When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Centers for Medicare & Medicaid Services (CMS). Agency for Healthcare Research and Quality (AHRQ) Technology Assessment Program. Technology assessment: Compendia for coverage of off-label uses of drugs and biologics in an anticancer chemotherapeutic regimen. Final report. [CMS Web site]. 05/07/07. Available at: http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=46&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=compendia&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d& . Accessed March 22, 2019.
Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual.Chapter 15: Covered medical and other health services. §50.4.5: Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. Rev 212, Issued: 11/06/15, Effective: 08/12/15. Implementation 02/10/16. [CMS Web site]. Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf . Accessed March 22, 2019.
Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 110.17: NCD for anti-cancer chemotherapy for colorectal cancer & Publication 100-04: Medicare Claims Processing. Transmittal 588: Coverage of colorectal anti-cancer drugs included in clinical trials. [CMS Web site]. 01/28/05. Available at:http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=291&ncdver=1&bc=BAABAAAAAAAA& . Accessed March 22, 2019.
Centers for Medicare & Medicaid Services (CMS). NCA for anticancer chemotherapy for colorectal cancer (CAG-00179N). [CMS Web site]. 01/28/05. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=90&ver=23&NcaName=Anticancer+Chemotherapy+for+Colorectal+Cancer&bc=BEAAAAAAAAAA&Accessed March 22, 2019.
Company Benefit Contracts.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [via subscription only]. Accessed March 22, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium™.[NCCN Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed March 22, 2019.
Novitas Solutions, Inc. Local Coverage Article A53049. Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents. [Novitas Solutions, Inc. Medicare Services Web site]. Original 10/01/2015; Revised: 06/14/2018. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53049&ver=71&Keyword=Unlabeled+Use+of+Drug&KeywordSearchType=Or&Date=&PolicyType=Both&ArticleType=SAD%7cEd&Cntrctr=323*1&KeyWordLookUp=Doc&SearchType=Advanced&CoverageSelection=Both&kq=true&bc=IAAAACAAAAAA& . Accessed March 22, 2019.
Truven Health Analytics. Micromedex® DrugDex® Compendium. [Internet database]. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed March 22, 2019.
US Food and Drug Administration (FDA). Regulatory Information. Federal Food, Drug, and Cosmetic Act. [FDA Web site]. 2018. Available at: https://www.fda.gov/regulatoryinformation/lawsenforcedbyfda/federalfooddrugandcosmeticactfdcact/default.htm. Accessed March 22, 2019.
Policy: 08.01.08d:Coverage of Prescription Oral Anticancer Drugs and/or Biologics as Provided Under the Company's Medical Benefit
Policy: 12.01.01as:Experimental/Investigational Services