Investigations will continue; coast isn’t clear yet

More than 500 orthopaedic surgeons attending the “Evolving Orthopaedic Surgeon–Industry Relationship” symposium during the 2009 Annual Meeting listened intently as Crane M. Pomerantz, JD, assistant U.S. Attorney for the District of Nevada, shared his personal views on “what I think is bad so you can self-police.”

“My concern is whether patients are getting your 100 per­cent undivided loyalties,” said Mr. Pomerantz. “While I appreciate the demands and the tensions on your practices, the government won’t sit idly by if patients are losing the benefit in the bargain.

“Everybody should know better by now. Everyone makes mistakes, but you can’t use the ‘honest mistake’ defense after what’s happened during the past 18 months. You can’t say ‘everyone is doing it.’ That doesn’t make it right.”

Mr. Pomerantz joined Tony Rankin, MD; Stuart L. Weinstein, MD; Christopher White, JD, general counsel for AdvaMed, the Advanced Medical Technology Association; and Kathleen McDermott, JD, a healthcare compliance professional, in examining the changes that have occurred in industry-surgeon relationships since September 2007.

Monitors are here
In welcoming the audience, Dr. Rankin noted that federal monitors were attending the Annual Meeting, along with compliance officers from many technical exhibitors.

Under the terms of settlement agreements signed in September 2007, federal monitors were assigned to five orthopaedic device makers that were under investigation for a period of 18 months; the monitoring period expired on March 28, 2009.

Investigations into smaller companies and individual surgeons are continuing, noted Dr. Rankin, and investigations are spreading to jurisdictions other than New Jersey. Additionally, federal legislation such as the Physician Payments Sunshine

Act is being considered. The reintroduced Sunshine Act, said Dr. Rankin, requires companies to disclose payments in excess of $100 to physicians—and carries a $1 million maximum penalty. Several states have also introduced legislation that would require disclosure of industry relationships.

Research is threatened
Speaking as an orthopaedic researcher, Dr. Weinstein noted that the recent enforcement activities have already affected orthopaedic research and education, as companies re-examine their commitments to these areas.

The shortage of Level 1 evidence in orthopaedics, said Dr. Weinstein, puts surgeons “at risk.” As innovators of new procedures and techniques, surgeons must work with industry, but these ties create potential biases. Orthopaedic research depends heavily on clinical trials, which are very expensive. Unfortunately, federal funds for research have been basically stagnant, and the recent investigations have slowed funds from industry.

New code of ethics for industry
According to Mr. White, the revised AdvaMed Code of Ethics encourages voluntary, ethical interactions between industry and healthcare professionals and distinguishes between interactions that advance medical technology and those that have potential to influence medical decision-making inappropriately.

The new code contains sections on royalty payments, the use of demonstration and evaluation products, reimbursement, educational and promotional items, and consulting agreements. It includes prohibitions on gifts, entertainment, and recreation.

Although compliance is voluntary, Mr. White pointed out that at least one state (Massachusetts) has referenced the AdvaMed Code of Ethics in legislation, giving it the force of law. “Scrutiny will not diminish,” he said.

Point/counterpoint
In their point/counterpoint, Ms. McDermott and Mr. Pomerantz traded views on the difference between law and ethics as well as on other legal issues. According to Ms. McDermott, every relationship includes a potential conflict of interest. The issue, she said, is “how do you manage it?”

She questioned, for example, the recent recommendation by the American Association of Medical Colleges that faculty not participate in industry speakers’ bureaus. “Is this the right way to approach the problem?” she asked.

For his part, Mr. Pomerantz focused on the anti-kickback statutes, whose application, he said, was “limited only by the creativity of prosecutors.

“It’s a two-way street,” he continued. “Both physicians and industry need to look at the transactions. If something changes hands as a reward for a referral or an incentive for future referrals, that’s bad.

“Give yourself the ‘straight-face’ test,” he advised. “Look in the mirror and ask yourself: Are you doing legitimate work for the money? Are the payments fair? Are they made for referrals? Can you answer ‘yes’ to the first two and ‘no’ to the third and keep a straight face?”

He also advised the audience to document all transactions and all discussions with patients about industry relationships. “People who are guilty don’t shine light on what they do,” he said.

Ms. McDermott agreed, saying “Good ethics is good law.”

Using common sense
In the question period that followed the presentations, audience members raised several issues. Dr. Rankin posed the questions to panelists.

When asked about the difference in “fair market value” rates for surgeons and federal monitors, Mr. Pomerantz responded, “I’d be barking up the wrong tree if I tried to assign a fair market price to a physician’s time. That’s not my job. As long as you are able to justify your request—and I recommend using an outside accountant to help—what’s fair market in one area for one physician may be very different from what’s fair market in another area for another physician.”

Mr. White responded to a question about how AdvaMed intends to enforce its code with companies. “We are not an enforcement agency,” he said, “but we know that the code is being incorporated into law, and we are requiring the chief executive officer to sign off on a statement that the company is committed to training and enforcing the code with staff. Those companies that make that commitment will be featured on our Web site.”

“What will happen on March 28?” asked one audience member. It won’t be a return to business as usual, agreed the panel. The environment has changed—and that change will be permanent.

Mary Ann Porucznik is managing editor of AAOS Now. She can be reached at porucznik@aaos.org