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

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October 2008: Volume 34, Number 10


 AHRQ Tool Helps Evaluate Disaster Planning


Beginning in September, all hospitals participating in the HHS Hospital Preparedness Program will have to provide summaries of their disaster drills. Aimed at helping hospitals meet this new requirement, AHRQ’s Tool for Evaluating Core Elements of Hospital Disaster Drills uses a series of evidence-based modules with standardized checklists to document the results of a disaster drill.

The modules look at a hospital’s performance in four key zones during a disaster: command center, decontamination, triage, and treatment. The tool is a compressed version of the evidence report developed by AHRQ’s Johns Hopkins University Evidence-based Practice Center in Baltimore. The tool is available on AHRQ’s website.


CMS Considers Paying for Warfarin Response Testing


CMS announced it will conduct a National Coverage Analysis to decide if Medicare should pay for pharmacogenetic testing for warfarin dosing. On its website, CMS said that “clearly, an individual patient’s initial response to warfarin therapy may be influenced by a multitude of factors well beyond genetic variation. We are concerned by the paucity of evidence available to determine what effect on overall health outcomes, if any, can be confidently attributed to treatment strategies that include pharmacogenomic testing in the determination of dosing.”

A decision in favor of pharmacogenetic testing would require all contractors to reimburse for the tests. Right now, each contractor decides individually whether to pay. CMS expects to issue its decision February 4, 2009.


AHRQ Comes Out Against PSA Screening After 75  


While AHRQ has remained skeptical of prostate cancer screening and refused to either support or reject the test based on a lack of evidence, now the agency’s U.S. Preventive Services Task Force (USPSTF) has definitively recommended against screening men older than 75, saying that potential harms such as erectile dysfunction, urinary incontinence, and bowel dysfunction outweigh the possible benefits of treating prostate cancer found in men of this age through screening. USPSTF still sees the evidence as too limited to take a stand on screening for younger men. The report is available on the AHRQ website.


NIH Revises Data Access Policies for Genome-Wide Association Studies 


After a research team discovered a novel method that can detect an individual SNP profile in a pool of 1,000 or more DNA samples, the NIH announced it would alter its data access policy for genome-wide association studies (GWAS) and only allow access to individual-level data by investigators approved by the NIH. NIH said that while the new bioinformatics technique was proven to work, it would still be very difficult to detect a specific person’s SNP profile in a pooled dataset, and the agency is unaware of any information being compromised.

NIH noted that other databases with similar datasets have also limited access to aggregate data, inclining the Wellcome Trust Case Control Consortium in the U.K. and the GBroad Institute of MIT and Harvard in Boston, Mass. More information on the policy changes are online.


Final ABN Instructions Released 


CMS announced instructions for a single Advance Beneficiary Notice of Noncoverage (ABN) for all providers. Previously, CMS offered provider-specific ABNs. Used to inform beneficiaries that Medicare may not cover a service, the new form replaces the General Use ABN (CMS-R-131-G), and the Lab ABN (CMS-R-131-L) for physician-ordered laboratory tests. The new form may also be used for voluntary notifications, in place of the Notice of Exclusion from Medicare Benefits (NEMB). It also includes a mandatory field for cost estimates of the items/services at issue, and presents a new beneficiary option whereby an individual may choose to receive an item or service and pay for it out-of-pocket, rather than have a claim submitted to Medicare. The announcement, form, and instructions are on the CMS website.