Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.

During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.

We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.

The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.

Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.

CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.

This should never be allowed to happen again.

Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.

We are not about to let that happen. Care To Live Continue Reading Care To Live Submits Moment of Silence to CMS »

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Human Health and Resources (HHS) transparency rules differs greatly between divisions. Center for Medicaid and Medicare (CMS) has been forthcoming with our Freedom of Information (FOIA) requests, while the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) continue stalling. 

Read more at Pharmalot http://www.pharmalot.com/2011/04/the-fda-conflicts-of-interest-provenge-e-mails/

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Correction: this is not the final response.

 http://caretolive.com/Pages%201%20to%2050%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%2051%20to%20100%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20101%20to%20151%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20152%20to%20200%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20201%20to%20250%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20251%20to%20300%20CTL%20CMS%20docs%20041811

http://caretolive.com/CTL%20CMS%200418%20docs%20301-385

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Today Care To Live received additional documents from the Center of Medicaid and Medicare Services in response to our Freedom of Information (FOIA) requests.

part-1-cms-foia-3_30_11.pdf

part-2-cms-foia-3_30_11.pdf

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part-4-cms-foia-3_30_11.pdf

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part-8-cms-foia-3_30_11.pdf

part-9-cms-foia-3_30_11.pdf

part-10-cms-foia-3_30_11.pdf

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Yes!

Patients and Advocates. I come to praise CMS, not to censor them.

As Care To Live expected, the Centers for Medicare and Medicaid Services announced today that Dendreon’s Provenge will be covered. There will be a brief comment period again, before this decision is formally made final. Approval of  Provenge immunotherapy, as well as payment for Provenge, were an uphill battle, but the next step, acceptance and usage, was well worth our efforts.

Thousands of men are currently receiving and loving Provenge!

As our most recent CMS foia documents (soon to be published here) will show, CMS created a firestorm when they announced that they were going to review Provenge to determine coverage.

A groundswell of support, by patients, doctors, congress, and advocates, came forth to push for national coverage.  We thank each and every one of you wholeheartedly. Provenge approval and accessibility was a labor of love/hate for many of us. CMS writes in their Decision Summary,

“The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act).”

CMS also said it is “requesting public comments on this proposed determination pursuant to section 1862 (l) of the Act. After considering the public comments, we will make a final determination and issue a final decision memorandum.”

CMS decision memo link:

http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=247&ver=7NcaName=Autologous+Cellular+Immunotherapy
+Treatment+of+Metastatic+Prostate+Cancer&bc=BEAAAAAAEAAA&

Dendreon Press Release link:

http://files.shareholder.com/downloads/DNDN/1208526489×0x455544/b045427e-a6cd-4064-86db-6e43b971f829/DNDN_News_2011_3_30_General.pdf

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Today CTL received an interim response to its two previous FOIA request made to CMS. The documents were retrieved upon a search performed by Dr Louis Jacques. We received 258 pages of which 74 pages were redacted under claimed exemptions of FOIA (5 U.S.C. 552 (b)(2), (b)(5) and (b)(6)).

Although the pdf’s are not in 100% chronological order it is probably easiest to comprehend each of the 5 individual pdfs, from back to front.

1-cms-foia-0221.pdf

2-cms-foia-02211.pdf

3-cms-foia-02-21.pdf

4-cms-foia–02-21.pdf

5-cms-foia-0221.pdf

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Care To Live To FDA, “Just Produce the Documents”.

Public servants. Hah! More like royalty in gilded cages. Conspiring in their posh abodes to put the kebosh on a cancer treatment without adequate reasons or transparency into their warped decision making process. They can’t use no favorable Advisory Committee hearings. Not when there was so much money on the table.

We seek confirmation of the corruption and retribution commensurate with the crime.

Who was lobbying the FDA and why?

The Care To Live Birthers are here.

Just produce the documents.

We fully intend to continue to force the issue including the removal of the inner sanctum of corrupt officials at the FDA, the CMS, the NCI and the HHS, who have been sabotaging our medical research, destroying valid, impressive, breakthough treatments and delaying approvals for years while they enrich themselves.

How blatant they are in their inconsistency. For such a statistically anal organization, the FDA can’t add one and one and get two. What a sneaky bunch of manipulating, self enriching bureaucrats, who through ignorance or greed, sabotaged a nation.

We demand consistent parameters for one treatment over another.

Yeah, Provenge is approved now. So what difference does it make?

It is at the very core of our democracy that these “regulatory” agencies, who get such a huge chunk of our tax dollars, actually do the jobs they are overpaid to do.

Transparency and Accountability.

FOIA OR BUST!

Join us!

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Care To Live, a not for profit corporation, tried to work with the Centers for Medicare and Medicaid Services (CMS) to avoid litigation in regards to CTL’s two FOIA requests but CMS gave no response. CTL’s Attorney, Kerry M. Donahue, had sent this letter to CMS inquiring about the requests:

kerrydonahuecmsletter.pdf

Once CMS did not respond, Kerry commenced litigation on CTL’s behalf on December 10, 2010:

ctlcmslitigationfile.pdf

Read more below at Ed Silverman’s Pharmalot site

Now, The Provenge Activists Are Suing Medicare

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Care To Live Counsel Kerry M. Donahue sent a letter to the Centers for Medicaid and Medicare Services (CMS), as a final gesture to resolve the Freedom Of Information (FOIA) conflicts with their agency. However, if the the status quo remains, and we receive no response, Kerry has already started preparing litigation against them and will file on December 10, 2010, if they choose to go down that road.

(Click picture to enlarge. Download pdf here kerrydonahuecmsletter.pdf)

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The CMS completely embarrassed itself yesterday!

The Center for Medicaid Services (CMS) had its long awaited MEDCAC meeting. It was designed to provide guidance to CMS as to whether they should pay for Medicare coverage for patients to receive Provenge. However, much of the meeting was spent with the CMS chairman trying to justify this futile exercise over a newly FDA approved, immunotherapy treatment already helping thousands of men with prostate cancer.

Further evidence of government incompetence was seen up close and personal. The chair of the meeting had a clear agenda. It turns out that he is on the payroll of the health insurance companies, as a consultant for them, which could easily explain his bias. Early on he allowed the speakers to express themselves, but his tone change toward the end.  His bias was revealed in his grandiose effort to paint the picture he wanted, by leading and sometimes even badgering the presenters, and interjecting his own emphasis as desired. His frequent shouting of “aha” was disgraceful.

CMS continues to refuse to provide documents to Care To Live as required under the Freedom of Information Act (FOIA), as to why this nonsense of a meeting ever came to be called in the first place. Litigation on this issue seems inevitable.

One issue clearly presented is that black men will be disproportionately unable to obtain a timely treatment that may actually have a more significant survival benefit for them. Black men are much more likely to get prostate cancer, and Provenge works even better in this population. It is a travesty that to obtain Provenge earlier, when the chances for three year survival are better, you will need either supplemental insurance or money.

The presenters at the meeting, including Dendreon, Urologic Oncologists, patients, patient advocates and concerned individuals who have followed Dendreon through its 5 year battle to bring Provenge to market, understand Provenge far better than CMS ever will.

As predicted, there will be no long term ill effects to Provenge. This government debacle was a waste of both taxpayer money, and Dendreon’s time, money and energy…which would have been better spent solving the supply problems.

In other words Provenge, will be covered by Medicare as anticipated. This very expensive exercise turned out to be a complete waste of thousands of peoples time and resources, as well as the taxpayer’s money.

Too much bad government!

This process was an ill thought out travesty by a power hungry organization. Much of the CMS meeting seemed to be an effort by the CMS chair to justify their huge waste of time and taxpayer money, which only made them look more incompetent.

It caused short term harm to Dendreon, however if we look at the bigger picture, it helped bring more attention to Provenge, and its groundbreaking immunotherapy treatment for cancer, which has now become one of the most well known cancer treatments in the world…

Now, about those supply problems…….

Popularity: 13%