Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Therapeutic Shoes and Orthopedic Shoes

Policy #:05.00.11i

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


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.

THERAPEUTIC SHOES

Therapeutic shoes, specifically designed inserts, and modifications to therapeutic shoes are considered medically necessary and, therefore, covered when they are prescribed by an eligible professional provider who is managing the medical condition of an individual who is diagnosed with diabetes and who also has one or more of the following complications of diabetes:
  • Partial or complete foot amputation
  • History of foot ulceration of either foot
  • History of pre-ulcerative calluses of either foot
  • Peripheral neuropathy with evidence of callus formation of either foot
  • Deformity of either foot
  • Poor circulation in either foot

In order for modifications to a therapeutic shoe or an insert or inlay used in a therapeutic shoe to be considered medically necessary and, therefore, covered, the therapeutic shoe itself must be medically necessary.

When only one foot is diagnosed with a diabetic foot condition or complication that meets the medical necessity criteria above, a pair of therapeutic shoes is considered medically necessary and, therefore, covered and eligible for reimbursement consideration.

For an individual whose condition meets all medical necessity requirements, only one pair of custom-molded therapeutic shoes or one pair of depth-inlay shoes is considered medically necessary and, therefore, covered per calendar year. Additionally:
  • Each eligible pair of custom-molded shoes includes specifically designed inserts and two additional pairs of inserts.
  • Each pair of depth-inlay shoes includes three pairs of specifically designed inserts in addition to the noncustomized removable inserts provided with these shoes.
  • To report the repair or replacement of covered therapeutic shoes, specifically designed inserts, and modifications to therapeutic shoes, report the code for the item itself appended with the appropriate modifier.

NONCOVERED THERAPEUTIC SHOES
Therapeutic shoes for an individual who has neither diabetes nor any of the complications of diabetes listed above are considered not medically necessary and, therefore, not covered.

When the quantity, type, and frequency of requests for therapeutic shoes exceeds that which is listed above, the therapeutic shoes are considered not medically necessary and, therefore, not covered.

Therapeutic shoes with deluxe features (eg, color, style, type of leather), as represented by Healthcare Common Procedure Coding System (HCPCS) code A5508 (for diabetics only, deluxe feature of off-the-shelf depth-inlay shoe or custom-molded shoe, per shoe), are a benefit contract exclusion and, therefore, not covered, as deluxe features do not contribute to the therapeutic function of the shoes.

When therapeutic shoes are a benefit contract exclusion, associated modifications to and/or the repair or replacement of the noncovered therapeutic shoes are also a benefit contract exclusion and, therefore, not covered.

ORTHOPEDIC SHOES AND ASSOCIATED MODIFICATIONS

Orthopedic shoes do not meet the definition of therapeutic shoes are not primarily medical in nature; therefore, they are not a covered benefit and are not eligible for reimbursement consideration under most products of the Company. Associated modifications to and/or the repair or replacement of orthopedic shoes are not a covered benefit and, therefore, are not eligible for reimbursement consideration. However:
  • For groups that have purchased orthopedic shoes as a benefit, orthopedic shoes are considered medically necessary and, therefore, covered in accordance with the terms of the group benefit contract. Individual member benefits must be verified.

REQUIRED DOCUMENTATION

The prescribing professional provider must also have an in-person visit with the individual during which the diabetes management is addressed within six months prior to the delivery of the shoes/inserts.

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 DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) 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 durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.

MANDATES

In accordance with the State of New Jersey's orthotic and prosthetic appliances mandate, members who are enrolled in New Jersey commercial products must obtain foot orthotics or other podiatric appliances from any licensed orthotist, prosthetist, or certified pedorthotist. The individual's physician must establish that the foot orthotic or other podiatric appliance is medically necessary for the individual.
Guidelines

Therapeutic shoes, specifically designed inserts, and modifications to therapeutic shoes are made and fitted by an orthotist or prosthetist. However, the reimbursement for the fitting or modification of medically necessary therapeutic shoes is included in the reimbursement for the item (ie, therapeutic shoe[s], insert[s]).

Reimbursement for the prescription of medically necessary therapeutic shoes is included in the evaluation and management (E&M) service provided by the prescribing eligible health care provider and, therefore, is not eligible for separate reimbursement by the Company.

BENEFIT APPLICATION

THERAPEUTIC SHOES
Subject to the terms and conditions of the applicable benefit contract, therapeutic shoes, specifically designed inserts, and modifications to therapeutic shoes are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.
  • Benefits for the repair or replacement of medically necessary therapeutic shoes, specifically designed inserts, and modifications to therapeutic shoes are applied in accordance with the terms of the group benefit contract related to the repair and replacement of prosthetics.

ORTHOPEDIC SHOES
Subject to the terms and conditions of the applicable benefit contract, orthopedic shoes and/or associated modifications to orthopedic shoes are not a covered benefit and, therefore, are not eligible for payment under the medical benefits of the Company’s products. However:
  • When an individual group has opted to allow coverage of orthopedic shoes, the items are covered under the medical benefits of the Company, in accordance with the applicable group contract.

Individual member benefits must be verified.

MANDATES

This policy is consistent with applicable state mandates. The laws of the state in which the group benefit contract is issued determine the applicable legislatively mandated coverage.
  • The State of New Jersey mandates coverage of orthotics for individuals enrolled in New Jersey commercial products when such items are determined to be medically necessary by the individual's physician. This mandate is effective for all newly issued contracts and contracts renewed on or after April 11, 2008.


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 professional provider. Therapeutic shoes are either custom-molded or depth-inlay shoes.

Custom-molded shoes are therapeutic shoes that are constructed over a positive model of an individual's foot and have removable inserts that can be altered or replaced as the individual's condition warrants.

Depth-inlay shoes are therapeutic shoes that have a full-length, heel-to-toe filler that, which, when removed, provides a minimum of 3/16 of an inch of additional depth to accommodate custom-molded or customized inserts. The depth-inlay itself refers to any removable material upon which the foot rests directly inside the shoe and that may be an integral design component of the shoe.

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 that 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 that 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 in the middle or to the side.

ORTHOPEDIC SHOES AND ASSOCIATED MODIFICATIONS

Orthopedic shoes, which are designed for individuals whose feet are impaired but otherwise essentially intact, are made for conditions such as bunions, hammer toes, blistering, callousing, and plantar fasciitis. These shoes may be custom-made or purchased off the shelf. Some examples of orthopedic shoes include oxford shoes that do not meet the definition of therapeutic shoes, corrective shoes, and high-top shoes. These shoes can be modified to accommodate specific characteristics of the feet or needs of the individual, such as split sizing, which is the provision of two shoes of different sizes.
References


American Orthopaedic Foot & Ankle Society (AOFAS). Shoes and orthotics for diabetics. [AOFAS Web site]. 2014. Available at:
http://www.aofas.org/footcaremd/conditions/diabetic-foot/Pages/Shoes-and-Orthotics-for-Diabetics.aspx. Accessed May 5, 2017.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered medical and other health services. 120: Prosthetic devices. [CMS Web site]. 10/01/03. Available at: http://www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed May 5, 2017.

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.] 10/01/03. Available at: http://www.cms.gov/manuals/Downloads/bp102c15.pdf. Accessed May 5, 2017.

Centers for Medicare & Medicaid Services (CMS). MLN Matters.An overview of Medicare covered diabetes supplies and services. [CMS Web site.] 08/28/12. Available at: http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0738.pdf. Accessed May 5, 2017.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 280.10: Prosthetic shoe. [CMS Web site.] Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=208&ncdver=1&bc=AgAAQAAAAAAAAA%3D%3D&. Accessed May 5, 2017.

Company Benefit Contracts.

Noridian. Local Coverage Determination (LCD). L33641: Orthopedic Footwear. [Noridian Web site]. Effective January 1, 2017. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Orthopedic+Footwear+LCD+and+PA/4405657c-dfe0-4d5c-98d7-6c1865cea4be
Accessed May 5, 2017.

Noridian. Local Coverage Article for Orthopedic Footwear- Policy Article. Effective January 1, 2017. (A52481). Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Orthopedic+Footwear+LCD+and+PA/4405657c-dfe0-4d5c-98d7-6c1865cea4be. Accessed May 5, 2017.

Noridian.Noncovered Items. Last Updated 06/08/2016. Available at:
https://med.noridianmedicare.com/web/jadme/topics/noncovered-items. Accessed July 26, 2016.

Noridian. Local Coverage Determination (LCD): Therapeutic Shoes for Persons with Diabetes (L33369). January 1, 2017. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Therapeutic+Shoes+for+Persons+with+Diabetes/e20fbc7e-6960-458b-8156-796e24e17152.
Accessed: May 5, 2017.

Noridian. Article for Therapeutic Shoes for Persons with Diabetes. A52501. Effective January 1, 2017. Available at: https://med.noridianmedicare.com/documents/2230703/7218263/Therapeutic+Shoes+for+Persons+with+Diabetes/e20fbc7e-6960-458b-8156-796e24e17152.
Accessed: May 5, 2017.

New Jersey (NJ) Department of Banking and Insurance (DOBI). Bulletin No. 08-10: P.L. 2007, c. 345 – Health benefits coverage for orthotic and prosthetic appliances. [NJ DOBI Web site]. 04/11/08. Available at: http://www.state.nj.us/dobi/bulletins/blt08_10.pdf. Accessed May 5, 2017.

New Jersey (NJ) Legislature. P.L. 2007, Chapter 345. Senate No. 502. Requires health benefits coverage by health insurers and SHBP for orthotic and prosthetic appliances and provides reimbursement. [NJ State Legislature Web site]. 01/13/08. Available at: http://www.njleg.state.nj.us/2006/Bills/AL07/345_.PDF. Accessed: May 5, 2017.

New Jersey (NJ) Legislature. 17B:26-2.1z: Individual health insurance policies to provide benefits for orthotic and prosthetic appliances. [NJ State Legislature Web site]. 04/11/08. Available at: http://statutes.laws.com/new-jersey/title-17b/section-17b-26/17b-26-2-1z Accessed May 5, 2017.

Pennsylvania (PA) Act 98 of 1998. Effective 02/12/1999.

Pennsylvania (PA) General Assembly. House Bill 401. An act establishing the state board of orthotics, prosthetics, and pedorthotics. [PA General Assembly Web site]. 02/09/05. Available at: http://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=HTM&sessYr=2005&sessInd=0&billBody=H&billTyp=B&billnbr=0401&pn=0426. May 5, 2017.

Pennsylvania (PA) General Assembly. House Bill 656. An act amending the PA Insurance Company Law of 1921 and providing reimbursement for diabetic supplies. [PA General Assembly Web site]. 10/27/97. Available at: http://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=PDF&sessYr=1997&sessInd=0&billBody=H&billTyp=B&billNbr=0656&pn=2505. Accessed May 5, 2017.





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

THE FOLLOWING CODE(S) ARE USED TO REPRESENT THERAPEUTIC SHOES:

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


THE FOLLOWING CODE(S) ARE USED TO REPRESENT INLAYS, AND MODIFICATIONS OF THERAPEUTIC SHOES:

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

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


THE FOLLOWING CODE(S) ARE USED TO REPRESENT CUSTOM-FABRICATED/FITTED PRESCRIPTION-REQUIRED SHOE FOR THE PREVENTION OR TREATMENT OF COMPLICATIONS OF DIABETES, USE THE FOLLOWING CODES:

L3252 Foot, shoe molded to patient model, Plastazote (or similar), custom fabricated, each

L3253 Foot, molded shoe Plastazote (or similar), custom fitted, each


NOT COVERED

THE FOLLOWING CODE IS USED TO REPRESENT A DELUXE ITEM, WHICH IS NOT A COVERED BENEFIT

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


THE FOLLOWING CODES ARE USED TO REPRESENT ORTHOPEDIC SHOES AND MODIFICATIONS TO ORTHOPEDIC SHOES, WHICH ARE NOT A COVERED BENEFIT

(However, when a member's purchased group benefit exists, orthopedic shoes are covered and eligible for reimbursement consideration by the Company according to the criteria specified in the group benefit contract)

L3201 Orthopedic shoe, Oxford with supinator or pronator, infant

L3202 Orthopedic shoe, Oxford with supinator or pronator, child

L3203 Orthopedic shoe, Oxford with supinator or pronator, junior

L3204 Orthopedic shoe, hightop with supinator or pronator, infant

L3206 Orthopedic shoe, hightop with supinator or pronator, child

L3207 Orthopedic shoe, hightop with supinator or pronator, junior

L3215 Orthopedic footwear, ladies shoe, oxford, each

L3216 Orthopedic footwear, ladies shoe, depth inlay, each

L3217 Orthopedic footwear, ladies shoe, hightop, depth inlay, each

L3219 Orthopedic footwear, mens shoe, oxford, each

L3221 Orthopedic footwear, mens shoe, depth inlay, each

L3222 Orthopedic footwear, mens shoe, hightop, depth inlay, each

L3230 Orthopedic footwear, custom shoe, depth inlay, each

L3251 Foot, shoe molded to patient model, silicone shoe, each

L3257 Orthopedic footwear, additional charge for split size

L3500 Orthopedic shoe addition, insole, leather

L3510 Orthopedic shoe addition, insole, rubber

L3520 Orthopedic shoe addition, insole, felt covered with leather

L3530 Orthopedic shoe addition, sole, half

L3540 Orthopedic shoe addition, sole, full

L3550 Orthopedic shoe addition, toe tap, standard

L3560 Orthopedic shoe addition, toe tap, horseshoe

L3570 Orthopedic shoe addition, special extension to instep (leather with eyelets)

L3580 Orthopedic shoe addition, convert instep to Velcro closure

L3590 Orthopedic shoe addition, convert firm shoe counter to soft counter

L3595 Orthopedic shoe addition, March bar



Revenue Code Number(s)

N/A


Misc Code

HCPCS MODIFIERS::


RA Replacement of a DME, orthotic or prosthetic item

RB Replacement of a part of a DME, orthotic or prosthetic item furnished as part of a repair


Coding and Billing Requirements


Cross References

Attachment A: Therapeutic Shoes and Orthopedic Shoes
Description: ICD-10 Coding




Policy History

05.00.11i
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.

REVISIONS FROM 05.00.11h
10/24/2018This policy has been reissued in accordance with the Company's annual review process.
04/01/2018The 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


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 01/02/2019
Version Reissued Date: N/A

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.