Medical policy: Negative Pressure Wound Therapy in the Outpatient Setting

Policy number: MP 4.004

Effective date: 6/1/2026

Policy

Initiation of a Powered Negative Pressure Wound Therapy

An initial therapeutic trial of not less than 2 weeks using a powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors (e.g., diabetes, nutrition, relief of pressure) may be considered medically necessary in the following indications:

• Chronic (> 90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors; OR
• Wounds in individuals with underlying clinical conditions that are known to negatively impact wound healing, which are nonhealing (at least 30 days), despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity) Malnutrition, while a risk factor, must be addressed simultaneously with the NPWT. OR
• Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure, AND there is exposed bone, cartilage, tendon, or foreign material within the wound.

Continuation of Powered Negative Pressure Wound Therapy

Continuation of the powered NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial 2-week therapeutic trial if the treatment trial has resulted in documented objective improvements in the wound, and if there is ongoing objective improvement during subsequent treatment. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.

Continuation of the powered NPWT system is considered investigational when any of the following occurs:

• The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound, OR
• The wound has developed evidence of wound complications contraindicating continued NPWT, OR
• The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.

Therapeutic trials of powered NPWT systems for the treatment of other acute or chronic wounds except as noted above are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Use of single-use NPWT systems (powered or nonpowered) is considered investigational for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds.

Policy guidelines

Contraindications to the use of negative pressure wound therapy (NPWT) systems include the following conditions as noted in a 2009 U.S. Food and Drug Administration (FDA) alert: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulae, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ.

In a 2011 update, the FDA noted additional deaths and injury reports with NPWT since 2009. Although rare, these complications can occur wherever NPWT systems are used, including hospitals, long-term care facilities, and at home. Bleeding was the cause of the most serious adverse events, including deaths. Most reports of wound infection were related to the retention of dressing pieces in the wounds. Recommendations for health care providers include the following: select individuals for NPWT carefully knowing that NPWT systems are contraindicated for certain wound types, and individual risk factors must be thoroughly considered before use; assure that the individual is monitored frequently in an appropriate care setting by a trained practitioner; be aware of complications associated with dressing changes such as infection and bleeding; be vigilant for potentially life-threatening complications, such as bleeding; and be prepared to take prompt action if they occur. The FDA reported that the safety and effectiveness of NPWT systems in newborns, infants, and children had not been established and, currently, there are no NPWT systems cleared for use in these populations.

Continuation of healing during use of the NPWT system should be monitored on a frequency of not less than every 14 days.

Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.

Powered NPWT systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing such as diabetes control, nutritional status, and relief of pressure.

The focus of these policy statements and guidelines is for the use of NPWT in the outpatient setting.

Cross-references:

• MP 1.158 Bio Engineered Skin, Soft Tissue Substitutes and Amniotic Membranes
• MP 2.033 Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non-Orthopedic Conditions
• MP 2.070 Hyperbaric Oxygen Therapy
• MP 4.028 Wound and Burn Management and Specialized Treatment Centers
• MP 6.026 Durable Medical Equipment (DME) and Supplies

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual. The FEP Medical Policy Manual can be found at: FEP Medical Policy Manual.

Description/background

Chronic Wounds

Management

The management and treatment of chronic wounds, including decubitus ulcers, is challenging. Furthermore, certain racial and ethnic groups, including African Americans, Hispanics, and Native Americans, experience higher diabetes prevalence, contributing to disparities in the risk for diabetic ulcers; these disparities are exacerbated when inequalities in access to health care result in delayed diagnosis and management.

Most chronic wounds will heal only if the underlying cause, i.e., venous stasis, pressure, infection, etc., is addressed. In addition, cleaning the wound to remove nonviable tissue, microorganisms, and foreign bodies is essential to create the optimal conditions for either re-epithelialization (i.e., healing by secondary intention) or preparation for wound closure with skin grafts or flaps (i.e., healing by primary intention). Therefore, debridement, irrigation, whirlpool treatments, and wet-to-dry dressings are common components of chronic wound care.

Negative pressure wound therapy (NPWT) consists of the use of a negative pressure therapy or suction device to aspirate and remove fluids, debris, and infectious materials from the wound bed to promote the formation of granulation tissue. The devices may be used as an adjunct to surgical therapy or as an alternative to surgery in a debilitated patient. Although the exact mechanism has not been elucidated, it is hypothesized that negative pressure contributes to wound healing by removing excess interstitial fluid, increasing the vascularity of the wound, reducing edema, and/or creating beneficial mechanical forces that lead to cell growth and expansion.

A non-powered (mechanical) NPWT system has also been developed; the Smart Negative Pressure (SNaP®) Wound Care System is portable and lightweight (3 oz.) and can be worn underneath clothing. This system consists of a cartridge, dressing, and strap; the cartridge acts as the negative pressure source. The system is reported to generate negative pressure levels similar to other NPWT systems. The system is fully disposable.

The focus of this evidence review is the use of NPWT in the outpatient setting. It is recognized that patients may begin using the device in the inpatient setting as they transition to the outpatient setting.

Regulatory status

Negative pressure therapy or suction devices cleared by the U.S. Food and Drug Administration (FDA) for treating chronic wounds include, but are not limited to: Vacuum-Assisted Closure® Therapy (V.A.C., also known as negative pressure wound therapy; 3M™/KCI); Versatile 1™ (V1) Wound Vacuum System (Blue Sky Medical), RENASYS™ EZ PLUS (Smith & Nephew), Foryou NPWT NP32 Device (Foryou Medical Electronics), SVED® (Cardinal Health), and PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew).

Portable systems include the RENASYS™ GO (Smith & Nephew), XLR8 PLUS (Genadyne Biotechnologies), extiCARE® 2400 NPWT System (Devon Medical), the V.A.C. Via™ (KCI), NPWT PRO to GO (Cardinal Health), and the PICO Single Use Negative Pressure Wound Therapy System (Smith & Nephew). The Prevena™ Incision Management System (KCI) is designed specifically for closed surgical incisions.

A nonpowered NPWT device, the SNaP® Wound Care System (now SNAP™ Therapy System) (3M™ previously Spiracur acquired by Acelity in 2015), is a Class II device requiring notification to market but not having the FDA premarket approval. In 2009, it was cleared for marketing by the FDA through the 510(k) pathway (K081406) and is designed to remove small amounts of exudate from chronic, traumatic, dehisced, acute, or subacute wounds and diabetic and pressure ulcers.

Negative pressure wound therapy devices with installation include the V.A.C. VERAFLO™ Therapy device (3M™/KCI/Acelity). It was cleared for marketing in 2011 by the FDA through the 510(k) pathway (K103156) and is designed to allow for controlled delivery and drainage of topical antiseptic and antimicrobial wound treatment solutions and suspensions. It is to be used with the V.A.C. Ulta unit, which is commercially marketed for use in the hospital setting. Installation is also available with Simultaneous Irrigation™ Technology tubing sets (Cardinal Health) for use with Cardinal Health SVED® and PRO NPWT devices, however, its use is not indicated for use in a home care setting (K161418).

No NPWT device has been cleared for use in infants and children.

In November 2009, the FDA issued an alert concerning complications and deaths associated with NPWT systems. An updated alert was issued in February 2011.

FDA product code: OMP.

Rationale

Summary of evidence

For individuals who have diabetic lower-extremity ulcers or amputation wounds who receive outpatient negative pressure wound therapy (NPWT), the evidence includes systematic reviews of randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, morbid events, quality of life (QOL), and treatment-related morbidity. There was a higher rate of wound healing and fewer amputations with NPWT, although the studies were at risk of bias due to lack of blinding. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have diabetic lower-extremity ulcers or amputation wounds who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A 2019 RCT compared the PICO device with standard NPWT. In this study, the PICO device demonstrated noninferiority for wound area reduction. A statistically significant benefit in complete wound closure was noted for patients with diabetic foot ulcers but was not duplicated in the per protocol population due to a high number of exclusions. One study of the SNaP System showed noninferiority to a V.A.C. device for wound size reduction. No significant difference in complete wound closure was reported. Interpretation of this study is limited by a high loss to follow-up. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic pressure ulcers who receive outpatient NPWT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. All trials are of low quality and at high risk of bias. Also, most study populations were treated in inpatient settings. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive outpatient NPWT, the evidence includes an RCT and a systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A single RCT in patients with nonhealing leg ulcers who were treated with skin grafts found a faster rate of healing with NPWT when used in the inpatient setting. No studies were identified on the effectiveness of NPWT as a primary treatment for leg ulcers or for the use of NPWT in the outpatient setting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lower-extremity ulcers due to venous insufficiency who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. A 2019 RCT compared the PICO device with standard NPWT. In this study, the PICO device demonstrated noninferiority for wound area reduction. No significant benefit in complete wound closure was found in this study of venous ulcers. One study of the SNaP System showed noninferiority to a V.A.C. device for wound size reduction. A subgroup analysis of this study found a significant difference in complete wound closure for patients with venous ulcers. However, interpretation of this study is limited by a high loss to follow-up and lack of a control group treated with standard dressings. Well-designed comparative studies with larger numbers of patients powered to detect differences in complete wound closure are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have burn wounds who receive outpatient NPWT, the evidence includes RCTs, systematic reviews, and case series. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. An interim report of an RCT evaluating NPWT in partial-thickness burns, summarized in a Cochrane review, did not permit conclusions on the efficacy of NPWT for this indication. A separate RCT comparing NPWT with split-skin grafts in patients with full-thickness burns did not show differences in graft take and wound epithelialization. A retrospective case series reported good functional outcomes for most patients who were treated with NPWT at a single center. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have traumatic or surgical wounds who receive NPWT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. Systematic reviews of RCTs in patients with surgical wounds have generally found lower risk of SSI; however, many studies are limited to short-term use of NPWT limiting applicability to the outpatient setting. For patients with traumatic wounds, a Cochrane review failed to find significant improvement in patients treated with NPWT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have traumatic or surgical wounds who receive portable, single-use outpatient NPWT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, morbid events, QOL, and treatment-related morbidity. The PICO device was studied in an adequately powered but unblinded RCT of combined in- and outpatient use after total joint arthroplasty and 2 single-center RCTs of combined in- and outpatient use after cesarean delivery in women with obesity or other risk factors for poor wound healing. The evidence base for the Prevena System in the outpatient setting is not sufficiently robust for conclusions on efficacy to be drawn. Well-designed comparative studies with larger numbers of patients treated in an outpatient setting are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional information

Overall, the evidence from comparative clinical trials has demonstrated there is a subset of problematic wounds for which the use of NPWT may provide a significant clinical benefit. However, due to clinical variability and limited data, it is not possible to determine prospectively which wounds are most likely to respond favorably to NPWT. In addition, clinical input supports a therapeutic trial of NPWT for chronic pressure ulcers that have failed to heal, for traumatic or surgical wounds that have failed to close when there is exposed bone, cartilage, tendon, or foreign material within the wound, and for nonhealing wounds in patients with underlying clinical conditions known to negatively impact wound healing. Therefore, a therapeutic trial of NPWT of not less than 14 days may be considered medically necessary for chronic wounds that have failed to heal, despite intense conventional wound therapy for at least 30 days, or for wounds of at least 30 days that have a high probability of failure to heal due to compounding factors involving the wound and the patient. For continued use of NPWT beyond 14 days to meet criteria for medical necessity, there must be objective evidence of wound healing, such as the development of healthy granulation tissue and progressive wound contracture.

Definitions

Comprehensive wound care program includes a minimum of all the following general measures:

• Documentation in the patient’s medical record of evaluation, care, and wound measurements by a licensed medical professional; and
• Application of dressings to maintain a moist wound environment; and
• Debridement of necrotic tissue when present; and
• Evaluation of and provision for adequate nutritional and vascular status

Granulating tissue refers to formation of granule-like projections on the internal surface of the wound that represents the outgrowth of new capillaries, bringing a rich blood supply to the wound, promoting healing.

Pressure (Decubitus) Ulcer is a type of wound that forms as a result of prolonged pressure against areas of the skin. This is commonly seen over the bony prominences, such as sacrum and heels, in bedridden and/or wheelchair confined individuals. Pressure ulcers are classified into four stages (and an unstageable category), to signify the degree of skin damage:

• Stage I- Intact skin with non-blanchable redness of a localized area usually over a bony prominence. Darkly pigmented skin may not have visible blanching; its color may differ from the surrounding area.
• Stage II- Partial thickness loss of dermis presenting as a shallow open ulcer with a red, pink wound bed, without slough. May also present as an intact or open/ruptured serum-filled blister.
• Stage III- Full thickness tissue loss. Subcutaneous fat may be visible, but bone, tendon, or muscle is not exposed. Slough may be present but does not obscure the depth of tissue loss. May include undermining and tunneling.
• Stage IV- Full thickness tissue loss with exposed bone, tendon, or muscle. Slough or eschar may be present on some parts of the wound bed. Often include undermining and tunneling.
• Unstageable- Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green, or brown) and/or eschar (tan, brown or black) in the wound bed. (Until enough slough and/or eschar is removed to expose the base of the wound, the true depth, and therefore stage, cannot be determined.)

Vascularity is the state of blood vessel development and functioning in an organ or tissue.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered:

Covered when medically necessary:

References

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