Melissa L. Jampol, Member of the Firm, and Alexis Boaz, Associate, in the Health Care & Life Sciences practice, in the firm’s New York and Washington, DC, offices, respectively, co-authored an article in the Bloomberg Health Law & Business News, titled “INSIGHT: Labs Must Follow Two Kickback Laws During Covid-19.”
Following is an excerpt:
In an effort to increase Covid-19 testing and diagnosis, there have been a series of regulatory rollbacks by Medicare and Medicaid.
the waiver of administrative sanctions for certain violations of the physician self-referral law (the Stark law) and the Federal Anti-Kickback Statute (AKS) for items and services furnished in good faith in response to Covid-19;
the decision by Medicare not to require an order from a treating physician as a condition of Medicare coverage of Covid-19 and certain related lab diagnostic testing; and
other flexibilities granted to clinical laboratories.
However, the first prosecution under the Eliminating Kickbacks in Recovery Act is an important reminder that despite the numerous changes to Medicare and Medicaid requirements applicable to clinical laboratory services during the Covid-19 public health emergency, laboratories still face risks as potential enforcement targets under EKRA.
This is particularly so as both the Department of Justice and the Office of Inspector General (OIG) for the Department of Health and Human Services have clearly stated that they intend to aggressively pursue detecting, investigating, and prosecuting wrongdoing related to Covid-19.