CMS Restricts Coverage Of Anti-Anemia Drugs For Cancer: Are Restrictions For ESRD Use Up Next?

May 25, 2007

The Centers for Medicare & Medicaid Services (“CMS”) continues to evaluate and modify, where necessary, Medicare coverage of anti-anemia drugs.  On May 14, 2007, after reviewing clinical evidence in peer-reviewed literature and considering concerns raised by a recent FDA advisory panel, CMS issued a Proposed Decision Memorandum restricting use of “Erythropoiesis Stimulating Agents” (“ESAs”) in cancer and related neoplastic conditions.  ESAs enhance red blood cell production by a hormone pathway that involves erythropoietin and erythropoietin receptors.  Citing safety concerns including thrombosis, cardiovascular events, tumor progression and reduced survival, CMS has decided that there is sufficient evidence to conclude that ESA treatment is not medically reasonable and necessary for certain Medicare beneficiaries undergoing anticancer therapy.  Contemporaneously, CMS will continue to review ESAs in the end-stage renal disease (“ESRD”) setting for possible Medicare coverage policy modification.

A 30-day public comment period on the Proposed Decision Memorandum ends June 14, 2007.  CMS requests public comments on the restriction of ESAs used to treat certain non-renal clinical conditions either because of the deleterious effect of ESAs on certain underlying diseases or because the underlying disease increases a patient’s risk of suffering adverse effects related to ESA use.  Generally, the clinical conditions include anemia caused by certain cancers or related chemotherapy.  CMS proposes that ESAs are only medically reasonable and necessary to treat cancer-related anemia in cancers in which the presence of erythropoietin receptors on either normal tissue/cell lines or malignant tissue/cell lines has been reported in peer-reviewed literature.  The cancers include, for example, bone, breast, cervical, hepatic, ovarian, prostate, and uterine cancers.  CMS would also impose certain clinical limitations on ESA use for treatment.

The Proposed Decision Memorandum reflects CMS’s evaluation of public comments on an internally generated National Coverage Decision (“NCD”) formally accepted and opened on March 14, 2007. The NCD reviewed Medicare coverage of non-renal use of ESAs.  CMS’s review follows several FDA Alerts issued in November 2006, and February and March 2007 regarding ESA safety.  Also, as we previously reported, on March 9, 2007, FDA strengthened its warning about cardiovascular and thrombotic events in several populations requiring and Black Box warning, and one Medicare contractor, Noridian, has issued a Local Coverage Decision (“LCD”) restricting off-label coverage and payment for three ESAs — ARANESP, EPOGEN, and PROCRIT. 

After the June 14th close of the public comment period on the Proposed Decision Memorandum, CMS plans to issue a final NCD within 60 days.  Interested parties should also monitor CMS’s website for further guidance on Medicare coverage of ESAs used to treat patients with ESRD.

By Kirk L. Dobbins

Categories: Reimbursement