Statements on Introduced Bills and Joint Resolutions

STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - September 14, 2006)

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By Mr. GRASSLEY (for himself and Mr. BAUCUS):

S. 3897. A bill to amend titles XI and XVIII of the Social Security Act to provide for the sharing of certain data collected by the Centers for Medicare & Medicaid Services with certain agencies, research centers and organizations, and congressional support agencies; from the Committee on Finance; to the Committee on Finance.

Mr. GRASSLEY. Mr. President, I am pleased to join my colleague from Montana, Senator BAUCUS, in introducing the Medicare Data Access and Research Act. Senator BAUCUS and I have long enjoyed a good working relationship in our roles as chairman and ranking member of the Finance Committee. Our work on this bill once again demonstrates our commitment to working in a bipartisan manner.

The Medicare Data Access and Research Act establishes a process through which Federal agencies and other researchers can access Medicare data for the purpose of health services research. This might seem like a pretty mundane issue to some people, but I can assure you that it is far from it. Medicare processes 500 million claims for benefits each year; millions of prescriptions have been filled under the new Medicare prescription drug benefit.

Linking data on hospital and physician services provided to Medicare beneficiaries to prescription drug data will offer a tremendous resource for researchers in our Federal agencies, as well as those based at universities and other research centers. What of research can these data support? They can support studies and analyses related to postmarketing surveillance of prescription drugs and research on drug safety. More concretely, analyzing the Medicare claims data can help agencies, such as the Food and Drug Administration FDA, identify situations like the one involving Vioxx more quickly, and provide a new valuable tool to enable the FDA to take swifter action to protect the public's health and well-being.

The Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality, and the National Institutes of Health all have missions that require the conduct of meticulous health services research. The Medicare database and access to it established under the bill we are introducing today will help these agencies fulfill their missions to study immunization rates; to develop and monitor the use of preventive screenings; conduct research on the clinical comparative effectiveness of prescription drugs; and to help prevent, diagnose, and treat disease.

To ensure access to the data, the bill requires the Secretary of Health and Human Services to enter data release agreements on an annual basis with these agencies. In entering the data release agreements, the Secretary must take appropriate steps to protect the confidentiality of the information, while maintaining the ability of researchers at Federal agencies to conduct meaningful analyses.

The bill also permits the Secretary to enter into data use agreements to permit researchers at universities and other organizations to have access to the data. As will be the case for the Federal agencies, these researchers may only use the data for purposes of advancing the public's health. They can conduct studies on the safety, effectiveness, and quality of health services.

Some people might be concerned that these data will be given to just anyone. That is not the case. In applying for data access, researchers at universities and other organizations will have to meet strict criteria. They must have well-documented experience in analyzing the type and volume of data to be provided under the agreement. They must agree to publish and publicly disseminate their research methodology and results. They must obtain approval for their study from a review board. They must comply with all safeguards established by the Secretary to ensure the confidentiality of information. These safeguards cannot permit the disclosure of information to an extent greater than permitted by the Health Insurance Portability and Accountability Act of 1996 and the Privacy Act of 1974.

The final section of the bill ensures that congressional support agencies, including the Congressional Budget Office, the Congressional Research Service, the Government Accountability Office, and the Medicare Payment Advisory Commission, also have access to data they need to carry out their functions and responsibilities. This body depends on the research and analyses conducted by those agencies to inform our deliberations and decisions on the Medicare Program.

Last year, Senator BAUCUS and I introduced the Medicare Value-Based Purchasing Act to establish a pay for performance system under Medicare. That bill was aimed at promoting quality and ensuring value under the Medicare Program. The bill that we are introducing today complements that objective. How can we promote quality and ensure value in Medicare? By having a better understanding of what services are effective, by knowing how we can help beneficiaries avoid illness and disease, by having insight about potential over-use and under-use of health care services, and by identifying troubling trends and patterns. How can we learn about those topics? By supporting rigorous health services research.

Mr. President, the Medicare Data Access and Research Act creates a sound framework for accomplishing that objective.

I ask unanimous consent that the text of the bill be printed in the RECORD.

There being no objection, the text of the bill was ordered to be printed in the RECORD, as follows:

S. 3897

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