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Aflibercept: Eylea®; Eylea® HD; Opuviz™; Yesafili™; Ahzantive™
Policy Number: PH-0026
Intravitreal
Last Review Date: 08/01/2024
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
- Length of Authorization 1-5
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)
- 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
- Opuviz 2 mg/0.05 mL injection: 1 single-dose vial kit or single-dose vial 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, Opuviz, & 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)
- Initial Approval Criteria 1-19
Coverage is provided in the following conditions:
|
- Patient is at least 18 years of age, unless otherwise specified; AND
Universal Criteria 1-5
- 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, Opuviz, and Yesafili Only)
Diabetic Macular Edema (DME) †*
Diabetic Retinopathy (DR) †*
Retinopathy of Prematurity (ROP) † Ф (Eylea, Ahzantive, Opuviz, 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, Opuviz, 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
- Renewal Criteria 1-19
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, Opuviz, 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
- Dosage/Administration 1-5
Indication |
Dose |
Neovascular (Wet) AMD |
Eylea, Ahzantive, Opuviz, 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)
|
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, Opuviz, 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, Opuviz, 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)
|
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, Opuviz, and Yesafili Only Administer 0.4 mg intravitreally per affected eye.
|
- 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, Opuviz, 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)
- Opuviz 2 mg/0.05 mL Solution for Injection, single-dose vial kit or single-dose vial: 64406-0028-xx
- Yesafili 2 mg/0.05 mL Solution for Injection, single-dose vial kit: 83257-0013-xx
- References
- Eylea [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; December 2023. Accessed July 2024.
- Eylea HD [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; December 2023. Accessed July 2024.
- Opuviz [package insert]. Yeonsu-gu, Incheon; Samsung Bioepis Co., Ltd.; May 2024. Accessed July 2024.
- Yesafili [package insert]. Cambridge, MA; Biocon Biologics Inc.; May 2024. Accessed July 2024.
- Ahzantive [package insert]. Planegg Germany; Formycon AG; June 2024. Accessed July 2024.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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
- 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.
- 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 |