The week of September 23rd, 2019 proved to be a busy week for the health care strike force. In a continued effort to target individuals participating in genetic testing, the Department of Justice charged 35 people alleging fraud using telemedicine companies to recruit patients for unnecessary genetic tests that cost Medicare a purported $2.1 million.
The “takedown” was dubbed Operation Double Helix and involved prosecutors in Georgia, Florida, and Louisiana. Doctors, telehealth companies, a marketer, and lab executives were among those charged.
One of the individuals charged in the Southern District of Florida is Minal Patel, CEO of genetic testing company LabSolutions. The Patel indictment alleges that patients were recruited via telemarketing campaigns and health fairs. Patel is accused of paying at least three individuals up to 50% of the cost of the genetic tests as a kickback for patient referrals. It appears that the three individuals that allegedly received kickbacks are cooperating with authorities.
Patel’s attorney has announced that he is proceeding to trial and will assert an advice of counsel defense.
Telehealth company owners Richard Garipoli of Lotus Health and Jamie Simmons of MedSymphony Meetmydoc were also charged in the Southern District of Florida, but by individual indictment. Garipoli and Simmons are accused of having doctors write “bogus orders” for genetic testing.
A marketer, Ivan Andre Scott, was charged in the Middle District of Florida. Scott’s indictment alleges that he recruited Medicare beneficiaries and provided these beneficiaries with self-administered genetic tests. Scott would pass the recruited beneficiaries’ Medicare information to doctors and telehealth companies so that they could bill for the unnecessary self-administered genetic tests.
Doctors were charged in Texas and Georgia with taking kickbacks and ordering unnecessary tests.
Operation Double Helix makes clear that genetic testing continues to be a hot spot for the DOJ. The takedown demonstrates that the DOJ is increasingly criminalizing what traditionally was a civil enforcement area. More alarming is that advice of counsel doesn’t even seem to be a barrier to criminal charges. The only way to combat this patent overcriminalization of civil regulatory violations is to file motions to dismiss, proceed to trial, file Rule 29s, and win.