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21st Century Cures Heads to the Senate

On July 10, the House of Representatives passed H.R.6, the 21st Century Cures Act with strong bipartisan support. With 230 bipartisan cosponsors, the bill passed comfortably by a roll call vote of 344-77. Seven Democrats joined 70 Republicans in voting against the bill. ASPS strongly supported this legislation, including provisions that facilitate collaborative research, streamline clinical trials, provide for interoperability of healthcare IT systems, and amend the Physician Payments Sunshine Act so that medical textbooks, peer-reviewed journals, journal reprints and journal supplements become exempt.

The bill previously experienced delays due to disagreements regarding how to cover its $9.23 billion 10 year cost. The bill's original $10 billion in funding over the next five years for the National Institutes of Health (NIH) was reduced to $8.75 billion during debate about offsets. Many Cures supporters would like to see this funding restored should the bill reach conference committee negotiations with the Senate.

21st Century Cures' NIH funding is classified as mandatory funding instead of discretionary funding, meaning that the funds will not be subject to spending caps and will not be revisited each year during the appropriations process. $7 billion in offsets comes from selling oil from the Strategic Petroleum Reserve, while limiting Medicaid payments for durable medical equipment to Medicare rates will save an additional $2.5 billion.

The legislation received backing from the White House, which expressed support for provisions advancing the president's precision medicine initiative as well as measures dealing with electronic health records (EHRs) and improvements to the clinical trial process. The White House also praised policies to incorporate the patient perspective into the drug development process and the development of biomarkers.

The administration did outline concerns regarding the wisdom of providing the NIH with additional funding without considering the preexisting budgetary implications of sequestration. The White House's statement went on to question whether the FDA will have the necessary resources to successfully execute the new responsibilities contained in 21st Century Cures while maintaining current performance levels. Finally, the administration expressed concerns about the impact of patent exclusivity exemptions on drug costs, and whether policies to bring drugs to market faster will negatively impact regulatory standards.

H.R. 6 is not expected to reach the Senate early in 2016. The Senate has held its own series of hearings on medical innovation through its Innovations for Healthier Americans initiative, but legislative language is not finalized.