L28826-LCD

Automated World Health

Local Coverage Determination (LCD) for Doxorubicin HCl (L28826)

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 L28826

LCD Title Doxorubicin HCl

Contractor's Determination Number AJ9000

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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

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

DOXORUBICIN HCL 10MG (ADRIAMYCIN PFS; ADRIAMYCIN RDF; RUBEX) - J9000/DOXORUBICIN HCL

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:

• Ewing’s sarcoma

• AIDS associated Kaposi’s sarcoma

• Cervical carcinoma

• Endometrial carcinoma

• 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.

013x Hospital Outpatient

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

J9000 INJECTION, DOXORUBICIN HYDROCHLORIDE, 10 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

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 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 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

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

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

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. 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.

The amount of drug, route and timing of administration, and any reaction to the patient should be documented in the medical record. In general, a facility should bill what is administered to the patient with attention to the code descriptor and quantity billed. In the event that only one patient needs a portion of the contents in the single use vial, then the remainder can be discarded. In such a situation, the entire contents of the vial can be billed. In no circumstances can multiple patients be billed for the entire contents of a single vial when the patients each received a portion of the drug from the same vial. With appropriate procedures, it is safe to reenter a medication vial labeled as single use. CMS issued a procedure, developed with the approval of the Centers for Disease Control, for safe re-entry into “single use” vials. Medicare expects this procedure to be used whenever feasible for efficient use of medications and minimal wasted drug. The hospital pharmacy record should have documentation on drug discarded for single use vials that is subsequently billed to a Medicare patient.

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 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:02/16/2009

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 (L28826) replaces LCD L25108 as the policy in notice. This document (L28826) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 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

Reason for Change