Saturday, August 14, 2010

Berwick's First Strike: Susan G. Komen Foundation and Ovarian Cancer Alliance Decry First-Ever Medicare Denials of FDA-Approved Cancer Drugs

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noting that it is effective for some patients and warning of a chilling effect on new drug development if approval is withdrawn...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.

Update: Under Dr. Berwick, Death Panels Coming to Life. Hat tips: Valerie Ward and Mark Levin.


Reliapundit said...

"For the first time, an FDA approved anti-cancer therapy may not be covered by Medicare.:

it has begun...

Matt said...

I suggest you read more about this because you have some facts incorrect.

First the story you link says:
an FDA-approved anti-cancer therapy MAY not be covered by Medicare.
'May not' and 'Won't be' are two very different things.

Second, CMS is simply reviewing Provenge to set their national coverage policy. The drug Provenge was only approved by the FDA in April so the Medicare providers are trying to figure out coverage guilde lines. And in fact right now you can get Provenge at most Medicare Regional centers.

It will be covered and people will be able to get it. With your tax dollars. Thank you.

Nahanni said...


Uh huh....Keep drinking that ObamaKool-Aid, hun.

I have had enough first hand experience with your holy "socialized medicine" in the forms of HealthCanada to know exactly what "socialized medicine" is.

Your Karma will be to learn how foolish and stupid you have been the hard and very painful way.

a swede said...

Matt, if this whole socialized medicine is so great then why would this even be an issue? Why are they even saying "may not" if it's so 100% clear as you say that it absolutely will be?

As Nahanni says, some of us has first hand experience with socialized medicine, some of us have been denied treatment because "right now we dont have the budget to check for X, come back in 18months if you're still alive then". That's why noone I know that has experience with the old US system as well as socialized medicine prefer the latter. The latter puts people in charge that tells everyone that they're covered while pulling the care from people that are too expensive (if they're dead by next election they wont vote anyway, right?)

If you had any honor and really believed what you just wrote, you'd be offering to pay for this treatment to anyone needing it if it's not covered. Since you claim it absoolutly will be, it's an easy offer for you, right? You could even offer the same thing for any other life saving drug that "may not" be covered, since you seem to claim it wont happen.

Some of us knows better, from personal experience.

Rorschach said...

And today we find out that Pelosi went to bat for Fred Baron to receive an experimental cancer drug. Do you get the impression that maybe his life was worth more because he was such a big democrat donor?

Anonymous said...

Evidently pain killers are cheaper than medication to address the disease.

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Home Energy said...

These approved cancers drugs are the things which are approved by the food and drug administration.