In case you missed it, the American Society of Clinical Oncologists (ASCO) wrote to CMS in support of Provenge. Here is what Dr. Allen Lichter, the CEO of ASCO, posted on the Medicare website:

Dear Drs. Paserchia and Fitterman:

On behalf of our 28,000 members who treat people
with cancer, the American Society of Clinical
Oncology (ASCO) is writing to express concern
about a recent action taken by the Centers for
Medicare & Medicaid Services (CMS).

On June 30, 2010, CMS opened an internally-
generated national coverage analysis (NCA) of
sipuleucel-T (Provenge®). Although we commend
CMS for taking steps to gather scientific
information about new cancer therapies, the
information provided by CMS regarding this NCA
lacks sufficient clarity regarding the purposes
underlying this action. In particular, we are
concerned that CMS may have plans to examine the
issue of whether to cover this therapy for its
FDA-approved indications. If that is the case,
this would be both counter-productive and ill-
advised. We believe that CMS is required by the
Social Security Act to cover drugs and biologics
for FDA-approved indications used in anticancer
chemotherapeutic regimens.

Since 1993, section 1861(t)(2)(A) of the Medicare
statute has provided a definition for drugs and
biologicals covered by the Medicare program that
explicitly includes those for use “in an
anticancer chemotherapeutic regimen for a
medically accepted indication. ” The statute
further defines “medically accepted indication”
to include “any use which has been approved by
the Food and Drug Administration” in 1861(t)(2)
(B). The statute thus clearly envisions that
Medicare coverage for cancer drugs will flow from
approval by FDA, and CMS has historically
followed this practice.

We urge CMS to withdraw the current NCA and look
for other means of communication to gather
information about this therapy, such as a
potential meeting with scientific experts to
address specific questions or a meeting of the
MedCAC (conducted outside of the context of an
NCA) to address specific questions. We
appreciate the longstanding and positive working
relationship that ASCO maintains with officials
throughout CMS, and we hope that you will
continue to look to ASCO and our members for
scientific and clinical expertise on this and
future issues.

Under any scenario, we urge CMS to provide clear
public statements regarding Medicare’s current
policies governing the coverage of this therapy
and to address the issue of how any potential
future changes in coverage policies at the local
or national levels could impact individuals who
might be mid-therapy. In practice, ambiguity and
uncertainty regarding coverage policies can act
as an unacceptable barrier to medically necessary
care.

Please do not hesitate to contact ASCO with any
scientific, clinical or administrative questions
involving cancer care provided in community-based
and other settings.

http://www.cms.gov/mcd/viewpubliccomments.asp?id=&cov_id=&state_id=&list_type=&goto=viewpubliccomment&nca_id=247

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Tags: ASCO, Breast Cancer, cancer, CMS, Dendreon, FDA, Healthcare, Medicare, Prostate Cancer, provenge

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