The recently released Sunshine Act rules on disclosing physician-drug industry ties could hamper medical innovation and education, one doctor warned at an event here on the topic.
When the reporting and collection of doctor compensation data from drugmakers, device companies, and group purchasing organizations starts later this year, some physicians may be less likely to participate in programs like pharma-sponsored educational events or collaborations because of the potential public backlash, David Caraway, MD, PhD, of St. Mary’s Regional Medical Center in Huntington, W.Va., said Monday.
“I have colleagues whose total transfer of value may be $250 a year, who told me they won’t do this any more because they don’t want their name in some newspaper article,” Caraway said at an event sponsored by the Healthcare Leadership Council, a coalition of healthcare industry executives. “Isn’t that awful? This is not an impactful financial incentive to that physician, but it’s a disincentive for innovation and for collaboration.”
The Sunshine Act rules, released Feb. 1, require the public disclosure of payments to physicians and teaching hospitals exceeding $10. Data collection will start on Aug. 1, and the Centers for Medicare and Medicaid Services (CMS) said data from 2013 is due by March 31, 2014. Results will be made public by Sept. 30, 2014.
Payments include consulting fees, food, research payments, and other forms of compensation. Ownership and investment interests by doctors will also be reported. Penalties range up to $150,000 annually for not reporting information and $1 million for knowingly not reporting data.
Advocates of the disclosure said it will expose conflicts of interest that could harm patient care and quality.
However, Caraway cautioned that if the Sunshine Act rules paint physicians with a negative brush, “it will have the effect of killing innovation and research.”
Policymakers and regulators must consider when crafting these plans what objective they are trying to achieve, said Guy Chisolm, PhD, director of the Cleveland Clinic’s Innovation Management and Conflict of Interest Program. For instance, how much less biased is a physician who receives $5,000 from a company compared with one who receives $10,000?
“There really aren’t any data to show that bias is less at that level and not the other,” he said. “Maybe it is, but there are no data there.”
The Cleveland Clinic’s own conflict-of-interest program requires robust informed consent forms and disclosure in manuscripts and presentations, Chisolm noted. They limit conflicted persons’ role in data collection and analysis.
“Our goal really in having a robust conflict-of-interest program is to decrease the influence of industry, money, and ties on research data on the well being of research subjects, and yet to help the flow of innovation and the progress of research,” Chisolm said.
However, publicizing drug industry-physician ties isn’t a cure-all, speakers said.
“Disclosure and transparency doesn’t do anything to mitigate bias,” Chisolm said. “Disclosure might tell you where you might look for bias, but it doesn’t do anything to mitigate it.”
The event’s sponsor, the Healthcare Leadership Council, said Monday that its members were generally satisfied with the way the Sunshine Act rules were presented; however, members are concerned with the website CMS is building to make the data public.
“Sunshine rules are a step in the right direction,” said Healthcare Leadership Council president Mary Grealy, even if they have to be modified in the future.
Once financial ties are made public, context will be critical in helping explain the money, panelists said. For example, a doctor may have received a large sum for participating in a clinical trial, but that amount may have only covered the trial’s operating expenses.
“Industry has to be part of the conversation and has to be part of the education process,” said Ryan Hohman, managing director of policy and public affairs at the patient advocacy group Friends of Cancer Cancer Research. “Like it or not, successful innovation requires commercial entities to be involved, and successful education of physicians will require all experts to be educating each other.”