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Groups call on Congress to stay out of EPO drug dispute |
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By Jeffrey Young
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Posted: 10/18/07 07:32 PM [ET] |
A coalition of consumer groups is urging Congress to stay out of a dispute about coverage of anemia medication between the Medicare agency and cancer doctors and drug makers, warning that taking sides on the issue would establish a “terrible precedent.”
Led by the Center for Science in the Public Interest (CSPI) and the Consumers Union, the groups on Tuesday weighed in on one of the battles being waged between lawmakers, the Centers for Medicare and Medicaid Services (CMS) and powerful interest groups. At stake are the medicines — called erythropoiesis-stimulating agents but more commonly referred to as EPO or ESAs — used to treat anemia in chemotherapy and kidney dialysis patients.
“Congress should set broad policy objectives and standards for Medicare, but congressional intervention regarding coverage policies for specific medical products would set a terrible precedent,” the groups wrote in a letter to Congress.
Last month, Reps. Anna Eshoo (D-Calif.) and Mike Rogers (R-Mich.) introduced legislation to overturn a CMS decision to restrict Medicare coverage of the anemia drugs. CMS’s “national coverage determination” in July followed a March decision by the Food and Drug Administration (FDA) to require on the drugs’ labels a strong “black box” warning about serious or fatal side effects when the drug is used at high levels.
Backing Eshoo and Rogers are the drug makers, the American Society for Clinical Oncology (ASCO), the American Society of Hematology patient groups and for-profit cancer and kidney disease centers, which have all been fighting off efforts by CMS and Congress to reduce Medicare spending on EPO.
The lawmakers and these special interests object to the CMS policy in part because it covers EPO at a level below what the FDA approved for chemotherapy patients suffering anemia symptoms.
By not covering EPO usage up to FDA-approved levels, Medicare’s payment policy “clearly interferes with the doctors’ decision,” said Rogers, a cancer survivor.
The drugs are manufactured by Amgen under the brand names Epogen and Aranesp and by Johnson & Johnson as Procrit. The medication stimulates red blood cell production in bone marrow and is intended to reduce the number of blood transfusions necessary for patients undergoing dialysis, chemotherapy and other serious treatments.
CMS “offered us no science” to explain its decision, said Rogers, who believes the agency was motivated by budgetary concerns. “They did it to save money.”
At an estimated cost of $2 billion a year, EPO is the single largest drug expense in the Medicare program. Rep. Pete Stark (D-Calif.) and others are eyeing changes to Medicare coverage of kidney dialysis to try to tamp down spending on the drugs.
Stark, however, agrees with the CMS coverage policy of EPO for cancer patients. Citing a letter from the FDA that describes CMS’s policy as “generally consistent” with FDA labeling and scientific research, Stark said Tuesday that “Facts are stubborn things. The FDA letter confirms what Amgen and Johnson & Johnson are spending millions of dollars to deny.”
Although Rogers said he and his colleagues would continue to push their bill, they want their efforts to encourage CMS to reconsider its policy without legislation. “We hope … that they’ll get the message pretty clearly,” he said.
The bill is a Congressional Review Act joint resolution, a rarely used mechanism for overturning executive branch regulations. CSPI and the other groups maintain that CMS and FDA decisions on EPO should not be subject to this legislative tool.
“We urge Congress not to interfere,” they wrote, calling it an “extremely technical issue.” They argued that Congress should defer to the “professional, objective physician-scientists at our nation’s health agencies.”
In addition to CSPI and the Consumers Union, the National Research Center for Women and Families, the National Women’s Health Network, the TMJ Foundation and the U.S. Public Interest Research Group signed the letter.
Rogers agreed with the groups that lawmakers should not use such resolutions often, but he contended that CMS left them with no choice. “It warrants an intervention by the United States Congress,” he said. “This is where they crossed the line and interfered with a patient-doctor decision.”
At the time CMS announced the new policy, the agency said the revised FDA warnings prompted its decision. “Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries in light of the FDA boxed warnings,” CMS Deputy Administrator Herb Kuhn said in a written statement July 30.
But CSPI and the other groups also question the ASCO’s motives in its campaign to overturn the CMS policy. “We cannot help but note that companies and physicians make enormous windfall profits from the sale and use” of the drugs, the letter says. “Self-serving arguments about the negative consequences of a proposed payment policy is no substitute for objective, scientific evidence.”
A senior ASCO official flatly denied the insinuation.
“ASCO’s guidelines for EPO or anything else are strictly based on evidence,” said Joseph Bails, chairman of ASCO’s government relations council and an oncologist. “This is about taking care of seriously ill patients.”
Amgen expressed a similar sentiment. “Decisions about coverage and reimbursement of cancer products should be consistent with the best interests of patients, based on the best available medical evidence, and should respect the professional judgment of practicing healthcare professionals,” the firm said in a written statement. |
