CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Medical Coverage Policy Autologous Serum Eye Drops

Defines coverage position for autologous serum eye drops for treatment of severe ocular surface disorders for Blue Cross Blue Shield - Rhode Island commercial and Medicare Advantage products. States medical necessity determination and coding guidance.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMedical Coverage Policy Autologous Serum Eye Drops

Policy CodePolicy N/A

Change Typeclarified

Effective DateOct 1, 2024

Next Review Date

Key ActionIf services are determined to be not medically necessary or non-covered, do not charge the member unless informed and agreed in writing in advance; follow the member's subscriber and participation agreement provisions.

SourceLink

POLICY UPDATE CHANGES

Policy states autologous serum eye drops are not covered due to insufficient evidence.

1Coverage Position (Not Covered)

2Key Codes Provided

Coverage Summary

Overview: Autologous serum eye drops are topical ophthalmic drops prepared from a patient’s own blood serum diluted to 20–50% to approximate tear components (growth factors, vitamins) and are proposed for severe ocular surface disorders such as Sjögren’s-related and non‑Sjögren’s tear deficiency, neurotrophic keratitis, and persistent epithelial defects.

Medical Necessity / Policy Statements

Policy Statement

Coverage determination:

Policy Statement: Autologous serum eye drops are not covered because evidence is insufficient to determine the effects of the technology on health outcomes.

Commercial Products Position

Commercial coverage statement:

Commercial Products Position: Autologous serum eye drops are considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes.

Prior Authorization

Plan requirement:

Prior Authorization: Prior authorization: Not applicable.

Medical Criteria

Medical criteria section:

Medical Criteria: Medical criteria: Not applicable.

Not Covered / Experimental Determination

Rationale for non‑coverage: The policy concludes that evidence is insufficient to determine the effects of autologous serum eye drops on health outcomes. Systematic reviews and guidance (Cochrane 2017; AAO report 2020) identified small RCTs and cohort studies suggesting possible short‑term symptom and sign improvement but judged the certainty of evidence as low or very low, with inconsistent findings, variable preparation protocols, limited follow‑up, and a lack of high‑quality randomized trials. Given these limitations, the policy finds the evidence insufficient to support coverage for both Commercial and Medicare Advantage products within the defined scope.

Coding Guidance

Unlisted ophthalmological service or procedureCPT

92499

Unlisted ophthalmological service or procedure

Unclassified biologics (Medicare Advantage and Commercial Products)HCPCS

J3590

Unclassified biologics

Billing Rule

Use unlisted codes for claims

There is no specific code for autologous serum eye drops; file CPT 92499 or HCPCS J3590 as applicable.

Suggested codes: 92499 (CPT), J3590 (HCPCS)

Provider Actions & Documentation

Documentation Required

Inform members about non-covered service

If services are determined to be not medically necessary or non-covered benefits, providers may not charge the member unless informed and agreed in writing in advance; follow member's subscriber agreement and participation agreement provisions.

Implementation note: Prior authorization is Not applicable. Providers must follow the member’s Evidence of Coverage/subscriber agreement and their participation agreement provisions and may not bill or charge members for services determined to be non‑covered unless the member has been informed and agreed in writing in advance.

Background & Evidence Summary

Background: Autologous serum eye drops are prepared from the patient’s own blood serum, typically diluted to 20–50% with sterile non‑preserved saline. The rationale is that serum contains growth factors, fibronectin, vitamins, and other epitheliotropic components similar to natural tears and may support corneal and conjunctival epithelial proliferation, migration, and differentiation.

Evidence limitations: Clinical evidence includes small randomized trials and cohort studies reporting short‑term improvements in symptoms and some clinical signs for severe dry eye and persistent epithelial defects; however, the overall certainty of evidence is low or very low due to small sample sizes, risk of bias, inconsistent protocols for preparation and concentration, and lack of large, high‑quality RCTs, limiting conclusions about long‑term benefit and safety.

Study / Source	Key Finding
Cochrane review (Pan et al., 2017)
Five RCTs (92 participants) with low/very low certainty; inconsistent possible short-term benefits; no evidence of effect after 2 weeks; recommended well‑planned, large RCTs.
AAO report (Shtein et al., 2020)
Review of 10 studies for severe dry eye and 4 for persistent epithelial defects; several studies showed improvement in symptoms or signs but conclusions limited by absence of controlled trials; adverse events rare.

Autologous serum eye dropsTopical ophthalmic drops prepared from the patient's own blood serum diluted with sterile non-preserved saline (commonly 20-50%).