01-306 Ostomy Supplies Notification of Medical Review

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


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 is tasked with performing claim review on a sample of ostomy supply claims from January 1, 2019 through December 31, 2019. The SMRC will conduct medical record reviews in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

All Ostomy Supply HCPCS as found in L33828 Ostomy Supplies

A4361, A4362, A4364, A4367, A4369, A4371, A4377, A4397, A4398, A4399, A4402, A4404, A4405, A4406, A4414, A4415, A4416, A4417, A4418, A4419, A4420, A4423, A4424, A4425, A4426, A4427, A4429, A4431, A4432, A4433, A4434, A4450, A4452, A4455, A5051, A5052, A5053, A5054, A5055, A5056, A5057, A5061, A5062, A5063, A5071, A5072, A5073, A5081, A5082, A5083, A5093, A5102, A5120, A5121, A5122, A5126, A5131, A6216, A4361, A4371, A4398, A4399, A4455, A5102, A5120

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 collection and submitting pertinent information to decrease provider burden.

Providers/suppliers are requested to submit each of the Documentation Requirements outlined below, if and as applicable to the claim on review.

  1. Detailed Written Order
  2. Dispensing Order, if applicable
  3. Documentation of the request for refill
  4. Supplier’s record documentation showing the reason for item(s) being replaced
  5. DME documentation of continued need and use
  6. Beneficiary’s medical records (which may include practitioner medical records, hospital records, nursing home records, home care nursing notes, physical/occupational therapy notes) that support the item(s) provided is/are reasonable and necessary
  7. Medical record documentation that supports the specific reason the treating practitioner ordered a frequency/quantity that exceeds utilization guidelines
  8. History and Physical reports (include medical history and current list of medications)
  9. Practitioner, nurse, and ancillary progress notes
  10. Operative/procedure report
  11. Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD), Policy Article, and Standard Documentation Requirement Article (A55426) requirements
  12. Proof of delivery
  13. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services
  14. Advance Beneficiary Notice of Liability (ABN); if applicable
  15. Any other supporting documentation
  16. If medical record documentation is submitted via esMD: Beneficiary identification, date of service, and provider of the service should be clearly identified on each page of the submitted documentation
  17. PLEASE NOTE: It is the responsibility of the supplier/provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met


  • Social Security Act (SSA), Title XVIII, § 1815(a). Payment to Providers of Services.
  • SSA, Title XVIII, § 1833(e). Payment of Benefits.
  • SSA, Title XVIII, Section 1834(j)(2)(B), (3), (5)(F)(iii). Requirements for Suppliers of Medical Equipment and Supplies.
  • SSA, Title XVIII, § 1861(s)(6). Part E – 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.
  • Code of Federal Regulations (CFR) Title 42, § 410.38. Durable Medical Equipment: Scope and Conditions.
  • CFR, Title 42, Section 414.200. Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices.
  • CFR Title 42, § 424.5(a)(6). Basic Conditions.
  • CFR Title 42, § 424.535. Revocation of Enrollment in the Medicare Program.
  • CFR Title 42, § 424.57(c)(12). Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges.
  • Medicare Benefit Policy Manual (MBPM), Publication 100-02, Chapter 15, § 110. Durable Medical Equipment – General.
  • Medicare Claims Processing Manual (MCPM), Publication 100-04, Chapter 20, § 10.2. Coverage Table for DME Claims.
  • MCPM, Publication 100-04, Chapter 20, Section 100. General Documentation Requirements.
  • MCPM, Publication 100-04, Chapter 30, § 50. Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN).
  • Medicare Program Integrity Manual (MPIM), Publication 100-08, Chapter 3, § Time Frames for Submission.
  • MPIM, Publication 100-08, Chapter 3, § No Response or Insufficient Response to Additional Documentation Requests.
  • MPIM, Publication 100-08, Chapter 3, § Signature Requirements.
  • MPIM, Publication 100-08, Chapter 3, § Amendments, Corrections and Delayed Entries in Medical Documentation.
  • MPIM, Publication 100-08, Chapter 4, § 4.26. Supplier Proof of Delivery Documentation Requirements.
  • MPIM, Publication 100-08, Chapter 4, § 4.26.1. Proof of Delivery and Delivery Methods.
  • MPIM, Publication 100-08, Chapter 5, § 5.2.4. Timing of the Order/Prescription.
  • MPIM, Publication 100-08, Chapter 5, § 5.2.5. When a New Order/Prescription is Required.
  • MPIM, Publication 100-08, Chapter 5, § 5.2.6. Refills of DMEPOS Items Provided on a Recurring Basis.
  • MPIM, Publication 100-08, Chapter 5, § 5.7. Nurse Practitioner or Clinical Nurse Specialist Rules Concerning Orders and CMNs.
  • MPIM, Publication 100-08, Chapter 5, § 5.8. Physician Assistant Rules Concerning Orders and CMNs.
  • MPIM, Publication 100-08, Chapter 5, § 5.9. Documentation in the Patient’s Medical Record.
  • MPIM, Publication 100-08, Chapter 5, § 5.11. Evidence of Medical Necessity.
  • MPIM, Publication 100-08, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in LCDs.
  • Local Coverage Determination (LCD) L33828 Ostomy Supplies. Effective October 1, 2015.
  • Local Coverage Article (LCA) A52487, Ostomy Supplies. Effective October 1, 2015.
  • LCA A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs. Effective January 1, 2017.
  • Medicare Learning Network (MLN) SE20007, Standard Elements for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Order, and Master List of DMEPOS items Potentially Subject to a Face-to-Face Encounter and Written Orders Prior to Delivery and, or Prior Authorization.
  • MLN ICN MLN909480, Provider Compliance Tips for Ostomy Supplies.

Last Updated Feb 16, 2022