House Members Introduce Bill To Require CMS To Reverse Medicare Coverage Decision For Anemia Medications
Main Category: Medicare / Medicaid / SCHIPArticle Date: 03 Oct 2007 - 5:00 PDT
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Reps. Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) on Thursday introduced a bill (HJ Res 54) that would reverse a CMS decision to limit Medicare coverage for use of anemia medications -- Aranesp, manufactured by Amgen, and Procrit, manufactured by Johnson & Johnson -- in cancer patients, CQ HealthBeat reports (CQ HealthBeat, 9/28).
According to a 61-page "national coverage determination" announced in July, Medicare will cover the medications, synthetic forms of the protein erythropoietin, to treat anemia caused by chemotherapy but not anemia caused by cancer. Under the decision, Medicare will cover the medications to treat anemia in cancer patients whose hemoglobin levels decrease to less than 10 grams per deciliter of blood. The decision will allow local Medicare contractors to determine whether to cover the medications to treat patients with myelodysplastic syndrome, a condition that can lead to leukemia (Kaiser Daily Health Policy Report, 7/31).
The legislation, a Congressional Review Act joint resolution, would require CMS to reverse the decision (Young, The Hill, 10/2). The House has not scheduled a vote on the bill, which requires approval from Congress and President Bush (CQ HealthBeat, 9/28).
The legislation likely will fail but might prompt CMS officials to revise the decision, according to Lehman Brothers analyst Tony Clapsis. A White House spokesperson declined to comment on the bill (Perrone, AP/Ventura County Star, 9/29).
In a letter sent earlier this year to CMS that included signatures from 235 House members, Eshoo wrote that the decision would require more cancer patients to undergo blood transfusions and could lead to shortages in the blood supply as a result. Fifty-two senators also signed a letter sent earlier this year to CMS in opposition of the decision (CQ HealthBeat, 9/28). In a letter sent last month to several physician groups, CMS officials wrote that they would not revise the decision without additional evidence (AP/Ventura County Star, 9/29).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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EPO Manufacturers And Cancer Societies Have At Least Two Lawmakers In Their Pocket Re Anemia Drugs
posted by Gregory D. Pawelski on 3 Oct 2007 at 10:11 pmRepresentatives Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) introduced legislation that would overturn a decision by the Centers for Medicare and Medicaid Services (CMS) to limit the circumstances under which Medicare will pay for anti-anemia treatments of cancer patients using pharmaceutical EPO. Legislation takes the form of a Congressional Review Act joint resolution, a rarely used tool that allows Congress to overturn regulatory decisions made by federal agencies.
The lawmakers allies in Congress, the American Society for Clinical Oncology, the American Society of Hematology and the cancer treatment center company US Oncology also are participating in the effort. The CMS policy affects the use of the drugs only for cancer patients, hence the fraternal organizations' involvement. The resolution is meant to serve as a reminder that special interests with a stake in Medicare coverage have friends in Congress.
Congress has been intensifying its scrutiny of Medicare spending on pharmaceutical EPO, which resprsents the single largest drug expense for the program. Some other key lawmakers view the manufacturers of EPO skeptically, citing Medicare's rising spending on the drugs. Earlier in the year, U.S. Oncology reported in their first quarter SEC Form 10-K report that cancer patients are suddenly using a lot less anemia drugs and as a result U.S. Oncology will bank $8-10 million a year less than expected.
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians' offices or cancer centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors' purchase price.
In panel discussion that highlighted the 12th annual conference of the National Comprehensive Cancer Network, Lee Newcomer, former chief medical officer and currently an executive with Minneapolis-based United Health Group, pointed out that in reviewing records of patients who were prescribed the drug erythropoietin -- an expensive agent that boosts blood supply in patients with anemia -- said that 44 percent of those patients had blood work-ups that would indicate they were not anemic.
New studies have raised questions whether these drugs might be harming patients. Those study results suggest the drugs may make the cancer worse. One such study published in the New England Journal of Medicine found that patients treated aggressively with Procrit had a higher risk of heart problems or death than those treated less aggressively.
And now there is emerging evidence that pharmaceutical EPO can feed the growth of tumors in cancer patients (it IS a "growth factor" afterall). A "growth factor" is about twenty small proteins that attach to specific receptors on the surface of stem cells in bone marrow and promote differentiation and maturation of these cells into morphotic constituents of blood.
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