Press release




The Centers for Medicare & Medicaid Services (CMS) today announced a set of new steps to improve care for cancer patients by expanding coverage for screening tests and treatments, developing better evidence on which treatments work best for beneficiaries with cancer, and implementing a demonstration program to measure and improve quality of care.

"We are moving aggressively to provide more up-to-date, higher quality care for cancer patients on Medicare," said CMS Administrator Mark B. McClellan, M.D., Ph.D.  "Seniors will have faster access to innovative cancer treatments that clearly work, and they will have better support for care that addresses the pain, nausea, and fatigue that cancer patients too often face."

The actions announced today include proposed coverage expansions for:

  • Additional "off-label" uses in clinical studies for new  "targeted" cancer drugs that are already approved for colorectal cancer, including oxaliplatin (Eloxatin), irinotecan (Camptosar), bevacizumab (Avastin), and cetusimab (Erbitux).
  • Positron emission tomography (PET) scans for cervical cancer, and for studies of PET for diagnosis and staging involving a broad range of additional types of cancer.

CMS also announced a $300 million nationwide demonstration program open to all oncologists to measure and improve the quality of care provided Medicare patients.

"We are working with the National Cancer Institute, oncologists, and the cancer community to develop better evidence to support the best possible treatment decisions for our beneficiaries," Dr. McClellan said. "There are too many unanswered questions in cancer care today for seniors and people with disabilities, and Medicare will help develop more practical evidence to improve care."

"The National Cancer Institute's goal of eliminating death and suffering due to cancer will require improvements in how the nation's health care delivery system works to provide quality care to patients," said Andrew C. von Eschenbach, M.D., Director of the National Cancer Institute. "Consequently, NCI is working with CMS to help provide the data that would serve to demonstrate efficacy of off-label chemotherapeutic drug usage and to expand the availability of advanced imaging, such as Position Emission Tomography, where such services can improve the management and overall quality of care of cancer patients."

The coverage expansions announced today reflect new procedures CMS is implementing to review scientific evidence for coverage decisions more rapidly. CMS also will include funding of the clinical and experimental costs of these drugs in nine clinical trials to learn more about the benefits and risks of certain "off-label" use of these treatments in Medicare beneficiaries.  The trials are sponsored in part by the National Cancer Institute, and the more rapid coverage decisions and expanded efforts to develop better evidence on cancer treatment in seniors are the result of the new CMS collaboration with NCI.

Medicare currently provides coverage for office-administered cancer drugs for FDA-approved indications or indications listed in certain drug compendia. Medicare does not routinely reimburse for drug costs for off-label indications that are not listed in these compendia, although Medicare does pay the routine costs of care for beneficiaries in federally funded trials.

CMS is also seeking public comment on the processes used by the private contractors that pay Medicare claims and set local drug coverage policies. CMS expects to collaborate with NCI, the American Society of Clinical Oncology, patient advocacy organizations and other stakeholders in this process.

PET is a diagnostic imaging procedure that has the ability to differentiate cancer from normal tissue in some patients, and can help in diagnosing and staging cancer and monitoring a patient's progress.  Medicare already covers PET scanning in many cancers for this purpose.  The proposed expansion in coverage for PET scans would make this test available for certain uses in patients with cervical cancer, because the available evidence indicates that PET can provide more reliable guidance than existing imaging methods on whether the patient's cancer has spread.

It also would make PET scans available to patients with other cancers where the PET scan is not currently covered, if the provider and patient are participating in certain PET clinical trials, or if the provider and patient are participating in a high quality PET registry.  Data collected as part of clinical studies will help doctors and Medicare beneficiaries make better-informed decisions about the effective use of PET. 

CMS also announced a national oncology demonstration to evaluate measures of patient well-being in office-based oncology practice, as a basis for addressing quality of life concerns for Medicare beneficiaries with cancer. 

"We want to work with oncologists to make sure we are addressing what should be our shared goal: improving the well-being of our beneficiaries with cancer," said Dr. McClellan.  "We want to provide the most effective support possible for our beneficiaries to get better outcomes from their cancer care, and this national demonstration program will provide useful information to help us work with cancer providers and patients to achieve this goal."

This one-year demonstration will focus on three major areas of concern for cancer patients: pain, nausea and vomiting, and fatigue. 

Practitioners participating in the project must provide three new codes describing a chemotherapy patient's status with respect to pain, nausea and vomiting, and fatigue.  To make it easier to collect this information, CMS has established 12 new temporary codes to be used by oncologists in billing for the administration of chemotherapy drugs, based on well-established scales used to assess a cancer patient's status in these important dimensions of quality of life. 

Oncologists can participate in the demonstration simply by providing the three relevant codes for a patient, in conjunction with billing for the patient's chemotherapy services.  Providers will receive a payment of $130 per patient per day for participating in the demonstration.

More information on the CMS proposed coverage decision for cancer drugs is at, and the decision for expanded PET scan coverage is at CMS expects to hold open-door forums and other opportunities for public discussion and comment of these new proposals on improving cancer care in the next few weeks.