L28837-LCD

Automated World Health

Local Coverage Determination (LCD) for Etoposide (Etopophos®,

Toposar®, Vepesid®, VP-16) (L28837)

Contractor Information

Contractor Name

First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28837

LCD Title

Etoposide (Etopophos®, Toposar®, Vepesid®, VP-16)

Contractor's Determination Number AJ9181

Primary Geographic Jurisdiction 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

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

Social Security Act, Section 1861 (t)(2)(B)

Indications and Limitations of Coverage and/or Medical Necessity

Etoposide (Etopophos®, Toposar®, VePesid®, VP-16)-J9181 & J9182/etoposide

Etoposide is a podophyllotoxin which inhibits DNA synthesis prior to mitosis by blocking topoisomerase II. Etoposide is FDA approved for the following indications:

• Management of refractory testicular tumors, in combination with other approved chemotherapeutic agents.

• In combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer.

Medicare will cover Etoposide for its FDA approved uses, as well as for the treatment of the following off-labeled indications:

• Primary peritoneal carcinoma

• Fallopian tube carcinoma

• Gastric carcinoma

• Hepatoblastoma

• Neuroblastoma

• Non-small cell lung carcinoma

• Testicular cancer

• Thymoma

• Osteosarcoma

• Ewing’s sarcoma

• Soft tissue sarcomas

• Cutaneous T cell lymphomas

• Breast carcinoma

• AIDS associated Kaposi’s sarcoma

• Endometrial carcinoma

• Ovarian germ cell tumors

• Bladder carcinoma

• Wilms’ Tumor

• Retinoblastoma

• Adrenocortical carcinoma

• Acute lymphocytic leukemia

• Acute nonlymphocytic leukemia

• Chronic myelocytic leukemia

• Hodgkin’s lymphoma

• Non-Hodgkin’s lymphoma

• Multiple myeloma

• Primary brain tumor

• Gestational trophoblastic tumor

• Cancer of Unknown Primary site (CUPs)

• Trophoblastic neoplasm

• Myelodysplastic syndromes (MDS)

. Neuroendocrine tumors (malignant poorly differentiated)

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

J9181 INJECTION, ETOPOSIDE, 10 MG

ICD-9 Codes that Support Medical Necessity

151.0 - 151.9 MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

155.0 MALIGNANT NEOPLASM OF LIVER PRIMARY

155.2 MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

160.0 - 160.9 MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

162.0 - 162.9 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

173.00 - 173.99 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

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

181 MALIGNANT NEOPLASM OF PLACENTA

182.0 - 182.8 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS - MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF BODY OF UTERUS

183.0 MALIGNANT NEOPLASM OF OVARY

183.2 MALIGNANT NEOPLASM OF FALLOPIAN TUBE

183.9 MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

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

191.0 - 191.9 opens in new window

194.0 - 194.9 opens in new window

MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

MALIGNANT NEOPLASM OF ADRENAL GLAND - MALIGNANT NEOPLASM OF ENDOCRINE GLAND SITE UNSPECIFIED

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

199.0 - 199.2 opens in new window

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

205.00 - 205.02 opens in new window

205.10 - 205.12 opens in new window

206.00 - 206.02 opens in new window

207.00 - 207.02 opens in new window

DISSEMINATED MALIGNANT NEOPLASM - MALIGNANT NEOPLASM ASSOCIATED WITH TRANSPLANT ORGAN

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

ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - ACUTE MYELOID LEUKEMIA, IN RELAPSE

CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - CHRONIC 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

209.30 MALIGNANT POORLY DIFFERENTIATED NEUROENDOCRINE CARCINOMA, ANY SITE

236.1 NEOPLASM OF UNCERTAIN BEHAVIOR OF PLACENTA

238.71 ESSENTIAL THROMBOCYTHEMIA

Printed on 9/29/2012. Page 4 of 7

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA

238.79 OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES

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 etoposide 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

Clinical Pharmacology Compendia, Etoposide. Revised 2009.

Printed on 9/29/2012. Page 5 of 7

Compendia-Based Drug Bulletin. (May 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

Food and Drug Administration (FDA) product label for Etoposide. Revised 2010.

National Comprehensive Cancer Network (2007). Non-Small Cell Lung Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

National Comprehensive Cancer Network, Inc. (NCCN) Drugs & Biologics Compendium, Etoposide, 2010.

National Comprehensive Cancer Network (NCCN). Neuroendocrine Tumors. Clinical Practice Guidelines in Oncology – V.2.2010.

Other Medicare contractor’s LCDs

Strosberg, J., Coppola, D., Klimstra, D., Phan, A., Kulke, M., Wiseman, G. & Kvols, L. (2010). The NANETS consensus guidelines for the diagnosis and management of poorly differentiated (high-grade) extrapulmonary neuroendocrine carcinomas. Pancreas 39 (6) 799-800].

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, July

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 02/01/2011

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. Changed diagnosis code range 173.0-173.9 to diagnosis code range 173.00-173.99. 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:02/01/2011 Original Effective Date 02/03/2011

LCR A2011-026

January 2011 Bulletin

Explanation of Revision: The following sections of the LCD were revised: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section, the off-label indication of “Neuroendocrine tumors (malignant poorly differentiated)” was added; and under the “ICD-9 Codes that Support Medical Necessity” section, ICD-9 code

209.30 was added. In addition, the “CMS National Coverage Policy” and “Sources of Information and Basis for Decision” sections were updated. The effective date of this LCD 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 (L28837) replaces LCD L25116 as the policy in notice. This document (L28837) 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

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

Reason for Change