POLICY BRIEFINGS


Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


THIS WEEK'S BRIEFING - JULY 13, 2015


H.R. 6 Heads to the Senate


The House of Representatives passed H.R. 6, the 21st Century Cures Act, with strong bipartisan support last week. 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. The bill had previously experienced delays due to disagreements regarding how to pay for the legislation, which will cost $9.23 billion over the next decade but will cut federal spending by $470 million through 2025, according to the Congressional Budget Office (CBO). 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 when the bill is conferenced with the Senate. 21st Century Cures will be paid for through mandatory funding instead of discretionary funding. This means 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. Prior to passage, lawmakers considered six amendments to the bill, including one from freshman Representative Dave Brat (R-Va.) which would have converted the bill’s $8.75 billion in mandatory funding for the NIH and $550 million for the Food and Drug Administration (FDA) into discretionary spending. If passed, the amendment would have jeopardized Democratic support for the bill. The amendment failed by a vote of 141-281. The House did adopt amendments to authorize NIH to establish a medical innovation prize for breakthrough science and another amendment to support young women and minority scientists. The legislation received backing from the White House, who 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 until later this fall, at the earliest. The Senate has held its own series of hearings on its Innovations for Healthier Americans, but legislative language for the initiative is not expected until later in the year. House leadership hopes to bring 21st Century Cures to conference and send to the President’s desk by the end of the year.



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