CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Intrastromal corneal ring segments (ICRS) implantation

Defines medical necessity, exclusions, and prior authorization requirements for implantation of intrastromal corneal ring segments for keratoconus, pellucid marginal degeneration, astigmatism after penetrating keratoplasty, myopia, and other indications for Medicare Advantage and Commercial products.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyIntrastromal corneal ring segments (ICRS) implantation

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2016

Next Review Date

Key ActionObtain prior authorization (required for Medicare Advantage, recommended for Commercial) via the online tool and document progressive vision deterioration, clear central cornea, corneal thickness >= 450 microns, and that corneal transplantation is the only remaining option.

POLICY UPDATE CHANGES

No material changes

1Covered Indication (keratoconus)

1Exclusion (myopia)

2Other indications considered insufficient evidence

Coverage Summary

Scope: Defines medical necessity, exclusions, and prior authorization requirements for implantation of intrastromal corneal ring segments (ICRS) across Medicare Advantage and Commercial products, including indications for keratoconus, pellucid marginal degeneration, post‑penetrating keratoplasty astigmatism, myopia (excluded), and other indications. Coverage stance: mixed. Effective date: 01/01/2016. Last review: 03/18/2026.

Medical-Necessity Criteria

Medicare Advantage Plans and Commercial Products - Medically Necessary for Keratoconus

Implantation of intrastromal corneal ring segments may be considered medically necessary when ALL of the following are met:

Medically necessary criteria for keratoconus

Age: Patient is 21 years of age or older>= 21 years
Progression: Patient has experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision with contact lenses or spectacles
Alternative to transplantation: Corneal transplantation is the only alternative to improve the patient's functional vision
Central cornea: Patient has a clear central cornea
Corneal thickness of 450 microns or greater at the proposed incision site>= 450 microns
Thickness measured at proposed incision site

Commercial Products - Not Medically Necessary

Commercial not medically necessary (non-keratoconus): Implantation of intrastromal corneal ring segments is considered not medically necessary for all other conditions (non-keratoconus indications) due to insufficient evidence

Medicare Advantage Plans - Not Covered

Medicare not covered (non-keratoconus): Implantation of intrastromal corneal ring segments is not covered for all other conditions as the evidence is insufficient to determine the effects of the technology on health outcomes

Exclusion - Myopia

Myopia exclusion: Implantation of intrastromal corneal ring segments is not covered and is a contract exclusion as a treatment of myopia

Provider Actions

Prior Authorization

Prior authorization requirement

Prior authorization is required for Medicare Advantage Plans and recommended for Commercial Products for implantation of intrastromal corneal ring segments (CPT 65785). Participating providers obtain authorization via the insurer's online preauthorization tool.

Affected code: 65785

Documentation Required

Clinical documentation to support medical necessity

Clinical documentation must demonstrate medical necessity for ICRS implantation and include: evidence of progressive deterioration in vision despite use of contact lenses or spectacles; documentation that corneal transplantation is the only remaining option to improve functional vision; clear central cornea on exam; and corneal thickness of 450 microns or greater at the proposed incision site.

Progressive deterioration in vision despite contact lenses/spectacles
Corneal transplantation is the only remaining option
Clear central cornea
Corneal thickness >= 450 microns at proposed incision site

Denial Risk

Denial risk for non-covered indications

Claims for implantation of intrastromal corneal ring segments (CPT 65785) for myopia are a contract exclusion and will not be covered. Other non-keratoconus indications are not covered or are considered not medically necessary due to insufficient evidence and are at high risk for denial.

Myopia treatment: contract exclusion (not covered)
Other non-keratoconus indications: not covered or not medically necessary

Background & Evidence

Intrastromal corneal ring segments (ICRS) are microthin soft plastic implants placed in the peripheral cornea to physically change corneal shape by flattening the front surface and correcting irregular astigmatism. They are an additive keratorefractive technique intended to reinforce the cornea, prevent further deterioration, and potentially defer or obviate the need for penetrating keratoplasty in appropriately selected patients. The device Intacs® received FDA premarket approval for reduction or elimination of mild myopia under labeled criteria (including age and refractive stability) and a separate FDA humanitarian device exemption indication for use in certain patients with keratoconus when specific criteria are met.

Source	Detail
FDA humanitarian device exemption criteria (Intacs) - keratoconus
Patients 21 years or older; progressive deterioration in vision such that contact lenses/spectacles no longer provide adequate functional vision; clear central cornea; corneal thickness >= 450 microns at proposed incision site; corneal transplantation is the only remaining option to improve functional vision

Glossary: ICRS — Intrastromal corneal ring segments: microthin soft plastic inserts placed in the corneal periphery to reshape the cornea. Keratoconus — a progressive bilateral dystrophy with paracentral steepening and stromal thinning that impairs visual acuity. Pellucid marginal degeneration — a noninflammatory progressive degenerative disease characterized by bilateral inferior peripheral corneal thinning causing irregular astigmatism and reduced functional vision.