Archive Article for Denileukin Difitox (e.g., Ontak ®) – Related to LCD L25820 (A46097)

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 

A46097 

Article Type 

Article

Key Article 

Yes

Article Title 

Denileukin Difitox (e.g., Ontak ®) – Related to LCD L25820 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 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
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 

12/01/2007

Article Revision Effective Date 

08/18/2008

Article Text 

This article defines coding and coverage for denileukin difitox 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.

Indications:
Denileukin difitox is approved for the treatment of patients with:

• Persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor
• Chronic lymphoid leukemia

Limitations:
Prior to the administration of denileukin difitox, the patient’s malignant cells should be tested for CD25 expression.

Only physicians experienced in the use of antineoplastic therapy and management of patients with cancer should use denileukin difitox. Patients treated with denileukin diftitox must be managed in a facility equipped and staffed for cardiopulmonary resuscitation and where the patient can be closely monitored for an appropriate period based on his or her health status.

Utilization:
Denileukin difitox is for intravenous (IV) use only. The recommended treatment regimen (one treatment cycle) is 9 or 18mcg/kg/day administered intravenously for five consecutive days every 21 days. Denileukin difitox should be infused over at least 15 minutes.

Coding Guidelines:

General Guidelines for claims submitted to Carriers or Intermediaries:

Claims for denileukin difitox should be submitted using HCPCS code J9160. The number of units (mg) should be reported in item 24G (quantity billed) of the 1500 claim form for Medicare Part B and in the CMS-1450 or its electronic equivalent for Medicare Part A.

For claims submitted to the carrier:

Denileukin difitox 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 

J9160

DENILEUKIN DIFTITOX, 300 MCG

ICD-9 Codes that are Covered 

202.10	MYCOSIS FUNGOIDES UNSPECIFIED SITE
202.11	MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.12	MYCOSIS FUNGOIDES INVOLVING INTRATHORACIC LYMPH NODES
202.13	MYCOSIS FUNGOIDES INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.14	MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.15	MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.16	MYCOSIS FUNGOIDES INVOLVING INTRAPELVIC LYMPH NODES
202.17	MYCOSIS FUNGOIDES INVOLVING SPLEEN
202.18	MYCOSIS FUNGOIDES INVOLVING LYMPH NODES OF MULTIPLE SITES
202.20	SEZARY'S DISEASE UNSPECIFIED SITE
202.21	SEZARY'S DISEASE INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.22	SEZARY'S DISEASE INVOLVING INTRATHORACIC LYMPH NODES
202.23	SEZARY'S DISEASE INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.24	SEZARY'S DISEASE INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.25	SEZARY'S DISEASE INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.26	SEZARY'S DISEASE INVOLVING INTRAPELVIC LYMPH NODES
202.27	SEZARY'S DISEASE INVOLVING SPLEEN
202.28	SEZARY'S DISEASE INVOLVING LYMPH NODES OF MULTIPLE SITES
202.70	PERIPHERAL T CELL LYMPHOMA, UNSPECIFIED SITE, EXTRANODAL AND SOLID ORGAN SITES
202.71	PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF HEAD, FACE, AND NECK
202.72	PERIPHERAL T CELL LYMPHOMA, INTRATHORACIC LYMPH NODES
202.73	PERIPHERAL T CELL LYMPHOMA, INTRA-ABDOMINAL LYMPH NODES
202.74	PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF AXILLA AND UPPER LIMB
202.75	PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.76	PERIPHERAL T CELL LYMPHOMA, INTRAPELVIC LYMPH NODES
202.77	PERIPHERAL T CELL LYMPHOMA, SPLEEN
202.78	PERIPHERAL T CELL LYMPHOMA, LYMPH NODES OF MULTIPLE SITES
202.80	OTHER MALIGNANT LYMPHOMAS UNSPECIFIED SITE
202.81	OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF HEAD FACE AND NECK
202.82	OTHER MALIGNANT LYMPHOMAS INVOLVING INTRATHORACIC LYMPH NODES
202.83	OTHER MALIGNANT LYMPHOMAS INVOLVING INTRA-ABDOMINAL LYMPH NODES
202.84	OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF AXILLA AND UPPER LIMB
202.85	OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF INGUINAL REGION AND LOWER LIMB
202.86	OTHER MALIGNANT LYMPHOMAS INVOLVING INTRAPELVIC LYMPH NODES
202.87	OTHER MALIGNANT LYMPHOMAS INVOLVING SPLEEN
202.88	OTHER MALIGNANT LYMPHOMAS INVOLVING LYMPH NODES OF MULTIPLE SITES
204.10	CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION
V10.79	PERSONAL HISTORY OF OTHER LYMPHATIC AND HEMATOPOIETIC NEOPLASMS

Other Information

Other Comments 

Sources of Information

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

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

U.S. Food and Drug Administration label approved 02/05/1999 accessed on line at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 11/19/2007.

United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.

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 revised 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.

This article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers and to retain the most clinically appropriate medical policy information within the jurisdiction, including off-label indications and approved indications from DrugPoints®.

The following indication has been added: chronic lymphoid leukemia. The following ICD-9-CM code has been added: 204.10. Thomson Healthcare DrugPoints® has been added to the “Article Text” paragraph and “Sources of Information”. Bill type codes have been added. Places of service for claims submitted to the carrier have been revised.

Cor#1 - Corrected version (published 12/01/2007) (effective 12/01/2007): ICD-9-CM codes have been moved to the "ICD-9-CM codes that are Covered" section of the article.
12/04/2007

This article has an effective date of 12/01/2007.

The original version of the corresponding LCD became effective on 12/01/2007.

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