Friday, October 13, 2006

Mark B. McClellan, M.D., Ph.D., announced today that the Centers for Medicare & Medicaid Services (CMS) seeks public input on a proposed regulation on using Medicare Part D claims data for research and quality initiatives that will improve the health care and health of seniors and persons with a disability.

Medicare drug claims would be linked to other Medicare information on patient care such as hospitalizations and physician visits, and made available to researchers and Federal agencies for studies only with appropriate privacy protections and safeguards, as required by the Privacy Act and HIPAA regulations.

"We have seen great improvements in the quality of health care based on identifying opportunities for better care based on Medicare information," CMS Administrator Mark B. McClellan, M.D., Ph.D., said. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs."

The proposed regulation will allow the Department of Health and Human Services and CMS to use Part D claims data to:

• Report on and evaluate the impact of drug use in the Medicare prescription drug program, including the interaction between prescription drug coverage and the services and utilization under traditional Medicare (Parts A & B) and the Medicare Advantage Program (Part C); and
• Conduct demonstration projects to evaluate the impact of drug coverage and make recommendations for improving the economy, efficiency, or effectiveness of the Medicare program.

The public is invited to comment on the most effective use of the data, including whether CMS should consider additional regulatory limitations for external researchers in order to further guard against the potential misuse of data for non-research commercial purposes, to assure that priority questions are addressed as quickly and effectively as possible, or to ensure that proprietary plan data or confidential beneficiary data are not released.

Under the proposed rule, the FDA, the National Institutes of Health, the Agency for Healthcare Research and Quality, and academic researchers would have access to the data to address these and other important public health-related questions.

The proposed rule will appear in the Oct. 17, 2006 Federal Register. Comments will be accepted on the proposed rule until December 18th, 2006.