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Provenge Archives | Judicial Watch

Judicial Watch, the public interest group that investigates and prosecutes government corruption, announced today that it has obtained documents from the Department of Health and Human Services regarding the controversial review of the prostate cancer treatment Provenge by the Centers for Medicare and Medicaid Services (CMS). Judicial Watch obtained the documents pursuant to a Freedom of Information Act (FOIA) lawsuit filed on January 3, 2011 (Judicial Watch v. Department of Health and Human Services (No. 11-0002)).

According to the documents, the purpose of this review, deemed a National Coverage Determination (NCD), is to determine if the FDA-approved Provenge treatment is “reasonable and necessary” and should therefore be reimbursed on a uniform and national level. The review was triggered by the fact that local Medicare contractors were not uniformly providing coverage for Provenge leading to multiple complaints by patients. Some contractors withdrew coverage in the middle of treatment. CMS is expected to post a “proposed decision” on its website March 30, 2011, with a final decision published 60 days after the public comment period for the proposed decision has ended.

Among the highlights from the documents uncovered by Judicial Watch:

  • The documents include a CMS Q&A sheet that denies cost was a factor in the decision to review Provenge. However, a June 8, 2010, internal email uncovered by Judicial Watch from William D. Rogers, Director of the CMS Physicians Regulatory Issues Team, to Louis B. Jacques, CMS Director, Coverage Analysis Group, states: “We discussed this on the last CMD [Contract Medical Director] call. $93,000 per treatment adds four months to life, 27,000 patients a year $2.6 billion dollars a year.” Medicare and the FDA are legally prohibited from denying approval of a medical treatment based solely on cost. Obama administration officials have denied that the review of Provenge had anything to do with the treatment’s costs.
  • A July 28, 2010, letter to Louis Jacques from Hans Bishop, Chief Operating Officer of Dendreon, the company that manufactures Provenge, and Mark Frohlich, Dendreon’s Chief Medical Officer, objecting to the “highly unusual” review of Provenge.

    While noting the “overwhelming clinical evidence” of Provenge’s effectiveness, and the FDA’s rigorous approval process, Dendreon asked the CMS to shut down the NDA: “We remind you that the patients we serve have late-stage cancer and few, if any, appealing treatment options available to them, with only chemotherapy as an FDA-approved alternative. Not only is Provenge clearly reasonable and necessary…but it provides an unambiguous survival benefit and real hope for patients battling their disease.” Dendreon argued to keep the system’s status quo, with local contractors making coverage decisions as coverage variations have “subsided.” The letter also suggests that coverage is required by law as a result of the FDA’s prior approval of the Provenge treatment for prostate cancer.

  • An internal CMS email indicating that the government hired health insurance giant Blue Cross Blue Shield, identified in public documents as an “external entity,” to conduct a technological assessment of Provenge’s clinical effectiveness. The involvement of Blue Cross Blue Shield raises concerns about a potential conflict of interest as private insurers use Medicare’s coverage determinations in setting their own coverage limits.

  • The documents include back-and-forth discussions between CMS and Dendreon about “comparative effectiveness.” In response to Dendreon’s request for clarification regarding the term “comparative effectiveness,” Jacque’s writes in a July 22, 2010, email to a CMS colleague: “Why do they need clarification?…We need to maintain an arms [sic] length relationship with them. We do no[t] owe them any questions.” Many have criticized comparative effectiveness research as a method to limit needed health care in order to reduce costs (i.e., death panels).

A number of the documents were distributed to CMS Administrator Donald Berwick, dubbed “Death Panel Donald” for his public comments endorsing health care rationing.

“Clearly, there is enormous public interest in the CMS decision to review Provenge given all of the talk of health care rationing and death panels associated with Obamacare. The American people get very nervous when the government decides to meddle in their health care and they have every right to be nervous given that we have unaccountable czars like Donald Berwick running Medicare and Medicaid. One can’t help but conclude from a review of these documents that there is a strong bias against Provenge in the Obamacare bureaucracy,” stated Judicial Watch President Tom Fitton.

A recent study shows that in 2010, only two of the 11 National Coverage Determinations led to “unrestricted positive coverage decisions.” The remaining decisions mandated restrictions of coverage of one type or another.

Documents Uncovered

Judicial Watch Investigates Charge HHS is Unlawfully Rationing Healthcare by Targeting FDA-approved Medical Treatment Based on Cost

Contact Information:

Press Office 202-646-5172, ext 305

Washington, DC — January 5, 2011
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.

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