CMS Releases Final Rule on Medicare Part D Claims Data

On May 22, 2008, the Centers for Medicare & Medicaid Services (CMS) released a display copy of a Final Rule to permit Medicare Part D claims data to be used for program monitoring, research, public health, care coordination, quality improvement, population of personal health records, and other purposes. 

The Final Rule allows CMS to disclose certain Medicare Part D claims data to other federal governmental agencies, states and external researchers.  However, such disclosures will be subject to certain protections for beneficiary privacy and commercially-sensitive plan information.  CMS has also released a Fact Sheet on the Final Rule.  The Final Rule is scheduled to appear in the Federal Register on May 28, 2008.

On May 22, 2008, the Department of Health and Human Services also issued a Press Release announcing collaborative efforts between the Food and Drug Administration (FDA) and CMS to improve patient safety and the quality of care. Specifically, HHS announced the Sentinel Initiative and reported that the Final Rule will allow CMS to share Medicare claims data with the FDA for purposes of the new initiative. 

The FDA is launching the Sentinel Initiative with the goal of creating and implementing a Sentinel System, which will be a national, integrated, electronic system for monitoring medical product safety.  According to the Press Release, the system will enable the FDA to analyze significantly more information than it can today by using vast databases of health information to detect early signs of emerging safety problems.

During a press conference on May 22, 2008, HHS also reported that the Sentinel Initiative will start with a database of more than the 25 million beneficiaries enrolled in the Medicare Part D prescription drug benefit and later include private databases through partnerships with private firms.