Right now, when doctors accept money or gifts from drug companies and devicemakers, that information is published on Open Payments, an online database created under the Affordable Care Act. The program has increased transparency in an era of murky conflicts of interest and has helped link physicians' prescribing habits to their industry connections.
But as Republican lawmakers rush toward repealing the Affordable Care Act, some observers fear the section of the law that created the Open Payments program will face the chopping block.
“I think it's in big trouble,” Arthur Caplan, a bioethicist at New York University Langone Medical Center in New York City, said. “I don't think most of the people who are trying to repeal (the Affordable Care Act) know it's there.”
The Open Payments program was created by the Physician Payments Sunshine Act, in Section 6002 of the ACA. It requires device- and drugmakers, as well as group purchasing organizations, to report payments to physicians and teaching hospitals for speaking fees, travel, research, gifts and meals. The CMS, the administrator of the program, then publishes that data online.
“It's the largest, most comprehensive database that we have on this issue,” said Dr. Aaron Kesselheim, an associate professor of medicine at Harvard Medical School in Cambridge, Mass.
Genevieve Pham-Kanter, an economist at Drexel University in Philadelphia who researches physician-industry relationships and conflicts of interest in medicine, said that the Sunshine Act has shed light on the extent of the ties between medical doctors and the pharmaceutical industry.
“Because of Open Payments, for example, we now know that about 40% of U.S. doctors receive industry payments and 65% of patients regularly visit doctors who receive industry payments,” Pham-Kanter said. “It has made the public more aware of the issue of industry payments,” she added, and the data available through Open Payments have also begun “to paint a compelling picture of the relationship between industry dollars and doctors' prescribing.”
Clinical researchers, however, said it could also reveal misleading information about how much clinicians were getting from sponsors and how the money was used, for example, to cover staffing costs. The 2015 data released in June showed $7.52 billion in payments to 620,000 physicians and 1,100 teaching hospitals. The American Medical Association and other industry groups disputed the accuracy of those numbers.
"These sorts of relationships can be positive, they can be negative," said Kesselheim. "I think the existence of the database and the transparency it provides is a good way of trying to promote accountability among both physicians and industry."
If the Sunshine Act is repealed, the public, researchers and the media alike would lose access to much of this information about financial ties between the industry and physicians. Although a handful of states, including Massachusetts, Vermont and Minnesota, mandated disclosures of industry payments prior to the ACA, the federal Sunshine Act pre-empted those laws where they required manufacturers to report the same information being submitted to the federal database. It's unclear what would happen to those state laws if the Sunshine Act were repealed.
Many provisions of the ACA are in jeopardy after Republicans last week laid the foundations for repeal through budget reconciliation by passing budget resolutions in the House and Senate.
Whether Republicans will ultimately be able to do away with the entire law or trim only its controversial components, such as the individual mandate, and leave intact others—such as the Sunshine Act—remains to be seen. By limiting them to repealing parts of the law that affect the budget, the budget reconciliation process could in fact protect the Physician Payments Sunshine Act.
“In the Sunshine Act, there's nothing there that requires payments raising revenues,” said Marc Rodwin, a professor of Law at Suffolk University Law School in Boston who has written about conflicts of interest in medicine. “At the moment, given where the politics stand, they're not going to be able to repeal the parts of the ACA that don't deal with the finances, and the Sunshine Act is part of that.”
In the long term, the ACA's fate—and that of the Sunshine Act—and what might replace it are less clear.
Some of the bills being circulated for replacement have sections on transparency, but they are not related to physician payments, according to Karen Pollitz, a senior fellow in health reform at the Kaiser Family Foundation.
At least one Republican has vowed to uphold the Sunshine Act.
“I'll continue to fight for the (Sunshine Act) if there's any effort to weaken it or end it,” Sen. Chuck Grassley, R-Iowa, said in an email. “The Sunshine Act is valuable to patients, consumers, researchers and the public as a whole,” he said, adding, “It makes sense, it's working well, and it should stay as is.”
Grassley refused to support the 21st Century Cures Act that passed in December until provisions it contained that would have weakened the Sunshine Act were removed.
The CMS, meanwhile, announced Tuesday a redesigned, updated Open Payments website. The database now contains payment information through June 30, 2016, and the fresh site also features new graphical ways to display information. The website when it first was unveiled, was criticized for not being intuitive and missing some information.