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"We are working with 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 Dr. Mark B. McClellan. "NCI-sponsored clinical trials offer patients safeguards, ensuring appropriate evaluation, selection, and use of cancer chemotherapy."

The actions expand coverage for additional off-label uses in CMS-selected clinical studies for drugs that are already approved for treatment of colorectal cancer, including oxaliplatin (Eloxatin), irinotecan (Camptosar), bevacizumab (Avastin), and cetuximab (Erbitux). Positron emission tomography (PET) scans for certain uses in evaluating patients with brain, cervical, ovarian, pancreatic, testicular, and other cancers will also be covered.

The decisions reflect Medicare's emphasis on ensuring that patients receive high-quality, medically necessary care and on developing better evidence by linking coverage to clinical data collection. The new drug policy will ensure that all Medicare contractors pay for the four anticancer drugs in selected clinical trials sponsored in part by NCI.

"The CMS-NCI partnership will enhance clinical evaluation of new medications to improve decision making about drug approval," said NCI Director Dr. Andrew C. von Eschenbach. "Ultimately, our goal in working with CMS is to improve the quality of and access to care for cancer patients everywhere."

The CMS Council on Technology and Innovation is developing draft guidance on this policy. An open-door forum will be held on February 14 to get public input. Comments can also be submitted to http://www.cms.hhs.gov/providers/cti. More information on CMS coverage decisions is located at http://cms.hhs.gov/coverage.