CurrentKaiser PermanentePolicy N/A

Clinical Review Criteria – Wound Care Treatments (coverage criteria)

Clinical review criteria governing medical necessity and coverage for a range of wound care treatments (including low-frequency noncontact ultrasound, electrical stimulation/electromagnetic therapy, maggot debridement, OASIS dressing, noncontact normothermic therapy, and tissue-engineered skin substitutes) for Kaiser Foundation Health Plan of Washington members and their providers.

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria – Wound Care Treatments (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document prior authorization with evidence of adequate perfusion (palpable pedal pulse or ABI ≥ 0.70) and a ≥4‑week trial of conventional therapy before certain skin substitutes are approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+treatment types

ABI ≥0.70ABI threshold

4 weeksconservative therapy trial

Insufficient evidenceMTAC conclusion for several adjuncts

08/09/2024

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Policy Positions

Skin substitutes — Diabetic foot ulcer (initial)

Covered when ALL of the following are met:

Diabetic foot ulcer criteria: Patient has diabetes (type 1 or type 2); treated foot has adequate blood supply as evidenced by a palpable pedal pulse or an ankle‑brachial index (ABI) >= 0.70; full‑thickness foot ulcer located on the plantar, medial, or lateral surface with no exposure of tendon, muscle, capsule, or bone; receiving conventional wound care and optimal glycemic management to continue during treatment; failure to respond to at least 4 weeks of consistent conventional therapy including off‑loading, moist dressings, optimal glycemic management, and serial debridement as clinically indicated; no wound infection (defined as <= 3+ growth on semi‑quantitative wound culture); no slough or eschar in the wound bed; no allergy to bovine products; other causes of neuropathy may be approved case‑by‑case by a medical director.ABI >= 0.70; 4 weeks conventional therapy

Only specified products are approved for diabetic ulcers.

Skin substitutes — Venous insufficiency ulcer (initial)

Covered when ALL of the following are met:

Venous insufficiency ulcer criteria: Receiving concurrent conventional wound care for a minimum of 4 weeks including appropriate compression of the extremity; treated extremity has adequate blood supply as evidenced by a palpable pedal pulse or an ankle‑brachial index (ABI) >= 0.70; full‑thickness ulcer due to venous insufficiency; lack of response to conventional therapy including moist dressings, serial debridement as indicated, and compression; no allergy to bovine, porcine, or ovine products; no wound infection (<= 3+ growth on semi‑quantitative culture); no slough or eschar in the wound bed; if diabetic, concurrent optimal glycemic management.ABI >= 0.70; 4 weeks conventional therapy

Only specified products are approved for venous ulcers.

Other modalities — coverage stance

Noncovered or not medically necessary per MCG/Medicare guidance: Noncontact Normothermic Wound Therapy (Warm‑Up), Electrical Stimulation and Electromagnetic Therapy, and Low Frequency Noncontact Nonthermal Ultrasound are identified as not medically necessary per MCG criteria for non‑Medicare members; Medicare national/local coverage guidance may also identify certain services as not covered for Medicare members.See MCG and CMS references

If requesting these services under MCG review, submit last 6 months of clinical notes to support medical necessity.

Low-frequency noncontact ultrasound (MIST) — Not meeting MTAC

Kaiser MTAC evidence-based coverage conclusions for low frequency noncontact nonthermal ultrasound:

MIST therapy stance: MTAC concluded available literature does not provide sufficient evidence that non‑thermal, noncontact low‑frequency ultrasound (MIST) is safe and/or more effective than standard debridement or standard wound care; the technology does not meet Kaiser Permanente Medical Technology Assessment Criteria.

Two RCTs and case series reviewed; methodological limitations and insufficient evidence.

Maggot debridement therapy — Not meeting MTAC

Kaiser MTAC evidence-based coverage conclusions for maggot debridement therapy:

MDT stance: MTAC concluded there is fair evidence that maggot debridement therapy (MDT) speeds debridement compared with hydrogel but no evidence of faster complete wound healing; overall MDT does not meet MTAC criteria for routine coverage.

RCTs and cohort studies reviewed; higher short‑term pain reports and limited evidence for MRSA eradication.

Medihoney (Manuka honey) dressings — Not meeting MTAC

Kaiser MTAC evidence-based coverage conclusions for Medihoney dressings:

Medihoney stance: MTAC concluded evidence is insufficient to determine whether Medihoney (Manuka honey) dressings improve healing rates in acute or chronic wounds; the therapy does not meet MTAC criteria for routine coverage.

Multiple small RCTs and systematic reviews with limited chronic wound data.

OASIS Wound Matrix — Not meeting MTAC

Kaiser MTAC evidence-based coverage conclusions for OASIS wound dressing:

OASIS stance evolution: Earlier MTAC review (2000) found no peer‑reviewed evidence; later reviews (2011) identified three RCTs suggesting possible safety/efficacy but with methodological limitations; overall MTAC concluded OASIS does not meet MTAC criteria for routine coverage.

Some RCTs were manufacturer‑funded and had analytic limitations; interpret results with caution.

Warm-up/MIRE — Informational

Other adjunctive modalities mentioned (informational):

Warm-up/MIRE stance: Warm‑Up (noncontact normothermic) therapy and MIRE (monochromatic near‑infrared photo energy) are described as adjuncts intended to increase local blood flow and moisture to support healing; manufacturer recommendations include warming to approximately 38°C and multiple warming sessions. MTAC evidence reviews identified mixed RCT results and methodological limitations and provided informational context rather than a positive coverage determination in this section.approx. 38°C (manufacturer recommendation)

Provide informational physiologic rationale; no MTAC coverage conclusion provided here.

Medically necessary skin substitutes (conditional)

Covered when ALL of the following are met

General: Use of the skin substitute products and Q/A/HCPCS codes listed as 'medically necessary' is covered only when the specific applicable policy criteria referenced elsewhere in this policy are satisfied.

See full policy for the detailed criteria that must be met prior to coverage (e.g., wound type, perfusion, prior conventional therapy).

Not medically necessary skin substitutes

Not covered products (examples from list)

Not medically necessary products: Use of any skin substitute product or associated HCPCS/Q code explicitly listed in the 'considered not medically necessary' sections of this policy is considered not medically necessary and is not covered.

Extensive list in the policy (chunks 41–54).

Warm-Up (noncontact normothermic) wound therapy

Warm-Up Therapy Evidence Summary: Randomized trials of Warm‑Up (noncontact normothermic) wound therapy showed mixed results with methodological limitations (small sample sizes, selection bias, lack of intention‑to‑treat analyses); MTAC concluded Warm‑Up does not meet Kaiser Permanente Medical Technology Assessment Criteria and is therefore positioned as not meeting criteria for routine coverage.

Manufacturer recommendation to warm wound to ~38°C; evidence limitations detailed in MTAC reviews.

Low-frequency non-contact non-thermal ultrasound

97610 Medicare Coverage: CPT 97610 (low‑frequency, non‑contact, non‑thermal ultrasound) is considered medically necessary for Medicare members when criteria in the applicable Medicare policy statements are met; for non‑Medicare members this therapy is considered not medically necessary in the policy excerpt.

Verify Medicare‑specific coverage criteria and documentation requirements.

Normothermic Wound Therapy - Not Medically Necessary

Normothermic wound warming

Normothermic Wound Therapy: Normothermic wound‑warming devices and supplies (A6000, E0231, E0232) are considered not medically necessary.

These device components are listed as not medically necessary in the policy.

Low Frequency Noncontact Non-Thermal Ultrasound - Mixed Coverage

Low frequency noncontact non-thermal ultrasound

Ultrasound Coverage: For non‑Medicare members CPT 97610 (low‑frequency noncontact non‑thermal ultrasound) is considered not medically necessary. For Medicare members CPT 97610 may be considered medically necessary when Medicare policy criteria are met.

Check Medicare criteria and documentation for CPT 97610.

Electrical Stimulation and Electromagnetic Therapy - Not Medically Necessary

Electrical stimulation and electromagnetic therapy

Electrical/EM Therapy: Electrical stimulation and electromagnetic therapy codes listed (including E0761, E0769, G0281, G0282, G0295, G0329 and other specified HCPCS/CPT codes) are considered not medically necessary.

MTAC reviews found insufficient evidence to determine that ES/EM improves chronic wound healing; these codes are listed as not medically necessary.

For Medicare members, CMS policy identifies several wound therapies as not covered under National Coverage Determinations (NCDs). Electrical stimulation and electromagnetic therapy and Non‑Contact Normothermic Wound Therapy (NNWT) are listed in Medicare coverage guidance as services that are not covered per Medicare criteria. In the Ambulatory Surgical Center (ASC) setting Medicare treats skin substitutes applied as dressings as non‑separately billable items; in outpatient hospital or clinic settings skin substitutes may be billable but remain subject to medical necessity determinations and applicable Medicare policy statements.

Contraindications for low‑frequency noncontact (MIST) ultrasound therapy include malignant wounds, wounds in tissue previously treated with radiation, bleeding disorders, and thrombophlebitis. MTAC concluded the available literature is insufficient to demonstrate that MIST is safe and more effective than standard debridement or wound care, and therefore it does not meet Kaiser MTAC criteria.

The OASIS Wound Matrix is derived from porcine small intestinal submucosa and is not approved for use in patients with third‑degree burns. The product should not be used in patients with known porcine allergies. MTAC reviews (including later RCT evidence) found methodological limitations and determined OASIS does not meet MTAC criteria for routine coverage.

Medihoney (Active Manuka honey) dressings are gamma‑irradiated honey‑impregnated products indicated for light to moderately exuding wounds. They should be avoided in patients with a known allergy to honey or bee venom. For patients with diabetes, clinicians should document a plan for blood glucose monitoring because of the product's sugar content. MTAC concluded evidence is insufficient to support routine coverage of Medihoney for wound healing.

An extensive list of specific skin substitute products and corresponding HCPCS/Q‑codes are designated not medically necessary when used as indicated in this policy. Examples include many branded dermal matrices, amniotic/amnion wraps, and other tissue‑engineered products appearing in the not‑medically‑necessary lists; use of any product or code on those lists may be denied as not medically necessary.

Components of noncontact wound‑warming systems are considered not medically necessary. Specifically, device and supply codes A6000, E0231, and E0232 (wound‑warming wound cover, temperature control unit, and warming card) are listed as not medically necessary.

For Medicare members, CPT 97610 (low‑frequency, noncontact, non‑thermal ultrasound) may be considered medically necessary when the member meets applicable Medicare‑specific criteria and documentation requirements in the relevant Medicare policy statements; coverage for non‑Medicare members differs and is addressed elsewhere in this policy.

For non‑Medicare members Kaiser references MCG criteria for determinations. Per MCG, Noncontact Normothermic Wound Therapy (Warm‑Up), Electrical Stimulation and Electromagnetic Therapy, and Low‑Frequency Noncontact Non‑Thermal Ultrasound are identified as not medically necessary based on available evidence and MCG guidance.

MTAC concluded that several adjunctive wound therapies do not meet Kaiser MTAC criteria based on available evidence: MIST (low‑frequency noncontact ultrasound), Maggot Debridement Therapy (MDT), Medihoney dressings, and the OASIS Wound Matrix were all reviewed and positioned as not meeting MTAC criteria due to limited or methodologically weak evidence for improved healing outcomes.

Warm‑Up noncontact normothermic wound therapy was reviewed in multiple randomized trials with small sample sizes and methodological limitations. MTAC determined the evidence is insufficient to meet Kaiser MTAC criteria and therefore Warm‑Up does not meet MTAC for routine coverage.

The policy includes explicit listings of skin substitute products and device/component codes that are considered not medically necessary. Providers should refer to the full not‑medically‑necessary code lists in the policy when billing; use of any listed code or product may result in claim denial.

Normothermic wound warming and multiple electrical stimulation/electromagnetic therapy codes are explicitly listed as not medically necessary. Examples called out include the warming system components A6000, E0231, E0232 and several ES/EM device and procedure codes (for example E0761, E0769, G0281, G0282, G0295, G0329), which are considered not medically necessary for routine coverage in the policy.

Medicare references cited in this policy include CMS Coverage Manuals and National Coverage Determinations addressing electrical stimulation and related wound therapies, as well as MLN/ASC guidance on billing for skin substitutes in Ambulatory Surgical Centers. These Medicare NCDs/LCDs and articles are foundational to Medicare‑member determinations and billing rules described in this policy.

Coding and Billing Codes

Medicare references (NCDs/LCDs/Articles)mixed

270.1, 270.2, 270.5, 270.6	CMS Coverage Manual/ NCD sections referenced for electrical stimulation, non-contact normothermic wound therapy, porcine skin and gradient pressure dressings, infrared therapy devices
L38904, L33831, A54563	Local Coverage Determination / Article codes referenced for wound and ulcer care and surgical dressings

Skin substitutes considered medically necessary when criteria metHCPCSCovered

Q4102	Qasis wound matrix_per sqcm.
Q4105	Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm.
Q4110	PriMatrix_per sq cm.
Q4151	AmnioBand or Guardian_per sq cm.
A2011	Supra sdrm, per square centimeter.
A2012	Suprathel_per square centimeter.
A4100	Skin substitute, fda cleared as a device, not otherwise specified.
Q4224	Human health factor 10 amniotic patch (hhf10-p) per square centimeter.

Skin substitutes and Warm-Up device components considered not medically necessaryHCPCSNot Covered

A2002	Mirragen Advanced Wound Matrix_per sq cm
A2004	XCelliStem_per sq cm
A2005	Microlyte Matrix_per sq cm
A2007	Restrata_per sq cm
Q4100	Skin substitute, not otherwise specified.
Q4101	Apligraf, per sq cm.
Q4103	Qasis burn matrix, per sq.
Q4106	Dermagraft_per sq cm.
Q4107	GRAFTJACKET per sq. cm.
Q4113	GRAFTJACKET XPRESS, injectable.

1–10 of 28

1/3

inv-35: Ankle-Brachial Index (ABI) — perfusion threshold

Ankle-Brachial Index (ABI) thresholdABI ≥ 0.70 is required to demonstrate adequate perfusion for tissue‑engineered skin substitute use

Alternative perfusion signPresence of a palpable pedal pulse may be used instead of ABI ≥ 0.70

Context of useRequired for diabetic foot ulcer and venous insufficiency ulcer criteria prior to skin substitute application

inv-36: Conventional therapy duration before skin substitute — minimum trial

Minimum conventional therapy durationAt least 4 weeks of consistent conventional wound care required prior to considering skin substitute

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required — Skin substitutes & selected adjunctive therapies

Tissue-engineered skin substitutes and selected adjunctive wound therapies may require prior authorization. Verify preauthorization before initiating treatment; submit clinical documentation per MCG when applicable. Request review for members whose plan requires prior authorization and for non-Medicare members where policies differ.

Verify authorization via the Pre-authorization Code Check for specific codes and plan types.
Medicare: In ASC settings skin substitutes applied as dressings are not separately billable; in outpatient hospital/clinic settings they may be billable — follow Medicare-specific guidance.
Non‑Medicare: many adjunctive therapies are reviewed against MCG criteria; see MCG A-0351 (Warm-Up), A-0242 (Electrical Stimulation/Electromagnetic) and the applicable MCG guideline for Low Frequency Noncontact Ultrasound.

Prior Authorization

Prior Authorization — Selected skin substitutes (headline)

Skin substitutes are medically necessary only when the applicable clinical criteria in the policy are met (examples: diabetic foot ulcers or venous insufficiency ulcers meeting the listed wound and therapy requirements). Use the listed HCPCS/Q-codes when requesting authorization so reviewers can apply the correct policy criteria.

Background and Clinical Context

Chronic wounds affect a meaningful portion of the population and arise from factors that impair normal healing—examples include venous or arterial insufficiency, neuropathy, infection, and pressure. Effective wound care centers on wound bed preparation (debridement, infection control, moisture balance) and addressing underlying contributors; tissue‑engineered skin substitutes and adjunctive therapies are considered only after conventional management and when specific clinical criteria are met.

Definitions

inv-64: Skin substitute (Tissue-engineered)

DefinitionTissue‑engineered skin substitute: bioengineered skin product that may be acellular (matrix/scaffold) or cellular (containing fibroblasts/keratinocytes) used as temporary or permanent wound coverings

OriginsProducts may be human allograft, autograft, or xenograft (e.g., bovine, porcine) depending on product

Clinical useUsed for chronic wounds nonresponsive to standard therapy, including specified diabetic foot and venous insufficiency ulcers when criteria are met

Product examples recommended in policyApproved examples include Integra, MTF biological products, AmnioExcell/AmnioMatrix, PriMatrix, and specified Oasis/Integra variants for indicated wounds

inv-65: Electrical stimulation / Electromagnetic therapy

Definition

Policy Summary

PayerKaiser Permanente

PolicyClinical Review Criteria – Wound Care Treatments (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Elements of conventional therapyIncludes appropriate off‑loading for foot ulcers or compression for venous ulcers, moist dressings, serial debridement as indicated, and optimal glycemic management when diabetic

Documentation expectationNo response to the 4‑week trial must be documented before skin substitute approval

inv-37: Wound warming target temperature

Manufacturer recommended target temperatureApproximately 38°C for Warm‑Up (noncontact normothermic) wound therapy warming card

Intended physiologic effectWarming to ~38°C is intended to increase blood flow and wound moisture to support healing

Typical manufacturer regimenManufacturer recommends three warming sessions per day during treatment courses

Include product-specific code(s) (Q- or A- codes) in the request (examples: Q4137, Q4105, A2011, A2012).
Only approved products listed under the ‘medically necessary’ section will be considered for coverage.
When a product is listed as Not Medically Necessary (see policy), anticipate denial risk.

Prior Authorization

Prior Authorization for Adjunctive Wound Therapies

Adjunctive wound therapies (e.g., Low-frequency noncontact ultrasound, Warm-Up normothermic therapy, electrical stimulation, electromagnetic therapy, and select wound dressings such as Medihoney or OASIS) have varied coverage: some are considered not medically necessary per MCG or internal review. Prior authorization is required when the member’s plan mandates it.

Low-frequency noncontact, nonthermal ultrasound (MIST) — not supported by Kaiser Permanente Medical Technology Assessment; for non‑Medicare members authorization is typically considered not medically necessary.
Warm-Up (noncontact normothermic) — MCG review concludes not medically necessary.
Electrical stimulation/electromagnetic therapies — MCG A-0242: considered not medically necessary.
Medihoney, OASIS — evidence conclusions vary; Medihoney and OASIS have been evaluated and often do not meet KP criteria — expect careful review or noncoverage.

Prior Authorization

Verify prior authorization

Before providing therapy, confirm an active prior authorization for the exact HCPCS/CPT/Q-code, product, and setting. If authorization is required but not obtained, services may be denied.

Use the Pre-authorization Code Check to confirm code-level requirements by plan.
For Medicare members, confirm billing rules: some skin substitute applications in ASCs are considered dressings and not separately billable; outpatient settings may bill separately.
Document authorization number and authorized date-range in the chart and billing submission.

Denial Risk

Denial triggers per MCG

Requests reviewed against MCG criteria frequently trigger denials when required conservative therapy or documentation is missing, when the specific product is listed as not medically necessary, or when codes/settings are inconsistent with Medicare billing rules.

Common denial triggers: lack of ≥4 weeks of consistent conservative wound care, missing evidence of adequate perfusion (palpable pedal pulses or ABI ≥0.70), ongoing infection, exposed tendon/muscle/bone, allergy to required product components.
Product-level denials occur when the requested skin substitute is listed in the policy as Not Medically Necessary.
Requests for Warm‑Up, Low-frequency ultrasound, electrical stimulation, and certain electromagnetic therapies are frequently denied per MCG conclusions.

Denial Risk

Ultrasound (MIST) — noncoverage risk

Ultrasound MIST (low-frequency, noncontact, nonthermal ultrasound) is not supported by Kaiser Permanente Medical Technology Assessment for wound healing and is commonly considered not medically necessary for non‑Medicare members; expect denial unless compelling, documented exception criteria are provided.

If requesting MIST for non‑Medicare members, include detailed wound history, prior conservative care timeline, objective wound measurements, and rationale for clinical exception.
For Medicare members, 97610 (low frequency, non-contact, non-thermal ultrasound) may be considered medically necessary when the policy criteria are met — confirm with plan-specific Medicare guidance.

Denial Risk

MDT (Maggot Debridement Therapy) — noncoverage risk

Maggot Debridement Therapy (MDT) evidence does not meet Kaiser Permanente criteria and the therapy is usually considered not medically necessary; anticipate noncoverage unless a documented exception is justified.

If requesting MDT, submit supporting evidence: prior unsuccessful conventional debridement, wound characteristics, infection status, and rationale why other methods are unsuitable.
Note that some plans or regions may not require medical necessity review for MDT — verify with the plan.

Denial Risk

Medihoney — noncoverage risk

Medihoney dressings (Manuka honey-based products) have mixed evidence and do not meet Kaiser Permanente Medical Technology Assessment criteria for routine coverage; expect denials unless specific clinical justification and documentation are provided.

If requesting Medihoney, include prior conservative care, wound type, allergy history (honey/bee venom), and blood glucose monitoring plan for diabetic patients.
Products cleared by FDA (e.g., Derma Sciences Medihoney) still require demonstration that trialed conservative measures failed per policy timelines.

Denial Risk

OASIS — noncoverage risk

OASIS Wound Matrix evidence is mixed and has previously not met KP criteria in several reviews; submissions often lack high-quality, conclusive evidence — expect elevated denial risk absent strong clinical documentation.

When requesting OASIS, include RCT-related documentation only if available, detailed wound chronology, prior therapies, infection status, and objective measurements of lack of healing after conservative care.
Porcine-derived products require allergy screening and documentation of informed consent related to porcine material.

Denial Risk

Denial risk — listed non-covered skin substitutes

Several named skin substitute products and HCPCS codes are listed as Not Medically Necessary in the policy — requests for these products will likely be denied. Confirm product-specific coverage before ordering.

Examples of commonly non-covered products/codes: A2002 (Mirragen), A2004 (Microlyte Matrix), Q4101 (Apligraf), Q4103 (Qasis), Q4106 (Dermagraft), Q4107 (GRAFTJACKET), and many A-/C-/Q-codes listed in the Not Medically Necessary lists.
This list is not exhaustive; verify current policy lists and code-level status via preauthorization tools.

Denial Risk

Denial risk — Warm‑Up device components

Devices and consumable components related to Warm‑Up normothermic therapy (cards, warming covers, device units) are listed as not medically necessary — claims for device components (E0231, E0232; A6000 series) are at high risk for denial.

Examples: E0231 (noncontact wound-warming device), E0232 (warming card), A6000 (noncontact wound-warming wound cover).
Do not bill or dispense device components without prior authorization and documented medical necessity.

Denial Risk

Denial risk — NMN therapies (Medicare vs Non‑Medicare)

Non‑Medicare determinations often label NMN (not medically necessary) therapies such as Warm‑Up, low frequency ultrasound, and electrical stimulation as not covered. For Medicare members, some of these codes may be considered medically necessary when policy criteria are met — treat Medicare vs non‑Medicare requests differently and document accordingly.

Non‑Medicare: Warm‑Up, ultrasound, electrical stimulation and certain electromagnetic therapies are typically NMN per MCG or KP assessment.
Medicare: 97610 (low-frequency, non-contact, non-thermal ultrasound) may be covered when criteria are met; verify Medicare-specific coverage rules and submit supporting documentation showing criteria fulfillment.

Documentation Required

Required documentation for MCG-reviewed services

For any service reviewed using MCG criteria, include the required supporting documentation in the authorization submission to avoid denials: clinical notes, wound measurements/photographs, perfusion testing, culture results, and records demonstrating ≥4 weeks of conservative therapy when required.

Minimum documentation: last 6 months of clinical notes from the requesting provider/specialist, wound measurements and photographs, ABI or palpable pulses, microbiology culture results (if relevant).
When MCG is used, explicitly cite the MCG guideline (e.g., A-0351, A-0242) and explain how the patient does or does not meet each element.
For Medicare members, include Medicare-relevant documentation and ensure setting-specific billing rules are addressed.

Billing Rule

Billing context for skin substitutes (Medicare vs Non‑Medicare)

Billing and coverage differ between Medicare and non‑Medicare members. Medicare treats certain skin substitutes in the ASC setting as non-separately billable dressings; outpatient/clinic settings may bill these products. Non‑Medicare members are subject to the policy lists and MCG reviews.

Confirm member type (Medicare vs Non‑Medicare) on the authorization request.
For Medicare members, follow MLN/Medicare guidance for setting-specific billing (ASC vs outpatient).
For Non‑Medicare members, follow the policy product lists and MCG determinations for medical necessity.

Documentation Required

MIST (Ultrasound) — documentation required

When requesting authorization for Ultrasound MIST, include detailed therapy documentation: wound assessment, frequency/duration of prior conservative care, microbiology, and justification for ultrasound over standard debridement methods.

Provide wound size, depth, location, duration, and serial measurements or photos.
Document prior debridement attempts and why further standard debridement is unsuitable.
Include device details, treatment frequency, and expected treatment duration in the request.

Documentation Required

MDT — documentation required

For MDT requests, include explicit procedural and logistical documentation: indication, prior therapies, wound characteristics, informed consent, sterile maggot sourcing, application density/timing, and clinical follow-up plans.

Document prior debridement attempts and contraindications to other methods.
Include details on maggot species, sterility, application method, dressing change frequency, and expected number of treatment cycles.
Attach clinician notes describing patient acceptance and social considerations ("yuck" factor) if relevant.

Documentation Required

Medihoney — documentation required

When Medihoney is requested, submit evidence of prior conservative treatment failure, wound characteristics, allergy history, and for diabetics, a blood glucose monitoring plan due to the sugar content of honey.

Include type/brand and size of Medihoney product and indication for use.
Provide documentation that standard moist dressings, debridement, infection control, and off‑loading (if applicable) were tried for the required timeframe.

Documentation Required

OASIS — documentation required

OASIS requests should include wound chronology, evidence of failure of conservative care, objective measurements, allergy screening for porcine products, and informed consent when porcine-derived materials are used.

Attach wound photos and documentation of serial measurements showing insufficient healing after ≥4 weeks of appropriate conservative care.
Document absence of porcine allergy and discuss porcine origin with the patient as part of consent.

Documentation Required

Documentation for medically necessary skin substitutes

For skin substitutes deemed medically necessary, include full documentation that meets the policy criteria: diagnosis, wound characteristics, objective perfusion data (ABI or pulses), demonstration of adequate conservative care, absence of infection, serial debridement records, product allergy checks, and planned off‑loading/compression where indicated.

Clearly map each clinical element in the submission to the policy’s required criterion (e.g., ABI ≥0.70, four weeks of documented conservative care components).
Specify exact product code and size (sq cm) being requested and indicate the number of square centimeters to be used.
Include plan for ongoing glycemic control for diabetic patients and documentation that off‑loading or compression has been implemented when required.

Documentation Required

Medicare documentation note

Medicare-specific documentation: when treating Medicare members, follow Medicare MLA/MLN guidance and include evidence that the service meets Medicare setting-specific rules (e.g., ASC vs outpatient billing distinctions). Attach any Medicare-pertinent prior authorization or local coverage determination (LCD) references.

For Medicare, document the care setting and rationale for separate billing if applicable.
Include Medicare-focused clinical evidence and cite any applicable LCDs or MLN guidance used in the decision.

Step Therapy

Step therapy before skin substitute use

Step therapy: Before initiating a skin substitute, many policies require a trial of conservative therapy (step therapy) for at least four weeks; document adherence to step requirements or obtain a medical director exception.

Conservative therapy generally includes serial debridement, moist wound dressings, off‑loading (for foot ulcers), compression (for venous ulcers), infection control, and optimal glycemic management.
If step therapy is not required by the plan for a specific product or clinical scenario, document the reason and obtain prior authorization.

Step Therapy

Conservative therapy required first

Conservative therapy is required first in most cases prior to skin substitute use. Ensure and document completion of the required conservative measures for the timeline specified in the policy (commonly ≥4 weeks).

Document dressings used, off‑loading or compression methods, serial debridements, and glycemic control measures.
Record wound measurements and photos at regular intervals to demonstrate lack of response.

Note

No step therapy requirements specified

Some situations and codes have no step therapy requirements specified in this policy. When no step therapy is stated, still provide thorough documentation of medical necessity and consult the Pre-authorization Code Check to verify plan-specific rules.

If unsure whether step therapy applies, contact medical management or use the Pre-authorization Code Check.
Do not assume coverage absence of explicit step therapy language; confirm per member’s benefit.

Electrical stimulation (ES): application of electrical current via electrodes placed in or near a wound; regimens include low‑intensity direct current (LIDC), high‑voltage pulsed current (HVPC), alternating current (AC), and transcutaneous methods

Electromagnetic therapyUses an electromagnet to generate fields (eg, short‑wave diathermy, pulsed short‑wave diathermy) with a field effect rather than direct contact

Regulatory noteNo ES or electromagnetic device has FDA clearance specifically for wound treatment per policy review

inv-66: Low-frequency noncontact nonthermal ultrasound

DefinitionLow‑frequency noncontact nonthermal ultrasound: ultrasound delivered without direct contact (25–40 kHz) using a saline coupling medium to promote wound cleansing and maintenance debridement

MechanismsProposed effects include cavitation, acoustic streaming, increased protein/collagen synthesis, angiogenesis, and reduced bioburden

Typical applicationUsually applied ~3 times per week; device (MIST) cleared by FDA in 2004 for wound cleansing and maintenance debridement

inv-67: Noncontact low-frequency ultrasound (MIST)

Specific modality (MIST)Noncontact low‑frequency ultrasound (MIST) transmits 25–40 kHz ultrasound via a fine sterile saline mist to the wound bed to aid cleansing and debridement

FDA status and contraindicationsCelleration MIST device cleared by FDA (2004); contraindicated for malignant wounds, radiation‑treated tissue, bleeding disorders, and thrombophlebitis

Evidence/coverage stanceMTAC concluded available literature is insufficient to show MIST is safe and/or more effective than standard debridement; does not meet MTAC criteria

inv-68: Maggot Debridement Therapy (MDT)

Definition and agentMaggot Debridement Therapy (MDT): application of sterile larvae (commonly Lucilia sericata) to wounds to mechanically and enzymatically debride necrotic tissue

Typical dosing and procedureLarvae applied at ~5–8 larvae per cm², contained with an oxygen‑permeable dressing; dressings changed daily and larvae replaced every 2–3 days

Regulatory status and evidenceMedical Maggots cleared by FDA (class II); MTAC concluded MDT speeds debridement compared with hydrogel but evidence insufficient for faster complete healing — does not meet MTAC criteria

inv-69: Medihoney (Active Manuka Honey dressing)

Product descriptionMedihoney (Active Manuka Honey dressing) is a gamma‑irradiated tulle dressing of ~95% Manuka honey and 5% calcium alginate indicated for light to moderately exuding wounds

Indications per manufacturer/FDAIndicated for diabetic foot ulcers, venous/arterial leg ulcers, pressure ulcers (partial/full thickness), burns, traumatic and surgical wounds

PrecautionsAvoid in patients with known allergy to honey or bee venom; monitor blood glucose in patients with diabetes due to sugar content

inv-70: OASIS Wound Matrix

Product compositionOASIS Wound Matrix: porcine small intestinal submucosa–derived biosynthetic extracellular matrix retaining ECM components (GAGs, proteoglycans, fibronectin, growth factors)

Indications and limitationsFDA approved for various partial‑ and full‑thickness wounds (trauma, ulcers, surgical wounds); not approved for third‑degree burns or patients with known porcine allergy

Evidence summaryEarly reviews found limited peer‑reviewed data; later RCTs (three) suggested possible safety/efficacy but methodological limitations led MTAC to conclude OASIS does not meet MTAC criteria

inv-71: Noncontact normothermic wound therapy (Warm-Up)

DefinitionNoncontact normothermic wound therapy (Warm‑Up): system with a noncontact wound cover, warming card, and temperature control unit intended to warm the wound to about 38°C

Intended effectWarming is intended to increase blood flow and wound moisture to support cell growth and healing

Coverage/availability noteNormothermic wound‑warming device components (A6000, E0231, E0232) are listed in the policy as considered not medically necessary