Pursuant to this national coverage determination, the off-label use of clinical items and services, including the use of the studied drugs oxaliplatin, irinotecan, cetuximab, or bevacizumab, are covered in specific clinical trials identified by the Centers for Medicare & Medicaid Services (CMS). The clinical trials identified by CMS for coverage of clinical items and services are sponsored by the National Cancer Institute (NCI) and study the use of one or more off-label uses of these four drugs in colorectal cancer and in other cancer types. The list of identified trials is on the CMS website at: http://www.cms.hhs.gov/coverage/download/id90b.pdf.

This policy does not alter Medicare coverage for items and services that may be covered or non-covered according to existing national coverage policy for Routine Costs in a Clinical Trial (National Coverage Determination Manual, section 310.1). Routine costs will continue to be covered as well as other items and services provided as a result of coverage of these specific trials in this policy. The basic requirements for enrollment in a trial remain unchanged.

The existing requirements for coverage of oxaliplatin, irinotecan, cetuximab, bevacizumab, or other anticancer chemotherapeutic agents for FDA-approved indications or for indications listed in an approved compendium are not modified.

Contractors shall continue to make reasonable and necessary coverage determinations under Section 1861 (t)(2)(B)(ii)(II) of the Act based on guidance provided by the Secretary for medically accepted uses of off-label indications of oxaliplatin, irinotecan, cetuximab, bevacizumab, or other anticancer chemotherapeutic agents provided outside of the identified clinical trials appearing on the CMS website noted above.

If a drug is being provided in the context of a clinical trial, please refer to Medicare Advantage Medical Policy Bulletin N-27, Clinical Trials.

NOTE:

In many situations, the cost of covering certain benefits related to clinical trials is not included in capitated payment rates a Medicare Advantage organization receives from CMS. In these instances, the provider of service is responsible for directly billing the appropriate Medicare intermediary or carrier. In order to determine coverage for routine costs or other services, or to obtain additional guidance concerning participation in a specific clinical trial, please refer to the Medicare Advantage medical policy governing the procedure or service. For additional information on clinical trials, please see www.cms.hhs.gov/clinicaltrialpolicies.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1861 (t)(2)(B)(ii)(II)

CMS Online Manual Pub. 100-4, Medicare Claims Processing, Transmittal 588, CR 3742

CMS Online Manual Pub. 100-3, Medicare National Coverage Determinations, Transmittal 38, CR 3742, Section 110.17