NONMEDICAL 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”).
Facial prostheses are covered under the Medicare Artificial Legs, Arms and Eyes benefit (Social Security Act §1861(s)(9)). In order for a beneficiary 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 to meeting the benefit policy, there are specific statutory payment policy requirements, discussed below, that also must be met.
Adhesives, adhesive remover, skin barrier wipes, and tape used in conjunction with a facial prosthesis are covered.
The following services and items are included in the allowance for a facial prosthesis and, therefore, are not separately billable to or payable by Medicare under the prosthetic device benefit:
Evaluation of the beneficiary
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
Claims for implanted components (e.g., titanium studs, magnets, etc.) and procedures used to affix the external facial prosthesis to the beneficiary are not the jurisdiction of the DME MAC. Claims for these items and services will be denied as wrong jurisdiction.
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.
Replacement of a facial prosthesis is covered in cases of loss or irreparable damage or wear or when required because of a change in the beneficiary’s condition that cannot be accommodated by modification of the existing prosthesis. When replacement involves a new impression/moulage rather than use of a previous master model, the reason for the new impression/moulage must be clearly documented in the supplier's records and available upon request.
Claims for facial prostheses from nonphysicians provided in an office or nursing home setting are submitted to the DME MAC. Claims for facial prostheses from physicians in these settings are submitted to the local carrier. Claims for facial prostheses provided in an outpatient hospital setting are submitted to the local intermediary. Facial prostheses provided in an inpatient hospital setting are included in the payment made to the hospital; and, therefore should not be submitted to the DME MAC. Implanted prosthesis anchoring components should not be billed to the DME MAC.
If an ocular prosthesis is dispensed to the beneficiary as an integral part of a facial prosthesis, the ocular prosthesis component must be billed by the supplier of the facial prosthesis. (For information on ocular prostheses that are not part of orbital prostheses, refer to the Eye Prostheses LCD.)
Skin care products related to the prosthesis, including but not limited to cosmetics, skin cream, cleansers, etc., are noncovered.
Claims for tape and adhesive (A4450, A4452, A5120) that are billed without an AV modifier or another modifier indicating coverage under a different policy will be rejected as missing information.
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 either code V2629 or L8048 is billed, the claim must be accompanied by a brief description of the item in the narrative field. When L8048 is provided, a drawing/photograph of the item provided must be available upon request.
The treating practitioner's records must contain information which supports the medical necessity of the item ordered. The prosthetist’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.
AV, KM, KN, RT and LT MODIFIERS:
Claims for tape and adhesive (A4450, A4452, A5120) that are submitted without AV modifier will be rejected as missing information.
When a replacement prosthesis is fabricated starting with a new impression/moulage, the KM modifier should be added to the code. When a replacement prosthesis is fabricated using a previous master model, the KN modifier should be added to the code.
The right (RT) and/or left (LT) modifiers must be used with facial prosthesis codes when applicable. Effective for claims with dates of service (DOS) on or after 3/1/2019, if bilateral prostheses using the same code are 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 with codes L8042, L8043 and L8045, L8046, without modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.
Codes for a facial prosthesis (L8040, L8041, L8042, L8043, L8044, L8045, L8046, L8047) describe a complete prosthesis, except as noted below for the use of code L8048 (UNSPECIFIED MAXILLOFACIAL PROSTHESIS, BY REPORT, PROVIDED BY A NON-PHYSICIAN).
A nasal prosthesis (L8040) is a removable superficial prosthesis, which restores all or part of the nose. It may include the nasal septum.
A midfacial prosthesis (L8041) is a removable superficial prosthesis, which restores part or all of the nose plus significant adjacent facial tissue/structures, but does not include the orbit or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek, upper lip, or forehead.
An orbital prosthesis (L8042) is a removable superficial prosthesis, which restores the eyelids and the hard and soft tissue of the orbit. It may also include the eyebrow. This code does not include the ocular prosthesis component.
An upper facial prosthesis (L8043) is a removable superficial prosthesis, which restores the orbit plus significant adjacent facial tissue/structures, but does not include the nose or any intraoral maxillary component. Adjacent facial tissue/structures include one or more of the following: soft tissue of the cheek or forehead. This code does not include the ocular prosthesis component.
A hemi-facial prosthesis (L8044) is a removable superficial prosthesis, which restores part or all of the nose plus the orbit plus significant adjacent facial tissue/structures, but does not include any intraoral maxillary component. This code does not include the ocular prosthesis component.
An auricular prosthesis (L8045) is a removable superficial prosthesis, which restores all or part of the ear.
A partial facial prosthesis (L8046) is a removable superficial prosthesis which restores a portion of the face but which does not specifically involve the nose, orbit, or ear.
A nasal septal prosthesis (L8047) is a removable prosthesis, which occludes a hole in the nasal septum but does not include superficial nasal tissue.
Code L8048 is a miscellaneous code. There are limited scenarios where the use of miscellaneous code L8048 is appropriate:
If a facial prosthesis is not described by a specific code, L8040, L8041, L8042, L8043, L8044, L8045, L8046, or L8047.
If a facial prosthesis has a component which is used to attach it to a bone-anchored implant or to an internal prosthesis (e.g., maxillary obturator), that component should be billed separately using code L8048. This code should not be used for implanted prosthesis-anchoring components.
Covered modifications or repairs are billed using code L8048 for any materials used and code L8049 for the labor components.
Code V2623 describes an ocular prosthesis, which is custom fabricated.
Code V2629 is used for an ocular prosthesis that is not custom fabricated (i.e., stock prosthesis).
When a new ocular prosthesis component is provided as an integral part of an orbital, upper facial or hemi-facial prosthesis, it should be billed using code V2623 or V2629 on a separate claim line. When a replacement facial prosthesis utilizes an ocular component from the prior prosthesis, the ocular prosthesis code should not be billed.
When a prosthesis is needed for adjacent facial regions, a single code must be used to bill for the item whenever possible. For example, if a defect involves the nose and orbit, this should be billed using the hemi-facial prosthesis code and not separate codes for the orbit and nose. This would apply even if the prosthesis is fabricated in two separate parts.
When codes A4450, A4452 and A5120 are used with a facial prosthesis, they must be billed with the AV modifier. For this policy, codes A4450, A4452 and A5120 are the only codes for which the AV modifier may be used.
Covered modifications or repairs are billed using code L8049 for the labor components and code L8048 for any materials used. Time reported using code L8049 should only be for laboratory modification/repair time and associated prosthetic evaluation used only for services after 90 days from the date of delivery of the prosthesis. Evaluation not associated with repair or modification is noncovered and should not be coded as L8049.
Adhesives, adhesive remover, and tape used in conjunction with a facial prosthesis should be billed using codes A4364, A4455, A4456, A4450, or A4452. The unit of service is specified for each code. For tape, one unit of service is 18 square inches. Therefore, a roll of tape 1/2" X 3 yds. would be 3 units; 1" x 3 yds. would be 6 units. Other skin care products related to the prosthesis should generally not be billed; but, if they are billed at the beneficiary's request, code A9270 (noncovered item or service) should be used.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.