L29155

 

DOCETAXEL (TAXOTERE®)

 

10/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

Docetaxel (Taxotere®)-J9171

Taxotere is FDA approved for the following indications:

• For treatment of locally advanced or metastatic breast cancer after failure of prior chemotherapy.

• Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

• Docetaxel as a single agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of platinum-based chemotherapy.

• Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.

• Docetaxel in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

• Docetaxel in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

• Docetaxel in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Medicare will cover Taxotere for its FDA approved uses, as well as for the treatment of the following off-labeled indications:

• Fallopian tube carcinoma.

• Primary peritoneal carcinoma.

• Small-cell lung carcinoma after first-line chemotherapy has failed.

• Bladder carcinoma, alone or in combination with other chemotherapeutic agents.

• Ovarian carcinoma, after platinum-based therapy has failed, or as first-line treatment in combination with carboplatin.

• Melanoma.

• Breast carcinoma, first-line therapy for locally advanced or metastatic.

• Non-small cell lung (NSCLC) carcinoma, first-line.

• Esophageal carcinoma, alone or in combination with other agents, for the treatment of advanced and/or metastatic esophageal carcinomas, including adenocarcinomas and squamous cell carcinomas.

• Gastric carcinomas, alone or in combination for the treatment of:

o Advanced and/or metastatic esophageal.

 Adenocarcinomas.

 Squamous cell carcinomas.

o Gastric.

 Adenocarcinomas.

 Squamous cell carcinomas.

o Gastroesophageal (GE) junction carcinomas which includes:

 Adenocarcinomas.

 Squamous cell carcinomas.

• Pancreatic carcinoma.

• Soft tissue sarcomas.

• Bone and articular cartilage.

• Second-line treatment of AIDS-related Kaposi’s sarcoma.

 

CPT/HCPCS Codes

 

 

 

J9171 INJECTION, DOCETAXEL, 1 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

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

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM 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

170.0 MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE

170.1 MALIGNANT NEOPLASM OF MANDIBLE

170.2 MALIGNANT NEOPLASM OF VERTEBRAL COLUMN EXCLUDING SACRUM AND COCCYX

170.3 MALIGNANT NEOPLASM OF RIBS STERNUM AND CLAVICLE

170.4 MALIGNANT NEOPLASM OF SCAPULA AND LONG BONES OF UPPER LIMB

170.5 MALIGNANT NEOPLASM OF SHORT BONES OF UPPER LIMB

170.6 MALIGNANT NEOPLASM OF PELVIC BONES SACRUM AND COCCYX

170.7 MALIGNANT NEOPLASM OF LONG BONES OF LOWER LIMB

170.8 MALIGNANT NEOPLASM OF SHORT BONES OF LOWER LIMB

170.9 MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED

171.0 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK

171.2 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER

171.3 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP

171.4 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF THORAX

171.5 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN

171.6 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF PELVIS

171.7 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED

171.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE

171.9 MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED

172.0 MALIGNANT MELANOMA OF SKIN OF LIP

172.1 MALIGNANT MELANOMA OF SKIN OF EYELID INCLUDING CANTHUS

172.2 MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

172.3 MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

172.4 MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK

172.5 MALIGNANT MELANOMA OF SKIN OF TRUNK EXCEPT SCROTUM

172.6 MALIGNANT MELANOMA OF SKIN OF UPPER LIMB INCLUDING SHOULDER

172.7 MALIGNANT MELANOMA OF SKIN OF LOWER LIMB INCLUDING HIP

172.8 MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN

172.9 MELANOMA OF SKIN SITE UNSPECIFIED

173.00 UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP

173.01 BASAL CELL CARCINOMA OF SKIN OF LIP

173.02 SQUAMOUS CELL CARCINOMA OF SKIN OF LIP

173.09 OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP

173.10 UNSPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS

173.11 BASAL CELL CARCINOMA OF EYELID, INCLUDING CANTHUS

173.12 SQUAMOUS CELL CARCINOMA OF EYELID, INCLUDING CANTHUS

173.19 OTHER SPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS

173.20 UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.21 BASAL CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.22 SQUAMOUS CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.29 OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.30 UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.31 BASAL CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.32 SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.39 OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.40 UNSPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK

173.41 BASAL CELL CARCINOMA OF SCALP AND SKIN OF NECK

173.42 SQUAMOUS CELL CARCINOMA OF SCALP AND SKIN OF NECK

173.49 OTHER SPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK

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

176.0 KAPOSI'S SARCOMA SKIN

176.1 KAPOSI'S SARCOMA SOFT TISSUE

176.2 KAPOSI'S SARCOMA PALATE

176.3 KAPOSI'S SARCOMA GASTROINTESTINAL SITES

176.4 KAPOSI'S SARCOMA LUNG

176.5 KAPOSI'S SARCOMA LYMPH NODES

176.8 KAPOSI'S SARCOMA OTHER SPECIFIED SITES

176.9 KAPOSI'S SARCOMA UNSPECIFIED SITE

183.0 MALIGNANT NEOPLASM OF OVARY

183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE

183.3 MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS

183.4 MALIGNANT NEOPLASM OF PARAMETRIUM

183.5 MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS

183.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA

183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA 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

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

 

 

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:

• Docetaxel, an antineoplastic agent belonging to the taxoid family, acts by disrupting cell replication.

• It is a derivative of 10-deacetylbaccatin 111, a compound extracted from the needles of the European yew tree.

• Docetaxel acts by disrupting the microtubular network in cells, an essential component of vital mitotic and interphase cellular functions.

 

Sources of Information and Basis for Decision

 

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

 

FCSO LCD 29155, Docetaxel (Taxotere®), 10/01/2011. 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.

 

Taxotere® (docetaxel) injection concentrate prescribing information, Sanofi-Aventis

 

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, February 2008.

 

 

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 2011-2013

 

CMS LCD DOCETAXEL (TAXOTERE®)