ModifiedPremera BluecrossPolicy 2.01.505

Hyperbaric Oxygen Therapy (HBOT) — Coverage Criteria

This policy governs medical necessity, investigational determinations, documentation, and coding for systemic and topical hyperbaric oxygen therapy for Premera Blue Cross members and applies to providers delivering HBOT.

Policy Summary

PayerPremera Bluecross

PolicyHyperbaric Oxygen Therapy (HBOT) — Coverage Criteria

Policy CodePolicy 2.01.505

Change TypeTiming updatecoding addition

Effective DateDec: 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization documenting Wagner grade and prior standard wound therapy for diabetic foot HBOT requests.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that HBOT be initiated within 24 hours of CRAO symptom onset.

Added HCPCS code E0446 for topical hyperbaric oxygen therapy.

Dec 1, 2024Effective date

Nov 11, 2024Last revised

Wagner ≥3Diabetic wound threshold

30 daysStandard wound therapy trial

20-40Typical HBOT course

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A4575, E0446Example codes

Medical Necessity and Investigational Determinations

Medically Necessary — Systemic HBOT

Systemic hyperbaric oxygen pressurization therapy may be considered medically necessary for the following conditions:

Covered indications list: Acute traumatic ischemia (e.g., crush injuries, reperfusion injury, compartment syndrome); profound anemia from exceptional blood loss when transfusion is impossible or must be delayed; carbon monoxide poisoning; central retinal artery occlusion (CRAO); compromised skin grafts or flaps; cyanide poisoning (acute); decompression sickness; gas embolism (acute); gas gangrene (clostridial myonecrosis); idiopathic sudden sensorineural hearing loss; necrotizing soft tissue infections; non-healing diabetic lower extremity wounds in individuals who meet all three criteria: (1) diagnosis of type 1 or type 2 diabetes with a lower extremity wound due to diabetes; (2) wound classified as Wagner grade III or higher; and (3) no measurable signs of healing after 30 days of an adequate course of standard wound therapy; chronic refractory osteomyelitis; pre- and post-treatment for dental surgery of an irradiated jaw (non-implant-related); soft tissue radiation necrosis (including radiation enteritis, cystitis, proctitis) and osteoradionecrosis;

Extracted verbatim list of medically necessary systemic HBOT indications from policy text.

Investigational / Not Covered

HBOT (systemic or topical) is considered investigational for all other indications, including but not limited to:

Investigational indications list: Acute peripheral arterial insufficiency; acute coronary syndromes (and adjunct to coronary interventions); acute ischemic stroke; acute osteomyelitis; acute surgical and traumatic wounds not meeting medically necessary criteria; acute thermal burns; autism spectrum disorder; Bell's palsy; bisphosphonate-related osteonecrosis of the jaw; bone grafts; brown recluse spider bites; carbon tetrachloride or hydrogen sulfide poisoning; cerebral edema; cerebral palsy; cerebrovascular disease; chronic arm lymphedema post-radiotherapy; chronic wounds other than specified diabetic wounds; delayed-onset muscle soreness; demyelinating diseases (eg, multiple sclerosis, ALS); early radiotherapy prophylaxis; fibromyalgia; fracture healing; herpes zoster; idiopathic femoral neck necrosis; inflammatory bowel disease (Crohn disease, ulcerative colitis); intra-abdominal and intracranial abscesses; lepromatous leprosy; meningitis; mental illness (PTSD, anxiety, depression); migraine; motor dysfunction after stroke; pseudomembranous colitis; pyoderma gangrenosum; radiation myelitis; radiation-induced injury in head/neck except specified medically necessary uses; refractory mycoses; retinopathy adjuncts; sickle cell crisis; spinal cord injury; traumatic brain injury; tumor sensitization for cancer treatments; and topical hyperbaric oxygen therapy in all situations (topical HBOT considered investigational).

Extracted verbatim investigational list as provided in policy.

Coverage stance by indication

Coverage and evidence summaries vary by indication; the policy provides evidence-based statements per condition.

Indications with sufficient evidence: Systemic HBOT is considered to improve net health outcome for chronic diabetic lower extremity ulcers and for certain radiation-related injuries (radionecrosis, osteoradionecrosis) based on randomized controlled trials and meta-analyses.

Summarized from policy evidence review.

Indications with insufficient or mixed evidence: For many other indications (including topical HBOT for wounds; carbon monoxide poisoning; necrotizing soft tissue infections; refractory osteomyelitis; acute thermal burns; acute surgical/traumatic wounds; various neurologic and miscellaneous conditions) the evidence is insufficient, mixed, or heterogeneous, preventing definitive coverage statements.

Summarized from policy evidence review.

Dosing and timing recommendations: UHMS-recommended pressures, session lengths, and frequencies are referenced by indication (examples in policy: diabetic lower extremity wounds commonly 2–2.5 ATA daily for typically ~30 sessions; radiation necrosis often 40–60 treatments; CRAO dosing 2–2.8 ATA with twice-daily treatments until plateau), and specific regimens vary by condition.

Medicare - Diabetic Wounds Coverage Criteria

Covered when ALL of the following Medicare criteria are met:

Medicare diabetic foot HBOT coverage: 1) Individual has type 1 or type 2 diabetes and a lower extremity wound due to diabetes; 2) wound is classified as Wagner Grade III or higher; 3) individual has failed an adequate course of standard wound therapy (no measurable signs of healing for at least 30 consecutive days).Wagner Grade III; ≥30 days of failed standard care

HBOT must be adjunctive to standard wound care; wounds must be evaluated at least every 30 days during HBOT and continued treatment is not covered without measurable healing within any 30-day treatment period.

Notable policy updates and operational criteria

Policy-level coverage stance and notable criteria changes from history

CRAO timing requirement removed: Requirement that HBOT be initiated within 24 hours of CRAO symptom onset removed.

Material change in timing requirement documented in policy history.

Topical HBOT coding added: HCPCS code E0446 was added for topical hyperbaric oxygen therapy.

Coding update recorded in policy history.

Diabetic wound utilization review recommendation: Guidance and historical notes reference a utilization review or reevaluation trigger for diabetic wounds after approximately 30 treatments (or 30 days) as an operational review point.30 treatments or 30 days

Operational review trigger noted in policy history and Medicare guidance.

The policy designates topical hyperbaric oxygen therapy (topical HBOT) as investigational in all situations. Topical HBOT (devices described under HCPCS A4575 and similar disposable topical “chamber” appliances) is addressed by this policy but is not considered a covered therapy because current evidence is insufficient to conclude an improvement in net health outcome for the range of wound types studied. Systemic HBOT indications and Medicare-based adjunctive use criteria are handled separately in the policy.

This policy explicitly does not address topical oxygen therapy in the absence of pressurization. The investigational determination applies to topical HBOT devices that provide pressurized oxygen; non‑pressurized topical oxygen wound care modalities are outside the scope of this medical policy.

Per the policy and Medicare national coverage guidance summarized herein, systemic HBOT for indications not listed as medically necessary is not covered by Medicare, and topical HBOT is not covered for any indication. Requests for systemic HBOT outside the listed medically necessary indications will generally be denied as not covered under Medicare rules cited in the policy.

This medical policy does not apply to Medicare Advantage. Providers and reviewers should verify benefit coverage and any Medicare Advantage plan rules separately with the member’s plan or benefits booklet.

HBOT (systemic or topical) for indications that are listed in the policy’s investigational section is considered not medically necessary / investigational. The investigational list covers a broad set of conditions (e.g., many neurologic, infectious, inflammatory, and musculoskeletal disorders and topical HBOT) for which the evidence is insufficient, inconsistent, or of limited quality to support coverage.

For many indications the evidence base is heterogeneous, limited, or inconsistent; systematic reviews, randomized trials, and case series yield mixed results across conditions. Where randomized trials and meta-analyses support benefit (for example, select diabetic ulcers and certain radiation-related injuries), the policy provides coverage language; for many other indications the policy lists HBOT as investigational because the available studies are insufficient in number, quality, or consistency to demonstrate improved net health outcomes.

Historically, clinical input and limited trial data have influenced the policy: in 2010 reviewers supported some additional indications based on basic science and case series, and some conditions (e.g., compromised skin grafts/flaps and necrotizing soft tissue infections) were debated. Despite clinical support from specialty reviewers, the policy retained investigational status for some of these indications because of paucity of high-quality published evidence at the time.

Over time the policy has been revised to add, remove, or clarify indications and operational guidance. Examples include deletions of previously listed medically necessary indications (e.g., cerebral edema and refractory mycoses in 2005), and more recent updates such as removal of the requirement to initiate HBOT within 24 hours for central retinal artery occlusion and the addition of HCPCS code E0446 for topical HBOT supplies/equipment.

Procedure and Supply Codes

HBOT related CPT/HCPCS codesmixed

99183	Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session.
A4575	Topical hyperbaric oxygen chamber; disposable.
E0446	Topical oxygen delivery system, not otherwise specified, includes all supplies and accessories.
60277	Hyperbaric oxygen under pressure; full body chamber; per 30-minute interval.

Added HCPCS CodesHCPCSCovered

E0446

Topical hyperbaric oxygen therapy

Wagner Ulcer Grade (diabetic wounds)

Wagner grade thresholdWagner ulcer grade 3 or higher

Scale range0 (no open lesion) to 5 (whole foot gangrene)

Grade 3 definitionUlcer penetrates deeper than grade 2 with abscess, osteomyelitis, or infection of tendon/tendon sheath

HBOT course reevaluation interval (diabetic wounds)

Reevaluation intervalReevaluation of HBOT course at 30-day intervals

Purpose of reevaluationShow continued progress in healing to justify ongoing HBOT

Prior Authorization, Documentation, and Utilization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required for hyperbaric oxygen therapy (HBOT). PA requests must demonstrate medical necessity and include required clinical documentation. Requests for investigational indications are at high risk for denial. Providers must verify member benefits and obtain PA prior to scheduling — this policy does not determine member benefit coverage.

Verify member benefits and limitations with the member's benefit booklet or customer service before pursuing authorization.
Investigational indications (see policy) are typically denied; include rationale and supporting evidence if requesting an exception.

Prior Authorization

Authorization Must Specify Treatment Parameters

The prior authorization must specify planned HBOT treatment parameters so reviewers can assess appropriateness and anticipate utilization.

Planned pressure (e.g., 2.0–2.5 ATA or other pressure based on indication).
Planned frequency (e.g., once daily, twice daily for necrotizing infections).

Clinical Background and Definitions

Hyperbaric oxygen therapy (HBOT) is delivered in two principal ways: systemic HBOT encloses the whole individual in a pressure chamber and provides 100% oxygen at pressures typically between 1.5 and 3.0 atmospheres absolute (ATA), raising tissue oxygen tensions and supporting physiologic mechanisms that promote wound healing and infection control. Topical HBOT delivers 100% oxygen directly to an open wound via a sealed sleeve or disposable chamber placed over the wound (e.g., HCPCS A4575); unlike systemic HBOT, topical HBOT delivers oxygen locally rather than by systemic circulation and is considered investigational by this policy due to limited and heterogeneous evidence.

Systemic HBOT — definition

DefinitionSealed chamber treatment delivering oxygen at pressures greater than 1.4 atmospheres absolute (ATA) to raise tissue oxygen tensions and achieve systemic oxygenation

Delivery methodIndividual is entirely enclosed in a pressure chamber and breathes oxygen; may be monoplace (pure oxygen) or multiplace (compressed air with oxygen delivery by mask/tent)

Typical pressure rangeCommon therapeutic pressures range from 1.5 to 3.0 ATA

Policy Changes and Timeline

2024policy updateLatest

Policy updated with literature review through June 7, 2024; removed requirement that HBOT be initiated within 24 hours of CRAO symptom onset; added HCPCS code E0446 for topical hyperbaric oxygen therapy.

2024-12-01annual review

Annual review approved November 11, 2024; effective December 1, 2024 (annual update and approval recorded).

2023-09-01annual review

Policy updated with literature review through April 28, 2023; wording standardized from 'patient' to 'individual'; policy statements otherwise unchanged.

Policy Summary

PayerPremera Bluecross

PolicyHyperbaric Oxygen Therapy (HBOT) — Coverage Criteria

Policy CodePolicy 2.01.505

Change TypeTiming updatecoding addition

Effective DateDec: 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization documenting Wagner grade and prior standard wound therapy for diabetic foot HBOT requests.

SourceLink

On This Page

Examples and ranges cited in the policy evidence and timing sections.

Utilization review triggerWounds must be evaluated at least every 30 days during HBOT

Diabetic foot ulcer coverage thresholds

Coverage prerequisitesWagner Grade III or higher and failed adequate standard wound therapy (no measurable healing for ≥30 days)

Diabetes requirementIndividual has type I or type II diabetes and a lower extremity wound due to diabetes

Adjunctive useHBOT must be used in addition to standard wound care and wounds evaluated at least every 30 days

Trial of standard wound therapy (prerequisite for HBOT)

Trial lengthAdequate trial of standard wound therapy defined as no measurable signs of healing for at least 30 consecutive days

Standard wound care elementsVascular assessment and correction, nutrition and glucose optimization, debridement, appropriate moist dressings, off-loading, infection treatment

Utilization review noteGuidance recommends utilization review after approximately 30 treatments

Planned total number of sessions (typical courses: diabetic wounds ~30 sessions, radiation injuries 40–60, others per indication).

Interval reassessment plan (reevaluation at 30-day intervals for most wound indications).

Step Therapy

Adjunctive HBOT Only After Adequate Standard Wound Therapy

For adjunctive HBOT for diabetic lower‑extremity wounds, Medicare and this policy require patients to have failed an adequate course of standard wound therapy before HBOT is authorized.

Document failure to respond to ≥30 consecutive days of standard wound care (no measurable signs of healing).
Standard wound care elements must be documented (see separate documentation callout).
HBOT is adjunctive — it must be used in addition to ongoing standard wound care.
Consider step-therapy: require documentation that standard therapies were attempted and failed before approving adjunctive HBOT.

Billing Rule

Prior Authorization and Correct Coding

Include the correct HCPCS/CPT coding on the PA request. Coding changes (including addition of topical HBOT code E0446) may affect benefit determination and claims processing; PA should reflect current, accurate codes to avoid denials or payment delays.

Use current HCPCS/CPT codes for systemic HBOT and, when applicable, topical HBOT (E0446 added to code set).
If coding is unclear, provide clinical description and intended billing codes on the PA request.
Benefit determination is code‑dependent — incorrect or out‑of‑date coding may trigger coverage denials.

Documentation Required

Reevaluation Requirement for Ongoing HBOT

Ongoing HBOT beyond the initial course requires interval reevaluation. For most wound indications, continued therapy is authorized only if there is documented measurable progress at the 30‑day reevaluation.

Reevaluation documentation should summarize response (wound measurements, percent reduction, photographic evidence) and justify additional sessions.
Utilization review is recommended after typical treatment thresholds (e.g., review after 30 treatments for diabetic wounds).
Continued HBOT is not covered if no measurable signs of healing are demonstrated within any 30‑day treatment period.

Denial Risk

Medicare Coverage Limits and Denial Triggers

Medicare national coverage limits and denial triggers must be followed for members covered under Medicare rules: adjunctive HBOT is covered only after no measurable healing for at least 30 days with standard wound therapy; continued HBOT is not covered if no measurable healing within any 30‑day period. Systemic HBOT for other indications and topical HBOT are not covered by Medicare.

Failure to document ≥30 days of standard wound therapy with no measurable healing is a common denial trigger.
Wounds must be evaluated at least every 30 days during HBOT; lack of documented improvement within a 30‑day interval should result in discontinuation per Medicare limits.
Systemic HBOT for indications not listed as medically necessary and topical HBOT are not covered under Medicare national policy.

Documentation Required

Suggested and Required Documentation Elements

Provide comprehensive documentation elements with the PA to support medical necessity and to expedite review.

Indication and ICD‑10 diagnosis.
Planned HBOT dosing: pressure (ATA), session duration, frequency, and total planned sessions.
Clinical history and physical exam, including onset and severity.
Prior and concurrent treatments (detailed chronology of standard wound therapy).
Baseline wound measurements and photographs; Wagner grade for diabetic foot ulcers.
Vascular assessment results and interventions, glycemic control status, nutritional assessment, debridement history, off‑loading measures, and infection management.
Planned interval reassessment schedule and objective criteria for continued therapy.

Documentation Required

Required Documentation for Diabetic Wound HBOT

For diabetic lower‑extremity wounds specifically, the PA must include detailed documentation of standard wound care and failure to heal after an adequate course.

History & physical exam documenting wound severity and Wagner ulcer grade.
Documentation of an adequate course (≥30 days) of standard wound therapy including vascular assessment/management, optimization of glycemic and nutritional status, debridement, moist wound care, off‑loading, and treatment of infection.
Objective wound measurements and photos demonstrating lack of measurable healing over the 30‑day period.
Documentation of any vascular interventions or reasons vascular correction was not feasible.

Step Therapy

Consider Step Therapy for Adjunctive Indications

Consider step‑therapy for adjunctive HBOT indications where the evidence is mixed: require documentation that standard (non‑HBOT) therapies were attempted and failed prior to authorizing HBOT.

Step requirement typically means an adequate documented trial of standard wound care (≥30 days) with no measurable healing.
Specify what constitutes adequate non‑HBOT therapy in the PA criteria to reduce inappropriate use.

Prior Authorization

Utilization Review After Treatment Thresholds

Utilization review (UR) is recommended after typical treatment thresholds to assess ongoing medical necessity and safety.

Perform UR after ~30 treatments for diabetic wounds and at other indication‑specific thresholds (e.g., 60 treatments for radiation necrosis).
UR should require objective evidence of continued healing and justify further sessions.

Billing Rule

Coding / Policy Version Risk

Coding/version mismatch risk: providers must ensure PAs, claims, and clinical documentation use updated policy language and current code sets. Changes over time (policy updates, added codes like E0446) can cause claim denials if not synchronized.

Confirm the effective policy/coding version at time of service and include correct codes on PA and claims.
If a new code or policy change applies to the requested service, note this on the PA to avoid processing delays.

Topical HBOT — definition and policy note

DefinitionLocal topical application of pressurized oxygen to a limb or wound via a sealed sleeve or disposable chamber (e.g., HCPCS A4575); supplies may be disposable or home-use

Typical regimenOften offered as ~90-minute sessions for several consecutive days with cycles repeated over weeks (examples in literature vary)

Policy stanceTopical HBOT is considered investigational (not proven) by this policy

Wagner Ulcer Grade — definition and coverage threshold

Definition and scaleWagner Ulcer Grade classifies diabetic foot ulcers from 0 to 5 (0=no open lesion; 5=whole foot gangrene)

Grade 3 criteriaUlcer penetrates to include abscess, osteomyelitis, or deep infection

Coverage relevanceWagner grade 3 or higher cited as threshold for HBOT coverage for diabetic lower extremity wounds

Systemic HBOT — alternate definition

Alternate definitionWhole-body enclosure in a pressure chamber where the individual breathes oxygen at >1 atmosphere, increasing arterial/tissue oxygen delivered systemically

MechanismRelies on systemic circulation to deliver highly oxygenated blood to tissues (used for infections, gas embolism, CO poisoning, non-healing wounds)

Chamber typesMonoplace chambers pressurized with pure oxygen or multiplace chambers pressurized with compressed air with oxygen delivered by mask/head tent

Topical HBOT — alternate definition

Technique descriptionDelivers 100% oxygen directly to an open, moist wound at slightly above atmospheric pressure using an appliance enclosing the wound (sleeve or disposable chamber)

Device examples/codingDisposable topical hyperbaric oxygen appliance described by HCPCS A4575; topical oxygen supplies also represented by E0446

Evidence/policy noteTopical HBOT has been investigated for diabetic and other skin ulcers but is considered investigational by this policy

Standard wound care (diabetic wounds)

Core elementsAssessment of vascular status with correction if possible; optimization of nutrition and glucose control; debridement to remove devitalized tissue; maintenance of a clean, moist granulation bed with appropriate dressings; off-loading; and treatment of infection

Documentation requirementFailure to respond to standard wound care is defined as no measurable signs of healing for at least 30 consecutive days

Role relative to HBOTHBOT must be used as adjunctive therapy in addition to documented standard wound care

Topical HBOT — HCPCS identifiers

Code identifierHCPCS code E0446 — Topical oxygen delivery system (not otherwise specified), includes supplies and accessories

Related topical codeHCPCS A4575 — Disposable topical hyperbaric oxygen chamber/appliance

Policy contextE0446 was added as a topical HBOT-related HCPCS code in policy updates

Central retinal artery occlusion (CRAO) — definition and timing update

DefinitionCentral retinal artery occlusion (CRAO)

Operational changeRemoved requirement that HBOT be initiated within 24 hours of CRAO symptom onset (policy history 2024)

Policy noteCRAO was previously added as a medically necessary indication in prior updates; timing requirement revised in 2024

2022-04-01policy renumbering & coverage change

Policy renumbered to 2.01.505 and central retinal artery occlusion (CRAO) added to list of medically necessary conditions.

2020-08-01policy reissue and coding change

Policy reissued as new policy 2.01.04; coding update removed HCPCS code A4575 and later coding adjustments followed.

1997-05-05policy creation

Policy added to Medicine Section as a new policy (initial creation and inclusion in medical policy history).