INTERNATIONAL MYELOMA FOUNDATION
Serving the Myeloma Community Since 1990
12650 Riverside Drive, Suite 206
North Hollywood, CA 91607-3421
Tel 818-487-7455
Fax 818-487-7454
TheIMF@myeloma.org
www.myeloma.org
June 4, 2007

The Honorable Michael Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Secretary Leavitt:

On behalf of the International Myeloma Foundation (IMF), an organization dedicated to improving the
quality of life of myeloma patients while working toward prevention and a cure, I am writing to express
our serious concern about the content and timing of the proposed decision memo recently issued by the
Centers for Medicare and Medicaid Services (CMS) that addresses the use of erythropoiesis stimulating
agents (ESAs) in the management of patients with myeloma, other forms of cancer, and related neoplastic
conditions. We respectfully suggest that the proposals in this decision memo are premature and
recommend they be withdrawn until appropriate determinations about the safety and efficacy of ESAs in
the management of cancer patients in general, and myeloma patients in particular, are made by the US
Food and Drug Administration (FDA).

The FDA has primary responsibility for determining the limits that are set forth in CMS's proposed
decision memo. Furthermore, the ESA controversy is currently under active review by FDA. As CMS
officials are certainly aware, the FDA's Oncologic Drugs Advisory Committee (ODAC) intensively
reviewed the available data in a meeting on May 10. The FDA's Cardiovascular and Renal Drugs
Advisory Committee (CRDAC) has also been asked to offer recommendations on the entire class of ESAs
later in the year. Even prior to the ODAC meeting, FDA had taken action to require "black box" warnings
for the products. FDA is currently considering the recommendations from ODAC, but the agency is not
compelled to follow them, and certainly will make no decisions prior to receipt of comments from the
CRDAC. Until FDA has made a decision to change the existing labeling of ESAs, Medicare should follow
the labeling as it is currently configured, certainly taking into account the warnings required by FDA.

Medicare compliance with FDA rulings is necessary, not just as a matter of medical evidence and
bureaucratic prudence, but also because it is compelled by the laws that govern Medicare coverage
policies. In 1993 Congress enacted legislation that was intended to resolve questions about the discretion
of Medicare officials and contractors to limit coverage of medically appropriate cancer therapies.
Accordingly, in §1861(t)(2) of the Social Security Act (42 U.S.C. §1395x(t)(2), the term "drugs" is
specifically defined to include "any drugs or biologicals used in an anticancer chemotherapeutic regimen
for a medically accepted indication," which is further defined to include "any use which has been
approved by the Food and Drug Administration" as well as any compendiasupported use that has not
been found by the Secretary to be medically inappropriate.

---

In light of these legal requirements, we believe that Medicare does not have discretion to restrict coverage
for FDAapproved drugs. In addition, if offlabel coverage of ESAs in patients with myeloma is to be
restricted in a manner that conflicts with compendia references, there must be a specific determination by
the Secretary that the restricted uses are medically inappropriate.

We take no position as to whether Medicare officials have identified appropriate limits on the use of these
products in treatment of myeloma because we believe that determination should not be made prior to a
determination on that issue by the Food and Drug Administration (FDA). It is our considered opinion
that the proposed decision memo should be withdrawn to await the decision by FDA as to the medically
appropriate uses of ESAs in myeloma and other forms of cancer, and any future coverage determination
by Medicare should be made in strict conformity with the terms of §1861(t)(2) of the Act.

We would appreciate your early action on this issue.

Sincerely


Susie Novis
President

cc: Leslie Norwalk, Acting Administrator, Centers for Medicare and Medicaid Services

---