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.


President Signs FDA User Fee Legislation

Last Monday the President signed S. 3187 into law (P.L. 112-144).  Among other provisions, the law reauthorizes PDUFA; reauthorizes MDUFA; authorizes new generic drug and biosimilars user fee programs; provides new incentives for the development of antibiotics; adds provisions to address drug shortages; adds a new fee program related to rare pediatric diseases; gives an additional five years of market exclusivity to manufacturers that develop new qualified infectious disease products (QIDPs); increases the federal penalties and prison times for persons who knowingly and intentionally commit acts related to trafficking in counterfeit drugs; and adds a requirement for the FDA to issue guidance on the use of the internet and social media to promote FDA regulated medical products.   CBO estimates that the law will reduce direct spending by $307 million and reduce deficits by $311 million over ten years.

Appropriations Standoff

While the House is scheduled to take up the FY 2013 Defense Appropriations bill this Wednesday, Senate Majority Leader Harry Reid is apparently resigned to forego any further scheduling of stand-alone spending bills in the Senate during the remaining 35 or so days left on the legislative calendar before the November elections.  Nonetheless, the House is intent on passing at least the DOD, Agriculture/FDA and Financial Services appropriations measures before the August recess.  If the Senate Majority Leader relents, it is possible that the VA/Military Construction spending bill could be approved in the Senate before the end of the fiscal year.  The lack of stand-alone action on the outstanding bills will force Congress to pass a continuing resolution to enable federal agency spending past the election, thus setting up a contentious post-election debate on the FY 2013 spending limits for most agencies, including HHS/CMS, etc.  As part of the expected lame-duck session, members will have to confront the significant “sequestration” cuts mandated under the Budget Control Act.  HHS estimates that beginning next year the cuts to HHS would amount to about a 7.8% spending reduction and lead to, among other things: the elimination of 2,300 new and competing NIH research grants; about 12,150 fewer patients receiving benefits under the AIDS Drug Assistance program; about 169,000 fewer individuals being admitted in substance use disorder treatment programs; and the curtailment of Medicare/Medicaid anti-fraud efforts.

House Republicans Again Push Through PPACA Repeal Bill

Spurred on by the Supreme Court’s decision upholding the PPACA, last week the House voted 244-185 to pass H.R. 6079, legislation to repeal all provisions of the PPACA.  Garnering just five Democrat votes, the bill is essential DOA in the Senate.  Republicans argued the job-killing aspects of the bill with House Speaker John Boehner stating that “This law continues to make our economy worse, and there is even more resolve to repeal this law….”  On the other hand, House Minority Leader Nancy Pelosi emphasized the benefits of the legislation stating that the Republican initiative would result in the cancellation of coverage for pre-existing medical conditions, remove additional Medicare prescription drug coverage, cancel coverage for children ages 26 and younger, remove preventive health benefits for women and repeal the end of lifetime insurance coverage limits.  Whether or not additional repeal efforts will be made in the House, such as eliminating the Medicaid maintenance of effort rule, remains to be seen.  Of note, CBO said it would not have a cost estimate of the effect of the repeal until the end of July.  Setting up talking points before the vote, the House Oversight and Government Reform Subcommittee on Health Care heard testimony from a number of physician groups who maintained the law will “destroy the doctor-patient relationship.”  One witness said that new bureaucracies and financial burdens will result from the PPACA’s provisions on EHR, ACOs and the IPAB.  Subcommittee Chairman Trey Gowdy said that the law will create a significant doctor shortage.  At another hearing by the full committee, Chairman Darrell Issa said “We know that Obamacare makes labor more expensive….” and a witness testified that the increased health care costs under the PPACA have directly affected job creation in the restaurant industry.  Rep. Elijah Cummings, the ranking member, said that Republicans were “continuing the same old scare tactics today, warning about massive job losses and economic ruin should the Affordable Care Act continue.”

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