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").
Orthopedic footwear is covered under the leg, arm, back, and neck braces, and artificial legs, arms and eyes benefit (Social Security Act §1861(s)(9)). In order for a beneficiary's DME 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.
Shoes, inserts, and modifications are covered in limited circumstances. They are covered in selected beneficiaries with diabetes for the prevention or treatment of diabetic foot ulcers. However, different codes are used for footwear provided under this benefit. See the medical policy on Therapeutic Shoes for Persons with Diabetes for details.
Shoes are also covered if they are an integral part of a covered leg brace described by codes L1900, L1920, L1980, L1990, L2000, L2005, L2010, L2020, L2030, L2050, L2060, L2080, or L2090. Oxford shoes (L3224, L3225) are covered in these situations. Other shoes, e.g. high top, depth inlay or custom for non-diabetics, etc. (L3649), are also covered if they are an integral part of a covered brace and if they are medically necessary for the proper functioning of the brace. Heel replacements (L3455, L3460), sole replacements (L3530, L3540), and shoe transfers (L3600, L3610, L3620, L3630 and L3640) involving shoes on a covered brace are also covered. Inserts and other shoe modifications (L3000, L3001, L3002, L3003, L3010, L3020, L3030, L3031, L3040, L3050, L3060, L3070, L3080, L3090, L3100, L3140, L3150, L3160, L3170, L3300, L3310, L3320, L3330, L3332, L3334, L3340, L3350, L3360, L3370, L3380, L3390, L3400, L3410, L3420, L3430, L3440, L3450, L3465, L3470, L3480, L3485, L3500, L3510, L3520, L3550, L3560, L3570, L3580, L3590 and L3595) are covered if they are on a shoe that is an integral part of a covered brace and if they are medically necessary for the proper functioning of the brace. Shoes and related modifications, inserts, heel/sole replacements or shoe transfers billed without a KX modifier will be denied as noncovered because coverage is statutorily excluded.
According to a national policy determination, a shoe and related modifications, inserts, and heel/sole replacements, are covered only when the shoe is an integral part of a brace. A matching shoe which is not attached to a brace and items related to that shoe must not be billed with a KX modifier and will be denied as noncovered because coverage is statutorily excluded.
Shoes which are incorporated into a brace must be billed by the same supplier billing for the brace. Shoes which are billed separately (i.e., not as part of a brace) will be denied as noncovered. A KX modifier must not be used in this situation.
Shoes are denied as noncovered when they are put on over a partial foot prosthesis or other lower extremity prosthesis (L5010, L5020, L5050, L5060, L5100, L5105, L5150, L5160, L5200, L5210, L5220, L5230, L5250, L5270, L5280, L5301, L5312, L5321, L5331, L5341, L5400, L5410, L5420, L5430, L5450, L5460, L5500, L5505, L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595 and L5600) which is attached to the residual limb by other mechanisms because there is no Medicare benefit for these items.
A foot pressure off-loading/ supportive device (A9283) is denied as noncovered because there is no Medicare benefit category for these items.
With the exception of the situations described above, orthopedic footwear billed using codes L3000, L3001, L3002, L3003, L3010, L3020, L3030, L3031, L3040, L3050, L3060, L3070, L3080, L3090, L3100, L3140, L3150, L3160, L3170, L3201, L3202, L3203, L3204, L3206, L3207, L3208, L3209, L3211, L3212, L3213, L3214, L3215, L3216, L3217, L3219, L3221, L3222, L3224, L3225, L3230, L3250, L3251, L3252, L3253, L3254, L3255, L3257, L3260, L3265, L3300, L3310, L3320, L3330, L3332, L3334, L3340, L3350, L3360, L3370, L3380, L3390, L3400, L3410, L3420, L3430, L3440, L3450, L3455, L3460, L3465, L3470, L3480, L3485, L3500, L3510, L3520, L3530, L3540, L3550, L3560, L3570, L3580, L3590, L3595, L3600, L3610, L3620, L3630, L3640, and L3649 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.
An order is not required for a heel or sole replacement or transfer of a shoe to a brace.
MODIFIERS
GY, KX, LT and RT MODIFIERS:
When billing for a shoe that is an integral part of a leg brace or for related modifications, inserts, heel/sole replacements or shoe transfer, a KX modifier must be added to the code. If the shoe or related item is not an integral part of a leg brace, the KX modifier must not be used.
When billing for a shoe replacement or shoe transfer that is an integral part of a leg brace, a KX modifier must be added to the code.
If the shoe and related modifications, inserts, and heel/sole replacements are not an integral part of a brace, the GY modifier must be added to each code.
If a KX or GY modifier is not included on the claim line, it will be rejected as missing information.
When billing for prosthetic shoes (L3250) and related items, diagnosis code(s) to the highest level of specificity describing the condition which necessitates the prosthetic shoes, must be included on each claim for the prosthetic shoes and related items.
When code L3649 with a KX modifier is billed, the claim must include a narrative description of the item provided as well as a brief statement of the medical necessity for the item. This must be entered in the narrative field of an electronic claim.
The right (RT) and/or left (LT) modifiers must be used with all footwear HCPCS codes in this policy (refer to the CODING GUIDELINES section for additional information).
CODING GUIDELINES
Oxford shoes that are an integral part of a brace are billed using codes L3224 or L3225 with a KX modifier. For these codes, one unit of service is each shoe. Oxford shoes that are not part of a leg brace must be billed with codes L3215 or L3219 without a KX modifier.
Other shoes (e.g., high top, depth inlay or custom shoes for non-diabetics, etc.) that are an integral part of a brace are billed using code L3649 with a KX modifier. Other shoes that are not an integral part of a brace must be billed using codes L3216, L3217, L3221, L3222, L3230, L3251, L3252, L3253, or L3649 without a KX modifier.
Depth-inlay or custom molded shoes for diabetics and related inserts and modifications are billed using A codes whether or not the shoe is an integral part of a brace. See the medical policy on Therapeutic Shoes for Persons with Diabetes for coverage, documentation, and additional coding guidelines.
Code A9283 (FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH) is used for an item that is designed primarily to reduce pressure on the sole or heel of the foot but that does not meet the definition of:
- A therapeutic shoe for diabetics or related insert or modification; or
- An orthopedic shoe or modification; or
- A walking boot
It may be a shoe-like item, an item that is used inside a shoe and may or may not extend outside the shoe, or an item that is attached to a shoe. It may be prefabricated or custom fabricated.
Code L3250 may be used only for a shoe that is custom fabricated from a model of a beneficiary and has a removable custom fabricated insert designed for toe or distal partial foot amputation. The shoe serves to hold the insert on the leg. Code L3250 must not be used for a shoe that is put on other types of leg prostheses (L5010, L5020, L5050, L5060, L5100, L5105, L5150, L5160, L5200, L5210, L5220, L5230, L5250, L5270, L5280, L5301, L5312, L5321, L5331, L5341, L5400, L5410, L5420, L5430, L5450, L5460, L5500, L5505, L5510, L5520, L5530, L5535, L5540, L5560, L5570, L5580, L5585, L5590, L5595 and L5600) that are attached to the residual limb by other mechanisms.
The right (RT) and/or left (LT) modifiers must be used with all footwear 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 modifiers RT and/or LT, or with RTLT on the same claim line and 2 UOS, will be rejected as incorrect coding.
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.
