Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, has conducted post-payment review of claims for Medicare Hyperbaric Oxygen (HBO) Therapy billed on dates of service from January 1, 2018 through December 31, 2018. Below are the review results:

Background

Over the years, HBO therapy services formed the basis of several Office of Inspector General (OIG) reports. Findings from these OIG reports note that Medicare beneficiaries received treatments for noncovered conditions, medical documentation did not adequately support treatments, and that Medicare beneficiaries received more treatments than were considered medically necessary. Recent OIG findings in two 2018 reports (A-01-15-00515 and A-04-16-06196) noted that documentation frequently did not support medical necessity of the services.

Reason for Review

CMS tasked Noridian, as the SMRC, to perform data analysis and conduct medical review. Noridian completed medical record review on claims in accordance with applicable statutory, regulatory, and sub-regulatory guidance.

Common Reasons for Denial

• No Response to the Documentation Request
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, 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. The documentation was not submitted or not submitted timely.
• Insufficient Documentation
  • CMS Internet-Only Manuals, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2 outlines a service is to be considered reasonable and necessary when it is furnished in accordance with accepted standards of medical practice. In addition, Local Coverage Determinations (LCDs) L3521, Hyperbaric Oxygen (HBO) Therapy, and L36504, Hyperbaric Oxygen (HBO) Therapy, indicate that documentation must include, “Documentation of the procedure (logs) including ascent time, descent time and pressurization level.” Documentation of the procedure was not submitted or missing one or more required elements.
• Standard Wound Therapy
  • Medicare National Coverage Determinations (NCD) Manual, Pub. No. 100-03, Chapter 1, Section 20.29 states “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.” The documentation did not support the beneficiary failed an adequate course of standard wound therapy.

References/Resources

• Social Security Act (SSA), Title XVIII, §§1833(e). Payment of Benefits
• SSA, Title XVIII, §§1862(a)(1)(A). Exclusions from Coverage and Medicare As Secondary Payer
• SSA, Title XVIII, §§1862(a)(1)(D). Exclusions from Coverage and Medicare as Secondary Payer
• SSA, Title XVIII, §§1862(a)(7). Exclusions from Coverage and Medicare as Secondary Payer
• SSA, Title XVIII, §§1862(a)(13)(C). Exclusions from Coverage and Medicare as Secondary Payer
• SSA, Title XVIII, §§1869(f)(1)(B). Determinations; Appeals
• SSA, Title XVIII, §§1879 (a)(1). Limitation on Liability of Beneficiary Where Medicare Claims are Disallowed
• 21 C.F.R. §868.5470(a). Hyperbaric Chamber
• 42 C.F.R. §424.5(a)(6). Basic Conditions
• CMS IOM, Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 20.29. Hyperbaric Oxygen Therapy. Effective April 3, 2017-present
• CMS Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20. Outpatient Hospital Services
• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, Section 20.9. National Correct Coding Initiative [NCCI]
• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 30, Section 50. Form CMS-R-131 Advance Beneficiary Notice of Noncoverage (ABN)
• CMS IOM, Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 30.0. Hyperbaric Oxygen (HBO) Therapy
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.3.2.4. Signature Requirements
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.6.2.2. Reasonable and Necessary Criteria
• CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4. Reasonable and Necessary Provisions in an 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

Last Updated Jun 9, 2021