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 who are scheduled in advance to assist with a procedure can be present,” she says. “They no longer come to schmooze, and because they no longer have carte-blanche access to our inventory or operating environment, it has been a huge change.”

Also, unrestricted grants need to be filtered through a division or department chair, who determines where the money gets directed. Freischlag says that there are no limitations on the amount that can be donated to Johns Hopkins in unrestricted grants, and they get deposited into specified accounts. These grants can support faculty, staff, research and patient education. “For unrestricted grants, we simply put a middle man between the company and the individual,” she says.

However, some see these grants as another potential for corruption. Samson suggests that academic facilities may be able to get around the current legislation via unrestricted grants. “For example, under the new initiatives, individual surgeons are beholden to the chief of surgery, providing a disincentive to work and learn on new products. Everything is now under the thumb of the division chiefs,” he says. “Also, unrestricted grants will not prevent a dishonest individual from skewing money his or her way. If you have a crooked physician, department chief or department head, he or she has the potential to utilize the funding in a crooked manner.”

“There is no such thing as an unrestricted grant,” Nissen concurs. “These so-called unrestricted grants to sustain CMEs are not unrestricted at all because the recipients provide a return on investment for industry. In fact, we need to eliminate industry-sponsored CME because it is not education; instead, it’s promotion.”

While Kimmelstiel questions who would pay for CME courses if industry funding stopped, Nissen suggests a “stronger body is needed with more specific rules” because the Accreditation Council for CME has had “extremely poor” oversight.

These types of strict policies are gaining traction at academic medical centers. In late July, Harvard Medical School in Boston put forth recommendations, prohibiting its physicians from receiving personal gifts, travel or meals from industry, other than travel and meals in the course of “allowed activities.” Nor can faculty participate in industry speakers bureaus or accept compensation for a speaking engagement.

Private practices

Private practices are being “reimbursed less and less, and we have to work harder and harder to maintain any kind of income,” Samson says. “The result is that we have less time and funding to travel to conferences and educational sessions; therefore, we have less information to expand our repertoire of patient services. These laws place a barrier between us and industry, so industry can no longer access providers to inform them about new technologies, techniques and pharmaceuticals, which could potentially benefit our patients.”

However, Nissen contends that private practices are at a much greater advantage under the various transparency initiatives. “Because private practices are self governing, they do not have the consequences of industry/physician relationships, as academic centers where staff tend to be much more closely scrutinized by their colleagues and governance structure,” he says.

“If a physician at a private practice receives $100,000 from a particular pharmaceutical company, there currently aren’t any consequences, as private practices don’t have any conflict-of-interest rules,” Nissen contends. “On the other hand, if a report emerges that a physician at an academic medical center is receiving large sums of money, and that physician is responsible for teaching medical students, he or she will more than likely face consequences from the hospital board and superiors.”

Yet, Samson suggests that the new federal initiatives are preventing interaction with industry, particularly for “invaluable” onsite training purposes. “When new technologies are first introduced into the operating room, it is helpful to have an industry representative present, as he or she deals exclusively with this product, and is therefore an expert,” he explains. “Now, we will need to pay for physician mentors to visit our practice for training purposes. If the funds aren’t present, private practices will have inferior training, and inferior training produces inferior patient outcomes.”

While Samson’s group has created a foundation for educational and scientific purposes, he notes that maintaining a “bona fide foundation requires a great deal of work and resources that many private practices do not possess.”

He predicts this will further drive physicians away from the profession. “We already have great numbers of older doctors retiring because of massive bureaucracy,” Samson says. “Add this component, and even more docs will pull out of the system entirely, which will affect the Medicare population.” He also suggests that while reimbursement deductions have driven the majority of private practice integrations, these initiatives may further proliferate the trend.

State gift bans

Currently, Massachusetts, Vermont and Minnesota have adopted the strictest state policies for physician/industry interactions. For example, Massachusetts enacted the Gift Ban Act in July 2009, which applies to Massachusetts physicians not only when they are in the state, but also where they travel. The ban also placed “strict limits” on CME and academically professional presentations, explains Kimmelstiel. 

“In the case of Massachusetts, the legislation has produced no positive effects, and only evidence of negative effects,” Kimmelstiel says. “The gift ban has essentially legislated the end of post-graduate medical education in this state.”

Kimmelstiel questions whether industry-sponsored CME truly creates a bias, referencing a survey of 1.6 million healthcare provider participants taking part in online CME activities, in which less than 1 percent reported bias. Yet, the survey found a slight, but significant trend toward the “perception” of more bias in commercially supported activities—0.8 versus 0.5. Also, 98 percent of the 9,500 physicians at the Cleveland Clinic reported that CME activities were free from bias in 2009, he reports.

Anecdotally, Kimmelstiel adds that in appealing to industry to support visiting professor grants for fellows and trainees at Tufts, he and colleagues were informed by a large pharmaceutical company that it preferred to stay clear of Massachusetts for altruistic purposes due to the liability possibilities with the new ban.

Dan Wolf, MS, in his Massachusetts Institute of Technology’s master’s thesis, sought to assess the effects of the recent gift ban in the year since the law was enacted. He found that 70 percent of industry respondents reported an “impaired ability to collaborate” with Massachusetts physicians and 83 percent reported a “decreased interest” with the state’s physicians. From the physicians’ perspective, 83 percent reported an “impaired ability” to collaborate with industry to develop new devices and new technologies. 

“You are going to see less innovation,” Samson says. “Once you place that barrier between industry and the physician, you decrease the stimulus to develop new concepts and ideas. As a result, there will be a sudden throwback in new ideas in the U.S.”

However, Nissen disagrees, saying the idea that an industry gift ban will stifle industry “doesn’t hold much weight. While we need national uniform policies in the U.S., many will use multiple excuses to be at the feed trough of industry, and very few of them make sense.”

In contrast, Kimmelstiel says: “Increasingly tight restrictions on free trade and interaction between manufacturers and prescribers truly reduce innovation, efficiency and productivity.”

(At the time of press, Massachusetts legislation was debating the repeal of the Gift Ban Act.)

Disclosure

While these initiatives garner clashes of ideas, most providers agree on the concept of transparency, especially for the sake of their patients.

“Disclosure is key and honest disclosure with your patients is integral to trust within that relationship,” Samson says. “Therefore, if industry wants to disclose that they gave me a $20 lunch or a $5 pen, it makes no difference as I inform my patients if we are working with industry on a device. However, to make the physician report all these factors will add another layer of bureaucracy that will prohibit physicians from focusing on their patients.”

Freischlag acknowledges an impetus behind new policies is to dissuade the public of the perception that there is corruption among physicians.

“It’s just a matter of ethics and proper policy that these relationships be made public,” Nissen concurs. “Our patients have a right to know. Money that is flowing from a variety of industries should be disclosed.”