LCD/NCD Portal

L29269

 

RETISERT (FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT)

 

02/02/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

• 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.

o 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

o Retisert as evidenced by recurrence of uveitis, Retisert may be replaced. The intended implantation regimen for

o 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

o epithelial herpes simplex,

o keratitis (dendritic keratitis),

o vaccinia, and

o varicella, and

o 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

o Short course of peri-ocular injections (6-8 weeks).

o Short course of systemic corticosteroid therapy (less than 3 months).

o Would be tried to see if the inflammation completely subsides before moving to Retisert.

 

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

 

 

Documentation 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 supports 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 (e.g., office notes, history and physical) supporting the signs, symptoms, and diagnosis.

 

Treatment Logic

• 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.

o Retisert consists of a tablet containing the active ingredient fluocinolone acetonide, a corticosteroid.

o 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.

o 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.

 

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.

 

02/02/2009

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 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.

 

CMS LCD L29269 Retisert (fluocinolone acetonide intravitreal implant)