Eye prosthesis (ocular prosthesis and related scleral devices)
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Governs coverage and medical necessity criteria for eye prostheses and related services (e.g., polishing, enlargement, reduction, scleral cover shells, ocular conformers) for Northwood members across Medicare, Commercial, and NH Medicaid lines where applicable.
For WellSense NH Medicaid QHP members, PROSE treatment and any scleral shell cover billed with HCPCS V2627 are considered experimental/investigational or not medically necessary for primary or secondary dry eye disease.
Effective 2/1/2023, SCO was removed as an applicable product for this policy because prior authorization will no longer be required for SCO members.
ICD-10 codes were added for HCPCS V2627.
Coverage and Medical Necessity Criteria
inv-01: Coverage Criteria
Covered when ALL of the following are met
Medicare members: refer to Medicare policy L33737/A52462 for specific criteria.
inv-02: PROSE / Scleral Cover Shell Indications
PROSE device coding and medical necessity
When used for indications other than the listed diagnoses, the device must be coded as V2531 (contact lens, scleral, gas permeable) and is subject to the Medicare refractive lens statutory coverage exclusion.
inv-03: Plan-specific Noncoverage for Dry Eye Disease
Not medically necessary/experimental for specific indication and plan
Applies to WellSense NH Medicaid QHP members as stated in policy.
Trial scleral cover shells are not separately payable; they are included in the allowance for HCPCS V2627. Claims for trial shells submitted as separate billable items will be denied per the policy. When a PROSE® device is used for indications other than the two listed diagnoses (sightless/shrunken eye from inflammatory disease or PROSE as substitute for lacrimal gland function in dry eye), the device must be coded as V2531 (contact lens, scleral, gas permeable, per lens) rather than V2627 and is subject to the Medicare refractive lens statutory coverage exclusion.
Use of HCPCS V2627 to bill PROSE® devices as treatment for primary or secondary dry eye (PROSE serving as substitute for lacrimal gland function; ICD-10 H04.121–H04.129) is a plan-specific coverage decision. For WellSense NH Medicaid QHP members, this use of V2627 is considered experimental, investigational, or not medically necessary and may be denied.
For WellSense NH Medicaid QHP members, PROSE® treatment and other scleral shell covers billed with HCPCS V2627 for the treatment of primary or secondary dry eye disease are considered experimental and investigational or not medically necessary because of the limited quality of evidence supporting efficacy for this indication. Providers should expect denials when V2627 is used for dry eye in this product.
PROSE® treatment and any scleral shell cover billed with HCPCS V2627 are treated as not medically necessary or experimental for treatment of primary or secondary dry eye disease for WellSense NH Medicaid QHP members. When PROSE® is used for the specific covered indications (sightless/shrunken eye from inflammatory disease, ICD-10 H44.521–H44.529), bill as V2627; when used for other indications, bill as V2531.
Coding and Billing Codes
| V2531 | Contact lens, scleral, gas permeable, per lens (used for PROSE devices when not for listed indications) |
| V2627 | Scleral shell cover / PROSE device (as referenced in policy) |
Provider Actions, Prior Authorization, and Billing Guidance
Medicare reference — check L33737/A52462; PA varies by product/line
Refer to Medicare medical policy L33737 and article A52462 for Medicare coverage criteria; prior authorization requirements may vary by product/line of business and by plan.
SCO prior authorization removed effective 2/1/2023
SCO (Special Needs) membership is no longer an applicable product for prior authorization under this policy effective 2/1/2023; prior authorization implications remain plan-dependent for other products.
Keep signed, dated order and medical records on file
Maintain the ordering practitioner’s signed and dated order and supporting medical records on file to substantiate medical necessity for the initial prosthesis and any covered procedures.
- Initial order must be signed and dated by the ordering physician/treating practitioner.
- Physician records must support medical necessity for the item ordered.
Ocularist documentation acceptable for replacement claims when non‑medical
Ocularist documentation is acceptable evidence for replacement prosthesis claims when replacement is due to non‑medical reasons (e.g., accidental loss); additional enlargements/reductions require documentation available on request.
- Ocularist documentation suffices for replacements prompted by accidental loss.
- Additional enlargement/reduction procedures must be supported by medical records on request.
Use RT/LT modifiers correctly — claims without correct side modifiers will be rejected
Claims billed without the RT and/or LT modifiers, or with RTLT on the same claim line billed with 2 units of service, will be rejected as incorrect coding.
- When the same code for bilateral items is billed on the same DOS, bill two separate claim lines using RT and LT with 1 UOS each.
- Do not use RTLT on the same claim line with 2 UOS.
Plan‑specific denial risk: V2627 billed for dry eye disease may be denied for WellSense NH Medicaid QHP
Use of HCPCS V2627 (PROSE/scleral shell) for treatment of primary or secondary dry eye disease is considered experimental/investigational or not medically necessary for WellSense NH Medicaid QHP members and may be denied.
- This is a plan‑specific denial risk that applies to WellSense NH Medicaid QHP members.
Background
An eye prosthesis is an artificial replacement for an absent or shrunken eye. Scleral cover shells — including PROSE® devices when used for specific indicated diagnoses — rest on the sclera and are used to treat a shrunken, sightless eye caused by inflammatory disease or to substitute for lacrimal gland function in select dry eye diagnoses. Coverage and coding depend on the clinical indication: for the two listed indications, PROSE® is coded as V2627; for other conditions, it should be coded as V2531.
Definitions
Medical Necessity Criteria and Adjustment Procedures
inv-25: DME Medical Necessity
Covered when clinical indications are documented
Medicare members should follow Medicare policy L33737/A52462 for detailed criteria.
inv-26: Adjustment Procedures
Adjustments to prosthesis
inv-27: Medical Necessity — Plan Specific
Plan-specific denial for dry eye disease when billed with V2627
This is a plan-specific coverage decision as stated in the policy.
Rental, Purchase, and DMEPOS Rules
| Equipment/Rule | Billing rule / Notes |
|---|---|
| {"text":"General DMEPOS","status":""},{"text":"Policy note: DMEPOS items primarily for non-medical purposes are not considered DME. Coverage determinations are contract-dependent and subject to terms, conditions, limitations, and exclusions. Policies provide criteria approved by Northwood's Medical Director. Capped rental rules apply per member contract and Medicare/NCD/LCD guidance.","status":""} |
| HCPCS / Item | Plan applicability / Notes |
|---|---|
| {"text":"V2627 — Scleral cover shell (PROSE device)","status":""},{"text":"For WellSense NH Medicaid QHP members: use of PROSE and any scleral shell billed with V2627 for primary or secondary dry eye disease is considered experimental/investigational or NOT medically necessary and may be denied. Documentation/coding guidance updated; ICD‑10 codes were added for V2627. SCO: effective 2/1/2023 SCO was removed as an applicable product for this policy (prior authorization no longer required for SCO members).","status":""} |
Replacement, Polishing, and Service Frequency
Documentation Requirements
Keep physician order and medical records available
Maintain the signed and dated order for the initial eye prosthesis and supporting medical records on file and provide documentation upon request to substantiate medical necessity.
- Keep the ordering practitioner’s signed order on file.
- Ensure medical records document the clinical indications for the device.
Non-Covered Items
Not covered: trial scleral cover shells billed separately are excluded because trial shells are included in the allowance for V2627. Additionally, when PROSE® or other scleral shell covers are billed as V2627 for the treatment of primary or secondary dry eye disease in WellSense NH Medicaid QHP members, the service is considered experimental, investigational, or not medically necessary and may be denied.
Revision History and Policy Changes
SCO was removed as an applicable product for this policy and will no longer require prior authorization for SCO members.
ICD-10 diagnosis codes were added for HCPCS code V2627 (PROSE/scleral shell).
Annual review completed with no further clinical changes documented on that date.
'Special Coverage Information per Plan' box added to clarify QHP and SCO/SNP plan-specific applicability and code V2627 references.
Revised RT and LT modifier billing instructions and updated coding guidelines for the PROSE device.
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