On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to improve upon the federal regulatory structure regarding Federal Drug Administration (FDA) approval and expediting the development of new drugs. Under the Bill, FDA funding would increase by $500 million. The Bill also provides for the authorization of new National Institutes of Health research grant funding, in the billions, including funding for Vice President Biden’s “moonshot” to cure cancer. Importantly, a proposed provision regarding reporting under the Sunshine Act was removed from the Bill. Specifically, the proposed provision would have exempted from the reporting requirements of the Physician Payment Sunshine Act payments from drug and device manufacturers to physicians for speaking at continuing medical education events and for contributing to medical textbooks, or medical journals.

On September 12, 2012, the Senate Special Committee on Aging held a roundtable hearing on the Sunshine Provisions in Section 6002 of the Patient Protection and Affordable Care Act (the “Sunshine Provisions”).  Under the Sunshine Provisions, certain drug and device manufacturers must annually report to the government many payments and other transfers of value they make to physicians and teaching hospitals.  Certain drug and device manufacturers and group purchasing organizations (“GPOs”) must also report ownership and investment interests in them held by physicians and their immediate family members.  In this post, we will report on the roundtable hearing, provide an overview of a Proposed Rule regarding the Sunshine Provisions, and discuss their implementation. Continue reading…