The CMS issued final regulations that will make Medicare Part D claims data available to the Food and Drug Administration, other government agencies and academic researchers for patient-safety initiatives.
The FDA specifically plans to use Medicare’s prescription drug data to pilot test its Sentinel Initiative, a new electronic system that will enable the agency to query a vast array of health information databases to more effectively identify post-market adverse events.
“With the Sentinel system we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew von Eschenbach, who joined HHS Secretary Mike Leavitt and acting CMS Administrator Kerry Weems at a news conference to announce the health IT initiatives. Instead, the FDA will have the ability to monitor a product’s performance in real time, he said.
Linking claims data from 25 million beneficiaries that have prescription drug coverage to other Medicare claims information, including diagnoses, medical treatments, hospitalizations and physician services will provide the FDA and other agencies and researchers with a new tool to investigate potential drug safety problems and questions about health outcomes, according to a statement from HHS.
Medicare beneficiaries with their high usage of medications and chronic health conditions, makes them the group most likely to benefit from the FDA Sentinel Initiative, Weems said.
In the second phase of this initiative, HHS hopes to expand this work to patients with private sector insurance, a CMS spokesman said.
Leaders on the Senate Finance Committee applauded the department’s efforts in a statement.
“I’m pleased that CMS is taking steps to safely allow qualified researchers to use Medicare data for research that will improve the program and the health of the American public,” said Senate Finance Chairman Max Baucus (D-Mont.), who had previously introduced legislation with ranking member Chuck Grassley (R-Iowa) to give researchers controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.
