Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Therapeutic Shoes
Policy #:MA05.020f

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Therapeutic shoes, inserts, and/or modifications to therapeutic shoes are considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has diabetes mellitus.
  • The professional provider has documented that the individual has one or more of the following conditions:
    • Previous amputation of the other foot, or part of either foot
    • History of previous foot ulceration of either foot
    • History of pre-ulcerative calluses of either foot
    • Peripheral neuropathy with evidence of callus formation of either foot
    • Foot deformity of either foot
    • Impaired circulation in either foot
  • The professional provider is treating the individual under a comprehensive plan of care for diabetes, the individual needs diabetic shoes, and both of the following criteria are met:
    • The professional provider must have an in-person visit with the individual during which diabetes management is addressed within 6 months prior to delivery of the shoes/inserts; and
    • The professional provider must document on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.
  • Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the individual.
  • At the time of delivery of the items selected, the supplier must conduct and document an in-person visit with the individual.
  • When the professional provider is treating an individual who has a foot deformity that cannot be accommodated by a depth shoe, a custom molded shoe may be considered.
If the above criteria are not met, the therapeutic shoes, inserts and/or modifications will be considered
not medically necessary and, therefore, not covered.

LIMITATIONS

Coverage of shoes and inserts is limited to one of the following, per calendar year:
  • One pair of custom-molded shoes (which includes inserts provided with these shoes) and two additional pairs of inserts; or
  • One pair of depth shoes and three pairs of inserts (not including the non-customized removable inserts provided with such shoes)

A modification of a custom-molded or depth shoe may be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications:
  • Rigid rocker bottoms
  • Roller bottoms
  • Wedges
  • Metatarsal bars
  • Offset heels

Other modifications to diabetic shoes include, but are not limited to, flared heels, velcro closures and inserts for missing toes.

Separate inserts dispensed independently of the diabetic shoe may be considered medically necessary and, therefore, covered if the supplier of the shoes documents in writing that the individual has appropriate footwear into which the insert can be placed.

Codes for inserts or modifications may only be used for items related to diabetic shoes.

NOT COVERED

Quantities of shoes, inserts, and/or modifications greater than those listed above will be considered not covered.

The following items are not covered by the Company because they are items not covered by Medicare. Therefore, they are not eligible for reimbursement consideration:
  • Compression molding to the individual's foot through heat and pressure: because these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category.
  • Inserts used in noncovered shoes.
  • Deluxe features of diabetic shoes because they do not contribute to the therapeutic function of the shoes (e.g., style, color type, or type of leather).

There is no separate payment for the fitting of the shoes, inserts, or modifications, or for the certification of need or prescription of the footwear.

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, therapeutic shoes, inserts, and/or modifications to therapeutic shoes are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Description

THERAPEUTIC SHOES

Therapeutic shoes is the term used for shoes that are specially designed and constructed to meet the medical needs of an individual who has specific complications resulting from diabetes. These shoes are available only by a prescription from an eligible health care provider. Therapeutic shoes are either a custom-molded or a depth shoe.

Custom-molded shoes are therapeutic shoes that are constructed over a positive model of an individual's foot; are made of leather or other suitable material of equal quality; have removable inserts that can be altered or replaced as the individual's condition warrants; and have some form of shoe closure.

Depth shoes are therapeutic shoes that have a full-length, heel-to-toe filler that, when removed, provides a minimum of 3/16 of an inch of additional depth to accommodate custom-molded or customized inserts; are made of leather or other suitable material of equal quality; have some form of shoe closure; and are available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American standard sizing schedule or its equivalent.

INSERTS FOR THERAPEUTIC SHOES
Inserts that are specifically designed for therapeutic shoes are total-contact, multiple-density, removable inlays that are molded directly to an individual's foot or a model of an individual's foot, and are made of a material suitable for an individual's medical condition. Such devices are used solely as inserts for therapeutic shoes and are not designed to be used in any other shoe.

MODIFICATIONS TO THERAPEUTIC SHOES
Modifications are features of a therapeutic shoe that may be used as a substitute for inserts. The following are examples of the most common types of modifications to therapeutic shoes:
  • Metatarsal bars are exterior bars that are placed behind the metatarsal heads in order to remove pressure from the metatarsal heads.
  • Offset heels are heels that are flanged at the base in the middle, to the side, or both, and are extended upward to the shoe in order to stabilize extreme positions of the hind foot.
  • Rigid rocker bottoms are exterior elevations with apex positions for 51-75 percent distance measured from the back end of the heel.
  • Roller bottoms (sole or bar) are the same as rocker bottoms, but the heel is tapered from the apex to the front tip of the sole.
  • Velcro closures are closures on therapeutic shoes that are used in lieu of shoe laces.
  • Wedges (posting) are for the hindfoot, forefoot, or both, and may be placed in the middle or to the side. The function of wedges is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization, equalized weight distribution or balance.

References

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered medical and other health services. 120: Prosthetic devices. [CMS Web site]. 02/01/19. Available at: http://www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed April 2, 2019.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered medical and other health services. 140: Therapeutic shoes for individuals with diabetes. [CMS Web site.] 02/01/19. Available at: http://www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed April 2, 2019.

Centers for Medicare & Medicaid Services (CMS). MLN Matters.An overview of Medicare covered diabetes supplies and services. [CMS Web site.] 08/16/18. Available at: http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0738.pdf. Accessed April 2, 2019.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Provider compliance tips for diabetic shoes. [CMS website]. 02/18. Available at: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ProviderComplianceTipsforDiabeticShoes-ICN909471.pdf. Accessed April 2, 2019.

Noridian Healthcare Solutions. Local Coverage Determination(L33369). Therapeutic Shoes for Persons with Diabetes. (Original date 10/01/2015). Revised: 04/01/2018. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Therapeutic+Shoes+for+Persons+with+Diabetes/e20fbc7e-6960-458b-8156-796e24e17152. Accessed: April 2, 2019.

Noridian Healthcare Solutions. Policy Article(A52501). Therapeutic Shoes for Persons with Diabetes. (Original 10/01/15). Revised 04/01/18. Available at:
https://www.cms.gov/medicare-coverage-database/license/cpt-license.aspx?from=~/overview-and-quick-search.aspx&npage=/medicare-coverage-database/details/article-details.aspx&articleId=52501&ver=23&DocType=Active&bc=AACAAAAAAAAA&. Accessed: April 2, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


A5500 For diabetics only, fitting (including follow-up), custom preparation and supply of off-the-shelf depth-inlay shoe manufactured to accommodate multidensity insert(s), per shoe

A5501 For diabetics only, fitting (including follow-up), custom preparation and supply of shoe molded from cast(s) of patient's foot (custom molded shoe), per shoe

A5503 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom molded shoe with roller or rigid rocker bottom, per shoe

A5504 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom molded shoe with wedge(s), per shoe

A5505 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom molded shoe with metatarsal bar, per shoe

A5506 For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom molded shoe with off-set heel(s), per shoe

A5507 For diabetics only, not otherwise specified modification (including fitting) of off-the-shelf depth-inlay shoe or custom molded shoe, per shoe

A5512 For diabetics only, multiple density insert, direct formed, molded to foot after external heat source of 230 degrees Fahrenheit or higher, total contact with patient's foot, including arch, base layer minimum of 1/4 inch material of shore a 35 durometer or 3/16 inch material of shore a 40 durometer (or higher), prefabricated, each

A5513 For diabetics only, multiple density insert, custom molded from model of patient's foot, total contact with patient's foot, including arch, base layer minimum of 3/16 inch material of shore a 35 durometer or higher, includes arch filler and other shaping material, custom fabricated, each

A5514: For diabetics only, multiple density insert, made by direct carving with cam technology from a rectified cad model created from a digitized scan of the patient, total contact with patient's foot, including arch, base layer minimum of 3/16 inch material of shore a 35 durometer (or higher), includes arch filler and other shaping material, custom fabricated, each.

NONCOVERED

A5508 For diabetics only, deluxe feature of off-the-shelf depth-inlay shoe or custom molded shoe, per shoe

A5510 For diabetics only, direct formed, compression molded to patient's foot without external heat source, multiple-density insert(s) prefabricated, per shoe



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Therapeutic Shoes
Description: ICD-10 codes






Policy History

MA05.02f
06/17/2019The version of this policy will become effective 06/17/2019. The policy has been updated to communicate the Company's continuing position on therapeutic shoes. For custom molded shoes, clarification is provided for individuals with a foot deformity that cannot be accommodated by a depth shoe, the individuals must also meet medically necessary criteria outlined in the medical policy for therapeutic shoes, inserts, and/or modifications to the therapeutic shoes. The policy has also been updated to include additional examples for modifications to diabetic shoes.

MA05.020e
01/01/2019This version of the policy will become effective 01/01/2019.
The following HCPCS code has been termed from the policy: K0903.
The following HCPCS code has been added to the policy: A5514.

MA05.020d
10/24/2018This policy has been reissued in accordance with the Company's annual review process.
04/01/2018
  • The following HCPCS code has been added to this policy:
    K0903 For diabetics only, multiple density insert, made by direct carving with cam technology from a rectified cad model created from a digitized scan of the patient, total contact with patient's foot, including arch, base layer minimum of 3/16 inch material of shore a 35 durometer (or higher), includes arch filler and other shaping material, custom fabricated, each

MA05.020c
10/01/2017This version of the policy will become effective 10/01/2017.

The following ICD-10 codes have been added to Attachment A in this policy.
E11.10 Type 2 diabetes mellitus with ketoacidosis without coma
E11.11 Type 2 diabetes mellitus with ketoacidosis with coma

MA05.020b
06/21/2017This policy was reviewed and reissued in accordance with the Company's Policy Confirmation Review track. Style Guide and References were updated accordingly.
10/01/2016This version of the policy will become effective 10/01/2016.

In accordance with the 10/1/2016 ICD-10 CM code update, the following changes occurred in this policy.
  • The following ICD-10 CM codes have been deleted from this policy:
    E08.321, E08.329, E08.331, E08.339, E08.341, E08.349, E08.351, E08.359,E09.321, E09.329, E09.331, E09.339 E09.341, E09.349, E09.351, E09.359, E10.321, E10.329, E10.331 E10.339, E10.341, E10.349 E10.351, E10.359, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E13.359
  • The following ICD-10 CM codes have been added to this policy:
    E08.3211, E08.3212, E08.3213, E08.3219, E08.3291, E08.3292, E08.3293, E08.3299, E08.3311, E08.3312, E08.3313, E08.3319, E08.3391, E08.3392, E08.3393, E08.3399, E08.3411, E08.3412, E08.3413, E08.3419, E08.3491, E08.3492, E08.3493, E08.3499, E08.3511, E08.3512, E08.3513 E08.3519, E08.3521, E08.3522, E08.3523, E08.3529, E08.3531, E08.3532, E08.3533, E08.3539 E08.3541, E08.3542, E08.3543, E08.3549, E08.3551, E08.3552, E08.3553, E08.3559, E08.3591, E08.3592, E08.3593, E08.3599, E08.37X1, E08.37X2, E08.37X3, E08.37X9, E09.3211, E09.3212, E09.3213, E09.3219, E09.3291, E09.3292, E09.3293, E09.3299, E09.3311, E09.3312, E09.3313, E09.3319, E09.3391, E09.3392, E09.3393, E09.3399, E09.3411, E09.3412, E09.3413, E09.3419, E09.3491, E09.3492, E09.3493, E09.3499, E09.3511, E09.3512, E09.3513, E09.3519, E09.3521, E09.3522, E09.3523, E09.3529, E09.3531, E09.3532, E09.3533, E09.3539, E09.3541, E09.3542, E09.3543, E09.3549, E09.3551, E09.3552, E09.3553, E09.3559, E09.3591, E09.3592, E09.3593, E09.3599, E09.37X1, E09.37X2, E09.37X3, E09.37X9, E10.3211, E10.3212, E10.3213, E10.3219, E10.3291, E10.3292, E10.3293, E10.3299, E10.3311, E10.3312, E10.3313, E10.3319, E10.3391, E10.3392, E10.3393, E10.3399, E10.3411, E10.3412, E10.3413, E10.3419, E10.3491, E10.3492, E10.3493, E10.3499, E10.3511, E10.3512, E10.3513, E10.3519, E10.3521, E10.3522, E10.3523, E10.3529, E10.3531, E10.3532, E10.3533, E10.3539, E10.3541, E10.3542, E10.3543, E10.3549, E10.3551, E10.3552, E10.3553, E10.3559, E10.3591, E10.3592, E10.3593, E10.3599, E10.37X1 E10.37X2, E10.37X3, E10.37X9, E11.3211, E11.3212, E11.3213, E11.3219, E11.3291, E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319, E11.3391, E11.3392, E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491, E11.3492, E11.3493, E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531 E11.3532, E11.3533, E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599, E11.37X1, E11.37X2, E11.37X3, E11.37X9, E13.3211, E13.3212, E13.3213, E13.3219, E13.3291, E13.3292, E13.3293, E13.3299, E13.3311, E13.3312, E13.3313, 13.3319, E13.3391, E13.3392, E13.3393, E13.3399, E13.3411, E13.3412, E13.3413, E13.3419, E13.3491, E13.3492, E13.3493, E13.3499, E13.3511, E13.3512, E13.3513, E13.3519, E13.3521, E13.3522, E13.3523, E13.3529, E13.3531, E13.3532, E13.3533, E13.3539, E13.3541, E13.3542, E13.3543, E13.3549, E13.3551, E13.3552, E13.3553, E13.3559, E13.3591, E13.3592, E13.3593, E13.3599, E13.37X1, E13.37X2, E13.37X3, E13.37X9

MA05.020a
10/02/2015 Applicable ICD-10 codes have been added to this policy.

MA05.020
01/01/2015This is a new policy.






Version Effective Date: 06/17/2019
Version Issued Date: 06/17/2019
Version Reissued Date: N/A