L28791-LCD

Automated World Health

Local Coverage Determination (LCD) for Carboplatin (Paraplatin®,

Paraplatin-AQ®) (L28791)

Contractor Information

Contractor Name

First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28791

LCD Title

Carboplatin (Paraplatin®, Paraplatin-AQ®)

Contractor's Determination Number AJ9045

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 10/01/2009 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

Carboplatin (Paraplatin®, Paraplatin-AQ®)-J9045

Carboplatin resembles an alkylating agent. Although the exact mechanism of action is unknown, it is thought to be similar to that of the bifunctional alkylating agents, that is, possible cross-linking and interference with the function of DNA.

Carboplatin is FDA approved for the following indications:

• For the initial treatment of advanced ovarian carcinoma in combination with other approved chemotherapeutic agents.

• For the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with cisplatin.

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

• Bladder carcinoma

• Primary brain tumors

• Breast carcinoma

• Endometrial carcinoma

• Head & neck carcinoma

• Small cell and non-small cell lung carcinoma

• Malignant melanoma

• Neuroblastoma

• Retinoblastoma

• Testicular carcinoma

• Wilms’ Tumor

• Esophageal carcinoma (also GE junction adenocarcinomas)

• Cervical carcinoma

• Cancer of Unknown Primary site (CUPs)

• Fallopian and peritoneal carcinomas of ovarian origin when used in combination with Paclitaxel

• Hodgkin’s lymphoma

• Non-Hodgkin’s lymphoma

• Hormone Refractory Prostate Cancer (HRPC)

• Stomach carcinoma

• Malignant neoplasm of the pleura (mesothelioma)

• Non-melanoma skin cancers (Merkel cell 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) 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

J9045 INJECTION, CARBOPLATIN, 50 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

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

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

163.0 - 163.9 opens in new window

172.0 - 172.9 opens in

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

MALIGNANT NEOPLASM OF PARIETAL PLEURA - MALIGNANT NEOPLASM OF PLEURA UNSPECIFIED

new window MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

180.0 - 180.9 opens in new window

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 ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE

182.0 MALIGNANT NEOPLASM OF CORPUS UTERI EXCEPT ISTHMUS

183.0 - 183.9 opens in new window

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

185 MALIGNANT NEOPLASM OF PROSTATE

186.0 - 186.9 opens in new window

MALIGNANT NEOPLASM OF UNDESCENDED TESTIS - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED TESTIS

188.0 - 188.9 opens in new window

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

190.6 MALIGNANT NEOPLASM OF CHOROID

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

195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

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

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

209.31 MERKEL CELL CARCINOMA OF THE FACE

209.32 MERKEL CELL CARCINOMA OF THE SCALP AND NECK

209.33 MERKEL CELL CARCINOMA OF THE UPPER LIMB

209.34 MERKEL CELL CARCINOMA OF THE LOWER LIMB

209.35 MERKEL CELL CARCINOMA OF THE TRUNK

209.36 MERKEL CELL CARCINOMA OF OTHER 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.

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

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

Carboplatin, Indications, for treatment of head and neck cancer. (2007). Clinical Pharmacology. Retrieved January 13, 2009 from http://clinicalpharmacology.com/default.asp?failcode=userlogout

Compendia-Based Drug Bulletin. (November 2006). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

Favaretto, A., Aversa, S., Paccagnella, A., Manzini, V., Palmisano, V., Oniga, F., et al. (2003). Gemcitabine Combined with Carboplatin in Patients with Malignant Pleural Mesothelioma. American Cancer Society, 97 (11) 2791-2797.

National Cancer Institute Factsheet. (2007). Merkel cell carcinoma: questions and answers. National Cancer Institute. Retrieved February 4, 2009 from http://www.cancer.gov/cancertopics/factsheet/Sites-Types/merkel- cell

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

NCCN Clinical Practice Guidelines in Oncology. (2009). Merkel cell carcinoma. National Comprehensive Cancer Network, V.1.2009. Retrieved January 13, 2009 from www.nccn.org

NCCN Drugs & Biologicals Compendium. (2008). Carboplatin for non-melanoma skin cancers – Merkel cell carcinoma. National Comprehensive Cancer Network. Retrieved January 13, 2009 from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx

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 02/01/2010

Revision History Number 2

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

Start Date of Notice Period:02/01/2010 Revised Effective Date: 10/01/2009

LCR A2010-015

January 2010 Bulletin

Explanation of Revision: Annual 2010 ICD-9-CM Update. Added diagnosis code range 209.31-209.36 with descriptors for Merkel cell carcinoma and deleted diagnosis code range 173.0-173.9. This revision is effective for claims processed on or after 01/28/2010 for dates of service on or after 10/01/2009.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:03/01/2009 Revised Effective Date: 04/02/2009

LCR A2009-042

March 2009 Bulletin

Explanation of Revision: The “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD was revised to add coverage for “Non-melanoma skin cancers (Merkel cell carcinoma).” Under the “ICD-9 Codes that Support Medical Necessity” section, diagnosis range 173.0-173.9 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 Original Effective Date:02/16/2009

LCR A2009-034FL LCR A2009-036PR/VI

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 (L28791) replaces LCD L25112 as the policy in notice. This document (L28791) 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 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 ICD9 Addition/Deletion