ModifiedCignaPolicy 0064

Negative pressure wound therapy (NPWT)/vacuum-assisted closure (VAC) — Coverage Criteria

This policy governs coverage and medical necessity criteria for powered and disposable negative pressure wound therapy devices and accessories for nonhealing wounds under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyNegative pressure wound therapy (NPWT)/vacuum-assisted closure (VAC) — Coverage Criteria

Policy CodePolicy 0064

Change TypeRevised and removed powered NPWT statements (annual review)

Effective DateMay 15, 2025

Next Review DateMay 15, 2026

Key ActionVerify current prior authorization requirements with Cigna because policy language for powered NPWT changed in the 5/15/2025 revision.

SourceLink

POLICY UPDATE CHANGES

Revised policy statements for powered negative pressure wound therapy (NPWT)/vacuum-assisted closure (VAC) for nonhealing wounds.

Removed policy statements for powered NPWT.

Annual review dated 5/15/2024 noted no changes to coverage.

97605/97606Powered NPWT codes considered medically necessary

97607/97608Disposable NPWT not covered

5–125 mmHgTypical pressure range

5/15/2025Most recent review

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AnnualReview frequency

Coverage and Medical Necessity Criteria

inv-01: Powered NPWT — Medical Necessity — covered when ALL criteria met

Covered when ALL of the following are met

Powered NPWT coverage: Powered NPWT/VAC (CPT 97605, 97606; HCPCS A6550, E2402) for nonhealing wounds is considered medically necessary when the member's benefit plan provides coverage for NPWT and clinical indications are met.

Coverage varies by plan; verify benefits.

inv-02: Disposable and Single-use NPWT — Not Covered — applies to any indication

Not covered (applies to any indication)

Disposable/non-powered and single-use battery-powered NPWT: Disposable non-powered mechanical NPWT (e.g., SNaP) and disposable single-use battery-powered NPWT (e.g., PICO, Prevena, V.A.C. Via, MyNeWT, Uno) (CPT 97607, 97608; HCPCS A9272) are not covered or reimbursable for any indication.

Applies regardless of clinical setting.

inv-03: Coverage considerations and evidence summary — summary of evidence and FDA guidance affecting coverage

Coverage considerations summarized from evidence and FDA guidance

General coverage context: NPWT may be considered for patients who have failed a comprehensive conventional wound therapy program or when accelerated granulation is needed and not achievable with topical methods; NPWT can be an alternative to invasive surgery in selected cases (e.g., poststernotomy mediastinitis).

Based on literature review and FDA guidance

Device-type indications: FDA-cleared indications exist for powered systems and several single-use devices for chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (diabetic, pressure), flaps and grafts, and some systems for closed surgical incisions/incision management (e.g., Prevena, PICO).

Refer to specific 510(k) labeling per device

Patient selection contra-indications and risks: Do not use NPWT for wounds with necrotic tissue with eschar, untreated osteomyelitis, unexplored fistula, malignancy in wound, or exposed vasculature/nerves/organs; consider bleeding risk, anticoagulation, friable vessels, vascular anastomosis, infected blood vessels, need for MRI/defibrillation/hyperbaric therapy, spinal cord injury, and circumferential dressings. Frequent monitoring by trained practitioners is required.

inv-04: Durable NPWT (97605/97606 + E2402/A6550) — criteria for covered use with durable pumps and documented wound assessment

Covered when using durable NPWT pumps with documented wound assessment and appropriate clinical indications as supported by the literature

Durable NPWT typical clinical support: Durable NPWT (electrical pumps) is supported for chronic lower extremity wounds and selected surgical/incisional applications; randomized trials comparing durable electrical pumps to mechanically powered or single-use devices demonstrated similar healing outcomes up to 16 weeks. Document wound assessment parameters consistent with trial inclusion (e.g., wound chronicity >30 days, adequate perfusion, absence of active infection).

Codes: CPT 97605/97606 and HCPCS A6550/E2402 represent durable NPWT services and supplies.

inv-05: Policy statement revisions (powered NPWT) — notes on revised/removed policy language

Policy revision notes

policy revision actions: Revised policy statements for powered NPWT and removal of powered NPWT‑specific statements were recorded during the 5/15/2025 annual review.

Providers should verify current prior authorization and coverage requirements following this revision.

Per the FDA safety communication, NPWT is contraindicated for wounds with the following conditions: necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, malignancy in the wound, exposed vasculature, exposed nerves, exposed anastomotic site, and exposed organs. The FDA also advises careful patient selection and frequent monitoring by a trained practitioner because serious complications (especially bleeding and infection) have been reported.

The FDA recommends that NPWT not be used for certain wound types and conditions, specifically: necrotic tissue with eschar present; untreated osteomyelitis; non-enteric and unexplored fistulas; malignancy in the wound; and wounds with exposed vasculature, exposed nerves, exposed anastomotic sites, or exposed organs. These contraindications should be confirmed against the most recent device labeling prior to initiating therapy.

Disposable, non-durable NPWT services are not covered under this policy. Specifically, CPT codes 97607 and 97608 and HCPCS code A9272 describing disposable or non-durable NPWT per-session services are listed as not covered or reimbursable for any indication.

The policy record shows that operational policy language specific to powered NPWT was revised and some powered NPWT statements were removed during the 5/15/2025 annual review. The revision entry notes the deletion of powered NPWT statements but does not itself list additional explicit exclusions in the cited sections; providers should verify current coverage and prior authorization requirements given this change.

Disposable non-powered mechanical NPWT (e.g., SNaP) and disposable single-use battery-powered NPWT devices (examples cited in the policy include PICO, Prevena, V.A.C. Via, MyNeWT, and Uno) are considered not covered. The policy explicitly identifies these single-use or non-powered systems (CPT 97607, 97608; HCPCS A9272) as not covered or reimbursable for any indication.

High-quality comparative evidence for routine incisional NPWT (iNPWT) is limited. Notably, the SUNRISE randomized controlled trial found that routine application of iNPWT to the closed surgical wound after emergency laparotomy did not reduce surgical site infection compared with standard dressings, and systematic reviews have noted insufficient high-quality evidence to support routine use across many wound types.

Claims billed using single-use/disposable NPWT per-session codes (CPT 97607, 97608) or HCPCS A9272 are not covered under this policy and, when submitted for services that the plan does not cover, will be denied as not medically necessary/not reimbursable.

The cited policy excerpts do not include explicit additional 'not medically necessary' condition listings tied to the removal of powered NPWT statements; the 5/15/2025 revision notes removal of powered NPWT language and therefore may imply operational changes. Providers should confirm current coverage determinations and any NMN language with Cigna following this policy revision.

Codes and Device Identifiers

Covered CPT CodesCPTCovered

97605	NPWT; simple, includes dressing (as listed in policy)
97606	NPWT; complex, includes dressing (as listed in policy)

Covered HCPCS CodesHCPCSCovered

A6550	Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories.
E2402	Negative pressure wound therapy electrical pump, stationary or portable

Not Covered / Disposable NPWT CodesmixedNot Covered

97607	Negative pressure wound therapy utilizing disposable, non-durable medical equipment; per session; total wound(s) surface area less than or equal to 50 square centimeters.
97608	Negative pressure wound therapy utilizing disposable, non-durable medical equipment; per session; total wound(s) surface area greater than 50 square centimeters.
A9272	Wound suction, disposable, includes dressing, all accessories and components, any type, each

No explicit codes listed in this excerptmixed

No codes listed

Considered Medically NecessarymixedCovered

97605	Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (DME), per session; total wound(s) surface area less than or equal to 50 square centimeters.
97606	Negative pressure wound therapy (eg, vacuum assisted drainage collection), utilizing durable medical equipment (DME), 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.
E2402	Negative pressure wound therapy electrical pump, stationary or portable

Not covered or reimbursablemixedNot Covered

97607	Negative pressure wound therapy, 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, 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.
A9272	Wound suction, disposable, includes dressing, all accessories and components, any type, each

FDA 510(k) device summaries citedmixed

K100821	FDA 510(k) summary - Prevena™ Incision Management System
K161432	FDA 510(k) - The MyNeWT Negative Pressure Wound Therapy System
K161599	FDA 510(k) - Uno Negative Pressure Wound Therapy System
K081406	FDA 510(k) - The SNaP ® Wound Care Device
K111170	FDA 510(k) - PICO Single Use Negative Pressure Wound Therapy System
K182323	FDA 510(k) - PICO 7Y Single Use Negative Pressure Wound Therapy System
K093526	FDA 510(k) - V.A.C. Via ™ Negative Pressure Wound Therapy System
K021500	FDA 510(k) - V.A.C. ®
K032310	FDA 510(k) - V.A.C. ®, mini V.A.C. ®, V.A.C. Freedom ™
K042134	FDA 510(k) - Versatile 1 Wound Vacuum System

1–10 of 12

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inv-21: NPWT pressure range — key value for typical pressure settings

Typical therapeutic range5–125 mmHg (adjustable to higher pressures depending on device)

Application modesContinuous or intermittent negative pressure depending on wound type

Dressing change intervalManufacturers recommend changing dressing at 48 hours, then 2–3 times per week as indicated

inv-22: PICO pump battery life — key value for device runtime (up to 168 hours)

Runtime (PICO)Up to 168 hours (7 days) of battery life; pump is designed to stop after 168 hours and will not restart

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization and coverage verification

Prior authorization and coverage verification: Confirm that the member's plan covers NPWT/DME before initiating therapy and obtain standard prior authorization when required. Where coverage is plan-dependent, refer to the customer’s benefit plan document; services billed with codes that are not covered under this policy may be denied.

Verify member eligibility and benefits for NPWT/DME prior to service.
Obtain prior authorization per payer requirements when plan covers NPWT.
Claims submitted without covered diagnosis/procedure codes applicable to the plan will be denied.

Prior Authorization

Device and indication–aligned prior authorization

Device and indication–aligned prior authorization: Prior authorization requests must specify the device type (durable electrical pump vs disposable mechanical or single-use battery-powered) and the clinical indication aligned with FDA-cleared intended uses. Coverage determination will be made based on device class, intended use, and applicable coverage criteria.

Clinical Background and Evidence Context

Chronic wounds (ulcers) are wounds that have not completed expected healing, typically beyond approximately 30 days, and often require interventions beyond conventional topical care. Negative pressure wound therapy applies localized vacuum to promote granulation tissue formation and re-epithelialization and is used in hospitals, clinics, long-term care and home settings. NPWT systems operate across typical pressure settings described in device labeling (commonly in the range of 5–125 mmHg), and clinical evidence for NPWT varies by wound type and device.

inv-41: Powered NPWT/VAC — short definition as key value

Short definitionPowered NPWT/VAC: a therapy applying localized vacuum via a dressing connected to a vacuum pump to promote wound healing by removing exudate and drawing wound edges together

SettingsUsed in hospitals, clinics, long-term care and home care; provides continuous or intermittent negative pressure

Pressure rangeTypically adjustable between 5–125 mmHg

inv-22: Disposable NPWT — definition examples (SNaP, PICO, Prevena, V.A.C. Via) as key value

Policy Revisions and Update Log

2025-05-15annual_reviewLatest

Revised policy statements for powered negative pressure wound therapy (NPWT)/vacuum-assisted closure (VAC) for nonhealing wounds and removed powered NPWT policy statements.

2024-05-15annual_review

Annual review noted no changes to coverage.

Policy Summary

PayerCigna

PolicyNegative pressure wound therapy (NPWT)/vacuum-assisted closure (VAC) — Coverage Criteria

Policy CodePolicy 0064

Change TypeRevised and removed powered NPWT statements (annual review)

Effective DateMay 15, 2025

Next Review DateMay 15, 2026

Key ActionVerify current prior authorization requirements with Cigna because policy language for powered NPWT changed in the 5/15/2025 revision.

SourceLink

On This Page

Per FDA safety communication and device labeling

Evidence-based limitations: High-quality comparative evidence is limited and benefits vary by wound type; some systematic reviews find insufficient evidence for routine use or for instillation NPWT; evidence supports use in specific subgroups and as alternative to surgery in some cases, but routine prophylactic use (e.g., iNPWT after emergency laparotomy) was not beneficial in a large RCT (SUNRISE).

Summarizes multiple reviews and trials

Single-use NPWT evidence: Randomized and comparative trials of single-use NPWT show mixed results: some RCTs and comparative studies report noninferiority or benefit in wound area reduction and closure rates (e.g., s-NPWT vs t-NPWT, SNaP vs VAC), but many studies are small or lack comparators; SUNRISE RCT found no SSI reduction with iNPWT after emergency laparotomy.

Device- and study-specific outcomes vary

Battery typeSupplied with two AA lithium batteries (PICO) — batteries can be replaced if required

Use settingsDesigned for hospital and homecare settings; performance depends on leak rate

inv-23: MyNeWT exudate threshold — key value for indicated removal capacity

Indicated exudate removal capacityRemoves low to moderate levels of exudate: <37.5 ml/day (MyNeWT clearance)

Substantial equivalenceMyNeWT was cleared as substantially equivalent to the PICO system

Typical indicationIntended to remove exudate and infectious materials to promote wound healing

For powered/durable NPWT, document FDA-cleared indications (e.g., chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts).

For disposable/non-powered or single-use battery-powered systems, include device identification and intended use; note that many disposable systems have separate 510(k) clearances but policy lists them as not covered for reimbursement in some plans.

Align prior auth request to device 510(k) summary when available.

Prior Authorization

Prior authorization for durable NPWT

Prior authorization for durable NPWT: Durable electrical-pump NPWT services (CPT 97605, 97606; HCPCS A6550, E2402) are considered medically necessary when policy criteria are met and require the standard prior authorization process.

Include wound size (total surface area ≤50 cm2 or >50 cm2 per CPT definitions).
Provide documentation of prior conservative wound care and rationale for NPWT.
List durable device HCPCS (A6550, E2402) on the prior authorization request.

Prior Authorization

Verify prior authorization after policy revision

Verify prior authorization after policy revision: After the 2025-05-15 revision that removed certain powered NPWT policy statements, providers must re-confirm current prior authorization requirements and anticipate possible changes in coverage determination or denial patterns if relying on prior rules.

Check for updated prior authorization rules following the policy revision dated 2025-05-15.
Do not assume past authorizations or historical guidance remain valid; re-submit or amend requests with current device and indication details as needed.

Denial Risk

Coding-related denials and potential denial risk

Coding-related denials and potential denial risk: Use the most appropriate codes and document covered diagnoses/procedures; billing disposable NPWT codes (CPT 97607, 97608; HCPCS A9272) where not covered may result in denial. Providers should anticipate denial risk when policy language changes or prior device-specific statements are removed.

Do not bill CPT 97607/97608 or HCPCS A9272 for plans that list those codes as not covered — such claims may be denied.
Ensure coding matches the device type (durable electrical pump codes vs disposable system codes).
After policy revisions, expect potential denials if prior assumptions about powered NPWT coverage are no longer supported.

Billing Rule

Coding and benefit documentation

Coding and benefit documentation: When submitting claims and authorization requests, use the most specific and appropriate CPT/HCPCS codes and include covered diagnosis codes and supporting clinical documentation consistent with the member’s benefit plan.

Include CPT 97605 or 97606 for durable NPWT and A6550/E2402 for durable device supplies/pumps where applicable.
Do not submit disposable NPWT codes (97607, 97608, A9272) for reimbursement when policy notes they are not covered for the plan.
Attach the member’s plan benefit language or reference when plan-specific coverage differs from the general policy.

Documentation Required

Required documentation elements

Required documentation elements: Prior authorization and claims must include patient selection rationale consistent with FDA labeling and safety guidance — wound type, wound chronicity, prior conservative therapy, comorbidities affecting healing, bleeding risk, and wound measurements (surface area).

Wound description: diagnosis, location, size (surface area), duration (>30 days for chronic wounds when applicable).
Prior treatment history: evidence of comprehensive conventional therapy failure (dressings, debridement, offloading, compression, infection control).
Safety considerations: anticoagulant use, bleeding risk, exposed vasculature/organs, untreated osteomyelitis, fistula status, and reason NPWT is appropriate despite risks.

Documentation Required

Clinical documentation commonly used in studies

Clinical documentation commonly used in studies: Include objective measures and study-aligned criteria where possible (wound chronicity >30 days, perfusion assessments such as transcutaneous oxygen or ankle-brachial index, wound size limits used in trials, and response to prior therapies).

Perfusion data: TcPO2 >30 mmHg, skin perfusion pressure >30 mmHg, or ABI between 0.7–1.2 when applicable.
Trial criteria: wound surface area thresholds and prior therapy duration used in comparative studies (e.g., >30 days of prior care, exclusion/inclusion criteria) to support medical necessity.
Document weekly wound assessments, dressing change frequency, and adverse events monitoring as reflected in clinical trials.

Note

Device identification references

Device identification references: When available, include FDA 510(k) summaries or device model information to identify the specific NPWT system used; these references help align device type with coverage and prior authorization requirements.

Provide 510(k) number or manufacturer/model (e.g., V.A.C. Therapy K021500, PICO K111170, SNaP K081406) when submitting prior authorization or appeals.
Use FDA 510(k) summaries to confirm intended use and labeling that support the requested therapy.
For novel or combination devices (e.g., NPWT with instillation), include clearance references (e.g., VeraFlo K211521) and intended-use statements.

Step Therapy

Therapy sequencing and step therapy context

Therapy sequencing and step therapy context: NPWT is generally intended for chronic wounds that have failed comprehensive conventional therapy, although it may serve as a primary or secondary option depending on wound type; consider NPWT as an alternative to surgery for selected patients.

Document failure of a comprehensive conventional wound care regimen before authorizing NPWT for chronic nonhealing wounds, unless clinical circumstances justify earlier use.
Consider NPWT as an alternative to surgical closure or as a bridge to surgery when supported by clinical evidence.
Step therapy: Providers should consider NPWT after reasonable conservative measures have not achieved expected wound improvement; no formal step-therapy program is specified in these sections, but clinical sequencing should be documented.

Definition and examplesDisposable NPWT: smaller disposable non-powered mechanical or single-use battery-powered systems (examples: SNaP, PICO, Prevena, V.A.C. Via)

Typical use casesProposed for smaller wounds or closed incisions after surgery in hospital, outpatient, or home settings

Device characteristicsOften single-patient use; some are pre-set for continuous therapy and include integrated dressing and canister (device-dependent)

inv-23: Powered NPWT — definition: system with electrically powered suction pump and dressing system

Core definitionPowered NPWT: a therapy system with an electrically powered suction pump and sterile dressing system intended to promote wound healing by continuous or intermittent negative pressure

IndicationsFDA-indicated for chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers, flaps and grafts (device labeling varies)

Regulatory statusNumerous powered NPWT systems have FDA 510(k) Class II clearance (e.g., V.A.C. Therapy)

inv-24: Disposable/single-use NPWT — definition for non-powered mechanical or single-use battery-powered devices

DefinitionDisposable/single-use NPWT: non-powered mechanical or single-use battery-powered negative pressure devices intended for wound management by applying negative pressure to remove fluids and infectious materials

ExamplesSNaP (mechanical spring), PICO (battery-powered single-use), Prevena (battery-powered disposable incision system), V.A.C. Via

Typical featuresCan be canisterless or ultraportable; often pre-set run times (device-dependent) and intended for single-patient use

inv-25: Contraindicated wound conditions (per FDA) — list of contraindications (eschar, osteomyelitis, unexplored fistulas, malignancy, exposed vasculature)

FDA-listed contraindicationsNecrotic tissue with eschar present; untreated osteomyelitis; non-enteric and unexplored fistulas; malignancy in the wound; exposed vasculature

Additional exposed structuresExposed nerves, exposed anastomotic sites, or exposed organs are contraindications

Safety recommendationFDA recommends careful patient selection and frequent monitoring by a trained practitioner to reduce serious complications (bleeding, infection)

inv-26: Single-use / disposable NPWT — definition and examples

Definition and useSingle-use / disposable NPWT: a non-durable, typically canisterless or ultraportable negative pressure dressing/system intended for single-patient use

Examples citedExamples include SNaP, PICO, Prevena and other single-use systems with FDA 510(k) clearance

Evidence noteRandomized and observational studies of single-use NPWT show mixed results; some device-specific trials and meta-analyses report benefit for select closed incisions

inv-27: Durable NPWT (electrical pump) — definition and CPT/HCPCS mapping

DefinitionDurable NPWT (electrical pump): a reusable negative pressure wound therapy system that uses an electrical pump and durable equipment

Typical coding mappingAssociated CPT codes: 97605 (≤50 cm2) and 97606 (>50 cm2); HCPCS: E2402 (electrical pump) and A6550 (wound care set/supplies)

Service componentsIncludes topical application(s), wound assessment, instruction for ongoing care, and use of durable equipment per session

inv-28: NPWT devices (examples) — device examples with FDA 510(k) summaries cited

Representative device examplesPrevena™ Incision Management System (K100821), MyNeWT (K161432), Uno (K161599), SNaP (K081406), PICO (K111170 / K182323), V.A.C. Via (K093526), V.A.C. (K021500 / K032310)

Regulatory referencesFDA 510(k) summaries are cited for each device and can inform device-specific indications and labeling

Clinical relevanceDevice-specific 510(k) clearances indicate intended uses (e.g., closed incision management, chronic wounds) which should guide selection and prior authorization