Print

Date Printed: June 23, 2017: 11:40 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-35

Original Effective Date: 05/15/15

Reviewed: 04/12/17

Revised: 05/15/17

Subject: Corticosteroid Intravitreal Implant

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References

Previous Version

 
           

DESCRIPTION:

Fluocinolone acetonide (Retisert®) 0.59 mg implant was FDA-approved in April 2005 for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. Dexamethasone (Ozurdex®) 0.7 mg implant was FDA-approved for macular edema due to branch or central retinal vein occlusion (BRVO/CRVO) in June 2009, for non-infectious posterior uveitis in September 2010, and for diabetic macular edema (DME) in June 2014. Fluocinolone acetonide (Iluvien®) 0.19 mg implant was FDA-approved in September 2014 for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Ozurdex was previously granted orphan designation by the FDA in September 1998 for the treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate, posterior, and panuveitis. Retisert was previously granted orphan designation status in July 2000 for the treatment uveitis involving the posterior segment of the eye.

Uveitis describes a wide range of conditions characterized by intraocular inflammation. It is a highly heterogeneous condition, varying in etiology, tissues involved, and extent of disease. Uveitis can be either infectious or noninfectious. Noninfectious uveitis is often associated with systemic autoimmune or auto-inflammatory diseases such as ankylosing spondylitis, sarcoidosis, or Behçet’s disease; however, most cases have no associated systemic condition. The classification scheme recommended by the Uveitis Study Group and the Standardization of Uveitis Nomenclature (SUN) Working Group is based on anatomic location. Anterior chamber inflammation is categorized as “anterior uveitis”, and includes iritis, iridocyclitis, and anterior cyclitis. Inflammation primarily affecting the vitreous is referred to as “intermediate uveitis”, and includes pars planitis, posterior cyclitis, and hyalitis. “Posterior uveitis” describes inflammation of the retina or choroid and accounts for 15% to 30% of diagnoses. Finally, “pan-uveitis” describes the situation where inflammation is seen throughout the anterior chamber, vitreous, and retina or choroid. According to the SUN criteria, disease is further classified according to onset (sudden or insidious), duration (limited or persistent), and course (acute, recurrent, or chronic). Therapy for noninfectious uveitis is aimed at suppressing the immune system, and ranges from topical therapy (e.g., corticosteroid eye drops) to systemic immunosuppression with either high-dose corticosteroids or a wide range of corticosteroid-sparing immunosuppressive medications.

Diabetic macular edema (DME) is the most common cause of visual impairment in patients with diabetes, affecting ~25% of diabetics during their lifetime. It is characterized by swelling of the macula due to gradual leakage of fluids from blood vessels leading to moderate vision loss. Tight glycemic and blood pressure control is first-line treatment to control diabetic retinopathy and DME. First-line medical treatment of DME is usually an intravitreal vascular endothelial growth factor (VEGF) inhibitor. Intravitreal corticosteroid implants are typically reserved for second-line use due the high incidence of cataract formation and increases in intraocular pressure (IOP).

In two phase III, randomized, double-blinded trials of patients with diabetic macular edema (n=656), an improvement of at least 15 letters in best corrected visual acuity (BCVA) was achieved in 18% to 21% of those who received dexamethasone intravitreal implant (mean of 4 treatments over 36 months) compared with 10% to 12% who received placebo. In two phase III, randomized, double-blinded trials of patients with macular edema following BRVO or CRVO, dexamethasone-treated patients had significantly greater improvement in BCVA from baseline to 90 days compared with sham-treated patient (29% vs. 11%). In a phase III, randomized, double-blinded trial of patients with noninfectious intermediate or posterior uveitis, a significantly greater percentage of patients receiving intravitreal dexamethasone implant achieved a vitreous haze score of zero (indicating no inflammation) compared with sham-treated patients (47% vs. 12%).

In a phase III, randomized, trial, fluocinolone acetonide 0.59 mg intravitreal implant effectively controlled intraocular inflammation, significantly reducing uveitis recurrence rates in patients with noninfectious posterior uveitis over a 3-year follow-up period. The preimplantation recurrence rate of 62% for the 0.59-mg implant group dropped to 4%, 10%, and 20% in years 1, 2, and 3, respectively, following implantation. However, there were significant increased incidents of intraocular hypertension and cataract formation. An increase in IOP was seen at week 4 (approximately 6 mm Hg) compared with no significant change in the non-implanted eyes. Cataracts severe enough to require surgery were more commonly seen in implanted eyes vs. non-implanted eyes (9.9% vs 2.7%).

Two identical phase III randomized, double-blinded, sham injection-controlled trials known as the FAME studies (FAME A and FAME B) were conducted for over 36 months to study the efficacy and safety of intravitreal inserts releasing 0.2 mcg/day (low dose) or 0.5 mcg/day (high dose) fluocinolone acetonide in patients with DME. The manufacturer submission only considered the 0.2 mcg/day of fluocinolone. The percentage of patients who gained 15 letters or more using the last observation carried forward was 28.7% (low dose) and 27.8% (high dose) compared with 18.9% in the sham group. Cataract surgery was performed in 80% of phakic patients in the low-dose group and 87.2% of the high-dose group vs. 27.3% of the sham group. The occurrence of laser or incisional glaucoma surgery by 36 months was 6.1% in the low-dose group and 10.6% in the high-dose group vs. 0.5% of the sham group.

POSITION STATEMENT:

Ozurdex

Dexamethasone (Ozurdex) implant meets the definition of medical necessity when ALL of the following are met:

1. Member will NOT receive ANY of the following medications concurrently with Ozurdex:

a. Aflibercept (Eylea)

b. Fluocinolone acetonide (Iluvien and Retisert) intravitreal implant

c. Pegaptanib (Macugen)

d. Ranibizumab (Lucentis)

2. The indication for use is ANY of the following and ALL of the indication specific criteria are met:

a. Chronic, non-infectious uveitis affecting the posterior segment of the eye (i.e., intermediate uveitis, posterior uveitis, or panuveitis)

i. At least ONE of the following:

• Member has had an inadequate response (i.e., unresolved uveitis) or has a contraindication to treatment with triamcinolone acetonide intravitreal injection (the contraindication must be specified)

• Member is receiving triamcinolone acetonide intravitreal injection but requires injections more often than every 12 weeks

b. Diabetic macular edema (DME)

c. Branch or central retinal vein occlusion (BRVO/CRVO)

3. Member does NOT have an active or suspected ocular or periocular infection

4. The dosage does not exceed one 0.7 mg implant per treated eye and it is not implanted more often than every 3 months (i.e., maximum of 4 implants per 12 months).

Approval duration: 1 year

Iluvien

Fluocinolone acetonide (Iluvien) implant meets the definition of medical necessity when ALL of the following are met:

1. Member has a diagnosis of diabetic macular edema (DME)

2. Member has been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP)

3. Member will NOT receive ANY of the following medications concurrently with Iluvien:

a. Aflibercept (Eylea)

b. Dexamethasone (Ozurdex) intravitreal implant

c. Fluocinolone acetonide (Retisert) intravitreal implant

d. Pegaptanib (Macugen)

e. Ranibizumab (Lucentis)

4. Member does NOT have an active or suspected ocular or periocular infection

5. The dosage does not exceed one 0.19 mg implant per treated eye and it is not implanted more often than every 34 months.

Approval duration: Single implant per treated eye within 2 months of approval.

Retisert

Fluocinolone acetonide (Retisert) implant meets the definition of medical necessity when ALL of the following are met:

1. Member has a diagnosis of chronic, non-infectious uveitis affecting the posterior segment of the eye (i.e., intermediate uveitis, posterior uveitis, or panuveitis)

2. Member has had an inadequate response (i.e., recurrent or unresolved uveitis) or has a contraindication to the dexamethasone implant (Ozurdex) (the contraindication must be specified)

3. For members with bilateral disease only (i.e., both eyes effected) - member has had an inadequate response to least ONE or contraindications to ALL of the following oral immunosuppressive agents (the contraindications must be specified):

a. Azathioprine

b. Cyclosporine

c. Methotrexate

d. Mycophenolate mofetil

e. Tacrolimus

3. Member will NOT receive ANY of the following medications concurrently with Retisert:

a. Aflibercept (Eylea)

b. Fluocinolone acetonide (Iluvien) intravitreal implant

c. Dexamethasone intravitreal implant (Ozurdex)

d. Pegaptanib (Macugen)

e. Ranibizumab (Lucentis)

4. Member does NOT have an active or suspected ocular or periocular infection

5. The dosage does not exceed one 0.59 mg implant per treated eye and it is not implanted more often than every 28 months.

.Approval duration: Single implant per treated eye within 2 months of approval.

Fluocinolone acetonide intravitreal implant 0.59 mg (Retisert) or 0.19 mg (Iluvien) or dexamethasone intravitreal implant 0.7 mg (Ozurdex) is considered investigational for the treatment of:

Birdshot retinochoroidopathy

Cystoid macular edema related to retinitis pigmentosa

Idiopathic macular telangiectasia type 1

Postoperative macular edema

Circumscribed choroidal hemangiomas

Proliferative vitreoretinopathy

Radiation retinopathy.

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Ozurdex

FDA-approval: indicated for the treatment of:

• macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

• non-infectious uveitis affecting the posterior segment of the eye

• diabetic macular edema (DME)

How supplied: a rod-shaped intravitreal implant containing 0.7 mg dexamethasone in the NOVADUR® solid polymer sustained-release drug delivery system. It is preloaded into a single-use plastic applicator supplied in a foil pouch.

Iluvien

FDA-approval: indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

How supplied: a non-bioerodable intravitreal implant in a drug delivery system containing 0.19 mg fluocinolone acetonide supplied in a sterile single use preloaded applicator with a 25-gauge needle, packaged in a tray sealed with a lid inside a carton. The implant is designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day and lasting 36 months.

Retisert

FDA-approval: indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The implant is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3 to 0.4 mcg/day over approximately 30 months. Following depletion as evidenced by recurrence of uveitis, the implant may be replaced.

How supplied: a tablet 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 silicone elastomer suture tab with silicone adhesive. Each implant is approximately 3 mm x 2 mm x 5 mm. Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap.

PRECAUTIONS:

Ozurdex

Contraindications

• Active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.

• Glaucoma patients who have cup to disc ratios of greater than 0.8.

• Torn or ruptured posterior lens capsule (risk of migration into the anterior chamber). Laser posterior capsulotomy in pseudophakic patients is NOT a contraindication.

• Known hypersensitivity to any components of this product.

Warnings

Intravitreal injection-related effects: Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.

Steroid-related effects: Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

Iluvien

Contraindications

• Active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.

• Glaucoma patients who have cup to disc ratios of greater than 0.8.

• Known hypersensitivity to any components of this product.

Warnings

Intravitreal injection-related effects: Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.

Steroid-related effects: Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. Not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

Risk of implant migration: The implant may migrate into the anterior chamber if the posterior lens capsule is not intact.

Retisert

Contraindications

• Active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye.

Warnings

Cataract formation: Nearly all phakic patients are expected to develop cataracts and require cataract surgery.

Endophthalmitis: Late onset endophthalmitis has been observed. Nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.

Increase in intraocular pressure: Use of corticosteroids may result in elevated IOP and/or glaucoma. IOP lowering medications were required in >75% of patients; filtering surgeries were required in >35% of patients.

Separation of implant components: Physicians should periodically monitor the integrity of the implant by visual inspection.

BILLING/CODING INFORMATION:

.The following codes may be used to describe:

HCPCS Coding: Ozurdex

J7312

Injection, dexamethasone, intravitreal implant, 0.1 mg

HCPCS Coding: Iluvien

J7313

Injection, fluocinolone acetonide, intravitreal implant, 0.01 mg

HCPCS Coding: Retisert

J7311

Fluocinolone acetonide, intravitreal implant

ICD-10 Diagnoses Codes: Ozurdex

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3519

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E09.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema

H20.041

Secondary noninfectious iridocyclitis, right eye

H20.042

Secondary noninfectious iridocyclitis, left eye

H20.043

Secondary noninfectious iridocyclitis, bilateral

H20.049

Secondary noninfectious iridocyclitis, unspecified eye

H30.001

Unspecified focal chorioretinal inflammation, right eye

H30.002

Unspecified focal chorioretinal inflammation, left eye

H30.003

Unspecified focal chorioretinal inflammation, bilateral

H30.009

Unspecified focal chorioretinal inflammation, unspecified eye

H30.011

Focal chorioretinal inflammation, juxtapapillary, right eye

H30.012

Focal chorioretinal inflammation, juxtapapillary, left eye

H30.013

Focal chorioretinal inflammation, juxtapapillary, bilateral

H30.019

Focal chorioretinal inflammation, juxtapapillary, unspecified eye

H30.021

Focal chorioretinal inflammation of posterior pole, right eye

H30.022

Focal chorioretinal inflammation of posterior pole, left eye

H30.023

Focal chorioretinal inflammation of posterior pole, bilateral

H30.029

Focal chorioretinal inflammation of posterior pole, unspecified eye

H30.031

Focal chorioretinal inflammation, peripheral, right eye

H30.032

Focal chorioretinal inflammation, peripheral, left eye

H30.033

Focal chorioretinal inflammation, peripheral, bilateral

H30.039

Focal chorioretinal inflammation, peripheral, unspecified eye

H30.041

Focal chorioretinal inflammation, macular or paramacular, right eye

H30.042

Focal chorioretinal inflammation, macular or paramacular, left eye

H30.043

Focal chorioretinal inflammation, macular or paramacular, bilateral

H30.049

Focal chorioretinal inflammation, macular or paramacular, unspecified eye

H30.101

Unspecified disseminated chorioretinal inflammation, right eye

H30.102

Unspecified disseminated chorioretinal inflammation, left eye

H30.103

Unspecified disseminated chorioretinal inflammation, bilateral

H30.109

Unspecified disseminated chorioretinal inflammation, unspecified eye

H30.111

Disseminated chorioretinal inflammation of posterior pole, right eye

H30.112

Disseminated chorioretinal inflammation of posterior pole, left eye

H30.113

Disseminated chorioretinal inflammation of posterior pole, bilateral

H30.119

Disseminated chorioretinal inflammation of posterior pole, unspecified eye

H30.121

Disseminated chorioretinal inflammation, peripheral, right eye

H30.122

Disseminated chorioretinal inflammation, peripheral, left eye

H30.123

Disseminated chorioretinal inflammation, peripheral, bilateral

H30.129

Disseminated chorioretinal inflammation, peripheral, unspecified eye

H30.131

Disseminated chorioretinal inflammation, generalized, right eye

H30.132

Disseminated chorioretinal inflammation, generalized, left eye

H30.133

Disseminated chorioretinal inflammation, generalized, bilateral

H30.139

Disseminated chorioretinal inflammation, generalized, unspecified eye

H30.20

Posterior cyclitis, unspecified eye

H30.21

Posterior cyclitis, right eye

H30.22

Posterior cyclitis, left eye

H30.23

Posterior cyclitis, bilateral

H30.891

Other chorioretinal inflammations, right eye

H30.892

Other chorioretinal inflammations, left eye

H30.893

Other chorioretinal inflammations, bilateral

H30.899

Other chorioretinal inflammations, unspecified eye

H30.90

Unspecified chorioretinal inflammation, unspecified eye

H30.91

Unspecified chorioretinal inflammation, right eye

H30.92

Unspecified chorioretinal inflammation, left eye

H30.93

Unspecified chorioretinal inflammation, bilateral

H34.8110

Central retinal vein occlusion, right eye, with macular edema

H34.8120

Central retinal vein occlusion, left eye, with macular edema

H34.8130

Central retinal vein occlusion, bilateral , with macular edema

H34.8190

Central retinal vein occlusion, unspecified eye, with macular edema

H34.8310

Tributary (branch) retinal vein occlusion, right eye, with macular edema

H34.8320

Tributary (branch) retinal vein occlusion, left eye, with macular edema

H34.8330

Tributary (branch) retinal vein occlusion, bilateral, with macular edema

H34.8390

Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema

H44.111

Panuveitis, right eye

H44.112

Panuveitis, left eye

H44.113

Panuveitis, bilateral

H44.119

Panuveitis, unspecified eye

ICD-10 Diagnoses Codes: Iluvien

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

E08.3211 – E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema

E08.3311 – E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema

E08.3411 – E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema

E08.3511 – E08.3519

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

E09.3211 – E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E09.3311 – E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E09.3411 – E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E09.3511 – E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.3211 – E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E10.3311 – E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E10.3411 – E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E10.3511 – E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.3211 – E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E11.3311 – E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E11.3411 – E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E11.3511 – E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.3211 – E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema

E13.3311 – E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema

E13.3411 – E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema

E13.3511 – E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema

ICD-10 Diagnoses Codes: Retisert

H20.041

Secondary noninfectious iridocyclitis, right eye

H20.042

Secondary noninfectious iridocyclitis, left eye

H20.043

Secondary noninfectious iridocyclitis, bilateral

H20.049

Secondary noninfectious iridocyclitis, unspecified eye

H30.001

Unspecified focal chorioretinal inflammation, right eye

H30.002

Unspecified focal chorioretinal inflammation, left eye

H30.003

Unspecified focal chorioretinal inflammation, bilateral

H30.009

Unspecified focal chorioretinal inflammation, unspecified eye

H30.011

Focal chorioretinal inflammation, juxtapapillary, right eye

H30.012

Focal chorioretinal inflammation, juxtapapillary, left eye

H30.013

Focal chorioretinal inflammation, juxtapapillary, bilateral

H30.019

Focal chorioretinal inflammation, juxtapapillary, unspecified eye

H30.021

Focal chorioretinal inflammation of posterior pole, right eye

H30.022

Focal chorioretinal inflammation of posterior pole, left eye

H30.023

Focal chorioretinal inflammation of posterior pole, bilateral

H30.029

Focal chorioretinal inflammation of posterior pole, unspecified eye

H30.031

Focal chorioretinal inflammation, peripheral, right eye

H30.032

Focal chorioretinal inflammation, peripheral, left eye

H30.033

Focal chorioretinal inflammation, peripheral, bilateral

H30.039

Focal chorioretinal inflammation, peripheral, unspecified eye

H30.041

Focal chorioretinal inflammation, macular or paramacular, right eye

H30.042

Focal chorioretinal inflammation, macular or paramacular, left eye

H30.043

Focal chorioretinal inflammation, macular or paramacular, bilateral

H30.049

Focal chorioretinal inflammation, macular or paramacular, unspecified eye

H30.101

Unspecified disseminated chorioretinal inflammation, right eye

H30.102

Unspecified disseminated chorioretinal inflammation, left eye

H30.103

Unspecified disseminated chorioretinal inflammation, bilateral

H30.109

Unspecified disseminated chorioretinal inflammation, unspecified eye

H30.111

Disseminated chorioretinal inflammation of posterior pole, right eye

H30.112

Disseminated chorioretinal inflammation of posterior pole, left eye

H30.113

Disseminated chorioretinal inflammation of posterior pole, bilateral

H30.119

Disseminated chorioretinal inflammation of posterior pole, unspecified eye

H30.121

Disseminated chorioretinal inflammation, peripheral, right eye

H30.122

Disseminated chorioretinal inflammation, peripheral, left eye

H30.123

Disseminated chorioretinal inflammation, peripheral, bilateral

H30.129

Disseminated chorioretinal inflammation, peripheral, unspecified eye

H30.131

Disseminated chorioretinal inflammation, generalized, right eye

H30.132

Disseminated chorioretinal inflammation, generalized, left eye

H30.133

Disseminated chorioretinal inflammation, generalized, bilateral

H30.139

Disseminated chorioretinal inflammation, generalized, unspecified eye

H30.20

Posterior cyclitis, unspecified eye

H30.21

Posterior cyclitis, right eye

H30.22

Posterior cyclitis, left eye

H30.23

Posterior cyclitis, bilateral

H30.891

Other chorioretinal inflammations, right eye

H30.892

Other chorioretinal inflammations, left eye

H30.893

Other chorioretinal inflammations, bilateral

H30.899

Other chorioretinal inflammations, unspecified eye

H30.90

Unspecified chorioretinal inflammation, unspecified eye

H30.91

Unspecified chorioretinal inflammation, right eye

H30.92

Unspecified chorioretinal inflammation, left eye

H30.93

Unspecified chorioretinal inflammation, bilateral

H44.111

Panuveitis, right eye

H44.112

Panuveitis, left eye

H44.113

Panuveitis, bilateral

H44.119

Panuveitis, unspecified eye

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: No National Coverage Determination (NCD) or Local Coverage Determination (LCD) was found at the time of the last guideline review date.

DEFINITIONS:

Anterior uveitis - inflammation occurring in the front of the eye (anterior chamber) which includes the iris and adjacent tissue known as the ciliary body. This diagnosis includes iritis, iridocyclitis, and anterior cyclitis. Generally less severe than other forms of uveitis.

Chronic uveitis – persistent uveitis (>3 months duration) with a relapse in less than 3 months after discontinuation of treatment.

Intermediate uveitis – inflammation occurring in the center of eye which is the vitreous. This diagnosis includes pars planitis, posterior cyclitis, and hyalitis.

Macular edema - swelling of the retina due to leaking of fluid from blood vessels within the macula (the central portion of the retina). Diabetic macular edema (DME) is macular edema that occurs in patients with diabetes.

Pan-uveitis – inflammation occurring throughout the eye including the anterior chamber, vitreous, and retina or choroid. This diagnosis includes diffuse uveitis and endophthalmitis.

Posterior uveitis - inflammation occurring in the back of the eye which includes the retina or choroid and accounts for 15% to 30% of diagnoses. This diagnosis includes retinitis, neuroretinitis, retinochoroiditis, chorioretinitis, choroiditis (focal, multifocal or diffuse), and papillitis.

Retinal vein occlusion - a blockage of one or more veins that carry blood away from the retina. Central retinal vein occlusion (CRVO) occurs when the blockage is in the main vein in the retina. Branch retinal vein occlusion (BRVO) occurs when the blockage is one of the smaller veins attached to the main vein in the retina.

RELATED GUIDELINES:

Vascular Endothelial Growth Factor Inhibitors for Ocular Neovascularization, 09-J1000-78

OTHER:

None

REFERENCES:

  1. American Optometric Association. Evidence-based clinical practice guideline: eye care of the patient with diabetes mellitus. St. Louis (MO): American Optometric Association; 2014.
  2. Barry RJ, Nguyen QD, Lee RW, et al. Pharmacotherapy for uveitis: current management and emerging therapy. Clin Ophthalmol. 2014 Sep 22;8:1891-911. doi: 10.2147/OPTH.S47778.
  3. Brady CJ, Villanti AC, Law HA, et al. Corticosteroid implants for chronic non-infectious uveitis. Cochrane Database Syst Rev. Feb 12 2016;2:CD010469.
  4. Campochiaro PA, Brown DM, Pearson A, et al: Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology 2012; 119(10):2125-2132.
  5. Cebeci Z and Kir N. Role of implants in the treatment of diabetic macular edema: focus on the dexamethasone intravitreal implant. Diabetes Metab Syndr Obes. 2015 Nov 16;8:555-66.
  6. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 Mar 22]. Available from: http://www.clinicalpharmacology.com/.
  7. Comyn O, Lightman SL, Hykin PG. Corticosteroid intravitreal implants vs. ranibizumab for the treatment of vitreoretinal disease. Curr Opin Ophthalmol 2013; 24(3):248-54.
  8. DRUGDEX System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 Mar 22]. Available from: http://www.thomsonhc.com/.
  9. Gado AS, Macky TA. Dexamethasone intravitreous implant versus bevacizumab for central retinal vein occlusion-related macular oedema: a prospective randomized comparison. Clin Experiment Ophthalmol. Sep-Oct 2014;42(7):650-655.
  10. Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008(1):CD005656.
  11. Holbrook JT, Sugar EA, Burke AE, et al. Dissociations of the Fluocinolone Acetonide Implant: The Multicenter Uveitis Steroid Treatment (MUST) Trial and Follow-up Study. Am J Ophthalmol. Apr 2016;164:29-36.
  12. Iluvien (fluocinolone acetonide intravitreal implant) [package insert]. Alpharetta, GA: Alimera Sciences, Inc.; November 2016.
  13. Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. Review.
  14. Kempen JH, Altaweel MM, Holbrook JT, et al. Randomized comparison of systemic anti-inflammatory therapy versus fluocinolone acetonide implant for intermediate, posterior, and panuveitis: the multicenter uveitis steroid treatment trial. Ophthalmology 2011; 118(10):1916-26.
  15. Kuppermann BD, Goldstein M, Maturi RK, et al. Dexamethasone intravitreal implant as adjunctive therapy to ranibizumab in neovascular age-related macular degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54.
  16. Lowder C, Belfort R Jr, Lightman S, et al.; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129 (5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
  17. Maturi Rk, Bleau L, Saunders J, Et Al. A 12-Month, Single-Masked, Randomized Controlled Study of Eyes with Persistent Diabetic Macular Edema after Multiple Anti-Vegf Injections to Assess the Efficacy of the Dexamethasone-Delayed Delivery System as an Adjunct to Bevacizumab Compared with Continued Bevacizumab Monotherapy. Retina. 2015 Aug;35 (8):1604-14.
  18. Maturi RK, Chen V, Raghinaru D, et al. A 6-month, subject-masked, randomized controlled study to assess efficacy of dexamethasone as an adjunct to bevacizumab compared with bevacizumab alone in the treatment of patients with macular edema due to central or branch retinal vein occlusion. Clin Ophthalmol. 2014 Jun 3;8:1057-64.Multicenter Uveitis Steroid Treatment Trial Research Group. Benefits of systemic anti-inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis, posterior uveitis, and panuveitis: fifty-four-month results of the Multicenter Uveitis Steroid Treatment (MUST) trial and follow-up study. Ophthalmology. Oct 2015;122(10):1967-1975.
  19. Multicenter Uveitis Steroid Treatment Trial Follow-up Study Research Group. Quality of life and risks associated with systemic anti-inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis, posterior uveitis, or panuveitis: fifty-four-month results of the Multicenter Uveitis Steroid Treatment trial and follow-up study. Ophthalmology. Oct 2015;122(10):1976-1986.
  20. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 Mar 22]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  21. Ozkok A, Saleh OA, Sigford DK, et al. THE OMAR STUDY: Comparison of Ozurdex and Triamcinolone Acetonide for Refractory Cystoid Macular Edema in Retinal Vein Occlusion. Retina. 2015 Jul;35(7):1393-400.
  22. Ozurdex (dexamethasone intravitreal implant) [package insert]. Irvine, CA: Allergan, Inc. Sept 2014.
  23. Panozzo G, Gusson E, Panozzo G, et al. Dexamethasone intravitreal implant for diabetic macular edema: indications for a PRN regimen of treatment. Eur J Ophthalmol. 2015;25(4):347–351.
  24. Pearson PA, Comstock TL, Ip M, et al: Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology 2011; 118(8):1580-1587.
  25. Pulido JS, Flaxel CJ, Adelman RA, et al. Retinal vein occlusions Preferred Practice Pattern Guidelines. Ophthalmology. Jan 2016;123(1):P182-208. PMID 26581559
  26. Regnier SA, Larsen M, Bezlyak V, et al. Comparative efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion: a network meta-analysis. BMJ Open. 2015;5(6):e007527.
  27. Retisert (fluocinolone acetonide implant) [package insert]. Rochester, NY: Bausch & Lomb; May 2012.
  28. Sharareh B, Gallemore R, Taban M, et al. Recalcitrant macular edema after intravitreal bevacizumab is responsive to an intravitreal dexamethasone implant in retinal vein occlusion. Retina. 2013;33(6):1227–1231.
  29. Triesence (triamcinolone acetonide injection, suspension) [package insert]. Alcon Laboratories, Inc.; Fort Worth, Texas. January 2016.
  30. Yeh S, Kim SJ, Ho AC, et al. Therapies for macular edema associated with central retinal vein occlusion: a report by the American Academy of Ophthalmology. Ophthalmology. Apr 2015;122(4):769-778.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 04/12/17.

GUIDELINE UPDATE INFORMATION:

05/15/15

New Medical Coverage Guideline.

08/15/15

Revision consisting of update to the position statement.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS coding update: added code J7313 and deleted codes C9450 and J3490.

02/15/16

Revision consisting of update to the position statement and new references.

05/15/16

Review and revision of guideline consisting of references.

10/01/16

Revision: ICD-10 code updates

05/15/17

Review and revision to guideline consisting of updating the description section, position statement, and references.

Date Printed: June 23, 2017: 11:40 AM