01-028 Therapeutic Shoes for Diabetics Notification of Medical Review

Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of claims for Medicare Part B therapeutic shoes for diabetics, billed on dates of service from July 1, 2018 through June 30, 2019. This notification includes the reasons for the review, documentation that will be requested in the Additional Documentation Request (ADR) letter, and resources providers/suppliers may wish to consult when submitting claims.

Background

Therapeutic shoes for diabetics, also known as diabetic shoes, are specialized shoes and/or inserts that are intended to reduce the risk of skin breakdown in diabetics with pre-existing foot disease(s). Therapeutic shoes and inserts are covered under the therapeutic shoes for individuals with diabetes benefit (Social Security Act §1861(s) (12)). Therapeutic shoes and inserts are covered, by Medicare Part B, if qualifying criteria and conditions are met. In 2018, the CERT Medicare Fee-for-Service Improper payment report noted an improper payment rate of 73.2% for this service.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian will complete medical record review on claims in accordance with applicable statutory, regulatory and sub-regulatory guidance.

Claim Sample Detail

HCPCS
  • A5500: For the 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
  • 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 or 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 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

Access related project details below.

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR to obtain the necessary documentation to perform the review. Documentation requested has been made specific to assist the provider in collecting and submitting pertinent information to decrease provider burden. Additionally, the specific requirements will aid in clarity on scope of review to allow the MAC redeterminations team to process the request accordingly and prevent overturning of correct decisions.

  1. Written verbal/dispensing order (if applicable)
  2. Detailed written order
  3. All pertinent medical record documentation to support therapeutic shoes are reasonable and necessary for persons with diabetes, including but not limited to:
    1. A diagnosis of diabetes
    2. Documentation to support the beneficiary has one or more of the following diabetic conditions:
      1. Previous amputation of the other foot, or part of either foot
      2. A history of pre-ulcerative calluses of either foot
      3. Peripheral neuropathy with evidence of callus formation of either foot
      4. A history of previous ulceration of either foot
      5. Foot deformity of either foot
      6. Poor circulation in either foot
    3. A signed physician certification statement to support the beneficiary needs therapeutic shoes/inserts under a comprehensive plan of care related to their diabetic condition
    4. Documentation to support the shoes are fitted and furnished by a podiatrist or other qualified individual (such as a pedorthist or orthotist)
      1. Documentation of an examination of the beneficiary’s feet to include description of the abnormalities that will be accommodated by the shoes and/or inserts
      2. Measurements of the beneficiary’s feet
      3. Documentation of an evaluation, at time of delivery, to include an assessment with the beneficiary wearing the shoes and/or inserts and documentation to support the shoes and/or inserts fit properly
  4. Advanced Beneficiary Notice (if applicable)
  5. Any and all other documentation to support the item(s) billed

References/Resources

  • Social Security Act (SSA), Title XVIII, §§1833(e). Payment of Benefits
  • SSA, Title XVIII, §§1833(o). Payment of Benefits
  • SSA, Title XVIII, §§1834(j)(2)(B). Special Payment Rules for Particular Items and Services
  • SSA, Title XVIII, §§1834(j)(5)(iii). Special Payment Rules for Particular Items and Services
  • SSA, Title XVIII, §§1861(s)(12). Miscellaneous Provisions
  • SSA, Title XVIII, §§1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer
  • SSA, Title XVIII, §§1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • 42 Code of Federal Regulations (C.F.R.) §424.5(a)(6). Basic Conditions
  • CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Sections 140. Covered Medical and Other Health Services
  • CMS IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, Section 20. Services Not Reasonable and Necessary
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3.8. No Response or Insufficient Response to Additional Documentation Requests
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. Reasonable and Necessary Criteria
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.2. Rules Concerning Orders
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.7. Documentation in the Patient’s Medical Record
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.8. Supplier Documentation
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9. Evidence of Medical Necessity
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in LCDs
  • Medicare General Information, Eligibility and Entitlement Manual, Publication 100-01, Chapter 1, Section 10.3. Supplementary Medical Insurance (Part B) – A Brief Description
  • Local Coverage Determination (LCD) L33369. Therapeutic Shoes for Persons with Diabetes. Effective October 1, 2015-present.
  • Local Coverage Article A52501. Therapeutic Shoes for Persons with Diabetes. Effective October 1, 2015-present
  • Local Coverage Article A55426. Standard Documentation Requirements for All Claims Submitted to DME MACs. Effective January 1, 2017-present

Last Updated Apr 16, 2020