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ph-90026

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Aflibercept: Eylea®; Eylea® HD; Opuviz™; Yesafili™; Ahzantive™; Enzeevu™; Pavblu™

Policy Number: PH-90026

Intravitreal

Last Review Date: 09/05/2024

Date of Origin: 02/07/2013

Dates Reviewed: 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 04/2015, 06/2015, 09/2015, 03/2016, 04/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 06/2019, 10/2019, 10/2020, 02/2021, 10/2021, 10/2022, 03/2023, 05/2023, 09/2023, 06/2024, 08/2024, 09/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.
  1. Length of Authorization 1-7

Coverage will be provided annually and may be renewed, unless otherwise specified.

  • Coverage for Retinopathy of Prematurity (ROP) will be provided initially for a total of 2 doses (1 dose per eye) and may be renewed as re-treatment for up to an additional 4 doses (2 doses per eye) (Refer to Section IV for re-treatment criteria)
  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • Eylea 2 mg/0.05 mL injection: 1 single-dose vial kit or single-dose pre-filled syringe per eye every 28 days
  • Ahzantive 2 mg/0.05 mL injection: 1 single-dose vial per eye every 28 days
  • Enzeevu 2 mg/0.05 mL injection: 1 single-dose vial kit or single-dose pre-filled syringe per eye every 28 days
  • Opuviz 2 mg/0.05 mL injection: 1 single-dose vial kit or single-dose vial per eye every 28 days
  • Pavblu 2 mg/0.05 mL injection: 1 single-dose vial or single-dose pre-filled syringe per eye every 28 days
  • Yesafili 2 mg/0.05 mL injection: 1 single-dose vial kit per eye every 28 days
  • Eylea HD 8 mg/0.07 mL injection: 1 single-dose vial kit or single-dose vial per eye every 25 days

B. Max Units (per dose and over time) [HCPCS Unit]:

Diagnosis

Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, & Yesafili

Eylea HD

Initial Dosing

Maintenance Dosing

Initial Dosing

Maintenance Dosing

Neovascular age-related macular degeneration (AMD)

4 units (4 mg) every 28 days x 3 doses

4 units (4 mg) every 28 days

16 units (16 mg) every 25 days x 3 doses

16 units (16 mg) every 56 days

Macular edema following retinal vein occlusion (RVO)

4 units (4 mg) every 28 days

4 units (4 mg) every 28 days

N/A

N/A

Diabetic Macular Edema (DME)/ Diabetic Retinopathy (DR)

4 units (4 mg) every 28 days x 5 doses

4 units (4 mg) every 28 days

16 units (16 mg) every 25 days x 3 doses

16 units (16 mg) every 56 days

Retinopathy of Prematurity (ROP)

4 unit (4 mg) x 1 dose

4 units (4 mg) every 10 days x 2 doses

N/A

N/A

(Max units are based on administration to both eyes)

  1. Initial Approval Criteria 1-21

Coverage is provided in the following conditions:

For PEEHIP Members Only

Bevacizumab is the preferred product for the following conditions: Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy.

  • Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product prior to initiating therapy with a non-preferred ophthalmic anti-VEGF agent. Patients who have been receiving a non-preferred agent may continue therapy with that product; AND

Lucentis or Eylea are the preferred products after bevacizumab products

  • All other products are considered non-preferred unless the patient is continuing treatment with a non-preferred product; OR
  • Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of both preferred products prior to moving to a non-preferred product; AND

For Commercial Members Only

Bevacizumab is the preferred product for the following conditions: Neovascular (Wet) Age Related Macular Degeneration, Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema, and Diabetic Retinopathy.

  • Patient must have either an intolerance, a contraindication or inadequate response to an adequate trial of at least ONE bevacizumab product prior to initiating therapy with a non-preferred ophthalmic anti-VEGF agent. Patients who have been receiving a non-preferred agent may continue therapy with that product: AND
  • Patient is at least 18 years of age, unless otherwise specified; AND

Universal Criteria 1-7

  • Patient is free of ocular and/or peri-ocular infections; AND
  • Patient does not have active intraocular inflammation; AND
  • Therapy will not be used with other ophthalmic VEGF inhibitors (i.e., brolucizumab-dbll, ranibizumab, bevacizumab, faricimab-svoa, etc.); AND
  • Patient’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment (Note: NOT applicable to patients with Retinopathy of Prematurity); AND
  • Patient has a definitive diagnosis of one of the following:

Neovascular (Wet) Age-Related Macular Degeneration (nAMD) †*

Macular Edema following Retinal Vein Occlusion (RVO) † (Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only)

Diabetic Macular Edema (DME) †*

Diabetic Retinopathy (DR) †*

Retinopathy of Prematurity (ROP) † Ф (Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only)

  • Patient is a premature infant with a maximum gestational age at birth of 32 weeks OR a birth weight of ≥ 800 to 1500 g

*Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only: Patients with an insufficient response during initial therapy administered every 4 weeks may continue with dosing every 4 weeks. Patients with an inadequate response to maintenance therapy administered every 8 weeks may increase the dosing frequency up to every 4 weeks. (Refer to Section V)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

  1. Renewal Criteria 1-20

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the universal and indication-specific relevant criteria as identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: endophthalmitis, retinal detachments, retinal vasculitis with or without occlusion, increase in intraocular pressure, arterial thromboembolic events; AND

Retinopathy of Prematurity (ROP) (Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only)

  • Patient still has the presence of active ROP requiring treatment; AND
  • At least 10 days have elapsed since receiving initial treatment; AND
  • Patient has not exceeded a maximum of 3 total doses per each affected eye

All Other Indications

  • Patient has had a beneficial response to therapy (e.g., improvement in best corrected visual acuity (BCVA) from baseline, etc.) and continued administration is necessary for the maintenance treatment of the condition
  1. Dosage/Administration 1-6

Indication

Dose

Neovascular (Wet) AMD

Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only

Initiation:

Administer 2 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days, monthly) for the first 12 weeks (3 months)

Maintenance:

Administer 2 mg intravitreally per affected eye once every 8 weeks (2 months); however, aflibercept may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly)

  • Additional efficacy was not demonstrated in most patients when aflibercept 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).
  • Patients may also be treated with one dose every 12 weeks after one year of effective therapy.

Eylea HD Only

Initiation:

Administer 8 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses

Maintenance:

Administer 8 mg intravitreally per affected eye once every 8 to 16 weeks, +/- 1 week

Macular Edema following RVO

Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only

Administer 2 mg intravitreally per affected eye once every 4 weeks (approximately every 25 days, monthly)

Diabetic Macular Edema (DME) & Diabetic Retinopathy (DR)

Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only

Initiation:

Administer 2 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days, monthly) for the first 5 injections

Maintenance:

Administer 2 mg intravitreally per affected eye once every 8 weeks (2 months); however, aflibercept may be dosed as frequently as 2 mg every 4 weeks (approximately every 25 days, monthly)

  • Additional efficacy was not demonstrated in most patients when aflibercept 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).

Eylea HD Only

Initiation:

Administer 8 mg intravitreally per affected eye once every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses

Maintenance:

Administer 8 mg intravitreally per affected eye once every 8 to 16 weeks, +/- 1 week

Retinopathy of Prematurity (ROP)

Eylea, Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only

Administer 0.4 mg intravitreally per affected eye.

  • Injections may be given bilaterally on the same day.
  • Injections may be repeated in each eye and the treatment interval between doses injected into the same eye should be at least 10 days for a maximum of 3 total doses per each affected eye.
  • NOTE: Treatment for this indication is ONLY applicable to the single-dose vial . Do NOT use the pre-filled syringe for the treatment of ROP.
  1. Billing Code/Availability Information

HCPCS Code(s):

  • J0178 – Injection, aflibercept, 1 mg; 1 billable unit = 1 mg (Eylea Only)
  • J0177 – Injection, aflibercept hd, 1 mg; 1 billable unit = 1 mg (Eylea HD Only)
  • J3590 – Unclassified biologics (Ahzantive, Enzeevu, Opuviz, Pavblu, and Yesafili Only)

NDC(s):

  • Eylea 2 mg/0.05 mL Solution for Injection, single-dose vial kit or single-dose pre-filled syringe: 61755-0005-xx
  • Eylea HD 8 mg/0.07 mL Solution for Injection, single-dose vial kit: 61755-0050-xx
  • Eylea HD 8 mg/0.07 mL Solution for Injection, single-dose vial: 61755-0051-xx
  • Ahzantive 2 mg/0.05 mL Solution for Injection, single-dose vial: xxxxx-xxxx-xx (N/A-TBD)
  • Enzeevu 2 mg/0.05 mL Solution for Injection, single-dose vial kit or single-dose pre-filled syringe: 61314-0504-xx
  • Opuviz 2 mg/0.05 mL Solution for Injection, single-dose vial kit or single-dose vial: 64406-0028-xx
  • Pavblu 2 mg/0.05 mL Solution for Injection, single-dose pre-filled syringe: 55513-0056-xx
  • Pavblu 2 mg/0.05 mL Solution for Injection, single-dose vial: 55513-0065-xx
  • Yesafili 2 mg/0.05 mL Solution for Injection, single-dose vial kit: 83257-0013-xx
  1. References
  1. Eylea [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; December 2023. Accessed July 2024.
  2. Eylea HD [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; December 2023. Accessed July 2024.
  3. Opuviz [package insert]. Yeonsu-gu, Incheon; Samsung Bioepis Co., Ltd.; May 2024. Accessed July 2024.
  4. Yesafili [package insert]. Cambridge, MA; Biocon Biologics Inc.; May 2024. Accessed July 2024.
  5. Ahzantive [package insert]. Planegg Germany; Formycon AG; June 2024. Accessed July 2024.
  6. Enzeevu [package insert]. Princeton, NJ; Sandoz Inc.; August 2024. Accessed August 2024.
  7. Pavblu [package insert]. Thousand Oaks, CA; Amgen, Inc.; August 2024. Accessed August 2024.
  8. Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, Ayala AR, et al.  Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. N Engl J Med. 2015 Mar 26; 372(13): 1193–1203. DOI: 10.1056/NEJMoa1414264.
  9. Wells JA, Glassman AR, Jampol LM, et al; Diabetic Retinopathy Clinical Research Network. Association of Baseline Visual Acuity and Retinal Thickness with 1-year Efficacy of Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema. JAMA Ophthalmol. 2016 Feb;134(2):127-34. doi: 10.1001/jamaophthalmol.2015.4599.
  10. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48.
  11. Szabo SM, Hedegaard M, Chan K, et al. Ranibizumab vs. aflibercept for wet age-related macular degeneration: network meta-analysis to understand the value of reduced frequency dosing. Curr Med Res Opin. 2015 Nov;31(11):2031-42.
  12. Gillies MC, Nguyen V, Daien V, et al. Twelve-Month Outcomes of Ranibizumab vs. Aflibercept for Neovascular Age-Related Macular Degeneration: Data from an Observational Study. Ophthalmology. 2016 Dec;123(12):2545-2553.
  13. Barthelmes D, Campain A, Nguyen P, et al. Effects of switching from ranibizumab to aflibercept in eyes with exudative age-related macular degeneration. Br J Ophthalmol. 2016 Dec;100(12):1640-1645.
  14. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418.
  15. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2019. Oct 2019. (Interim update March 2022).
  16. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2019. Oct 2019.
  17. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Committee, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2019. Oct 2019. (Interim Update March 2022).
  18. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – January 2022. Accessed at https://www.rcophth.ac.uk/wp-content/uploads/2015/07/Retinal-Vein-Occlusion-Guidelines-2022.pdf.   
  19. Wells JA, Glassman AR, Ayala AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial. Ophthalmology 2016;123(6):1351-9. doi.org/10.1016/j.ophtha.2016.02.022.
  20. Stahl A, Sukgen EA, Wu WC, et al.; FIREFLEYE Study Group. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022 Jul 26;328(4):348-359. doi: 10.1001/jama.2022.10564.
  21. Stahl A, Nakanishi H, Lepore D, et al. Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity: Two-Year Efficacy and Safety Outcomes in the Nonrandomized Controlled Trial FIREFLEYE next. JAMA Netw Open. 2024;7(4):e248383. doi:10.1001/jamanetworkopen.2024.8383
  22. National Government Services, Inc. Local Coverage Article: Billing and Coding: Ranibizumab and biosimilars, Aflibercept, Aflibercept HD, Brolucizumab-dbll and Faricimab-svoa (A52451). Centers for Medicare & Medicaid Services, Inc. Updated on 03/20/2024 with effective date of 04/01/2024. Accessed July 2024.
  23. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding: Aflibercept (EYLEA®) (A53387). Centers for Medicare & Medicaid Services, Inc. Updated on 03/19/2024 with effective date of 04/01/2024. Accessed July 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

E08.311

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

E08.319

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema

E08.3211

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

E08.3212

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

E08.3213

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

E08.3219

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

E08.3291

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye

E08.3292

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye

E08.3293

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3299

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

E08.3311

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

E08.3312

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

E08.3313

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

E08.3319

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

E08.3391

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E08.3392

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E08.3393

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3399

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

E08.3411

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

E08.3412

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

E08.3413

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

E08.3419

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

E08.3491

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye

E08.3492

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye

E08.3493

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E08.3499

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E08.3511

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

E08.3512

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

E08.3513

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

E08.3519

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

E08.3591

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, right eye

E08.3592

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, left eye

E08.3593

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, bilateral

E08.3599

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, unspecified eye

E08.37X1

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, right eye

E08.37X2

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, left eye

E08.37X3

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, bilateral

E08.37X9

Diabetes mellitus due to underlying condition with diabetic macular edema, resolved following treatment, unspecified eye

E09.311

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

E09.319

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema

E09.3211

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

E09.3212

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

E09.3213

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

E09.3219

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

E09.3291

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye

E09.3292

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

E09.3293

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E09.3299

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

E09.3311

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

E09.3312

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

E09.3313

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

E09.3319

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

E09.3391

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E09.3392

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E09.3393

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E09.3399

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

E09.3411

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

E09.3412

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

E09.3413

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

E09.3419

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

E09.3491

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E09.3492

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E09.3493

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E09.3499

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E09.3511

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

E09.3512

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

E09.3513

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

E09.3519

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

E09.3591

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

E09.3592

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

E09.3593

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

E09.3599

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye

E09.37X1

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E09.37X2

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E09.37X3

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E09.37X9

Drug or chemical induced diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

 E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E10.319

Type 1 diabetes mellitus with unspecified diabetic retinopathy without 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

E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3291

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye

E10.3292

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

E10.3293

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E10.3299

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3391

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E10.3392

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E10.3393

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E10.3399

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E10.3491

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E10.3492

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E10.3493

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E10.3499

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E10.3591

Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

E10.3592

Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

E10.3593

Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

E10.3599

Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye

E10.37X1

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E10.37X2

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E10.37X3

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E10.37X9

Type 1 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

E11.319

Type 2 diabetes mellitus with unspecified diabetic retinopathy without 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

E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3291

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye

E11.3292

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

E11.3293

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E11.3299

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3391

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E11.3392

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E11.3393

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E11.3399

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E11.3491

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E11.3492

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E11.3493

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E11.3499

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

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

E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E11.3591

Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

E11.3592

Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

E11.3593

Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

E11.3599

Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye

E11.37X1

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E11.37X2

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E11.37X3

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E11.37X9

Type 2 diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

E13.319

Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema

E13.3211

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

E13.3212

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

E13.3213

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

E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3291

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye

E13.3292

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye

E13.3293

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3299

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3311

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

E13.3312

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

E13.3313

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

E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3391

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye

E13.3392

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye

E13.3393

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3399

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3411

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

E13.3412

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

E13.3413

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

E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

E13.3491

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye

E13.3492

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye

E13.3493

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral

E13.3499

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, unspecified eye

E13.3511

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

E13.3512

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

E13.3513

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

E13.3591

Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

E13.3592

Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

E13.3593

Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

E13.3599

Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, unspecified eye

E13.37X1

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, right eye

E13.37X2

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, left eye

E13.37X3

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, bilateral

E13.37X9

Other specified diabetes mellitus with diabetic macular edema, resolved following treatment, unspecified eye

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

H35.1

Retinopathy of prematurity

H35.10

Retinopathy of prematurity, unspecified

H35.101

Retinopathy of prematurity, unspecified, right eye

H35.102

Retinopathy of prematurity, unspecified, left eye

H35.103

Retinopathy of prematurity, unspecified, bilateral

H35.109

Retinopathy of prematurity, unspecified, unspecified eye

H35.111

Retinopathy of prematurity, stage 0, right eye

H35.112

Retinopathy of prematurity, stage 0, left eye

H35.113

Retinopathy of prematurity, stage 0, bilateral

H35.119

Retinopathy of prematurity, stage 0, unspecified eye

H35.121

Retinopathy of prematurity, stage 1, right eye

H35.122

Retinopathy of prematurity, stage 1, left eye

H35.123

Retinopathy of prematurity, stage 1, bilateral

H35.129

Retinopathy of prematurity, stage 1, unspecified eye

H35.131

Retinopathy of prematurity, stage 2, right eye

H35.132

Retinopathy of prematurity, stage 2, left eye

H35.133

Retinopathy of prematurity, stage 2, bilateral

H35.139

Retinopathy of prematurity, stage 2, unspecified eye

H35.141

Retinopathy of prematurity, stage 3, right eye

H35.142

Retinopathy of prematurity, stage 3, left eye

H35.143

Retinopathy of prematurity, stage 3, bilateral

H35.149

Retinopathy of prematurity, stage 3, unspecified eye

H35.151

Retinopathy of prematurity, stage 4, right eye

H35.152

Retinopathy of prematurity, stage 4, left eye

H35.153

Retinopathy of prematurity, stage 4, bilateral

H35.159

Retinopathy of prematurity, stage 4, unspecified eye

H35.161

Retinopathy of prematurity, stage 5, right eye

H35.162

Retinopathy of prematurity, stage 5, left eye

H35.163

Retinopathy of prematurity, stage 5, bilateral

H35.169

Retinopathy of prematurity, stage 5, unspecified eye

H35.3210

Exudative age-related macular degeneration, right eye, stage unspecified

H35.3211

Exudative age-related macular degeneration, right eye, with active choroidal neovascularization

H35.3212

Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization

H35.3213

Exudative age-related macular degeneration, right eye, with inactive scar

H35.3220

Exudative age-related macular degeneration, left eye, stage unspecified

H35.3221

Exudative age-related macular degeneration, left eye, with active choroidal neovascularization

H35.3222

Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization

H35.3223

Exudative age-related macular degeneration, left eye, with inactive scar

H35.3230

Exudative age-related macular degeneration, bilateral, stage unspecified

H35.3231

Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization

H35.3232

Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization

H35.3233

Exudative age-related macular degeneration, bilateral, with inactive scar

H35.3290

Exudative age-related macular degeneration, unspecified eye, stage unspecified

H35.3291

Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization

H35.3292

Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization

H35.3293

Exudative age-related macular degeneration, unspecified eye, with inactive scar

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes

Jurisdiction

NCD/LCA/LCD Document (s)

Contractor

6, K

A52451

National Government Services, Inc.

J, M

A53387

Palmetto GBA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC