609 Form

1

Medical Policy Suprachoroidal Delivery of Pharmacologic Agents Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 609

BCBSA Reference Number: 9.03.19A (For Plan internal use only) NCD/LCD: NA Related Policies
• Photodynamic Therapy #599 • Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization, #600 • Epiretinal Radiation for Age-Related Macular Degeneration, #610
• Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions, #343

Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Suprachoroidal delivery of a pharmacologic agent is INVESTIGATIONAL.
Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes

2

Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list. The following CPT code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue:

CPT Codes CPT codes:

Code Description 67516 Suprachoroidal space injection of pharmacologic agent (separate procedure)

Description Age-related macular degeneration and diabetic neuropathy are the most prevalent causes of visual impairment and are classified as posterior segment ocular diseases due to the location of the affected eye structures in the back two thirds of the eye. These posterior structures include the vitreous humor, retina, choroid, macula, and optic nerve. Delivery of pharmacologic agents to the suprachoroidal space is being investigated for treatment of posterior eye segment diseases, as current modes of drug delivery to the eye (topical and systemic) often lack bioavailability and fail to deliver therapeutic levels of drugs to the retina and posterior segment structures. Examples of drugs used via suprachoroidal injection to treat age related macular degeneration include ranibizumab and pegaptanib. For treatment of diabetic neuropathy, an example is triamcinolone acetonide. A microcannula system (the delivery method of suprachoroidal injection) originates from this same idea and combines a drug delivery channel with a fiber-optic light source to allow transmission of light to the tip of the microcannula for illumination and guidance. One potential advantage of suprachoroidal injection would be the ability to minimize systemic side effects while delivering higher local tissue levels of drugs, assuming high local levels lead to improved outcomes. Weighed against this potential benefit is the risk of localized tissue damage from the microcannula. An example of a device for suprachoroidal delivery of a pharmacologic agent includes the iTrack™ from iScience Interventional. All devices for suprachoroidal delivery of a pharmacologic agent are considered investigational regardless of the commercial name, the manufacturer or FDA approval status.

Summary Evidence remains insufficient to evaluate whether suprachoroidal delivery of pharmacologic agents improves the net health outcome. Thus, this procedure is considered investigational.

Policy History
Date Action 4/2026 Annual policy review. Policy updated with literature though April 2026. Policy statements unchanged. 4/1/2026.
9/2024 Clarified coding information 11/2022 Annual policy review. Policy updated with literature review through October 2022. No references added. Policy statements unchanged. 2/2020 Policy updated with literature review through February 1, 2020, references added. Policy statements unchanged. 2/2015 Annual policy review. New references added. 1/2014 Updated to remove deleted CPT code 0186T.

3

11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
2/2011 Reviewed - Medical Policy Group – Psychiatry and Ophthalmology. No changes to policy statements. 1/19/2011 Medical Policy 609 -effective 1/19/2011 describing ongoing non-coverage.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Yeh S, Khurana RN, Shah M, et al. Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial. Ophthalmology 2020 Jul;127(7):948-955.
2. Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: An in-depth look at efficacy and safety. Am J Manag Care. 2023;29(2 Suppl):S19-S28.
3. Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone acetonide suprachoroidal injectable suspension for uveitic macular edema: Integrated analysis of two phase 3 studies. Ophthalmol Ther. 2023;12(1):577-591
4. Price KW, Albini TA, Yeh S. Suprachoroidal injection of triamcinolone - review of a novel treatment for macular edema caused by noninfectious uveitis. US Ophthalmic Rev. 2020;13(2):76-79.
5. US Food and Drug Administration (FDA). Summary of Safety and Effectiveness: iScience Surgical Ophthalmic Microcannula (iTRACK) - June 22, 2004. http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K041108. Accessed November 24, 2014.
6. Gilger BC, Mandal A, Shah S, et al. Episcleral, intrascleral, and suprachoroidal routes of ocular drug delivery - recent research advances and patents. Recent Pat Drug Deliv Formul. 2014;8(2):81-91. PMID 25001638
7. Olsen, T. Drug delivery to the suprachoroidal space shows promise. Retina Today; March 2007. http://retinatoday.com/2007/03/0307_10.html. Accessed November 24, 2013.
8. Del Amo EM, Urtti A. Current and future ophthalmic drug delivery systems. A shift to the posterior segment. Drug Discov Today. Feb 2008;13(3-4):135-143. PMID 18275911
9. Rizzo S, Ebert FG, Bartolo ED, et al. Suprachoroidal drug infusion for the treatment of severe subfoveal hard exudates. Retina. Apr 2012;32(4):776-784. PMID 21817959
10. Tetz M, Rizzo S, Augustin AJ. Safety of submacular suprachoroidal drug administration via a microcatheter: retrospective analysis of European treatment results. Ophthalmologica. 2012;227(4):183-189. PMID 22354263