Proposed Medicare restrictions on the use of biologic drugs Aranesp, Epogen and Procrit to treat cancer patients for anemia resulting from chemotherapy have been eased considerably in the wake of a public outcry contending the guidelines went too far and would reduce patients' quality of life.

The Centers for Medicare and Medicaid Services issued a final "national coverage determination" on July 30th that will enable doctors to use the biologics at an earlier stage of anemia than initially proposed, and will also allow their use for treatment of a bone-marrow disorder called myelodysplasia.

The new guidelines, however, continue to restrict coverage of the biologics to treatment of anemia -- not to prevention of anemia -- and Medicare reiterated it will only cover use of the drugs to treat anemia caused chemotherapy, not anemia caused by the cancer itself.

The new rules apply only to coverage of the biologics to treat anemia in cancer patients -- not patients with kidney failure, who are covered by separate Medicare rules. Regulations for these patients are expected to be revised following a hearing this fall by an FDA advisory panel.

Medicare had proposed in May to sharply limit coverage for use of the anemia biologics by cancer patients after a number of studies showed increased cardiovascular risks among patients on the drugs, and the FDA subsequently required new warnings on the drugs' labels.

But in the public comment period that followed, Medicare received more than 2,600 comments -- many from doctors and patient groups -- complaining that the proposed curbs on use of anemia biologics was overly severe, and might possibly harm patients.

Under the revised guidelines, Medicare will allow doctors to begin treatment for anemia when hemoglobin falls below 10 grams per deciliter of blood. It previously had proposed requiring that doctors wait until hemoglobin dropped below 9.

Medicare also relented on disallowing treatment for myelodysplasia, and now will leave the decision up to local contractors that provide Medicare coverage.

But the final rules are still far more restrictive than the Medicare guidelines in effect for anemia biologics before May. They disallow coverage of the drugs to treat any cancer-related anemia that results from cancer itself, radiation therapy alone, or that is related to vitamin or mineral deficiency.

Medicare also will not cover use of the anemia biologics to treat patients with leukemia, uncontrolled hypertension, or certain other conditions where there is concern the drugs might do more harm than good.

"Our goal was to maintain physician autonomy while ensuring the safety of our Medicare beneficiaries in light of FDA boxed warnings," said CMS Acting Deputy Administrator Herb Kuhn in a prepared statement.