In April 2014, House Energy and Commerce Chairman Fred Upton (R-MI) and Congresswoman Diana DeGette (C-CO) launched a cross-country series of roundtable discussions with stakeholders of all background to discuss medical innovation and, in particular, how to accelerate discovery and bring cures to patients, faster. The effort was dubbed "21st Century Cures," and it quickly gained widespread bipartisan support.

The listening tour has informed a sizable piece of legislation encompassing provisions that will affect the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services. It has moved swiftly through the Energy and Commerce Committee, passing the full committee by an almost unprecedented unanimous vote before Memorial Day. Chairman Upton remains committed to enacting the bill before the end of this calendar year--earning praise from former Speaker Newt Gingrich and author of The Emperor of All Maladies Dr. Siddartha Mukherjee, among many others--but the bill must overcome several challenges before it makes it to the president's desk.

First, there are procedural complications. Due to the breadth of the bill, multiple committees share jurisdiction over it. The Appropriations, Ways & Means, Budget, and Rules Committees will need to consider the bill, or waive their jurisdiction, before it can be brought to the House floor. The bill has been referred to the Ways & Means Committee, and if it and other committees consider the bill, it will push a floor vote in the House past Chairman Upton's goal of the end of June.

The Senate is another obstacle on the way to final passage. Health, Education, Labor and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN) and Senator Richard Burr (R-NC) have launched their own initiative directed at accelerating cures, titled "Innovations for Healthier Americans." In public meetings, Senator Burr has stated that the Senate will consider its own bill and that the end of 2016 is a more realistic goal for its final passage. Chairman Upton himself concedes that moving his bill whole cloth through the upper chamber will be a challenge.

Finally, the substance of the bill itself may prove to be a hurdle. Despite the initial fanfare for the bill, as the 21st Century Cures Act evolves and stakeholders dig deeper into the details, they’re finding more they don't like. For example, advocates remain wary of several provisions in the bill, including a new mandatory research funding stream called the Innovation Fund (see CQ coverage here, subscription required). The Fund would provide NIH $10 billion over five years to supplement the base budget as appropriated by Congress and “support biomedical research through the funding of basic, translational, and clinical research;” health services, behavioral, and social science research are conspicuously omitted from the list of research eligible for this funding. Within these categories, the Fund is earmarked for very specific types of projects, including emerging scientist initiated research and a new “Accelerating Advancement Program.” And of course, the money is not without its strings. Many in the community fear that Section 1022, “Increasing Accountability at the NIH,” would open the door for increased politicization of research funded by the NIH, as it requires Institute and Center directors to sign off on all research grants awarded by their respective Institutes.

Most notably, the Innovation Fund is not permanent. Advocates are concerned that the agency will face a funding cliff in five years when Innovation Fund expires, similar to the cliff following the expiration of the American Recovery and Reinvestment Act (ARRA). There is also the very real risk that the Innovation Fund will follow the path of the Prevention and Public Health Fund and will be used to supplant rather than supplement the agency’s current base funding.

Beyond the provisions related to discovery, experts have expressed concerns about the “development” provisions that would roll back regulations governing drug and device approval and the impact on patient safety (see New England Journal of Medicine commentary), as well as the “delivery” provisions that relate to interoperability (see “Life as a Healthcare CIO” blog).

There are some provisions in the NIH portion of the bill that could benefit health services research, specifically in the realm of data. For example, the bill would allow the NIH Director to require grantees, on a case-by-case basis, to share the data they collect in NIH funded research and require the NIH to standardize certain patient inclusion criteria. It would also instruct NIH and FDA to enter into a collaborative a Clinical Trial Data System Agreement to implement a system to make de-identified clinical trial data from qualified clinical trials available for purposes of conducting further research. The bill also attempts to address the difficulty government scientists face in trying to attend scientific conferences, though arguably not forcefully enough.

AcademyHealth has provided input on the Cures initiative (see here and here) and is keeping a watchful eye on the legislation as it progresses in both chambers. We will continue to urge lawmakers to support the full continuum of health research, including health services research, and will keep you apprised of our activities and new developments.

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