Archive Article for TOPOTECAN Hydrochloride (Hycamtin®)

Archive 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
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
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

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
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
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

08/18/2008

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. 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 and Limitations:
Topotecan is FDA 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.

Medicare will cover Hycamtin for its FDA approved use, as well as for the treatment of the following off-labeled indicatons:

• Non-small cell carcinoma of the lung

• Myelodysplastic syndrome (MDS)

• Chronic myelomonocytic leukemia (CMML)

• Cervical carcinoma

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:

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

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 - 162.9	MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED
180.0 - 180.9	MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVIX UTERI UNSPECIFIED SITE
183.0 - 183.9	MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE
197.6	SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM
205.10 - 205.11	CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - MYELOID LEUKEMIA CHRONIC IN REMISSION
238.71 - 238.79	ESSENTIAL THROMBOCYTHEMIA - OTHER LYMPHATIC AND HEMATOPOIETIC TISSUES

Other Information

Other Comments
Sources of Information FDA Label Previous First Coast LCD # L22306 American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007. 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 08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD 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.
Revision History Explanation
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.

Related Documents
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