Noridian Healthcare Solutions, LLC (Noridian), as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted 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. Below are the review results:

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.

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.

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 performed 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 conducted medical record reviews in accordance with applicable waivers, flexibilities, statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• Medical Necessity:
  • Refer to Social Security Act 1862, Internet Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. “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.” Documentation submitted did not support reasonable and necessary criteria was met. The documentation did not include evidence of failure of an adequate course of standard wound therapy and the wound was due to diabetes with a classification of Wagner grade III or higher.
• Requested Records Not Received
  • Refer to Internet-only Manual Pub 100-08, Chapter 3, Section 3.2.3.8, 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). The PIM 100-08, Chapter 3, Section 3.2.3.8 requires providers/suppliers to respond to requests for documentation within 45 calendar days of the additional documentation request for the dates of service under review. The documentation was not submitted or not submitted timely.
• Incomplete and/or Insufficient Documentation:
  • Refer to 42 CFR 424.5(a)(6), Social Security Act 1862(a)(1)(A), Social Security Act 1833(e). The documentation was insufficient to support that the beneficiary had failed to respond to standard wound care or the beneficiary had a diabetic wound classified Wagner grade III or higher, prior to HBO. The documentation was insufficient to support measurable signs of improvement of the diabetic wound after 30 days of Hyperbaric Oxygen (HBO) therapy.

References/Resources

Title XVIII of the Social Security Act (SSA)

• § 1833(e). Payment of Benefits
• § 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

• Ch. 1, § 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, § 3.3.2.4. Signature Requirements

• Ch. 3, § 3.6.2.2. Reasonable and Necessary Criteria

• Ch. 13, § 13.5.4. Reasonable and Necessary Provisions in an LCD

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 Dec 28, 2023