Medicare Compliance & Reimbursement

The federal government has launched a joint initiative by the Food and Drug Administration and the Centers for Medicaid & Medicare Services that will use existing electronic claims and medical records data to improve the safety of medical products. The new electronic system, called the Sentinel Initiative, will enable agencies to "tremendously increase" their surveillance of medical products, Health & Human Services Secretary Mike Leavitt says in a May 22 press release.

The FDA will use the Sentinel Initiative to identify post-market adverse events and help move the nation toward a system that delivers safer and better quality healthcare, the release says.

"We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market," Leavitt says. "In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of healthcare services."

The FDA has issued a white paper, "The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety," that describes the characteristics of the proposed system. The system would:

• draw data from sources like electronic health records and medical claims;

• strengthen the FDA's ability to query other systems quickly and securely for relevant product safety information, within appropriate privacy guidelines;

• support research and epidemiology studies and the agency's existing risk identification and analysis processes; and

• provide a framework for new ways to widely disseminate timely medical-product and health-related information.

CMS final regulation CMS-4119-F allows federal agencies, states and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis, the release says.

The Medicare Part D database includes about 1 billion claims per year, and as part of the Sentinel Initiative, it will be a valuable resource for patient-safety analyses, the release says. Researchers will gain a powerful new investigative tool by combining the massive Part D database with other Medicare claims information such as diagnoses, medical treatments, hospitalizations and physician services.

The Sentinel System, which is one of the provisions of the FDA Amendments Act of 2007, will be able to monitor a product's performance in millions of patients in real time, says FDA Commissioner Andrew C. von Eschenbach: "The era of 'wait and see' is going to become the era of 'tell me right now.' "