ModifiedPremera BluecrossPolicy N/A

Negative Pressure Wound Therapy (NPWT) Devices

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This policy governs coverage and clinical criteria for powered and single-use negative pressure wound therapy devices for outpatient wound care, affecting providers treating adolescents and adults (and notes investigational status in children ≤11).

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ModifiedPremera BluecrossPolicy N/A

Negative Pressure Wound Therapy (NPWT) Devices

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Policy Summary

PayerPremera Bluecross

PolicyNegative Pressure Wound Therapy (NPWT) Devices

Policy CodePolicy N/A

Change TypeRevision with age-scope updates

Effective DateSep 4, 2026

Last ReviewMay 12, 2026

Next Review DateNov 1, 20269d

Key ActionObtain prior authorization for an initial powered NPWT trial (approved up to 30 days) and document objective improvement for re-authorization.

SourceLink

POLICY UPDATE CHANGES

This policy has been revised.

Title changed from 'Negative Pressure Wound Therapy (NPWT) Devices in Adults' to 'Negative Pressure Wound Therapy (NPWT) Devices'.

Added age-based investigational statement for individuals aged 11 years and younger.

Consideration of age statement updated to: NPWT systems are only FDA approved for use in adolescents and adults aged 12 years and older.

Deleted documentation section requesting documentation of wound evaluation location.

Removed statement that this policy only applies to adults aged 19 and older.

30-dayinitial approval period length

2-weekminimum initial therapeutic trial duration

>=14dminimum trial for select chronic wounds

>=90dprior intensive therapy before NPWT

11 yrsinvestigational age cutoff

>=12 yrsFDA minimum approved age

Coverage and Medical Necessity Criteria

Initial Therapy — Powered NPWT (97605, 97606)

Covered when ALL of the following apply to an initial powered NPWT (CPT 97605/97606) therapeutic trial of not less than 2 weeks as part of a comprehensive wound care program:

Initial therapy general requirement: Initial therapeutic trial duration of not less than 2 weeks using a powered NPWT system

Indications (ANY of the following): Chronic (greater than 90 days) stage III or IV pressure ulcer that has failed to heal despite optimal wound care AND (high-volume drainage that interferes with healing OR standard dressings cannot be maintained due to anatomic factors)high-volume drainage defined as exudate exceeding 150-200 mL/day

Includes definition of chronic >90 days

Indications (ANY of the following): Nonhealing wound for at least 30 days despite optimal wound care in an individual with underlying clinical conditions known to negatively impact wound healing (examples: diabetes, malnutrition — must be addressed simultaneously with NPWT, small vessel disease, morbid obesity [BMI ≥40])non-healing ≥30 days

Indications (ANY of the following): Traumatic or surgical wound with failure of immediate or delayed primary closure AND exposed bone, cartilage, tendon, or foreign material within the wound

Continuation Therapy — Powered NPWT

Continuation of powered NPWT (CPT 97605/97606) may be considered medically necessary following an initial 2-week therapeutic trial when ALL of the following are met:

Continuation requirements

Objective improvement (AT LEAST ALL of the following): Healthy granulation tissue; progressive wound contracture with decreasing depth; commencement of epithelial spread from wound margins

Authorization period: Initial authorization for an NPWT therapeutic trial may be approved for up to 30 days; re-authorization may be approved for additional 30-day periods with documentation of continued objective improvement

Not Medically Necessary / Investigational

Circumstances where powered NPWT is considered not medically necessary or investigational:

Not medically necessary — continuation: Continuation is not medically necessary when the initial therapeutic trial or subsequent treatment period has not resulted in documented objective improvement OR the wound has developed complications that contraindicate continued NPWT OR the wound has healed sufficiently that grafting can be performed or it can be anticipated to heal completely

Not medically necessary — trial without criteria: Therapeutic trials of powered NPWT systems for acute or chronic wounds that do not meet the initiation or continuation criteria stated in this policy are considered not medically necessary

Investigational — single-use systems: Single-use NPWT systems (powered or nonpowered) (CPT 97607, 97608) are considered investigational for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds

Investigational — pediatric:

Coverage Criteria and Evidence Summaries by Wound Type

Coverage positions and summary of the evidence vary by wound type and device; where evidence is limited or inconsistent, NPWT may be considered a therapeutic trial under specified conditions:

Diabetic lower‑extremity ulcers and amputation wounds: Systematic reviews and RCTs report higher wound healing rates and fewer amputations with NPWT; for portable/single‑use devices some RCTs show noninferiority for wound area reduction but evidence is limited and inconsistent for net health outcome across devices

Well‑designed comparative studies with larger outpatient populations are needed

Chronic pressure ulcers (stage III/IV): Clinical trial data are low quality and heterogeneous, but clinical input and guideline statements support use as a therapeutic trial for chronic stage III/IV pressure ulcers that have failed intense conventional therapy

Consider therapeutic trial when wound >90 days and other criteria met

Lower‑extremity venous ulcers: RCTs of single‑use devices report noninferiority for area reduction but no consistent benefit in complete wound closure; evidence insufficient to conclude outpatient net health outcome

Guideline‑Based Coverage Groups

Relevant guideline recommendations and consensus statements that inform coverage groupings:

Closed incision/ciNPT for high‑risk surgical incisions: Consensus recommendations (Willy et al. 2017) support evaluating surgical patients for comorbidities or procedural risk (eg, obesity, diabetes, complex surgery) and considering closed incision negative pressure therapy for patients at increased risk of infection

NPWT for chronic stage III/IV pressure ulcers: Wound Healing Society (2023) states NPWT is a safe and effective treatment for chronic stage III or IV pressure ulcers and iNPWT may reduce postoperative complications after flap reconstruction

NPWT after diabetic foot debridement: NICE recommends considering NPWT after surgical debridement for diabetic foot ulcers on the advice of a multidisciplinary foot care team, while noting the evidence is limited and of low quality

Caution for diabetic‑related foot infections (DFIs): IWGDF/IDSA (2023) suggests not using NPWT for DFIs (conditional, low‑quality evidence); this may be interpreted as advising against routine coverage of NPWT for DFIs absent strong justification

Age Considerations

Age‑based coverage statements informed by FDA clearances and policy updates:

FDA‑approved age group: NPWT systems are FDA approved for use in adolescents and adults aged 12 years and olderage >= 12 years

Investigational age group: Use of NPWT systems is considered investigational for individuals aged 11 years and youngerage <= 11 years

Per FDA safety communications, contraindications for negative pressure wound therapy include: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulae, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ. The FDA has also reported rare but serious adverse events including bleeding and retained dressing pieces, and recommends careful patient selection, frequent monitoring by trained practitioners, and vigilance for complications during dressing changes.

Powered NPWT should be used as part of a comprehensive wound care program that also addresses diabetes control, nutritional status, pressure relief, and other factors that influence healing. The FDA noted that continuation of healing should be monitored at least every 14 days while using NPWT, and defined criteria for anticipated complete healing (eg, healthy granulation to within 5 mm of the surface and wound edges reduced to ≤2 cm).

Therapeutic trials of powered NPWT systems that do not meet the policy’s specified initiation or continuation criteria are considered not medically necessary and may be denied. Clinical input from specialty societies and academic centers supports therapeutic trials only for selected indications (for example, chronic stage III/IV pressure ulcers that have failed to heal, traumatic or surgical wounds with exposed bone/cartilage/tendon/foreign material, or nonhealing wounds in patients with comorbidities that impair healing).

Providers should document that NPWT is being requested as a second-line or therapeutic trial after appropriate conservative measures have failed; routine or first-line use for acute or chronic wounds outside these circumstances is generally not supported by clinical input or the policy.

No NPWT device has been FDA cleared for use in neonates, infants, or children. The FDA has stated that the safety and effectiveness of NPWT systems in these pediatric populations have not been established.

The FDA classification and device clearances referenced in the policy therefore support adult and adolescent use only where regulatory clearance exists; pediatric requests should note the absence of FDA clearance for neonates, infants, and children.

This medical policy does not apply to Medicare Advantage plans. Coverage determinations are subject to member benefit plan limits and conditions; providers and members should consult the member benefit booklet or contact customer service to determine applicability under a specific plan.

Therapeutic trials of powered NPWT systems for treatment of acute or chronic wounds that do not meet the policy’s stated initiation or continuation criteria are considered not medically necessary. This includes continued use when the initial trial did not produce documented objective improvement, when complications contraindicate ongoing NPWT, or when the wound has healed sufficiently to allow grafting or anticipated complete healing.

Most clinical input and several guideline statements indicate that NPWT is not appropriate as a routine first-line therapy for wounds that have not first failed conservative measures. Consensus guidance (for example, closed-incision NPWT recommendations) supports targeted use in patients at increased risk (eg, obesity, diabetes, complex surgery), and other guideline reviews report low-quality or mixed evidence for routine outpatient NPWT in many wound types.

Accordingly, NPWT should be considered a therapeutic trial or second-line intervention in selected patients when conservative management has failed or when specific high-risk features justify its use; routine application without prior appropriate measures is not supported by the clinical input summarized in the policy.

The 2023 IWGDF/IDSA guidance for diabetic-related foot infections issues a conditional, low-quality recommendation suggesting against the use of NPWT for DFIs. Use of NPWT contrary to this guidance for diabetic-related foot infections may require strong supporting rationale and could affect coverage decisions.

The policy explicitly states that use of NPWT systems is considered investigational for individuals aged 11 years and younger. The document also clarifies that NPWT systems are FDA approved for adolescents and adults aged 12 years and older, and the investigational designation for younger children was added in the policy update.

Billing, Codes, and Key Clinical Thresholds

Covered and associated procedure/HCPCS codesmixedCovered

97605	Negative pressure wound therapy (e.g., vacuum-assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters.
97606	Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing durable medical equipment (DME), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters.
97607	Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters.
97608	Negative pressure wound therapy (e.g., vacuum assisted drainage collection), utilizing disposable, non-durable medical equipment including provision of exudate management collection system, topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 square centimeters.
A6550	Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories.
A9272	Wound suction, disposable, includes dressing and all accessories and components, any type, each.
E2402	Negative pressure wound therapy electrical pump, stationary or portable.
K0743	Suction pump, home model, portable, for use on wounds.
K0744	Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 sq in or less.
K0745	Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 sq in but less than or equal to 48 sq in.

1–10 of 11

1/2

Regulatory codes and classificationsmixed

FDA product code: OMP

FDA product classification for NPWT devices

HCPCS/CPT code history and updatesmixed

No codes listed

inv-18: High-volume drainage — key value for exudate >150-200 mL/day

High-volume drainageExudate exceeding 150-200 mL/day that overwhelms NPWT dressings, breaks seal integrity, and hinders healing

Clinical implicationIndication for initiation of powered NPWT when drainage interferes with healing or standard dressings cannot be maintained

Documentation notePresence of high-volume drainage should be recorded in medical records for initial trial justification

inv-19: Chronic pressure ulcer duration — key value for >=90 days for stage III/IV

Threshold>= 90 days for stage III or IV pressure ulcers that have failed to heal despite optimal wound care

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Authorization duration and re-authorization

Initial authorization for a powered NPWT initial therapeutic trial may be approved for 30 days; re-authorization may be approved for additional 30-day periods when documented objective improvements in the wound are present.

Initial approval: 30 days for a powered NPWT initial therapeutic trial when criteria are met.
Re-authorization: additional 30-day periods allowed with documented objective wound improvements.

Step Therapy

Therapeutic trial and continuation criteria

A therapeutic trial of powered NPWT of not less than 14 days is required for chronic wounds; continuation beyond the trial is permitted only when there is documented objective improvement in the wound.

Minimum therapeutic trial duration: ≥14 days for chronic wounds that failed intense conventional therapy.
Continuation requires objective evidence of healing (see continuation criteria).

Background and Clinical Context

Negative pressure wound therapy (NPWT) applies controlled suction to the wound bed to remove fluids, debris, and infectious material, which promotes development of healthy granulation tissue and wound contraction. NPWT is commonly used for large or hard-to-heal wounds—such as chronic pressure ulcers, traumatic or surgical wounds with exposed structures, and selected diabetic lower-extremity wounds—as part of a comprehensive wound care program that also addresses diabetes control, nutrition, and pressure relief.

Key Definitions and Terms

inv-42: Pressure ulcer stages — succinct stage definitions for I-IV

Stage INonblanchable erythema of intact skin; no skin break

Stage IIPartial-thickness skin loss involving epidermis and/or dermis (break in top two layers)

Stage IIIFull-thickness tissue loss; may extend into subcutaneous fat but not through underlying fascia (affects fatty tissue)

Stage IVFull-thickness tissue loss with exposed or directly palpable muscle, tendon, ligament, cartilage, or bone; deep wound potentially involving these structures

inv-43: High-volume drainage definition — exudate >150-200 mL/day

DefinitionExudate exceeding 150-200 mL/day that overwhelms NPWT dressings, breaks seal integrity, and hinders healing

Policy Summary

PayerPremera Bluecross

PolicyNegative Pressure Wound Therapy (NPWT) Devices

Policy CodePolicy N/A

Change TypeRevision with age-scope updates

Effective DateSep 4, 2026

Last ReviewMay 12, 2026

Next Review DateNov 1, 20269d

Key ActionObtain prior authorization for an initial powered NPWT trial (approved up to 30 days) and document objective improvement for re-authorization.

SourceLink

On This Page

Use of NPWT systems is considered investigational for individuals aged 11 years and under

Burn wounds: RCTs and systematic reviews are heterogeneous with limited quality; evidence is insufficient to determine an improved net health outcome for outpatient NPWT

Traumatic or surgical wounds: Systematic reviews show some reduction in surgical site infection in select settings (mostly short‑term/inpatient); outpatient net health outcome is not established for many perioperative or traumatic indications

Therapeutic trial criteria for chronic/high‑risk wounds: A therapeutic trial of NPWT of at least 14 days may be considered medically necessary for chronic wounds that have failed to heal despite ≥90 days of intensive conventional therapy, or for wounds ≥30 days with a high probability of failure due to patient or wound factors; continuation beyond 14 days requires objective evidence of healing (granulation tissue, progressive contracture)Therapeutic trial >=14 days; prior conservative therapy >=90 days; wound age >=30 days for high‑risk designation

Associated requirement

Stage III/IV classification per pressure ulcer staging definitions must be documented

Role in therapy selectionMeets one of the initiation indications for a therapeutic trial of powered NPWT

inv-20: Non-healing wound — key value for >=30 days despite optimal care

Non-healing wound definitionAt least 30 days despite optimal wound care

Examples of contributing conditionsDiabetes, malnutrition (must be addressed concurrently), small vessel disease, morbid obesity

Use in initiation criteriaNon-healing ≥30 days in patients with negative healing factors qualifies for consideration of a therapeutic NPWT trial

inv-21: Morbid obesity — BMI >=40 kg/m² definition

DefinitionMorbid obesity defined as body mass index (BMI) ≥40 kg/m²

ContextListed as an example of an underlying clinical condition known to negatively impact wound healing

DocumentationBMI should be recorded when cited as a contributing factor to nonhealing wounds

inv-22: Therapeutic trial duration — key value for >=14 days

Therapeutic trial minimum duration>= 14 days (initial therapeutic trial for NPWT)

PurposeMinimum trial before considering continuation; continuation requires documented objective improvement

Authorization implicationInitial trial period may be authorized for 30 days, but a >=14-day trial is required to assess response

inv-23: Prior conventional therapy duration for chronic wounds — key value for >=90 days

Required duration of prior conventional therapy>= 90 days of intensive conventional wound therapy for chronic wounds before NPWT trial consideration

Evidence requirementDocumentation should show the wound failed to heal after prior conventional care

Continuation criteria linkTherapeutic trial of NPWT is considered after this prior therapy threshold; objective improvement needed for continued use

inv-24: Wound age threshold for high probability of failure — key value for >=30 days

Wound age threshold>= 30 days for wounds considered to have high probability of failure to heal due to compounding factors

Clinical useQualifies wound for consideration of a therapeutic NPWT trial when combined with patient/wound risk factors

DocumentationRecord wound onset/date to support age threshold at time of authorization/review

Prior Authorization

Pediatric use — authorization alert

Prior authorization should note that pediatric use is unsupported by FDA clearance; if NPWT is requested for neonates, infants, or children, the member’s age must be documented in the authorization request.

No NPWT device has been FDA cleared for use in neonates, infants, or children.
Document patient age when requesting authorization for patients younger than FDA-cleared populations.

Note

Verify member benefits

Verify member benefits and plan-specific prior authorization requirements before requesting NPWT; coverage is subject to the limits and conditions of the member benefit plan.

Consult the member benefit booklet or customer service to determine applicability and any prior authorization requirements.
This policy does not apply to Medicare Advantage.

Step Therapy

Therapeutic trial requirement

An initial therapeutic trial of at least 2 weeks (minimum 14 days) is required before continuation; the trial and any continuation period must document objective improvement such as granulation tissue and wound contracture.

Initial therapeutic trial: not less than 2 weeks using a powered NPWT system.
Continuation requires documented objective improvements (healthy granulation tissue, progressive wound contracture, commencement of epithelial spread).

Note

Position in treatment sequence

Use of NPWT is positioned as a therapeutic trial or second-line option after failure of first-line/conservative measures for chronic pressure ulcers and select traumatic or surgical wounds with exposed bone/cartilage/tendon/foreign material.

Consider NPWT after failure of intensive conventional therapy (eg, chronic stage III/IV pressure ulcers >90 days).
Consider NPWT for traumatic/surgical wounds that failed primary closure with exposed bone/cartilage/tendon/foreign material.

Step Therapy

Step therapy

No formal step therapy requirements are specified in the policy sections; the policy requires a therapeutic trial and documented improvement but does not mandate prior step-wise therapies beyond conventional care described in criteria.

Policy does not specify an enforced step-therapy program.
Clinical criteria require prior conventional therapy durations for certain chronic wounds (see documentation requirements).

Documentation Required

Required documentation

Medical records must document that medical necessity criteria are met for the initial 2-week trial and for continuation, including office visit notes with history/physical and provider rationale for NPWT initiation.

Include office visit notes with relevant history and physical.
For the initial 2-week trial: document reason NPWT is required (eg, stage III/IV pressure ulcer >90 days failed optimal care, high-volume drainage, nonhealing ≥30 days with adverse conditions, or traumatic/surgical wound with exposed structures).
For continuation: document objective improvements (healthy granulation tissue, progressive wound contracture/decreasing depth, commencement of epithelial spread).

Documentation Required

Required clinical documentation

For chronic wounds, document prior conventional wound therapy of at least 90 days and evidence that the wound has failed to heal; include start and end dates of the NPWT therapeutic trial and objective healing measures.

Prior conventional therapy duration: ≥90 days for chronic wounds before considering NPWT trial.
Record start and end dates of the therapeutic NPWT trial and objective measures such as granulation tissue formation and wound contracture.

Documentation Required

Device regulatory and setting documentation

Document the device type, its FDA clearance status, and whether the device and its features (for example instillation) are indicated for the intended care setting (some instillation systems are not indicated for home use).

List device model and whether it is a powered, portable, or single-use system.
Document FDA clearance and any setting limitations (eg, instillation systems indicated for hospital use only).

Documentation Required

Documentation changes

The policy removed a prior documentation requirement requesting documentation of wound evaluation location; no new mandatory documentation items were added in that specific change.

Deleted documentation item: wound evaluation location.
Continue to supply required clinical documentation detailed elsewhere in the policy.

Denial Risk

Not medically necessary when criteria unmet

Therapeutic trials of powered NPWT systems for wounds that do not meet the stated initiation or continuation criteria are considered not medically necessary and may be denied.

Requests for NPWT not meeting the policy criteria (including trial duration and objective improvement) are at high risk for denial.
Single-use NPWT systems (97607, 97608) are considered investigational for acute or chronic wounds.

Denial Risk

Denial triggers for continuation

Continuation requests may be denied when the initial trial did not result in documented objective improvement, if complications contraindicate continued NPWT, or if the wound has sufficiently healed to allow grafting or anticipated complete healing.

Denial triggers include absence of documented objective improvement after the trial.
Denial may follow new wound complications (eg, infection, bleeding) or when healing has progressed to graftable status or anticipated complete healing.

Documentation Required

Evidence required for continued coverage

Continued coverage beyond a 14-day therapeutic trial requires objective evidence of wound healing, such as development of healthy granulation tissue and progressive wound contracture with decreasing depth.

Objective healing evidence required: healthy granulation tissue, progressive wound contracture (decreasing depth), commencement of epithelial spread.
Lack of these findings may lead to denial of continued NPWT coverage.

Denial Risk

NPWT for Diabetic Foot Infections — guideline caution

IWGDF/IDSA 2023 guidelines suggest not using NPWT for diabetic-related foot infections (conditional, low-quality evidence); when NPWT is requested for DFIs, provide strong clinical justification and additional supporting evidence.

Guideline statement: IWGDF/IDSA 2023 suggests not using NPWT for DFIs (conditional, low-quality).
Requests for NPWT for DFIs should include rationale addressing guideline caution and supporting clinical evidence.

Billing Rule

Benefit verification required

Before requesting authorization, verify member benefits and whether the member’s plan imposes any limits or prior authorization requirements; coverage determination is subject to the member benefit plan.

Consult the member benefit booklet or contact customer service to determine applicability and any plan limits.
Prior authorization may be required per benefit; confirm plan-specific prior authorization processes.

RelevancePresence of high-volume drainage is an initiation indication for powered NPWT when it interferes with healing or dressings cannot be maintained

ActionDocument drainage volume as part of justification for NPWT trial

inv-44: Morbid obesity (policy definition) — BMI >=40 kg/m²

Policy definitionMorbid obesity defined as BMI ≥40 kg/m²

Clinical roleListed among conditions known to negatively impact wound healing and justify NPWT consideration for nonhealing wounds

DocumentationRecord BMI when cited as contributing factor to impaired healing

inv-45: Contraindications — list of contraindications per FDA (short items)

Necrotic tissue with escharContraindication per FDA

Untreated osteomyelitisContraindication per FDA

Nonenteric or unexplored fistulaeContraindication per FDA

Malignancy in the woundContraindication per FDA

Exposed nerve, anastomotic site, or organContraindication per FDA

inv-46: Nonpowered (mechanical) NPWT system — device definition (disposable systems)

DefinitionPortable, fully disposable NPWT system consisting of a cartridge, dressing, and strap where the cartridge provides negative pressure (mechanical/nonpowered)

ExampleSmart Negative Pressure Wound Care System described as a lightweight, fully disposable device

CharacteristicCartridge acts as negative pressure source and can generate levels similar to other NPWT systems

inv-47: Negative pressure wound therapy (NPWT) — definition of NPWT

DefinitionUse of negative pressure or suction devices to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote granulation tissue formation and wound healing

Clinical roleAdjunct to surgical therapy or alternative to surgery in debilitated patients; part of comprehensive wound care

MechanismMay remove excess interstitial fluid, increase vascularity, reduce edema, and create mechanical forces that support cell growth

inv-48: Neonates, infants, children (FDA definitions) — age band definitions

NeonatesBirth to 28 days

Infants29 days to less than 2 years

Children2 years to less than 12 years

inv-49: FDA-approved population — adolescents and adults >=12 years

FDA-approved population per policyAdolescents and adults aged 12 years and older

Policy notePolicy states NPWT systems are FDA approved for use in this age group

Implication for authorizationDevice requests for this age group align with FDA-cleared population described in policy

inv-50: Investigational population — individuals aged 11 years and younger

Investigational populationIndividuals aged 11 years and younger are considered investigational for NPWT per policy

Policy changePolicy added investigational statement for individuals aged 11 years and younger

Authorization considerationPrior authorization should note pediatric use is unsupported by FDA clearance for these ages