Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare Part B Hyperbaric Oxygen Therapy of Lower Extremities Diabetic Wounds billed for dates of service January 1, 2020, through June 30, 2022. 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. HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 days of treatment with standard wound therapy and must be used in addition to standard wound care.

Recent Office of Inspector General (OIG) findings in two 2018 reports (A-01-15-00515 and A-04-16-06196), noted that documentation frequently did not support HBO services were medically necessary in accordance with Medicare requirements.

The SMRC previously completed a data analysis and medical review project on outpatient HBO therapy claims. A potential vulnerability was identified for claims billed for the treatment of diabetic wounds of the lower extremities.

Reason for Review

Centers for Medicare & Medicaid Services (CMS) tasked Noridian, as the SMRC, to perform data analysis and conduct medical record review on hyperbaric oxygen therapy services. The SMRC will perform medical record review on supporting documentation, to determine if claims for HBO for the treatment of diabetic wounds of the lower extremities were reasonable and necessary. 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/Resources

Documentation Requirements

Listed below are the specific documentation requirements that will be included in each ADR, to obtain the necessary documentation to perform the review. The documentation requested has been made specific to assist the provider in collecting and submitting pertinent information, decreasing provider burden.

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

1. Documentation to support a systemic condition, neuropathy, vascular impairment
2. Physician medical documentation detailing 30-day prior course of treatment, including all interventions and/or evaluations
3. Documentation to support that the entire body was exposed to the oxygen increased atmospheric pressure and administered in a chamber.
4. Wound care assessment and supporting documentation.
5. 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. Respiratory treatments and oxygen therapy records).
6. Wound care notes.
7. Diabetic lower extremity wounds-Wagner grade classification, diagnostic testing to support Wagner grade and documentation of prior failed treatment.
8. Initial Hyperbaric Oxygen Therapy (HBOT) evaluation/consultation.
9. Documentation to support National Coverage Determination (NCD), Local Coverage Determination (LCD) and/or Policy Article.
10. Signature log or signature attestation for any missing or illegible signatures within the medical record (all personnel providing services).
11. Advance Beneficiary Notice of Non-Coverage (ABN)/Notice of Medicare Non-Coverage (NOMNC).
12. Any other supporting documentation.
13. 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.
14. PLEASE NOTE: It is the responsibility of the supplier or provider to obtain all documentation from the ordering/referring provider to ensure medical necessity criteria have been met.

References/Resources

Title XVIII of the Social Security Act (SSA)

• § 1833(e). Payment of Benefits.
• § 1842(p)(4). Provisions Related to the Administration of Part B
• § 1862(a)(1)(A). Exclusions from Coverage and Medicare as Secondary Payer.
• § 1862(a)(1)(D). Exclusions from Coverage and Medicare as Secondary Payer.
• § 1862(a)(7). Exclusions from Coverage and Medicare as Secondary Payer.
• § 1862(a)(13)(C). Exclusions from Coverage and Medicare as Secondary Payer.
• § 1869(f)(1)(B). Determinations; Appeals.
• § 1879 (a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed.

Title 21 of the Code of Federal Regulations (CFR)

• § 868.5470(a). Hyperbaric Chamber.

Title 42 CFR

• § 424.5(a)(6) Basic Conditions.

Medicare National Coverage Determinations (NCD) Manual, Publication 100-03

• Ch1, § 20.29. Hyperbaric Oxygen Therapy. Effective April 3, 2017-present.

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

• Ch. 23, § 20.9. National Correct Coding Initiative [NCCI].
• Ch. 30, § 50. Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN).
• Ch. 32, § 30. Hyperbaric Oxygen (HBO) Therapy.

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

• Ch. 3, § 3.6.2.2. Reasonable and Necessary Criteria.
• Ch. 3, § 3.3.2.4. Signature Requirements.
• Ch. 13, § 13.5.4. Reasonable and Necessary Provisions in an LCD.
• Ch. 3, § 3.2.3.8. No Response or Insufficient Response to Additional Documentation Request

Local Coverage Determination (LCD)

• LCD L35021. Hyperbaric Oxygen (HBO) Therapy. Effective October 1, 2015-August 27, 2020.
• LCD L36504. Hyperbaric Oxygen (HBO) Therapy. Effective April 11, 2016- August 27, 2020.

Local Coverage Article (LCA)

• A57800. Billing and Coding: Hyperbaric Oxygen (HBO) Therapy. Effective October 03, 2018 – August 27, 2020
• A56714. Billing and Coding: Hyperbaric Oxygen (HBO) Therapy. Effective July 7, 2019 – August 27, 2020
• A55788. Response to Comments: Hyperbaric Oxygen (HBO) Therapy. Effective April 11, 2016- August 27, 2020

Last Updated Jan 19, 2023