CMS Scleral Shell Coverage Policy Update (NCD 235): What Billing Teams Need to Know for 2026

The Centers for Medicare & Medicaid Services has modified National Coverage Determination NCD 235, which governs Medicare coverage of scleral shells—hard scleral contact lenses used primarily as prosthetic devices. This policy update, effective March 12, 2026, clarifies the specific clinical scenarios under which Medicare will pay for scleral shells as prosthetic devices under §1861(s)(8) of the Social Security Act. Billing teams serving ophthalmology, optometry, and oculoplastics practices should review documentation protocols now to ensure claims align with CMS's medical necessity criteria.

What Is a Scleral Shell Under CMS NCD 235?

CMS defines a scleral shell (also called a scleral shield) as a catchall term for hard scleral contact lenses. The key anatomical distinction matters for billing: a scleral shell fits over the entire exposed surface of the eye, unlike a standard corneal contact lens, which covers only the central non-white area encompassing the pupil and iris.

This distinction isn't just clinical—it's the foundation of how CMS categorizes these devices for coverage purposes. Because a scleral shell can substitute for the function of a missing or non-functioning anatomical structure, CMS treats it as a prosthetic device under the Medicare benefit policy manual rather than as a routine vision item, which would generally not be covered under Medicare Part B.

The policy is housed under the Prosthetic Devices benefit category. Billing teams should not confuse scleral shells with standard contact lenses billed under vision benefits—these are separate coverage pathways with different documentation requirements.

CMS Coverage Criteria for Scleral Shells: Two Distinct Indications

NCD 235 identifies two specific clinical scenarios where Medicare payment may be made for a scleral shell. Both hinge on the device functioning as a prosthetic substitute for a diseased or absent anatomical structure—not as corrective eyewear.

Indication 1: Sightless, Shrunken Eye Due to Inflammatory Disease

When an eye has been rendered sightless and shrunken by inflammatory disease, a scleral shell may serve essentially as an artificial eye. In this scenario, CMS recognizes that the device can:

This is the stronger of the two coverage pathways. The clinical record should document the sightless condition, the inflammatory etiology, and the medical rationale for choosing a scleral shell over surgical intervention. Claims in this scenario are covered under §1861(s)(8) of the Act as a prosthetic device.

Indication 2: Severe Dry Eye (Lacrimal Gland Failure)

The second covered indication is more narrowly defined—and significantly harder to support with documentation. CMS will cover a scleral shell as a prosthetic device in the rare case when it is used to treat dry eye of diverse etiology where lacrimal gland function has failed.

The mechanism CMS describes is specific: artificial tears evaporate quickly under normal conditions, requiring frequent instillation. When the lacrimal gland fails, a scleral contact lens can act as a protective barrier against atmospheric drying, greatly prolonging the half-life of artificial tears and reducing the need for frequent drops. In this context, the lens substitutes, in part, for the functioning of the diseased lacrimal gland.

CMS uses the word "rare" deliberately here. Billing a scleral shell under the dry eye indication for routine aqueous-deficient dry eye without documented lacrimal gland failure is unlikely to survive medical necessity review. Documentation should include:

Coverage vs. Non-Coverage: What NCD 235 Does Not Address

NCD 235 does not address scleral lenses billed purely for refractive correction (e.g., keratoconus management with gas-permeable scleral lenses billed as corrective lenses). Those scenarios fall under different coverage rules—and typically don't qualify for Medicare Part B coverage unless a separate prosthetic device rationale is documented.

The policy also does not designate any use of scleral shells as experimental or investigational. The two indications described are affirmatively covered under the prosthetic device benefit. Uses outside those two indications simply lack a CMS coverage pathway under this NCD.

Affected Codes

The policy does not list specific CPT or HCPCS codes. Billing teams should reference their Medicare Administrative Contractor (MAC) for applicable HCPCS codes—commonly A-codes used for prosthetic devices and ocular prostheses—and verify local coverage policies that may supplement this NCD. Consult Chapter 15, §§120 and 130 of the Medicare Benefit Policy Manual for additional coding guidance.

Related ICD-10 Diagnosis Codes

The policy does not list specific ICD-10-CM codes. The following diagnosis categories are clinically relevant based on the covered indications described in NCD 235—confirm with your MAC before using:

Work with your coding team to assign the most specific ICD-10-CM codes available based on the treating physician's documented diagnosis.

What Your Billing Team Should Do