Clinical labs must pay attention to regulatory rules during the COVID-19 pandemic.
Federal and state regulatory agencies are already starting to investigate and prosecute fraud and abuse of COVID-19 testing and treatment. Clinical laboratories and pathology groups should be aware of these recent activities and ensure that their activities are compliant with statutes such as Eliminating Kickbacks in Recovery Act of 2018 (EKRA) and Anti-Kickback Statute (AKS).
Recent areas being focused on by regulatory agencies include the following:
- The advertisement of treatments and tests that have not been proven or authorized
- Arranging and paying for kickbacks as compensation for referrals to clinical laboratories
- Encouraging or performing COVID-19 testing that is medically unnecessary
- Marking activities that target Medicare beneficiaries
An individual from Georgia was charged by U.S. Attorney’s Office for the District of New Jersey on March 30, 2020, for arranging a COVID-19 related kickback scheme. In this scheme, the individual allegedly arranged to obtain kickbacks on a per-test basis and have them bundled with a much more expensive respiratory pathogen panel (RPP) test.
Clinical laboratories can avoid regulatory issues by ensuring that each test billed has a valid medical order. Medical necessity rules will still apply, even in a regulatory environment that may seem more relaxed in some ways.
Clinical labs should also consider evaluating their marketing relationships and ensuring that marketing compensation is not related to testing volumes. Labs that work with independent marketing firms should be especially conscientious that all AKS, EKRA, and state anti-kickback laws are being followed.