Article for Topotecan Hydrochloride (Hycamtin®) – Related to LCD L25820 (A47580)

Contractor Information

Contractor Name 

National Government Services, Inc.  

Contractor Number 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Contractor Type 

Carrier

Fiscal Intermediary

MAC – Part A

MAC – Part B

Article Information

Article ID Number 

A47580 

Article Type 

Article

Key Article 

Yes

Article Title 

Topotecan Hydrochloride (Hycamtin®) – Related to LCD L25820 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2008 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Original Article Effective Date 

07/18/2008

Article Revision Effective Date 

01/01/2009

Article Text 

This article defines coding and coverage for topotecan hydrochloride including off-label indications. National Government Services Local Coverage Determination (LCD) “Coverage of Drugs and Biologicals for Label and Off-Label Uses” allows coverage for off-label indications only if the United States Pharmacopeia Drug Information (USP-DI), the American Hospital Formulary Services (AHFS) and/or Thomson Healthcare DrugPoints® (as described in the LCD) define such indications or if National Government Services has published an article or LCD expanding such coverage. Effective for dates of service on or after 11/25/2008, American Hospital Formulary Services (AHFS), Clinical Pharmacology, NCCN Drugs and Biologics Compendium and/or Thomson Micromedex DrugDex® compendium has replaced the USP-DI and Thomson Healthcare DrugsPoints®. Providers may request approval for additional off-label indications by submitting this request in writing with supporting medical literature. The aforementioned National Government Services LCD, which describes the requirements for such a request, can be accessed on our contractor Web site at www.NGSMedicare.com or on the Medicare Coverage Database at www.cms.hhs.gov/mcd.

Abstract:
Topotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. The cytotoxicity of topotecan is thought to be due to double strand DNA damage.

Indications:
Topotecan is approved for the following indications:

• Treatment of metastatic ovarian carcinoma after failure of first-line or subsequent chemotherapy
• Treatment of small cell lung carcinoma (SCLC) in patients who have responded to chemotherapy with other agents and who have relapsed more than 2 or 3 months after completion of chemotherapy
• In combination with cisplatin for the treatment of Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
• Non-small cell carcinoma of the lung

• Myelodysplastic syndrome (MDS)
• Chronic myelomonocytic leukemia (CMML)
• Cervical carcinoma
• Nephroblastoma
• Primary central nervous system lymphoma, relapsed or refractory, non-immunocompromised

Indications expanded by this article
Primary peritoneal carcinoma

Fallopian tube carcinoma

Utilization:
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.

Documentation 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.

Coding Guidelines:

For claims submitted to the carrier or Part B MAC:

Topotecan hydrochloride should be billed using chemotherapy administration codes and is payable in the following places of service: office (11), skilled nursing home for patients in a Part A stay (31) [if the drug is supplied by the facility, no claims for the drug should be submitted to the Part B carrier.], nursing facility for patients not in a Part A stay (32) and independent clinic (49) only when supplied as an “incident to” service by the physician.

Coverage Topic 

Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Prescription Drugs

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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

11x	Hospital-inpatient (including Part A)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
85x	Special facility or ASC surgery-rural primary care hospital (eff 10/94)

CPT/HCPCS Codes 

J9350

INJECTION, TOPOTECAN, 4 MG

ICD-9 Codes that are Covered 

158.8	MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM
158.9	MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED
162.0	MALIGNANT NEOPLASM OF TRACHEA
162.2	MALIGNANT NEOPLASM OF MAIN BRONCHUS
162.3	MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG
162.4	MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG
162.5	MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG
162.8	MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG
162.9	MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED
173.0	MALIGNANT NEOPLASM OF skin of lip
173.1	MALIGNANT NEOPLASM OF eyelid, including canthus
173.2	MALIGNANT NEOPLASM OF skinof ear and external autidory canal
173.3	MALIGNANT NEOPLASM OF skin of other and unspecified parts of face
173.4	MALIGNANT NEOPLASM OF  scalp and skin of neck
173.5	MALIGNANT NEOPLASM OF skin of trunk, except scrotum
173.6	MALIGNANT NEOPLASM OF skin of upper limb, including shoulder
173.7	MALIGNANT NEOPLASM OF  skin of lower limb, including hip
173.8	MALIGNANT NEOPLASM OF  other specified sites of skin
173.9	MALIGNANT NEOPLASM OF skin, site unspecified
180.0	MALIGNANT NEOPLASM OF ENDOCERVIX
180.1	MALIGNANT NEOPLASM OF EXOCERVIX
180.8	MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CERVIX
180.9	MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE
183.0	MALIGNANT NEOPLASM OF OVARY
183.2	MALIGNANT NEOPLASM OF FALLOPIAN TUBE
183.3	MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS
183.4	MALIGNANT NEOPLASM OF PARAMETRIUM
183.5	MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS
183.8	MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA
183.9	MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE
189.0	MALIGNANT NEOPLASM OF kidney,  except pelvis
189.1	MALIGNANT NEOPLASM OF renal pelvis
197.6	SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM
198.3	Secondary malignant neoplasm of brain and spinal cord
200.50	Primary central nervous system lymphoma unspecified site, extranodal and solid organ sites
200.51	Primary central nervous system lymphoma, lymph nodes of head, face, and neck
200.52	Primary central nervous system lymphoma, intrathoracic lymph nodes
200.53	Primary central nervous system lymphoma, intra-abdominal lymph nodes
200.54	Primary central nervous system lymphoma, lymph nodes of axilla and upper limb
200.55	Primary central nervous system lymphoma, lymph nodes of inguinal region and lower limb
200.56	Primary central nervous system lymphoma, intrapelvic lymph nodes
200.57	Primary central nervous system lymphoma, spleen
200.58	Primary central nervous system lymphoma, lymph nodes of multiple sites
205.10	CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
205.11	MYELOID LEUKEMIA CHRONIC IN REMISSION
205.12	CHRONIC MYELOID LEUKEMIA, IN RELAPSE
238.71	ESSENTIAL THROMBOCYTHEMIA
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
239.2	Neoplasms of unspecified nature, bone, soft tissue, and skin

Other Information

Other Comments 

Sources of Information

American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.

Clinical Pharmacology

FDA Label

NCCN Drugs and Biologics Compendium accessed at: http://www.nccn.org/

Previous First Coast LCD # L22306

Thomson Micromedix DrugDex® accessed at: http://www.thomsonhc.com/home/dispatch

Thomson Healthcare DrugPoints® at http://www.thomsonhc.com/home/dispatch

United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
Previous First Coast LCD# L25101

Revision History Explanation 

Article published January 2009: Source of revision – Internal: The “Article Text” and “Sources of Information” have been revised to include compendia recognized by CMS based on Change Request 6191 (Compendia as Authoritative Sources for Use in the Determination of a Medically Accepted Indication of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen, effective 11/25/2008). This article has been reviewed using all listed compendia and nephroblastoma and primary central nervous system lymphoma, relapsed or refractory, non-immunocompromised have been added to the “Indications” section of the article. The following ICD-9-CM codes, 173.0-173.9, 189.0, 189.1, 198.3, 200.50-200.58 and 239.2 have been added to the “ICD-9-CM Codes That Support Medical Necessity” section of the article effective for dates of service on or after 11/25/2008. Based on the annual HCPCS update, the description for HCPCS code J9350 has changed. Minor changes were made to reflect current template language.

Article published October 2008: Source of revision – Internal (annual ICD-9-CM code updates for 2009). The “ICD-9-CM Codes That Support Medical Necessity” section of the article is modified as follows: the description for ICD-9-CM code 205.10 has been modified. ICD-9-CM code 205.12 has been added. The first sentence in “Indications” has been revised to remove “FDA.” Reference to “Hycamtin” has been removed from the “Indications” section of the article and approved indications have been combined.

This article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the article is effective on August 1, 2008; for Upstate New York – Part B, the article is effective on September 1, 2008; and for New York and Connecticut – Part A, the article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

The CMS Statement of Work for the J13 Medicare Administrative Contract (MAC) requires that the contractor retain the most clinically appropriate medical policy information within the jurisdiction. This First Coast Service Options policy is being promulgated to the J13 MAC and all National Government Services jurisdictions as an article attachment to the LCD for Coverage of Drugs and Biologicals for Label and Off-Label Uses (LCD ID# L25820).

08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.


08/10/2008 - This policy was updated by the ICD-9 2008-2009 Annual Update.

11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.

11/09/2008 - The description for CPT/HCPCS code J9350 was changed in group 1

Related Document

Article(s)
A44930 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental Instructions Article
LCD(s)
L25820 - Drugs and Biologicals, Coverage of, for Label and Off-Label Uses