Tag Archives: Clay T. Lee

Feds Exhibit Continued Interest in Prosecuting Illegal Relationships Between Laboratories and Marketers

 

 

 

 

On July 8, 2019, Anthony Camillo, owner of Allegiance Medical Laboratory and AMS Medical Laboratory, was sentenced to 30 months in prison by a federal judge in the Eastern District of Missouri. He was ordered to pay $3.4 million in restitution for violations of the anti-kickback statute, associated conspiracy charges, and illegal kickbacks related to various health care fraud schemes to defraud federal health care benefit programs. Those operating in the clinical laboratory testing space or referring specimens to such laboratories should know that what happened in this case is likely a bellwether of continued enforcement action by the federal government with respect to marketing arrangements involving laboratory testing of human tissue.

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Whether Worth Less or Worthless, Quality of Care Issues Under the FCA are Worth Noting

On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene requirements of residents, (4) take prophylactic measures to prevent pressure ulcers, and (5) use physical restraints only when necessary. The FCA makes it illegal for anyone to submit claims (or cause claims to be submitted) for reimbursement to Medicare or Medicaid that are known to be false or based on false information. This settlement also resolves allegations that the Director of Operations, CEO, and several Vanguard companies caused false and/or fraudulent claims to be submitted.  Both the CEO and Director of Operations agreed to pay $250,000, and Vanguard will enter into a chain-wide corporate integrity agreement. The $18 million settlement is the largest “worthless services” settlement to date in Tennessee.

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OIG Published “Work Plan” Affecting Durable Medical Equipment Industry

On January 16, 2018, the Department of Health and Human Services Office of Inspector General (OIG) published its most recent update to the agency’s “Work Plan.”  Of note to Durable Medical Equipment (DME) manufacturers, suppliers and prescribers, OIG signaled increased interest in the investigation of three specific off-the-shelf orthotic devices identified by the HCPCS codes:

  • L0648—back bracing
  • L0650—back bracing
  • L1833—knee bracing
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State AGs Think Opioid Class Actions Will Be the Next “Big Tobacco” Settlement

At this point, it’s not really ground-breaking news that America has a problem with opioid drugs. By way of anecdote, when I became a federal prosecutor in 2011, the last heroin case that had been prosecuted in the Nashville U.S. Attorney’s office was in the early-1990s; although, to be fair, there were then lots of what we called “pill” cases involving opioids. When I left the office in 2017, at least half of the office’s major investigations were directly related to opioids–some pills, but mostly outright heroin or fentanyl/carfentanyl . In Nashville, Tennessee, OxyContin (which is an opioid-based painkiller) can be worth up to $1.25/milligram (mg). That means that just one 80mg OxyContin has a street value of $100. Price, is of course, a reflection of demand and demand, in this case, is driven by addiction.

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