Centers for Medicare & Medicaid Services

Content Section

Publication Number

13-3

Manual Section Number

110.17

Version Number

Effective Date of this Version

1/28/2005

Implementation Date

4/18/2005

Benefit Category

Incident to a physician's professional Service

Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), and bevacizumab (Avastin™) are anti-cancer chemotherapeutic agents approved by the Food and Drug Administration (FDA) for the treatment of colorectal cancer. Anti-cancer chemotherapeutic agents are eligible for coverage when used in accordance with Food and Drug Administration (FDA)-approved labeling (see section 1861(t)(2)(B) of the Social Security Act (the Act)), when the off-label use is supported in one of the authoritative drug compendia listed in section 1861(t)(2)(B)(ii)(I) of the Act, or when the Medicare contractor determines an off-label use is medically accepted based on guidance provided by the Secretary (section 1861(t)(2)(B)(ii)(II).

Indications and Limitations of Coverage

B. Nationally Covered Indications

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.

C. Other

This policy does not alter Medicare coverage for items and services that may be covered or non-covered according to the 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.

(This NCD last reviewed March 2005.)

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R38NCD.pdf

Revision History

06/2005 - Use of oxaliplatin (Eloxatin™), irinotecan (Camptosar®), cetuximab (Erbitux™), or bevacizumab (Avastin™) covered in clinical trials identified by CMS and sponsored by National Cancer Institute. Effective date 01/28/2005. Implementation date 04/18/2005 for Carriers, 07/05/2005 for FI's. (TN 38) (CR 3742)

Claims Processing Instructions

TN 588 (Medicare Claims Processing)

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.