Medicare opens access to Part D data

WASHINGTON, D.C. - Government agencies and qualified researchers will be able to tap into Medicare Part D claims data to learn more about drug coverage and safety under a new policy issued by the Centers for Medicare and Medicaid Services (CMS). The aim is to utilize information from some 1 billion pharmacy claims each year to better understand how beneficiaries use and respond to prescription drugs. CMS expects to get a more accurate picture of beneficiary out-of-pocket spending levels, patient compliance with prescribed treatments, how many seniors reach the coverage gap, how many reach catastrophic coverage, and how specific benefit designs contribute to favorable drug utilization.

The CMS rules also establish procedures for permitting academic researchers to access Part D data to evaluate the Medicare drug benefit and medication use. The policy aims to ensure protection of patient privacy and of plan sponsors' confidential commercial information. Researchers will not have access to data on plan bids, rebates, risk-sharing or reinsurance policies. Most information on patients, drugs, prescribers, dispensers and plans will be aggregated and de-identified. Insurers and pharmaceutical companies will not be able to obtain data directly, but can fund academic research utilizing the Medicare information, provided that study results are made available to the public.

ENSURING DRUG SAFETY

FDA aims to access the Medicare drug benefit data as part of its Sentinel Initiative to improve medical product risk detection and evaluation. The FDA Amendments Act of 2007 encourages this move by instructing FDA to establish a system that can access pharmacy data on 25 million patients by 2010 and 100 million by 2012. In addition to establishing a more active drug safety monitoring system, the initiative aims to expand adverse-event reporting by health professionals and to improve FDA's ability to communicate new safety information to providers and patients.

FDA has been working on this program for several years. The agency already has agreements that allow it to pose specific questions about the safety or outcome of a medical product to government and private health systems. These include data bases operated by the Department of Defense, the Veterans Administration, Ingenix (UnitedHealth Group), Vanderbilt University, Kaiser Foundation, Harvard Pilgrim and others. Medicare data will greatly expand the scope of information available for specific analyses.

The ultimate goal is to create a system that can generate safety signals in real time.

Such a program would be able to evaluate safety issues identified for newly approved drugs instead of waiting years to see how a new medical product affects broader patient populations.