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Regulation and Compliance > Federal Regulation

CMS Sets Drug Program Data Rules

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A new final regulation could help the Center for Medicare & Medicaid Services learn whether ready access to prescriptions really cuts overall health care costs.

The CMS, an arm of the U.S. Department of Health and Human Services, has released a final rule governing the collection and sharing of Medicare Part D prescription drug program claims data.

The new final rule, scheduled to take effect June 27, will apply to all Part D program claims data collected since Jan. 1, 2006, when the program began operating, CMS officials write in a preamble to the proposed final rule, which appears today in the Federal Register.

The CMS based the final rule on a draft released in October 2006. The draft rule attracted 116 comments from members of the public, officials report.

The final regulations permit the secretary of Health and Human Services to gather and share a wide variety of claims data, including pieces of information such as the patient’s date of birth and gender, the date care was provided, the identity of the Part D sponsor and Part D plan, the date the claim was paid, the identity of the pharmacy that filled the prescription, and an indication of whether the patient has reached the “donut hole.”

The donut hole is the gap between a Part D plan’s routine coverage limit and the start of catastrophic prescription benefits.

The final rule requires HHS to take steps to protect personal information.

But HHS will be able share the data with researchers in such a way that, in some cases, the researchers will be able to correlate drug plan claims information for specific patients with Medicare Part A hospitalization claims and Medicare Part B physician and outpatient services claims for the same patients.

Combining the claims data “will enable the secretary to analyze the prescription drug utilization of chronically ill patients over time, and determine whether increases in prescription utilization do, in fact, result in fewer hospitalizations,” officials write in the preamble.

Congress created the Part D program, in the Medicare Prescription Drug, Improvement and Modernization Act of 2003, partly to see whether some Medicare patients were ending up in the hospital because they could not afford the drugs used in preventive care efforts, officials write.

Because researchers tend to exclude very old patients from research trials, analysis of the Part D claims data and combinations of Part D claims data with other Medicare claims data could be especially helpful in studies of the effects of prescription drugs on the elderly, officials write.

Access to Part D data also could help researchers develop personal health record systems that incorporate Part D claims data, officials write.

Some commenters suggested that data releases used in the development of legislative proposals and evaluations should leave out plan identifiers, and that the CMS ought to seek permission from Part D plans before using data from specific plans.

“Although we are willing to partner with plan sponsors as needed, we do not believe that voluntary cooperation by Part D sponsors would provide the kind of comprehensive data sets we need to perform the research, evaluations, reporting and other functions that are described in this final rule,” CMS officials write.

Voluntary agreements would lead to incomplete data, and a provision of the MMA already appears to give the CMS the authority to collect claims data without seeking voluntary agreements, officials write.

In a response to comments regarding Freedom of Information Act requests, CMS officials note that they would not see the Part D data releases permitted by the new final rule as FOIA releases.

One commenter asked the CMS what plan sponsors should do when state privacy laws conflict with the new Part D data final regulations.

Normally, federal statutes require Part D plans to comply with state and federal privacy laws, CMS officials write.

“If there is a belief that a particular state law is in direct conflict with our federal requirements, plan sponsors should bring those specific cases to our attention for individual review,” officials write.

CMS officials observe that the new regulations apply only to claims data, not to other types of data, such as utilization review data, and that the regulations do not affect other data collection provisions, such as statute provisions that permit the collection of the data needed to perform audits.


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