L29182-LCD

Automated World Health

Local Coverage Determination (LCD) for Gemcitabine (Gemzar®) (L29182)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29182

LCD Title

Gemcitabine (Gemzar®)

Contractor's Determination Number J9201

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 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 11/15/2011 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, 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 Gemcitabine (Gemzar®)-J9201

Gemcitabine is a deoxycytidine analogue antimetabolite which is structurally related to cytarabine. In contrast to cytarabine, it has greater membrane permeability and enzyme affinity, as well as prolonged intracellular retention. The compound acts as an inhibitor of DNA synthesis, and its mechanism of action appears to be cell- cycle specific.

Gemcitabine is FDA approved for the following indications:

• In combination with paclitaxel for first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines are clinically contraindicated.

• As first-line therapy for locally advanced (nonresectable Stage II or III) or metastatic (Stage IV)

adenocarcinoma of the pancreas. It is also indicated as second-line therapy for patients who have previously been treated with fluorouracil.

• In combination with cisplatin as first-line therapy for inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung carcinoma.

• In combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.

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

• Primary peritoneal carcinoma

• Fallopian tube carcinoma

• Breast carcinoma

• Advanced or relapsed epithelial ovarian carcinoma used alone or in combination with other chemotherapeutic agents

• Bladder carcinoma, Metastatic bladder (urothelial) carcinoma

• Transitional cell carcinoma of kidney and ureter

• Relasped Hodgkin’s and non-Hodgkin’s lymphoma (used alone or in combination with other agents)

• Locally advanced, unresectable, or metastatic biliary tract and gallbladder carcinomas

• Intrahepatic bile duct(s) carcinoma

• Testicular germ cell tumors (Relapsed/refractory, progressive, metastatic, or nonseminomatous gonadal and extragonadal germ cell tumors)

• Soft tissue sarcomas

• Germ cell tumors

• Ovarian germ cell tumors

. Advanced or recurrent endometrial carcinoma (used as a single agent or in combination with other chemotherapy drugs)

. Relapsed or refractory non-Hodgkin’s lymphoma (NHL) (diffuse large B-cell lymphoma) in combination with oxaliplatin (Eloxatin) as second-line therapy.

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.

999x Not Applicable

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

J9201 INJECTION, GEMCITABINE HYDROCHLORIDE, 200 MG

ICD-9 Codes that Support Medical Necessity

155.1 MALIGNANT NEOPLASM OF INTRAHEPATIC BILE DUCTS

156.0 - 156.9 opens in new window

157.0 - 157.9 opens in new window

158.0 - 158.9 opens in new window

162.0 - 162.9 opens in new window

MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

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

MALIGNANT NEOPLASM OF RETROPERITONEUM - MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

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

164.2 MALIGNANT NEOPLASM OF ANTERIOR MEDIASTINUM

164.3 MALIGNANT NEOPLASM OF POSTERIOR MEDIASTINUM

164.8 MALIGNANT NEOPLASM OF OTHER PARTS OF MEDIASTINUM

164.9 MALIGNANT NEOPLASM OF MEDIASTINUM PART UNSPECIFIED

171.0 - 171.9 opens in new window

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

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

181 MALIGNANT NEOPLASM OF PLACENTA

182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS

183.0 - 183.9 opens in new window

186.0 - 186.9 opens in new window

188.0 - 188.9 opens in new window

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

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

189.1 * MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

189.3 MALIGNANT NEOPLASM OF URETER

194.4 MALIGNANT NEOPLASM OF PINEAL GLAND

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

198.1 SECONDARY MALIGNANT NEOPLASM OF OTHER URINARY ORGANS

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

* Note – Diagnosis code 189.0 only to be used for transitional cell cancer of the bladder residing in the kidney (renal transitional cell carcinoma).

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.

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

Brown, J., Smith, J., Ramondetta, L., Sood, A., Ramirez, P., Coleman, R., et al. (2010). Combination of gemcitabine and cisplatin is highly active in women with endometrial carcinoma, Cancer.

Compendia-Based Drug Bulletin. (November 2010). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, Uterine neoplasms. Version 1.2011

Printed on 9/29/2012. Page 4 of 6

National Comprehensive Cancer Network (2006). Pancreatic Adenocarcinoma. Clinical Practice Guidelines in Oncology – V.1.2006.

National Comprehensive Cancer Network (NCCN). (2011). NCCN Drugs & Biologics CompendiumTM: Gemcitabine hydrochloride. Retrieved from http://www.nccn.org.

National Comprehensive Cancer Network (NCCN). (2011). NCCN TM Version 3.2011 Diffuse Large B-Cell Lymphoma. Retrieved from http://www.nccn.org.

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, March 2010.

Advisory Committee Meeting Notes This 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 01/01/2011

Revision History Number 2

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

Start Date of Notice Period:12/01/2011 Revised Effective Date: 11/15/2011

LCR B2011-113

November 2011 Connection

Explanation of Revision: LCD revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to add the following off-labeled indication: Relapsed or refractory non-Hodgkin’s lymphoma (diffuse large B-cell lymphoma) in combination with oxaliplatin (Eloxatin®) as second-line therapy. The ‘Sources of Information and Basis for Decision’ section of the LCD has also been updated. 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:01/01/2011 Revised Effective Date: 12/02/2010

LCR B2010-077

December 2010 Update

Explanation of Revision: Under the off-labeled indications section of the “Indication and Limitations of Coverage and/or Medical Necessity” section of the LCD, the indication of advanced or recurrent endometrial carcinoma used as a single agent or in combination with other chemotherapy drugs was added. Under the “ICD-9 Codes that Support Medical Necessity” section of the LCD, diagnosis code 182.0 and descriptor was added. In addition, the “Sources of Information and Basis for Decision” section was updated. 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:02/02/2009

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 (L29182) replaces LCD L25071 as the policy in notice. This document (L29182) is effective on 02/02/2009.

Reason for Change