In This Issue...
House Panels Pass Bill Repealing IPAB
The House Energy and Commerce and House Ways and Means committees have approved legislation, H.R.452, the Medicare Decisions Accountability Act, to repeal the Independent Payment Advisory Board (IPAB) created by the 2010 health care reform law. Starting in 2014, the IPAB would be empowered to make cuts to Medicare payments without congressional authorization, if certain health care spending limits were exceeded. AACC supports this repeal. The Association believes that any health care cuts should be transparent and open to stakeholder participation -- neither of which would exist under IPAB. If you would like to see a copy of the bill, please go to the congressional Web site, THOMAS. For a copy of AACC's position, please visit the Association Web site.
AHRQ Seeks Feedback on Planned Troponin Study
At the request of AACC, the Agency for Healthcare Research and Quality (AHRQ) is sponsoring a systematic review, "Troponin Cardiac Marker Interpretation During Renal Function Impairment." This study is being conducted by the Scientific Research Center (SRC) in Oregon which is currently seeking feedback on the key questions used to guide the study. (SRC is research alliance involving Oregon Health & Science University, Kaiser Permanente Center for Health Research and the Portland Veterans Affairs Medical Center). If you are interested in reviewing the questions, and providing input to SRC, please visit the AHRQ Web site. SRC is accepting comments through March 28, 2012.
IRS Seeks Comments on Medical Device Excise Tax
The Internal Revenue Service (IRS) published a proposed rule in the February 7, 2012 Federal Register (pages 6028-6038), providing guidance on how the government plans to implement the new 2.3 excise tax on the sale of certain medical devices. Included in the 2010 health care reform law, the tax is scheduled to take effect on January 1, 2013. Although the provision applies to most instruments and reagents, it does include a retail exemption for certain devices purchased by the general public, such as eyeglasses, contact lenses, and hearing aids. The IRS is accepting comments on this proposal through May 7th. The agency is also planning a public hearing on May 16th. To view a copy, please visit the FR Web site.
FDA Agrees Not to Charge Labs User Fees for LDT review
As part of the reauthorization negotiations involving the Medical Device User Fee and Modernization Act, the Food and Drug Administration (FDA) has agreed not to charge laboratories a fee for reviewing laboratory developed tests (LDTs) (as they do medical device manufacturers), if it chooses to regulate such tests. Over the past few years, the FDA has been working on guidance to formally extend its oversight over LDTs. The agency has not yet announced a date when the guidance will be released; however, it will focus initially on high risk tests, extending oversight to all LDTs over time, it has stated. Congress hopes to take up the reauthorization agreement this summer, before the current user fee program expires in September. The minutes of the February 14th FDA-Industry forum discussing this issue are available on the agency Web site.