Sponsored by
MEDICARE NEWS
For Immediate release
CMS Office of Media Affairs
January 28, 2005
The Centers for Medicare & Medicaid Services (CMS) today issued two
national coverage decisions for improving care for cancer patients by
expanding coverage for diagnostic tests and chemotherapy treatments for
Medicare beneficiaries.
"We are working with the National Cancer Institute (NCI), the oncology
community and cancer patient advocates to ensure that patients get the
care they need and to develop the evidence needed by doctors and
patients to make informed decisions about their treatment" said CMS
Administrator Mark B. McClellan, M.D., Ph.D. "NCI-sponsored clinical
trials offer patients safeguards ensuring appropriate evaluation,
selection, and use of cancer chemotherapy."
The actions announced today include coverage expansions for:
* Additional "off-label" uses in CMS selected clinical studies for
new cancer drugs that are already approved for colorectal cancer,
including oxaliplatin, irinotecan, bevacizumab, and cetuximab.
* Positron emission tomography (PET) scans for certain uses in
evaluation of patients with of brain, cervical, ovarian, pancreatic,
ovarian, and testicular cancers, as well as for a broad range of other
cancers.
These two coverage decisions reflect Medicare's emphasis on ensuring
that patients receive high quality, medically necessary care and on
developing better evidence by linking coverage to the collection of
clinical data.
The cancer drug policy will ensure that all Medicare contractors pay
for the four anti-cancer drugs in selected clinical trials sponsored in
part by the National Cancer Institute (NCI). This coverage is an
expansion of current CMS coverage for off-label treatments.
Off-label uses mentioned in certain drug compendia will continue to be
covered, and contractors will continue to have the authority to pay for
off-label use of the drugs for patients not enrolled in these trials.
The CMS policy will also ensure funding for certain routine costs of
clinical items and services provided to patients enrolled in these
trials, where funding for the drugs services was not previously
available.
"Our final decision reflects input from the oncology community, cancer
patient advocates, and experts at the National Cancer Institute to add
to the evidence needed by doctors and seniors to get the most out of
increasingly innovative and personalized cancer therapies," McClellan
said.
"NCI-sponsored clinical trials offer patients safeguards ensuring
appropriate evaluation, selection, and use of cancer chemotherapy."
McClellan added. "It's particularly important for these studies to
close the knowledge gaps for seniors and people with disabilities, who
have been less likely to participate in such studies."
"Our partnership with CMS will enhance clinical evaluation of new
medicines to improve decision making regarding drug approval," said
Andrew von Eschenbach, MD, NCI Director. "Ultimately, our working
relationship with the CMS is about improving the quality of and access
to cancer care for cancer patients everywhere."
Medicare currently provides coverage for physician-administered cancer
drugs for FDA-approved indications or indications listed in certain drug
compendia. Medicare does not routinely pay for drug costs for off-label
indications that are not listed in these compendia, although Medicare
does pay for the routine services provided to beneficiaries in federally
funded trials.
"Expanding coverage for the experimental and routine services provided
to Medicare beneficiaries enrolled in these NCI sponsored trials is an
important first step in getting better evidence for decisions," said Dr.
Sean Tunis, the chief medical officer for CMS. "We will also be
initiating an extensive dialog with patient advocates, clinical
oncologists, the pharmaceutical and biotech industry, commercial payers
and other stakeholders to ensure that the most important questions are
identified and answered."
In addition to the positive coverage decisions, CMS will shortly
announce a proposed decision that will maintain current policies for the
use of ibritumomab tiuxetan and tositumomab. This decision will propose
to maintain the existing requirement for coverage of these agents as
outlined in current law and regulations. Under current policy coverage
of off-label use is based on local coverage policy. Federal law
requires that all off-label uses listed in specific compendia must be
covered, and other unlisted uses are at contractor discretion.
CMS also announced new coverage for PET scanning for a range of
cancers. PET is a diagnostic imaging procedure that has the ability to
differentiate cancer from normal tissue, and may add important
information beyond conventional imaging studies in diagnosing and
staging cancer and monitoring a patient's progress during treatment.
The expansion in PET scan benefits makes this test available to
patients when the patient and doctor participate in high quality
clinical studies or submit information to a PET database. The data
collected as part of this policy will help ensure that the PET
information is used accurately and appropriately in patient management
and will also help doctors and Medicare beneficiaries make
better-informed choices about their health care.
The PET database is being developed by a working group that includes
representatives from clinical oncologists, imaging organizations,
academic institutions, and industry. Medicare coverage will become
effective when the database is fully established within the next several
months.
The CMS Council on Technology and Innovation will now begin to develop
a draft guidance document on this policy approach in order to make the
process more systematic, predictable and transparent. An open door
forum on this topic will be held on Feb 14, 2005, to obtain public input
on linking coverage to practical trials and databases. In addition,
comments on this approach can be submitted to the CTI website
(www.cms.hhs.gov/providers/cti). An initial draft guidance will be
issued in by March 31, 2005, at which time additional public feedback
will be solicited.
More information on CMS coverage decisions is located at
http://cms.hhs.gov/coverage.
###