WASHINGTON—Oncologists have protested to the Centers for Medicare & Medicaid Services (CMS) that new rules restricting coverage of erythopoiesis-stimulating agents (ESAs) contradict Food and Drug Administration's approved labeling for the drugs and tie the hands of physicians treating cancer patients with chemotherapy-induced anemia. The regulations control payments for use of darbepoetin alfa(Drug information on darbepoetin alfa) (Aranesp, Amgen) and erythropoietin(Drug information on erythropoietin) alfa (Epogen, Amgen; Procrit, Ortho Biotech).

The new Medicare coverage determination has also attracted congressional attention. A majority of members of both Houses have written CMS to express their concerns, and Sens. Arlen Spector
(R-Penn), Tom Harkin (D-Iowa), and Frank Lautenberg (D-NJ) have introduced a resolution in the Senate ordering CMS to confer with the oncology community and make appropriate revisions to its policy.

Starting January 1, 2008, physicians will be required to submit data on a patient's hemoglobin levels along with any claim for an ESA. However, CMS expects physicians to begin following the coverage decision immediately.

CMS put out the new rules based on a policy that patients with anemia secondary to chemotherapy should receive ESAs only when their hemoglobin level is less than 10 g/dL.

"The new policy also denies coverage of ESAs whenever a patient's hemoglobin goes above 10 g/dL. This latter restriction is inconsistent with both the FDA-
approved labeling and national guidelines, and we strongly disagree with this restriction," Joseph S. Bailes, MD, chair of ASCO's Government Relations Council, said in a letter to Steve Phurrough, MD, MPA, director of CMS's Coverage & Analysis Group, Office of Clinical Standards & Quality.

In his letter, Dr. Bailes pointed out that the FDA-approved label for Procrit/Epogen indicates that the dose "should be titrated for each patient to achieve and maintain the lowest hemoglobin level sufficient to avoid the need for blood transfusion and not to exceed 12 g/dL." The labeling for darbepoetin is similar.

The CMS approach, Dr. Bailes said, "is entirely different from the instructions for use specified in the FDA-approved label." Further, he noted, ASCO/ASH guidelines recommend consideration of ESA therapy when hemoglobin falls below 10 g/dL (for most patients) with a treated hemoglobin not to exceed 12 g/dL.

One-time dose escalation