CurrentKaiser PermanentePolicy N/A

INTACS (intrastromal corneal ring segments) for keratoconus — Medical necessity criteria

Medical necessity criteria for use of INTACS inserts to treat keratoconus for Georgia Region members; intended for Quality Resource Management and utilization review staff and providers making coverage decisions.

Policy Summary

PayerKaiser Permanente

PolicyINTACS (intrastromal corneal ring segments) for keratoconus — Medical necessity criteria

Policy CodePolicy N/A

Change TypeReviewed/Revised (no material changes)

Effective Date2/8/2005

Next Review DateN/A

Key ActionObtain prior authorization and document age (>=21), clear central cornea, corneal thickness (>=450 microns), progression or contact lens intolerance, and that transplant is only remaining option.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

65785CPT code listed for procedure

21+minimum patient age for INTACS

>=450µmmin corneal thickness

10%approx transplant rate

Coverage Criteria for INTACS (Intrastromal Corneal Ring Segments)

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INTACS for keratoconus — Initial therapy

Covered when ALL of the following are met:

INTACS coverage criteria: Patient meets all of the conditions listed below

Age: Patient is 21 years of age or older>=21 years

Visual progression or intolerance: Patient has experienced progressive deterioration in vision such that they can no longer achieve adequate functional vision on a daily basis with contact lenses or spectacles OR patient is intolerant to contact lenses and attempts at refitting have failed

Document prior attempts at refitting or conservative measures (glasses, rigid contact lenses, attempted refitting)

Corneal status: Clear central cornea

Corneal thickness of 450 microns or greater at the proposed incision site>=450 microns

Measure thickness at proposed incision site

Surgical alternative: Corneal transplantation is the only remaining option to improve functional vision

INTACS considered as an alternative to avoid or defer transplant per FDA guidance and expert opinion

The policy does not list any specific contraindications for INTACS; the document indicates NIA (not available) under the contraindications section. Providers should note that no explicit contraindicating conditions are specified in this policy text.

INTACS are not considered useful for patients with more advanced vision loss for whom corneal transplantation is the indicated treatment. The policy limits coverage to cases where corneal transplantation is the only remaining option to improve functional vision or where INTACS may be used to avoid transplantation, and specifies other required criteria (age, clear central cornea, sufficient corneal thickness, and failure or intolerance of conservative measures) that must be met for coverage.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required for INTACS

Prior authorization is required when requesting INTACS (CPT 65785). The prior authorization request must document that the patient meets the policy indications (age 21 or older, clear central cornea, corneal thickness ≥450 microns at the proposed incision site, progressive deterioration in vision despite conservative therapy, and that corneal transplantation is the only remaining option to improve functional vision).

Prior auth required for CPT 65785
Include documentation of all indication elements (age, central cornea clarity, corneal thickness ≥450 microns at incision site, progressive vision loss, transplant as only remaining option)

Prior Authorization

Conservative Therapy Required Before INTACS

Conservative measures are expected prior to consideration of INTACS. Document attempts at non-surgical management — including appropriate spectacle correction and rigid (hard) contact lens use with attempted refitting — and persistent inability to achieve functional vision or intolerance to contact lenses despite these measures.

Document adequate trial of spectacles and rigid contact lenses
Document attempted contact lens refitting and reasons for intolerance or failure to achieve functional vision

Documentation Required

Required Clinical Documentation for PA Request

The prior authorization submission must include clinical documentation demonstrating progressive deterioration in vision and inability to achieve functional vision with contact lenses or spectacles. Provide specifics: recent visual acuity measurements, documentation of progression over time, corneal imaging/topography, corneal thickness measurement at the proposed incision site, documentation of clear central cornea, and records of contact lens fitting attempts and intolerance.

Recent visual acuity and evidence of progression
Corneal topography/imaging and pachymetry at proposed incision site
Documentation of contact lens trials, refitting attempts, and intolerance or inability to attain functional vision

Denial Risk

Denial Risk Triggers

Procedures that do not meet the stated indications or lack required documentation are at high risk for denial. Common denial triggers include: patient age under 21, corneal thickness <450 microns at the proposed incision site, unclear central cornea, absence of documented progressive vision deterioration, or missing evidence of adequate conservative therapy and contact lens refitting attempts.

Age <21 years
Corneal thickness <450 microns at proposed incision site
No clear central cornea documented
No documentation of progressive vision loss or failed conservative therapy

Background

Keratoconus is a progressive, non-inflammatory ectasia of the central cornea characterized by thinning and steepening that leads to myopia and irregular astigmatism. Disease progression varies from slow to rapid and can produce a range of visual impairment, sometimes severely affecting daily activities such as driving or reading. Initial management is with spectacles and contact lenses; as the cornea becomes more irregular, rigid contact lenses are often required. When adequate vision cannot be achieved with conservative measures or when contact lens intolerance persists, corneal transplantation may be recommended (required in about 10% of patients).

Definitions

inv-12: INTACS

DefinitionClear, thin semicircular intrastromal corneal ring segments implanted in the peripheral/mid-corneal layers to reshape corneal curvature and reduce myopia and astigmatism in keratoconus

FDA statusINTACS inserts were approved by the US Food and Drug Administration in 2004 for management of keratoconus

MechanismPlaced in the corneal periphery to flatten the cornea from within without tissue removal

inv-13: Keratoconus

DefinitionKeratoconus is a progressive, non-inflammatory ectasia of the central cornea characterized by thinning and steepening that leads to decreased vision and irregular astigmatism

Clinical courseMay begin as myopia and astigmatism, can progress rapidly or slowly, and may eventually require rigid contact lenses or corneal transplantation

CodingRelevant ICD-10 codes include H18.609; Q13.4; H18.619