L29269-LCD

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Local Coverage Determination (LCD) for Retisert (fluocinolone acetonide intravitreal implant) (L29269)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29269

LCD Title

Retisert (fluocinolone acetonide intravitreal implant)

Contractor's Determination Number J7311

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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

Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Uveitis, mainly posterior segment uveitis, accounts for up to 10% of blindness in the United States, and up to 15% worldwide. Many experts rank uveitis among the leading causes of preventable blindness in the middle age group in the Western world. Severe visual impairment has been reported in up to 28% of patients with intermediate uveitis, and in up to 46% in patients with posterior uveitis. Unilateral legal blindness can develop in approximately 22% of patients with posterior uveitis. The effect of uveitis in this age group has significant socioeconomic impact, as it includes the working age range. Years of vision loss are higher per case than with age

-related eye diseases.

Noninfectious uveitis affecting the posterior segment of the eye encompasses a heterogeneous group of inflammatory diseases, many of which are idiopathic and/or systemic in origin. Based on anatomical classification, posterior segment uveitis involves inflammation of various structures of the uvea and includes intermediate uveitis, posterior uveitis and panuveitis. The disease is characterized by chronic inflammation, ultimately leading to cellular and structural dysfunction and eventual vision loss. Due to the aggressive and invasive nature of the disease, it is associated with a high incidence of complications, which contribute to overall visual morbidity. The main cause of visual impairment in uveitis affecting the posterior segment is the ultimate development of cystoid macular edema, cataracts, or a combination thereof. Of particular importance, is the fact that visual morbidity does not result from a single episode of uveitis, but rather recurrent episodes of inflammation resulting in cumulative damage. Poor visual outcomes are significantly associated with duration of inflammation and recurrent episodes of inflammation. Therefore, inflammation must be controlled long term if patients are going to be spared visual impairment and blindness.

Retisert (fluocinolone acetonide intravitreal implant) is a single-indication orphan drug, which is FDA-approved for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

Retisert consists of a tablet containing the active ingredient fluocinolone acetonide, a corticosteroid. The tablet is encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a polyvinyl alcohol suture tab with silicone adhesive. Each Retisert is approximately 3 mm x 2 mm x 5 mm.

Retisert is surgically implanted into the posterior segment of the affected eye through a pars plana incision. The implant contains one tablet of 0.59 mg of fluocinolone acetonide. Retisert is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 µg/day, decreasing over the first month to a steady state between 0.3-

0.4 µg/day over approximately 30 months (2.5 years). Following depletion of fluocinolone acetonide from Retisert as evidenced by recurrence of uveitis, Retisert may be replaced. The intended implantation regimen for Retisert 0.59mg is once every 2.5 years by intravitreal insertion through an aseptic surgical sclerotomy into the eye to be treated.

Medicare will consider Retisert (fluocinolone acetonide intravitreal implant) medically reasonable and necessary for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye for services rendered on or after the FDA-approval date of April 8, 2005.

Retisert is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex, keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infections of the eye and fungal diseases of ocular structures. Retisert is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of its preparation and to other corticosteroids.

Limitations:

Generally, it would be expected that a short course of peri-ocular injections (6-8 weeks) or a short course of systemic corticosteroid therapy (less than 3 months) would be tried to see if the inflammation completely subsides before moving to Retisert.

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

67027 IMPLANTATION OF INTRAVITREAL DRUG DELIVERY SYSTEM (EG, GANCICLOVIR IMPLANT), INCLUDES CONCOMITANT REMOVAL OF VITREOUS

J7311 FLUOCINOLONE ACETONIDE, INTRAVITREAL IMPLANT

ICD-9 Codes that Support Medical Necessity For Procedure Code J7311 Only:

360.11 SYMPATHETIC UVEITIS

360.12 PANUVEITIS

362.18 RETINAL VASCULITIS

363.00 FOCAL CHORIORETINITIS UNSPECIFIED

363.10 DISSEMINATED CHORIORETINITIS UNSPECIFIED

363.12 DISSEMINATED CHOROIDITIS AND CHORIORETINITIS PERIPHERAL 363.13* DISSEMINATED CHOROIDITIS AND CHORIORETINITIS GENERALIZED

363.20 CHORIORETINITIS UNSPECIFIED

363.21 PARS PLANITIS

* Code first with any underlying disease

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

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 performing physician must include the clinical indication/medical necessity for the Retisert (fluocinolone acetonide intravitreal implant). Documentation must state the signs, symptoms, or diagnosis that support the need for the service. Documentation will not be required with the submission of each claim. Because an unlisted/nonspecific code is used to bill Retisert, request for documentation will be sent to the provider. The documentation submitted should include the operative/procedure report and medical records (eg, office notes, history and physical) supporting the signs, symptoms, and diagnosis.

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

Gritz, D.; Wong, I. (2004) Incidence and Prevalence of Uveitis in Northern California. Ophthamol, 111, 491-500.

Jaffe, G., McCallum, R., Branchaud, B., Skalak, C., Butuner, Z., Ashton, P. (2005). Long-term follow-up results of a pilot trial of a fluocinolone acetonide implant to treat posterior uveitis. Ophthalmology, 112, 1192-1198.

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 12/04/2008

Revision History Number Original

Revision History Explanation 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 (L29269) replaces LCD L22288 as the policy in notice. This document (L29269) is effective on 02/02/2009.

Reason for Change