LCD/NCD Portal

NCD110.17

 

ANTI-CANCER CHEMOTHERAPY FOR COLORECTAL CANCER

 

 

Effective Date of this Version

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

 

 

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

 

 

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.

 Bevacizumab.

o 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.gov/coverage/download/id90b.pdf.

 

 

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).

o 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.

o 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.)

 

 

Claims Processing Instructions

 

• TN 588 (Medicare Claims Processing)Transmittal Information

 

 

Coverage Transmittal Link

 

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

 

 

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.

• Original consideration for Anticancer Chemotherapy for Colorectal Cancer (CAG-00179N) opens in new window

 

 

Medicare NCD Link