Eye Prostheses - Policy Article

**NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES**

For any item to be covered by Medicare, it must 1) be eligible for a defined
Medicare benefit category, 2) be reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the functioning of a malformed
body member, and 3) meet all other applicable Medicare statutory and
regulatory requirements. Information provided in this policy article relates
to determinations other than those based on Social Security Act 1862(a)(1)(A)
provisions (i.e. "reasonable and necessary").

Eye prostheses are covered under the Medicare Artificial Legs, Arms and Eyes
benefit (Social Security Act 1861(s)(9)). In order for a beneficiary's
equipment to be eligible for reimbursement the reasonable and necessary (R&N)
requirements set out in the related Local Coverage Determination must be met.
In addition, there are specific statutory payment policy requirements,
discussed below, that also must be met.

Trial scleral cover shells are not separately payable. They are included in
the allowance for scleral cover shells, V2627.

The following services and items are included in the allowance for a eye
prosthesis and, therefore, are not separately billable to or payable by
Medicare under the prosthetic device benefit:

  * Evaluation of the beneficiary

  * Pre-operative planning

  * Cost of materials

  * Labor involved in the fabrication and fitting of the prosthesis

  * Modifications to the prosthesis made at the time delivery of the prosthesis or within 90 days thereafter

  * Repair due to normal wear or tear within 90 days of delivery

  * Follow-up visits within 90 days of delivery of the prosthesis

Modifications to a prosthesis are separately payable when they occur more than
90 days after delivery of the prosthesis and they are required because of a
change in the beneficiary's condition.

Repairs are covered when there has been accidental damage or extensive wear to
the prosthesis that can be repaired. If the expense for repairs exceeds the
estimated expense for a replacement prosthesis, no payments can be made for
the amount of the excess.

Follow-up visits which occur more than 90 days after delivery and which do not
involve modification or repair of the prosthesis are noncovered services.

Claims for eye prostheses from nonphysicians provided in an office or nursing
home setting are submitted to the DME MAC. Claims for eye prostheses from
physicians in these settings are submitted to the applicable A/B MAC. Claims
for eye prostheses provided in an outpatient hospital setting are submitted to
the applicable A/B MAC. Eye prostheses provided in an inpatient hospital
setting are included in the payment made to the hospital; therefore, claims
should not be submitted to the DME MAC.

Claims for implanted components (e.g., titanium studs, magnets, etc) and
procedures used to affix the ocular prosthesis to the beneficiary are not the
jurisdiction of the DME MAC. Claims for these items and services will be
denied as wrong jurisdiction.

Replacement of an ocular prosthesis because of loss or irreparable damage may
be reimbursed without a treating practitioner's order when it is determined
that the prosthesis as originally ordered still fills the beneficiary's
medical needs.



**REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO FINAL RULE 1713 (84 Fed.
Reg Vol 217)**

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a
Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the
DME MACs provide a list of the specified codes, which is periodically updated.
The required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol
217) that do not meet the face-to-face encounter and WOPD requirements
specified in the LCD-related Standard Documentation Requirements Article
(A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied
as not reasonable and necessary. If the WOPD is not obtained prior to
delivery, payment will not be made for that item even if a WOPD is
subsequently obtained by the supplier. If a similar item is subsequently
provided by an unrelated supplier who has obtained a WOPD prior to delivery,
it will be eligible for coverage.



**POLICY SPECIFIC DOCUMENTATION REQUIREMENTS**  
  
In addition to policy specific documentation requirements, there are general
documentation requirements that are applicable to all DMEPOS policies. These
general requirements are located in the DOCUMENTATION REQUIREMENTS section of
the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located
at the bottom of this Policy Article under the Related Local Coverage
Documents section for additional information regarding GENERAL DOCUMENTATION
REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS.

When billing for an item or service at a greater frequency than that described
in the policy, there must be documentation in the beneficiary's medical
records that corroborates the order and supports the medical necessity of the
items and quantities billed. This information must be available upon request.

The treating practitioner's records must contain information which supports
the medical necessity of the item ordered. The ocularist's documentation of
the necessity for a replacement prosthesis is appropriate documentation for
that claim if the replacement is necessitated by other than medical reasons.



**CODING GUIDELINES**  
  
Trial scleral shells must be billed with code L9900.

The right (RT) and/or left (LT) modifiers must be used with all HCPCS codes in
this policy. Effective for claims with dates of service (DOS) on or after
3/1/2019, when the same code for bilateral items (left and right) is billed on
the same date of service, bill each item on two separate claim lines using the
RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use
the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed
without the RT and/or LT modifiers, or with RTLT on the same claim line and 2
UOS, will be rejected as incorrect coding.

PROSE Device

PROSE (BostonSight, Needham, MA) devices are designed to rest on the sclera or
white part of the eye and are used to treat ocular surfaces diseases,
including some types of "dry eye." For Medicare billing purposes the correct
HCPCS coding for this item is determined based upon the condition(s) being
treated. When the PROSE device is used as a treatment for either of the
following indications listed below, the correct HCPCS code to use is V2627
(SCLERAL COVER SHELL):

  * Treatment of an eye rendered sightless and shrunken by inflammatory disease; or,

  * Treatment of "dry eye" where the PROSE device serves as a substitute for the function of the diseased lacrimal gland.

When the PROSE device is used for any conditions other than those listed
above, the device must be coded with HCPCS code V2531 (CONTACT LENS, SCLERAL,
GAS PERMEABLE, PER LENS (FOR CONTACT LENS MODIFICATION, SEE 92325)) and is
subject to the Medicare refractive lens statutory coverage exclusion.

Suppliers should contact the Pricing, Data Analysis and Coding (PDAC)
Contractor for guidance on the correct coding of these items.