The Centers for Medicaid and Medicare (CMS), under enormous public pressure, proposed that Provenge, a Food and Drug Administration (FDA) approved treatment for prostate cancer, be covered by insurance following a controversial “review.” A final decision on the issue is expected to be published 60 days after the public comment period for the proposed decision has ended.
On the same day as the CMS decision, Judicial Watch released hundreds of pages of documents from the Obama Department of Health and Human Services (HHS) detailing how and why the review was instituted. And here’s one of our major finds: While the Obama administration claimed the cost of Provenge had nothing to do with their review, these documents suggest otherwise. (Remember Medicare and the FDA are legally prohibited from denying approval of a medical treatment based solely on cost.)
Judicial Watch filed a FOIA request with HHS over Provenge after the press reported the CMS had taken the rare step of calling for a review Provenge to see if it is “reasonable and necessary” and should be covered by Medicaid and Medicare.
The move caused widespread panic among those patients who depend on the treatments to live, as well as anyone else who had heard all about health care rationing and “death panels” under Obamacare. (Let’s not forget, Obama named “Death Panel Donald” Berwick to head CMS and Berwick is on record supporting the idea of health care rationing, so these fears are not unfounded.)
When HHS stonewalled the FOIA request, Judicial Watch sued for the documents on January 3, 2011. And just last week it received some pretty interesting material.
According to these new documents, the purpose of the Provenge review, deemed a National Coverage Determination (NCD), is to determine if the FDA-approved treatment should be reimbursed on a uniform and national level. The CMS claims the review was triggered by the fact that local Medicare contractors were not uniformly providing coverage for the Provenge, leading to multiple complaints by patients. Some contractors withdrew coverage in the middle of treatment.
Here are some other highlights from the documents, beginning with an interesting excerpt regarding the cost issue:
•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 from William D. Rogers, Director of the CMS Physicians Regulatory Issues Team, to Louis B. Jacques, CMS Director of 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." 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 NCD: “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 serious 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 expressing concern over the review were distributed to CMS Administrator Donald Berwick himself.
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.
If you read these documents for yourself, you’ll see there was a strong bias against Provenge in the Obamacare bureaucracy. Fortunately, pressure from patients, the public, Congress and groups like Judicial Watch forced the government’s hand.
I’m willing to bet that HHS bureaucrats gave Provenge a pass (as the law seems to require), because they knew that Judicial Watch was set to expose their questionable decision-making process.
Still, this decision most certainly does not put an end to the issue of health care rationing. 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.
Donald Berwick said it himself. It’s not a matter of if we ration health care, it’s a matter of when.