L29228

 

MITOMYCIN (MUTAMYCIN®, MITOMYCIN-C)

 

01/01/2013

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Mitomycin (Mutamycin®, mitomycin-C)-J9280

• Mitomycin concentrate may be used intravenously or as a topical bladder instillation.

 

• Mitomycin is Food and Drug Administration (FDA) approved for the following indications:

o Treatment of gastric and pancreatic carcinoma.

 Mitomycin for injection is NOT recommended as single-agent, primary therapy.

 It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed.

 Mitomycin is NOT recommended to replace appropriate surgery and/or radiation.

• Mitomycin will be covered for its FDA approved uses, as well as for the treatment of the following off-labeled indications:

o Bladder carcinoma (topical treatment of superficial transitional cell carcinoma of the urinary bladder).

o Cervical squamous cell carcinomas.

o Breast carcinoma.

o Esophageal carcinoma.

o Head & neck carcinoma.

o Non-small cell lung carcinoma.

o Prostatic carcinoma.

o Gallbladder.

o Advanced biliary carcinoma.

o Colorectal & anal carcinoma.

o Chronic myelocytic & myelomonocytic leukemias.

o For palliative treatment of adenocarcinoma of the stomach or pancreas unresponsive to surgery. and/or radiotherapy, in combination with other agents.

 

CPT/HCPCS Codes

 

 

 

J9280 INJECTION, MITOMYCIN, 5 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

 

140.0 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER

140.1 MALIGNANT NEOPLASM OF LOWER LIP VERMILION BORDER

140.3 MALIGNANT NEOPLASM OF UPPER LIP INNER ASPECT

140.4 MALIGNANT NEOPLASM OF LOWER LIP INNER ASPECT

140.5 MALIGNANT NEOPLASM OF LIP UNSPECIFIED INNER ASPECT

140.6 MALIGNANT NEOPLASM OF COMMISSURE OF LIP

140.8 MALIGNANT NEOPLASM OF OTHER SITES OF LIP

140.9 MALIGNANT NEOPLASM OF LIP UNSPECIFIED VERMILION BORDER

141.0 MALIGNANT NEOPLASM OF BASE OF TONGUE

141.1 MALIGNANT NEOPLASM OF DORSAL SURFACE OF TONGUE

141.2 MALIGNANT NEOPLASM OF TIP AND LATERAL BORDER OF TONGUE

141.3 MALIGNANT NEOPLASM OF VENTRAL SURFACE OF TONGUE

141.4 MALIGNANT NEOPLASM OF ANTERIOR TWO-THIRDS OF TONGUE PART UNSPECIFIED

141.5 MALIGNANT NEOPLASM OF JUNCTIONAL ZONE OF TONGUE

141.6 MALIGNANT NEOPLASM OF LINGUAL TONSIL

141.8 MALIGNANT NEOPLASM OF OTHER SITES OF TONGUE

141.9 MALIGNANT NEOPLASM OF TONGUE UNSPECIFIED

142.0 MALIGNANT NEOPLASM OF PAROTID GLAND

142.1 MALIGNANT NEOPLASM OF SUBMANDIBULAR GLAND

142.2 MALIGNANT NEOPLASM OF SUBLINGUAL GLAND

142.8 MALIGNANT NEOPLASM OF OTHER MAJOR SALIVARY GLANDS

142.9 MALIGNANT NEOPLASM OF SALIVARY GLAND UNSPECIFIED

143.0 MALIGNANT NEOPLASM OF UPPER GUM

143.1 MALIGNANT NEOPLASM OF LOWER GUM

143.8 MALIGNANT NEOPLASM OF OTHER SITES OF GUM

143.9 MALIGNANT NEOPLASM OF GUM UNSPECIFIED

144.0 MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH

144.1 MALIGNANT NEOPLASM OF LATERAL PORTION OF FLOOR OF MOUTH

144.8 MALIGNANT NEOPLASM OF OTHER SITES OF FLOOR OF MOUTH

144.9 MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED

145.0 MALIGNANT NEOPLASM OF CHEEK MUCOSA

145.1 MALIGNANT NEOPLASM OF VESTIBULE OF MOUTH

145.2 MALIGNANT NEOPLASM OF HARD PALATE

145.3 MALIGNANT NEOPLASM OF SOFT PALATE

145.4 MALIGNANT NEOPLASM OF UVULA

145.5 MALIGNANT NEOPLASM OF PALATE UNSPECIFIED

145.6 MALIGNANT NEOPLASM OF RETROMOLAR AREA

145.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PARTS OF MOUTH

145.9 MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED

146.0 MALIGNANT NEOPLASM OF TONSIL

146.1 MALIGNANT NEOPLASM OF TONSILLAR FOSSA

146.2 MALIGNANT NEOPLASM OF TONSILLAR PILLARS (ANTERIOR) (POSTERIOR)

146.3 MALIGNANT NEOPLASM OF VALLECULA EPIGLOTTICA

146.4 MALIGNANT NEOPLASM OF ANTERIOR ASPECT OF EPIGLOTTIS

146.5 MALIGNANT NEOPLASM OF JUNCTIONAL REGION OF OROPHARYNX

146.6 MALIGNANT NEOPLASM OF LATERAL WALL OF OROPHARYNX

146.7 MALIGNANT NEOPLASM OF POSTERIOR WALL OF OROPHARYNX

146.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF OROPHARYNX

146.9 MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE

147.0 MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX

147.1 MALIGNANT NEOPLASM OF POSTERIOR WALL OF NASOPHARYNX

147.2 MALIGNANT NEOPLASM OF LATERAL WALL OF NASOPHARYNX

147.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF NASOPHARYNX

147.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NASOPHARYNX

147.9 MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE

148.0 MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX

148.1 MALIGNANT NEOPLASM OF PYRIFORM SINUS

148.2 MALIGNANT NEOPLASM OF ARYEPIGLOTTIC FOLD HYPOPHARYNGEAL ASPECT

148.3 MALIGNANT NEOPLASM OF POSTERIOR HYPOPHARYNGEAL WALL

148.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF HYPOPHARYNX

148.9 MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE

149.0 MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED

149.1 MALIGNANT NEOPLASM OF WALDEYER'S RING

149.8 MALIGNANT NEOPLASM OF OTHER SITES WITHIN THE LIP AND ORAL CAVITY

149.9 MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

150.0 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS

150.1 MALIGNANT NEOPLASM OF THORACIC ESOPHAGUS

150.2 MALIGNANT NEOPLASM OF ABDOMINAL ESOPHAGUS

150.3 MALIGNANT NEOPLASM OF UPPER THIRD OF ESOPHAGUS

150.4 MALIGNANT NEOPLASM OF MIDDLE THIRD OF ESOPHAGUS

150.5 MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS

150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS

150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 MALIGNANT NEOPLASM OF CARDIA

151.1 MALIGNANT NEOPLASM OF PYLORUS

151.2 MALIGNANT NEOPLASM OF PYLORIC ANTRUM

151.3 MALIGNANT NEOPLASM OF FUNDUS OF STOMACH

151.4 MALIGNANT NEOPLASM OF BODY OF STOMACH

151.5 MALIGNANT NEOPLASM OF LESSER CURVATURE OF STOMACH UNSPECIFIED

151.6 MALIGNANT NEOPLASM OF GREATER CURVATURE OF STOMACH UNSPECIFIED

151.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF STOMACH

151.9 MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE

153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON

153.2 MALIGNANT NEOPLASM OF DESCENDING COLON

153.3 MALIGNANT NEOPLASM OF SIGMOID COLON

153.4 MALIGNANT NEOPLASM OF CECUM

153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS

153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE

153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE

153.9 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

156.0 MALIGNANT NEOPLASM OF GALLBLADDER

156.1 MALIGNANT NEOPLASM OF EXTRAHEPATIC BILE DUCTS

156.2 MALIGNANT NEOPLASM OF AMPULLA OF VATER

156.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF GALLBLADDER AND EXTRAHEPATIC BILE DUCTS

156.9 MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

157.0 MALIGNANT NEOPLASM OF HEAD OF PANCREAS

157.1 MALIGNANT NEOPLASM OF BODY OF PANCREAS

157.2 MALIGNANT NEOPLASM OF TAIL OF PANCREAS

157.3 MALIGNANT NEOPLASM OF PANCREATIC DUCT

157.4 MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS

157.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF PANCREAS

157.9 MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

160.0 MALIGNANT NEOPLASM OF NASAL CAVITIES

160.1 MALIGNANT NEOPLASM OF AUDITORY TUBE MIDDLE EAR AND MASTOID AIR CELLS

160.2 MALIGNANT NEOPLASM OF MAXILLARY SINUS

160.3 MALIGNANT NEOPLASM OF ETHMOIDAL SINUS

160.4 MALIGNANT NEOPLASM OF FRONTAL SINUS

160.5 MALIGNANT NEOPLASM OF SPHENOIDAL SINUS

160.8 MALIGNANT NEOPLASM OF OTHER ACCESSORY SINUSES

160.9 MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

161.0 MALIGNANT NEOPLASM OF GLOTTIS

161.1 MALIGNANT NEOPLASM OF SUPRAGLOTTIS

161.2 MALIGNANT NEOPLASM OF SUBGLOTTIS

161.3 MALIGNANT NEOPLASM OF LARYNGEAL CARTILAGES

161.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARYNX

161.9 MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

162.0 MALIGNANT NEOPLASM OF TRACHEA

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

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

180.0 MALIGNANT NEOPLASM OF ENDOCERVIX

180.1 MALIGNANT NEOPLASM OF EXOCERVIX

180.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX

180.9 MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

185 MALIGNANT NEOPLASM OF PROSTATE

188.0 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER

188.1 MALIGNANT NEOPLASM OF DOME OF URINARY BLADDER

188.2 MALIGNANT NEOPLASM OF LATERAL WALL OF URINARY BLADDER

188.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF URINARY BLADDER

188.4 MALIGNANT NEOPLASM OF POSTERIOR WALL OF URINARY BLADDER

188.5 MALIGNANT NEOPLASM OF BLADDER NECK

188.6 MALIGNANT NEOPLASM OF URETERIC ORIFICE

188.7 MALIGNANT NEOPLASM OF URACHUS

188.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BLADDER

188.9 MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK

205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION

205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

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

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

o The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

Treatment Logic

• Mitomycin is classified as an antitumor antibiotic.

• It inhibits DNA synthesis by causing cross-linking. It also inhibits RNA and protein synthesis.

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin. (May 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO LCD 29228, Mitomycin (Mutamycin®, Mitomycin-C), 01/01/2013. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

National Comprehensive Cancer Network (2006). Pancreatic Adenocarcinoma. Clinical Practice Guidelines in Oncology – V.1.2006.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, July 2007.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 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.

 

© Automated Clinical Guidelines, LLC 2013

 

CMS LCD MITOMYCIN (MUTAMYCIN®, MITOMYCIN-C)