On July 10, 2015, the House of Representative passed H.R. 6, the 21st Century Cures Act (“Cures Act”), with strong bipartisan support by a vote of 344-77. This medical innovation reform legislation represents the culmination of more than a year of work by the House Energy & Commerce Committee (“E&C Committee”) on the 21st Century Cures Initiative, led by E&C Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO). The Cures Act now moves to the Senate, which has separately been considering medical innovation reforms.
As Ropes & Gray previously reported here and here, the E&C Committee released discussion drafts of the Cures Act in January and April 2015. The April discussion draft had been significantly pared down relative to the January discussion draft, as several potentially controversial proposals, including those relating to drug exclusivity and laboratory-developed tests, were eliminated. Since the release of the April discussion draft, the Cures Act has evolved once again. As passed by the House, the Cures Act, which currently spans 362 pages, contains numerous new proposals affecting drug and device manufacturers, as well as substantial changes to a number of proposals found in the April discussion draft. Very few proposals have been cut from the Cures Act since the April discussion draft; the only significant proposal to be axed related to the sharing of data from NIH-funded research.
The Cures Act would make significant changes in all of the following areas:
FDA: The key FDA-related provisions that have been added to or substantially changed in the Cures Act since the April discussion draft are described here.
Medicare/Medicaid/Enforcement: The Cures Act also contains significant changes to the Medicare and Medicaid programs, with implications for a wide range of stakeholders across the health care industry besides drug and device manufacturers, including payors, home health agencies, hospitals, and ambulatory surgery centers. The bill also creates new civil monetary penalties applicable to Federal grants, contracts, and funding agreements. These changes are summarized here.
Digital Health: The Cures Act would impose significant new requirements related to the regulation of health information technology (“IT”), especially creating new standards for interoperability and prohibiting information blocking. These provisions will be of interest to makers and vendors of health IT and to providers wanting to make use of Medicare Meaningful Use reimbursement and other Federal benefits, and are summarized here.
Regulation of Clinical Research: The Cures Act would facilitate and encourage the inclusion of underrepresented subpopulations in clinical research, minimize unnecessary and duplicative administrative requirements (including federal and institutional), and promote the broad availability of clinical research data, with adequate security and privacy measures, to advance medical product innovation. These changes will be of interest to drug and device manufacturers, hospitals, academic medical centers, universities/medical schools, institutional review boards, and contract research organizations, and are summarized here.