Life Science Compliance Update

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November 30, 2016

21st Century Cures No Longer Includes Open Payments Exemption for Reprints, Textbooks and Non Promotional Education

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We previously wrote about the updated version of the 21st Century Cures bill – one that we, along with many others, thought would pass both the House and the Senate with minimal edits, if any. However, the new bill no longer includes a provision that would have exempted drug makers from disclosing non promotional continuing medical education (CME) payments to physicians, including text books and reprints.

The version of the bill released late last week would have allowed manufacturers to be exempt from reporting industry payments to physicians for textbooks, journal reprints, and for speaking at continual medical education events.

This change follows a speech by Senator Elizabeth Warren on Monday, where she described the exemption as covering up bribery. She relayed her belief, which is that drug companies have opted to “cozy up to enough people in Congress to pass this Cures bill that would let drug companies keep secret any splashy junkets or gifts associated with ‘medical education’ and make it harder for enforcement agencies to trace those bribes.”

The opposition to the exemption even crossed party lines, with Senator Chuck Grassley planning to “object to unanimous consent to take up the 21st Century Cures Bill in the Senate,” unless the reporting exemption was removed. As a reminder, Grassley was a co-author of the Physicians Payment Sunshine Act, which requires drug makers and medical device makers to disclose payments they make to physicians to a public database.

Grassley believes that 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.”

He further went on to say, “a lot of earlier payments to doctors were under the umbrella of Continuing Medical Education. 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."

Grassley, Warren, and other critics of the exemption have long complained that CME and textbooks have the ability to influence physicians to prescribe expensive brand-name drugs, and that transparency is undermined if drug and device companies are permitted to avoid reporting the value of such sessions and handouts.”

John Kamp, executive director of the Coalition for Healthcare Communication, however, expressed his disappointment at the removal of such a “reasonable provision that enables doctors to be fully informed about medicines.”

This is a disappointment but the vast majority of accredited CME still falls under an exemption for Open Payments reporting as long as the applicable manufacturer does not select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.   

Interestingly enough, the 21st Century Cures Act is one of the most lobbied healthcare bills in recent history, with almost 1500 lobbyists representing 420 companies, universities, and other organizations looking to influence the bill’s contents..

It was just last summer when more than 100 national and state medical societies backed a Senate bill to create the exemption, complaining of “onerous and burdensome reporting obligations…that have already chilled the dissemination of medical textbooks and peer-reviewed medical reprints and journals,” seeking to avoid “a similar negative impact” on CME.

The House is still expected to pass the bill on Wednesday, November 30, but only time will tell if it will pass with this most recent edit, and what other edits may be waiting in the wings.

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