Berwick’s First Strike: Susan G. Komen Foundation and Ovarian Cancer Alliance Decry First-Ever Medicare Denials of FDA-Approved Cancer Drugs
posted at 6:09 pm on August 14, 2010 by directorblue
Just days after the recess appointment of Donald Berwick, the controversial new head of Medicare and Medicaid, the Ovarian Cancer National Alliance posted the following grim news: for the first time in history, an FDA-approved anti-cancer therapy may not be covered by Medicare.
Provenge, a vaccine to treat the recurrence of prostate cancer, has been approved by the Food and Drug Administration (FDA)… Medicare usually covers the cost of FDA-approved anti-cancer therapies. However, the Centers for Medicare and Medicaid Services (CMS) is still reviewing whether it will cover Provenge, and at what rate.
The CMS statute states that Medicare must cover therapies that are reasonable and necessary, while the FDA is instructed to approve drugs that are safe and effective. Because of the conflicting Federal coverage and approval requirements, there are some non-FDA approved drugs (called off-label drugs) that are paid for by CMS. However, with respect to Provenge, it appears that CMS is arguing that while the treatment is safe and effective, it may not be reasonable and necessary. For the first time, an FDA approved anti-cancer therapy may not be covered by Medicare.
A life-saving cancer treatment “may not be reasonable and necessary”? Gee, that kind of decision-making by an unelected federal bureaucracy certainly sounds like a death panel to me.
Say, I thought the President said that pre-existing conditions would always be covered. Isn’t cancer a pre-existing condition?
Oh. What’s this?
Susan G. Komen for the Cure and Ovarian Cancer National Alliance Appeal to FDA and Key Lawmakers on Avastin Issue
Patient Access and the Impact on Development of New Treatments at the Heart of Komen for the Cure’s Concerns
Susan G. Komen for the Cure® and the Ovarian Cancer National Alliance (OCNA) today urged the U.S. Food and Drug Administration (FDA) to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn…
…In a joint letter sent to the FDA and key Congressional lawmakers Thursday, Komen for the Cure and the OCNA wrote, “We are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.”
…According to Komen, the decision to use Avastin should be made between a woman and her doctor after a thoughtful conversation that carefully considers the drug’s benefits and risks. Komen does not want to see access limited by Medicare and Medicaid.
Gee, and I thought no one would be denied coverage by ObamaCare.
Didn’t the President himself say, “I want seniors to know, despite what some have said, these reforms will not cut your guaranteed benefits.”
That’s what President Obama told us, endlessly and repeatedly, for months on end.
Do you mean to say he was lying?
Folks, this is precisely why the cancer survival rate for the U.K. is so much lower than that of the U.S. — and, in some cases, lower than Eastern Europe’s. And why Donald Berwick’s nickname is Dr. Death.
America’s seniors are about to find out that having coverage is not the same thing as receiving care. And our seniors are about to pay the piper.
Hat tips: Valerie Ward and Mark Levin. Cross-posted at: Doug Ross @ Journal.