Transparency or suspicion? A wrong turn for reports on financial ties in medicine

Federal regulators should back off plans to put an anti-fraud unit in charge of a list detailing payments and transfers from manufacturers to doctors and hospitals.

Posted Nov. 12, 2012.

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A law meant to shine a light on financial relationships between physicians and pharmaceutical, medical device and biologics companies instead is threatening to put a cloud over legitimate interactions between doctors and industry.

The Sunshine Act, part of the Affordable Care Act, requires manufacturers to submit a list of physicians and teaching hospitals who received from them a transfer of value of $10 or more, or multiple transfers of less than $10 that cumulatively exceeds $100. It also requires manufacturers to list any physicians, or their immediate family members, who hold ownership stakes in their companies. Some items, such as drug samples and educational materials intended for patients, are exempt from being reported.

The Sunshine Act, as written, could give physicians and their patients the chance to have an open conversation about why those relationships exist. For example, in many cases they are related to physicians’ participation in clinical trials. Such disclosure is in line with positions the American Medical Association has put forth calling for informed judgment for patients and a focus on their benefit, all the while requiring meaningful independence from industry for doctors.

The problem is, the Centers for Medicare & Medicaid Services intends to have its Center for Program Integrity — in plain language, its anti-fraud unit — carry out the Sunshine Act. By putting the center in charge of the collection and distribution of public reports on physician-industry interactions, CMS is making it appear that it is now the ethical police of the profession. It creates the impression that any physician who appears on the list, no matter how limited financially or legitimate the nature of the interaction, is somehow engaged in behavior that could be seen as ethically or legally suspect. Rather than encourage transparency, CMS’ proposed final rule could have a chilling effect on beneficial interactions between doctors and researchers that help advance medicine.

CMS should leave ethical enforcement to the profession. Instead of what it’s proposing, CMS should leave data collection, reporting and appeals to another part of the agency and reserve CPI only for matters involving compliance with the law.

The CMS’ proposed final rule has yet to be put into effect. The AMA put forth its concerns about CMS’ action in an Oct. 10 letter to the agency’s acting administrator, Marilyn Tavenner. The letter, signed by AMA Executive Vice President and CEO James L. Madara, MD, stated AMA’s objections that CMS would:

  • Expand the act beyond its intentions by proposing that some indirect transfers, such as certified continuing medical education in which sponsoring manufacturers have no input into the content, speakers or attendees, be included in the reporting.
  • Allow physicians to be listed as receiving payments or transfers if they were employed or affiliated by an organization that got them — even if those physicians individually never received them.
  • Not provide physicians a sufficient mechanism for appealing or challenging any information appearing on the list. Manufacturers submit the information and have 45 days to make any appeals, but physicians have no guarantees that they will see companies’ lists on an ongoing basis so they may make corrections.

All of these issues become even more critical in light of CMS’ decision to elevate CPI as the one to implement the Sunshine Act. The purpose of the act is “not to supplant the role of the profession in regulating ethical conduct or to create new fraud and abuse laws,” Dr. Madara wrote. In fact, CMS said the same thing in its proposed final rule: “We recognize that disclosure alone is not sufficient to differentiate beneficial, legitimate financial relationships from those that create conflict of interests or are otherwise improper.”

An example laid out in the AMA letter is that suddenly there could be a stigma attached to industry-physician collaborations that facilitate the application of knowledge on the human genome. If physicians risk being seen as somehow engaging in untoward behavior because of who is managing a list, then it jeopardizes the sharing of information and resources for necessary and appropriate medical care.

At the Senate roundtable on the Sunshine Act, held in December 2011, a wide range of stakeholders agreed that the Sunshine Act is there to promote those ideals, not to chill or curb transactions that advance the art and science of medicine. There is still time for CMS to rethink its rule in that light so that its list promotes openness and dialogue, not a climate of unwarranted suspicion.

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