Clinical UM Guideline


Subject:Therapeutic Shoes, Inserts or Modifications for Individuals with Diabetes
Guideline #:  CG-DME-19Current Effective Date:  04/15/2014
Status:ReviewedLast Review Date:  02/13/2014

Description

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

Clinical Indications

Medically Necessary:

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 evidence of callus formation of either foot, or
    5. foot deformity of either foot, or
    6. poor circulation in either foot.
  3. The certifying physician who is managing the individual's systemic diabetes condition has certified that indications (1) and (2) 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.

A custom-molded shoe is considered medically necessary when the individual has a foot deformity that cannot be accommodated by a depth shoe.

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 
A5500For 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
A5501For 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
A5503For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe with roller or rigid rocker bottom, per shoe
A5504For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe with wedge(s), per shoe
A5505For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe with metatarsal bar, per shoe
A5506For diabetics only, modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe with off-set heel(s), per shoe
A5507For diabetics only, not otherwise specified modification (including fitting) of off-the-shelf depth-inlay shoe or custom-molded shoe, per shoe
A5508For diabetics only, deluxe feature of off-the-shelf depth-inlay shoe or custom-molded shoe, per shoe
A5510For diabetics only, direct formed, compression molded to patient's foot without external heat source, multiple density insert(s), prefabricated, per shoe
A5512For 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
A5513For 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-9 Diagnosis[For dates of service prior to 10/01/2014]
249.00-249.91Secondary diabetes mellitus
250.00-250.93Diabetes mellitus
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
E08.00-E08.9Diabetes mellitus due to underlying condition
E09.00-E09.9Drug or chemical induced diabetes mellitus
E10.10-E10.9Type 1 diabetes mellitus
E11.00-E11.9Type 2 diabetes mellitus
E13.00-E13.9Other specified diabetes mellitus
  
Discussion/General Information

Diabetes is a chronic illness in which the body does not properly produce or use insulin. Foot ulcerations, infection, peripheral neuropathy, and lower extremity amputations are some of the 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. This clinical UM guideline is based on Medicare criteria.

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 (e.g., 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 (e.g., 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. Lavery LA, La Fontaine J, Kim PJ. Preventing the first or recurrent ulcers. Med Clin North Am. 2013; 97(5):807-820.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012; 35 Suppl 1:S11-63.
  2. 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 26, 2013.                                       
  3. Spencer S. Pressure relieving interventions for preventing and treating diabetic foot ulcers. Cochrane Database Syst Rev. 2000; (3):CD002302.
Websites for Additional Information
  1. American Diabetes Association. Available at: http://www.diabetes.org/. Accessed on December 26, 2013.
Index

Custom-Molded Shoes
Diabetes
Inserts
Therapeutic Shoes

History
StatusDateAction
Reviewed02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Definition and Reference sections updated.
Reviewed02/14/2013MPTAC review. Reference section updated.
Reviewed02/16/2012MPTAC review. Definition and Reference sections updated.
Reviewed02/17/2011MPTAC review. Discussion, Definitions, Reference links and Index updated.
Reviewed02/25/2010MPTAC review. Place of service section removed. References updated.
Reviewed02/26/2009MPTAC review. References updated.
 10/01/2008Updated coding section with 10/01/2008 ICD-9 changes.
Reviewed02/21/2008MPTAC 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".
Reviewed03/08/2007MPTAC review. References & General Information updated. Coding updated; removed HCPCS A5509, A5511, K0628, K0629 deleted 12/31/2005.
Reviewed03/23/2006MPTAC review. Reference added.
New12/01/2005MPTAC initial guideline development.
Pre-Merger Organizations

Last Review Date

Document Number

Title

Anthem, Inc.

 

 No document
Anthem CO/NV

10/29/2004

DME.710Therapeutic Shoes for Individuals with Diabetes
Anthem CT

 

Benefit DetailFoot Orthotics
WellPoint Health Networks, Inc.

 

 No document