LCD Reference Article Billing and Coding Article

Billing and Coding: Aflibercept (EYLEA®)

A53387

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
NOT AN LCD REFERENCE ARTICLE
This article is not in direct support of an LCD.

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General Information

Source Article ID
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Article ID
A53387
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Aflibercept (EYLEA®)
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
04/01/2024
Revision Ending Date
N/A
Retirement Date
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Article Guidance

Article Text

Effective November 18, 2011, September 21, 2012, July 29, 2014, October 6, 2014, March 25, 2015, and May 13, 2019 respectively, Aflibercept (EYLEA®) was approved by the Food and Drug Administration (FDA) for the treatment of patients with:

  • Neovascular (Wet) Aged-related Macular Degeneration (AMD)

  • Macular Edema following Retinal Vein Occlusion (RVO)

  • Diabetic Macular Edema (DME)

  • Diabetic Retinopathy (DR)

For AMD the recommended dose is 2 mg (0.05 mL) administered by intravitreal injection every four weeks for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) once every 8 weeks (2 months) by intravitreal injection. Although EYLEA® may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA® was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 12 weeks (3 months).

For Macular Edema following RVO the recommended dose is 2 mg (0.05 mL) administered by intravitreal injection once every 4 weeks (monthly).

For DME the recommended dose is 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 5 injections, and then 2 mg (0.05 mL) every 2 months (8 weeks) by intravitreal injection. Although EYLEA® may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA® was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months).

For Diabetic retinopathy (DR) the recommended dose is 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) once every 8 weeks (every 2 months). Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every 8 week administration); some patients may require every 4 week (monthly) dosing after the first 20 weeks of therapy (5 months).

To bill aflibercept services, submit the following claim information on CMS Form 1500:

• J0177 OR J0178

• 67028 – Intravitreal injection of a pharmacologic agent (separate procedure)

Note: It is not reasonable and necessary to inject more than one anti-vascular endothelial growth factor (VEGF) medication (bevacizumab, ranibizumab, aflibercept) in the same eye during the same treatment session. It is not typical to inject one anti-VEGF medication in one eye and another in the other eye. If different medications are injected into each eye during the same DOS, the rationale for this therapy must be documented in the medical record and the billing modifier (RT/LT) must be appended to the correct drug.

Intravitreal injection for the treatment of macular edema more frequently than every 4 weeks regardless of which drug is used for any given injection i.e., alternating drugs every 2 weeks will not be covered.

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Coding Information

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CPT/HCPCS Modifiers

Group 1

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LT

RT

 

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ICD-10-CM Codes that Support Medical Necessity

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

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ICD-10-PCS Codes

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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.

Code Description

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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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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
04/01/2024 R14

Under Article Text revised verbiage from “J0178 – Injection, aflibercept, 1 mg” to “J0177 OR J0178.” Under CPT/HCPCS Codes Group 1: Codes added J0177. This revision is due to the 2024 Q2 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/24.

04/22/2021 R13

Under Article Text removed the verbiage “Note: Quantity to be billed 67028 is 1 as this is a bilateral procedure.”

10/24/2019 R12

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. Under Article Title changed the title to “Billing and Coding: Aflibercept (EYLEA®)”. Under CPT/HCPCS Modifiers added modifiers RT and LT. Formatting, punctuation and typographical errors were corrected throughout the article.

07/04/2019 R11

Under Article Text added the verbiage “and May 13, 2019” to the first paragraph, removed the verbiage “in patients with Diabetic Macular Edema (DME)” from the fourth bullet, and replaced the fifth paragraph with the verbiage “For Diabetic retinopathy (DR) the recommended dose is 2 mg (0.05 mL) once every 4 weeks (monthly) for the first 5 injections, followed by 2 mg (0.05 mL) once every 8 weeks (every 2 months). Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every 8 week administration); some patients may require every 4 week (monthly) dosing after the first 20 weeks of therapy (5 months)”. Formatting, punctuation and typographical errors were corrected throughout the article.

05/17/2018 R10

Under Article Text in the fifth paragraph added the verbiage “Although EYLEA® may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when Eylea® was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 week (monthly) dosing after the first 20 weeks (5 months)”.

 At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 

 

 

02/26/2018 R9 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.
02/01/2018 R8

Under Article Text corrected capitalization errors, added the registered trademark symbol, deleted the “s” from weeks in the second and fourth paragraph and added “monthly” to the fourth and fifth paragraph. Under CPT/HCPCS Codes added J0178 and 67028.

08/04/2016 R7 Under Article Text for Age-related Macular Degeneration (AMD) added the verbiage “Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 12 weeks (3 months)” to the end of the second sentence. For Diabetic Macular Edema (DME) added the verbiage “Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated in most patients when EYLEA was dosed every 4 weeks compared to every 8 weeks. Some patients may need every 4 weeks (monthly) dosing after the first 20 weeks (5 months)” to the end of the fourth sentence. In the second Note: added the verbiage “Intravitreal injection for the treatment of macular edema more frequently than every 4 weeks regardless of which drug is used for any given injection i.e. alternating drugs every two weeks will not be covered”. The additional verbiage is effective for dates of service on or after May 26, 2016.
02/04/2016 R6 Under Article Text removed CRVO and BRVO information as they are not relevant to the current package insert, revised dosing instructions for Macular Edema following RVO and DME and revised the code description for CPT code 67028.
10/01/2015 R5 Under Article Text added FDA approved indication for Eylea, Diabetic Retinopathy (DR) with Diabetic Macular Edema (DME). Added FDA dosing instructions for DR with DME.
10/01/2015 R4 Under Article Text added FDA approved indication for Eylea, Diabetic Macular Edema (DME). Added FDA dosing instructions for DME.
10/01/2015 R3 Added to CMS Manual Explanations under Associated Documents Publication 100-02, Ch. 15, §50, Drugs and Biological.
10/01/2015 R2 Under Article Text added addition coverage for BRVO per FDA. Added dosing instructions for BRVO.
10/01/2015 R1 Added HCPCS codes from body of Article Text to HCPCS Coding.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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Public Versions
Updated On Effective Dates Status
03/19/2024 04/01/2024 - N/A Currently in Effect You are here
04/12/2021 04/22/2021 - 03/31/2024 Superseded View
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Keywords

  • Aflibercept
  • EYLEA®