GOVERNMENT & MEDICINE

Anemia drug guidelines offered to counter Medicare policy

Medical society authors say the government went too far in restricting coverage.

By Dave Hansen, AMNews staff. Nov. 12, 2007.

Washington -- Two national medical societies issued guidelines on Oct. 22 for treating chemotherapy-related anemia with erythropoiesis-stimulating agents to pressure Medicare into expanding its coverage. Their move follows a decision by Aetna to cover a more relaxed protocol for the medications than the government adopted.

The guidelines, released by the American Society of Clinical Oncology and the American Society of Hematology, recommend using ESAs to treat chemotherapy-induced anemia when a patient's hemoglobin falls below 10g/dL and for low-risk myelodysplasia. They recommend titrating dosage after levels rise to 12g/dL.

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In contrast, Medicare will only cover ESAs when a chemotherapy patient's hemoglobin levels fall below 10g/dL and will cease coverage if it exceeds that level after four weeks of treatment, according to a Centers for Medicare & Medicaid Services' July 30 national coverage determination. CMS restricted the use of ESAs after the Food and Drug Administration warned that epoetin agents raise the risk for strokes and heart attacks.

The new medical society guidelines are intended to pressure CMS into raising the maintenance level of hemoglobin at which it will cover treatment, said Samuel Silver, MD, PhD, ASH executive committee councilor and professor of internal medicine at the University of Michigan. "Basically we are looking at the 10-to-12 range. The maintenance level for CMS is under 10," he explained.

ASH believes the Medicare policy reflects a misinterpretation of the evidence, the group said in a statement. It has sent the updated guidelines to CMS in the hopes the agency will reopen and revise its coverage policy.

The medical societies worry that the CMS policy will force patients to repeatedly stop and start treatment as they exceed and then drop below 10g/dL. "It whipsaws the patient back and forth," Dr. Silver explained. Patients, already severely inconvenienced by chemotherapy, would need to have blood draws for reimbursement purposes instead of treatment. Medical staff also would be inconvenienced by unnecessary patient monitoring, he added.

The ASCO/ASH guidelines cautioned against ESAs for cancer patients who are not on chemotherapy, because recent trials show increased thromboembolic risks and decreased survival.

ASCO Government Relations Council Chair Joseph Bailes, MD, still advises physicians to follow CMS' guidelines to receive reimbursement for Medicare patients.

CMS stands by its decision

The agency does not plan to change its policy, said Barry Straub, MD, CMS director of office standards and policy. "We are reacting to the FDA black-box warning, which is the most serious action the FDA can take, short of pulling a product off market," he said.

The ASCO/ASH guidelines follow Aetna's Oct. 5 decision to cover a less-restrictive ESA protocol than Medicare's policy. Erythropoietin analog treatment is medically necessary when a chemotherapy patient's hemoglobin level falls below 10g/dL, announced Aetna. However, it will be covered when patients display symptoms of anemia and have hemoglobin levels between 10g/dL and 12g/dL. Unlike CMS, Aetna decided to cover ESAs as maintenance treatment without requiring hemoglobin levels to fall below 10g/dL.

ESAs, such as epoetin and darbepoetin, stimulate bone marrow to produce red blood cells. They are manufactured by Amgen as Aranesp and by Johnson & Johnson as Procrit. Amgen also produces Epogen for patients with kidney disease.

Amgen issued a statement welcoming Aetna's decision. "[T]he aspects of the [Medicare] national coverage determination that have alarmed leading physicians (such as the initiation, maintenance and dose adjustment rules) are dramatically different under Aetna's policy," the company stated. "Amgen remains very concerned that the current NCD limits the ability for physicians to treat their patients with Medicare appropriately and is resulting in Medicare beneficiaries receiving different care than privately covered patients."

Private payers often follow Medicare's lead in setting their coverage policies.

Rep. Anna Eschoo (D, Calif.) and Sen. Max Baucus (D, Mont.) have introduced legislation that would nullify CMS' decision. The House and Senate have not voted on the bills.

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