The Centers for Medicare & Medicaid Services (CMS) seek 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.”

Today, CMS issued a proposed regulation that 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 proposed regulation continues the approach of using Medicare data through data use agreements with individual institutions to assess health care for beneficiaries.  Medicare data has been used in prior studies to evaluate rates of Medicare spending and spending growth, to assess the impact of drugs and procedures on health outcomes, and to identify the extent to which practice parallels evidence based standards. 

Under the proposed rule, other federal agencies and researchers would be able to use the prescription drug data under the same safeguards that exist today for other Medicare data.  These include obtaining only the minimum data needed to complete the study, not releasing beneficiary and provider identifiers unless absolutely necessary for the study, and where identifiers are disclosed, ensuring strict privacy protections are in place. 

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.

The proposed rule would provide for the use the claims information that is now being collected for Part D payment purposes for other research, analysis, reporting, and public health functions, including, for example:

• Obtaining more accurate, complete, and timely information on potentially serious side effects associated with the use of prescription drugs in certain clinical circumstances, such as where Food and Drug Administration (FDA) or other experts have identified a potential safety concern;
• Determining the potential for cost savings in chronic disease management as a result of more effective adherence to recommended prescription drug therapies;
• Identifying groups of beneficiaries who are not receiving evidence-based recommended drug therapies, and ascertaining effective strategies to increase adherence to recommended treatments, to assist in reducing health disparities and improving care for all beneficiaries.

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 18^th,  2006.