CurrentKaiser PermanentePolicy N/A

Clinical Review Intacs Implants Ga

Defines medical necessity criteria for INTACS (intrastromal corneal ring segments) implantation in members with keratoconus in the Georgia region, including eligible diagnosis codes, required clinical findings, age and corneal measurements, and referenced CPT code for billing.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Intacs Implants Ga

Policy CodePolicy N/A

Change TypeReviewed/Revised (3/14/2024) — no material clinical changes

Effective DateFeb 8, 2005

Next Review Date

Key ActionProvide documentation of diagnosis, age, progressive vision deterioration despite spectacles/contact lenses, contact lens intolerance and refitting attempts, clear central cornea, corneal thickness (>=450 microns) at proposed incision site, and statement that corneal transplantation is the only remaining option to improve functional vision.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed/revised with last revision date 3/14/2024; no clinical policy statement changes indicated in document.

1Covered CPT code

3Listed ICD-10 diagnosis codes

>=450Minimum corneal thickness requirement

Coverage Summary

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Defines medical necessity criteria for INTACS (intrastromal corneal ring segments) implantation for members with keratoconus in the Georgia region. Policy status: covered_with_criteria. Effective date: 2005-02-08; Last review: 2024-03-14.

Key required threshold: corneal thickness of >= 450 microns at the proposed incision site. Covered billing codes include CPT 65785 (INTACS insertion) and listed ICD-10 diagnosis codes for keratoconus (three codes listed).

Policy TitleClinical Review Intacs Implants Ga

PayerKaiser Permanente

StatusCURRENT

Effective Date2005-02-08

Last Review2024-03-14

Policy NumberN/A

Scope SummaryDefines medical necessity criteria for INTACS implantation in members with keratoconus in the Georgia region, including eligible diagnosis codes, required clinical findings, age and corneal measurements, and referenced CPT code for billing.

Minimum corneal thickness requirement>= 450 microns at proposed incision site

Medical-Necessity Criteria

Medically Necessary Indications for INTACS (Initial Therapy)

Covered when ALL of the following are met:

Diagnosis of keratoconus
ICD-10 codes provided (H18.609; Q13.4; H18.619)
Age: Patient is 21 years of age or older
Progressive vision deterioration: Patient has experienced progressive deterioration in vision such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles
Clear central cornea: Patient has clear central corneas
No central corneal scarring or opacity that would preclude visual improvement
Corneal thickness at the proposed incision site of 450 microns or greater>= 450 microns
Corneal transplantation status: Corneal transplantation is the only remaining option to improve functional vision
Contact lens intolerance: Patient has become intolerant to contact lenses and an attempt at refitting does not resolve the problem
Expert opinion referenced (Dr. Cameron Johnson, TSPMG Ophthalmologist)

Provider Actions & Prior Authorization

Prior Authorization

Documentation to support medical necessity

Provide documentation to support medical necessity for INTACS implantation for keratoconus as described below.

Diagnosis code: one of H18.609, Q13.4, or H18.619 (ICD-10)
Patient age: 21 years or older
Evidence of progressive deterioration in vision despite spectacles or contact lenses such that adequate functional vision on a daily basis cannot be achieved
Documentation of contact lens intolerance and that an attempt at refitting has not resolved the problem
Clear central cornea (no central corneal scarring or opacity that would preclude improvement)
Corneal thickness measurement at the proposed incision site of 450 microns or greater (>= 450 microns)
Statement that corneal transplantation is the only remaining option to improve functional vision
Affected codes: H18.609, Q13.4, H18.619, CPT 65785

Background, Evidence & Definitions

INTACS are clear, thin semicircular intrastromal corneal ring segments implanted in the peripheral cornea during an outpatient procedure to reshape and flatten the cornea from within without removing tissue, maintaining corneal structural integrity. They are intended to reduce myopia and astigmatism and can restore functional vision, potentially deferring the need for corneal transplantation.

The device was approved by the US Food and Drug Administration for keratoconus in July 2004 and is supported by clinical studies and expert opinion. INTACS are intended for patients who are no longer able to achieve adequate vision with spectacles or contact lenses and who have adequate corneal structure (including a clear central cornea and sufficient corneal thickness).

Evidence includes the FDA approval in 2004 for management of keratoconus and multiple clinical studies from 2001–2003 reporting corneal flattening and improved uncorrected and best-corrected visual acuity after Intacs implantation in selected patients.

A UptoDate review (Keratoconus, December 2020) summarizes that intrastromal corneal ring segments were FDA approved in 2004, have been studied alone and in combination with collagen cross-linking, and that several authors report corneal flattening and significant improvement in refractive error, while noting limited usefulness in more advanced vision loss.

Term	Definition
Clear central cornea
No central corneal scarring or opacity that would preclude visual improvement from INTACS (as implied by indications)
Contact lens intolerance
Patient cannot tolerate contact lenses and refitting attempts have not resolved the problem

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Intacs Implants Ga

Policy CodePolicy N/A

Change TypeReviewed/Revised (3/14/2024) — no material clinical changes

Effective DateFeb 8, 2005

Next Review Date

SourceLink

On This Page

OpenPayer

Clinical Review Intacs Implants Ga

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions & Prior Authorization

Background, Evidence & Definitions

Revision History

H18.609	Keratoconus, unspecified eye
Q13.4	Disorders of cornea and conjunctiva (congenital), Keratoconus
H18.619	Keratoconus, bilateral or other specified? (as listed in policy)