The Centers for Medicare and Medicaid Services, amid pressure from doctors, medical societies, and patient advocacy groups, has come out with new, less stringent rules on the coverage of two popular anemia drugs. The move comes less than three months after CMS proposed to sharply limit coverage for Aranesp (darbepoetin alfa, Amgen) and Procrit (epoetin alfa, Ortho Biotech), drugs known medically as erythropoiesis-stimulating agents (ESAs). Though designed to improve patient safety, the proposed changes caused an uproar that resulted in the filing of more than 2,600 public comments with CMS. Opponents called the cuts draconian and said they could potentially compromise patients' quality of life.

The new rules apply mostly to cancer patients who receive chemotherapy that causes anemia and people with the bone marrow disorder myelodysplasia (MDS). Under the new guidelines, CMS will allow the drugs, which mimic a chemical called erythropoietin to stimulate red blood cell growth, to be used by patients whose cancers have proteins that may respond to the chemical. The agency also lifted restrictions on using the drugs in patients without heart disease.

"We're happy to see that CMS rolled back or pulled back a little bit on what they proposed in the original National Coverage Determination [NCD]," said Matthew Farber, M.A., manager of provider economics and public policy at the Association of Community Cancer Centers (ACCC) in Rockville, Md. "We're glad to see they rolled back some of the more serious issues we had with the NCD, but there are still some issues in place that we are concerned about."

Farber, however, believes that level is still too low and will negatively impact hospital resources as well as patients. "The target with the [hemoglobin] levels was 10 to 12. It's a little difficult to get to a range of 10," he noted. "We have concerns about that, obviously. In addition to the impacts on patients who have chemotherapy-induced anemia, we are concerned with the impact on hospitals and on the broader population."

Farber went on to explain that ESAs are most effective on patients with hemoglobin levels of 10 gm/dL or higher; those with lower hemoglobin levels must receive a blood transfusion to replenish their red blood cell supply. "This proposal would increase the number of blood transfusions that are necessary. If patients are in rural areas, they might have to travel long distances to get one, and that's increased stress for the patient," Farber explained. "But it also puts a stress on hospital resources and on blood supplies."

Hospitals are just as concerned as Farber about the possible strain on resources. A survey of 650 hospitals conducted by the ACCC last month found that 41% of the institutions believe an increase in blood transfusions of 30% would make it difficult to operate normally. An additional 16.5% said an increase of 10% or less would pose a problem, and 22% claimed any increase would strain resources. The survey was designed to measure the impact of an increased number of blood transfusions on hospital resources and services, such as blood supply, bed space, personnel, and equipment.

In addition to the hemoglobin levels, CMS also relaxed its rules on the treatment of MDS. Under fire from patient advocacy groups for initially denying coverage, CMS has now proposed to let local contractors decide whether to pay for MDS treatment. The treatment is not formally approved by the Food & Drug Administration.

Concerns over risky or excessive use of Aranesp and Procrit led CMS to maintain its stipulation that ESAs not be used to treat any anemia of cancer that is not related to chemotherapy or caused by radiation therapy.

Amgen officials criticized the revised coverage restrictions and accused CMS of undermining doctors' ability to decide how best to administer ESA therapy.