Education & Training
FindACode.com
Find A Code, LLC
Article Text
This article defines coding and coverage for oxaliplatin including off-label indications. National Government Services/HealthNow New York Inc. (UMD) Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI) and/or the American Hospital Formulary Services (AHFS) define such indications or if National Government Services/UMD has published an article or LCD expanding such coverage. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services/UMD LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.umd.nycpic.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.
Abstract:
Oxaliplatin for injection (EloxatinŽ) is an organoplatinum complex used as an antineoplastic agent. In the human body, oxaliplatin metabolizes to form active oxaliplatin derivatives that help create DNA crosslinks with resulting inhibition of DNA replication, transcription and cell-cycle nonspecific cytotoxicity.
Indications:
22 Oxaliplatin, used in combination with infusional 5-FU/LV, ("FOLFOX.") is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy, with the combination of bolus 5-FU/LV and irinotecan.
22 First line therapy in combination with infusional 5-FU/LV for the treatment of patients with advanced metastatic carcinoma of the colon or rectum
22 Coverage is extended to include patients receiving oral capecitabine as an alternative to infusional 5-FU, in combination with oxaliplatin.
Note: Claims for capecitabine are submitted to the appropriate Medicare Durable Medical Equipment Regional Carrier (DMERC)
22 Adjuvant therapy in patients with stage 3 colon cancer who have undergone complete resection of the primary tumor, when used in combination with infusional 5-FU and leucovorin. National Governement Services will also reimburse the oxaliplatin when given with 5-FU and capecitabine.
22 Oxaliplatin has been approved for use as an adjuvant therapy in patients with stage II colon cancer, in combination with 5-fluorouracil/leucovorin.
22 Oxaliplatin, in combination with irinotecan or fluorouracil with leucovorin or folinic acid, is covered for use in patients with advanced/metastatic malignant neoplasm of the stomach.
Indications expanded by this Article:
22 As treatment for pancreatic cancer
22 As treatment for advanced small bowel adenocarcinoma when used in combination with infusional fluorouracil (e.g., FOLFOX or OxMdG).
Utilization:
For colon or colorectal cancer, oxaliplatin should be administered as part of a FOLFOX or XELOX regimen. For gastric carcinoma, oxaliplatin should be administered in combination with irinotecan or fluorouracil with leucovorin or folinic acid. For small bowel adenocarcinoma, oxaliplatin should be administered in combination with 5-FU chemotherapy.
Coding Guidelines:
Carrier Guidelines:
Oxaliplatin should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier.], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an "incident to" service by the physician.
American Society of Health-System Pharmacists, Inc. AHFS Drug InformationŽ. Bethesda, MD: 2007.
Locher C, Malka D, Boige V, et al. Combination chemotherapy in advanced small bowel adenocarcinoma. Oncol. 2005;69:290-294.
U.S. Food and Drug Administration label accessed on line at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 02/02/2008.
United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Chemotherapy (Outpatient)
Prescription Drugs
13 - Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85 - Special facility or ASC surgery-rural primary care hospital (eff 10/94)
This article defines coding and coverage for oxaliplatin including off-label indications. National Government Services/HealthNow New York Inc. (UMD) Local Coverage Determination (LCD) "Coverage of Drugs and Biologicals for Label and Off-Label Uses" allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI) and/or the American Hospital Formulary Services (AHFS) define such indications or if National Government Services/UMD has published an article or LCD expanding such coverage. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services/UMD LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.umd.nycpic.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.
Abstract:
Oxaliplatin for injection (EloxatinŽ) is an organoplatinum complex used as an antineoplastic agent. In the human body, oxaliplatin metabolizes to form active oxaliplatin derivatives that help create DNA crosslinks with resulting inhibition of DNA replication, transcription and cell-cycle nonspecific cytotoxicity.
Indications:
22 Oxaliplatin, used in combination with infusional 5-FU/LV, ("FOLFOX.") is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy, with the combination of bolus 5-FU/LV and irinotecan.
22 First line therapy in combination with infusional 5-FU/LV for the treatment of patients with advanced metastatic carcinoma of the colon or rectum
22 Coverage is extended to include patients receiving oral capecitabine as an alternative to infusional 5-FU, in combination with oxaliplatin.
Note: Claims for capecitabine are submitted to the appropriate Medicare Durable Medical Equipment Regional Carrier (DMERC)
22 Adjuvant therapy in patients with stage 3 colon cancer who have undergone complete resection of the primary tumor, when used in combination with infusional 5-FU and leucovorin. National Governement Services will also reimburse the oxaliplatin when given with 5-FU and capecitabine.
22 Oxaliplatin has been approved for use as an adjuvant therapy in patients with stage II colon cancer, in combination with 5-fluorouracil/leucovorin.
22 Oxaliplatin, in combination with irinotecan or fluorouracil with leucovorin or folinic acid, is covered for use in patients with advanced/metastatic malignant neoplasm of the stomach.
Indications expanded by this Article:
22 As treatment for pancreatic cancer
22 As treatment for advanced small bowel adenocarcinoma when used in combination with infusional fluorouracil (e.g., FOLFOX or OxMdG).
Utilization:
For colon or colorectal cancer, oxaliplatin should be administered as part of a FOLFOX or XELOX regimen. For gastric carcinoma, oxaliplatin should be administered in combination with irinotecan or fluorouracil with leucovorin or folinic acid. For small bowel adenocarcinoma, oxaliplatin should be administered in combination with 5-FU chemotherapy.
Coding Guidelines:
Carrier Guidelines:
Oxaliplatin should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier.], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an "incident to" service by the physician.
Additional Information:
Sources of InformationAmerican Society of Health-System Pharmacists, Inc. AHFS Drug InformationŽ. Bethesda, MD: 2007.
Locher C, Malka D, Boige V, et al. Combination chemotherapy in advanced small bowel adenocarcinoma. Oncol. 2005;69:290-294.
U.S. Food and Drug Administration label accessed on line at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 02/02/2008.
United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
History:
This article replaces LCD #DR024G04 that was end dated 04/23/2008.Coverage Topic:
Chemotherapy (Inpatient)Chemotherapy (Outpatient)
Prescription Drugs
Bill Code:
11 - Hospital-inpatient (including Part A)13 - Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85 - Special facility or ASC surgery-rural primary care hospital (eff 10/94)
