Archive
API

National Coverage Determination (NCD)

Anti-Cancer Chemotherapy for Colorectal Cancer

110.17

Expand All | Collapse All

Tracking Information

Publication Number
13-3
Manual Section Number
110.17
Manual Section Title
Anti-Cancer Chemotherapy for Colorectal Cancer
Version Number
1
Effective Date of this Version
01/28/2005
Ending Effective Date of this Version
Implementation Date
04/18/2005
Implementation QR Modifier Date

Description Information

Benefit Category
Incident to a physician's professional Service


Please 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 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 Administrative Contractor (MAC) 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 (NCD), 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 Web site 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 (NCD 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.

MACs 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.
Cross Reference

CED page
Claims Processing Instructions

Transmittal Information

Transmittal Number
38
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/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)
Other

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.

Coding Analyses for Labs (CALs)

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

Additional Information

Other Versions
Title Version Effective Between
Anti-Cancer Chemotherapy for Colorectal Cancer 1 01/28/2005 - N/A You are here
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
Submit Feedback/Ask a Question