Automated World Health
L28930
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.
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.
13x Hospital Outpatient
21x Skilled Nursing - Inpatient (Including Medicare Part A)
22x Skilled Nursing - Inpatient (Medicare Part B only)
23x Skilled Nursing - Outpatient
85x Critical Access Hospital
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.
0636 Pharmacy - Drugs Requiring Detailed Coding
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 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.
© Automated Clinical Guidelines, LLC 2013
CMS LCD MITOMYCIN (MUTAMYCIN®, MITOMYCIN-C)