Local Coverage Article Billing and Coding

Billing and Coding: FDA approves Iluvien for Diabetic Macular Edema

A54750

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Contractor Information

Article Information

General Information

Article ID
A54750
Article Title
Billing and Coding: FDA approves Iluvien for Diabetic Macular Edema
Article Type
Billing and Coding
Original Effective Date
12/30/2015
Revision Effective Date
11/07/2019
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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.

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CMS National Coverage Policy

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Article Guidance

Article Text

On September 26, 2014, The US Food and Drug Administration approved ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg 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. ILUVIEN® is an intravitreal implant of fluocinolone acetonide and is the first DME treatment to deliver 36 months of continuous, low-dose corticosteroid with a single injection. The ILUVIEN® intravitreal implant is designed to release fluocinolone acetonide/day at an initial rate of 0.25 µg/day.

To submit a Part B claim:

  • Submit HCPCS code J7313 (fluocinolone acetonide intravitreal implant,0.19 mg )
  • Total Dosage 0.19 mg, placed in narrative field
  • One of the ICD-10 diagnoses below.

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

CPT/HCPCS Codes

Group 1 Codes
CodeDescription
67028 INTRAVITREAL INJECTION OF A PHARMACOLOGIC AGENT (SEPARATE PROCEDURE)
J7313 INJECTION, FLUOCINOLONE ACETONIDE, INTRAVITREAL IMPLANT (ILUVIEN), 0.01 MG

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(29 Codes)
Group 1 Paragraph

Covered ICD-10 Codes

Group 1 Codes
CodeDescription
E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E10.3211 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E10.3212 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E10.3213 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3311 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E10.3312 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E10.3313 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3411 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E10.3412 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E10.3413 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E10.3511 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E10.3512 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E10.3513 Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral
E10.3521 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye
E10.3522 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye
E10.3523 Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral
E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
E11.3211 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye
E11.3212 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye
E11.3213 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3311 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye
E11.3312 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye
E11.3313 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3411 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye
E11.3412 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye
E11.3413 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral
E11.3511 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye
E11.3512 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye
E11.3513 Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Additional ICD-10 Information

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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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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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 article, 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 article should be assumed to apply equally to all Revenue Codes.

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Other Coding Information

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/07/2019 R6

Under CPT/HCPCS Codes Group 1: Codes the description was changed for HCPCS code J7313. This revision is due to 4th quarter CPT®/HCPCS Code update and becomes effective on 10/1/2019.

10/03/2019 R5

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

02/26/2018 R4 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
10/01/2016 R3

Annual review with no revisions made.

10/01/2016 R2 Under ICD-10 Codes That Support Medical Necessity added ICD-10 codes E10.3211, E10.3212, E10.3213, E10.3311, E10.3312, E10.3313, E10.3411, E10.3412, E10.3413, E10.3511, E10.3512, E10.3513, E10.3521, E10.3522, E10.3523, E11.3211, E11.3212, E11.3213, E11.3311, E11.3312, E11.3313, E11.3411, E11.3412, E11.3413, E11.3511, E11.3512 and E11.3513. Under ICD-10 Codes That Support Medical Necessity deleted ICD-10 codes E10.321, E10.331, E10.341, E10.351, E11.321, E11.331, E11.341 and E11.351.
01/04/2016 R1 Under Article Text added the specific HCPCS code for fluocinolone acetonide intravitreal implant 0.19 mg J7313. Removed required information for not otherwise specified code.

Associated Documents

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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
10/28/2019 11/07/2019 - N/A Currently in Effect You are here
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Keywords

  • Iluvien