External Breast 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").  
  
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.  
  
A mastectomy sleeve (L8010) is denied as noncovered, since it does not meet
the definition of a prosthesis.  
  
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](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, 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  
  
  
 **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.