Automated World Health
L29249
PACLITAXEL (TAXOL®)
02/02/2009
Indications and Limitations of Coverage and/or Medical Necessity
Paclitaxel (Taxol®)-J9265
• Paclitaxel is FDA approved for treatment of the following indications:
o Adjuvant treatment of node-positive breast cancer when administered sequentially to standard doxorubicin-containing combination chemotherapy.
o Metastatic breast carcinoma after failure of combination chemotherapy or at relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
o Advanced carcinoma of ovary - first-line therapy in combination with cisplatin, and subsequent therapy.
o As a second-line treatment for AIDS-associated Kaposi’s sarcoma.
o Non-small cell lung carcinoma in combination with Cisplatin as a first-line treatment for patients who are not candidates for radiation therapy or potentially curative surgery.
• Medicare will cover Paclitaxel for its FDA approved uses, as well as for the treatment of the following off-labeled indications:
o First line therapy for treatment of metastatic breast cancer - as a single agent or in combination with other chemotherapy agents.
o Bladder carcinoma.
o Cervical carcinoma.
o Endometrial carcinoma.
o Esophageal carcinoma.
o Head & neck carcinoma.
o Small cell and non-small cell lung carcinoma.
o Prostatic carcinoma.
o Advanced gastric carcinoma - in combination therapy.
o Malignant pleural effusion.
o Cancer of Unknown Primary site (CUPs).
o Fallopian and peritoneal carcinomas of ovarian origin when used in combination with Carboplatin or Cisplatin.
o Testicular germ cell carcinoma.
o Soft tissue sarcomas.
o Used in combination with carboplatin for the treatment of malignant melanoma.
CPT/HCPCS Codes
J9265 INJECTION, PACLITAXEL, 30 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
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
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
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
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
182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS
182.1 MALIGNANT NEOPLASM OF ISTHMUS
182.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS
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
186.0 MALIGNANT NEOPLASM OF UNDESCENDED TESTIS
186.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS
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
197.2 SECONDARY MALIGNANT NEOPLASM OF PLEURA
197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM
199.0 DISSEMINATED MALIGNANT NEOPLASM
199.1 OTHER MALIGNANT NEOPLASM OF UNSPECIFIED SITE
199.2 MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN
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
• Paclitaxel is an antimicrotubule agent.
• It interferes with the normal cellular microtubule function that is required for interphase and mitosis.
Sources of Information and Basis for Decision
Compendia-Based Drug Bulletin. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.
FCSO LCD 29249, Paclitaxel (Taxol®), 02/02/2009. 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 (2007). Ovarian Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.
Rao, R., Holtan, S., Ingle, J., Croghan, G., Kottschade, L., Creagan, E., et al. (2005). Combination of paclitaxel and carboplatin as second line therapy for patients with metastatic melanoma. American Cancer Society, 375-382.
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, March 2007.
Zimpfer-Rechner, C., Hofmann, U., Figl, R., Becker, J., Trefzer, U., Keller, I., et al. (2003). Randomized phase II study of weekly paclitaxel versus paclitaxel and carboplatin as second-line therapy in disseminated melanoma: a multicentre trial of the Dermatologic Co-operative Oncology Group. Melanoma Research 13(5): 531-536.
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