April 3, 2020

Enforcement Alert: Regulatory Agencies Investigating COVID-19 Testing, Treatment, Ancillary Services

Holland & Knight Alert
William F. Gould | Brian Hayes | Sam J. Louis | Justo A. Mendez | Jeremy M. Sternberg

Highlights

  • While the COVID-19 pandemic has not yet peaked in the United States, federal and state prosecuting and regulatory agencies are already devoting resources to investigating and prosecuting fraud, waste and abuse associated with COVID-19 testing, treatment and ancillary services.
  • Healthcare providers, health insurers and clinical laboratory facilities should be particularly aware of these activities.
  • In the understandable rush to test and treat in order to quell the pandemic and save lives, it will remain important for healthcare providers that order the COVID-19 tests, and the clinical laboratories that perform them, to adhere to the evolving U.S. Centers for Disease Control and Prevention (CDC) guidelines for testing and U.S. Food and Drug Administration (FDA) regulations for safety and efficacy.

While the COVID-19 pandemic has not yet peaked in the United States, federal and state prosecuting and regulatory agencies are already devoting resources to investigating and prosecuting fraud, waste and abuse associated with COVID-19 testing, treatment and ancillary services. Healthcare providers, health insurers and clinical laboratory facilities should be particularly aware of these activities.

Specifically, regulatory agencies are investigating and prosecuting:

  • unauthorized fraudulent COVID-19 test kits (On March 30, 2020, the U.S. Attorney's Office for the District of New Jersey charged an individual with a kickback scheme in an effort to obtain kickbacks on a per-test basis for COVID-19 tests, provided that those tests were bundled with a much more expensive respiratory pathogen panel (RPP) test.)
  • the advertisement and marketing of unproven and unauthorized medications and treatments
  • testing for COVID-19 that lacks medical necessity
  • offering and paying kickbacks in exchange for referrals to clinical laboratories
  • marketers and marketing groups targeting Medicare beneficiaries
  • claims that cannabis oils and related products can mitigate, prevent, treat, cure or diagnose COVID-19

In the understandable rush to test and treat in order to quell the pandemic and save lives, it will remain important for healthcare providers that order the COVID-19 tests, and the clinical laboratories that perform them, to adhere to the evolving U.S. Centers for Disease Control and Prevention (CDC) guidelines for testing and U.S. Food and Drug Administration (FDA) regulations for safety and efficacy. In addition, as telemedicine becomes more prominent in the diagnosis and treatment of COVID-19, primary care physicians and other healthcare providers performing services should familiarize themselves with the recently modified telehealth rules.

Clinical laboratories billing federal healthcare programs and/or commercial payors must ensure that there is a valid medical order for each test billed. While some regulations have been temporarily relaxed due to the public health emergency, medical necessity rules are still in effect.

When performing COVID-19 test for "cash patients" who chose to cover the cost of testing on their own, clinical laboratories should educate the cash patient on the medical criteria for testing and document acknowledgement that no third-party payor will be billed for the test.

The healthcare industry should be especially wary of retaining independent healthcare marketers or marketing groups for the promotion of COVID-19 testing. These sorts of activities, particularly those involving paying a percentage of collections or a fee per sample to a marketer or marketing group, bear significant risks under the federal Anti-Kickback Statute, state anti-kickback statutes and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA).

How Can Holland & Knight Assist You?

Holland & Knight has a comprehensive team of healthcare regulatory compliance attorneys that can help healthcare providers, commercial payors and clinical laboratories remain both compliant and competitive during this public health crisis. Contact one of the authors for additional information and guidance.   

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the authors of this alert for timely advice


Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem. Moreover, the laws of each jurisdiction are different and are constantly changing. If you have specific questions regarding a particular fact situation, we urge you to consult competent legal counsel.

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