LCD/NCD MedicationsL28890-LCD

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Local Coverage Determination (LCD) for Infliximab (Remicade TM ) (L28890)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28890

LCD Title Infliximab (Remicade TM )

Contractor's Determination Number AJ1745

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 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 04/18/2012

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 100-2, Medicare Benefit Policy, Chapter 1, Section 30; Chapter 15, Section 50

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3 Indications and Limitations of Coverage and/or Medical Necessity

Infliximab (Remicade TM) is a chimeric monoclonal antibody that binds specifically to tumor necrosis factor alpha (TNFa) and blocks its activity. Overproduction of tumor necrosis factor alpha, which is a key inflammatory mediator, leads to inflammation in conditions such as Crohn’s disease, rheumatoid arthritis and other autoimmune diseases.

Medicare will consider the use of Infliximab to be medically reasonable and necessary in the following circumstances:

• To reduce the signs and symptoms and induce and maintain clinical remission in adult and pediatric patients with moderately to severely active Crohn’s disease in patients who have had an inadequate response to conventional therapy (e.g., corticosteriods, aminosalicylates, and immunosuppressive agents).

• To reduce the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure for patients with fistulizing Crohn’s disease. Normally, the patient receives an infusion for this indication at weeks 0, 2, & 6. Subsequent treatments will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• To reduce the signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function, in patients with psoriatic arthritis. Normally, the patient receives an infusion for this indication at weeks 0, 2, and 6. Subsequent treatments will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• When used in combination with methotrexate, to reduce the signs and symptoms, inhibit the progression of structural damage and improve physical function in patients with moderately to severely active rheumatoid arthritis. Normally, the patient receives an infusion of Infliximab for this indication at weeks 0, 2, & 6 and then approximately every eight (8) weeks.

• To reduce the signs and symptoms in patients with active ankylosing spondylitis. Normally the patient receives an infusion for this indication at 0, 2 and 6 weeks. Subsequent treatment will be covered if the patient responds to the initial treatment as demonstrated by a reduction in signs and symptoms.

• For the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate. Remicade should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Normally the patient receives an infusion at 0, 2 and 6 weeks and every 8 weeks thereafter.

• To reduce signs and symptoms, achieve clinical remission and mucosal healing, and eliminate corticosteroids use in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy. Normally, the patient receives an infusion for this indication at 0, 2 and 6 weeks, and then every 8 weeks thereafter.

Note: For patients, who are unable to tolerate methotrexate or in the rare instance that Methotrexate is contraindicated for a patient, treatment with Infliximab alone will be covered only if documentation is maintained in the patient’s record that clearly indicates the reason that the patient cannot take methotrexate.

See the Limitations section below for Individual Consideration for Takayasu’s disease (ICD-9-CM code 446.7).

LIMITATIONS

Diagnosis code 446.7 (Takayasu’s disease) is not a covered diagnosis given its use has not been demonstrated to be a standard of care and claims can be denied as not medically reasonable and necessary. MAC J9 will address individual consideration for claims with this diagnosis and records may be requested for prepayment review. The documentation must clearly support that the patient was refractory to standard treatments such as treatment with corticosteroids or cytotoxic drugs, and that no reasonable alternative treatments were available. The record should clearly outline the indication (diagnostic criteria) and medical need (episode of care).

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.

013x Hospital Outpatient

021x Skilled Nursing - Inpatient (Including Medicare Part A) 023x Skilled Nursing - Outpatient

071x Clinic - Rural Health

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J1745 INJECTION INFLIXIMAB, 10 MG

ICD-9 Codes that Support Medical Necessity

555.1 REGIONAL ENTERITIS OF SMALL INTESTINE

555.2 REGIONAL ENTERITIS OF LARGE INTESTINE

555.3 REGIONAL ENTERITIS OF SMALL INTESTINE WITH LARGE INTESTINE

555.9 REGIONAL ENTERITIS OF UNSPECIFIED SITE

556.1 ULCERATIVE (CHRONIC) ENTEROCOLITIS

556.2 ULCERATIVE (CHRONIC) ILEOCOLITIS

556.3 ULCERATIVE (CHRONIC) PROCTITIS

556.4 ULCERATIVE (CHRONIC) PROCTOSIGMOIDITIS

556.5 LEFT-SIDED ULCERATIVE (CHRONIC) COLITIS

556.6 UNIVERSAL ULCERATIVE (CHRONIC) COLITIS

556.8 OTHER ULCERATIVE COLITIS

556.9 ULCERATIVE COLITIS UNSPECIFIED

565.1 ANAL FISTULA

569.81 FISTULA OF INTESTINE EXCLUDING RECTUM AND ANUS

696.1 PSORIATIC ARTHROPATHY

696.2 OTHER PSORIASIS AND SIMILAR DISORDERS

714.0 RHEUMATOID ARTHRITIS

714.2 OTHER RHEUMATOID ARTHRITIS WITH VISCERAL OR SYSTEMIC INVOLVEMENT

720.0 ANKYLOSING SPONDYLITIS

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 that is maintained by the performing physician must substantiate the medical necessity for the use of Infliximab by clearly indicating the relevant clinical signs and symptoms related to the medical condition for which this drug is indicated. The documentation must also include all prior treatment regimes and the patient’s response to that therapy.

For fistulizing Crohn’s disease, episodic retreatment will be covered if the medical record substantiates that the patient had a reduction in the clinical signs and symptoms of the disease after the initial treatment.

For rheumatoid arthritis, the medical record must clearly indicate:

• the patient is receiving Infliximab in combination with Methotrexate; or

• the patient is intolerant of methotrexate; or

• the patient has a medical condition that contraindicates the use of methotrexate.

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

Gottlieb, A; Evans, R., et al (2004). Infliximab induction therapy for patients with severe plaue-type psoriasis: A randomized, double blind, placebo-controlled trial. Journal of the American academy of Dermatology 51(4). Retrieved from http://www.home.mdconsult.com on August 11, 2005.

Hoffman, G.., Merkel, P., Brasington, R., Lenschow, D., & Liang, P. (2004). Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu Arteritis. Arthritis & Rheumatism, 50 (7), 2296-2304.

Infliximab Injection (2004). Medline Plus Drug information. Retrieved from http://www.nlm.nih.gov.medlineplus/druginfo/medmaster on August 11, 2005.

Lipsky, P.E., Van der Heijde, D., St. Clair, E.W., Furst, D.E., Breeveld, F.C., Kalden, J.R., Smolen, J.S., Weisman, M., Emery, P., Feldman, M., Harriman, G.R., & Maini, R.N. (2000). Infliximab and methotrexate in the treatment of rheumatoid arthritis. The New England Journal of Medicine, 343, 1594-1602.

Medical News Today (2004). Remicade Lowers Spinal Inflammation in Patients with Ankylosing Spondylitis. Retrieved from http://www.medicalnewstoday.com on August 11, 2005.

Molloy, E., Langford, C., Clark, T., Gota, C. & Hoffman, G. (2008). Anti-tumour necrosis factor therapy in patients with refractory Takayasu arteritis: long-term follow-up. Annals of Rheumatic Diseases, 67: 1567-1569.

Ogilvie, A., Antoni, C., Dechant, C., et al. (2001). Treatment of psoriatic arthritis with antitumor necrosis factor a antibody clears skin lesions of psoriasis resistant to treatment with methotrexate. British Journal of Dermatology, 144, 1932-1939. This article supports the use of this drug for psoriatic arthritis.

Pharmaceutical News (2004). Analysis shows Remicade reduces pain associated with Chron’s disease. Retrieved from http://www.news-medical.net on August 11, 2005.

Remicade TM package insert, 1999-2002.

Remicade TM Package insert revised September 2005. Remicade TM Package insert revised September 2006.

Rutgeerts, P., Feagan, A., Olson, J. et al (2005). A randomized Placebo-Controlled Trial of Infliximab Therapy for Active Ulcerative Colitis: Act I Trial. Gastroenterology, 128 (4) (2). The American Gastroenterological Association.

Sandborn, W., Rachmilewitz, D., Hanauer, S., et al (2005). Infliximab Induction and Maintenance Therapy for Ulcerative Colitis: the Act 2 Trial. Gastroenterology, 128 (4) (2). The American Gastroenterological Association.

Vanden Bosch, F., Kruithof, E., Baeten, D., et al. (2002). Randomized double-blind comparison of chimenic monoclonal antibody to tumor necrosis factor a (Infliximab) versus placebo in active spondylarthropathy. Arthritis

& Rheumatism, 46(3), 755-765. This article supports the use of this drug for ankylosing spondylarthropathy.

Advisory Committee Meeting Notes This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy 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 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:05/01/2012 Revision Effective Date:04/18/2012

LCR A2012-030

April 2012 Connection

Explanation of Revision: Under the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD, a reference was made to the new subheading of ‘Limitations’ section for Individual Consideration for Takayasu’s disease (ICD-9-CM code 446.7). Under the ‘Limitations’section, verbiage was added regarding a request for records for individual consideration for diagnosis code 446.7. In addition, the ‘CMS National Coverage Policy’ section, ‘Utilization Guidelines’ section and ‘Sources of Information and Basis for Decision’ section were updated. The effective date of this LCD 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:02/16/2009

LCR A2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28890) replaces LCD L1387 as the policy in notice. This document (L28890) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 71 was changed

8/1/2010 - The description for Revenue code 0636 was changed

Reason for Change Coverage Change (actual change in medical parameters)