Automated World Health
Local Coverage Determination (LCD) for Doxorubicin HCl (L29156)
Contractor Information
Contractor Name
First Coast Service Options, Inc. opens in new window
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Contractor Number
09102
Contractor Type
MAC - Part B
LCD Information
Document Information
LCD ID Number L29156
LCD Title Doxorubicin HCl
Contractor's Determination Number J9000
Primary Geographic Jurisdiction opens in new window Florida
Oversight Region Region IV
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Original Determination Effective Date
For services performed on or after 02/02/2009 Original Determination Ending Date
Revision Effective Date
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, Chapter 15, Section 50
CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 40
CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3
Indications and Limitations of Coverage and/or Medical Necessity
DOXORUBICIN HCL 10MG (ADRIAMYCIN PFS; ADRIAMYCIN RDF; RUBEX) - J9000
Doxorubicin is an anthracycline glycoside; it is classified as an antibiotic but is not used as an antimicrobial agent. It selectively kills malignant cells and produces tumor regression in a variety of human neoplasms.
Doxorubicin may be administered intravenously, intra-arterially, and as a topical bladder instillation Doxorubicin is FDA approved for treatment of the following indications:
• Acute lymphoblastic leukemia
• Acute myeloblastic leukemia
• Transitional cell bladder carcinoma
• Breast carcinoma
• Gastric carcinoma
• Bronchogenic carcinoma
• Ovarian carcinoma
• Thyroid carcinoma
• Neuroblastoma
• Wilm’s tumor
• Hodgkin’s disease
• Soft tissue and bone sarcomas
• Malignant lymphoma
• Doxorubicin is also FDA approved for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.
Medicare will cover Doxorubicin for its FDA approved uses, as well as for the treatment of the following off- labeled indications:
• Cervical carcinoma
• Ewing’s sarcoma
• Endometrial carcinoma
• AIDS associated Kaposi’s sarcoma
• Head and neck carcinoma
• Non-small cell lung carcinoma
• Pancreatic carcinoma
• Prostatic carcinoma
• Ovarian germ cell tumors
• Multiple myeloma
• Chronic lymphocytic leukemia
• Primary hepatocellular carcinoma
• Hepatoblastoma
• Thymoma
• Gestational trophoblastic tumors
• Retinoblastoma
• Primary peritoneal carcinoma
• Esophageal carcinoma
• Adrenocortical carcinoma
• Vaginal carcinoma
• Testicular carcinoma
• Carcinoid tumors
• Bladder carcinoma prophylaxis
• Fallopian tube carcinoma
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.
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.
99999 Not Applicable
CPT/HCPCS Codes
J9000 INJECTION, DOXORUBICIN HYDROCHLORIDE, 10 MG
ICD-9 Codes that Support Medical Necessity
140.0 - 149.9 opens in new window
MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY
150.0 - 150.9 opens in new window
151.0 - 151.9 opens in new window
152.0 - 152.9 opens in new window
153.0 - 153.9 opens in new window
155.0 - 155.2 opens in new window
156.0 - 156.9 opens in new window
157.0 - 157.9 opens in new window
MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE
MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE
MALIGNANT NEOPLASM OF DUODENUM - MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE
MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE
MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY
MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART 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
MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED
164.0 MALIGNANT NEOPLASM OF THYMUS
164.8 MALIGNANT NEOPLASM OF OTHER PARTS OF MEDIASTINUM
170.0 - 170.9 opens in new window
171.0 - 171.9 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
MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE - MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED
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
180.0 - 180.9 opens in new window
MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE
181 MALIGNANT NEOPLASM OF PLACENTA
182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS
183.0 MALIGNANT NEOPLASM OF OVARY
183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE
183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE
184.0 MALIGNANT NEOPLASM OF VAGINA
185 MALIGNANT NEOPLASM OF PROSTATE
186.0 - 186.9 opens in new window
188.0 - 188.9 opens in new window
MALIGNANT NEOPLASM OF UNDESCENDED TESTIS - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS
MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED
189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS
190.5 MALIGNANT NEOPLASM OF RETINA
193 MALIGNANT NEOPLASM OF THYROID GLAND
194.0 - 194.9 opens in new window
MALIGNANT NEOPLASM OF ADRENAL GLAND - MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED
195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK
197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM
198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW
200.00 - 200.88 opens in new window
201.00 - 201.98 opens in new window
RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES
HODGKIN'S PARAGRANULOMA UNSPECIFIED SITE - HODGKIN'S DISEASE UNSPECIFIED TYPE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.00 - 202.98 opens in new window
203.00 - 203.02 opens in new window
204.00 - 204.02 opens in new window
204.10 - 204.12 opens in new window
205.00 - 205.92 opens in new window
206.00 - 206.02 opens in new window
207.00 - 207.02 opens in new window
NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES
MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MULTIPLE MYELOMA, IN RELAPSE
ACUTE LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE LYMPHOID LEUKEMIA, IN RELAPSE
CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
- CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE
ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - UNSPECIFIED MYELOID LEUKEMIA, IN RELAPSE
ACUTE MONOCYTIC LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
- ACUTE MONOCYTIC LEUKEMIA, IN RELAPSE
ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE ERYTHREMIA AND ERYTHROLEUKEMIA, IN RELAPSE
236.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLACENTA
259.2 CARCINOID SYNDROME
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.
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. (February 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.
National Comprehensive Cancer Network (2006). Hodgkin Disease/Lymphoma. 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, February 2007.
Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.
Start Date of Comment Period
End Date of Comment Period
Start Date of Notice Period 12/04/2008
Revision History Number Original
Revision History Explanation Revision Number:Original Start Date of Comment Period:N/A
Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009
LCR B2009-
December 2008 Bulletin
This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).
For Florida (00590) this LCD (L29156) replaces LCD L25060 as the policy in notice. This document (L29156) is effective on 02/02/2009.
Reason for Change
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All Versions
Updated on 11/30/2008 with effective dates 02/02/2009 - N/A Read the LCD Disclaimer opens in new window