Bradley attorney Jason Mehta was quoted in GenomeWeb on the Department of Health and Human Services (HHS) decision to crackdown on genetic testing fraud. HHS decided to focus on this last fall after receiving several alerts from the Centers for Medicare and Medicaid Services that they were seeing billing irregularities around genetic testing. Shortly after, HHS and the U.S. Department of Justice (DOJ) indicted more than 30 people involved in fraud schemes that billed Medicare for $2.1 billion of genetic tests. Schemes often involved recruiters buying a list of Medicare beneficiaries who they would call and try to convince to submit samples for testing.
Mehta said that he has seen a "dramatic uptick" in questions around genetic testing, both retrospectively from clients who are responding to indictments or subpoenas from DOJ and prospectively from clients trying to evaluate proposed arrangements.
"I think in some part that reflects the reality that the use of cancer and genetic testing tools is increasing, and so with more testing there is going to be more scrutiny and more questions," he said.
Mehta said that based on the genetic testing indictments that have been made public thus far, "there's a real focus on alleged illicit marketing arrangements, and the government not liking the fact that marketers were getting a commission on the tests that they brought in."
That is a pretty standard application of the anti-kickback statute, he said. "Those cases, I think, are pretty standard fare, and I'm not surprised that DOJ has brought those cases, even when the defendants might have some defense."
More generally, Mehta said that as healthcare marketing becomes more direct, both the government and marketers are working to arrive at new understandings of what is and is not acceptable.
"The government is adjusting to what they think is permissible or not, and I think marketers, particularly the ones that want to get it right are adjusting, as well," he said. "So, I do think we are going to get more evolving and sophisticated arrangements, some of which will be problematic and some of which probably will pass muster under current laws."
Mehta said that one element factoring into the government's ability to identify and prosecute fraud was the advance in data analytics, noting that during his time as an assistant US attorney, these capabilities evolved dramatically.
"When I started at the Justice Department in 2012, I could see high-level spending data, like, here is how much doctors' billing contributed to healthcare spending, but it was hard to get more granular than that," he said. "When I left the Justice Department, the level of sophistication had increased to where I was able to query almost any doctor in the country and look at what their prescription habits were, what their diagnostic testing habits were, and I could do the same by beneficiary."
"By the time I left, I could build almost an entire case solely on data analytics," he said.
Another change Mehta noted during his time in government was a growing level of coordination between DOJ and other agencies, which he suggested could be relevant to genetic testing given the skepticism the US Food and Drug Administration has expressed around the utility of some cancer and pharmacogenomic testing.
"I would certainly expect as we get further downstream with more tranches of indictments, and I do think more are coming, I would expect DOJ to go after more subtle forms of alleged fraud schemes, and I would expect them to be coordinating more with FDA and other government partners," he said.
The complete article, “HHS Expects Drop-off in Genetic Testing Fraud Following Recent Crackdown,” first appeared in GenomeWeb on January 29, 2020.