Clinical UM Guideline

This document addresses orthopedic footwear including shoes, inserts and modification to shoes for individuals who do not have diabetes.

Note: Please see the following related document for additional information:

• CG-DME-19 Therapeutic Shoes, Inserts or Modifications for Individuals with Diabetes

Medically Necessary:

Shoes, inserts, and modifications are considered medically necessary only in the limited circumstances described below:

1. Shoes are considered medically necessary if they are an integral part of a leg brace that is medically necessary.
2. Heel replacements, sole replacements and shoe transfers involving shoes on a medically necessary leg brace are also considered medically necessary.
3. Inserts and other shoe modifications (such as lifts, wedges, arch supports and other additions) are considered medically necessary if they are on a shoe that is an integral part of a medically necessary leg brace, if they are medically necessary for the proper functioning of the brace.
4. Prosthetic shoes are considered medically necessary if they are an integral part of a prosthesis for individuals with a partial foot amputation.

Not Medically Necessary:

Orthopedic footwear that does not meet the criteria above is considered not medically necessary.

A matching shoe that is not attached to a brace and items related to that shoe are considered not medically necessary.

Shoes are considered not medically necessary when they are put on over partial foot prosthesis or other lower extremity prosthesis that is attached to the residual limb by mechanisms other than being an integral part of the prosthesis.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

Orthopedic footwear including shoes, inserts and modifications to shoes are utilized for the alignment, support, prevention, or correction of deformities or to improve the function of movable parts of the body. Orthotics includes braces which are used to support a weak joint or joints.

The medical necessity of orthopedic footwear including shoes, inserts and modification to shoes for individuals who do not have diabetes is based on the evaluation of the individual’s needs and capabilities in relation to the following definition of medical necessity (CGS, 2020).

• The orthopedic footwear is reasonable and necessary for the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member.

This document is based on peer-reviewed published literature and Medicare criteria.

There is currently no available evidence addressing medical indications for footwear, inserts, and modifications that are not intended to address the alignment, support, prevention, or correction of deformities, or to improve the function of movable parts of the body. This includes shoes not attached to a brace or shoes when put on over partial foot or other lower extremity prosthesis.

Peer Reviewed Publications:

1. Janisse DJ, Janisse E. Shoe modification and the use of orthoses in the treatment of foot and ankle pathology. J Am Acad Orthop Surg. 2008; 16(3):152-158.
2. McDermott P, Wolfe E, Lowry C, et al. Evaluating the immediate effects of wearing foot orthotics in children with joint hypermobility syndrome (JHS) by analysis of tempero-spatial parameters of gait and dynamic balance: A preliminary study. Gait Posture. 2018; 60:61-64.
3. Prenton S, Hollands KL, Kenney LP. Functional electrical stimulation versus ankle foot orthoses for foot drop: a meta-analysis of orthotic effects. J Rehabil Med. 2016; 48:646-656.
4. Prenton S, Hollands KL, Kenney LP, et al. Functional electrical stimulation and ankle foot orthoses provide equivalent therapeutic effects on foot drop: A meta-analysis providing direction for future research. J Rehabil Med. 2018; 50(2):129-139.
5. Rasenberg N, Riel H, Rathleff MS, et al. Efficacy of foot orthoses for the treatment of plantar heel pain: A systematic review and meta-analysis. Br J Sports Med. 2018; 52(16):1040-1046.
6. Reichenbach S, Felson DT, Hincapié CA, et al. Effect of biomechanical footwear on knee pain in people with knee osteoarthritis: The BIOTOK randomized clinical trial. JAMA. 2020; 323(18):1802-1812.
7. Whittaker GA, Munteanu SE, Menz HB, et al. Foot orthoses for plantar heel pain: A systematic review and meta-analysis. Br J Sports Med. 2018; 52(5):322-328.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Durable medical equipment reference list. NCD #280.1. Effective May 5, 2005. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=190&ncdver=2&keyword=Durable%20medical%20equipment%20reference%20list&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on April 22, 2024.
2. CGS Administrators, LLC. Jurisdictions B and C. Local Coverage Determination for Orthopedic Footwear (L33641). Revised 01/01/2020. Available at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=33641&ver=21&keyword=Orthopedic%20Footwear&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1. Accessed on April 22, 2024.

Orthopedic Footwear

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.