November 2008 Clinical Laboratory News: Regulatory News

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November 2008: Volume 34, Number 11

 National Children’s Study Enters Next Phase

NIH announced additional study centers that will collect data for the agency’s National Children’s Study, a comprehensive study that will examine the effect of genes and the environment on children’s health. AACC has endorsed the study and is advising NIH on laboratory-related issues, and the association’s Pediatric Reference Range Committee plans to use the data gathered from the study to develop pediatric reference ranges.

NIH named 27 new study centers that will be funded in 2008, which will manage 39 locations, bringing the total of new and existing study centers to 36, with a total of 72 locations. Once fully operational, the study will have approximately 40 study centers recruiting volunteers for the planned 105 locations throughout the U.S. A complete list of the new study centers is on the National Institute of Child Health and Human Development website.

Project Will Develop Decision-Support Tool for Genetic Breast Cancer Tests

A new $1 million federal project funded by AHRQ will develop and implement four computer-based, decision-support tools to boost clinicians’ effective use of genetic breast cancer tests. The first pair of tools will assess whether a woman with a family history of cancer should be tested for BRCA1 and BRCA2 gene mutations. The other two tools will help determine which patients should get gene expression profiling tests. The project will be completed by the non-profit, independent research institute RTI International within about 16 months. The project came about in response to recommendations from the HHS Secretary’s Advisory Committee on Genetics, Health, and Society, which found that there are extensive gaps in knowledge about genetic tests and how they affect patient care.


Proposed Bill Gives Docs, Hospitals Incentive to Adopt HIT 

Introduced by Rep. Pete Stark (D-Calif.), chairman of the House Ways and Means Committee, the Health-e Information Technology Act of 2008 (H.R.6898) would require the government to create clear standards for an interoperable, open-source health information technology (HIT) system and offer it at little or no cost to providers within a defined timeframe. Under the bill, physicians who install and use the approved system could receive incentive payments totaling up to $40,000 over 5 years, and hospitals that do the same might get up to several million dollars. The incentives would eventually be phased out after several years, at which point Medicare payments would be reduced for those not using the HIT system. The bill also includes privacy protections following the HIPPA model, laying out boundaries on permissible uses and disclosures of patient health information. The bill is on the Library of Congress website.

CMS Releases 2009 Payment Recommendations

After receiving public feedback during its July 14th meeting in Baltimore, the agency recently released its payment recommendations for six new CPT codes to take effect on January 1, 2009. CMS’s preliminary crosswalk decisions call for reimbursement of two of the new codes to come in significantly lower than laboratory groups had lobbied for. For instance, MPO would be reimbursed at $18.09, less than half of the industry-recommended crosswalk to codes worth more than $47. Similarly, CMS recommends crosswalking oncoprotein to two codes reimbursed at $43.32 combined; the industry recommended crosswalk would have paid $89.99. CMS is recommending payment on four other codes at about the level lab groups had suggested. CMS’s recommendations are available on their website.

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