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 - JUNE 25, 2012


FDA User Legislation Scheduled for Enactment


Under suspension of the rules, the House passed, with an amendment, the previously passed Senate bill, S. 3187, which reauthorizes the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA), authorizes new user fees for generic and biologic drugs, contains the Generating Antibiotic Incentives Now (GAIN) Act providing additional exclusivity periods and priority review by the FDA for manufacturers developing new antibiotics for a serious and life-threatening infection, and bans certain synthetic drugs (e.g. bath salts) among other provisions.  The Senate Majority leader has scheduled a cloture vote in the Senate for early this week with enactment expected before the upcoming week-long July 4th recess.  Early passage of the legislation will enable the FDA to administer the law before the current user fee authorization expires on September 30th.


Appropriations


On Wednesday the House is scheduled to take up H.R. 5973, the FY 2013 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act.  The House Appropriations Committee also passed the FY 2013 Financial Services spending bill which includes restrictions on transferring funds between HHS and the IRS for PPACA purposes as well as a restriction on PPACA federal health insurance exchanges from using federal funds for administrative costs related to abortion.


Other Notable Health Legislation


The House passed H.R. 3668, legislation which increases the penalties against individuals and companies involved in selling counterfeit prescription drugs.  The bill’s passage sets up a formal or informal conference with the Senate’s bill, S. 1886.  Also, facing a month-end deadline to freeze student loan interest rates at 3.4% for another year, Senate leaders have apparently reached an agreement to extend the loan rate and pay for the $6 billion cost of the legislation.  It remains to be seen to what extent the final offsets will include PPACA or other health-related cuts which the House included in the bill previously sent to the Senate.


Supreme's to Rule on PPACA This Week


Although today is the last scheduled day for the Court to sit to issue decisions before the summer recess, it is likely additional decision dates will be added. The Supreme Court begins announcing its decisions at 10AM.  Regardless, the White House and Congress are gearing up to react to the court’s decision on the constitutionality of the individual mandate and other provisions of the PPACA.  House Republican leaders warned their members against “spiking the ball” if the court strikes down some or all of the law.  Regardless of the decision, it is expected that House Republicans will schedule another vote to repeal the PPACA or whatever remains of the law after the Supreme Court decision.  Their intent to replace the PPACA with “step by step” reforms will likely be delayed until after the November elections.  Minority Leader Nancy Pelosi responded as follows: “It is a sad day when Republicans continue to cheer against health benefits Americans are already enjoying, while running out the clock on the economy and pursuing policies that are dangerous to a thriving middle class.  No one, except perhaps House Republicans, actually believes they ‘are focused on the economy.’”  The Supreme Court decision will also unleash the stays on the numerous other federal cases involving the PPACA, including among other suits: the constitutionality of the Independent Payment Advisory Board; whether First Amendment rights are violated by the PPACA’s mandate for religiously affiliated hospitals and other organizations to provide contraception and other services they say violate their religious values; and whether the law unconstitutionally prevents the expansion of doctor owned hospitals.



June 25, 2012: | Page 1 Page 2

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