While most physicians agree that transparency is an integral aspect of contemporary cardiology practice, a fundamental disagreement is brewing about the potential benefits and harms of new state and federal regulations that seek to further limit interactions between industry and providers via gift bans and restrictions on continuing medical education (CME) funding. One camp asserts this trend could inhibit innovation, while the other camp contends that stricter divisions are necessary to prevent potential conflicts of interest.
Physician Payment Sunshine Act
The Physician Payment Sunshine Act, within the Patient Protection and Affordable Care Act signed into law March 28, requires hospitals to declare payments from manufacturers and submit to the HHS Secretary data on drug samples including recipient, amount, theft and losses. For CME, grants should be reported if they are requested on behalf of a specific physician and/or are given to a teaching hospital. In addition, federal anti-kickback laws, the Stark Law and the National Institutes of Health now are seeking to prohibit conflicts of interest.
With this kind of federal legislation, it is “always unclear how it will affect local legislation. For instance, will it supersede or replace local legislation, such as the recently enacted state gifts ban in Massachusetts?” asks Carey Kimmelstiel, MD, director of the cardiac cath lab at Tufts Medical Center in Boston. “Also, if a physician has to disclose all relationships with collaborative partners, it can inhibit collaboration.”
These types of laws are “already beginning to stifle our ability to learn, develop and apply new technologies,” explains Russell H. Samson, MD, from the four-surgeon private practice Sarasota Vascular Specialists, as well as an associate professor of vascular surgery at Florida State University Medical School and president of Mote Vascular Foundation in Sarasota, Fla. “While there have been past abuses by a few individuals, the entire profession has been painted as being able to be bought by industry. Even though the intentions behind these draconian regulations are well-meaning, there has been little forethought about the pejorative downstream effects.”
Conversely, Julie A. Freischlag, MD, chair of the surgery department at Johns Hopkins Hospital in Baltimore, doesn’t see the Sunshine Act as a hindrance to innovation. Instead, she suggests it is a control issue, “as certain doctors would like the check in their own hand, so those individuals can designate funding as they deem appropriate.”
Likewise, Steven E. Nissen, MD, chairman of the Cleveland Clinic Foundation’s department of cardiovascular medicine, sees no cons with the Sunshine Act. “As a result of the Act, everyone in the medical community, including the media and the public, will see who is receiving money from whom, resulting in improved transparency,” he says.
Academic medical centers
After Johns Hopkins received a “D” from an outside reviewer for its lack of policies related to interactions with industry, the provider adopted a more concrete strategy and Freischlag adopted the catchphrase “don’t eat anything and reveal everything” for her department. “Previously, we didn’t have any policies in place that precluded employees from interacting with industry in whatever manner suited them,” Freischlag says.
As part of its overhaul, Johns Hopkins posted a new policy on its website, including that employees cannot receive any gifts from industry, except only educational materials, but even those cannot contain too much promotional content.
Consulting has been the most complicated aspect for department chairs to track. “It’s not only how much our employees receive in compensation, but also how much time is being committed to a particular company, compared with how much time is being spent at the hospital or in the classroom,” she adds.
Johns Hopkins also eliminated vendor meals either onsite or offsite. However, one exception is that food can be accepted at certain programs, if it is “modest and provided for everyone.”
Another change that the facility undertook was the decision to stop the free drug sample handouts to patients over the course of a year, which was particularly hard in inner-city clinics. “The perception is that you’re promoting a particular company’s medication,” Freischlag says.
The most important change, according to Freischlag, is limiting industry representatives in the operating rooms. “Only those representatives