L28835-LCD

Automated World Health

Local Coverage Determination (LCD) for Epirubicin Hydrochloride (Ellence™) (L28835)

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 L28835

LCD Title

Epirubicin Hydrochloride (Ellence™)

Contractor's Determination Number AJ9178

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. 100-2, Medicare Benefit Policy Manual, Chapter 1, Section 30-30.1

CMS Manual System, Pub. 100-2, Medicare Benefit Policy Manual, Chapter 15, Section 50

CMS Manual System, Pub. 100-4, Medicare Claims Processing Manual, Chapter 17, Sections 10, 20 and 40 CMS Manual System, Pub. 100-4, Medicare Claims Processing Manual, Chapter 23, Section 20.9-20.96 CMS Manual System, Pub. 100-8, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity

Epirubicin Hydrochloride (Ellence™)-J9178

Epirubicin Hydrochloride for injection is an anthracycline cytotoxic agent, intended for intravenous administration. It is the 4-epimer of doxorubicin and is a semi-synthetic derivative of daunorubicin.

Epirubicin HCl is FDA approved for the following indications:

• For injection as a component of adjuvant therapy in patients with evidence of axillary-node tumor involvement following resection of primary breast cancer.

Medicare will consider Epirubicin HCl medically reasonable and necessary when provided for its FDA approved uses, as well as for the treatment of the following off-labeled indications:

• As a single agent and in combination therapy with other agents for the treatment of locally unresectable and metastatic gastric carcinoma.

• In combination with other agents for the treatment of esophageal and esophagogastric junction carcinomas and adenocarcinomas.

• As a single agent and in combination therapy with other agents, for the treatment of advanced non-small cell lung carcinoma and limited and extensive small cell lung carcinoma.

• As a single agent and in combination therapy with other agents, for the treatment of stage III and IV FIGO ovarian carcinoma.

• In combination therapy with other agents for the treatment of Hodgkin’s lymphoma.

• As a single agent and in combination therapy with other agents for the treatment of non-Hodgkin’s lymphoma.

• As a single agent and in combination therapy with other agents and/or surgery for the treatment of soft tissue sarcomas in place of Doxorubicin.

• As a single agent and in combination therapy with other agents, for the treatment of metastatic breast carcinoma.

• Primary peritoneal carcinoma

• 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

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

J9178 INJECTION, EPIRUBICIN HCL, 2 MG

ICD-9 Codes that Support Medical Necessity

150.0 - 150.9 opens in new window

151.0 - 151.9 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

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

162.0 - 162.9 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

183.0 - 183.9 opens in new window

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG 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

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

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

200.00 - 200.88 opens in new window

201.00 - 201.98 opens in new window

202.00 - 202.98 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

NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

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.

Documentation in the medical record must support epirubicin hydrochloride was given for an indication specified in this Local Coverage Determination (LCD). The amount of drug, route & timing of administration, and any reaction of 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 (see coding guidelines if applicable). 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. Under no circumstances can multiple patients be billed for the entire contents of a single vial when the each patient received a portion of the drug from the same vial. With appropriate procedures, it is safe to re-enter 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 drug wastage. The hospital pharmacy record should have

documentation on drugs discarded from single-use vials that are 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. (May 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

National Comprehensive Cancer Network (2007). Breast Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

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, June 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 (L28835) replaces LCD L25115 as the policy in notice. This document (L28835) 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 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

Reason for Change