CMS Proposes to Expand Access to Part D Data for Research

On January 10, 2014, the Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to alter key components of the Medicare Advantage (MA) and Part D Programs (Proposed Rule). Understandably, the Proposed Rule garnered significant attention with respect to its potential impact on MA and Part D plan sponsors and their beneficiaries. The Proposed Rule, however, also proposed notable expansions to Part D data access that, to date, have received much less attention from affected stakeholders. While CMS recently announced that it will not finalize many parts of the Proposed Rule at this time as a result of strong public feedback it received regarding those proposals, the agency has indicated that it intends to proceed with the rulemaking process to finalize the proposed Part D data access provisions upon consideration of any public comments it has received.

In the Proposed Rule, CMS proposed to rescind an existing rule that prohibits the agency from releasing unencrypted prescriber, pharmacy and plan identifiers contained in prescription drug event (PDE) records to certain external researchers. The Proposed Rule would make this data available to such researchers, subject to certain conditions, and would greatly expand access to this rich data asset. CMS also clarified that it is permitted to release Part D “nonfinal action data” to entities outside of CMS, which will enable both external entities and non-CMS government agencies to distinguish original prescription data from amended or deleted versions of the Part D data.

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