01-307 Orthopedic Footwear Notification of Medical Review

Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare DME billed on dates of service from January 1, 2019, through December 31, 2019. Below are the review results:

Project ID Project Title Error Rate
01-307 Orthopedic Footwear 69%


In 2019, the CERT Medicare Fee-for-Service Improper payment report noted an improper payment rate of 84.7% for this service category. This service type was listed in the top 20 service type improper payment rates for DMEPOS.

Orthopedic footwear is covered under the “leg, arm, back, and neck braces, and artificial legs, arms and eyes” benefit (Social Security Act §1861(s)(9)). Coverage is provided when coverage, coding, and documentation requirements are met.

Reason for Review

The SMRC was tasked with performing claim review on a sample of Orthopedic Footwear claims from January 1, 2019, through December 31, 2019. The SMRC conducted medical record reviews in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

  • No Response to the Documentation Request
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section B/C, requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request. The documentation was not submitted or not submitted timely.
  • Medical Necessity of the Item Billed
    • Refer to applicable Local Coverage Determinations L33641 and L33686 and Local Coverage Articles A52481, A52457 (these include JB, JC, JA, JD), A55426 (all DME MACs). The supply or accessory is denied as the base equipment is denied. Documentation did not support that the billed item was used for the covered base item (brace and/or shoe).
  • Supplier Documentation Requirements
  • The treating practitioner’s order, Certificate of Medical Necessity, supplier prepared statement, or the practitioner’s attestation, by itself, does not provide sufficient documentation of medical necessity. Refer to Medicare Program Integrity Manual 100-08, Chapter 5, Section 5.9.  There must be information in the patient’s medical record supporting the medical necessity for the item, and substantiates the answers on the CMN (if applicable), or DIF (if applicable), or information on a supplier prepared statement or physician attestation (if applicable).


Social Security Act (SSA) Title XVIII

  • § 1815(a) Payment to Providers of Services
  • § 1833(e) Payment of Benefits
  • §§ 1834(2) (A-B), (3), (5) (A-C) (F)(III), (h), (20)(G)(II) Special Payment Rules for Particular Items and Services
  • §§ 1861(n), (s)(6)(9) Miscellaneous Provisions
  • §§ 1862(a)(1)(A), (8) Exclusions from Coverage and Medicare as Secondary Payer
  • §§ 1879(a)(1), (2), (h) (1-3) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
  • §§ 1893(f)(7)(A)(B) (i-iv), (h)(4)(B) Medicare Integrity Program

Code of Federal Regulations (CFR) Title 42

  • 410.3 Scope of benefits
  • 410.36 Medical supplies, appliances, and devices: Scope and conditions
  • 410.38(g)(2) Durable Medical Equipment: Scope and Conditions
  • 411.15(f), (k)(1) Particular services excluded from coverage
  • 411.404 Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary
  • 411.406 Criteria for determining that a provider, practitioner, or supplier knew that services were excluded from coverage as custodial care or as not reasonable and necessary
  • 411.408 Refunds of amounts collected for physician services not reasonable and necessary, payment not accepted on an assignment-related basis
  • 414.200 Payment for Durable Medical Equipment and Prosthetic and Orthotic Device
  • 424.5(a) (4-6), (b) Basic Conditions
  • 424.57(c)(12) Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges
  • 424.516 Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program
  • 424.535 Revocation of enrollment in the Medicare program
  • 424.57(c)(12) Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges

Internet Only Manual (IOM), Medicare National Coverage Determinations (NCD) Manual (MBPM), Pub. 100-03

  • Chapter (Ch.) 1, § 280.1 Durable Medical Equipment Reference List
  • Ch. 1, § 280.10 Prosthetic Shoe

Internet Only Manual (IOM), Medicare General Information, Eligibility and Entitlement Manual (MGIEEM), Pub. 100-01

  • Ch. 1, § 10.3 Supplementary Medical Insurance (Part B) – A Brief Description

Internet Only Manual (IOM), Medicare Benefit Policy Manual (MBPM), Pub. 100-02

  • Ch. 15, § 110 Durable Medical Equipment – General
  • Ch. 15, § 130 Leg, Arm, Back, and Neck Braces, Trusses, and Artificial Legs, Arms, and Eyes
  • Ch. 15, § 140 Therapeutic Shoes for Individuals with Diabetes
  • Ch. 15, § 290 Foot Care
  • Ch. 16, § 20 Services Not Reasonable and Necessary

Internet Only Manual (IOM), Medicare Claims Processing Manual (MCPM), Pub. 100-04

  • Ch. 20, § 30.3 Certain Customized Items
  • Ch. 20, § 30.4 Other Prosthetic and Orthotic Devices
  • Ch. 20, § 30.9 Payment of DMEPOS Items Based on Modifiers
  • Ch. 20, § 40.1 General
  • Ch. 20, § 100 General Documentation Requirements
  • Ch. 30, § 50 Advance Beneficiary Notice of Noncoverage (ABN)

Internet Only Manual (IOM), Medicare Program Integrity Manual (MPIM), Pub. 100-08

  • Ch. 3, § 3, § Additional Documentation Request Required and Optional Elements
  • Ch. 3, § No Response or Insufficient Response to Additional Documentation Requests
  • Ch. 3, § Documents on Which to Base a Determination  
  • Ch. 3, § Signature Requirements
  • Ch. 3, § 3.6 Determinations Made During Medical Review
  • Ch. 4, § Supplier Proof of Delivery Documentation Requirements
  • Ch. 4, § Proof of Delivery and Delivery Methods
  • Ch. 4, § Exceptions
  • Ch. 4, § Proof of Delivery Requirements for Recently Eligible Medicare FFS Beneficiaries
  • Ch. 5, § 5.2 Rules Concerning DMEPOS
  • Ch. 5, § 5.7 Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs
  • Ch. 5, § 5.9 Documentation in the Patient’s Medical Record
  • Ch. 5, § 5.10 Supplier Documentation
  • Ch. 5, § 5.11 Evidence of Medical Necessity
  • Ch. 13, § 13.5.4 Reasonable and Necessary Provisions in LCDs

Related Local Coverage Determinations (LCDs)

  • L33641 Orthopedic Footwear
  • L33686 Ankle-Foot/Knee-Ankle-Foot Orthosis

Related Local Coverage Articles (LCAs)

  • A52457 Article for Ankle-Foot/Knee-Ankle-Foot Orthoses
  • A52481 Orthopedic Footwear
  • A55426 Standard Documentation Requirements for All Claims Submitted to DME MACs

Last Updated Sep 27, 2022