Automated World Health
Local Coverage Determination (LCD) for Carboplatin (Paraplatin®, Paraplatin-AQ®) (L29089)
Contractor Information
Contractor Name
First Coast Service Options, Inc. opens in new window
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Contractor Number 09102
Contractor Type MAC - Part B
LCD Information
Document Information
LCD ID Number L29089
LCD Title
Carboplatin (Paraplatin®, Paraplatin-AQ®)
Contractor's Determination Number J9045
Primary Geographic Jurisdiction opens in new window Florida
Oversight Region Region IV
AMA CPT/ADA CDT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.
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 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, 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 CARBOPLATIN (PARAPLATIN(R), PARAPLATIN-AQ(R)) - 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.
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
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
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
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.
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
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 B2010-024
January 2010 Update
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 01/19/2010 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: 03/24/2009
LCR B2009-050
March 2009 Update
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 Revised Effective Date:02/02/2009
LCR B2009-044FL LCR B2009-045PR/VI
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 (L29089) replaces LCD L25064 as the policy in notice. This document (L29089) is effective on 02/02/2009.
Reason for Change ICD9 Addition/Deletion
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All Versions
Updated on 01/15/2010 with effective dates 10/01/2009 - N/A
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