Reimbursement and Liability Implications of Not Pursuing an Emergency Use Authorization for COVID-19 Laboratory-Developed Tests

Reimbursement Implications for Not Seeking an EUA

Not seeking an EUA is likely to have a cascading effect on clinical lab reimbursement for COVID-19 LDTs during the COVID-19 public health emergency (PHE). Certain pieces of legislation have tied coverage expectations for COVID-19 tests to those that are provided pursuant to an FDA approval or an actual or pending EUA.

The Family First Coronavirus Act (FFCRA) as amended by the Coronavirus Aid, Relief and Economic Security Act (CARES Act), requires most commercial payors to cover medically appropriate COVID-19 diagnostic tests, without requiring cost sharing, prior authorization or medical-management limitations. Effectively, FFCRA requires commercial payors to reimburse laboratories even if they are not in-network with the payor – a big advantage given how challenging it can be for some laboratories to get a participation agreement with commercial payors.  There is a catch though – the only COVID-19 tests that qualify for these FFCRA reimbursement protections are those that meet one of the following criteria:

1. Is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the FDCA.
2. The developer has requested or intends to request, EUA under section 564 of the FDCA, unless and until the EUA has been denied or the developer does not submit a request within a reasonable timeframe [i.e., 15 days based on FDA guidance].
3. Is developed in and authorized by a state that has notified the Secretary of HHS of its intention to review tests intended to diagnose COVID–19.
4. Another test that the HHS Secretary determines appropriate in guidance.

Source: https://www.jdsupra.com/legalnews/reimbursement-and-liability-15574/