Article - Billing and Coding: Aflibercept (EYLEA®) (A53387)
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`Contractor Information
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`CONTRACTOR NAME
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`CONTRACT TYPE
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`CONTRACT NUMBER
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`JURISDICTION
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`STATES
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`Palmetto GBA
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`Palmetto GBA
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`Palmetto GBA
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`Palmetto GBA
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`Palmetto GBA
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`Palmetto GBA
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`Palmetto GBA
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`A and B MAC
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`A and B MAC
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`A and B MAC
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`10112 - MAC B
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`10212 - MAC B
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`10312 - MAC B
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`A and B and HHH MAC
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`11202 - MAC B
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`A and B and HHH MAC
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`11302 - MAC B
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`A and B and HHH MAC
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`11402 - MAC B
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`A and B and HHH MAC
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`11502 - MAC B
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`J - J
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`J - J
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`J - J
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`J - M
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`J - M
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`J - M
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`J - M
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`Alabama
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`Georgia
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`Tennessee
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`South Carolina
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`Virginia
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`West Virginia
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`North Carolina
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`Article Information
`General Information
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`Article ID
`A53387
`
`Article Title
`Billing and Coding: Aflibercept (EYLEA®)
`
`Article Type
`Billing and Coding
`
`Original Effective Date
`10/01/2015
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`Revision Effective Date
`04/22/2021
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`Revision Ending Date
`N/A
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`Retirement Date
`N/A
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`Created on 11/22/2021. Page 1 of
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`AMA CPT / ADA CDT / AHA NUBC Copyright
`Statement
`
`CPT codes, descriptions and other data only are copyright 2020 American
`Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.
`
`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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`Copyright © 2013 - 2021, the American Hospital Association, Chicago,
`Illinois. Reproduced by CMS with permission. No portion of the American
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`Exhibit 2175
`Page 01 of 07
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`CMS National Coverage Policy
`N/A
`Article Guidance
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`Article Text
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`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:
`
`•
`•
`•
`•
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`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:
`
`• J0178 - Injection, aflibercept, 1 mg
`
`• 67028 – Intravitreal injection of a pharmacologic agent (separate procedure)
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`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.
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`Created on 11/22/2021. Page 2 of
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`Exhibit 2175
`Page 02 of 07
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`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 weekswill not be covered.
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`Coding Information
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`CPT/HCPCS Codes
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`Group 1 Paragraph:
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`N/A
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`Group 1 Codes:
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`
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`| J0178
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`
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`CODE DESCRIPTION
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`INTRAVITREAL INJECTION OF A PHARMACOLOGIC AGENT (SEPARATE PROCEDURE)
`67028
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`|INJECTION, AFLIBERCEPT, 1 MG |
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`CPT/HCPCS Modifiers
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`Group 1 Paragraph:
`
`LT
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`RT
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`Group 1 Codes:
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`N/A
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`ICD-10-CM Codes that Support Medical Necessity
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`N/A
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`ICD-10-CM Codes that DO NOT Support Medical Necessity
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`N/A
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`Additional ICD-10 Information
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`N/A
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`Bill Type Codes
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`Created on 11/22/2021. Page 3 of 7
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`Exhibit 2175
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`Page 03 of 07
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`Exhibit 2175
`Page 03 of 07
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`Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.
`Absenceof a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absenceofall
`Bill Types indicates that coverageis not influenced by Bill Type and the article should be assumedto apply equally
`to all claims.
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`N/A
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`Revenue Codes
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`Contractors may specify Revenue Codesto help providers identify those Revenue Codestypically used to report
`this service. In most instances Revenue Codesare purely advisory. Unless specified in the article, services
`reported under other Revenue Codesare equally subject to this coverage determination. Complete absence ofall
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`Revenue Codesindicates that coverage is not influenced by Revenue Codeandthe article should be assumed to
`apply equally to all Revenue Codes.
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`N/A
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`Other Coding Information
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`N/A
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`Revision History Information
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`
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`REVISION REVISION|REVISION HISTORY EXPLANATION
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`HISTORY
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`HISTORY
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`DATE
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`NUMBER
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`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 removeall coding from LCDs and
`incorporate into related Billing and Coding Articles. Under Article Title changed thetitle
`to “Billing and Coding: Aflibercept (EYLEA®)”. Under CPT/HCPCS Modifiers added
`modifiers RT and LT. Formatting, punctuation and typographical errors were corrected
`throughoutthe article.
`
`07/04/2019 |Ri1
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`Under Article Text added the verbiage “and May 13, 2019”to the first paragraph,
`removedthe 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,
`
`Created on 11/22/2021. Page 4 of 7
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`Exhibit 2175
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`Page 04 of 07
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`Exhibit 2175
`Page 04 of 07
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`

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`REVISION
`HISTORY
`DATE
`
`REVISION
`HISTORY
`NUMBER
`
`REVISION HISTORY EXPLANATION
`
`05/17/2018 R10
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`02/26/2018 R9
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`02/01/2018 R8
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`08/04/2016 R7
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`punctuation and typographical errors were corrected throughout the article.
`
`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.
`
`
`
`
`
`
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`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.
`
`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.
`
`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
`
`Created on 11/22/2021. Page 5 of
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`7
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`Exhibit 2175
`Page 05 of 07
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`

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`REVISION
`HISTORY
`DATE
`
`REVISION
`HISTORY
`NUMBER
`
`REVISION HISTORY EXPLANATION
`
`after May 26, 2016.
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`02/04/2016 R6
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`10/01/2015 R5
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`10/01/2015 R4
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`10/01/2015 R3
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`10/01/2015 R2
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`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.
`
`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.
`
`Under Article Text added FDA approved indication for Eylea, Diabetic Macular Edema
`(DME). Added FDA dosing instructions for DME.
`
`Added to CMS Manual Explanations under Associated Documents Publication 100-02, Ch.
`15, §50, Drugs and Biological.
`
`Under Article Text added addition coverage for BRVO per FDA. Added dosing instructions
`for BRVO.
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`10/01/2015 R1
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`Added HCPCS codes from body of Article Text to HCPCS Coding.
`
`Associated Documents
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`Related Local Coverage Documents
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`N/A
`Related National Coverage Documents
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`N/A
`Statutory Requirements URLs
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`Title XVIII Social Security Act 1862(a)(1)
`Rules and Regulations URLs
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`N/A
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`CMS Manual Explanations URLs
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`Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, §50
`Other URLs
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`N/A
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`Public Versions
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`UPDATED ON
`
`EFFECTIVE DATES
`
`STATUS
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`04/12/2021
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`10/14/2019
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`04/22/2021 - N/A
`
`Currently in Effect (This Version)
`
`10/24/2019 - 04/21/2021
`
`Superseded
`
`Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.
`
`Created on 11/22/2021. Page 6 of
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`Exhibit 2175
`Page 06 of 07
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`

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`Keywords
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`•
`•
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`Aflibercept
`EYLEA®
`
`Created on 11/22/2021. Page 7 of
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`7
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`Exhibit 2175
`Page 07 of 07
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