by a health care provider purchased on or after January 15, 2022, and during the public health emergency. Coverage may, but is not required to, be provided for OTC COVID-19 tests purchased without a provider order or individualized clinical assessment before January 15, 2022.
Q7. Are plans and issuers required to cover, without the imposition of any cost sharing, a follow-up colonoscopy conducted after a positive non-invasive stool-based screening test or direct visualization test (e.g., sigmoidoscopy, CT colonography)?
Yes. A plan or issuer must cover and may not impose cost sharing with respect to a colonoscopy conducted after a positive non-invasive stool-based screening test or direct visualization screening test for colorectal cancer for individuals described in the USPSTF recommendation. As stated in the May 18, 2021 USPSTF recommendation, the follow-up colonoscopy is an integral part of the preventive screening without which the screening would not be complete. The follow-up colonoscopy after a positive non-invasive stool-based screening test or direct visualization screening test is therefore required to be covered without cost sharing in accordance with the requirements of PHS Act section 2713 and its implementing regulations.
Q8. When must plans and issuers begin providing coverage without cost sharing for a follow-up colonoscopy after a positive non-invasive stool-based screening test or direct visualization test based on the new USPSTF recommendation?
Plans and issuers must provide coverage without cost sharing consistent with the May 18, 2021 USPSTF recommendation regarding colorectal cancer screening and in accordance with the requirements under PHS Act section 2713 for plan years (in the individual market, policy years) beginning on or after the date that is one year after the date the recommendation was issued. In this case, the recommendation is considered to have been issued as of May 31, 2021, so plans and issuers must provide coverage without cost sharing for plan or policy years beginning on or after May 31, 2022.
The V-BID Center Director, Dr. Mark Fendrick, is available for questions and comments at vbidcenter@umich.edu.
