CMS has issued final regulations that will make Medicare Part D claims data available to the FDA and other agencies, as well as academic researchers, for use in patient-safety initiatives. The FDA has said that it will use the data to pilot-test its Sentinel Initiative, a new electronic system that will let the agency query a large number of health information databases in an effort to more effectively detect post-market adverse events resulting from use of approved drugs and medical devices. This program won't only detect the events, it will allow the agency to monitor the performance of drugs and devices in real time, said FDA and CMS officials. The Sentinel program links claims data from 25 million beneficiaries with prescription drug coverage to other Medicare claims information, including diagnoses, treatments, hospitalizations and physician services.
To learn more about this announcement:
- read this Modern Healthcare article (reg. req.)
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