June 2007 Clinical Laboratory News: Washington Profiles

June 2007: Volume 33, Number 6

 Competitive Bidding Returns to CMS

The Office of Management and Budget (OMB) has completed its review of the Medicare competitive bidding demonstration for laboratory services and returned it to CMS for further action. While a response is expected in the near future, CMS has not said whether OMB recommended any changes or when it will be moving forward with the project.

The demonstration project would take place at two sites with staggered starting times, 1 year apart, for 3 years. The entire clinical laboratory community, including AACC, is critical of the project, which requires all commercial and outpatient hospital laboratories within the selected areas billing more than $100,000 in Medicare testing in 2005 to submit bids. Only winning laboratories—those that submit separate bids or as part of a consortium—will be allowed to conduct tests on Medicare patients. The demonstration project would bar those laboratories that are neither selected nor part of a winning consortium from performing Medicare testing for its duration.

Additional information on this demonstration project can be found on the CMS Web site.

House Passes Genetic Information Nondiscrimination Act

After 12 years and much effort on the part of groups such as the Coalition for Genetic Fairness and the Personalized Medicine Coalition, the House of Representatives has finally passed the Genetic Information Nondiscrimination Act (H.R. 493). The bill, also known as GINA, was sponsored by Reps. Louise M. Slaughter (D-NY) and Judy Biggert (R-Ill.).The bill should win quick approval in the Senate, since previous versions were unanimously approved there in 2003 and 2005.

President Bush also supports this legislation and has pressured Congress to approve the legislation and bring it to his desk, so he can sign it into law. “I really want to make it clear to the Congress that I hope they pass legislation that makes genetic discrimination illegal,” he said at a January roundtable discussion on advances in cancer prevention at the NIH. “In other words, if a person is willing to share his or her genetic information, it is important that that information not be exploited in improper ways—and Congress can pass good legislation to prevent that from happening. In other words, we want medical research to go forward without an individual fearing of personal discrimination.”

GINA makes it illegal for group health plans and health insurers to deny coverage to individuals or charge higher premiums based solely on a genetic predisposition to a specific disease. In addition, the legislation bars employers from using individuals’ genetic information when making hiring, firing, job placement, or promotion decisions. Additional information on GINA is available on Rep. Slaughter’s Web site.

Senate Approves Revised MDUFMA Goals

In early May, the Senate approved the FDA’s recommendations for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA II). This user fee program is part of the FDA Revitalization Act, which is awaiting approval by the House, as of press time. After its approved by the House, select members from Congress will negotiate a compromise bill before a vote is taken on the final bill by both the House and Senate.

These FDA recommendations for MDUFMA II are the result of negotiations with the Advanced Medical Technology Association (AdvaMed). The recommendations include several provisions to improve performance goals for review times and revise rates for user fees that manufacturers pay to FDA to cover costs associated with the review and on-going regulation of medical devices. In particular, the recommendations reduce the application fees overall for premarket review applications (PMAs), PMA supplements, and 510(k)s through the establishment of a nominal annual fee program. Smaller manufacturers are eligible for reduced user fees. The proposed performance goals also shorten the decision time for both PMA and 510(k) application reviews, as well as require the FDA to provide guidance documents to assist companies through the application and review process.

A summary of the FDA revitalization act is available online on the congressional Web site, THOMAS . Additional information on the MDUFMA recommendations is also online.

HHS Establishes New
Biomedical Research Department

In late April, HHS Secretary Michael Leavitt announced the establishment of the Biomedical Advanced Research and Development Authority (BARDA). This office will manage Project BioShield, which will procure and develop medical countermeasures for chemical, biological, radiological, and nuclear agents and other emerging infectious diseases that fall outside of the scope of Project BioShield. BARDA will also incorporate all the programs, mission responsibilities, and organizational functions previously housed in the HHS Office of Public Health Emergency Medical Countermeasures, which will be absorbed in the reorganization process.

BARDA will provide an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies, according to an HHS press release. “The creation of BARDA enhances the opportunity for innovation in our efforts to develop effective medical countermeasures against a host of public health threats, either natural or manmade,” said Secretary Leavitt. “I am pleased that Congress recognized the importance of advanced development in the establishment of BARDA, and the President’s FY 2008 budget request of $189 million for this purpose will help further the department’s efforts to bridge the gap between the National Institutes of Health’s research and development programs and Project BioShield.”

Companion Newborn Screening
Bill Introduced in House

Reps. Lucille Roybal-Allard (D-Calif.) and Mike Simpson (R-Idaho) have introduced the “Newborn Screening Saves Lives Act” (H.R.1634), which calls for preventing newborn deaths and illnesses through improved education and coordination of care. This legislation is necessary because many states do not test for all the recommended disorders nor do they inform the parents of the availability of these tests, according to Rep. Roybal-Allard.

If enacted, the bill would require education and training in newborn screening and relevant new technologies for healthcare professionals and state laboratory personnel; education and information for parents, families and patient advocacy and support groups about newborn screening; a coordinated system of follow-up care for newborns and their families after screening and diagnosis; and resources for states to expand and improve their newborn screening programs. The bill would also encourage states to test for the full panel of disorders recommended by HRSA and require the CDC to ensure the quality of laboratories involved in newborn screening so that tests are as accurate as possible.

To date, no hearings have been scheduled on this legislation. Additional information on this bill is available on the congressional Web site, THOMAS. A press release from Rep. Roybal-Allard is also available online.


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