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Posted on: 01/29/2005

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 ( 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


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