Medicare’s National Coverage Determination (NCD) 20.29 lists the clinical conditions for which Hyperbaric Oxygen Therapy (HBOT) is covered by Medicare. The list of conditions for which HBOT is covered includes “diabetic wounds of the lower extremities” (also referred to as Wagner Grade 3 diabetic foot ulcers) if, among other requirements, there is documentation of at least 30 days of standard therapy without measurable signs of healing prior to initiating HBOT.
Regional Medicare Administrative Contractors (MACs) may issue supplemental guidance and impose documentation requirements that go beyond the provisions outlined in a National Coverage Determination (NCD). Noridian Healthcare Solutions posted an instructional video on Hyperbaric Oxygen Therapy which defines a Wagner Grade 3 Diabetic Foot Ulcer (DFU) as: “A lesion that has penetrated deeper than Grade 2, and there is an abscess, osteomyelitis, pyarthrosis, plantar space abscess, or infection of the tendon and the tendon sheath.”
Thus, a Wagner Grade 3 DFU as defined by Noridian, requires medical and often surgical intervention as part of the standard of care to properly manage complications such as abscess, pyarthrosis, tendon infection or osteomyelitis. Specifically:
- Abscess: Standard treatment is incision and drainage with appropriate antibiotic therapy. Incision and drainage is a surgical procedure with a 10-day global period.
- Pyarthrosis (Septic Joint): Standard care requires urgent joint drainage and antibiotic therapy. Arthrotomy procedures commonly carry a 90-day global period.
- Infection of Tendon or Tendon Sheath: Standard treatment includes incision, drainage, and frequently synovectomy, typically accompanied by antibiotics. These procedures generally carry a 90-day global period.
- Osteomyelitis:
- Non-surgical management with prolonged antibiotic therapy may be appropriate in selected patients without exposed bone, undrained abscess, or significant peripheral vascular disease.
- Surgical management may include debridement, partial bone excision, or amputation, often followed by approximately six weeks of antibiotic therapy. Surgical procedures commonly carry a 90-day global period.
The above interventions are not elective; they are medically necessary components of evidence-based treatment for infected diabetic foot ulcers. Furthermore, they are frequently prerequisites to fulfilling the 30-day “standard wound therapy” requirement under NCD 20.29. So far, so good.\
However, in 2024, Noridian published Hyperbaric Oxygen (HBO) Therapy Services Documentation Requirements, which specifies that, “[The Hyperbaric Oxygen] NCD does not cover surgical or injuries complicated by diabetes.”
Here’s the problem: If the statement that “NCD does not cover surgical or injuries complicated by diabetes” is interpreted to mean that complications of diabetes requiring surgical intervention are excluded from HBOT coverage, we have a serious conundrum. Such an interpretation is in direct conflict with:
- The clinical definition of Wagner Grade 3 DFU by Noridian
- The 30-day standard therapy prerequisite of NCD 20.29.
- Established standards of care endorsed by organizations such as the Infectious Diseases Society of America and the International Working Group on the Diabetic Foot.
Nearly all Wagner Grade 3 DFUs require procedural intervention to manage the pathology that defines them as Wagner 3 lesions in the first place! To exclude cases in which required surgery has been performed would effectively eliminate HBOT coverage for the very population of diabetic ulcers expressly identified by the NCD as eligible when standard therapy fails.
Under Medicare law [SSA §1862(a)(1)(A)], an LCD may not restrict coverage for items or services that are explicitly covered under an NCD. NCD 20.29 does not state that “surgical procedures or injuries complicated by diabetes” are excluded from coverage of HBOT. Instead, the NCD focuses on:
- The presence of a diabetic lower extremity wound classified as Wagner Grade 3 or higher;
- Failure of 30 days of standard wound therapy;
- Ongoing measurable improvement during HBOT.
The NCD certainly does not prohibit HBOT in cases where surgical intervention has occurred as part of standard wound management of diabetic wounds of the lower extremity.
However, the current phrasing in Noridian’s documentation guidance introduces ambiguity and may be interpreted inconsistently with the language and intent of NCD 20.29. Hyperbaric practitioners have notified the Undersea and Hyperbaric Medical Society (UHMS) that Medicare auditors have denied HBOT charges for Wagner 3 DFUs that underwent appropriate surgical management. Without clarification, this overly broad and inaccurate interpretation risks:
- Improper denials of medically necessary therapy;
- Increased documentation burden without a clear statutory basis;
- Delays in care for patients with advanced diabetic foot infections.
Formal clarification of the Noridian language is needed to ensure that medically necessary surgical interventions, performed as part of standard wound therapy, are not interpreted by auditors as a reason to disqualify from coverage otherwise eligible beneficiaries under NCD 20.29
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
