LCD for Oxaliplatin for Injection (Eloxatin) (L17632)

 

Contractor Information

Contractor Name 

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator) 

Contractor Number 

00390 

Contractor Type 

FI 

 

LCD Information

LCD ID Number 

L17632 

 

LCD Title 

Oxaliplatin for Injection (Eloxatin) 

 

Contractor's Determination Number 

L17632 

 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.  

 

CMS National Coverage Policy 

Title XVIII of the Social Security Act, Section 1862 (a) (7). This section excludes routine physical check-ups.

Title XVIII of the Social Security Act, Section 1862 (a) (1) (A). This section allows coverage and payment for only those services that are considered to be reasonable and medically necessary.

Title XVIII of the Social Security Act, Section 1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

CMS Manual System, Pub. 100-2, Medicare Benefit Policy, Chapter 15, Section 50, 50.1 (http://www.cms.hhs.gov/manuals/)

CMS Manual System, Pub. 100-3, Medicare National Coverage Determinations, Chapter 1, Section 310 (http://www.cms.hhs.gov/manuals/) 

 

Primary Geographic Jurisdiction 

New Jersey
Tennessee
 

 

Secondary Geographic Jurisdiction 

Alaska
Alabama
Arkansas
Arizona
California
Colorado
Connecticut
Florida
Georgia
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Mississippi
North Carolina
North Dakota
Nebraska
New Jersey
New Mexico
Nevada
New York
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming
 

 

Oversight Region 

Region IV
 

 

 

Original Determination Effective Date 

For services performed on or after 07/15/2003  

 

Original Determination Ending Date 

 

 

Revision Effective Date 

For services performed on or after 11/24/2004  

 

Revision Ending Date 

 

 

Indications and Limitations of Coverage and/or Medical Necessity 

INDICATIONS

1. ELOXATIN, used in combination with infusional 5-FU/LV, is indicated for the treatment of advanced carcinoma of the colon or rectum. (FDA Labeled Indication)

2. Current data suggests that the regimen of oxaliplatin in combination with oral capecitabine (Xeloda), the XELOX regimen is as effective as the FOLFOX regimen above, with greater convenience for patients. This is generally used as oral capecitabine, 1000 mg/m2 BID on days 1 – 14 with IV oxaliplatin 130 mg/m2 on day 1, in a 21 day treatment cycle. Riverbend will approve use of oxaliplatin in this regimen, without the concomitant use of IV 5-FU, for metastatic carcinoma of the colon for both first line therapy as well as after a failed treatment regimen of 5-FU and irinotecan. (Off Label Indication)

3. Eloxitin will be COVERED and considered medically necessary for all FDA approved and indicated uses in appropriate neoplasm tissue types for dates of service subsequent to FDA approval.

4. Eloxitin will be COVERED for off label use if that use is listed as medically ACCEPTED in the United States Pharmacopoeia Drug Information (USPDI).

5. Eloxitin will be covered for other anti-cancer therapy IF it is is being used in accordance with an established protocol run by a National Center for Excellence for cancer therapy. To be covered under this provision the patient must be fully enrolled in the center's protocol; it is not sufficient for a practitioner to merely "follow" a published protocol.

LIMITATIONS

The FDA approval of Oxaliplatin (Eloxatin) is based on the phase III results of the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin (5-FU/LV) in the Adjuvant Treatment of Colon Cancer (MOSAIC) trial, showing that the addition of oxaliplatin to conventional adjuvant chemotherapy for colon cancer reduced the risk of cancer recurrence by 24% in the overall population who had undergone complete resection of the primary tumor.

The addition of oxaliplatin to 5-FU/LV significantly increased disease-free survival at four years compared with 5-FU/LV alone in the overall study population (76% vs 69%; P = .0008) and in the subgroup with stage III desease (70% vs 61%; P = .002). The addition of oxaliplatin did not benefit overall survival.

1. At this point and time, there is not enough evidence in peer reviewed literature for the first line use of oxaliplatin as a single agent in metastatic carcinoma of the colon. Use of oxaliplatin as a single agent in metastatic carcinoma of the colon is considered investigational.

2. Eloxitin will be considered INVESTIGATIONAL for all uses not described under indications, above.
 

 

Coverage Topic 

Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
 

 

Coding Information

Bill Type Codes: 

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

 

 

Revenue Codes: 

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0250

Pharmacy-general classification

0252

Pharmacy-nongeneric drugs

0280

Oncology-general classification

0335

Radiology therapeutic-chemotherapy IV

0510

Clinic-general classification

 

 

CPT/HCPCS Codes 

 

J9263

INJECTION, OXALIPLATIN, 0.5 MG

 

 

ICD-9 Codes that Support Medical Necessity 

 

153.0 - 153.9

MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.0

MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION

154.1

MALIGNANT NEOPLASM OF RECTUM

154.2

MALIGNANT NEOPLASM OF ANAL CANAL

154.3

MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE

154.8

MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

 

 

Diagnoses that Support Medical Necessity 

 

 

ICD-9 Codes that DO NOT Support Medical Necessity 

 

 

 

 

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation 

 

 

Diagnoses that DO NOT Support Medical Necessity 

 

 

General Information

Documentation Requirements 

Medical records must clearly document the medical necessity for the drug and the frequency of its usage. For services that exceed the accepted standard of recommended dosage and/or frequency, documentation must be submitted to support the medical necessity of such services.

Documentation supporting the medical necessity of this item, such as ICD-9-CM codes, must be submitted with each claim. Claims submitted without such evidence will be denied as being not medically necessary.

All coverage criteria must be documented in the patient’s medical record and made available to Medicare upon request. This information should be generally submitted on reconsideration only. 

 

Appendices 

 

 

Utilization Guidelines 

Medical records must clearly document the medical necessity for the drug and the frequency of its usage. The dose and frequency of administration should be consistent with the FDA approved labeling. For services that exceed the accepted standard of recommended dosage and/or frequency, documentation must be submitted to support the medical necessity of such services. 

 

Sources of Information and Basis for Decision 

Manufacturer’s Package Insert for Eloxatin® from Sanofi-Synthelabo

FDA approval letter for Eloxatin (oxaliplatin)

Other contractors’ policies: Alabama Blue Shield, HGSA Pennsylvania, Cahaba GBA Georgia, Empire Medicare Services, Cigna Medicare.

Alberts SR. Intrahepatic Therapy For Resected Hepatic Metastases From Colorectal Carcinoma. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):48-51. Review.

Andre T, Bensmaine MA, Louvet C, et al: Multicenter Phase II Study Of Bimonthly High-Dose Leucovorin, Fluorouracil Infusion, And Oxaliplatin For Metastatic Colorectal Cancer Resistant To The Same Leucovorin And Fluorouracil Regimen. J Clin Oncol. 1999 Nov;17(11):3560-8.

Bensmaine, de Gramont A, Brienza S, et al: Factors Predicting For Efficacy Of Oxaliplatin In Combination With 5-Fluorouracil (5-FU)+/-Folinic Acid (FA) In A Compassionate-Use Cohort Of 370 5-FU-Resistant Advanced Colorectal Cancer (CRC) Patients. Eur J Cancer. 2000 Dec;36(18):2335-43.

Bensmaine MA, Marty M, de Gramont A, et al: Factors Predicting Efficacy Of Oxaliplatin In Combination With 5-Fluorouracil (5-FU) +/- Folinic Acid In A Compassionate-Use Cohort Of 481 5-FU-Resistant Advanced Colorectal Cancer Patients. Br J Cancer. 2001 Aug 17;85(4):509-17.

Berlin J. New Directions In The Treatment Of Advanced Colorectal Cancer. Oncology (Huntingt). 2001 Mar;15(3 Suppl 5):27-30. Review.

Berlin J. Second-Line Therapy In Colorectal Cancer. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):21-6. Review.

Brienza S, Bensmaine MA, Soulie P, et al: Oxaliplatin Added To 5-Fluorouracil-Based Therapy (5-FU +/- FA) In The Treatment Of 5-FU-Pretreated Patients With Advanced Colorectal Carcinoma (ACRC): Results From The European Compassionate-Use Program. Ann Oncol. 1999 Nov;10(11):1311-6.

Cvitkovic E, Bekradda M. Oxaliplatin: A New Therapeutic Option In Colorectal Cancer.

Semin Oncol. 1999 Dec;26(6):647-62. Review.

Goldberg R. Oxaliplatin In Colorectal Cancer: Current Studies. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):42-7. Review.

Goldberg RM, Morton RF, Sargent DJ, et al. N9741: oxaliplatin (OXAL) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or OXAL + CPT-11 in advanced colorectal cancer (CRC): initial toxicity and response data from a GI Intergroup Study. Program and abstracts of the American Society of Clinical Oncology 38th Annual Meeting; May 18-21, 2002; Orlando, Florida. Abstract 511.

Haller DG. Safety Of Oxaliplatin In The Treatment Of Colorectal Cancer. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):15-20. Review.

Levi F, Misset JL, Brienza S, et al: A Chronopharmacologic Phase II Clinical Trial With 5-Fluorouracil, Folinic Acid, And Oxaliplatin Using An Ambulatory Multichannel Programmable Pump. High Antitumor Effectiveness Against Metastatic Colorectal Cancer. Cancer. 1992 Feb 15;69(4):893-900.

Lorusso PM. Oxaliplatin In Tumors Other Than Colorectal Cancer. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):33-7. Review.

Levi FA, Zidani R, Vannetzel JM, et al: Chronomodulated Versus Fixed-Infusion-Rate Delivery Of Ambulatory Chemotherapy With Oxaliplatin, Fluorouracil, And Folinic Acid (Leucovorin) In Patients With Colorectal Cancer Metastases: A Randomized Multi-Institutional Trial. J Natl Cancer Inst. 1994 Nov 2;86(21):1608-17.

Medscape Conference Coverage, based on selected sessions at the: 38th Annual Meeting of the American Society of Clinical Oncology, May 18 - 21, 2002, Orlando, Florida. Jordan D. Berlin, MD, Craig Lockhart, MD: Treatment of Colorectal Cancer: An Overview of the Latest Data. http://www.medscape.com/viewarticle/436140

Mani S, Manalo J, Bregman D. Novel Combinations With Oxaliplatin. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):52-8. Review.

Misset JL, Bleiberg H, Sutherland W, et al: Oxaliplatin Clinical Activity: A Review. Crit Rev Oncol Hematol. 2000 Aug;35(2):75-93. Review.

Mitchell EP. Oxaliplatin With 5-FU Or As A Single Agent In Advanced/Metastatic Colorectal

Cancer. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):30-2. Review.

Morrison JG, White P, McDougall S, et al: Validation Of A Highly Sensitive ICP-MS Method For The Determination Of Platinum In Biofluids: Application To Clinical Pharmacokinetic Studies With Oxaliplatin. J Pharm Biomed Anal. 2000 Dec;24(1):1-10.

Rothenberg ML. Efficacy Of Oxaliplatin In The Treatment Of Colorectal Cancer. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):9-14. Review.

Ryan DP. Rectal Cancer: Integrating Oxaliplatin Into Chemoradiation Studies. Oncology (Huntingt). 2000 Dec;14(12 Suppl 11):38-41. Review.

Soulie P, Garrino C, Bensmaine MA, et al: Antitumoral Activity Of Oxaliplatin/Cisplatin-Based Combination Therapy In Cisplatin-Refractory Germ Cell Cancer Patients. J Cancer Res Clin Oncol. 1999 Dec;125(12):707-11.

Borner, et al, Phase II Study of Capecitabine & Oxaliplatin in First & Second-Line Treatment of Advanced or Metastatic Colorectal Cancer, JCO, v 20, no 7 (Apr1, 2002), pp1759 – 1766

Scheithauer et al, Randomized Multicenter Phase II Trial of Two Different Shedules of Capecitabine Plus Oxaliplatin as First-line Treatment in Advanced Colorectal Cancer, JCO, v 21, no 7 (Apr 1, 2003), pp 1307 - 1312 

 

Advisory Committee Meeting Notes 

 

 

Start Date of Comment Period 

06/29/2004 

 

End Date of Comment Period 

08/12/2004 

 

Start Date of Notice Period 

08/13/2004 

 

Revision History Number 

17632b 

 

Revision History Explanation 

Indications and Limitations of Coverage and/or Medical necessity--updated FDA approval based on study results

11/26/2005 - CPT/HCPCS code C9205 was deleted from group 1

10/30/2007 - Frequently Asked Questions restored to Appendices

03/18/2008 - Removed unprintable/bad characters per CMS email as of 02/28/2008

03/19/2008 - Frequently Asked Questions removed from Appendices 

 

Reason for Change 

Other
 

Last Reviewed On Date 

03/19/2008 

 

Related Documents 

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Other Versions 

Updated on 03/18/2008 with effective dates 11/24/2004 - N/A

Updated on 10/30/2007 with effective dates 11/24/2004 - N/A

Updated on 11/24/2004 with effective dates 11/24/2004 - N/A

Updated on 10/27/2004 with effective dates 07/15/2003 - N/A

Updated on 06/24/2004 with effective dates 03/22/2004 - 06/24/2004