Monday, January 10, 2011

Prostate CA Vaccine Stirs Interest, Lawsuits

By Charles Bankhead, Staff Writer, MedPage Today

For the second time in as many months, the Centers for Medicare and Medicaid Services (CMS) finds itself named in a lawsuit related to the agency's handling of the prostate cancer immunotherapy sipuleucel-T (Provenge).

Judicial Watch, a Washington-based public interest group, has sued HHS to gain access to documents related to the CMS decision to conduct a one-year national coverage analysis to assess whether the therapy is "reasonable and necessary," thus qualifying for Medicare coverage.

According to a Freedom of Information Act request filed in last November, Judicial Watch wants access to "all records concerning CMS' national coverage analysis of the vaccine Provenge, including but not limited to the criteria being used to analyze Provenge."

The legal action apparently has evolved from a suspicion that the national coverage analysis is the first step toward cost-based healthcare rationing.

In a statement posted on the Judicial Watch website, representatives of the organization noted that sipuleucel-T "costs $93,000 to administer the three necessary treatments. Medicare and the FDA are legally prohibited from denying approval of a medical treatment based solely on cost. Yet, multiple press reports suggest that cost is the major factor in the unusual decision by CMS to undertake a review of the treatment which could signal a move by the Obama administration to begin implementing healthcare rationing based on the cost of treatments."
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