ph-0081
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Macugen (pegaptanib)

Policy Number: PH-0081

 

(Intravitreal)

 

Last Review Date: 10/01/2019

Date of Origin: 01/01/2012

Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 03/2016, 05/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 10/2018, 10/2019

  1. Length of Authorization

Coverage will be provided annually and may be renewed.

  1. Dosing Limits

          A.  Quantity Limit (max daily dose) [Pharmacy Benefit]:

  • 0.3 mg injection: 1 injection per eye every 42 days

          B.  Max Units (per dose and over time) [Medical Benefit]:

  • 2 billable units every 42 days

(Max units are based on administration to both eyes)

  1. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient is 18 years or older; AND
  • Patient is free of ocular and/or peri-ocular infections; AND
  • Patient has a definitive diagnosis of one of the following:
  • Neovascular (Wet) age-related macular degeneration (AMD) †
  • Diabetic Macular Edema (DME) ‡
  • Diabetic Retinopathy (DR) ‡

FDA Approved Indication(s); Compendium recommended indication(s)

  1. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: endophthalmitis and retinal detachments; increase in intraocular pressure; arterial thromboembolic events, hypersensitivity, etc.; AND
  • Patient had a beneficial response to therapy; AND
  • Continued administration is necessary for the maintenance treatment of the condition
  1. Dosage/Administration

Indication

Dose

All Indications

0.3 mg once every 6 weeks by intravitreous injection into the eye to be treated

  1. Billing Code/Availability Information

Jcode:

J2503– Injection, pegaptanib sodium, 0.3 mg; 1 billable unit = 0.3 mg

NDC:

Macugen 0.3 mg Solution for Injection: 68782-0001-xx

  1. References
  1. Macugen [package insert]. Bridgewater, NJ; Valeant Pharmaceuticals North America LLC; July 2016. Accessed September 2019.
  2. Cunningham ET Jr, Adamis AP, Altaweel M, et al. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-57.
  3. Gonzalez VH, Giuliari GP, Banda RM, et al. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol 2009;93:1474-78.
  4. Cunningham ET Jr, Adamis AP, Altaweel M, et al. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology 2005;112:1747-57.
  5. Adamis AP, Altaweel M, Bressler NM, et al. Changes in retinal neovascularization after pegaptanib (Macugen) therapy in diabetic individuals. Ophthalmology 2006;113:23–8.
  6. Hornan D, Edmeades N, Krishnan R, et al. Use of pegaptanib for recurrent and non-clearing vitreous haemorrhage in proliferative diabetic retinopathy. Eye (Lond) 2010;24(8):1315-19.
  7. 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.
  8. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2017. Nov 2017.
  9. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2017. Nov 2017.
  10. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2017. Nov 2017.
  11. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/standards-publications-research/clinical-guidelines.
  12. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases (A56716). Centers for Medicare & Medicaid Services, Inc. Updated on 7/7/2019 with effective date of 10/3/2018. Accessed September 2019.

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

E08.3521

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E08.3522

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E08.3523

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E08.3529

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E08.3531

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E08.3532

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E08.3533

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E08.3539

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E08.3541

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E08.3542

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E08.3543

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E08.3549

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E08.3551

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

E08.3552

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

E08.3553

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

E08.3559

Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, 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

E09.3521

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E09.3522

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E09.3523

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E09.3529

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E09.3531

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E09.3532

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E09.3533

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E09.3539

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E09.3541

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E09.3542

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E09.3543

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E09.3549

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E09.3551

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

E09.3552

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

E09.3553

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

E09.3559

Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, 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

E10.3521

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E10.3522

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E10.3523

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E10.3529

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E10.3531

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E10.3532

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E10.3533

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E10.3539

Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E10.3541

Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E10.3542

Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E10.3543

Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E10.3549

Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E10.3551

Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye

E10.3552

Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye

E10.3553

Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

E10.3559

Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, 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

E11.3521

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E11.3522

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E11.3523

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E11.3529

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E11.3531

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E11.3532

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E11.3533

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E11.3539

Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E11.3541

Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E11.3542

Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E11.3543

Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E11.3549

Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E11.3551

Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye

E11.3552

Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye

E11.3553

Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

E11.3559

Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, 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

E13.3521

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

E13.3522

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

E13.3523

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

E13.3529

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, unspecified eye

E13.3531

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

E13.3532

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

E13.3533

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

E13.3539

Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, unspecified eye

E13.3541

Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

E13.3542

Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

E13.3543

Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

E13.3549

Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, unspecified eye

E13.3551

Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye

E13.3552

Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye

E13.3553

Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

E13.3559

Other specified diabetes mellitus with stable proliferative diabetic retinopathy, 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

H35.32

Exudative age-related macular degeneration

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)

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 Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Jurisdiction(s): N (9)

NCD/LCD Document (s): A56716

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A56716&bc=gAAAAAAAAAAA&

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, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

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

 

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