Download Memorandum Sample - ALLERGAN RETINA COVERAGE

Denied Claims
Provider name, address, and date
Re: patient name
Date of Birth: patient’s date of birth
Policy ID/Group: patient’s information
Policyholder: patient information
Dear name of payer,
I am writing to support coverage (or) to appeal denial of a claim for treatment of my patient, patient name, with
OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, which is reported under code J7312 (injection,
dexamethasone intravitreal implant, 0.1 mg) for the treatment of macular edema following specify branch or
central retinal vein occlusion.
OZURDEX® (dexamethasone intravitreal implant) is delivered via NOVADUR® technology
OZURDEX® intravitreal implant uses the NOVADUR® solid polymer drug delivery system, which is proprietary
to Allergan. OZURDEX® implant is injectable and biodegradable. Each implant comes preloaded in a specially
designed, single-use applicator. OZURDEX® is administered as an in-office procedure by Retina Specialists.
The efficacy of OZURDEX® intravitreal implant was assessed in the GENEVA trials (Global Evaluation of
ImplaNtable DExamethasone in Retinal Vein Occlusion With Macular EdemA), two identical, randomized,
prospective, multicenter, masked, sham-controlled, 6-month, phase 3 trials involving 853 patients with macular
edema following branch or central retinal vein occlusion who received OZURDEX® 0.7 mg or sham.1,2
Indication and Usage
Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of macular
edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION. The intravitreal injection procedure should be carried out
under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for
elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms
suggestive of endophthalmitis without delay.
IMPORTANT SAFETY INFORMATION
Contraindications
Ocular or Periocular Infections: OZURDEX® (dexamethasone intravitreal implant) is contraindicated in
patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and
conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella,
mycobacterial infections, and fungal diseases.
Please see additional Important Safety Information on next page.
With OZURDEX® (dexamethasone intravitreal implant), more RVO patients gained 3 lines of vision
significantly faster than with sham in pivotal trials1,3
Twenty percent to 30% of OZURDEX® patients (n = 427) gained 3 lines within 1 to 2 months (vs 7% to 12%
with sham; n = 426).1,3 The duration of effect persists approximately 1 to 3 months after onset of this effect.1
OZURDEX® produced a mean gain of 9.8 letters at day 60 (versus 3.1 letters with sham) with a significant P
value of < .001.1,2
The efficacy of OZURDEX® has been proven in both branch and central retinal vein occlusion1,2
Regardless of RVO type, more OZURDEX® patients gained 3 lines within 1 to 2 months (than sham-treated
patients).1
With OZURDEX® intravitreal implant, fewer patients had significant vision loss as compared with sham1,2
By day 90, 3.5% of OZURDEX® patients (n = 427) had a loss of at least 15 letters vs 6.8% of sham patients
(n = 426) (P= .030).1,2
IOP data from phase 3 clinical trials1
A peak of 15.7% of patients receiving OZURDEX® (dexamethasone intravitreal implant) (n = 421) had an
increase in intraocular pressure (IOP) ≥ 10 mm Hg from baseline at day 60 vs 0.2% of sham patients (n = 423).1
Most IOP increases were managed with topical medication. At day 90, 29.7% of OZURDEX® patients (n = 421)
were on IOP-lowering medications (vs 3.5% of sham patients; n = 423).1 Three OZURDEX® patients (3/421)
received IOP-lowering surgery1 (one case was due to neovascular glaucoma).2
IMPORTANT SAFETY INFORMATION (continued)
Contraindications (continued)
Glaucoma: OZURDEX® is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than
0.8.
Torn or Ruptured Posterior Lens Capsule: OZURDEX® is contraindicated in patients whose posterior lens
capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy
in pseudophakic patients is not a contraindication for OZURDEX® use.
Hypersensitivity: OZURDEX® is contraindicated in patients with known hypersensitivity to any components of
this product.
Warnings and Precautions
Intravitreal Injection‐related Effects: Intravitreal injections, including those with OZURDEX®, have been
associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments.
Patients should be monitored regularly following the injection.
Steroid‐related Effects: Use of corticosteroids including OZURDEX® may produce posterior subcapsular
cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular
infections due to bacteria, fungi, or viruses.
Please see additional Important Safety Information on next page.
2
On date, patient name was diagnosed with macular edema following specify branch or central retinal vein
occlusion; insert relevant ICD-9-CM codes. Specifically, the results of my examination determined that the
patient requires treatment . This condition has impacted the patient’s visual acuity.
I determined that it was medically necessary to treat patient name with OZURDEX ® (dexamethasone intravitreal
implant).
I treated patient name by intravitreal injection of OZURDEX®. OZURDEX® is reported on the claim form using
code J7312 (injection, dexamethasone intravitreal implant, 0.1 mg) (or) C9256 (injection, dexamethasone
intravitreal implant, 0.1 mg) with appropriate modifier indicating whether the injection was administered to the
right, left, or both eyes.
The patient had improved visual acuity with prior therapy with OZURDEX®. Based on this outcome, I plan to
treat patient name with OZURDEX® as follows: describe planned course of treatment and duration.
IMPORTANT SAFETY INFORMATION (continued)
Warnings and Precautions (continued)
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex because of the
potential for reactivation of the viral infection.
Adverse Reactions
Adverse reactions reported by greater than 2% of patients in the first 6 months following injection of
OZURDEX® for retinal vein occlusion include: intraocular pressure increased (25%), conjunctival hemorrhage
(22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous
detachment (2%), and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421)
of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.
Please see accompanying full Prescribing Information.
Sincerely,
Your signature
Your name
1. Data on file, Allergan, Inc.
2. Haller JA, Bandello F, Belfort R Jr, et al; for OZURDEX® GENEVA Study Group. Randomized, shamcontrolled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein
occlusion. Ophthalmology. 2010;117(6):1134-1146.
3. OZURDEX® Prescribing Information.
©2014 Allergan, Inc., Irvine, CA 92612 ® marks owned by Allergan Inc. APC55EL14 143547
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