August 2007 Clinical Laboratory News: Washington Profiles
August 2007: Volume 33, Number 8
Biomarker Consortium Solicits Proposals
The NIH’s Biomarker Consortium is now accepting project proposals or “concepts” through a new Web site. The site is designed to provide principal investigators, research managers, prospective grantees in government, non-profit, and industry sectors, as well as science and health policy organizations and advocacy groups with funding resources.
Financial support for approved concepts is procured through fundraising efforts by the Foundation for the NIH. When approved, concepts are developed into formal project proposals. When approved by the consortium’s executive committee, the NIH foundation then secures the funds for implementation. To date, over $6 million has been raised to support the consortium’s lung cancer and lymphoma biomarker projects.
Additional information is available online.
Health IT Bill Advances to Senate Floor
In late June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved the bi-partisan health IT legislation, the Wired for Health Care Quality Act (S.1693), which would bring together the public and private sectors to create a paperless electronic medical records healthcare system. The bill has been sent to the Senate for voting. During the last congressional session, similar legislation passed the Senate unanimously. AACC has endorsed this measure.
Initially introduced in 2005, the consensus measure is supported by Committee Chairman Sen. Edward Kennedy (D-Mass.), along with Senators Mike Enzi (R-Wyo.), Hillary Clinton (D-N.Y.) and Orrin Hatch (R-Utah). The legislation seeks to codify the Office of National Coordinator for Information Technology; create a public-private partnership to develop interoperability standards; require all federal health IT purchases to conform to these standards; provide financial assistance to needy healthcare providers to adopt health IT; and authorize grants for the creation of regional and local networks of healthcare providers. A full copy of S. 1693 is available on the Congressional Web site, THOMAS.
Senators Angered by Potential CMS Hospital Cuts
CMS is proposing to cut hospital payments by 2.4% in 2008 and 2009, as it anticipates hospitals will inappropriately bill for certain services at higher rates as a result of the forthcoming coding changes. In response, Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Republican Charles Grassely (R-Iowa) recently wrote to CMS to express their concerns about these planned reimbursement cuts based on the new severity-based DRG payment system. The senators argue against CMS taking this premature action, stating that any “action should be based on reality, not speculation.” A copy of the letter and its accompanying press release is available on the Finance Committee Web site.
NIH Awards Cancer Genome Funds
In early July, the NIH awarded eight two-year grants totaling $3.4 million as part of The Cancer Genome Atlas (TCGA) pilot project. TCGA is an initiative by the NIH’s National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), and was launched in December 2005 to test the feasibility of a large-scale, systematic approach to identify the changes that occur in the genomes of cancer cells. The goal of TCGA is to generate genomic information that the research community can use to develop new and improved strategies for detecting, treating, and preventing cancer.
The types of tumors being studied in this pilot project include brain, ovarian, and lung cancers, which together account for more than 200,000 cases of cancer in the U.S. This project will establish a publicly available database that individual researchers can use to study the genomic changes of specific cancers to develop new targets for a new generation of drugs and diagnostics. TCGA data will be made available through public databases supported by NCI’s Cancer Biomedical Informatics Grid and the National Library of Medicine’s National Center for Biotechnology Information. Additional information about TCGA is available online.
Task Force Releases Chlamydia Screening Guidelines
The Agency for Healthcare Research and Quality’s (AHRQ) U.S. Preventive Services Task Force (USPSTF) has released updated screening guidelines for detecting chlamydia. The Task Force now recommends screening for all sexually active non-pregnant women age 24 and younger and for older non-pregnant women considered at increased risk. In addition, the guidelines recommend against screening for women age 25 and older, whether or not they are pregnant, if they are not at increased risk. The guidelines also conclude that the Task Force could not determine the balance of benefits and harms of screening men for chlamydia, due to insufficient evidence.
In terms of detection, the USPSTF found fair evidence that nucleic acid amplification tests (NAATs) can identify chlamydia infection in asymptomatic men and women with high test specificity. However, in low prevalence populations, a positive test is more likely to be a false positive than a true positive, even using the most accurate tests currently available. A full copy of the screening recommendations is available on the AHRQ Web site.