Local Coverage Determination (LCD) for Docetaxel (Taxotere®) (L28825)

 

 

Contractor Information

 

Contractor Name

First Coast Service Options, Inc. opens in new window

 

 

Contractor Number 09101

 

 

Contractor Type MAC - Part A

 

LCD Information

Document Information

LCD ID Number L28825

 

LCD Title

Docetaxel (Taxotere®)

 

 

Contractor's Determination Number AJ9171

 

 

Primary Geographic Jurisdiction opens in new window Florida

 

 

Oversight Region Region IV

 

 

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

 

 

Original Determination Effective Date

For services performed on or after 02/16/2009 Original Determination Ending Date

 

Revision Effective Date

For services performed on or after 10/01/2011 Revision Ending Date

 

 

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 1, Section 30-30.1

CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10, 20 and 40 CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, Section 20.9-20.96 CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Docetaxel (Taxotere®)-J9171

 

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.

 

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 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 advanced and/or metastatic esophageal, gastric, and/or gastroesophageal (GE) junction carcinomas which includes adenocarcinomas and 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.

 

013x Hospital Outpatient

021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

085x 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 - 149.9 opens in new window

150.0 - 150.9 opens in new window

151.0 - 151.9 opens in new window

157.0 - 157.9 opens in new window

 

MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

 

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

 

160.0 - 160.9 opens in new window

161.0 - 161.9 opens in

 

MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

 

new window MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

 

162.0 - 162.9 opens in new window

170.0 - 170.9 opens in new window

171.0 - 171.9 opens in new window

 

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED

 

 

172.0 - 172.9 opens in

 

MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED

 

new window MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

 

173.00 - 173.09 opens in new window

173.10 - 173.19 opens in new window

173.20 - 173.29 opens in new window

 

173.30 - 173.39 opens in new window

173.40 - 173.49 opens in new window

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

176.0 - 176.9 opens in

 

UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP

UNSPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS - OTHER SPECIFIED MALIGNANT NEOPLASM OF EYELID, INCLUDING CANTHUS UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF EAR AND EXTERNAL AUDITORY

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

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

UNSPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK - OTHER SPECIFIED MALIGNANT NEOPLASM OF SCALP AND SKIN OF NECK

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

 

new window KAPOSI'S SARCOMA SKIN - KAPOSI'S SARCOMA UNSPECIFIED SITE

 

183.0 - 183.9 opens in new window

 

MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

 

185 MALIGNANT NEOPLASM OF PROSTATE

 

188.0 - 188.9 opens in new window

 

MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

 

195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

 

 

 

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

 

 

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

XX000 Not Applicable

 

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

 

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD. Back to Top

 

 

 

General Information

Documentations 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. This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy. 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. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

 

Appendices

 

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

 

 

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/.

 

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.

 

Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from numerous societies.

 

 

Start Date of Comment Period

 

End Date of Comment Period

 

Start Date of Notice Period 01/01/2010

 

Revision History Number 2

 

Revision History Explanation Revision Number: 2 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011

 

LCR A2011-078

September 2011 Connection

 

Explanation of Revision: Annual 2012 ICD-9-CM Update. Deleted diagnosis codes 173.0, 173.1, 173.2, 173.3 and

173.4. Added new diagnosis code ranges 173.00-173.09, 173.10-173.19, 173.20-173.29, 173.30-173.39, and 173.40-173.49. The effective date of this revision is based on date of service.

 

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

 

LCR A2010 - 011

December 2009 Bulletin

 

Explanation of Revision: Annual 2010 HCPCS Update. Added HCPCS code J9171. Deleted HCPCS code J9170. The “Contractor’s Determination Number” was changed from J9170 to J9171. The effective date of this revision is based on date of service.

 

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

 

LCR A2009-

December 2008 Bulletin

 

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

 

For Florida (00090) this LCD (L28825) replaces LCD L25114 as the policy in notice. This document (L28825) is effective on 02/16/2009.

 

 

 

11/15/2009 - CPT/HCPCS code J9170 was deleted from group 1

 

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

 

8/1/2010 - The description for Revenue code 0636 was changed

 

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

 

Reason for Change

 

Related Documents

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LCD Attachments

There are no attachments for this LCD.

 

All Versions

Updated on 09/15/2011 with effective dates 10/01/2011 - N/A Updated on 08/01/2010 with effective dates 01/01/2010 - 09/30/2011 Updated on 08/01/2010 with effective dates 01/01/2010 - N/A Updated on 12/21/2009 with effective dates 01/01/2010 - N/A Updated on 11/29/2008 with effective dates 02/16/2009 - N/A

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