01-306 Ostomy Supplies Findings of Medical Review

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

Project ID Project Title Error Rate
01-306 Ostomy Supplies 68%


For any item to be covered by Medicare, it must be eligible for a defined Medicare benefit category, be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member and meet all other applicable Medicare statutory and regulatory requirements. The quantity of ostomy supplies needed by a beneficiary is determined primarily by the type of ostomy, its location, its construction, and the condition of the skin surface surrounding the stoma. There will be variation according to individual beneficiary need and their needs may vary over time. The actual quantity needed for a particular beneficiary may vary depending on the factors that affect the frequency of barrier and pouch change.

Reason for Review

The SMRC was tasked with performing claim review on a sample of ostomy supply 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
    • No documentation was received in response to the additional documentation request (ADR) letter. Refer to Social Security Act (SSA) Title XVIII, Section 1815(a), 1833(e), & 1862(a)(1)(A).
  • Medical Necessity
    • The medical record documentation contains an error not otherwise specified. The medical record documentation did not support medical necessity. Refer to Social Security Act (SSA) Title XVIII, Section 1862(a)(1)(A), no payment may be made under part A or part B for any expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.
    • For a beneficiary’s item(s) to be eligible for reimbursement, all benefit requirements, and the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met.
  • Medical Records Missing to Support Medical Necessity
    • 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.


Social Security Act (SSA) Title XVIII

  • § 1815(a). Payment to Providers of Services.
  • § 1833(e). Payment of Benefits.
  • §1834(j)(2)(B), (3), (5)(F)(iii). Requirements for Suppliers of Medical Equipment and Supplies.
  • § 1861(s)(6). Part E – Miscellaneous Provisions.
  • § 1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer.
  • § 1879(a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed.

Code of Federal Regulations (CFR) Title 42

  • 410.38. Durable Medical Equipment: Scope and Conditions.
  • 414.200. Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices.
  • 424.5(a)(6). Basic Conditions.
  • 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.

IOM Medicare Benefit Policy Manual (MBPM) Publication 100-02

  • Chapter (Ch.) 15, § 110. Durable Medical Equipment – General.

IOM, Medicare Claims Processing Manual (MCPM) Publication 100-04

  • Ch. 20, § 10.2. Coverage Table for DME Claims.
  • Ch. 20, § 100. General Documentation Requirements.
  • Ch. 30, § 50. Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN).

IOM, Medicare Program Integrity Manual (MPIM) Publication 100-08

  • Ch. 3, § Time Frames for Submission.
  • Ch. 3, § No Response or Insufficient Response to Additional Documentation Requests.
  • Ch. 3, § Signature Requirements.
  • Ch. 3, § Amendments, Corrections and Delayed Entries in Medical Documentation.
  • Ch. 4, § 4.26. Supplier Proof of Delivery Documentation Requirements.
  • Ch. 4, § 4.26.1. Proof of Delivery and Delivery Methods.
  • Ch. 5, § 5.2.4. Timing of the Order/Prescription.
  • Ch. 5, § 5.2.5. When a New Order/Prescription is Required.
  • Ch. 5, § 5.2.6. Refills of DMEPOS Items Provided on a Recurring Basis.
  • Ch. 5, § 5.7. Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs.
  • Ch. 5, § 5.8. Physician Assistant Rules Concerning Orders and CMNs.
  • Ch. 5, § 5.9. Documentation in the Patient’s Medical Record.
  • Ch. 5, § 5.11. Evidence of Medical Necessity.
  • Ch. 13, Section 13.5.4. Reasonable and Necessary Provisions in LCDs.

Local Coverage Determinations (LCD)

  • L33828 Ostomy Supplies. Effective October 1, 2015.

Local Coverage Articles (LCA)

  • A52487, Ostomy Supplies. Effective October 1, 2015.
  • A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs. Effective January 1, 2017.


Last Updated Oct 31, 2022