LCD/NCD MedicationsL29202-LCD

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Local Coverage Determination (LCD) for Interferon (L29202)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number

09102

Contractor Type

MAC - Part B

LCD Information

Document Information

LCD ID Number L29202

LCD Title Interferon

Contractor's Determination Number J9212

Primary Geographic Jurisdiction 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 10/01/2011

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 Manuals Pub 100-02, Chapter 15, Section 50-50.1

Indications and Limitations of Coverage and/or Medical Necessity

Interferons are naturally occurring small proteins with both antiviral and antiproliferative properties. Interferons exert their cellular effects by binding to specific membrane receptors on the cell surface and subsequently initiate a complex sequence of intracellular events.

Interferon alfacon-1 is a recombinant non-naturally occurring type-1 interferon. Interferon alfa-2B is sterile protein product produced by recombinant DNA techniques. The exact mechanism of action is unknown, but appears to involve direct antiproliferative action against tumor cells or viral cells to inhibit replication, modulation of the host immune response by enhancing the phagocytic activity of macrophages, and augmentation of specific cytotoxicity of lymphocytes for target cells.

Alfa-N3 is a naturally occurring antiviral agent derived from human leukocytes. It attaches to membrane receptors and causes cellular changes, including increased protein synthesis. Gamma-1B, a biological response modifier, is a single-chain polypeptide containing 140 amino acids.

Interferon beta-1a (Q3025)

Medicare will consider the administration of Interferon beta-1a medically reasonable and necessary for the following indication: multiple sclerosis.

Interferon alfacon-1 (J9212)

Medicare will consider the administration of Interferon alfacon-1 medically reasonable and necessary for the following indications: chronic hepatitis C and hairy cell leukemia.

Interferon alfa-2B (J9214)

Medicare will consider the administration of Interferon Alfa-2B medically reasonable and necessary for the following indications: acute or chronic hepatitis C, chronic hepatitis B, condylomata acuminata, hairy cell leukemia, malignant melanoma, AIDS-related Kaposi’s sarcoma, head and neck cancer, bladder cancer, brain cancer, carcinoid syndrome, chronic lymphocytic leukemia, chronic myelocytic leukemia, cutaneous T-cell lymphoma, esophageal cancer, renal cancer, multiple myeloma, non-Hodgkin’s lymphoma, mycosis fungoides, essential thrombocytosis, essential thrombocythemia, osteosarcoma, ovarian cancer, pancreatic cancer, skin cancer, colorectal cancer, polycythemia vera, and laryngeal papillomatosis.

Medicare will consider the administration of Interferon Alfa-2B medically necessary for the off-label indication of peritoneum cancer.

Interferon alfa-N3 (J9215)

Medicare will consider the administration of Interferon alfa-N3 medically reasonable and necessary for the following indications: chronic hepatitis C, condylomata acuminata, hairy cell leukemia, malignant melanoma, AIDS-related Kaposi’s sarcoma, bladder cancer, carcinoid syndrome, chronic myelocytic leukemia, renal cancer, multiple meyloma, non-Hodgkin’s lymphoma, mycosis fungoides, essential thrombocytosis, ovarian cancer, and laryngeal papillomatosis.

Medicare will consider the administration of Interferon alfa-N3 medically necessary for the off-label indication of peritoneum cancer.

Interferon gamma-1B (J9216)

Medicare will consider the administration of Interferon gamma-1B medically reasonable and necessary for the following indications: chronic granulomatous disease.

Limitations:

The self-administration of Interferons alfacon-1, alfa-2B, alfa-N3, and gamma-1B are noncovered by Medicare.

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

J9212 INJECTION, INTERFERON ALFACON-1, RECOMBINANT, 1 MICROGRAM J9214 INJECTION, INTERFERON, ALFA-2B, RECOMBINANT, 1 MILLION UNITS

J9215 INJECTION, INTERFERON, ALFA-N3, (HUMAN LEUKOCYTE DERIVED), 250,000 IU J9216 INJECTION, INTERFERON, GAMMA 1-B, 3 MILLION UNITS

Q3025 INJECTION, INTERFERON BETA-1A, 11 MCG FOR INTRAMUSCULAR USE

ICD-9 Codes that Support Medical Necessity For Q3025 (Interferon beta-1a):

340 MULTIPLE SCLEROSIS

For J9212 (Interferon Alfacon-1):

070.54 CHRONIC HEPATITIS C WITHOUT HEPATIC COMA

202.40 - 202.48 opens in new window

LEUKEMIC RETICULOENDOTHELIOSIS UNSPECIFIED SITE - LEUKEMIC RETICULOENDOTHELIOSIS INVOLVING LYMPH NODES OF MULTIPLE SITES

For J9214 (Interferon alfa-2B):

070.41 ACUTE HEPATITIS C WITH HEPATIC COMA

070.44 CHRONIC HEPATITIS C WITH HEPATIC COMA

070.51 ACUTE HEPATITIS C WITHOUT MENTION OF HEPATIC COMA

070.54 CHRONIC HEPATITIS C WITHOUT HEPATIC COMA

070.59 OTHER SPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA

078.11 CONDYLOMA ACUMINATUM

140.0 - 149.9 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

150.0 - 150.9 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

153.0 - 153.9 MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.0 - 154.8 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

157.4 MALIGNANT NEOPLASM OF ISLETS OF LANGERHANS

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

161.0 - 161.9 MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

170.0 - 170.9 MALIGNANT NEOPLASM OF BONES OF SKULL AND FACE EXCEPT MANDIBLE -

MALIGNANT NEOPLASM OF BONE AND ARTICULAR CARTILAGE SITE UNSPECIFIED

172.0 - 172.9 MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

173.00 - 173.99 UNSPECIFIED MALIGNANT NEOPLASM OF SKIN OF LIP - OTHER SPECIFIED MALIGNANT NEOPLASM OF SKIN, SITE UNSPECIFIED KAPOSI'S SARCOMA SKIN - KAPOSI'S SARCOMA UNSPECIFIED SITE

176.0 - 176.9 KAPOSI'S SARCOMA SKIN - KAPOSI'S SARCOMA UNSPECIFIED SITE

183.0 - 183.9 MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

184.4 MALIGNANT NEOPLASM OF VULVA UNSPECIFIED SITE

188.0 - 188.9 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

189.1 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

191.0 - 191.9 MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE

200.00 - 200.88 RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.00 - 202.98 NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

203.00 - 203.82 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE

204.10 CHRONIC LYMPHOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

204.12 CHRONIC LYMPHOID LEUKEMIA, IN RELAPSE

205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE

238.4 POLYCYTHEMIA VERA

238.71 ESSENTIAL THROMBOCYTHEMIA

259.2 CARCINOID SYNDROME

289.9 UNSPECIFIED DISEASES OF BLOOD AND BLOOD-FORMING ORGANS

For J9215 (Interferon alfa-N3):

070.54 CHRONIC HEPATITIS C WITHOUT HEPATIC COMA

078.11 CONDYLOMA ACUMINATUM

158.8 MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM

158.9 MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED

161.0 - 161.9 MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

172.0 - 172.9 MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

176.0 - 176.9 KAPOSI'S SARCOMA SKIN - KAPOSI'S SARCOMA UNSPECIFIED SITE

183.0 - 183.9 MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE

188.0 - 188.9 MALIGNANT NEOPLASM OF TRIGONE OF URINARY BLADDER - MALIGNANT NEOPLASM OF BLADDER PART UNSPECIFIED

189.1 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.2 MALIGNANT NEOPLASM OF RENAL PELVIS

200.00 - 200.88 RETICULOSARCOMA UNSPECIFIED SITE - OTHER NAMED VARIANTS OF LYMPHOSARCOMA AND RETICULOSARCOMA INVOLVING LYMPH NODES OF MULTIPLE SITES

202.00 - 202.98 NODULAR LYMPHOMA UNSPECIFIED SITE - OTHER AND UNSPECIFIED MALIGNANT NEOPLASMS OF LYMPHOID AND HISTIOCYTIC TISSUE INVOLVING LYMPH NODES OF MULTIPLE SITES

203.00 - 203.82 MULTIPLE MYELOMA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION - OTHER IMMUNOPROLIFERATIVE NEOPLASMS, IN RELAPSE

205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE

259.2 CARCINOID SYNDROME

289.9 UNSPECIFIED DISEASES OF BLOOD AND BLOOD-FORMING ORGANS

For J9216 (Interferon gamma-1B):

288.1 FUNCTIONAL DISORDERS OF POLYMORPHONUCLEAR NEUTROPHILS

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician must substantiate the medical necessity for the use of the specific Interferon by indicating the condition for which it is being administered. The drug name, dosage, and route of administration must also be recorded. This information is normally found in the

office/progress notes or medication administration record.

Appendices

Utilization Guidelines N/A

Sources of Information and Basis for Decision

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

Physician Desk Reference (2004). Montvale, NJ: Medical Economics Company, Inc.

Thevenot, T., Regimbeau, C., Ratziu, V., Leroy, V., Opolon, P., Poynard, T. (2001) Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C in naïve patients: 1999 update. Hepatology, 1, 45-62.

United States Pharmacopeia Drug Information (USPDI). (2006). Oncology Online for Health Care Professionals. Micromedex, Inc. Available: http://www.thomsonhc.com/home/dispatch

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 advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 10/01/2009

Revision History Number 2

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

Start Date of Notice Period:10/01/2011 Revised Effective Date:10/01/2011

LCR B2011-101

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Change diagnosis code range 173.0-173.9 to diagnosis code range 173.00-173.99 for HCPCS code J9214. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:10/01/2009 Revised Effective Date: 09/04/2009

LCR B2009-092

September 2009 Update

Explanation of Revision: Updated the “ICD-9 Codes that Support Medical Necessity” section to add diagnosis code

238.71 for HCPCS code J9214 (Interferon alfa-2b). The effective date of this revision is based on process date.

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-

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 (L29202) replaces LCD L5711 as the policy in notice. This document (L29202) is effective on 02/02/2009.

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

Reason for Change