Scleral Shell — NCD 235 | CMS Coverage Update

CMS modified NCD 235 governing scleral shell coverage under Medicare, effective January 9, 2026. Here's what billing teams need to know.

The Centers for Medicare & Medicaid Services updated NCD 235 in its Medicare coverage policy for scleral shells (also called scleral shields). This National Coverage Determination defines when Medicare covers these prosthetic devices — and the two covered indications are narrow. The policy does not list specific HCPCS or CPT codes, which creates a documentation burden your billing team needs to address now.

CMS Scleral Shell Coverage Criteria and Medical Necessity Requirements 2026

NCD 235 is the National Coverage Determination governing Medicare coverage of scleral shells (scleral shields) as prosthetic devices. The coverage policy is grounded in §1861(s)(8) of the Social Security Act, which covers prosthetic devices that replace the function of a body part. Two covered indications exist. Neither is broadly applied, and the documentation requirements for each are different.

First indication: the sightless, shrunken eye. When inflammatory disease renders an eye both sightless and physically shrunken, a scleral shell may eliminate the need for surgical enucleation and prosthetic implant. In this role, the device acts essentially as an artificial eye. It also supports the surrounding orbital tissue. Medicare covers the scleral shell in this situation as a prosthetic device under §1861(s)(8).

The medical necessity bar here is specific. The eye must be both sightless and shrunken. Sightless alone is not enough. Shrunken alone is not enough. Your documentation needs to establish both conditions, and it should connect them to inflammatory disease as the cause.

Second indication: severe dry eye disease. CMS also covers scleral shells in rare cases where the lacrimal gland has failed and artificial tears alone are inadequate. The scleral shell acts as a barrier against atmospheric drying, dramatically extending the effective half-life of artificial tears. In this role, it substitutes — partially — for a diseased lacrimal gland.

The word "rare" is doing real work in this policy. CMS is not covering scleral shells for common dry eye. The coverage policy applies when lacrimal gland failure drives the need, not general ocular surface disease. Your clinical documentation must make that distinction explicit.

The benefit category for both indications is Prosthetic Devices. That framing matters for billing. This is not billed as a contact lens or an optical device. It is billed as a prosthesis that replaces or substitutes for a body part's function.

Prior authorization requirements are not specified within NCD 235 itself. However, your Medicare Administrative Contractor may have a local coverage determination (LCD) that adds prior authorization or additional documentation requirements on top of this NCD. Check with your MAC before January 9, 2026 to confirm no additional requirements apply in your region.

CMS Scleral Shell Exclusions and Non-Covered Indications

NCD 235 does not cover scleral shells used as standard contact lenses for vision correction. This is a hard exclusion by implication — the coverage policy is built entirely around prosthetic function, not refractive correction.

The dry eye indication is explicitly "rare." That is CMS language in the policy, not editorial interpretation. A scleral shell prescribed for general dry eye syndrome, moderate dry eye, or ocular surface disease without documented lacrimal gland failure will not meet medical necessity under this NCD. Expect a claim denial if your documentation does not establish lacrimal gland failure as the underlying condition.

Similarly, cosmetic use — fitting a scleral shell over a disfigured but not sightless or shrunken eye purely for appearance — does not meet coverage criteria. The policy is focused on functional replacement, not cosmetic restoration.

Coverage Indications at a Glance

CMS Scleral Shell Billing Guidelines and Action Items 2026

The absence of specific HCPCS codes in NCD 235 is the first problem your billing team needs to solve. The policy defines the covered indications clearly, but it does not hand you a code. That gap creates real claim denial risk if you're not billing the right way.

If you're not sure how this NCD applies to your specific patient mix or provider types, talk to your compliance officer before January 9, 2026. The two covered indications are narrow enough that an edge-case claim — say, a scleral shell for a patient who is sightless but whose eye isn't shrunken — could fall outside NCD 235 entirely.

CPT, HCPCS, and ICD-10 Codes for Scleral Shells Under NCD 235

NCD 235 does not list specific CPT or HCPCS codes. This is a known gap in this coverage policy.

Your billing team needs to identify the correct HCPCS code through your MAC's published billing instructions. Some MACs publish companion billing guidelines that map specific codes to NDCs or device categories not listed in the NCD itself.

The policy cross-references the Medicare Benefit Policy Manual, Chapter 1 §§40 and 120.1 and Chapter 15 §§120 and 130. Review those sections for additional coding context. Chapter 15 §120 and §130 cover prosthetic devices and artificial eyes respectively, and they may contain coding guidance relevant to your claims.

No Specific Codes Listed in NCD 235

Until CMS or your MAC publishes explicit code assignments for scleral shell billing under this NCD, your scleral shell billing will require manual verification. Do not assume the code you used last year is the right one without confirming it against current MAC guidance.