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New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
Date:5/22/2008

noses, medical treatments, hospitalizations, and physician services, will provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation.

Publication of the final rule today will enable CMS to use Medicare Part D claims data for research, program oversight and evaluation, care coordination, quality improvement, and performance measurement initiatives. In compliance with beneficiary privacy protections, as required by the Federal Privacy Act and HIPAA regulations, and while protecting commercially sensitive data, Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.

CMS will be developing guidelines and workshops to inform researchers on how they can request these data.

The CMS final rule and a related fact sheet may be viewed at http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp.

Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

CONTACT: HHS Press Office, +1-202-690-6343; FDA Press Office, +1-301-827-6242; or CMS Office of Media Affairs, +1-202-690-6145


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SOURCE U.S. Department of Health and Human Services
Copyright©2008 PR Newswire.
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