The Medicare Payment Advisory Commission appears to be renewing its interest in shaking loose Part D claims data from CMS to help inform questions about drug access and health care quality under Medicare.

The issue arose during discussion of the Medicare Part D program at a Nov. 8 MedPAC meeting in Washington, D.C.

Panelists expressed disappointment that a CMS proposed rule on Part D data sharing has languished since it was published in October 2006.

CMS has told MedPAC a revised rule is going though the federal agency "clearance" process. Even if it is released, a final rule may face legal challenge, MedPAC members suggested.

Nevertheless, the panel discussed developing a recommendation to Congress directing CMS to make claims data available regularly and in a "timely" manner to congressional support agencies and selected executive branch agencies. The goal is to aid evaluations of the Medicare program, public health and safety issues.

As discussed, the recommendation did not address release of such data to private researchers. A formal recommendation on data sharing may be taken up at the group's December meeting, according to MedPAC Chairman Glenn Hackbarth. The group's next formal report to Congress is scheduled for March.

The CMS proposal suggested that prescription drug data collected from Part D sponsors could be used to evaluate whether providing drug coverage lowers total Medicare health care costs.

Data sharing could also allow other federal agencies and private researchers to obtain more accurate, complete and timely information on potentially serious side effects, the proposal states.

In subsequent comments, pharmaceutical industry groups cautioned that drug claims data alone would give an incomplete picture of the impact of drug coverage on overall health care costs.

The Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America also advocated a more clearly defined process for the release of information.

In Congress, prospects for current legislation to establish a Medicare data sharing program seem uncertain. Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa, reintroduced a bill, S.1507, in the spring that would allow use of Medicare claims data to promote drug safety surveillance and research.

The bill has not yet progressed beyond its committee assignment.

Discussing plans for the legislation in Sept. 20 remarks on the Senate floor, Sen. Grassley said: "I look forward to completing our goals for Medicare data later this year and including this on legislation within the purview of the Finance Committee."

Grassley's comments were made during the Senate's consideration of the FDA Amendments Act, which contains a provision about FDA's use of Medicare data in operating an adverse event surveillance program.

Sen. Baucus raised questions about whether the data could be provided without amending the Social Security Act, which governs Medicare. Baucus chairs the Senate Finance Committee, which has jurisdiction over the SSA.

In response to Baucus' concerns, FDAAA co-author Sen. Edward Kennedy, D-Mass., conceded FDA's use of Medicare data could not be carried out without amending the SSA. "I acknowledge that under current law that is not possible," Kennedy said, agreeing to collaborate on "conforming amendments" in the future.

Grassley and Baucus are working on a package of Medicare legislation that includes a physician payment "fix" and may also include cuts in funding for the Medicare Advantage program. Comparative effectiveness research has also been identified as a priority item for inclusion in the package.

However, timing for any action on Medicare legislation would appear to depend on the outcome of ongoing efforts to reauthorize the State Children's Health Insurance Program.

-Cathy Kelly (c.kelly@elsevier.com)

[Editor's note: This story appears courtesy of the editorial staff of "The Pink Sheet," your source for coverage of pharmaceuticals and biotechnology. For a sample copy, call customer service at 800-332-2181.]

Part D Claims Data Sharing: Lack Of Progress Gets MedPAC’s Attention

More from Archive

More from Pink Sheet