01-144 Hyperbaric Oxygen (HBO) for Lower Extremities (LE) Diabetic Wounds Part 2Findings of Medical Review
Noridian Healthcare Solutions, LLC, (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid (CMS), has conducted post-payment review of claims for Medicare Hyperbaric oxygen therapy (HBO) for the treatment of diabetic wounds on the lower extremity (LE) with dates of service January 1, 2023, through December 31, 2024. Below are the review results:
| Project ID | Project Title | Error Rate | No Response to ADR Denials |
|---|---|---|---|
| 01-144 | Hyperbaric Oxygen (HBO) for Lower Extremities (LE) Diabetic Wounds Part 2 | 20% | 28% |
Background
Hyperbaric oxygen (HBO) therapy is a modality in which the entire body is exposed to oxygen under increased atmospheric pressure as referenced within the National Coverage Determination (NCD) 20.29 Hyperbaric Oxygen Therapy. Medicare covers HBO therapy for beneficiaries with specific conditions outlined within the NCD as an adjunctive to ongoing standard therapy, showing no measurable signs of healing for at least 30 days of treatment with standard wound therapy. The NCD 20.29, also outlines provisions of standard therapy and evaluation for the diagnosis of diabetic wounds of the lower extremity.
For beneficiaries with diabetic wounds on the lower extremities, HBO therapy may be covered when the following criteria are met:
- The beneficiary has type I or type II diabetes and the wound is a result of diabetes; and
- the wound is classified as a Wagner grade III or higher; and
- the beneficiary has failed an adequate course of standard wound therapy.
The SMRC did complete data analysis and medical record reviews in November 2023, on claims billed for HBO therapy for the treatment of diabetic wounds in the lower extremities and identified an overall claim error rate of 92%.
Reason for Review
The SMRC was tasked to perform data analysis and conduct medical record reviews on claims billed for HBO therapy for the treatment for diabetic wounds on the LE with dates of service January 1, 2023, through December 31, 2024.
The SMRC conducted medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.
Common Reasons for Denial
- Non-Response to the Additional Documentation Request (ADR)
- Refer to Social Security Act (SSA) Title XVIII, Section (§§) 1815(a), 1833(e), & 1862(a)(1)(A). No documentation was received in response to the ADR letter.
- Documentation did not Support the Number of Units Billed
- Refer to Internet-Only Manual (IOM), 100-08, Medicare Program Integrity Manual (MPIM) Chapter (Ch.) 3, §§3.6.2.4 and 3.6.2.5, Medicare Claims Processing Manual (MCPM) Ch. 23. The documentation submitted did not support the number of units billed on the claim. Claims were correct coded to reflect units supported within the medical records.
- Documentation did not support Off-Loading Measures
- Refer to SSA 1833e; National Coverage Determination (NCD) 20.29. The documentation submitted did not support any off-loading measures were utilized with standard wound care for patients with diabetic wounds.
ReferencesSocial Security Act (SSA), Title XI
Section (§)1135 Authority to Waive Requirements During National Emergencies (if applicable)
Social Security Act (SSA), Title XVIII
- §1833(e) Payment of Benefits
- §1862(a)(1)(A) Exclusion from Coverage and Medicare as a Secondary Payer
- §1869(f)(1)(B) Determinations; Appeals
- §1879 (a)(1) Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
Title 42 Code of Federal Regulations (CFR)
- §411.15(k)(1) Services excluded from coverage
- §424.5(a)(6) Basic Conditions
Internet-Only Manual (IOM), Medicare National Coverage Determinations (NCD) Manual, Publication (Pub.) 100-03
Chapter (Ch.) 1, §20.29 Hyperbaric Oxygen Therapy
IOM, Medicare Benefit Policy Manual (MBPM), Pub. 100-02
Ch. 16 §20 General Exclusions from Coverage
IOM, Medicare Claims Processing Manual (MCPM), Pub. 100-04
- Ch. 23, §20.9 National Correct Coding Initiative [NCCI]
- Ch. 30, §50 Advance Beneficiary Notice of Noncoverage (ABN)
- Ch. 32, §30 Hyperbaric Oxygen (HBO) Therapy
IOM, Medicare Program Integrity Manual (MPIM), Pub. 100-08
- Ch. 3, §3.3.2.4 Signature Requirements
- Ch. 3, §3.6.2.2 Reasonable and Necessary Criteria
Other
- National Correct Coding Initiative Edits (NCCI). NCCI Policy Manual for Medicare Services. Effective January 1, 2023-December 31, 2024
Last Updated Apr 9, 2026