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.


Bill to Be Considered by Full Energy and Commerce Committee This Week

The House Energy and Commerce Health Subcommittee favorable reported out the 21st Century Cures draft bill to the full Committee for consideration by a voice vote with no amendments. The Subcommittee marked up the bipartisan medical innovation bill last week, following the release of an updated draft that reflects the most recent bipartisan negotiations on previously unresolved issues such as telemedicine and interoperability of electronic health records. Updates to the bill would allow the U.S. Department of Health and Human Services inspector general to investigate possible information blocking. The latest draft dropped a provision to grant longer exclusivity periods for manufacturers of dormant therapies for unmet medical needs, and will no longer provide U.S. generic drug manufacturers longer periods of protection from global competition. These exclusivity periods would prevent competitors from selling the same drugs. Instead, the bill marked up by the Subcommittee includes a six-month extension of market exclusivity for drugs that treat rare diseases. Some Democrats expressed concerns that this provision will hinder patient access to the treatments. Republicans fought for its inclusion, arguing that the incentive will encourage more investment in the development of “orphan drugs,” which the Food and Drug Administration (FDA) defines as treatments for diseases affecting fewer than 200,000 Americans. Orphan drug status can also be granted to companies whose products will not be profitable within seven years of FDA approval. The latest 21st Century Cures Act legislation includes the addition of a seven-year reauthorization of the rare pediatric disease priority review voucher program. The program gives manufacturers of a rare pediatric disease drug a voucher for faster FDA review of another product. Manufactures are allowed to sell the vouchers to another company. During the markup, members from both sides of the aisle expressed support for the bill but stressed that the draft is not final and that more work remains to be done. Funding for the FDA continues to be a point of contention. While the bill includes $10 billion over five years in mandatory spending for the National Institutes of Health (NIH), as well as yearly increases to boost the NIH’s budget by an additional $5 billion by 2018, no additional funding is included for the FDA. Democrats are pushing for the inclusion of additional FDA resources to enable the agency to meet its new obligations as a result of 21st Century Cures and to approve new cures in a safe and timely manner. How the bill will be offset is still unknown. Energy and Commerce Committee Chairman Fred Upton (R-Mich.) has stated that the bill will be fully offset, though it may be possible that leadership will be left to negotiate pay-fors after the bill clears the Committee. The full Energy and Commerce Committee will consider the legislation this week. Chairman Upton has reiterated his hopes to have the bill on the House floor by June and enacted into law later this year. Meanwhile, the Senate’s parallel “Healthier Americans” initiative is on a much slower track. While the chamber plans to produce its own bill, Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-Tenn.) has said that he does not expect to bring a bill to the floor before early 2016.

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