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”).
External Breast Prostheses are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(8)). In order for a beneficiary’s supplies 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.
The useful lifetime expectancy for silicone breast prostheses is 2 years. The useful lifetime expectancy for a nipple prostheses is 3 months. For fabric, foam, or fiber filled breast prostheses, the useful lifetime expectancy is 6 months. Replacement sooner than the useful lifetime because of ordinary wear and tear will be denied as noncovered.
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, 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 discussed below.
The diagnosis code must be included on each claim for the prosthesis or related item.
If the patient's medical condition changes, this should be documented by the patient's treating practitioner submitting a new order which explains the need for a different type of breast prosthesis. The order must be kept in the supplier's files but need not be submitted with the claim.
Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by the treating practitioner.
CODING GUIDELINES
Code L8000 describes a bra with pockets that are intended to hold a mastectomy form or breast prosthesis held adjacent to the chest wall. Bras coded L8000 do not include an integrated breast prosthesis (for bras with integrated breast prosthesis, see codes L8001 and L8002). Products described by code L8000 may be constructed of any material (e.g., cotton, Lycra, polyester or other materials), any size, and with or without integrated structural support (e.g., underwire).
Codes L8001 and L8002 describe a bra with integrated breast prosthesis, either unilateral or bilateral, respectively. Products described by codes L8001 and L8002 may be constructed of any material (e.g., cotton, polyester or other materials), with any type or location of closure, any size, with or without integrated structural support (e.g., underwire).
Code L8015 describes a camisole type undergarment with polyester fill used post mastectomy.
A custom fabricated prosthesis is one which is individually made for a specific patient starting with basic materials. Code L8035 describes a molded-to-patient-model custom breast prosthesis. It is a particular type of custom fabricated prosthesis in which an impression is made of the chest wall and this impression is then used to make a positive model of the chest wall. The prosthesis is then molded on this positive model.
Code A4280 should be used when billing for an adhesive skin support that attaches an external breast prosthesis directly to the chest wall.
The right (RT) and/or left (LT) modifiers must be used with these codes. 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 modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding. Bras and similar inherently bilateral items (L8000 - L8002, L8015) are exempt from the RTLT requirement.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
