November 2007 Clinical Laboratory News: Washington Profiles

November 2007: Volume 33, Number 11

Senators Introduce Bill to Repeal Competitive Bidding

In late September, the Senate version of legislation to repeal competitive bidding was introduced by Ken Salazar (D-Colo.), Pat Roberts (R-Kan.), and Maria Cantwell (D-Wash.). The bipartisan bill, the “Preserving Access to Laboratory Services Act of 2007” (S. 2099), would halt the current plans for CMS to test a market-based pricing model for laboratory services as mandated by Congress under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

This Senate version comes shortly after Rep. Nydia M. Veláquez (D-N.Y.) introduced a similar bill—H.R. 3453—in the House. This bill, “The Community Clinical Laboratory Fairness in Competition Act of 2007”, was introduced following a July 25 hearing before the House of Representatives Committee on Small Business, which is chaired by Rep. Veláquez. Since the bill was introduced, it has gained four cosponsors: Reps. Diana DeGette (D-Colo.), Charles W. Boustany, Jr. (R-La.), Bart Gordon (D-Tenn.), and Jim Matheson (D-Utah).

The clinical laboratory community has been pressing for the repeal of this program and is encouraged by these legislative efforts. “The clinical laboratory fee schedule is the wrong place to be looking for cost savings given that laboratory services under Medicare have already been reduced 40% in real terms since 1984,” said Alan Mertz, President of the American Clinical Laboratory Association. “Laboratory services are just what the name implies—services, not commodities. Ironically, the misnamed Medicare competitive bidding demo will mean less competition, not more.” Full copies of these bills are available on the Congressional Web site, THOMAS.

FDA Bill Reauthorizes Device User Fees

The House and Senate have now passed the Food and Drug Administration Amendments Act of 2007, which will reauthorize the user fee program for pharmaceutical and device manufacturers. Under the Medical Device User Fee Amendments (MDUFMA) of 2007 section of the larger FDA bill, the agency will collect approximately $287 million in user fees from device manufacturers over a 5-year period between 2008 and 2012. While existing application fees will be reduced beginning in 2008, there will be new types of medical device user fees. These include annual fees for periodic reporting on class III devices and an annual registration fee for a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer. In addition, the FDA is currently updating guidance on qualifying for a small business designation. Under MDUFMA, small business device manufacturers qualify for discounted user fee rates. Additional information is available on the FDA’s MDUFMA Web site.

HHS Outlines Agency’s Personalized Healthcare Efforts

On Sept. 19, HHS Secretary Michael Leavitt announced that work in biomedical science, health IT, and healthcare delivery should be focused on producing “the right treatment, at the right time” for each individual patient. These remarks accompanied the release of Personalized Health Care: Opportunities, Pathways, Resources, a long-range plan for achieving individualized treatment for patients through using genetic information and health information technology (IT).

The report describes how the exploding knowledge of the human genome will increase the capacity to predict, detect, preempt, and treat disease by enabling physicians to “look beneath” visible symptoms and see signs and causes of disease at the molecular level. The report also describes how health IT can make patient information accessible securely, while maintaining confidentially, as well as how it can support high quality care. The report includes descriptions of the opportunities presented by science and technology, and it outlines areas were work is needed. “Personalized health care means knowing what works, knowing why it works, knowing whom it works for, and applying that knowledge for patients,” Leavitt wrote. “These goals may sound elementary, but a generation of effort lies ahead of us in achieving them.” The report is available on the HHS Web site.

Joint Commission Prohibits Reporting Retaliation

In early September, The Joint Commission issued a rule stating that all hospital staff—including physicians and medical personnel—can report patient safety and quality concerns to the accrediting organization without fear of retaliation. The revised requirement, which will become effective January 1, 2008, means that accredited hospitals must inform all staff and medical staff that any employee or any physician who has concerns about safety or quality of care provided in the hospital may report these concerns to the Joint Commission. Additional information can be found online at the accrediting organization's Web site.

NIH Releasing Framingham Clinical Data

The NIH announced in early October that it is releasing a significant amount of genetic and clinical data from the decades long Framingham Heart Study. The data will be free to qualified investigators. Agency officials said that genetic, clinical, and lab results from as many as 9,300 participants will be available as a data set. This data set—called the SNP Health Association Resource or SHARe—can be accessed through the National Center for Biotechnology Information’s Database of Genotypes and Phenotypes Web site.

The Framingham Heart Study—which is still ongoing—began in 1948 with more than 5,200 participants. In 1971, additional participants—5,000 spouses and children—were added, along with another 4,000 in 2002. Additional information can be found online.


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