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:
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Evaluation of the beneficiary
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Pre-operative planning
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Cost of materials
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Labor involved in the fabrication and fitting of the prosthesis
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Modifications to the prosthesis made at the time delivery of the prosthesis or within 90 days thereafter
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Repair due to normal wear or tear within 90 days of delivery
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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.
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):
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.
