Genetic Testing & Telehealth Headline Holiday Healthcare News

 In COVID-19, Blog, Government Compliance & Investigations

They say that paperwork waits for no one, and healthcare news does not pause over holidays. While many of us were grilling burgers and watching fireworks – with proper social distancing and masks, of course – genetic testing and telehealth created headlines in the healthcare space. One was for the wrong reasons, the other relating to apparent bipartisan deregulation.

Genetic Testing

Genetic testing made the headlines with a new False Claims Act (FCA) settlement just north of us Nashville. On July 1, 2020, the United States Attorney’s Office for the Western District of Kentucky announced an $8.25 million settlement with Agendia, Inc., a molecular diagnostics testing company based in California. The Medicare fraud settlement originated with a qui tam complaint filed by a whistleblower and resolved allegations that Agendia “conspired with hospitals to artificially delay ordering [one of its breast cancer-related] genetic assay[s] in order to circumvent Medicare’s 14-Day Rule . . . .” During the relevant period, the 14-Day Rule “prohibited laboratories from separately billing Medicare for tests performed on specimens if a physician ordered the test within 14 days of the patient’s discharge from a hospital . . . .”

The United States alleged that Agendia schemed around the rule by (1) refusing to perform its genetic assay if a Medicare patient had been discharged less than 14 days earlier; and/or (2) employing a “Medicare hold” system, which “automatically held orders for Medicare patients at the time they were received . . . until 14 days after the patient’s discharge.” In a separate settlement, Lourdes Hospital in Paducah, Kentucky, resolved allegations that it was complicit in Agendia plan. This benefited the hospital because they “avoided paying Agendia for the testing.”


The Agendia Settlement is a reminder of the importance of compliance, particularly in matters of genetic testing. Genetic testing is a relatively new field of medicine, and as such may trigger questions from enforcement authorities regarding medical necessity, particularly when used prophylactically or in an effort to guide the course of future treatment. Entities using genetic testing have enough to worry about without alleged failures like regulatory and anti-kickback compliance.

The Agendia Settlement is a reminder of the importance of compliance, particularly in matters of genetic testing


In June, I wrote that Telehealth is Here to Stay, noting its expansion during COVID-19, the near unanimity among commentators in support of that expansion beyond the pandemic, and the integration of telehealth into the University of Pittsburgh Medical Center (UPMC) Pinnacle’s electronic health records (EHR) platform. Since then, I noted on Twitter that another healthcare facility has taken similar steps. A similar story dropped just yesterday. Around the holiday, the HealthIT press reported more activity.

All of this happened despite the fact that telehealth visits have been declining since April.

It is not surprising to see a decrease in telehealth visits as states try to reopen and individuals who have delayed care requiring in-person appointments return to physicians’ offices. The real question is not whether telehealth visits will come down from their peaks, but whether enough people will find them valuable to continue the momentum behind liberalization of telehealth regulations beyond COVID-19. Assuming that happens, healthcare entities should watch carefully for CMS’s proposal for balancing telehealth accessibility with regulation of the growing industry.

Subscribe to the SRVH blog for further updates and contact the lawyers in our Government Compliance & Investigations or Healthcare groups with any questions or concerns.

Photo By hywards from Shutterstock

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