Medicare Rejects Claims for Experimental Drugs Some Medicare drug plans reject claims when doctors prescribe drugs for uses other than those approved by the Food and Drug Administration. Now an advocacy group is suing Medicare to make it pay for drugs that doctors may prescribe for any use.
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Medicare Rejects Claims for Experimental Drugs

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Medicare Rejects Claims for Experimental Drugs

Medicare Rejects Claims for Experimental Drugs

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Some people feel down during the holidays because they're sick or in pain. Of course, many try to fight that. And that leads us to a story of what happens when medicine clashes with government regulation. People want access to drugs. The government could pay but it wants proof the drugs will be effective.

NPR's Joanne Silberner reports.

JOANNE SILBERNER: The battleground for this dispute is the Medicare prescription drug program. 67-year-old Judith Layzer gets her prescription drug insurance this way. She's got a rare form of ovarian cancer; nothing was stopping its progress. Her oncologist prescribed her hormonal medication approved by the Food and Drug Administration to be used on occasion as a fertility drug. But Judith Lazer is using it every day for ovarian cancer at a cost of several hundred thousand dollars a year.

Preliminary studies suggest that it may work, but they're far from conclusive. So her insurance, a private Medicare part D plan, followed Medicare's rule that it can't cover treatments without evidence. And that upset Judith Layzer.

Ms. JUDITH LAYZER: Furious, angry - I felt desperate. I felt like my whole life was being taken away from me.

SILBERNER: Her previous insurance had paid for the drug. She wasn't expecting this.

Ms. LAYZER: You never know. It could really happen to anyone, not just me with my ovarian cancer. To have an accident or to have a disease and to suddenly be faced with huge expenses, and if they don't fit into a certain category, you could be devastated.

SILBERNER: And then there's Maurice Hilton. His problem started 10 years ago when his house collapsed during a tornado, crushing his head. He had to have part of his brain removed, leaving him with constant headaches.

Mr. MAURICE HILTON: People think, oh, a headache. I'm laying there in a ball, underneath my covers in bed, and I'm a pretty big man, I'm whimpering like a baby.

SILBERNER: Sixteen Excedrin a day helped, but his doctor was concerned about his kidneys so he moved Hilton on to other drugs, finally finding a narcotic for cancer pain that worked on his headaches. At first, Hilton's Medicare drug insurance program paid for the drug then stopped. Hilton called to complain and here's what they told him...

Mr. HILTON: Well, we don't see where it's covered because you don't have cancer. And it says there in plain black and white that it is a cancer pain medication. I'm, like, yeah, but if you take the cancer part off, it says pain medication.

SILBERNER: It's hard to say how many people there are like Maurice Hilton or Judith Layzer. Dina Wizmur is a lawyer with an advocacy group, the Medicare Right Center, and she has helped Judith Layzer file a case against the government.

Ms. DINA WIZMUR (Lawyer, Medicare Right Center): People that it does affect, it's devastating - completely devastating. These are people who have been searching for years for something to help either ease a symptom of their illness or actually cure the illness. These are people who are in the most dire situations and it's always for the most expensive medication that many of them cannot afford to pay without coverage.

SILBERNER: So why would Medicare not allow coverage?

Dr. JEFF KELLMAN (Staff Physician, Centers for Medicare & Medicaid Services): This isn't a monetary issue at all. This is, specifically, a safety issue.

SILBERNER: Jeff Kellman is an official with Medicare. He says Medicare allows for drug usage that is approved by the Food and Drug Administration and more.

Dr. KELLMAN: It is not only the FDA approved use under part D, but there are three specific textbooks that have approved use that's in the law.

SILBERNER: So health care analysts say there have to be rules. Physician/Economist Allan Garber of Stanford University.

Dr. ALAN GARBER (Founding Director, Center for Health Policy and Center for Primary Care and Outcomes Research, Stanford University): The government is in a really tough spot here. Throughout history, drugs have been used over and over and over again in the belief of both patients and physicians that they were working. When later, we discovered not only were they ineffective, but they were harming people, and in some cases, even killing them.

SILBERNER: That happened in a different context with a treatment for breast cancer about a decade ago. Insurers were pressured into paying for an experimental treatment even before it was fully tested.

When studies were finally done, they showed that the therapy hurt more women and saved fewer lives than other conventional treatments. But sometimes, experimental treatments do pan out. The question is, who should pay for the hope and promise before the evidence is in?

The argument for Medicare is now on the courts where Judith Layzer's suit is awaiting a response from the government.

Joanne Silberner, NPR News.

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