Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
  
  The rules say that medically necessary services are those that are reasonable and necessary for the diagnosis or 
treatment of an illness or injury. Medically necessary services include services to improve the functioning of a 
malformed body member. You can find this rule in the Social Security Act, Section 1862(a)(1)(A). 
 
Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria 
are met: 
 
1. The beneficiary has diabetes mellitus (Reference diagnosis code section below); and 
2. The certifying physician has documented in the beneficiary's medical record one or more of the 
    following conditions: 
    a. Previous amputation of the other foot, or part of either foot, or 
    b. History of previous foot ulceration of either foot, or 
    c. History of pre-ulcerative calluses of either foot, or 
    d. Peripheral neuropathy with evidence of callus formation of either foot, or 
    e. Foot deformity of either foot, or    
    f. Poor circulation in either foot; and 
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the 
    beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs 
    diabetic shoes. For claims with dates of service on or after 01/01/2011, the certifying physician must: 
     - Have an in-person visit with the beneficiary during which diabetes management is addressed  
       within 6 months prior to delivery of the shoes/inserts; and 
     - Sign the certification statement (refer to the Policy Specific Documentation Requirements      
       section below) on or after the date of the in-person visit and within 3 months prior to delivery of 
       the shoes/inserts. 
4. Prior to selecting the specific items that will be provided, the supplier must conduct and document an 
    in-person evaluation of the beneficiary. (Refer to the Policy Specific Documentation Requirements 
    section below.) 
5. At the time of in-person delivery to the beneficiary of the items selected, the supplier must conduct an 
    objective assessment of the fit of the shoe and inserts and document the results. A beneficiarys  
    subjective statements regarding fit as the sole documentation of the in-person delivery does not meet 
    this criterion. 
 
If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. 
When codes are billed without a KX modifier (see Policy Specific Documentation Requirements section 
below), they will be denied as noncovered. 
 
In order to meet criterion 2, the certifying physician must either: 
 
   i. Personally document one or more of criteria a  f in the medical record of an in-person visit within 6 
      months prior to delivery of the shoes/inserts and prior to or on the same day as signing the certification 
      statement; or 
  ii. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with 
      information from the medical records of an in-person visit with a podiatrist, other M.D or D.O., 
      physician assistant, nurse practitioner, or clinical nurse specialist that is within 6 months prior to 
     delivery of the shoes/inserts, and that documents one of more of criteria a  f. 
 
The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective 
for claims with dates of service on or after 1/1/2011. 
 
Note: The certification statement is not sufficient to meet the requirement for documentation in the medical 
          record. 
 Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier 
had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the 
items that meet the beneficiarys needs. Both components of the visit (criteria 4 and 5 above) must be clearly 
documented. 
 
For beneficiaries meeting the coverage criteria, coverage is limited to one of the following within one calendar 
year (January  December): 
 
 One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 
   additional pairs of inserts (A5512, A5513, or A5514); or 
 One pair of depth shoes (A5500) and 3 pairs of inserts (A5512, A5513, or A5514) (not including the 
   non-customized removable inserts provided with such shoes). 
 
You can find this rule in the Local Coverage Article: Therapeutic Shoes for Persons with Diabetes-Policy 
Article (A52501) effective November 5, 2020. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.