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From Health Law Daily, October 8, 2013

No real change as partial government shutdown enters second week

By Paul Clark

At an October 8 White House briefing President Obama pressed House Speaker John Boehner (R-Ohio) to hold a vote on a “clean” continuing resolution to temporarily fund federal government operations, noting that between a minority of Republican House members and most Democratic House members there were enough votes to pass such a bill.

In recent days, Boehner has been seeking to link the passage of temporary funding bills with an increase in the federal debt ceiling. On October 8, he said, “Listen, there’s never been a president in our history that did not negotiate over the debt limit. Never. Not once. As a matter of fact, President Obama negotiated with me over the debt limit in 2011.”

National Economic Council Director Gene Sperling said on Oct. 7 that the President is willing to negotiate with Republicans over a budget deal, as long as it doesn’t involve the debt ceiling. ““The president has made clear that the era of threatening default has to be over,” Sperling said at Politico’s Playbook Breakfast in Washington. “He is willing to negotiate on sequester replacement, on small or a medium or a large agreement.”

As the partial government shutdown enters its second week with no signs of ending, here is an update some of the government functions related to the health care market.

FDA activities. The FDA on October 7 posted an updated list of activities the agency was continuing during the shutdown. FDA activities related to medical products generally are limited to “excepted” work involving the safety of human life or the protection of property, including criminal law enforcement work; and activities funded by carryover user fee balances. The agency does not think that the lapse in appropriations will affect its routine product review process for submissions within the scope of the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA programs, provided that applicable fees were paid before October 1, 2013.

Scheduled advisory committee meetings regarding the approval of, or postmarketing safety issues may go forward during the lapse period, subject to constraints on resources and travel.

The FDA will not accept PDUFA applications or supplements that require payment of a fee (e.g., New Drug Applications (NDAs) or certain Biologics License Applications (BLAs)), unless the FY 2014 fee was paid prior to October 1, 2013. The agency will still accept new regulatory submissions for which no fee is required, if the product is within the scope of the PDUFA program.

CMS. A blog post on the website of Franco Signor, which specializes in Medicare Secondary Payer (MSP) Compliance, noted that key personnel who work on MSP issues at CMS and the Social Security Administration (SSA) have been furloughed. Post settlement compromises or reductions requiring CMS intervention under 42 C.F.R. §411.28 (recovery and compromise of claims) is off-line. CMS contractors that work on MSP compliance, including Coordination of Benefits Contractors; Medicare Secondary Payer Recovery Contractors; and Workers Compensation Review Contractors are not impacted and remain operational.

Courts. The district court for the Northern District of Illinois is suspending all civil litigation involving the United States or one of its agencies for 14 days as a result of workforce reductions brought about by the shutdown.

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