CMS draft report spotlights gene tests for elderly

In today's genomic era, personalized medicine offers new options to improve healthcare delivery, especially for vulnerable populations such as the elderly. To advance this agenda, the Centers for Medicare and Medicaid Services (CMS) turns to the Agency for Healthcare Research and Quality (AHRQ) to provide data on the latest genetic testing technologies that may benefit older people.

On April 4, 2012, a draft technology assessment, "Update on mapping the landscape of genetic tests for non-cancer diseases/conditions," was released for public comment by the Technology Assessment Program (TAP) of AHRQ. This document (Part A) updates previous genetic test technology assessments of the same name made in 2008 and 2010 (http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=49).

The 2012 genetic test update reports on newly identified tests, highlighting in one-page summaries the test names, relevant biomarkers, test purposes, designated clinical uses, types of specimen needed, specific associated conditions or diseases, and FDA clearance status.

Technology assessments from AHRQ are derived by request of the CMS Coverage and Analysis Group. CMS reviews new technologies available for its constituency during meetings of its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).

According to CMS representatives, MEDCAC "was established to provide independent guidance and expert advice to CMS on specific clinical topics."

The agency says that the members of the committee independently examine "data and information on the effectiveness and appropriateness of medical items and services, that are or may be eligible for Medicare coverage. MEDCAC judges the strength of the available evidence and makes recommendations to CMS based on that evidence."

Online database

AHRQ publishes the genomic landscape update from data submitted by the Evidence-based Practice Center at the Institute for Clinical Research and Health Policy Studies of Tufts Medical Center. GeneTestTracker, an online database research tool that lists genetic and genomic tests, was developed at the Evidence-based Practice Center.

Joseph Lau, MD, the center's director, explained the genesis of the Practice Center's software program.

"This database was started in mid-2008 under a task order contract with AHRQ and is updated regularly to produce quarterly reports of new gene tests for CMS. We also produce a comprehensive report of gene tests for cancer and non-cancer disease/conditions in alternate years."

Using the NIH definition of genetic testing, and a specially designed algorithm, researchers at Tufts performed a comprehensive internet-based "grey literature" search. The investigators searched only for genetic tests already being used in clinical practice that have specific applicability to Medicare-age adults. They compared new findings to currently available tests.

Tests of non-cancerous diseases and conditions were reviewed for one or more categories of use, including prevention/screening, diagnostic, prognostic, therapeutic, disease monitoring, and risk stratification.

Of the 17 new genetic tests identified for 2012, eight are for cardiovascular disease and three are for Romano Ward syndrome. Celiac disease, Marfan disease, pulmonary arterial hypertension, and narcolepsy have one test each.

Also identified were two multipanel genetic tests, available from several manufacturers, that can assess patient metabolic response to a wide range of genetically susceptible drugs used in psychiatry, gastroenterology, anticoagulation, and other conditions.

Since the inception of the technology assessment in 2007, genetic testing has become available for 90 diseases and conditions. These include rare diseases such as Bardet-Biedl syndrome, Krabbe disease, and Crigler-Najjar syndrome, as well as conditions more commonly occurring in older people, such as Alzheimer's disease, osteoporosis, Parkinson's disease, and primary open-angle glaucoma.

Also included in the draft is a list of pharmacogenomic biomarkers found in drug labels from the FDA website. This list is available at http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm.

Barbara L. Hesselgrave is a freelance medical writer in Baltimore, Md.