The Official News & Technical Journal Of The International Society For Pharmacoeconomics And Outcomes Research
ISPOR Comments on the Medicare Rx Data Elements
Intro by Bradley Martin PharmD, PhD, RPh, Associate Professor and Head of the Division of Pharmaceutical Evaluation and Policy,
College of Pharmacy University of Arkansas for Medical Sciences, Little Rock, AK, USA


In December 2003, Congress enacted the Medication Prescription Drug, Improvement, and Modernization Act of 2003, which establishes a new Part D benefit that will provide outpatient prescription drug coverage beginning in January 2006. The Medicare Part D is a complex plan in which beneficiaries will have deductibles, variable copays, a benefit gap or “doughnut hole”, and catastrophic coverage. The Part-D benefit will be largely administered by private prescription benefit management (PBM) companies which will develop formularies and negotiate rebates with manufacturers. This legislation offers dramatic research opportunities for ISPOR members. Never before has a single piece of legislation extended prescription coverage to so many Americans, over estimated 37 million in 2006. One of the limitations with using past Medicare data has been the inability to link physician and hospital utilization with prescription utilization for most beneficiaries. When Medicare Part-D is implemented in January 2006, these prescription utilization data will be collected by the Centers for Medicare and Medicaid Services (CMS) from PBMs to calculate payments under several different mechanisms. On January 31, 2005, ISPOR was asked to provide input using researchers perspectives regarding the types of information about prescription drugs use that they would like to have available. ISPOR was given a pre-decisional document describing the data elements that were proposed to be collected for each prescription drug event (PDE) record and the ISPOR retrospective database SIG members swung into action providing comments to CMS in a very tight 28 day deadline. Below and at the ISPOR website at:, are the comments we offered to CMS regarding the prescription drug event records organized in four categories. We are grateful that CMS recognizes the research value of these data and are thinking beyond the routine payment uses of these data to support important policy, economic, and epidemiologic research applications of the data. We will continue to work with CMS to help guide the development of these data and to advocate on behalf of all ISPOR researchers to ensure Medicare data can be used to support a broad spectrum or research activities

To view the ISPOR comments, see:
This was an initiative of the ISPOR Retrospective Database Special Interest Group Database Development Working Group.

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