Weekly Washington Policy Check-Up

November 11, 2011

Pardon Our Dust

We recently launched this new site and are still in the process of updating some of our archived content. Some details of this article may be incomplete, links may be broken, and other elements may not display properly yet. We appreciate your patience and understanding.




  • N/A – State Work Period






House easily passes FDA User Fee bill

On Wednesday, the House easily passed legislation to reauthorize FDA user fee programs to fund the agency’s review of prescription drugs and medical devices, collectively known as UFAs. The bill, which is substantively very similar to legislation passed by the Senate last week, would also create two new user fee programs for generic and biologic drugs. In addition, the bill contains provisions to reform FDA’s medical device review process, and address drug shortages.

Notable differences between the respective chambers’ bills, unlike the House bill, the Senate bill contains language to streamline FDA’s ability to reclassify devices into more stringently reviewed categories. The Senate version also includes a strict timeline for the establishment of a unique device identification system for devices, while the House provides for a less binding requirement that the Secretary begin promulgation of such a regulation. Those issues will have to be reconciled in conference, as will incentives for antibiotic developers, which are more generous in the House version.

Ways and Means Committee marks up medical device tax repeal legislation

On Thursday, the House Ways and Means Committee favorably reported legislation introduced by Rep. Paulsen (H.R. 436) to repeal the 2.3% excise tax on medical devices, created as a $20 billion revenue provision to partially offset the cost of the Patient Protection and Affordable Care Act (PPACA). The House is expected to vote on the legislation as early as June 4th.

Veterans Affairs Subcommittee finds flaws in VA Dept.’s prosthetic policies

VA OIG conducted the audit to evaluate VA’s medical centers’ (VAMC) prosthetic inventory management. They found VHA cannot accurately account for prosthetic inventories. Specifically, VAMC inventories exceeded current needs for almost 47 percent of approximately 93,000 specific prosthetic items and inventories were too low for nearly 11 percent of the items. As a result, VAMCs spent about $35.5 million buying prosthetics in excess of current needs – increasing the risks of supply expiration. Inaccurate inventories disrupt patient care due to shortages and lead to losses associated with diversion. VAOIG recommended the Under Secretary for Health develop plans to implement an improved inventory system and develop a training-to-certification program for prosthetic inventory managers.



GAO: Small business tax credit less popular than expected

Fewer small employers claimed the Small Employer Health Insurance Tax Credit in tax year 2010 than were estimated to be eligible. While 170,300 small employers claimed it, estimates of the eligible pool by government agencies and small business advocacy groups ranged from 1.4 million to 4 million. The cost of credits claimed was $468 million. Most claims were limited to partial rather than full percentage credits (35 percent for small businesses) because of the average wage or full-time equivalent (FTE) requirements. 28,100 employers claimed the full credit percentage. In addition, 30 percent of claims had the base premium limited by the state premium average. http://www.gao.gov/products/GAO-12-549

Panel: Men can skip PSA test

In a recommendation certain to be both ignored and widely criticized, government health advisers said most men should not get a common blood test for prostate cancer, saying it often caused more harm than good. But the U.S. Preventive Services Task Force also notes that many men really would prefer to be screened, so it says each man should decide with his doctor whether to get the test, which checks for levels of a protein called prostate specific antigen. PSA rises when the prostate grows but this growth could come from cancer or from harmless conditions – and when men have prostate cancer it’s often so slow-growing that something else is likely to kill them first. Read more

Growth in Health Care costs slows for the 4th consecutive year

Health costs will rise just 7.5 percent in 2013, according to projections released on Thursday by PriceWaterhouseCoopers, and employers who are trying to cut health expenses are contributing a fair amount to these savings. “The big picture out of this report is, we have now identified four years in a row of historically low growth rate in an industry that previously had been known for rapid, large growth, and that is significant,” said Ceci Connolly, who heads the company’s Health Research Institute. ‘Is it possible we are entering a new normal of somewhat more constrained growth in health care spending?”


Oregon eyes a new take on ACOs: Medicaid Reform

Groups ask Congress for meaningful use changes

The nation’s largest medical groups are asking Congress to change a proposed Medicare rule that would regulate financial incentives to physicians who use electronic health records.

The American Medical Association, the American Academy of Family Physicians, the American Osteopathic Association and other interest groups made their appeals over the Medicare meaningful use Stage Two proposal in letters sent Friday to Republican members of the House Ways and Means Committee. They say they’re worried about how the different systems can talk to each other, rushed implementation deadlines and the retroactive financial penalties for noncompliance.

If you have any questions, please contact Stephanie Kennan (SKennan@mwcllc.com) or Brian Looser (BLooser@mwcllc.com) at McGuireWoods Consulting.

McGuireWoods Consulting LLC
2001 K Street
Suite 400
Washington, DC 20006-1040