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Conducting Clinical Trials

  • Posted: 01/09/2006
  • Reviewed: 10/07/2010

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Clinical Trials Covered Under the Medicare Anti-Cancer Drugs National Coverage Decision

On January 28, 2005, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD), No. CAG-00179N, covering the off-label use of certain anti-cancer drugs.

The NCD covers nine specific National Cancer Institute-sponsored clinical trials of colorectal cancer and other cancer types (see Table 2, below). The trials are investigating one or more of the following anti-cancer drugs: oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), or bevacizumab (Avastin™).

The nine trials are now permanently closed to new accruals. 

More information:

Doesn’t Medicare already pay for patients' routine costs when they join a clinical trial?

Yes, since 2000 Medicare has paid for patients’ routine care costs (such as office visits and regular medical tests) when they enroll in federally funded clinical trials. For more information about this basic coverage, see Medicare Clinical Trial Policies.

The 2005 Anti-Cancer Drugs NCD policy provides additional coverage for those Medicare beneficiaries who enroll in one of the nine specific clinical trials listed in Table 2 - for example, the costs of pretreatment and prerandomization tests (as defined by each study protocol).

Major differences between the two policies are described in Table 1.

Table1: Comparison of Medicare Policies

2000 Clinical Trials Policy
2005 Anti-Cancer Drug NCD
What kind of costs are covered?Routine costs associated with the patients’ medical care in the clinical trial.Both routine and nonroutine costs associated with the patients’ care in any of the nine trials. An example of a nonroutine cost would be an additional lab or imaging test required by the study protocol for data analysis.
Does the policy pay for off-label use of anti-cancer drugs?Maybe. Coverage of off-label use varies depending on whether the trial in question meets the policy's requirements.Yes, off-label use is covered for the anti-cancer drugs in all nine trials.

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What about billing procedures?

Billing instructions for the nine clinical trials covered under the 2005 Anti-Cancer Drugs NCD can be found via the links on the following Web page maintained by the National Cancer Institute's Cancer Trial Support Unit (CTSU): CTSU Menu Trials Included in Medicare Pilot.

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Will insurers other than Medicare provide the same coverage for these nine trials?

  • The 2005 Anti-Cancer Drugs NCD coverage applies only to Medicare plans. This includes “ordinary” Medicare as well as Medicare plans provided via Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), etc.
  • Some states have passed laws requiring that Blue Cross/Blue Shield plans, HMOs, PPOs, and other insurance companies pay, at least in part, for cancer clinical trials. States with such laws are listed on NCI's Web site at States That Require Health Plans to Cover Patient Care Costs in Clinical Trials.
  • If no law exists, some private insurers frequently “follow the lead” of Medicare in their decisions about paying for clinical trials. Your billing office may wish to call or e-mail their contact at the particular insurer, telling them that Medicare has made a special decision. Sending this Medicare coverage information will inform them of this CMS determination and may help impact their decision on coverage.

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Table 2: Clinical Trials Covered Under the 2005 Anti-Cancer Drugs NCD


Study #
Study Title
Study Status
C80405Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal CancerClosed to accrualNationwide
E2204Bevacizumab or Cetuximab Given Together With Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By SurgeryClosed to accrualNationwide
E4203Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal CancerClosed to accrualNationwide
E5202Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon CancerClosed to accrualNationwide
E5204Chemotherapy With or Without Bevacizumab in Treating Patients With Stage II or Stage III Rectal CancerClosed to accrualNationwide
NSABP-R-04Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal CancerClosed to accrualNationwide
RTOG-0522Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck CancerClosed to accrualNationwide
S0502Phase III Randomized Study of Imatinib, with or without Bevacizumab, in Patients with Metastatic or Unresectable Gastrointestinal Stromal TumorsClosed to accrualNationwide
7325Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic or Locally Advanced Unresectable Colorectal Cancer or Other Solid TumorsClosed to accrualLimited Regions

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