American Association for Clinical Chemistry
Better health through laboratory medicine
April 2007 Clinical Laboratory News: Washington Profiles

April 2007: Volume 33, Number 4

Reimbursement Reform Bill Introduced in House

A bipartisan bill seeking to evaluate a new Medicare payment system for molecular diagnostic tests was introduced in the House of Representatives in early March. The bill, the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321), is sponsored by Reps. Bobby Rush (D-Ill.), Michael Ferguson (R-N.J.), Mike Thompson (D-Calif.), and Phil English (R-Pa.). The legislation, which has been endorsed by the Advanced Medical Technology Association (AdvaMed), establishes a demonstration project to evaluate a new Medicare payment system for molecular diagnostic tests; improves current processes for obtaining adequate reimbursement for new clinical diagnostic lab tests; provides more transparency with respect to Medicare reimbursement decisions; and affords timely correction of historic payment errors that often lead to inadequate payment. Additional information, including a full copy of the legislation, is available on THOMAS.

Newborn Screening Bill Introduced in Senate

In mid-February, Senators Chris Dodd (D-Conn.) and Orrin Hatch (R-Utah) introduced the Newborn Screening Saves Lives Act (S.634), which calls for additional federal funds to educate parents and health care providers about newborn screening, improve follow-up care for infants with an illness detected through newborn screening, and help states expand and improve their newborn screening programs. The bill is similar to legislation introduced by Dodd and former Senator Mike Dewine (R-Ohio) during the past two legislative sessions.

There are significant variations among newborn screening programs–some testing for as few as four disorders, others as many as 36. The Health Resources and Services Administration (HRSA), the government agency with oversight of newborn screening, has urged states to expand to 29 the number of conditions subject to newborn screening. This bill seeks to address this issue through a number of educational and funding measures. These include educating and training healthcare professionals and state laboratory personnel in newborn screening and relevant new technologies; educating and informing parents, families and patient advocacy and support groups about newborn screening; establishing a coordinated system of follow-up care for newborns and their families after screening and diagnosis; providing resources to states to expand and improve their newborn screening programs and encouraging states to test for the full panel of disorders, as recommended by HRSA; and requiring 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 issue, but similar legislation is expected to be introduced in the House shortly. A full copy of the legislation is available on THOMAS.

Medical Technology Legislation Introduced in Senate

Senator Maria Cantwell (D-Wash.) recently re-introduced S.605, the “Allied Health Professions Reinvestment Act”, to increase federal funding for allied health education and training, including medical technology programs. Supported by AACC and a number of other laboratory organizations, this legislation attempts to reverse the growing shortage of medical technologists, medical technicians, and other laboratory personnel. This bill provides federal grants to promote allied health professions and scholarships and loans for students. A full copy of the bill is available on THOMAS.

House Member Seeks Ban on Patenting of Human Genetic Material

Representative Xavier Becerra (D-Calif.) recently introduced legislation, the Genomic Research and Accessibility Act (H.R. 977), which would ban the patenting of genetic materials. The bill is prospective and does not apply to those patents already in existence.

The legislation, which is supported by the College of American Pathologists, the American College of Medical Genetics, and the Association for Molecular Pathology, and others, is similar to a bill introduced by former Rep. Lynn Rivers (D-Mich.) in 2002. Rep. Dave Weldon (R-Fla.), who co-sponsored the original legislation, is also a co-sponsor of H.R. 977.

Budget Office Recommends Co-pay to Reduce Deficit

The Congressional Budget Office’s 2007 report has presented more than 250 options for altering federal spending and revenues, which include establishing a 20% Medicare co-payment for clinical laboratory services. According to CBO, the adoption of this cost-sharing proposal would save the federal government $1.1 billion in 2008 and $8.3 billion over five years. CBO’s rationale for this proposal is that it would make the cost-sharing requirements under Medicare more uniform and discourage some beneficiaries from requesting or undergoing those laboratory tests “of little expected benefit” if they had to pay part of the costs. The office does acknowledge, however, that only a small portion of the savings would come from better use of laboratory services by beneficiaries, while additional savings will likely come from shifting costs from the Medicare program to its enrollees. The congressional group also recognizes that laboratories would have higher billing costs under their proposals. A full copy of the document is available at the CBO Web site.

CMS Accepting Medicare Provider Surveys

CMS is conducting its second annual Medicare Contractor Provider Satisfaction Survey (MCPSS), and as of press time, is continuing to accept responses beyond the initial February deadline. The survey, sent out to more than 35,000 randomly selected providers in early January, requested feedback on various aspects of the provider-contractor relationship. The agency plans to make the survey results available in July. Additional information can be found on the CMS Web site.

Kennedy Supports “Home-Brew” Oversight

In early March, Senators Edward Kennedy (D-Mass.) and Gordon H. Smith (R-Ore.) introduced the Laboratory Test Improvement Act (S. 736). The bill will mandate that providers of laboratory-developed or “home-brew” tests supply the FDA with analytical and clinical validity of their tests. This validity information will be compiled into a database by the FDA, and will then be available to the public via the Internet.

Under the proposed legislation, laboratories will be given time to comply with the regulations and provide the FDA with the necessary information. A full copy of the bill can be found on THOMAS, the congressional Web site.