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Survey: Patients harmed by anemia drug policy

But the Centers for Medicare & Medicaid Services is skeptical of the poll and is sticking by its Medicare coverage decision.

By Dave Hansen, AMNews staff. Feb. 25, 2008.

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Washington -- A new Medicare coverage policy on drug treatment for anemic cancer patients is hurting care, according to a survey of doctors released last month.

Ninety-one percent of oncologists and hematologists reported adverse patient events in the 12 weeks after the July 30 implementation of the national coverage determination on erythropoiesis-stimulating agents. The poll was sponsored by U.S. Oncology, which funds, develops, and helps manage 443 cancer centers in 39 states. It surveyed 307 physicians from Nov. 26, 2007, to Dec. 11, 2007. The organization limited the number of affiliated physicians involved in the poll to 20% of all respondents.

The most common event reported by doctors was a transfusion that could have been avoided if Medicare's old ESA coverage rules were still in place. Seventy-three percent of those surveyed said this problem had occurred. Sixty-five percent said they had a patient remain symptomatic for anemia despite sticking to the new ESA policy.

The Centers for Medicare & Medicaid Services decision limits ESA treatment to a maximum of eight weeks after a chemotherapy session. It also requires physicians to wait until hemoglobin levels drop below 10 g/dL before starting therapy.

The decision was prompted by preliminary evidence that use of the drugs, known as epoetin and darbepoetin, may result in strokes and heart attacks if used too readily in cancer patients with anemia from chemotherapy. The drugs also may make tumors worse, CMS concluded.

The survey results critical of the new CMS policy came as no surprise to Michael Kolodziej, MD, an Albany, N.Y., oncologist who is chair of U.S. Oncology's Pharmaceutical and Therapeutics Committee. "In my own practice it is pretty much what we observed," he said.

The policy's strict 10 g/dL standard makes it difficult to keep patient's hemoglobin levels steady because there's often a lag in results, Dr. Kolodziej said. "If the patient is 9.9 g/dL, they get the drugs. They come back in a month and it is 10.1 g/dL, and they have to wait."

Many private insurers cover ESA treatment when a patient's hemoglobin level is between 10 g/dL and 12 g/dL, Dr. Kolodziej noted. "Most oncologists are very comfortable with that," he said. "Our point is that there is no issue when the drug is used as advised."

Government stands firm

But CMS is sticking to its decision. "The ability to draw any meaningful conclusion from this survey is extremely limited," said CMS Chief Medical Officer Barry Straube, MD, who also is director of CMS' Office of Clinical Standards and Quality. "It does not appear to be a carefully designed survey tool and represents opinion, not scientific evidence."

The agency has not received any documented cases of negative outcomes from the oncology community, Dr. Straube stated. The Dept. of Health and Human Services has issued no reports of blood shortages or unusual use of blood, he added.

It's too early to have collected the medical data needed to show the decision's negative effects, said Lee S. Schwartzberg, MD, medical director of the West Clinic in Memphis, Tenn. The survey "is the first empirical data I've seen on the issue," he said.

Dr. Schwartzberg said his clinic, which specializes in oncology, hematology and radiology treatment, definitely sees more transfusions because of the coverage decision. "Patients get the best clinical benefits of relieving symptoms of anemia when they are in the 10 g/dL to 12 g/dL range," he explained. "The [coverage policy] effectively shuts that from happening because you can't start until you're below 10 and must stop as per Medicare if you're above 10."

ESA treatment costs roughly three times as much as a transfusion, said Dan Cohen, senior vice president for public relations and public policy for U.S. Oncology. But that overlooks hidden costs, he said. Older patients don't tolerate transfusions very well, he noted. ESA treatment takes only a few minutes, while a transfusion may mean going to the hospital for the better part of the day to receive two units of blood, he said.

The new policy "is tough on folks," said Peter G. Ellis, MD, director of the Medical Oncology Network, University of Pittsburgh Cancer Centers.

Major insurance companies have not embraced the CMS protocol, Cohen said. "If they thought this would provide major savings, they would have adopted it."

"This is really the first step I feel of government stepping directly into patients and saying, 'We know what is a better course of treatment than yourselves,' " Cohen added.

The Food and Drug Administration's Oncologic Drugs Advisory Committee is meeting in March for a nonbinding review of its recommendations on the labeling and use of ESAs as therapy for anemia during chemotherapy. There is a chance the panel will modify the guidelines when it meets in March, Dr. Kolodziej said. "CMS will follow FDA's lead," he predicted. "If the FDA severely restricts the use of drugs, I think there's no chance CMS will reconsider."

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