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Update: 21st Century Cures Reported Out of Committee

Following a year of roundtables, hearings and bipartisan negotiations, the House Energy and Commerce Committee voted unanimously 51-0 to approve H.R. 6, the 21st Century Cures Act, which seeks to spur the pace of medical innovation, support biomedical research, and overhaul the way the Food and Drug Administration (FDA) evaluates new medical products.

ASPS submitted a comment letter in support of the legislation to sponsors in May. In this letter, ASPS commented in support of several provisions, including:

  • Clarification of the HIPAA regulations to allow for the definition of health care operations to explicitly include research, which will allow for registries to use/disclose private health information (PHI) for research purposes without individual authorization or institutional review board wavers
  • Revisions to the HIPAA regulations to allow registries to receive payment in exchange for PHI when PHI is used for research purposes
  • Review by a centralized institutional review board with the intent to streamline clinical trials
  • Interoperability between electronic health records
  • >Updates to the Sunshine Act to exempt medical textbooks, peer-reviewed journals, journal reprints and journal supplements from reporting

ASPS also highlighted our concern with the lack of clarification regarding data ownership collected through private-public partnerships and the removal of the Accelerating Innovation in Medicine (AIM) Act language from the bill.

Negotiations on how to cover the bill's cost continued in the days leading up to the vote. An amendment agreed upon by the committee and forwarded to the House would entirely pay for the $13 billion cost of the 21st Century Cures Act through savings achieved elsewhere.

The legislation will generate $5.2 billion in savings by drawing down the strategic petroleum reserve, and will save $5 to $7 billion by adjusting the timing of Medicare pre-payments to Medicare Advantage plans that cover prescription drugs (MA-PD) sponsors so that the government, and not the insurers, recoups interest revenue. $2.8 billion in savings are generated by a proposal to limit the durable medical equipment match rates in Medicaid to the Medicare competitive bidding process payment level. The limitation of federal payments for x-ray imaging services in order to incentivize the use of digital imaging would save an additional $200 million.

This bill provides the FDA with $550 million in mandatory funding over five years through a Cures Innovation Fund. A measure to encourage Lyme disease research, as well as language exempting certain FDA user fees from sequestration, based on a bill passed by the House during the 113th Congress, was also added to the 21st Century Cures package.

H.R. 6 will now be sent to the House floor for consideration. The bill's number is a positive signal from House leadership, as bill numbers 1 through 10 are reserved for priorities of the speaker of the House.

Rep. Fred Upton (R-Mich.), one of the bill's authors, has said that the Ways and Means Committee will likely have a referral period to comment on the legislation. He hopes to consider the bill on the House floor in June, with the goal of sending the legislation to the president's desk by the end of the year.