CMS Makes Medicare Part D Data Available For the FDA Sentinel Initiative, External Research, and Other Outside Uses

As the Centers for Medicare and Medicaid Services (“CMS”) recently noted, the Medicare program currently serves approximately 44 million beneficiaries.  Participation in Part D, the Medicare Prescription Drug Benefit enacted in 2003, is voluntary, but in 2008 Medicare Part D had about 25 million enrolled beneficiaries. Claims data for those 25 million Part D beneficiaries
contains significant information about prescription drug use, particularly when combined with claims data available from Medicare Part A (institutional providers such as hospitals and skilled
nursing facilities) and Medicare Part B (suppliers, including physician services, and items including durable medical equipment). CMS has now amended and finalized a regulation (“the CMS Final Rule”), 42 C.F.R. § 423.505, which will allow the release of Part D claims data for public health and safety research, quality initiatives, care coordination and other research and analysis, subject to protections for patient privacy and commercially sensitive information
relating to health plans.

…To view the entire article, click on the link below.

Reprinted with permission from The ABA Health Law Section.