FDAnews
www.fdanews.com/articles/90296-phrma-supports-limited-medicare-data-sharing

PHRMA SUPPORTS LIMITED MEDICARE DATA SHARING

December 21, 2006

PhRMA is tentatively supporting the Centers for Medicare & Medicaid Services' (CMS) proposal to collect and share prescription drug plan data, but is concerned that the agency may overreach by using the information to compare different products.

The CMS issued a proposed rule in October requiring any entities offering prescription drug coverage under the Medicare Rx law to provide the agency with data about the products they offer as part of their contracts with the government. The rule is meant to provide data necessary to improve the working of the Medicare program, limit adverse drug events and do comparative drug studies.

PhRMA is supporting the proposal with several caveats. While the group believes that the data "offers a valuable new resource that, if used well, can help advance the goals of higher quality and value in healthcare," there are limits to its usefulness, PhRMA said in Dec. 18 comments to the CMS.

Medicare claims data alone "will not be sufficient to draw definitive conclusions." Instead, that information must be combined with other evidence, including clinical trial data. This is true regarding comparative drug studies, according to PhRMA. It is a "misguided notion" for the CMS and other government entities to believe that Medicare claims data by itself can provide sufficient information to compare different products, Randy Burkholder, PhRMA's senior director for policy, said.

Medicare claims data lack the complete diagnostic and medical data, the full documentation of patient encounters and clinical and health outcomes data necessary to make conclusions about efficacy between products. PhRMA would be opposed to the CMS using that data alone for comparative studies, he added. "We don't think it's good science or good policy." (http://www.fdanews.com/did/5_248/)