ucked into the 21st Century Cures legislation that was negotiated by the House and Senate late last week is a controversial provision to exempt companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals, or textbooks.
The move — which has sparked objections from Senator Chuck Grassley (R-Iowa) — is the latest in a long-running attempt to roll back requirements for reporting such payments to a federal database that tracks financial relationships between companies and physicians.
Known as OpenPayments, the database was launched in 2014 in response to concerns that financial ties between drug and device makers and doctors may unduly influence medical practice and research. It was included in the Sunshine Act provision in the Affordable Care Act. As we noted previously, an analysis earlier this year found that payments can affect prescription rates.
Grassley, who was instrumental in pushing legislation that led to the database, may try to place a hold on the bill “unless this provision is removed,” he said in a statement. “The Sunshine Act brings transparency to a big part of the health care system for public benefit. Transparency brings accountability wherever it’s applied. With taxpayers and patients paying billions of dollars for prescription drugs and medical devices, and prices exploding, disclosure of company payments to doctors makes more sense than ever.”
Consumer groups are echoing this sentiment. “In a time of increasing concern about drug prices and spending, it would be unwise to reduce transparency about the financial relationships associated with drug promotion,” said Allan Coukell, senior director for health programs at the Pew Charitable Trusts (the language can be found in section 4009).
However, groups that represent physicians and pharmaceutical marketers argue the reporting requirement would stifle access to important information and have a detrimental effect on continuing medial education (CME) programming. CME payments are made by manufacturers or group purchasing organizations to CME providers, which are either commercial firms or nonprofits that organize courses for physicians.
Last June, more than 100 national and state medical societies backed a Senate bill to create an exemption. The groups complained about “onerous and burdensome reporting obligations … that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals.” They sought to avoid “a similar negative impact” on CME sessions.
“OpenPayments is really supposed to capture when industry is trying to influence an physician and simply giving out reprints or supporting education is not the same as buying a meal,” said Thomas Sullivan, president of Rockpointe, a CME provider. “No one wants to be reported on simply for participating in an activity.”
“This is about patient care — doctors need good information fast and this facilitates the process,” said John Kamp, who heads the Coalition for Healthcare Communication, a group of ad agencies and medical publishers. “I want my doctors to have information about whatever the latest science is saying.” He noted that the Food and Drug Administration is currently weighing rules for allowing companies to distribute information to physicians about unapproved uses of medicines.
CME, however, has been particularly controversial, with accusations that drug and device makers not only fund the courses, but may also control the educational curriculum. Last year, industry support for CME totaled $693 million, a 2 percent rise, from the previous year, according to the latest report from the Accreditation Council for Continuing Medical Education, which regulates CME activities.
“A lot of earlier payments to doctors were under the umbrella of Continuing Medical Education,” Grassley said. “We shouldn’t create a loophole that would let drug and medical device companies mask their payments to doctors under a payment category that’s too broad and could gut the spirit and the letter of the Sunshine Act.”
A spokeswoman for Grassley added that he would also like to extend the reporting requirement to nurse practitioners and physician assistants. Along with Senator Richard Blumenthal (D-Conn.), he introduced a bill for such an expansion, but the effort went nowhere.
One critic of the exemptions was especially pointed.
“Major medical associations have lobbied relentlessly to hide the fact that physicians get pricey textbooks and other educational gifts from drug companies,” said Daniel Carlat, who runs a company that publishes CME newsletters for mental health practitioners. “We know that such gifts influence doctors to prescribe expensive brand name drugs. Undermining the Sunshine Act in this way is bad for consumers and humiliating for doctors, who should know better.”
This post has been updated to include a comment from Senator Chuck Grassley.