mid intense criticism, lawmakers have removed a controversial provision in the 21st Century Cures Act that would have exempted companies from reporting payments made to doctors for receiving continuing medical education sessions, medical journals, or textbooks.
The provision “is not going to be in the bill when it gets to the House floor” on Wednesday for a vote, a spokeswoman for Representative Diana DeGette, a Democrat from Colorado, wrote us. The change came one day after Senator Chuck Grassley (R-Iowa) threatened to put a hold on the entire bill unless the language was removed. We asked the House Energy and Commerce Committee for comment and will pass along any reply.
The exemption — which was widely supported by drug and device makers, as well as physicians — was an 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.
However, amid complaints from industry and physician groups, the Centers for Medicare and Medicaid Services has, more than once, revised language that would have created an exemption for reporting the value of continuing medical education, or CME, and medical information handouts. In late 2014, however, CMS officially omitted the language and, ever since, Republican lawmakers have made it a goal to formally create an exemption.
Groups that represent physicians and pharmaceutical marketers argue the reporting requirement would stifle access to important information and have a detrimental effect on 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.
As we noted previously, more than 100 national and state medical societies last June 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.
But CME has been 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 most recent report from the Accreditation Council for Continuing Medical Education, which regulates CME activities.
Critics have complained that CME and expensive textbooks can influence doctors to prescribe expensive brand name drugs. As they see it, transparency is undermined if drug and device companies are allowed to avoid reporting the value of such sessions and handouts.