Whether it's bribes, gifts, vacations, lobster dinners, or even branded pens that write underwater, Big Pharma is one of the busiest lobbyists in the business of medicine, sometimes to the detriment of health. With phenomena like a spike in the controversial diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in American youth leading to instant riches for pharmaceutical companies prescribing Ritalin, relationships between doctors and pharmaceutical sales reps are yet again coming under active fire by the government.
The U.S. Department of Justice (DOJ) and the Office of Inspector General (OIG) are seeking legal aid in targeting physician's improper financial relationships with pharmaceutical manufacturers and medical device manufacturers, said Frederick R. Ball, a partner of Duane Morris LLP, the law firm involved with the initiative.
Ball issued an online ‘alert' March 6 on jdsupra.com, a repository of legal information, and on his law firm's website, informing the public that the OIG for the U.S. Department of Health and Human Services and the DOJ are teaming up against physician malpractice, threatening to prosecute violators in criminal and civil courts of law.
"DOJ and OIG are particularly concerned about arrangements in which pharmaceutical manufacturers or medical device manufacturers pay physicians' consulting fees, pay for physicians to travel for seminars, and pay physicians advanced royalties for the development of medical devices or pharmaceutical products, as well as other ways in which pharmaceutical manufacturers and/or medical device manufacturers can provide remuneration to physicians that may influence prescribing activity or use of medical device products, " Ball wrote.
While Ball admitted that there lies a thin, gray line between appropriate and inappropriate physician financial relations with those in the business of medicine, he said that the clarity of the federal Anti-kickback Statute is the best tool for drawing a line in the sand.
"The Anti-kickback statute is a federal statute -- although many states have parallel ones -- that states that if the reimbursement for the medical procedure or device is being paid by a federal program such as Medicaid or Medicare, it is illegal for the person who is making the decision of what the treatment is going to be to receive remuneration from the person providing the product," Ball said.
The law, almost 40 years old, states that anyone caught receiving or paying anything of value to influence the referral of federal health care can be charged with a violation and punished by five years in prison, $25,000 in criminal fines, $50,000 in civil crimes, and prohibited from employment in federal health care programs.
"Nobody looks good in an orange suit," Ball joked half-heartedly. (It's true, not even Bruce Willis can pull it off.)
Ball is one of the 15 Duane Morris Physician Practice Group lawyers that will consult with both suspect and cautious physicians on behalf of the OIG and DOJ.
"Physicians looking to enter some kind of [financial] arrangement will want to consult with an attorney," he explained. "It's [white-collar crime] a minefield for physicians, [and] they have to be careful. We'd look at the proposed arrangement and if it complied with the anti-kickback statute-and if it did not, we'd make changes in the arrangements."
Ball said he thought that after attempts at targeting pharmaceutical companies and medical device manufacturers didn't exactly succeed in mitigating physician malpractice, the DOJ and OIG decided to fight the battle on two fronts and began
targeting physicians too.
Lewis Morris, Chief Counsel for OIG, is quoted in The New York Times in concurrence with Ball.
"What we need to do is make examples of a couple of doctors so that their colleagues see that this isn't worth it," he said. "We want to send the message to the physician community -- particularly surgeons -- that you can't do this."
Surgeons are especially susceptible to bribes from device manufacturers because they help design medical surgical equipment, Ball said.
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