When the Office of Inspector General issued its pharma marketing guidance in 2003, some experts predicted that drug companies would initially curtail their excesses, and after a while the feds would ease up and the pendulum would swing back to the middle, as had happened after other government crackdowns. But that was before the advent of Medicare Part D.
Under the new program, the federal government will become the single largest purchaser of pharmaceuticals, and thus its interest in keeping costs down and preventing fraud and abuse will increase exponentially. As James G. Sheehan, associate U.S. attorney, Department of Justice, Philadelphia, cautioned at the Second Annual Pharmaceutical Meeting Planners Forum, you can expect federal and state governments to intensify their scrutiny of pharma marketing practices — including meetings and CME. (See cover story, page 26.)
I heard the same message during a pharma compliance audioconference produced by HCPro Inc. in April. The OIG will be under pressure from Congress to demonstrate that it is effectively monitoring Medicare Part D, said attorney Daniel A. Kracov, co-head, pharmaceutical and medical device practice, Arnold & Porter, Washington, D.C. He added bluntly: “Scalps will be taken.”
And who are these investigators who may come knocking on your door? At industry conferences, I've heard jokes about regulatory cops — well, the term is apt. Many OIG investigators were, in fact, police officers. They still have the right to carry guns 24/7 and continue to see themselves as cops, said Dara A. Corrigan, who co-heads the pharma group with Kracov. As the former acting Inspector General, she provided a fascinating — and instructive — inside peek at their perspective: They're a zealous group, she said, who view issues in black-and-white terms. Skeptical of for-profit enterprises, they tend to believe that healthcare should not be a for-profit industry. As government employees, they live in a world of spending restrictions and few perks. Don't expect them to sympathize when you get push-back for refusing to pay for spouses' meals at physician events.
So, if you're waiting for the pendulum to swing back toward the middle, I suggest you reconsider your approach. At the pharma forum, co-produced bymagazine and the Center for Business Intelligence, meeting planners discussed how they've partnered with their procurement and legal departments, proving that they have an important role in cost control and . The next step, as one speaker said, is for pharma planners to show their compliance departments that they have an important part to play in ensuring that their companies' events for healthcare professionals stay on the right side of the law.
For those of you who work with pharma companies — independent planners, medical education and communication company professionals, and CME providers — the regulatory environment also offers an opportunity to demonstrate your expertise in compliance.
Corrigan said that if compliance officers view the industry through the eyes of OIG investigators, it will enable them to better assess their programs. The same holds true for you. The more you understand about OIG's perspective, and pharma companies' compliance priorities, the better able you will be to prove yourself a trustworthy, invaluable partner during these stressful times.