Clinical UM Guideline



Subject: Therapeutic Shoes, Inserts or Modifications for Individuals with Diabetes
Guideline #:  CG-DME-19 Current Effective Date:    03/29/2017
Status: Revised Last Review Date:    02/02/2017

Description

This document addresses therapeutic shoes, inserts or modifications to therapeutic shoes for individuals with diabetes. Therapeutic shoes may be custom-molded or depth shoes.

Clinical Indications

Medically Necessary:

  1. Therapeutic shoes, inserts or modifications to therapeutic shoes are considered medically necessary if the following criteria are met:
    1. The individual has diabetes mellitus; and
    2. The individual has one or more of the following conditions:
      1. previous amputation of the other foot or part of either foot, or
      2. history of previous foot ulceration of either foot, or
      3. history of pre-ulcerative calluses of either foot, or
      4. peripheral neuropathy with loss of protective sensation in the foot and with evidence of callus formation of either foot, or
      5. foot deformity of either foot, or
      6. peripheral vascular disease involving the treated foot; and
    3. The physician who is managing the individual's systemic diabetes condition has certified that indications (A) and (B) above are met and that he/she is treating the individual under a comprehensive plan of care for his/her diabetes and that the individual needs therapeutic shoes, inserts or modifications to therapeutic shoes.
  2. A custom-molded shoe is considered medically necessary when the individual has a foot deformity that cannot be accommodated by a depth shoe.
  3. A modification of a custom-molded or depth shoe is considered medically necessary as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications:
    1. rigid rocker bottoms
    2. roller bottoms
    3. wedges
    4. metatarsal bars
    5. offset heels

Not Medically Necessary:

Any shoes, shoe inserts or modifications that do not meet the above criteria are considered not medically necessary.

Coding

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.

HCPCS  
A5500 For diabetics only, fitting (including follow-up), custom preparation and supply of off-the-shelf depth-inlay shoe manufactured to accommodate multi-density 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
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
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 ¼ 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
   
ICD-10 Diagnosis  
E08.00-E08.9 Diabetes mellitus due to underlying condition
E09.00-E09.9 Drug or chemical induced diabetes mellitus
E10.10-E10.9 Type 1 diabetes mellitus
E11.00-E11.9 Type 2 diabetes mellitus
E13.00-E13.9 Other specified diabetes mellitus
   
Discussion/General Information

Therapeutic footwear is commonly used in clinical practice for preventing and healing of foot ulcers in persons with diabetes. Diabetes is a chronic illness in which the body does not properly produce or use insulin. Foot ulcerations, infections, peripheral neuropathy, and lower extremity amputations are common consequences of diabetes. Effective management (including therapeutic shoes, inserts or modifications) of these factors may assist in the prevention of or delay of adverse outcomes. Recent systematic literature reviews (Bus, 2016a; van Netten, 2016) indicate that sufficient data is available to support the use of therapeutic footwear for the prevention of recurrent foot ulcers in diabetics and additional data is needed related to the prevention of a first foot ulcer.

According to Bus and colleagues (2016b), on behalf of the International Working Group on the Diabetic Foot (IWDF), peripheral neuropathy leads to loss of protective sensation which is one of the most important risk factor for foot ulcerations in diabetics. Loss of protective sensation can result in elevated levels of mechanical pressure which is a significant contributing factor in the development of diabetic foot ulcers.

The American Diabetes Association (ADA) (2017) does not generally recommend the routine prescription of therapeutic footwear for diabetics. However, they do indicate that the use of custom therapeutic footwear can help reduce the risk of future foot ulcers in individuals at high risk. The ADA lists the following as high risk diabetic foot conditions: history of ulcer or amputation, deformity, loss of protective sensation or peripheral arterial disease.

This Anthem clinical UM guideline is based on peer reviewed published literature, Medicare criteria and current American Diabetes Association standards.

Definitions

American standard last sizing schedule: The numerical sizing system used for shoes in the United States.

Custom-molded shoe: A shoe that

Depth shoe: A shoe that

Metatarsal bars: Exterior bars that are placed behind the metatarsal heads in order to remove pressure from the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exact purpose.

Offset heel: A heel flanged at its base either in the middle, to the side, or a combination, that is then extended upward to the shoe in order to stabilize extreme positions of the hind foot.

Rigid rocker bottoms: Exterior elevations with apex position for 51% to 75% distance measured from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. The apex must be positioned behind the metatarsal heads and taper off sharply to the front tip of the sole. Apex height helps to eliminate pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe. The heel of the shoe tapers off in the back in order to cause the heel to strike in the middle of the heel.

Roller bottoms (sole or bar): The same as rocker bottoms except the heel is tapered from the apex to the front tip of the sole.

Therapeutic shoe insert for diabetics described by HCPCS code A5512: Is a total contact, multiple density, prefabricated, removable inlay that is directly molded to the individual's foot or a model of the individual's foot and that is made of a suitable material with regard to the individual's condition. The material responsible for maintaining the shape of the device is called the base layer and must be heat moldable. This material usually constitutes the bottom layer of the device and must be of a sufficient thickness and durometer to maintain its shape during use (at least ¼ inch of Shore A 35 or higher, or 3/16 inch of Shore A 40 or higher). Modifications such as additional arch fill may be necessary to achieve and maintain total contact.

Therapeutic shoe insert for diabetics described by HCPCS code A5513; Is a total contact, custom fabricated, multiple density removable inlay that is molded to a model of the individual's foot or a model of the individual's foot so and that is made of a suitable material with regard to the individual's condition. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length or toe shape. The base layer of the device must be of a sufficient thickness and durometer to maintain its shape during use (at least 3/16 inch of Shore A 35 material or higher). The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact. The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable.

Wedges (posting): Are either for hind foot, fore foot, or both and may be in the middle or to the side. The function 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

Peer Reviewed Publications:

  1. Bus SA, van Deursen RW, Armstrong DG, et al; International Working Group on the Diabetic Foot (IWGDF). Footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in patients with diabetes: a systematic review. Diabetes Metab Res Rev. 2016a; 32 Suppl 1:99-118.
  2. Lavery LA, La Fontaine J, Kim PJ. Preventing the first or recurrent ulcers. Med Clin North Am. 2013; 97(5):807-820.
  3. van Netten JJ, Price PE, Lavery LA, et al; International Working Group on the Diabetic Foot (IWGDF). Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev.  2016; 32 Suppl 1:84-98.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Diabetes Association. Standards of Medical Care in Diabetes--2017.Available at: http://professional.diabetes.org/sites/professional.diabetes.org/files/media/dc_40_s1_final.pdf. Accessed on December 28, 2016.
  2. Bus SA, Armstrong DG, van Deursen RW, et al; International Working Group on the Diabetic Foot. IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes. Diabetes Metab Res Rev. 2016b; 32 Suppl 1:25-36.
  3. Lewis J, Lipp A. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2013; (1):CD002302.
  4. Medicare Benefit Policy Manual (IOM 100-02). Therapeutic Shoes for Individuals with Diabetes. Chapter 15, Section 140. Rev. 1, 10-01-03. Available at: http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf. Accessed on December 28, 2016.   
Websites for Additional Information
  1. American Diabetes Association. Available at: http://www.diabetes.org/. Accessed on December 28, 2016.
Index

Custom-Molded Shoes
Diabetes
Inserts
Therapeutic Shoes

History
Status Date          Action
Revised 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Formatting updated in Clinical Indications Section. Medically Necessary statement updated to address peripheral neuropathy with loss of protective sensation and peripheral vascular disease. Discussion and References sections updated.
Reviewed 02/04/2016 MPTAC review. Description, Discussion, References and Definitions sections updated. Removed ICD-9 codes from Coding section.
Revised 02/05/2015 MPTAC review. Medically necessary statements reformatted and clarified. References section updated.
Reviewed 02/13/2014 MPTAC review. Definitions and References sections updated.
Reviewed 02/14/2013 MPTAC review. References section updated.
Reviewed 02/16/2012 MPTAC review. Definitions and References sections updated.
Reviewed 02/17/2011 MPTAC review. Discussion, Definitions, References links and Index updated.
Reviewed 02/25/2010 MPTAC review. Place of service section removed. References updated.
Reviewed 02/26/2009 MPTAC review. References updated.
  10/01/2008 Updated coding section with 10/01/2008 ICD-9 changes.
Reviewed 02/21/2008 MPTAC review. Description, Discussion and References updated. The wording "diabetic shoes" in Medically necessary statement #3 was replaced with "therapeutic shoes, inserts or modifications to therapeutic shoes".
Reviewed 03/08/2007 MPTAC review. References & General Information updated. Coding updated; removed HCPCS A5509, A5511, K0628, K0629 deleted 12/31/2005.
Reviewed 03/23/2006 MPTAC review. Reference added.
New 12/01/2005 MPTAC initial guideline development.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

  No document
Anthem CO/NV

10/29/2004

DME.710 Therapeutic Shoes for Individuals with Diabetes
Anthem CT

 

Benefit Detail

Foot Orthotics

 

WellPoint Health Networks, Inc.

 

 

No document