Life Science Compliance Update

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October 29, 2013

Physician Payment Sunshine Act: Radiologists Concerned With Potential Mischaracterizations of Relationships With Industry

A recent article from DiagnosticImaging.com discussed what diagnostic radiologists "need to know" about the Physician Payment Sunshine Act. The article pointed out a previous survey, which showed that more than half of physicians do not know about the Sunshine Act or that certain payments made to physicians by applicable manufacturers will be made public. This survey "echoes" the experience of Nogah Haramati, MD.

"The vast majority of individuals with whom I've discussed this act have never heard of it," said the professor of clinical radiology at Albert Einstein College of Medicine, who wrote about the Sunshine Act for the June 2013 issue of the Journal of the American College of Radiology.

Radiologists need to care because the Sunshine reports may not paint an accurate picture. For example, a manufacturer may report a $50,000 grant in the travel or the research category, leading to misperception issues. "It may look like the physician went on great junkets to the South Pacific, whereas it was used to send 12 graduate students to a conference in Detroit," Haramati said.

The law requires that vendors report transfers of value to physicians and teaching hospitals, but it does not include reporting gains by individual medical students and PhD researchers, Haramati added.

"Even if it appears as $200,000 for research, it's difficult to explain when a patient says 'you're getting fat on it,' and I say 'but I really run this lab,'" he said. "That database can introduce a credibility problem into the equation, which may be the lawmakers' intent."

"The difficult cases will be those in which [a physician is] doing nothing improper and the relationship is entirely legitimate, yet it can give the appearance of some type of undue influence on your practice of medicine," said Craig B. Garner, JD, an attorney in Santa Monica, Calif. "Those cases will require you to assess how much that income means to you. There's not always something wrong with doing work for these companies, but there is such a stigma these days that any nexus can be negative," Garner told Health Leaders Media.

While physicians can appeal to the manufacturer if they believe the reported information is incorrect, "they're under no obligation to change anything," Haramati said, adding that the government penalties for manufacturer noncompliance are steep. A physician can request that a manufacturer re-categorize a payment, but the manufacturer "will defer to their legal advisors and take what they deem to be the safest route. The relationship with the physician is one thing. Draconian financial penalties are another. It's hard to argue with the government."

Lavish dinners, trips, and gifts to physicians dried up years back, and institutions like Haramati's already have a restrictive manufacturer policy, the article notes. "Physicians can be fired for receiving anything of value from a vendor." To be on the safe side, "Haramati tells colleagues and staff it's best to avoid attending manufacturer-sponsored events since a portion of the event cost may be attributed to each physician attending."

Haramati requires manufacturers "to provide a written guarantee that he receives no value from and won't appear in the database for any activity or conference call he participates in. If the manufacturer can't provide a guarantee, he pulls out." "I don't want to appear in the database," he said.

Unfortunately, this is the exact kind of negative effect and stigma we have been concerned with from the very beginning—that the Sunshine Act would discourage physicians from collaborating with industry to develop new treatments, conduct research, educate their peers, and even receive new clinical data and information to improve their knowledge, competency and patient care.

"A physician concerned about looking bad in the database should take proactive measures to be transparent and up front with patients, said Bob Still, practice administrator at MRI Group in Lancaster, Penn. He recommends that practices participating in clinical trials or working with vendors on new and emerging equipment state this on their websites, since using cutting edge equipment can benefit the patients."

"I don't think there's anything wrong with a practice saying they receive remuneration to do this kind of research," Still said.

With respect to the burden of Sunshine reporting, Still noted that most of the tasks will fall on industry and various staff members of a physicians practice. Still recommended that practices review payments quarterly and that physicians take some responsibility for overseeing compliance if they choose to have relationships with industry.

For those physicians not involved with manufacturers, there may be little to report. "General diagnostic radiologists have less contact with manufacturers than interventional radiologists who buy a lot of devices, Still said." Hospital-based physicians probably also have less exposure because the institution is buying the equipment, though the radiology group may participate in purchases as advisors.

"Imaging center owners have to be more aware of the Sunshine Act, he said, cognizant of ramifications of interactions with the sales people."

Physicians, like Haramati, want to stay out of the database completely, but since industry is so intertwined with medicine – and since physicians don't have ultimate control – he's unsure whether that's feasible.

"Will I succeed? It's very hard to tell," Haramati said, noting that he recently lectured at an academic meeting organized by a skeletal radiology professional society in India.

While the meeting was sponsored by several vendors, the professional society paid for his economy travel arrangements. "I was very careful," he said. "I received nothing from any vendor. However, am I aware of all vendor funding of the meeting? Will any vendor ascribe a part of the costs to me? I don't know."

Ultimately, the Sunshine Act "will have a profound effect on the relationship between physicians and the rest of the healthcare industry," says Robert Hitchcock, MD, FACEP, a practicing physician and vice president and chief medical informatics officer with T-System, a nationwide company based in Dallas that helps physicians improve efficiency and maximize revenue. This is particularly true given that physicians have limited ability to challenge or dispute a payment or its description once the company posts it.

"What this means for most physicians is that they will seriously rethink any collaboration they might have with drug companies," Hitchcock says. "As a practicing physician, I really don't want my name on a list for having been to this CME and gotten this amount of money from Pfizer and this amount from Schering-Plough. I know that I personally will no longer be attending CME that is sponsored like that."

Morever, even when attending professional meetings that are not sponsored by drug companies, Hitchcock says he will have to be careful about the social functions he attends. Breakfasts and social hours often are sponsored by drug companies, and Hitchcock says he will no longer attend those because his name would show up on the disclosure lists.

"I think once physicians see this happening, it's going to have a really chilling effect on their relationships with the healthcare industry," he says. "A lot of what is going to be disclosed is just a normal part of doing business, but I'm not sure I want my ownership value in a GPO, for instance, to be put out there for public consumption. It's like putting my taxes out there for anyone who wants to see."

Physicians must reexamine their relationships with drug and device makers, Hitchcock advises. More than ever before, he says, watch for the line between an informative interaction and the exchange of something that has monetary value. Talking with a drug company representative and accepting samples for your patients should be no problem, he says.

"Try to avoid, at all costs, accepting anything of monetary value," he says. "That will keep your name off the lists."

As a result, while most patients will not be concerned with whether physician shave a financial relationships with manufacturers, physicians should be prepared in those "few cases" to explain such relationships and "why it does not affect their clinical decision-making" said David Schweighoefer, JD, a partner with the law firm of Walter Haverfield in Cleveland. "I have spoken with some physician clients who intend to explain that relationship, however innocuous, to the patient up front so that there is no misunderstanding later."

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