American Association for Clinical Chemistry
Better health through laboratory medicine
February 2008 Clinical Laboratory News: Regulatory Profiles

February 2008: Volume 34, Number 2

CMS Posts Follow-Up from Bidder’s Conference

CMS has updated the portion of its Web site that presents information about the competitive bidding demonstration project by posting questions and answers from the December 5, 2007 conference held in San Diego. The series of 10 questions and responses address a number of issues, such as: will there be an anti-mark-up rule between laboratories? Can referring and reference labs share bid prices with each other if both are submitting bids? And can a lab participate in the demonstration if it enters the competitive bidding area market after the demonstration has started without having participated in the bidding process?

This document can be viewed at the CMS Website.

EGAPP Releases Statement on Genetic Testing Recommendations

The CDC’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group has declined to recommend for or against cytochrome P450 (CYP450) gene testing to guide treatment for patients beginning depression therapy with SSRI drugs, saying that further clinical trials are needed to determine the test’s usefulness.

In the first of a planned series of recommendation statements on the use of genetic tests in clinical practice, the EGAPP Working Group reported it found no evidence linking testing for CYP450 to clinical outcomes in adults treated with SSRIs.

The National Office of Public Health Genomics at the CDC established the EGAPP Working Group in 2005 to support the development of a systematic process for evaluating genetic tests in clinical practice. This independent, multidisciplinary panel prioritizes and selects tests, reviews CDC-commissioned evidence reports and other contextual factors, highlights critical knowledge gaps, and provides guidance on appropriate use of genetic tests in specific clinical scenarios. For additional information about EGAPP, visit

     HIV Testing for Pregnant N.J. Women Mandatory

On Dec. 26, 2007 Acting New Jersey Governor Richard J. Codey signed a new law requiring pregnant women to undergo HIV testing at the beginning of pregnancy and during the third trimester. If the mother objects, the healthcare practitioners will note the objection and the newborn will be tested for the virus. If the mother has a positive test result, newborns will also be tested.

According to an article in the Washington Post, New Jersey became the fifth state to require HIV testing for pregnant women, and the fourth to require newborn HIV screening. It appears to be the only state requiring both.

The CDC has recommended that HIV screening become a routine part of prenatal testing. CDC estimates are that 100–200 children are infected by their mothers annually.

NIH Launches Human Microbiome Project

NIH has officially launched the Human Microbiome Project (HMP), which will use $115 million over 5 years to support research into microbes that inhabit the human body and their roles in human health and disease.

Advances in DNA sequencing technologies have created a new field of research, called metagenomics, allowing comprehensive examination of microbial communities, even those comprised of uncultivable organisms. Instead of examining the genome of an individual bacterial strain that has been grown in a laboratory, the metagenomic approach allows analysis of genetic material derived from complete microbial communities harvested from natural environments. In the HMP, this method will complement genetic analyses of known isolated strains, providing unprecedented information about the complexity of human microbial communities.

NIH has issued grant announcements for investigators to develop early-stage informatics and hardware tools to advance microbial science. The program initially will sequence the genomes of 600 microbes, creating a total collection of 1,000 microbial genomes and a reference for investigators. For additional information about this project, go to the NIH Website.

Newborn Screening Bill Passes Senate

On December 13, 2007, the Senate passed AACC-supported legislation, S.1858, the “Newborn Screening Saves Lives Act of 2007.” Sponsored by Sen. Christopher Dodd (D-Conn.), this legislation establishes training in newborn screening technologies, and grant programs to provide education in congenital, genetic, and metabolic disorders. The bill also calls for improving laboratory quality standards and increasing consumer awareness and knowledge of family support services, research, and other resources in newborn screening.

Similar legislation, H.R.1634, sponsored by Lucille Roybal-Allard (D-Calif.) was introduced in the House of Representatives in March 2007. For additional information about these bills, visit

Bill to Increase Medicare Physician Fees Clears Congress

The Medicare, Medicaid, and SCHIP Extension Act of 2007 (S. 2499) has become law, having passed the U.S. House of Representatives on December 19 and signed into action by President George Bush on December 29. The legislation temporarily spares physicians from a -10.1% payment update stipulated by the sustainable growth rate formula, which was slated to begin on Jan. 1, and instead grants a 0.5% increase in Medicare physician fees for 6 months, through June 30. It also extends the “grandfather” protection that allows qualified independent laboratories to bill Medicare Part B for the technical component of pathology services to hospital patients.

Sen. Max Baucus (D-Mont.) sponsored the bill and Sen. Charles Grassley (R-Iowa) cosponsored it. To learn more, go to the Congressional Website.