Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it filed a lawsuit on January 3, 2011, against the Obama Department of Health and Human Services (HHS) regarding a controversial decision by the Centers for Medicare and Medicaid Services (CMS) to undertake a one-year review of the prostate cancer treatment Provenge to determine if the treatment is “reasonable and necessary” and should therefore be reimbursed (Judicial Watch v. U.S. Department of Health and Human Services (Case No. 11-002)).

Provenge, the first ever therapeutic vaccine cancer treatment approved by the Food and Drug Administration (FDA), was shown to have extended life spans by an average of four months in clinical trials with few side effects. It 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.

Judicial Watch’s original FOIA request, filed on November 9, 2010, seeks the following information: “All records concerning CMS’s national coverage analysis of the vaccine Provenge, including but not limited to the criteria being used to analyze Provenge.”Health and Human Services was required by law to respond to Judicial Watch’s request by December 15, 2010. However, to date, the agency has failed to provide any documents or indicate why documents should be withheld. Nor has it indicated when a response is forthcoming.CMS Administrator Donald Berwick is on record supporting the idea of rationing healthcare based on cost. Berwick said the following in a June 2009 interview with Biotechnology Healthcare: “The social budget is limited — we have a limited resource pool. It makes terribly good sense to at least know the price of an added benefit, and at some point we might say nationally, regionally, or locally that we wish we could afford it, but we can’t…

The decision is not whether or not we will ration care, the decision is whether we will ration with our eyes open.”Owing to the controversy surrounding Berwick’s statements, President Obama bypassed Senate confirmation and made Berwick a “recess appointment,” a decision criticized by both Democrats and Republicans in Congress.“The Obama administration claims there is no merit to the charge that the Provenge decision is the first step in implementing healthcare rationing so why not release these records? What does the Obama administration have to hide? Provenge is an FDA approved drug that has a proven track record and the Obama administration has no legal right to deny this treatment based on its cost. But the American people are right to be concerned about this Provenge review, given the fact that a man dubbed ‘Death Panel Donald’ Berwick is in charge of Medicare and Medicaid,” stated Judicial Watch President Tom Fitton.