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.


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, on Thursday. Negotiations on offsets for the bill, aimed at spurring the pace of medical innovation, supporting biomedical research, and overhauling the way the Food and Drug Administration (FDA) evaluates new medical products, continued in the days leading up to the vote. The markup was actually delayed for 24 hours with less than two hours’ notice in order to finalize the question of how to pay for the deal. The manager’s 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. 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. A proposal to offset the bill using changes to the 340B Drug Discount Program was dropped. The previous version of the legislation contained no potential offsets and did not deliver any additional funding to the FDA. This bill provides the agency 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 the month of June, with the goal of sending the legislation to the President’s desk by the end of the year.

December 31, 1969: | Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10



 -  2019

 +  2018