Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the Centers for Medicare and Medicaid Services (CMS), is conducting post-payment review of claims for 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. 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.

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:

1. The beneficiary has type I or type II diabetes and the wound is a result of diabetes; and
2. the wound is classified as a Wagner grade III or higher; and
3. 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 is 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 will conduct medical record reviews in accordance with applicable waivers/flexibilities/statutory, regulatory, and sub-regulatory guidance.

Claim Sample Detail

Access related project details below.

• Documentation Requirements
• References

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.

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

1. Medical record documentation to support the lower extremity wound is a result of diabetes
2. Medical record documentation to support a systemic condition, neuropathy, or vascular impairment
3. Initial Hyperbaric Oxygen Therapy (HBOT) evaluation/consultation
4. Physician medical record documentation detailing prior course of treatment, including all interventions and/or evaluations of the diabetic wound
5. Medical record documentation to support the entire body was exposed to increased atmospheric pressure (hyperbaric oxygen) and administered in a chamber
6. Wound care assessment, wound care notes, and supporting documentation
7. Medical record documentation that the beneficiary has failed standard wound care therapy prior to the initiation of hyperbaric oxygen therapy
8. Nursing Documentation (i.e., Nursing notes and admission assessment – Lines; Medication & IV administration records; nursing treatment sheets such as: Skin care/wound care treatment sheets)
9. Medical record documentation to support the Wagner grade classification, diagnostic testing to support Wagner grade, and documentation of prior failed treatment
10. Medical record documentation to support national requirements
11. Providers/suppliers are encouraged to review the documentation prior to submission, to ensure that signature information is available when authenticity is not conclusively documented. Please include a signature log or signature attestation for any missing or illegible signature within the medical record.
12. If an electronic health record is utilized, include your facility’s process of how the electronic signature is created. Include an example of how the electronic signature displays once signed by the physician.
13. Advance Beneficiary Notice of Non-Coverage (ABN/Notice of Medicare Non-Coverage (NOMNC)
14. Any other supporting/pertinent documentation
15. 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
16. Please Note: The supplier or provider is responsible for obtaining all documentation from the ordering/referring provider to ensure medical necessity criteria have been met.

References

Social 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

• Ch. 1, §20.29 Hyperbaric Oxygen Therapy

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

• Chapter (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 Jul 15, 2025