01-020 Outpatient Hyperbaric Oxygen Therapy (HBO) Notification of Medical Review

 Noridian Healthcare Solutions, LLC, as the Supplemental Medical Review Contractor (SMRC) for the CMS, is conducting post-payment review of claims for Medicare Part B of A, Hyperbaric Oxygen (HBO) Therapy billed on dates of service from January 1, 2018, through December 31, 2018. 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

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 will complete medical record review on claims in accordance with applicable statutory, regulatory and sub-regulatory guidance.

Claim Sample Detail

HCPCS
  • G0277: Hyperbaric oxygen under pressure, full body chamber, per 30-minute interval

Access related project details below.

Documentation Requirements

Below is a list of specific documentation requirements that will be included in each ADR letter, to obtain the necessary documentation to perform the medical record review. Documentation requested has been made specific to assist the supplier in collecting and submitting pertinent information thereby reducing provider burden. Additionally, the specific requirements will aid in clarity on scope of review to allow the MAC redeterminations teams to process the request accordingly and prevent overturning of correct decisions.

  1. History and physical, at a minimum should include prior medical and/or surgical interventions and previous HBO treatments
  2. Physician or Non-Physician Practitioner (NPP) order for date of service
  3. Diagnosis related to the provision of HBO therapy and all related services to include onset date of diagnosis
  4. Initial evaluation and re-evaluations
  5. Progress/attendance records for each visit billed
    1. Description of physical findings
    2. Types of treatment(s) provided
    3. Number of treatment(s) provided
    4. Effect of treatment received
    5. Assessment of any progress made
    6. Treatment time to support units billed
  6. Documentation of the procedure (logs) including ascent time, descent time and pressurization level. There should be a treatment plan identifying timeline and treatment goals.
  7. All pertinent radiology and laboratory reports per HBO National Coverage Determinations (NCDs)/Local Coverage Determinations (LCDs) (if applicable)
  8. Evidence the wound has been evaluated at least every 30 days for signs of significant improvement
  9. For diabetic wounds, evidence that previous standard treatments failed after a minimum treatment time of 30 days and evidence the wound meets the Wagner grade III criteria
  10. For necrotizing fasciitis, laboratory reports that confirm the diagnosis are required and must be present as support for payment of HBO
  11. For osteomyelitis, x-ray findings and bone cultures confirming the diagnosis are required and must be present as support for payment of HBO
  12. For gas gangrene, x-ray findings and laboratory reports to support presence of condition
  13. For radionecrosis, documentation of date and anatomical site of prior radiation treatments
  14. For skin grafts, documentation supporting date of skin graft and compromised stat of graft site
  15. Any and all other documentation as required per HBO NCD/LCD (if applicable)
  16. Full detailed itemization of services, including revenue codes
  17. Legible handwritten physician and/or clinician signatures
    1. Signature logs and Signature Attestation Statement should be submitted when physician and/or clinician signatures are illegible
  18. Valid electronic physician and/or clinician signatures
    1. If an electronic health record is used, the Electronic Order Signature Process Form should be submitted to verify provider’s Electronic Ordering System is secure
  19. Advance Beneficiary Notice of Noncoverage (ABN), if applicable

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 Internet Only Manual (IOM), Publication 100-02, Medicare Benefit Policy Manual, Chapter 6, Section 20. Outpatient Hospital Services
  • 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 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-present
  • LCD L36504. Hyperbaric Oxygen (HBO) Therapy. Effective April 11, 2016-present

Last Updated Jul 25, 2019