Automated World Health
L28825
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.
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
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.
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