[Congressional Record Volume 153, Number 86 (Thursday, May 24, 2007)]
[Senate]
[Pages S6868-S6869]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GRASSLEY (for himself and Mr. Baucus):
  S. 1507. A bill to amend title XVIII of the Social Security Act to 
provide for drug and health care claims data release; to the Committee 
on Finance.
  Mr. GRASSLEY. Mr. President, I am pleased to join my colleague from 
Montana, Senator Baucus in introducing the Access to Medicare Data Act 
of 2007. This legislation is based on S. 3897, the Medicare Data Access 
and Research Act, which Senator Baucus and I introduced in the 109th 
Congress.
  The bill we are introducing today establishes a framework under which 
Federal agencies within the Department of Health and Human Services 
would have access to Medicare data, including data collected under the 
Medicare prescription drug benefit, to conduct research consistent with 
the agencies' missions. The legislation also creates a process through 
which university-based and other researchers who

[[Page S6869]]

meet a strict set of requirements would be permitted to use Medicare 
data for research purposes.
  As I said last year, Medicare data, particularly prescription drug 
data, are an immense resource that can support critical health services 
research, especially research on drug safety. Examining Medicare data 
could help the FDA identify situations, such as the one involving Vioxx 
more quickly and to take quick action to protect the public's health 
and safety.
  But the FDA isn't the only place that this important research can and 
should occur. The study issued earlier this week in the New England 
Journal of Medicine regarding the prescription medicine Avandia clearly 
demonstrates that point. Researchers from the Cleveland Clinic found 
that there are serious problems with Avandia a drug that has been on 
the market for 8 years and is used to treat diabetes. Specifically, the 
researchers believe that taking Avandia increases the likelihood that a 
diabetic patient will have a heart attack and maybe even die. The 
researchers came to this conclusion after reviewing information from 42 
clinical trials. Making Medicare data available to researchers like 
those at the Cleveland Clinic will offer another avenue for them to 
take in conducting research like this.
  I want to be clear that, similar to last year's bill, the Access to 
Medicare Data Act won't permit just anyone to get the Medicare data. 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.
  I am hopeful that we can get this bill approved soon. I, for one, 
don't want to be standing here next year talking about another Vioxx or 
another Avandia. We need to improve and create more opportunities for 
the government, as well as other researchers, to spot potential trouble 
with a drug more quickly and to take swifter steps to protect the 
public's health and safety. The Access to Medicare Data Act will help 
us accomplish that critical goal.
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