Nearly 100 national and state medical societies from around the United States are backing a Senate bill that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education, or CME, sessions, medical journals, or textbooks. Among them are the American Medical Association and the American College of Cardiology.
The move is the latest push in a long-running effort to roll back requirements for reporting such payments to a federal database, which 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 firms 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. A recent analysis found that payments can affect prescription rates.
But more than once over the past few years, the Centers for Medicare and Medicaid Services, which maintains the database, appeared to change its mind on reporting requirements for CME payments, in particular. These payments are made by manufacturers or group purchasing organizations to CME providers, which are either commercial firms or nonprofits that organize courses for physicians.
CME has been a particularly controversial issue, with accusations that drug and device companies not only fund the courses but they also tightly 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.
In late 2014, CMS ultimately decided that reporting CME payments would be required. As far as the agency is concerned, medical information — whether in the form of courses, journals, or textbooks — has value that physicians would otherwise have to pay for themselves. However, the CMS decision prompted a lobbying push by industry and medical societies to eliminate the reporting requirement.
In the House, the reporting exemption was tucked into the controversial 21st Century Cures Act, a wide-ranging bill that was passed in hopes of speeding medical innovation, although critics say the legislation would lower some standards for approving medicines and devices. The Senate is taking a piecemeal approach, though, and in late May, a separate bill addressing the exemption was introduced.
The support from the medical societies for the bill, which is called the Protect Continuing Physician Education and Patient Care Act, is hardly surprising. In a letter to US Senator John Barrasso, a Wyoming Republican and a physician who introduced the bill, the medical groups argue, however, that Congress initially intended to create such exemptions and CMS may hurt medical practice.
“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by CMS that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent” CME, they wrote to Barrasso in a June 29 letter.
“This legislation would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive,” the medical groups continued. “The Sunshine Act was not passed to limit or construct additional barriers to the dissemination of new medical knowledge that improves patient health outcomes.”
One CME provider, meanwhile, argued that since industry support for CME has shifted following sustained scrutiny, the reporting exemption should be granted.
“When a company gives a grant to an accredited CME provider, it’s pretty hands off. They’re not supposed to suggest speakers or influence the curriculum, for instance,” said Thomas Sullivan, president of Rockpointe. “So if a company that supports commercial CE has no control (over the use of its grant dollars), I don’t see why that should be reported. Doctors don’t have the direct relationship with the company.”
But a publisher of CME journals believes an exemption is not warranted.
“It’s a stretch to view free textbook and free medical education as being anything other than a benefit to physicians,” said Daniel Carlat, who runs a company that publishes CME newsletters for mental health practitioners. “These are not direct benefits to patients. The only way these would benefit patients is if a drug company gave free books or courses to patients themselves.”
As for CMS, we asked the agency whether it will consider a rule change and for a response to the letter. We will update you accordingly.
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