Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Part B therapeutic shoes for diabetics billed on dates of service from July 1, 2017 through June 30, 2019. Below are the review results:

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 completed medical record review on claims in accordance with applicable statutory, regulatory and sub-regulatory guidance.

Common Reasons for Denial

• Incomplete/insufficient Documentation
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9.
    For any DMEPOS item to be covered by Medicare, the patient’s medical record must contain sufficient documentation of the patient’s medical condition to substantiate the necessity for the type and quantity of items ordered and for the frequency of use or replacement (if applicable). Neither a physician’s order nor a CMN nor a supplier prepared statement nor a physician attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician or supplier. There must be information in the patient’s medical record that supports the medical necessity for the item and substantiates the answers on the CMN (if applicable) or information on a supplier prepared statement or physician attestation (if applicable).
• Supplier Documentation Requirements
  • CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.10.
    The supplier should obtain as much documentation from the patient’s medical record as they determine they need to assure themselves that coverage criteria for an item have been met. If the information in the patient’s medical record does not adequately support the medical necessity for the item, the supplier is liable for the dollar amount involved unless a properly executed ABN of possible denial has been obtained. The submitted documentation did not include medical records, from the prescribing physician, to support coverage criteria.
• Non-Response to ADR
  • Medicare Program Integrity manual 100-08, Chapter 3, Section 3.2.3.8 required providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request for the dates of service under review .

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 DMEPOS Orders Prescriptions
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.9. Documentation in the Patient’s Medical Record
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.10. Supplier Documentation
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 5, Section 5.11. 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 Nov 17, 2021