Local Coverage Determination (LCD) for Leucovorin (Wellcovorin®) (L29213)

 

 

Contractor Information

 

Contractor Name

First Coast Service Options, Inc. opens in new window

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Contractor Number 09102

 

 

Contractor Type MAC - Part B

 

 

LCD Information

Document Information

LCD ID Number L29213

 

 

LCD Title

Leucovorin (Wellcovorin®)

 

 

Contractor's Determination Number J0640

 

 

 

Primary Geographic Jurisdiction opens in new window Florida

 

 

Oversight Region Region IV

 

 

 

AMA CPT/ADA CDT 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

 

 

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

 

Revision Effective Date

 

 

 

Revision Ending Date

 

 

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See § 1869 (f)(1)(A)(i) of the Social Security Act.

Unless other wise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 50

CMS Manual System, Pub. 100-20, CR 3631 and CR 3818

 

 

Indications and Limitations of Coverage and/or Medical Necessity

Leucovorin is a reduced form of folic acid, which is readily converted to other reduced folic acid derivatives. It is used as an antidote, antianemic and as a chemotherapeutic adjunct.

 

Medicare will consider Leucovorin medically reasonable and necessary when used for any of the following FDA approved indications:

 

as an antidote for the toxic affects of the folic acid antagonists such as Methotrexate, Pyrimethamine, or Trimethoprim;

 

as a rescue agent after high-dose Methotrexate therapy;

 

as an adjunct to Fuorouracil in the palliative treatment of advanced colorectal cancer; and

 

as a treatment for megaloblastic anemias associated with sprue, nutritional deficiency, pregnancy, and infancy when oral folic acid therapy is not feasible.

 

Note: Leucovorin is not recommended for use in the treatment of pernicious anemia or other megaloblastic anemias secondary to lack of Vitamin B12, since it may produce hematologic remissions while neurologic manifestations continue to progress.

 

Medicare will cover Leucovorin for the FDA approved indications as well as for the treatment of the following off- labeled indications:

 

Head and neck squamous cell carcinoma, when used in combination with agents such as Fluorouracil or high-dose Methotrexate

 

Ewing’s sarcoma when used in combination with high-dose Methotrexate

 

Non-Hodgkin’s lymphoma when used in combination with high-dose Methotrexate Gestational trophoblastic tumors when used in combination with high-dose Methotrexate Breast carcinoma when used in combination with Fluorouracil

Gastric carcinoma when used in combination with Fluorouracil or Floxuridine Pancreatic carcinoma when used in combination with Fluorouracil

Bladder carcinoma when used in combination with Fluorouracil Prostate carcinoma when used in combination with Fluorouracil Ovarian carcinoma when used in combination with Fluorouracil Cervical carcinoma when used in combination with Fluorouracil Endometrial carcinoma when used in combination with Fluorouracil Malignant neoplasm of the small intestine

Esophageal carcinoma when used in combination with Fluorouracil or Floxuridine Liver carcinoma when used in combination with Fluorouracil

Gallbladder and extrahepatic bile duct carcinoma when used in combination with Fluorouracil Cancer of unknown primary site (CUPs)

Adrenal cortex carcinoma when used in combination with Fluorouracil Vulvar carcinoma when used in combination with Fluorouracil

Penile carcinoma when used in combination with Fluorouracil Malignant neoplasm of testis

 

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.

 

 

 

99999 Not Applicable

 

CPT/HCPCS Codes

J0640 INJECTION, LEUCOVORIN CALCIUM, PER 50 MG

 

ICD-9 Codes that Support Medical Necessity

 

 

140.0 - 149.9 opens in new window

150.0 - 150.9 opens in new window

151.0 - 151.9 opens in new window

152.0 - 152.9 opens in new window

153.0 - 153.9 opens in new window

154.0 - 154.8 opens in new window

155.0 - 155.2 opens in new window

156.0 - 156.9 opens in new window

157.0 - 157.9 opens in new window

160.0 - 160.9 opens in new window

161.0 - 161.9 opens in

 

MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

MALIGNANT NEOPLASM OF DUODENUM - MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE

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

MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

 

new window MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS

162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG

162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG

162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG

162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG

162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

 

170.0 - 170.9 opens in new window

 

MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED

 

171.0 - 171.9 opens in new window

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

180.0 - 180.9 opens in new window

 

MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

 

181 MALIGNANT NEOPLASM OF PLACENTA

182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS

183.0 MALIGNANT NEOPLASM OF OVARY

184.1 MALIGNANT NEOPLASM OF LABIA MAJORA

184.2 MALIGNANT NEOPLASM OF LABIA MINORA

184.3 MALIGNANT NEOPLASM OF CLITORIS

184.4 MALIGNANT NEOPLASM OF VULVA UNSPECIFIED SITE

185 MALIGNANT NEOPLASM OF PROSTATE

186.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS

187.1 MALIGNANT NEOPLASM OF PREPUCE

187.2 MALIGNANT NEOPLASM OF GLANS PENIS

187.3 MALIGNANT NEOPLASM OF BODY OF PENIS

187.4 MALIGNANT NEOPLASM OF PENIS PART UNSPECIFIED

187.7 MALIGNANT NEOPLASM OF SCROTUM

 

188.0 - 188.9 opens in new window

191.0 - 191.9 opens in new window

194.0 - 194.9 opens in new window

 

MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

MALIGNANT NEOPLASM OF ADRENAL GLAND - MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED

 

195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK

198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

 

199.0 - 199.2 opens in new window

200.00 - 200.88 opens in new window

201.00 - 201.98 opens in new window

202.00 - 202.98 opens in new window

 

DISSEMINATED MALIGNANT NEOPLASM - MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN

RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES

NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

 

236.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLACENTA

281.2 FOLATE-DEFICIENCY ANEMIA

281.3 OTHER SPECIFIED MEGALOBLASTIC ANEMIAS NOT ELSEWHERE CLASSIFIED

579.1 CELIAC DISEASE

579.2 TROPICAL SPRUE

 

648.20 - 648.24 opens in new window

 

ANEMIA OF MOTHER COMPLICATING PREGNANCY CHILDBIRTH OR THE PUERPERIUM UNSPECIFIED AS TO EPISODE OF CARE - POSTPARTUM ANEMIA

 

960.8 POISONING BY OTHER SPECIFIED ANTIBIOTICS

961.4 POISONING BY ANTIMALARIALS AND DRUGS ACTING ON OTHER BLOOD PROTOZOA

963.1 POISONING BY ANTINEOPLASTIC AND IMMUNOSUPPRESSIVE DRUGS

995.20 UNSPECIFIED ADVERSE EFFECT OF UNSPECIFIED DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

995.29 UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

 

 

 

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

 

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

 

Diagnoses that DO NOT Support Medical Necessity N/A

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General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring provider must substantiate the medical necessity for the use of Leucovorin by clearly indicating the condition for which this drug is being used. This

documentation is usually found in the history and physical or in the office/progress notes.

 

Appendices

 

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

 

Sources of Information and Basis for Decision

Compendia-Based Drug Bulletin. (November 2005). The Association of Community Cancer Centers. [On-Line]. Available:    http://www.accc-cancer.org/cgi-bin/nds/nvbcgfh.exe.

 

Facts and Comparisons. (2002, September). Chemotherapy Regimens. Drugs Facts and Comparisons, 1811- 1816d. Supported off-labeled indications for Leucovorin.

 

The United States Pharmacopeia Drug Information (USP DI). (2005). The Association of Community Cancer Centers (ACCC). [On-Line]. Available: http://www.accc-cancer.org/cgi-bin/nds/nvbcgfh.exe.

 

 

 

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.

 

 

 

Start Date of Comment Period

 

End Date of Comment Period

 

Start Date of Notice Period 12/04/2008

 

Revision History Number Original

 

Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

 

LCR B2009-

December 2008 Bulletin

 

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

 

For Florida (00590) this LCD (L29213) replaces LCD L13836 as the policy in notice. This document (L29213) is effective on 02/02/2009.

 

Reason for Change

 

Related Documents

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Updated on 11/30/2008 with effective dates 02/02/2009 - N/A Read the LCD Disclaimer opens in new window